Per Olav Vandvik

• Nagraj, Sumanth Kumbargere; Hafver, Tandekile Lubelwana; Reinthaler, Valerie; Velde, Stijn Van de; Zaror, Carlos & Shen, Yan Jiao [Show all 16 contributors for this article] (2026). Understanding what works in disseminating clinical practice guidelines: A qualitative evidence synthesis. Journal of Clinical Epidemiology. ISSN 0895-4356. 196. doi: 10.1016/j.jclinepi.2026.112313. Full text in Research Archive
• Eachempati, Prashanti; Guyatt, Gordon; Vandvik, Per Olav; Guerin, Philippe J.; Dahal, Prabin & Barnes, Karen I. [Show all 7 contributors for this article] (2026). SPICE-GRADE: simultaneous processing of indirect causal evidence in complex pathways using GRADE — an exploratory case study. Journal of Clinical Epidemiology. ISSN 0895-4356. 194. doi: 10.1016/j.jclinepi.2026.112219. Full text in Research Archive
• Foroutan, Farid; Weiss, Jessica; Mayer, Martin; Bache-Mathiesen, Lena Kristin; Agoritsas, Thomas & Vandvik, Per Olav [Show all 11 contributors for this article] (2026). Discriminating clinical prediction models: how outcome incidence and decision thresholds shape clinical utility and apt AUROC values. Journal of Clinical Epidemiology. ISSN 0895-4356. 195. doi: 10.1016/j.jclinepi.2026.112293. Full text in Research Archive
• Vandvik, Per Olav; Agarwal, Arnav; Rylance, Jamie; Agoritsas, Thomas; Guyatt, Gordon & Leo, Yee Sin [Show all 8 contributors for this article] (2026). Summary of WHO clinical practice guidelines for influenza. The BMJ. 392, p. e087397–e087397. doi: 10.1136/bmj-2025-087397. Full text in Research Archive
• Zeng, Linan; Li, Ranyi; Li, Shelly Anne; Clarissa, Sherinne; Agoritsas, Thomas & Chen, Jingjing [Show all 12 contributors for this article] (2026). Development of an educational video to support guideline panels in incorporating patient values and preferences into recommendation-making: qualitative one-on-one interviews and brainstorming meetings. BMJ Open. 16(2). doi: 10.1136/bmjopen-2025-101468. Full text in Research Archive
• Guyatt, Gordon; Iorio, Alfonso; Beer, Hans De; Owen, Andrew; Agoritsas, Thomas & Murad, M. Hassan [Show all 26 contributors for this article] (2025). Core GRADE 5: rating certainty of evidence—assessing indirectness. The BMJ. 389. doi: 10.1136/bmj-2024-083865. Full text in Research Archive
• Rayner, Daniel G.; Shah, Darsh; Dai, Si Cheng; Gou, David; Chen, Jason Z.X. & Agarwal, Arnav [Show all 11 contributors for this article] (2025). Prognostic models for cardiovascular and kidney outcomes in people with type 2 diabetes: living systematic review and meta-analysis of observational studies. BMJ Medicine. 4(1). doi: 10.1136/bmjmed-2025-001369. Full text in Research Archive
• Guyatt, Gordon; Agoritsas, Thomas; Brignardello-Petersen, Romina; Mustafa, Reem A.; Rylance, Jamie & Foroutan, Farid [Show all 24 contributors for this article] (2025). Core GRADE 1: Overview of the Core GRADE approach. The BMJ. 389. doi: 10.1136/bmj-2024-081903. Full text in Research Archive
• Guyatt, Gordon; Vandvik, Per Olav; Iorio, Alfonso; Agarwal, Arnav; Yao, Liang & Eachempati, Prashanti [Show all 17 contributors for this article] (2025). Core GRADE 7: Principles for moving from evidence to recommendations and decisions. The BMJ. 389. doi: 10.1136/bmj-2024-083867. Full text in Research Archive
• Nong, Kailei; Jeppesen, Britta Tendal; Shi, Qingyang; Agoritsas, Thomas; Guyatt, Gordon H. & White, Heath [Show all 36 contributors for this article] (2025). Medications for adults with type 2 diabetes: A living systematic review and network meta-analysis. The BMJ. doi: 10.1136/bmj-2024-083039. Full text in Research Archive
• Halvorsen, Natalie Grace Mosteiro; Hassan, Cesare; Correale, Loredana; Pilonis, Nastazja Dagny; Helsingen, Lise Mørkved & Spadaccini, Marco [Show all 14 contributors for this article] (2025). Benefits, burden, and harms of computer aided polyp detection with artificial intelligence in colorectal cancer screening: microsimulation modelling study. BMJ Medicine. 4(1). doi: 10.1136/bmjmed-2025-001446. Full text in Research Archive
• Ibrahim, Sara; Siemieniuk, Reed A.C.; Oliveros, Maria Jose; Islam, Nazmul; Martinez, Juan Pablo Diaz & Izcovich, Ariel [Show all 42 contributors for this article] (2025). Drug treatments for mild or moderate covid-19: Systematic review and network meta-analysis. The BMJ. 389. doi: 10.1136/bmj-2024-081165. Full text in Research Archive
• Chowdhury, Saifur R.; Islam, Nazmul; Zhou, Qi; Hasan, Md Kamrul; Chowdhury, Mahmudur Rahman & Siemieniuk, Reed AC [Show all 12 contributors for this article] (2025). Metformin for covid-19: systematic review and meta-analysis of randomised controlled trials. BMJ Medicine. 4(1). doi: 10.1136/bmjmed-2024-001126. Full text in Research Archive
• Guyatt, Gordon; Wang, Ying; Eachempati, Prashanti; Iorio, Alfonso; Murad, M. Hassan & Hultcrantz, Monica [Show all 14 contributors for this article] (2025). Core GRADE 4: Rating certainty of evidence - Risk of bias, publication bias, and reasons for rating up certainty. The BMJ. doi: 10.1136/bmj-2024-083864. Full text in Research Archive
• Guyatt, Gordon; Zeng, Linan; Brignardello-Petersen, Romina; Prasad, Manya; Beer, Hans De & Murad, M. Hassan [Show all 18 contributors for this article] (2025). Core GRADE 2: Choosing the target of certainty rating and assessing imprecision. The BMJ. 389. doi: 10.1136/bmj-2024-081904. Full text in Research Archive
• Zaror, Carlos; Klenner, Maura; Song, Yang; Agoritsas, Thomas; Balaciano, Giselle & Sanguine, Verónica [Show all 14 contributors for this article] (2025). Adapting World Health Organization COVID-19 living guidelines balancing methodological rigor with efficiency and flexibility: a case study from Argentina. Journal of Clinical Epidemiology. ISSN 0895-4356. 184. doi: 10.1016/j.jclinepi.2025.111823. Full text in Research Archive
• Guyatt, Gordon; Yao, Liang; Murad, M. Hassan; Hultcrantz, Monica; Agoritsas, Thomas & Beer, Hans De [Show all 20 contributors for this article] (2025). Core GRADE 6: Presenting the evidence in summary of findings tables. The BMJ. 389. doi: 10.1136/bmj-2024-083866. Full text in Research Archive
• Yang, Mengting; Luo, Yuan; He, Tong; Diao, Sha; Li, Hailong & Zou, Kun [Show all 15 contributors for this article] (2025). Application of artificial intelligence to measure and predict patient values and preferences: a scoping review. npj Digital Medicine. 8, p. 1–12. doi: 10.1038/s41746-025-02156-2. Full text in Research Archive Show summary

  Patients’ voices are often difficult to capture directly in healthcare decisions. This scoping review examines how artificial intelligence (AI) has been applied to measure and predict patient values and preferences, aiming to evaluate its potential to generate reliable, patient-centered evidence, identify opportunities and challenges, and explore AI tools in literature reviews. Analyzing 67 studies, we summarize how AI processes diverse data sources such as social media, clinical records, and patient surveys to extract population- and individual-based patient values and preferences. Researchers have applied AI for efficient data preprocessing, extraction, analysis, integration, and modeling. Despite promising validation results (e.g., >80% accuracy in data preprocessing), key challenges remain, such as data quality issues, lack of real-world validation, and ethical concerns. This review underscores the potential of AI in patient values and preferences research and calls for greater transparency and real-world implementation to better align healthcare delivery with patient needs.

• Seterelv, Siri Schøyen; Gupta, Samir; Kouri, Andrew; Florez, Ivan D; Agoritsas, Thomas & Vandvik, Per Olav [Show all 7 contributors for this article] (2025). From international guidelines to practice: a multimethod evaluation of BMJ Rapid Recommendations focusing on suitability for adaptation and implementation. BMJ Open. 15(12), p. e114609–e114609. doi: 10.1136/bmjopen-2025-114609. Full text in Research Archive Show summary

  Objectives We aimed to assess usage and explore factors influencing the suitability of British Medical Journal (BMJ) Rapid Recommendations—a set of international guidelines meeting standards of trustworthiness—for adaptation and implementation, further defined as implementability. Design Qualitative descriptive study with a multimethod approach. Participants We used citation screening and a survey to identify groups that had used any of a sample of 14 BMJ Rapid Recommendations in adoption, adaptation, de novo guideline development or implementation. Setting 12 participants from a range of country income levels were interviewed, using semistructured interviews. Methods Interviews were analysed using thematic analysis to identify themes related to implementability of the guidelines. We compared these findings with those from a critical appraisal conducted using three different appraisal tools. Results BMJ Rapid Recommendations are used in high-income, middle-income and low-income countries. We identified 33 instances of use. Our thematic analysis of the interviews uncovered 14 challenges to implementability, categorised under perceived trustworthiness, comprehensibility and practical relevance. The critical appraisals gave the BMJ Rapid Recommendations high scores on validity, but low scores on implementability and measurability. The challenges found in the interviews were generally corroborated by the appraisals, but the comparison also exposed tensions such as the complex interaction between methodological rigour and perceived credibility, the balance between novelty and compatibility with current practice, and the difficulty of offering globally applicable yet locally practical guidance. Conclusion Implementability challenges may limit effective use of international guidelines globally. Recognising and reflecting on tensions between rigour, credibility and contextual feasibility may help improve their uptake and value. The next phase of this research will explore strategies to enhance guideline implementability during their development.

• Guyatt, Gordon; Schandelmaier, Stefan; Brignardello-Petersen, Romina; Beer, Hans De; Prasad, Manya & Murad, M. Hassan [Show all 18 contributors for this article] (2025). Core GRADE 3: Rating certainty of evidence - Assessing inconsistency. The BMJ. 2025. doi: 10.1136/bmj-2024-081905. Full text in Research Archive
• Hirschel, Tiffany; Vandvik, Per Olav & Agoritsas, Thomas (2025). Clinicians' experience with infographic summaries from the BMJ Rapid Recommendations: a qualitative user-testing study among residents and interns at a large teaching hospital in Switzerland. BMJ Open. 15(2). doi: 10.1136/bmjopen-2023-083032. Full text in Research Archive
• Foroutan, Farid; Vandvik, Per Olav; Helsingen, Lise Mørkved; Kalager, Mette; Rutter, Matt & Selby, Kevin [Show all 26 contributors for this article] (2025). Computer aided detection and diagnosis of polyps in adult patients undergoing colonoscopy: a living clinical practice guideline. The BMJ. doi: 10.1136/bmj-2024-082656. Full text in Research Archive
• Barnard-Kelly, Katharine; Battelino, Tadej; Brosius, Frank C.; Ceriello, Antonio; Cosentino, Francesco & Gavin, James R. [Show all 26 contributors for this article] (2025). Defining patient-reported outcomes in diabetes, obesity, cardiovascular disease, and chronic kidney disease for clinical practice guidelines - perspectives of the taskforce of the Guideline Workshop. Cardiovascular Diabetology. 24(1), p. 68–68. doi: 10.1186/s12933-024-02550-2. Full text in Research Archive Show summary

  Recent clinical practice guidelines for diabetes, obesity, cardiovascular disease (CVD) and chronic kidney disease (CKD) emphasise a holistic, person-centred approach to care. However, they do not include recommendations for the assessment of patient-reported outcomes (PROs), which would – dependent on the topic of guideline – be important for improving shared decision-making, patients’ concordance with guideline recommendations, clinical outcomes and health-related quality of life (HRQoL). The Taskforce of the Guideline Workshop discussed PROs in diabetes, obesity, CVD and CKD as well as the relevance of their inclusion in clinical practice guidelines for the management of these conditions.

• Busse, Jason W; Genevay, Stéphane; Agarwal, Arnav; Standaert, Christopher J; Carneiro, Kevin & Friedrich, Jason [Show all 26 contributors for this article] (2025). Commonly used interventional procedures for non-cancer chronic spine pain: a clinical practice guideline. The BMJ. 388. doi: 10.1136/bmj-2024-079970. Full text in Research Archive Show summary

  Clinical question: What is the comparative effectiveness and safety of commonly used interventional procedures (such as spinal injections and ablation procedures) for chronic axial and radicular spine pain that is not associated with cancer or inflammatory arthropathy? Current practice: Chronic spine pain is a common, potentially disabling complaint, for which clinicians often administer interventional procedures. However, clinical practice guidelines provide inconsistent recommendations for their use. Recommendations: For people living with chronic axial spine pain (≥3 months), the guideline panel issued strong recommendations against: joint radiofrequency ablation with or without joint targeted injection of local anaesthetic plus steroid; epidural injection of local anaesthetic, steroids, or their combination; joint-targeted injection of local anaesthetic, steroids, or their combination; and intramuscular injection of local anaesthetic with or without steroids. For people living with chronic radicular spine pain (≥3 months), the guideline panel issued strong recommendations against: dorsal root ganglion radiofrequency with or without epidural injection of local anaesthetic or local anaesthetic plus steroids; and epidural injection of local anaesthetic, steroids, or their combination. How this guideline was created: An international guideline development panel including four people living with chronic spine pain, 10 clinicians with experience managing chronic spine pain, and eight methodologists, produced these recommendations in adherence with standards for trustworthy guidelines using the GRADE approach. The MAGIC Evidence Ecosystem Foundation provided methodological support. The guideline panel applied an individual patient perspective when formulating recommendations. The evidence: These recommendations are informed by a linked systematic review and network meta-analysis of randomised trials and a systematic review of observational studies, summarising the current body of evidence for benefits and harms of common interventional procedures for axial and radicular, chronic, non-cancer spine pain. Specifically, injection of local anaesthetic, steroids, or their combination into the cervical or lumbar facet joint or sacroiliac joint; epidural injections of local anaesthetic, steroids, or their combination; radiofrequency of dorsal root ganglion; radiofrequency denervation of cervical or lumbar facet joints or the sacroiliac joint; and paravertebral intramuscular injections of local anaesthetic, steroids, or their combination. Understanding the recommendations: These recommendations apply to people living with chronic spine pain (≥3 months duration) that is not associated with cancer or inflammatory arthropathy and do not apply to the management of acute spine pain. Further research is warranted and may alter recommendations in the future: in particular, whether there are differences in treatment effects based on subtypes of chronic spine pain, establishing the effectiveness of interventional procedures currently supported by low or very low certainty evidence, and effects on poorly reported patient-important outcomes (such as opioid use, return to work, and sleep quality).

• Guyatt, Gordon; Hultcrantz, Monica; Agoritsas, Thomas; Iorio, Alfonso; Vandvik, Per Olav & Montori, Victor M. (2025). Why Core GRADE is needed: Introduction to a new series in the BMJ. The BMJ. doi: 10.1136/bmj-2024-081902. Full text in Research Archive
• Hassan, Cesare; Rizkala, Tommy; Mori, Yuichi; Spadaccini, Marco; Misawa, Masashi & Antonelli, Giulio [Show all 31 contributors for this article] (2024). Computer-Aided Diagnosis for the Resect and Discard Strategy for Colorectal Polyps: A Systematic Review and Meta-Analysis. The Lancet Gastroenterology and Hepatology. ISSN 2468-1253. 9(11), p. 1010–1019. doi: 10.1016/S2468-1253(24)00222-X. Full text in Research Archive Show summary

  Background: The Resect and Discard strategy allows endoscopists to replace post-polypectomy pathology with real-time prediction of polyp histology during colonoscopy (optical diagnosis). The present systematic review and meta-analysis investigated how the implementation of computer-aided diagnosis (CADx) for polyp pathology affected the Resect and Discard strategy. Methods: We conducted a search of MEDLINE, EMBASE, and Scopus databases, covering studies published from inception to June 5, 2024. No language restrictions were applied. We included diagnostic accuracy studies that evaluated the real-time optical diagnosis performance of CADx systems, as compared to histology, for polyps ≤5mm in the entire colon. The aim was to estimate the potential benefits and harms associated with integrating CADx assistance into the endoscopist optical diagnosis, both before and after its implementation. The primary outcome were the proportion of polyps that would have avoided pathological assessment (main benefit) and the proportion of polyps incorrectly predicted (main harm) due to false-positive or -negative optical diagnosis. When the endoscopists were involved in the optical diagnosis, our analysis included only their predictions made with high confidence. We used a random effect model to calculate all outcomes. Findings: Our literature search identified a total of 377 studies, 11 of which met eligibility criteria. A total of 11 studies with 7,400 polyps were eligible for analysis. Three studies (1,817 patients; A total of 11 studies with 7,400 polyps were eligible for analysis. Three studies (1,817 patients; 4,086 polyps) provided data to directly compare the primary benefit/harm outcome measures between the CADx-unassisted and CADx-assisted strategies. There was no significant difference between the CADx-unassisted and CADx-assisted strategies for the proportion of polyps that would have avoided pathological assessment (3,588/4,086, 90% vs. 3,653/4,086 90%; risk ratio: 1.01; 95% CI: 0.99, 1.04; I^2 108 =53.49%; low certainty evidence; 3 studies; Egger test p=0.18). CADx-assisted strategy reduced the proportion of incorrectly predicted polyps as compared with CADx-unassisted strategy (582/3,588, 13% vs. 523/3,653, 12%; risk ratio: 0.88; 95% CI: 0.79, 0.98; I^2=0%; low certainty evidence; 3 studies; Egger test p=0.18) mainly due to a decrease in false positive diagnosis. Interpretation: CADx-assistance failed to improve the main outcomes of Resect-and-Discard strategy in clinical studies, questioning its value in clinical practice. Funding: European Commission (Horizon Europe 101057099). The Japan Society of Promotion of Science (No. 22H03357). Associazione Italiana per la Ricerca sul Cancro (AIRC): IG 2022 – ID. 27843 project – P.I. Hassan Cesare. Registration: PROSPERO CRD42024508440

• Hassan, Cesare; Misawa, Masashi; Rizkala, Tommy; Mori, Yuichi; Sultan, Shahnaz & Facciorusso, Antonio [Show all 26 contributors for this article] (2024). Computer-Aided Diagnosis for Leaving-In-Situ of Colorectal Polyps: A Systematic Review and Meta-analysis. Annals of Internal Medicine. ISSN 0003-4819. 177(7), p. 919–929. doi: 10.7326/M23-2865. Full text in Research Archive Show summary

  Backround: Computer-aided diagnosis (CADx) allows prediction of polyp histology during colonoscopy, which may reduce unnecessary removal of nonneoplastic polyps. However, the benefits and potential harms of CADx are still unclear. Purpose: To quantify the benefit and harm of using CADx in colonoscopy for the optical diagnosis of small (≤5-mm) rectosigmoid polyps. Data Sources: Medline, Embase, and Scopus were searched for articles published before 22 December 2023. Study Selection: Histologically verified diagnostic accuracy studies that evaluated the real-time performance of physicians in predicting neoplastic change of small rectosigmoid polyps without or with CADx assistance during colonoscopy. Data Extraction: The clinical benefit and harm were estimated on the basis of accuracy values of the endoscopist before and after CADx assistance. The certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. The outcome measure for benefit was the proportion of polyps predicted to be nonneoplastic that would avoid removal with the use of CADx. The outcome measure for harm was the proportion of neoplastic polyps that would be not resected and left in situ due to an incorrect diagnosis with the use of CADx. Histology served as the reference standard for both outcomes. Data Synthesis: Ten studies, including 3620 patients with 4103 small rectosigmoid polyps, were analyzed. The studies that assessed the standalone performance of CADx (9 studies; 3237 polyps) showed a sensitivity of 87.3% (95% CI, 79.2% to 92.5%) (SR) and specificity of 88.9% (CI, 81.7% to 93.5%) (SR) in predicting neoplastic change. In the studies that compared histology prediction performance before versus after CADx assistance (4 studies; 2503 polyps), there was no difference in the proportion of polyps predicted to be nonneoplastic that would avoid removal (55.4% vs. 58.4%; risk ratio [RR], 1.06 [CI, 0.96 to 1.17]; moderate-certainty evidence) or in the proportion of neoplastic polyps that would be erroneously left in situ (8.2% vs. 7.5%; RR, 0.95 [CI, 0.69 to 1.33]; moderate-certainty evidence). Limitation: The application of optical diagnosis was only simulated, potentially altering the decision-making process of the operator. Conclusion: Computer-aided diagnosis provided no incremental benefit or harm in the management of small rectosigmoid polyps during colonoscopy. Primary Funding Source: European Commission. (PROSPERO: CRD42023402197)

• Zou, Xinyu; Shi, Qingyang; Vandvik, Per Olav; Mao, Yunhe; Agarwal, Arnav & Ponte, Belen [Show all 12 contributors for this article] (2024). Sodium-glucose co-transporter-2 inhibitors in patients with chronic kidney disease with or without type 2 diabetes: systematic review and meta-analysis. BMJ Medicine. Full text in Research Archive Show summary

  Abstract Objective To examine cardiovascular and kidney benefits and harms of sodium-glucose co-transporter-2 (SGLT-2) inhibitors stratified by risk in adults with chronic kidney disease regardless of diabetes status. Design Systematic review and meta-analysis. Data sources Ovid Medline, Embase, and Cochrane Central from database inception to 15 June 2024. Eligibility criteria for selecting studies Randomised controlled trials that compared SGLT-2 inhibitors with placebo or standard care with no SGLT-2 inhibitors in adults with chronic kidney disease with a follow-up duration of ≥12 weeks were eligible. Secondary analyses based on subpopulations from randomised controlled trials and publications not in English language were excluded. Data synthesis Random effects meta-analyses were conducted, with effect estimates presented as risk ratios with 95% confidence intervals (CIs). Absolute treatment effects were estimated over a five year duration for individuals with varied risks of cardiovascular and kidney complications based on the Kidney Disease Improving Global Outcomes (KDIGO) risk stratification system. Certainty of evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach. Results Evidence from 13 randomised controlled trials (29 614 patients) informed treatment effect estimates. In relative terms, SGLT-2 inhibitors reduced all cause death (risk ratio 0.85 (95% CI 0.74 to 0.98)), cardiovascular death (0.84 (0.74 to 0.96)), kidney failure (0.68 (0.60 to 0.77)), non-fatal stroke (0.73 (0.57 to 0.94)), non-fatal myocardial infarction (0.75 (0.60 to 0.93)), and admission to hospital for heart failure (0.68 (0.60 to 0.78)). No credible subgroup effects were found from diabetes status, heart failure status, estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, and follow-up duration. Absolute effect estimates across these outcomes over a five year period varied across risk groups based on baseline risks of cardiovascular and kidney events. Effects of SGLT-2 inhibitors in the group at low risk included seven fewer all- cause deaths, four fewer admissions to hospital for heart failure per 1000 individuals, and no effects on kidney failure. Effects in the higher risk group included 48 fewer all cause deaths, 58 fewer kidney failures, and 25 fewer admissions to hospital for heart failure per 1000 individuals. Although SGLT-2 inhibitor use was associated with a relative increase in the risk of harms, including genital infection (2.66 (95% CI 2.07 to 3.42)), ketoacidosis (2.27 (1.30 to 3.95)), and symptomatic hypovolaemia (1.29 (1.15 to 1.44)), absolute differences for all harm outcomes were small. Conclusions Among people who have chronic kidney disease either with type 2 diabetes or not, SGLT-2 inhibitors improved cardiovascular and kidney outcomes with varying degrees of absolute benefit depending on an individual's baseline risks of cardiovascular and kidney-related sequelae. Absolute benefits and harms stratified by risk and associated with SGLT-2 inhibitors should inform individual decision making at the patient level.

• Zeraatkar, Dena; Kawano-Dourado, Leticia; Kristianslund, Eirik Klami & Vandvik, Per Olav (2024). Proactive therapeutic drug monitoring of biologic drugs in patients with inflammatory bowel disease, inflammatory arthritis, and psoriasis: systematic review and meta-analysis. BMJ Medicine. doi: 10.1136/bmjmed-2024-000998. Full text in Research Archive Show summary

  Abstract Objective To address the efficacy and safety of proactive therapeutic drug monitoring of biologic drugs for patients with inflammatory bowel disease, inflammatory arthritis, and psoriasis. Design Systematic review and meta-analysis. Data sources Medline, Embase, Central, and CINAHL, from database inception to 23 May 2024. Eligibility criteria for selecting studies Trials including people with inflammatory bowel disease, inflammatory arthritis, and psoriasis were selected. Selected trials also randomly assigned people to either proactive therapeutic drug monitoring of tumour necrosis factor-alpha inhibitors or other biologic drugs in the intervention group, and to either no therapeutic drug monitoring or standard care in the control group. Reviewers worked independently and in duplicate to screen search records and collect data from eligible trials. For each outcome, a frequentist, pairwise, random effects meta-analysis was done and the certainty of evidence was assessed using GRADE (grading of recommendations, assessment, development, and evaluations). Results Of 10 eligible trials identified, reporting on 2383 patients, two investigated induction with infliximab (533 patients), four assessed maintenance with infliximab (901 patients), and three assessed maintenance with adalimumab (710 patients). One trial was of maintenance with infliximab, adalimumab, and etanercept (239 patients). For patients who had induction with infliximab, the effects of proactive therapeutic drug monitoring on remission and adverse events were uncertain. Low certainty evidence suggested that proactive therapeutic drug monitoring may have little or no effect on disease activity, physical function, mental health, and quality of life. For patients who had maintenance with infliximab, low certainty evidence suggested that proactive therapeutic drug monitoring may increase the proportion of patients who had sustained disease control or remission (relative risk 1.26 (95% confidence interval (CI) 1.14 to 1.40), absolute risk difference of 146 more per 1000 patients treated for one year (95% CI 78 to 224). Additionally, this treatment and monitoring may reduce disease worsening, and may have little or no effect on disease activity, physical function, mental health, and quality of life. The effects of proactive therapeutic drug monitoring of infliximab on adverse events and formation of anti-drug antibodies were uncertain. For patients who had maintenance with adalimumab, the effects of proactive therapeutic drug monitoring were uncertain. Conclusion Proactive therapeutic drug monitoring of infliximab during maintenance may help patients to have sustained disease control or remission. No compelling evidence supported the effectiveness of proactive therapeutic drug monitoring of infliximab during induction or proactive therapeutic drug monitoring of adalimumab during maintenance.

• Hassan, Cesare; Misawa, Masashi; Rizkala, Tommy; Mori, Yuichi; Sultan, Shahnaz & Facciorusso, Antonio [Show all 25 contributors for this article] (2024). Computer-Aided Diagnosis for Leaving Colorectal Polyps In Situ A Systematic Review and Meta-analysis. Annals of Internal Medicine. ISSN 0003-4819. 177(7), p. 919–928. doi: 10.7326/M23-2865. Full text in Research Archive
• Hunskaar, Birk Bårdson Stokke; Løvsletten, Per Olav; Achille, Frankie Alexander Spencer; Heen, Anja Fog; Agoritsas, Thomas & Vandvik, Per Olav (2024). MATCH-IT: A decision support tool for multiple comparisons presenting data from network meta-analysis to facilitate guideline development. Clinical and Public Health Guidelines. 1(4). doi: 10.1002/gin2.70003. Full text in Research Archive Show summary

  Introduction: Network meta‐analysis (NMA) provides unprecedentedopportunities to compare multiple treatment options (multiple comparisons)and are increasingly being used to inform clinical practice guidelines.However, the overwhelming amount of data generated from NMAs ischallenging to present in comprehensible overviews for end‐users, guidelinepanelists included. Acknowledging these challenges, we developedMATCH‐IT—an interactive evidence summary displaying NMA results formultiple comparisons. In this study, we conducted user‐testing and furtherdeveloped MATCH‐IT to support guideline panels in moving from NMAevidence to recommendations.Methods: We user‐tested the tool with guideline panelists and observed theuse of the tool in panel meetings. User‐testing sessions and guidelinemeetings were recorded, transcribed, and analyzed. The analysis informedthe iterative development in the tool.Results: We included four guideline panels and tested the tool with 15panelists (four chairs, four methodologists, five clinic

• Mthethwa, Mashudu; Mbeye, Nyanyiwe Masingi; Effa, Emmanuel; Arikpo, Dachi; Blose, Ntombifuthi & Brand, Amanda [Show all 21 contributors for this article] (2024). Newborn and child health national and provincial clinical practice guidelines in South Africa, Nigeria and Malawi: a scoping review. BMC Health Services Research. 24(1). doi: 10.1186/s12913-024-10682-0. Full text in Research Archive Show summary

  Low and middle-income countries remain disproportionately affected by high rates of child mortality. Clinical practice guidelines are essential clinical tools supporting implementation of effective, safe, and cost-effective healthcare. High-quality evidence-based guidelines play a key role in improving clinical management to impact child mortality. We aimed to identify and assess the quality of guidelines for newborn and child health published in South Africa, Nigeria and Malawi in the last 5 years (2017–2022). We identified 40-guidelines from the three countries. Of these, 8/40 reported being adopted from a parent guideline. More guidelines (n = 19) provided guidance on communicable diseases than on non-communicable diseases (n = 8). Guidelines were most often developed by national health ministries (n = 30) and professional societies (n = 14). Eighteen guidelines reported on stakeholder consultation; with Nigeria (10/11) and Malawi (3/6) faring better than South Africa (5/23) in reporting this activity. The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach was used in 1/7 guidelines that reported assessing certainty of evidence. Overall guidelines scored well on two AGREE II domains: scope and purpose median (IQR) score 68% (IQR 47–83), and clarity of presentation 81% (67–94). Domains critical for ensuring credible guidance scored below 20%: rigour of development 11% (4–32) and editorial independence 6% (0–27).

• Hassan, Cesare; Rizkala, Tommy; Mori, Yuichi; Spadaccini, Marco; Misawa, Masashi & Antonelli, Giulio [Show all 33 contributors for this article] (2024). Computer-aided diagnosis for the resect-and-discard strategy for colorectal polyps: a systematic review and meta-analysis. The Lancet Gastroenterology and Hepatology. ISSN 2468-1253. 9(11), p. 1010–1019. doi: 10.1016/S2468-1253(24)00222-X. Full text in Research Archive
• Løvsletten, Per Olav; Wang, Xiaoqin; Pitre, Tyler; Ødegaard, Marte; Veroniki, Areti Angeliki & Lunny, Carole [Show all 9 contributors for this article] (2024). A systematic survey of 200 systematic reviews with network meta-analysis (published 2020–2021) reveals that few reviews report structured evidence summaries. Journal of Clinical Epidemiology. ISSN 0895-4356. 173. doi: 10.1016/j.jclinepi.2024.111445. Full text in Research Archive Show summary

  Objectives - To map whether and how systematic reviews (SRs) with network meta-analysis (NMA) use presentation formats to report (a) structured evidence summaries – here defined as reporting of effects estimates in absolute effects with certainty ratings and with a method to rate interventions across one or more outcome(s) – and (b) NMA results in general.<p> <p>Study Design and Setting - We conducted a systematic survey, searching MEDLINE (Ovid) for SRs with NMA published between January 1, 2020, and December 31, 2021. We planned to include a random sample of publications, with predefined mechanisms in place for saturation, and included SRs that met prespecified quality criteria and extracted data on presentation formats that reported: (a) estimates of effects, (b) certainty of the evidence, or (c) rating of interventions.<p> <p>Results - The 200 eligible SRs, from 158 unique Journals, utilized 1133 presentation formats. We found structured evidence summaries in 10 publications (5.0%), with 3 (1.5%) reporting structured evidence summaries across all outcomes, including benefits and harms. Sixteen of the 133 SRs (11.7%) reporting dichotomous outcomes included estimates of absolute effects. Seventy-six SRs (38.0%) reported both benefits and harms and 26 SRs (13.0%) reported certainty ratings in presentation formats, 20 (76.9%) used Grading of Recommendations Assessment, Development and Evaluation and 6 (23.1%) used Confidence In Network Meta-analysis. Surface Under the Cumulative Ranking Curve was the most common method to rate interventions (69 SRs, 34.5%). NMA results were most often reported using forest plots (108 SRs, 54.0%) and league tables (93 SRs, 46.5%).<p> <p>Conclusion - Most SRs with NMA do not report structured evidence summaries and only rarely do such summaries include reporting of both benefits and harms; those that do offer effective user-friendly communication and provide models for optimal NMA presentation practice.

• Kredo, Tamara; Effa, Emmanuel; Mbeye, Nyanyiwe; Mabetha, Denny; Schmidt, Bey-Marrié & Rohwer, Anke [Show all 14 contributors for this article] (2024). Evaluating the impact of the global evidence, local adaptation (GELA) project for enhancing evidence-informed guideline recommendations for newborn and young child health in three African countries: a mixed-methods protocol. Health Research Policy and Systems. 22(1). doi: 10.1186/s12961-024-01189-5. Full text in Research Archive Show summary

  Background: Poverty-related diseases (PRD) remain amongst the leading causes of death in children under-5 years in sub-Saharan Africa (SSA). Clinical practice guidelines (CPGs) based on the best available evidence are key to strengthening health systems and helping to enhance equitable health access for children under five. However, the CPG development process is complex and resource-intensive, with substantial scope for improving the process in SSA, which is the goal of the Global Evidence, Local Adaptation (GELA) project. The impact of research on PRD will be maximized through enhancing researchers and decision makers’ capacity to use global research to develop locally relevant CPGs in the field of newborn and child health. The project will be implemented in three SSA countries, Malawi, South Africa and Nigeria, over a 3-year period. This research protocol is for the monitoring and evaluation work package of the project. The aim of this work package is to monitor the various GELA project activities and evaluate the influence these may have on evidence-informed decision-making and guideline adaptation capacities and processes. The specific project activities we will monitor include (1) our ongoing engagement with local stakeholders, (2) their capacity needs and development, (3) their understanding and use of evidence from reviews of qualitative research and, (4) their overall views and experiences of the project. Methods: We will use a longitudinal, mixed-methods study design, informed by an overarching project Theory of Change. A series of interconnected qualitative and quantitative data collections methods will be used, including knowledge translation tracking sheets and case studies, capacity assessment online surveys, user testing and in-depth interviews, and non-participant observations of project activities. Participants will comprise of project staff, members of the CPG panels and steering committees in Malawi, South Africa and Nigeria, as well as other local stakeholders in these three African countries. Discussion: Ongoing monitoring and evaluation will help ensure the relationship between researchers and stakeholders is supported from the project start. This can facilitate achievement of common goals and enable researchers in South Africa, Malawi and Nigeria to make adjustments to project activities to maximize stakeholder engagement and research utilization. Ethical approval has been provided by South African Medical Research Council Human Research Ethics Committee (EC015-7/2022); The College of Medicine Research and Ethics Committee, Malawi (P.07/22/3687); National Health Research Ethics Committee of Nigeria (01/01/2007).

• Kawano-Dourado, Leticia; Kristianslund, Eirik; Zeraatkar, Dena; Jani, Meghna; Makharia, Govind & Hazlewood, Glen [Show all 23 contributors for this article] (2024). Proactive therapeutic drug monitoring of biologic drugs in adult patients with inflammatory bowel disease, inflammatory arthritis, or psoriasis: a clinical practice guideline. The BMJ. 387. doi: 10.1136/bmj-2024-079830. Full text in Research Archive
• Indregard, Anne Marthe Rustad; Nussle, Hans Martin; Hagen, Milada; Vandvik, Per Olav; Tesli, Martin Steen & Gather, Jakov [Show all 7 contributors for this article] (2024). Open-door policy versus treatment-as-usual in urban psychiatric inpatient wards: a pragmatic, randomised controlled, non-inferiority trial in Norway. The Lancet Psychiatry. ISSN 2215-0374. 11(5), p. 330–338. doi: 10.1016/S2215-0366(24)00039-7. Full text in Research Archive Show summary

  Background - Open-door policy is a recommended framework to reduce coercion in psychiatric wards. However, existing observational data might not fully capture potential increases in harm and use of coercion associated with open-door policies. In this first randomised controlled trial, we compared coercive practices in open-door policy and treatment-as-usual wards in an urban hospital setting. We hypothesised that the open-door policy would be non-inferior to treatment-as-usual on the proportion of patients exposed to coercive measures.<p> <p>Methods - We conducted a pragmatic, randomised controlled, non-inferiority trial comparing two open-door policy wards and three treatment-as-usual acute psychiatric wards at Lovisenberg Diaconal Hospital in Oslo, Norway. An exemption from the consent requirements enabled inclusion and random allocation of all patients admitted to these wards using an open list (2:3 ratio) administrated by a team of ward nurses. The primary outcome was the proportion of patient stays with one or more coercive measures, including involuntary medication, isolation or seclusion, and physical and mechanical restraints. The non-inferiority margin was set to 15%. Primary and safety analyses were assessed using the intention-to-treat population. The trial is registered with ISRCTN registry and is complete, ISRCTN16876467.<p> <p>Findings - Between Feb 10, 2021, and Feb 1, 2022, we randomly assigned 556 patients to either open-door policy wards (n=245; mean age 41·6 [SD 14·5] years; 119 [49%] male; 126 [51%] female; and 180 [73%] admitted to the ward involuntarily) or treatment-as-usual wards (n=311; mean age 41·6 [4·3] years; 172 [55%] male and 138 [45%] female; 233 [75%] admitted involuntarily). Data on race and ethnicity were not collected. The open-door policy was non-inferior to treatment-as-usual on all outcomes: the proportion of patient stays with exposure to coercion was 65 (26·5%) in open-door policy wards and 104 (33·4%) in treatment-as-usual wards (risk difference 6·9%; 95% CI –0·7 to 14·5), with a similar trend for specific measures of coercion. Reported incidents of violence against staff were 0·15 per patient stay in open-door policy wards and 0·18 in treatment-as-usual wards. There were no suicides during the randomised controlled trial period.<p> <p>Interpretation - The open-door policy could be safely implemented without increased use of coercive measures. Our findings underscore the need for more reliable and relevant randomised trials to investigate how a complex intervention, such as open-door policy, can be efficiently implemented across health-care systems and contexts.

• Agarwal, Arnav; Zeng, Xiaoxi; Li, Sheyu; Rayner, Daniel; Foroutan, Farid & Aertgeerts, Bert [Show all 18 contributors for this article] (2024). Sodium-glucose cotransporter-2 (SGLT-2) inhibitors for adults with chronic kidney disease: a clinical practice guideline. BMJ (Clinical Research Edition). ISSN 0959-8138. 387. doi: 10.1136/bmj-2024-080257. Full text in Research Archive
• Durão, Solange; Effa, Emmanuel; Mbeye, Nyanyiwe; Mthethwa, Mashudu; McCaul, Michael & Naude, Celeste [Show all 17 contributors for this article] (2024). Using a priority setting exercise to identify priorities for guidelines on newborn and child health in South Africa, Malawi, and Nigeria. Health Research Policy and Systems. 22(1). doi: 10.1186/s12961-024-01133-7. Full text in Research Archive Show summary

  Background Sub-Saharan Africa is the region with the highest under-five mortality rate globally. Child healthcare decisions should be based on rigorously developed evidence-informed guidelines. The Global Evidence, Local Adaptation (GELA) project is enhancing capacity to use global research to develop locally relevant guidelines for newborn and child health in South Africa (SA), Malawi, and Nigeria. The first step in this process was to identify national priorities for newborn and child health guideline development, and this paper describes our approach. Methods We followed a good practice method for priority setting, including stakeholder engagement, online priority setting surveys and consensus meetings, conducted separately in South Africa, Malawi and Nigeria. We established national Steering Groups (SG), comprising 10–13 members representing government, academia, and other stakeholders, identified through existing contacts and references, who helped prioritise initial topics identified by research teams and oversaw the process. Various stakeholders were consulted via online surveys to rate the importance of topics, with results informing consensus meetings with SGs where final priority topics were agreed. Results Based on survey results, nine, 10 and 11 topics were identified in SA, Malawi, and Nigeria respectively, which informed consensus meetings. Through voting and discussion within meetings, and further engagement after the meetings, the top three priority topics were identified in each country. In SA, the topics concerned anemia prevention in infants and young children and post-discharge support for caregivers of preterm and LBW babies. In Malawi, they focused on enteral nutrition in critically ill children, diagnosis of childhood cancers in the community, and caring for neonates. In Nigeria, the topics focused on identifying pre-eclampsia in the community, hand hygiene compliance to prevent infections, and enteral nutrition for LBW and preterm infants. Conclusions Through dynamic and iterative stakeholder engagement, we identified three priority topics for guideline development on newborn and child health in SA, Malawi and Nigeria. Topics were specific to contexts, with no overlap, which highlights the importance of contextualised priority setting as well as of the relationships with key decisionmakers who help define the priorities.

• Løvsletten, Per Olav; Hunskaar, Birk Bårdson Stokke; Heen, Anja Fog; Bekkering, Geertruida; Poel, Louise Vanden & Zeraatkar, Dena [Show all 13 contributors for this article] (2024). Physicians found an interactive tool displaying structured evidence summaries for multiple comparisons understandable and useful: a qualitative user testing study. Journal of Clinical Epidemiology. ISSN 0895-4356. 172. doi: 10.1016/j.jclinepi.2024.111399. Full text in Research Archive
• Wang, Yang; Zhang, Shipeng; Du, Heyue; Li, Jing; Khan, Safi U. & Aertgeerts, Bert [Show all 16 contributors for this article] (2023). Safety of ezetimibe in lipid-lowering treatment: systematic review and meta-analysis of randomised controlled trials and cohort studies. BMJ Medicine. 1(1). doi: 10.1136/bmjmed-2022-000134. Full text in Research Archive Show summary

  Objective: To determine the harms of ezetimibe in people who need lipid-lowering treatment. Design: Systematic review and meta-analysis. Data sources: Randomised controlled trials and cohort studies. Eligibility criteria for selecting studies: Studies comparing ezetimibe with placebo, standard care, or other lipid-lowering agents in people who need lipid-lowering treatment with a follow-up duration of at least six months (or 24 weeks). The relative effects for potential harms of ezetimibe were pooled by use of random effect pairwise meta-analyses for randomised controlled trials and the evidence from observational studies was narratively summarised. The certainty of evidence was assessed using the Grading of Recommendation Assessment, Development, and Evaluation. Results: 48 randomised controlled trials with 28 444 participants (median follow-up 34 weeks, range 24-312 weeks) and four observational studies with 1667 participants (median follow-up 282 weeks, range 72-400 weeks) were included. The meta-analyses of randomised trials showed moderate to high certainty that ezetimibe was not associated with cancer (relative risk 1.01; 95% confidence interval 0.92 to 1.11), fractures (0.90; 0.74 to 1.10), discontinuation due to any adverse event (0.87; 0.74 to 1.03), gastrointestinal adverse events leading to discontinuation (1.34; 0.58 to 3.08), myalgia or muscular pain leading to discontinuation (0.82; 0.51 to 1.33), neurocognitive events (1.48; 0.58 to 3.81), or new-onset diabetes (0.88; 0.61 to 1.28). The narrative analysis of observational studies provided consistent findings. No credible subgroup effects were identified for the harm outcomes, including shorter versus longer follow-up duration of trials. Conclusions: Ezetimibe results in little to no difference in adverse events or other undesirable effects compared with placebo, usual care or other lipid-lowering agents. Review registration: PROSPERO CRD42020187437. Keywords: Coronary disease; Pharmacology.

• Hunskaar, Birk Bårdson Stokke; Løvsletten, Per Olav; Muller, Ashley & Vandvik, Per Olav (2023). Interpretation and use of a decision support tool for multiple treatment options: A combined randomised controlled trial and survey of medical students. BMJ Evidence-Based Medicine. ISSN 2515-446X. doi: 10.1136/bmjebm-2023-112370. Full text in Research Archive Show summary

  Abstract Objectives To investigate medical students’ ability to interpret evidence, as well as their self-assessed understandability, perceived usefulness and preferences for design alternatives in an interactive decision support tool, displaying GRADE evidence summaries for multiple treatment options (Making Alternative Treatment CHoices Intuitive and Trustworthy, MATCH-IT). Design A combined randomised controlled trial and survey. Participants were presented with a clinical scenario and randomised to one of two versions of the MATCH-IT tool (A/B), instructed to explore the evidence and decide on a recommendation. Participants answered a questionnaire assessing interpretation, treatment recommendation self-assessed understandability and perceived usefulness before exposure to the other MATCH-IT version and asked questions on design preferences. Setting Online lecture in an evidence-based medicine (EBM) introductory course. Participants 149 third-year medical students. 52% (n=77) had 6 months of clinical training and 48% (n=72) had preclinical training only. Interventions The MATCH-IT tool version A uses colour coding to categorise interventions by magnitude and direction of effects and displays all outcomes in a table on entry. Version B has no colour coding, and the user must decide which outcomes to display in the table. Main outcome measures Interpretation of evidence, treatment recommendation, perceived usefulness and understandability, preference for format and design alternatives. Results 82.5% (n=123) of medical students correctly answered ≥4 out of 5 multiple choice questions assessing interpretation of data. 75.8% (n=114) of students made a treatment recommendation in accordance with an expert panel for the same clinical scenario. 87.2% (n=130) found the tool understandable while 91.9% perceived the tool as useful in addressing the clinical scenario. Conclusion Medical students with no prior training in EBM can interpret and use the MATCH-IT tool. Certain design alternatives were preferred but had no bearing on interpretation of evidence or understandability of the tool.

• Busse, Jason W.; Casassus, Rodrigo; Carrasco-Labra, Alonso; Durham, Justin; Mock, David & Zakrzewska, Joanna M. [Show all 20 contributors for this article] (2023). Management of chronic pain associated with temporomandibular disorders: a clinical practice guideline. The BMJ. 383. doi: 10.1136/bmj-2023-076227. Full text in Research Archive
• Zeng, Linan; Helsingen, Lise Mørkved; Bretthauer, Michael; Agoritsas, Thomas; Vandvik, Per Olav & Mustafa, Reem A. [Show all 15 contributors for this article] (2023). A novel framework for incorporating patient values and preferences in making guideline recommendations: guideline panel surveys. Journal of Clinical Epidemiology. ISSN 0895-4356. doi: 10.1016/j.jclinepi.2023.07.003. Full text in Research Archive
• Alme, Tomas Nordheim; Andreasson, Anna; Asprusten, Tarjei Tørre; Bakken, Anne Karen; Beadsworth, Michael BJ & Boye, Birgitte [Show all 51 contributors for this article] (2023). Chronic fatigue syndromes: real illnesses that people can recover from. Scandinavian Journal of Primary Health Care. ISSN 0281-3432. 41(4), p. 372–376. doi: 10.1080/02813432.2023.2235609. Full text in Research Archive Show summary

  The ‘Oslo Chronic Fatigue Consortium’ consists of researchers and clinicians who question the current narrative that chronic fatigue syndromes, including post-covid conditions, are incurable diseases. Instead, we propose an alternative view, based on research, which offers more hope to patients. Whilst we regard the symptoms of these conditions as real, we propose that they are more likely to reflect the brain's response to a range of biological, psychological, and social factors, rather than a specific disease process. Possible causes include persistent activation of the neurobiological stress response, accompanied by associated changes in immunological, hormonal, cognitive and behavioural domains. We further propose that the symptoms are more likely to persist if they are perceived as threatening, and all activities that are perceived to worsen them are avoided. We also question the idea that the best way to cope with the illness is by prolonged rest, social isolation, and sensory deprivation.Instead, we propose that recovery is often possible if patients are helped to adopt a less threatening understanding of their symptoms and are supported in a gradual return to normal activities. Finally, we call for a much more open and constructive dialogue about these conditions. This dialogue should include a wider range of views, including those of patients who have recovered from them.

• Zeng, Linan; Li, Shelly-Anne; Yang, Mengting; Yan, Lijiao; Helsingen, Lise Mørkved & Bretthauer, Michael [Show all 15 contributors for this article] (2023). Qualitative study of guideline panelists: innovative surveys provided valuable insights regarding patient values and preferences. Journal of Clinical Epidemiology. ISSN 0895-4356. doi: 10.1016/j.jclinepi.2023.07.014. Full text in Research Archive
• Shi, Qingyang; Nong, Kailei; Vandvik, Per Olav; Guyatt, Gordon H.; Schnell, Oliver & Rydén, Lars [Show all 40 contributors for this article] (2023). Benefits and harms of drug treatment for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials. The BMJ. 381, p. e074068–e074068. doi: 10.1136/bmj-2022-074068. Full text in Research Archive
• Hassan, Cesare; Spadaccini, Marco; Mori, Yuichi; Foroutan, Farid; Facciorusso, Antonio & Gkolfakis, Paraskevas [Show all 23 contributors for this article] (2023). Real-Time Computer-Aided Detection of Colorectal Neoplasia During Colonoscopy : A Systematic Review and Meta-analysis. Annals of Internal Medicine. ISSN 0003-4819. 176(9), p. 1209–1220. doi: 10.7326/M22-3678. Full text in Research Archive
• Owen, Andrew; Diaz, Janet Victoria; Gyatt, Gordon; Lamontagne, Francis; Stegemann, Miriam & Vandvik, Per Olav [Show all 7 contributors for this article] (2022). WHO Living Guidelines on antivirals for COVID-19 are evidence-based. The Lancet. ISSN 0140-6736. 400(10369), p. 2196–2198. doi: 10.1016/S0140-6736(22)02306-6. Full text in Research Archive
• Li, Jing; Du, Heyue; Wang, Yang; Aertgeerts, Bert; Guyatt, Gordon & Hao, Qiukui [Show all 17 contributors for this article] (2022). Safety of proprotein convertase subtilisin/kexin 9 inhibitors: A systematic review and meta-analysis. Heart. ISSN 1355-6037. 18(16). doi: 10.1136/heartjnl-2021-320556. Full text in Research Archive
• O'Connor, Denise; Johnston, Renea V; Brignardello-Petersen, Romina; Poolman, Rudolf W; Cyril, Sheila & Vandvik, Per Olav [Show all 7 contributors for this article] (2022). Arthroscopic surgery for degenerative knee disease (osteoarthritis including degenerative meniscal tears). Cochrane Database of Systematic Reviews. 2022(3), p. 1–158. doi: 10.1002/14651858.CD014328. Full text in Research Archive
• McCaul, Michael; Tovey, David; Young, Taryn; Welch, Vivian; Dewidar, Omar & Goetghebeur, Mireille [Show all 15 contributors for this article] (2022). Resources supporting trustworthy, rapid and equitable evidence synthesis and guideline development: results from the COVID-19 evidence network to support decision-making (COVID-END). Journal of Clinical Epidemiology. ISSN 0895-4356. 151, p. 88–95. doi: 10.1016/j.jclinepi.2022.07.008. Full text in Research Archive
• Zou, Xinyu; Shi, Qingyang; Vandvik, Per Olav; Guyatt, Gordon; Lang, Chim C. & Parpia, Sameer [Show all 13 contributors for this article] (2022). Sodium–Glucose Cotransporter-2 Inhibitors in Patients With Heart Failure A Systematic Review and Meta-analysis. Annals of Internal Medicine. ISSN 0003-4819. 175(6), p. 851–861. doi: 10.7326/M21-4284. Full text in Research Archive
• Zeraatkar, Dena; Cusano, Ellen; Martinez, Juan PD; Qasim, Anila; Mangala, Sophia & Kum, Elena [Show all 17 contributors for this article] (2022). Use of tocilizumab and sarilumab alone or in combination with corticosteroids for covid-19: systematic review and network meta-analysis. BMJ Medicine. 1(1). doi: 10.1136/bmjmed-2021-000036. Full text in Research Archive Show summary

  Objective: To compare the effects of interleukin 6 receptor blockers, tocilizumab and sarilumab, with or without corticosteroids, on mortality in patients with covid-19. Design: Systematic review and network meta-analysis. Data sources: World Health Organization covid-19 database, a comprehensive multilingual source of global covid-19 literature, and two prospective meta-analyses (up to 9 June 2021). Review methods: Trials in which people with suspected, probable, or confirmed covid-19 were randomised to interleukin 6 receptor blockers (with or without corticosteroids), corticosteroids, placebo, or standard care. The analysis used a bayesian framework and assessed the certainty of evidence using the GRADE approach. Results from the fixed effect meta-analysis were used for the primary analysis. Results: Of 45 eligible trials (20 650 patients) identified, 36 (19 350 patients) could be included in the network meta-analysis. Of 36 trials, 27 were at high risk of bias, primarily due to lack of blinding. Tocilizumab, in combination with corticosteroids, suggested a reduction in the risk of death compared with corticosteroids alone (odds ratio 0.79, 95% credible interval 0.70 to 0.88; 35 fewer deaths per 1000 people, 95% credible interval 52 fewer to 18 fewer per 1000; moderate certainty of evidence), as did sarilumab in combination with corticosteroids, compared with corticosteroids alone (0.73, 0.58 to 0.92; 43 fewer per 1000, 73 fewer to 12 fewer; low certainty). Tocilizumab and sarilumab, each in combination with corticosteroids, appeared to have similar effects on mortality when compared with each other (1.07, 0.86 to 1.34; eight more per 1000, 20 fewer to 35 more; low certainty). The effects of tocilizumab (1.12, 0.91 to 1.38; 20 more per 1000, 16 fewer to 59 more; low certainty) and sarilumab (1.07, 0.81 to 1.40; 11 more per 1000, 38 fewer to 55 more; low certainty), when used alone, suggested an increase in the risk of death. Conclusion: These findings suggest that in patients with severe or critical covid-19, tocilizumab, in combination with corticosteroids, probably reduces mortality, and that sarilumab, in combination with corticosteroids, might also reduce mortality. Tocilizumab and sarilumab, in combination with corticosteroids, could have similar effectiveness. Tocilizumab and sarilumab, when used alone, might not be beneficial.

• Khan, Safi U; Yedlapati, Siva H; Lone, Ahmad N; Hao, Qiukui; Guyatt, Gordon & Delvaux, Nicolas [Show all 12 contributors for this article] (2022). PCSK9 inhibitors and ezetimibe with or without statin therapy for cardiovascular risk reduction: A systematic review and network meta-analysis. The BMJ. 2022(377). doi: 10.1136/bmj-2021-069116. Full text in Research Archive
• Hao, Qiukui; Aertgeerts, Bert; Guyatt, Gordon; Bekkering, Geertruida E; Vandvik, Per Olav & Khan, Safi U [Show all 27 contributors for this article] (2022). PCSK9 inhibitors and ezetimibe for the reduction of cardiovascular events: A clinical practice guideline with risk-stratified recommendations. The BMJ. 2022(377). doi: 10.1136/bmj-2021-069066. Full text in Research Archive
• Carrano, Francesco M.; Iossa, Angelo; Lorenzo, Nicola Di; Silecchia, Gianfranco; Kontouli, Katerina-Maria & Mavridis, Dimitris [Show all 38 contributors for this article] (2022). EAES rapid guideline: systematic review, network meta-analysis, CINeMA and GRADE assessment, and European consensus on bariatric surgery–extension 2022. Surgical Endoscopy. ISSN 0930-2794. 36, p. 1709–1725. doi: 10.1007/s00464-022-09008-0. Full text in Research Archive
• Milone, Marco; Adamina, Michel; Arezzo, Alberto; Bejinariu, Nona; Boni, Luigi & Bouvy, Nicole [Show all 17 contributors for this article] (2022). UEG and EAES rapid guideline: Systematic review, meta-analysis, GRADE assessment and evidence-informed European recommendations on TaTME for rectal cancer. Surgical Endoscopy. ISSN 0930-2794. 36(4), p. 2221–2232. doi: 10.1007/s00464-022-09090-4. Full text in Research Archive
• Izcovich, Ariel; Siemieniuk, Reed Alexander; Bartoszko, Jessica Julia; Ge, Long; Zeraatka, Dena & Kum, Elena [Show all 15 contributors for this article] (2022). Adverse effects of remdesivir, hydroxychloroquine and lopinavir/ritonavir when used for COVID-19: systematic review and meta-analysis of randomised trials. BMJ Open. 12(3). doi: 10.1136/bmjopen-2020-048502. Full text in Research Archive
• Zeng, Linan; Walsh, Michael; Guyatt, Gordon H; Siemieniuk, Reed A C; Collister, David & Booth, Michelle [Show all 22 contributors for this article] (2022). Plasma exchange and glucocorticoid dosing for patients with ANCA-associated vasculitis: A clinical practice guideline. The BMJ. doi: 10.1136/bmj-2021-064597. Full text in Research Archive
• Riaz, Irbaz Bin; Fuentes, Harry E.; Naqvi, Syed Arsalan Ahmed; Huan, He; Sipra, Qurat-Ul-Ain Riaz & Tafur, Alfonso J. [Show all 16 contributors for this article] (2022). Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clinic proceedings. ISSN 0025-6196. 97(2), p. 308–324. doi: 10.1016/j.mayocp.2020.10.041. Full text in Research Archive Show summary

  Objective: To maintain living, interactive evidence (LIvE) on the benefits and harms of different treatment options in adults with cancer-associated thrombosis (CAT). Methods: We have used a novel LIvE synthesis framework to maintain this living, interactive systematic review since September 19, 2018. Randomized controlled trials evaluating the efficacy and safety of direct oral anticoagulants (DOACs) compared with low-molecular-weight heparin for CAT are included in this analysis. Details of LIvE synthesis framework are available at the website https://cat.network-meta-analysis.com. Results: The results are constantly updated as new information becomes available (https://cat.network-meta-analysis.com/CAT.html). The living, interactive systematic review currently includes 4 randomized controlled trials (N=2894). Direct comparisons show that DOACs significantly decrease recurrent venous thromboembolism (VTE) events compared with dalteparin (odds ratio [OR], 0.59; 95% CI, 0.41 to 0.86; I2, 25%) without significantly increasing major bleeding (OR, 1.34; 95% CI, 0.83 to 2.18; I2, 28%). Mixed treatment comparisons show that apixaban (OR, 0.41; 95% credible interval [CrI], 0.16 to 0.95) and rivaroxaban (OR, 0.58; 95% CrI, 0.37 to 0.90) significantly decrease VTE recurrent events compared with dalteparin. Edoxaban significantly increases major bleeding compared with dalteparin (OR, 1.73; 95% CrI, 1.04 to 3.16), and rivaroxaban significantly increases clinically relevant nonmajor bleeding compared with dalteparin and other DOACs. There are no significant differences between DOACs in terms of VTE recurrences and major bleeding. Conclusion: DOACs should be considered a standard of care for the treatment of CAT except in patients with a high risk of bleeding. Current evidence favors the use of apixaban for the treatment of CAT among other DOACs. Registration: Open Science Framework (https://osf.io/dth86). Trial registration: ClinicalTrials.gov NCT02744092 NCT02746185 NCT03139487 NCT02583191. Copyright © 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

• Heen, Anja Fog; Lytvyn, Lyubov; Shapiro, Michael; Guyatt, Gordon; Siemieniuk, Reed Alexander Cunningham & Zhang, Yuan [Show all 9 contributors for this article] (2021). Patient values and preferences on valve replacement for aortic stenosis: A systematic review. Heart. ISSN 1355-6037. p. 1–7. doi: 10.1136/heartjnl-2020-318334. Full text in Research Archive Show summary

  Abstract The review aims to summarise evidence addressing patients’ values, preferences and practical issues on deciding between transcatheter aortic valve insertion (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. We searched databases and grey literature until June 2020. We included studies of adults with aortic stenosis eliciting values and preferences about treatment, excluding medical management or palliative care. Qualitative findings were synthesised using thematic analysis, and quantitative findings were narratively described. Evidence certainty was assessed using CERQual (Confidence in the Evidence from Reviews of Qualitative Research) and GRADE (Grading of Recommendations Assessment, Development and Evaluation). We included eight studies. Findings ranged from low to very low certainty. Most studies only addressed TAVI. Studies addressing both TAVI and SAVR reported on factors affecting patients’ decision-making along with treatment effectiveness, instead of trade-offs between procedures. Willingness to accept risk varied considerably. To improve their health status, participants were willing to accept higher mortality risk than current evidence suggests for either procedure. No study explicitly addressed valve reintervention, and one study reported variability in willingness to accept shorter duration of known effectiveness of TAVI compared with SAVR. The most common themes were desire for symptom relief and improved function. Participants preferred minimally invasive procedures with shorter hospital stay and recovery. The current body of evidence on patients’ values, preferences and practical issues related to aortic stenosis management is of suboptimal rigour and reports widely disparate results regarding patients’ perceptions. These findings emphasise the need for higher quality studies to inform clinical practice guidelines and the central importance of shared decision-making to individualise care fitted to each patient.

• Buchan, Tayler A.; Malik, Abdullah; Chan, Cynthia; Chambers, Jason; Suk, Yujin & Zhu, Jie Wei [Show all 15 contributors for this article] (2021). Predictive models for cardiovascular and kidney outcomes in patients with type 2 diabetes: Systematic review and meta-analyses. Heart. ISSN 1355-6037. 107(24), p. 1962–1973. doi: 10.1136/heartjnl-2021-319243. Full text in Research Archive
• Bartoszko, Jessica; Siemieniuk, Reed A.C.; Kum, Elena; Qasim, Anila; Zeraatkar, Dena & Ge, Long [Show all 40 contributors for this article] (2021). Prophylaxis against covid-19: Living systematic review and network meta-analysis. BMJ. British Medical Journal. ISSN 0959-8146. 373, p. 1–19. doi: 10.1136/bmj.n949. Full text in Research Archive
• Siemieniuk, Reed A.C.; Bartoszko, Jessica J; Martinez, Juan Pablo Díaz; Kum, Elena; Qasim, Anila & Zeraatkar, Dena [Show all 36 contributors for this article] (2021). Antibody and cellular therapies for treatment of covid-19: A living systematic review and network meta-analysis. The BMJ. 374, p. 2231–2231. doi: 10.1136/bmj.n2231. Full text in Research Archive
• Honarmand, Kimia; Penn, Jeremy; Agarwal, Arnav; Siemieniuk, Reed A.C.; Brignardello-Petersen, Romina & Bartoszko, Jessica [Show all 19 contributors for this article] (2021). Clinical trials in COVID-19 management & prevention: A meta-epidemiological study examining methodological quality. Journal of Clinical Epidemiology. ISSN 0895-4356. 139, p. 68–79. doi: 10.1016/j.jclinepi.2021.07.002. Full text in Research Archive
• Heen, Anja Fog; Vandvik, Per Olav; Brandt, Linn; Achille, Frankie; Guyatt, Gordon Henry & Akl, Elie A. [Show all 8 contributors for this article] (2021). Decision aids linked to evidence summaries and clinical practice guidelines: results from user-testing in clinical encounters. BMC Medical Informatics and Decision Making. 21, p. 1–15. doi: 10.1186/s12911-021-01541-7. Full text in Research Archive Show summary

  Abstract Background: Tools for shared decision-making (e.g. decision aids) are intended to support health care professionals and patients engaged in clinical encounters involving shared decision-making. However, decision aids are hard to produce, and onerous to update. Consequently, they often do not refect best current evidence, and show limited uptake in practice. In response, we initiated the Sharing Evidence to Inform Treatment decisions (SHARE-IT) project. Our goal was to develop and refne a new generation of decision aids that are generically produced along digitally structured guidelines and evidence summaries. Methods: Applying principles of human-centred design and following the International Patient Decision Aid Standards (IPDAS) and GRADE methods for trustworthy evidence summaries we developed a decision aid prototype in collaboration with the Developing and Evaluating Communication strategies to support Informed Decisions and practice based on Evidence project (DECIDE). We iteratively user-tested the prototype in clinical consultations between clinicians and patients. Semi-structured interviews of participating clinicians and patients were conducted. Qualitative content analysis of both user-testing sessions and interviews was performed and results categorized according to a revised Morville’s framework of user-experience. We made it possible to produce, publish and use these decision aids in an electronic guideline authoring and publication platform (MAGICapp). Results: Direct observations and analysis of user-testing of 28 clinical consultations between physicians and patients informed four major iterations that addressed readability, understandability, usability and ways to cope with information overload. Participants reported that the tool supported natural fow of the conversation and induced a positive shift in consultation habits towards shared decision-making. We integrated the functionality of SHARE-IT decision aids in MAGICapp, which has since generated numerous decision aids. Conclusion: Our study provides a proof of concept that encounter decision aids can be generically produced from GRADE evidence summaries and clinical guidelines. Online authoring and publication platforms can help scale up production including continuous updating of electronic encounter decision aids, fully integrated with evidence summaries and clinical practice guidelines. Keywords: Decision aids, Shared decision-making, Clinical practice guidelines.

• Palmer, Suetonia C.; Tendal, Britta; Mustafa, Reem A.; Vandvik, Per Olav; Li, Sheyu & Hao, Qiukui [Show all 44 contributors for this article] (2021). Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: Systematic review and network meta-analysis of randomised controlled trials. BMJ. British Medical Journal. ISSN 0959-8146. 372, p. 1–14. doi: 10.1136/bmj.m4573. Full text in Research Archive
• Li, Sheyu; Vandvik, Per Olav; Lytvyn, Lyubov; Guyatt, Gordon; Palmer, Suetonia C. & Rodriguez-Gutierrez, René [Show all 28 contributors for this article] (2021). SGLT-2 inhibitors or GLP-1 receptor agonists for adults with type 2 diabetes: A clinical practice guideline. The BMJ. 373. doi: 10.1136/bmj.n1091. Full text in Research Archive Show summary

  Clinical question: What are the benefits and harms of sodium-glucose cotransporter 2 (SGLT-2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists when added to usual care (lifestyle interventions and/or other diabetes drugs) in adults with type 2 diabetes at different risk for cardiovascular and kidney outcomes? Current practice: Clinical decisions about treatment of type 2 diabetes have been led by glycaemic control for decades. SGLT-2 inhibitors and GLP-1 receptor agonists are traditionally used in people with elevated glucose level after metformin treatment. This has changed through trials demonstrating atherosclerotic cardiovascular disease (CVD) and chronic kidney disease (CKD) benefits independent of medications' glucose-lowering potential. Recommendations: The guideline panel issued risk-stratified recommendations concerning the use of SGLT-2 inhibitors or GLP-1 receptor agonists in adults with type 2 diabetes• Three or fewer cardiovascular risk factors without established CVD or CKD: Weak recommendation against starting SGLT-2 inhibitors or GLP-1 receptor agonists.• More than three cardiovascular risk factors without established CVD or CKD: Weak recommendation for starting SGLT-2 inhibitors and weak against starting GLP-1 receptor agonists.• Established CVD or CKD: Weak recommendation for starting SGLT-2 inhibitors and GLP-1 receptor agonists.• Established CVD and CKD: Strong recommendation for starting SGLT-2 inhibitors and weak recommendation for starting GLP-1 receptor agonists.• For those committed to further reducing their risk for CVD and CKD outcomes: Weak recommendation for starting SGLT-2 inhibitors rather than GLP-1 receptor agonists. How this guideline was created: An international panel including patients, clinicians, and methodologists created these recommendations following standards for trustworthy guidelines and using the GRADE approach. The panel applied an individual patient perspective. The evidence: A linked systematic review and network meta-analysis (764 randomised trials included 421 346 participants) of benefits and harms found that SGLT-2 inhibitors and GLP-1 receptor agonists generally reduce overall death, and incidence of myocardial infarctions, and end-stage kidney disease or kidney failure (moderate to high certainty evidence). These medications exert different effects on stroke, hospitalisations for heart failure, and key adverse events in different subgroups. Absolute effects of benefit varied widely based on patients' individual risk (for example, from five fewer deaths in the lowest risk to 48 fewer deaths in the highest risk, for 1000 patients treated over five years). A prognosis review identified 14 eligible risk prediction models, one of which (RECODe) informed most baseline risk estimates in evidence summaries to underpin the risk-stratified recommendations. Concerning patients' values and preferences, the recommendations were supported by evidence from a systematic review of published literature, a patient focus group study, a practical issues summary, and a guideline panel survey.

• Riaz, Irbaz Bin; He, Huan; Ryu, Alexander J.; Siddiqi, Rabbia; Naqvi, Syed Arsalan Ahmed & Yao, Yuan [Show all 22 contributors for this article] (2021). A Living, Interactive Systematic Review and Network Meta-analysis of First-line Treatment of Metastatic Renal Cell Carcinoma[Formula presented]. European Urology. ISSN 0302-2838. 80(6), p. 712–723. doi: 10.1016/j.eururo.2021.03.016. Full text in Research Archive
• Busse, Jason W.; Vankrunkelsven, Patrick; Zeng, Linan; Heen, Anja Fog; Merglen, Arnaud & Campbell, Fiona [Show all 22 contributors for this article] (2021). Medical cannabis or cannabinoids for chronic pain: A clinical practice guideline. The BMJ. 374. doi: 10.1136/bmj.n2040. Full text in Research Archive Show summary

  Abstract Clinical question: What is the role of medical cannabis or cannabinoids for people living with chronic pain due to cancer or non-cancer causes? Current practice: Chronic pain is common and distressing and associated with considerable socioeconomic burden globally. Medical cannabis is increasingly used to manage chronic pain, particularly in jurisdictions that have enacted policies to reduce use of opioids; however, existing guideline recommendations are inconsistent, and cannabis remains illegal for therapeutic use in many countries. Recommendation: The guideline expert panel issued a weak recommendation to offer a trial of non-inhaled medical cannabis or cannabinoids, in addition to standard care and management (if not sufficient), for people living with chronic cancer or non-cancer pain. How this guideline was created: An international guideline development panel including patients, clinicians with content expertise, and methodologists produced this recommendation in adherence with standards for trustworthy guidelines using the GRADE approach. The MAGIC Evidence Ecosystem Foundation (MAGIC) provided methodological support. The panel applied an individual patient perspective. The evidence: This recommendation is informed by a linked series of four systematic reviews summarising the current body of evidence for benefits and harms, as well as patient values and preferences, regarding medical cannabis or cannabinoids for chronic pain. Understanding the recommendation: The recommendation is weak because of the close balance between benefits and harms of medical cannabis for chronic pain. It reflects a high value placed on small to very small improvements in self reported pain intensity, physical functioning, and sleep quality, and willingness to accept a small to modest risk of mostly self limited and transient harms. Shared decision making is required to ensure patients make choices that reflect their values and personal context. Further research is warranted and may alter this recommendation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

• Lamontagne, Francois; Agoritsas, Thomas; Siemieniuk, Reed A.C.; Rochwerg, Bram; Bartoszko, Jessica & Askie, Lisa [Show all 53 contributors for this article] (2021). A living WHO guideline on drugs to prevent covid-19. The BMJ. doi: 10.1136/bmj.n526. Full text in Research Archive
• Antoniou, Stavros A.; Mavridis, Dimitris; Kontouli, Katerina Maria; Drakopoulos, Vasileios; Gorter-Stam, Marguerite & Eriksson, Sture [Show all 13 contributors for this article] (2021). EAES rapid guideline: appendicitis in the elderly. Surgical Endoscopy. ISSN 0930-2794. 35(7), p. 3233–3243. doi: 10.1007/s00464-021-08524-9. Full text in Research Archive
• Shi, Q; Wang, Y; Hao, Qiukui; Vandvik, Per Olav; Guyatt, Gordon & Li, J [Show all 27 contributors for this article] (2021). Pharmacotherapy for adults with overweight and obesity: a systematic review and network meta-analysis of randomised controlled trials. The Lancet. ISSN 0140-6736. 399(10321), p. 259–269. doi: 10.1016/S0140-6736(21)01640-8. Full text in Research Archive
• Marx, Nikolaus; Ryden, Lars; Brosius, Frank; Ceriello, Antonio; Cheung, Michael & Cosentino, Francesco [Show all 17 contributors for this article] (2021). Towards living guidelines on cardiorenal outcomes in diabetes: A pilot project of the Taskforce of the Guideline Workshop 2020. Diabetes Research and Clinical Practice. ISSN 0168-8227. 177, p. 108870–108870. doi: 10.1016/j.diabres.2021.108870. Full text in Research Archive
• Vandvik, Per Olav; González-González, José Gerardo; González-Colmenero, Alejandro Díaz; Millán-Alanís, Juan Manuel; Lytvyn, Lyubov & Solis, Ricardo Cesar [Show all 12 contributors for this article] (2021). Values, preferences and burden of treatment for the initiation of GLP-1 receptor agonists and SGLT-2 inhibitors in adult patients with type 2 diabetes: a systematic review. BMJ Open. 11(7), p. e049130–-e049130. doi: 10.1136/bmjopen-2021-049130. Full text in Research Archive
• Naci, Huseyin; Kesselheim, Aaron S; Røttingen, John-Arne; Salanti, Georgia; Vandvik, Per Olav & Cipriani, Andrea (2020). Producing and using timely comparative evidence on drugs: Lessons from clinical trials for covid-19. BMJ. British Medical Journal. ISSN 0959-8146. 371:m3869, p. 1–6. doi: 10.1136/bmj.m3869. Full text in Research Archive
• Siemieniuk, Reed A.C.; Bartoszko, Jessica J; Ge, Long; Zeraatkar, Dena; Izcovich, Ariel & Kum, Elena [Show all 53 contributors for this article] (2020). Drug treatments for covid-19: living systematic review and network meta-analysis. The BMJ. 370. doi: 10.1136/bmj.m2980. Full text in Research Archive Show summary

  Abstract Objective To compare the effects of treatments for coronavirus disease 2019 (covid-19). Design Living systematic review and network meta-analysis. Data sources WHO covid-19 database, a comprehensive multilingual source of global covid-19 literature, up to 3 December 2020 and six additional Chinese databases up to 12 November 2020. Study selection Randomised clinical trials in which people with suspected, probable, or confirmed covid-19 were randomised to drug treatment or to standard care or placebo. Pairs of reviewers independently screened potentially eligible articles. Methods After duplicate data abstraction, a bayesian network meta-analysis was conducted. Risk of bias of the included studies was assessed using a modification of the Cochrane risk of bias 2.0 tool, and the certainty of the evidence using the grading of recommendations assessment, development and evaluation (GRADE) approach. For each outcome, interventions were classified in groups from the most to the least beneficial or harmful following GRADE guidance. Results 85 trials enrolling 41 669 patients met inclusion criteria as of 21 October 2020; 50 (58.8%) trials and 25 081 (60.2%) patients are new from the previous iteration; 43 (50.6%) trials evaluating treatments with at least 100 patients or 20 events met the threshold for inclusion in the analyses. Compared with standard care, corticosteroids probably reduce death (risk difference 17 fewer per 1000 patients, 95% credible interval 34 fewer to 1 more, moderate certainty), mechanical ventilation (29 fewer per 1000 patients, 54 fewer to 1 more, moderate certainty), and days free from mechanical ventilation (2.6 fewer, 0.2 fewer to 5.0 fewer, moderate certainty). The impact of remdesivir on mortality, mechanical ventilation, length of hospital stay, and duration of symptoms is uncertain, but it probably does not substantially increase adverse effects leading to drug discontinuation (0 more per 1000, 9 fewer to 40 more, moderate certainty). Azithromycin, hydroxychloroquine, lopinavir/ritonavir, interferon-beta, and tocilizumab may not reduce risk of death or have an effect on any other patient-important outcome. The certainty in effects for all other interventions was low or very low. Conclusion Corticosteroids probably reduce mortality and mechanical ventilation in patients with covid-19 compared with standard care, whereas azithromycin, hydroxychloroquine, interferon-beta, and tocilizumab may not reduce either. Whether or not remdesivir confers any patient-important benefit remains uncertain. Systematic review registration This review was not registered. The protocol is included as a supplement. Readers’ note This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication. This version is the second update of the original article published on 30 July 2020 ( BMJ 2020;370:m2980), and previous versions can be found as data supplements. When citing this paper please consider adding the version number and date of access for clarity.

• Helsingen, Lise M.; Zeng, Linan; Siemieniuk, Reed A.C.; Lytvyn, Lyubov; Vandvik, Per Olav & Agoritsas, Thomas [Show all 8 contributors for this article] (2020). Establishing thresholds for important benefits considering the harms of screening interventions. BMJ Open. 10:e037854(12), p. 1–9. doi: 10.1136/bmjopen-2020-037854. Full text in Research Archive
• Marx, Nikolaus; Rydén, Lars E.; Brosius, Frank; Ceriello, Antonio; Cheung, Michael & Cosentino, Francesco [Show all 15 contributors for this article] (2020). Proceedings of the Guideline Workshop 2019: Strategies for the Optimization of Guideline Processes in Diabetes, Cardiovascular Diseases, and Kidney Diseases. Diabetes Technology & Therapeutics. ISSN 1520-9156. 22(7), p. 546–552. doi: 10.1089/dia.2020.0086. Full text in Research Archive
• Moynihan, Ray; Bero, Lisa; Hill, Sue; Johansson, Minna; Lexchin, Joel & MacDonald, Helen [Show all 16 contributors for this article] (2020). Pathways to independence: Towards producing and using trustworthy evidence. BMJ (Clinical Research Edition). ISSN 0959-8138. 367. doi: 10.1136/bmj.l6576. Full text in Research Archive Show summary

  We all want to base our healthcare decisions on trustworthy evidence. Yet the landmark 2009 Institute of Medicine report identified widespread financial conflicts of interest across medical research, education, and practice.1 It highlighted that extensive industry influence may be jeopardising “the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public’s trust in medicine.” 1 At the same time there’s increasing appreciation across nations and within clinical and scientific communities of the problem of too much medicine.2-5 Overtesting, overdiagnosis, and overtreatment divert resources from tackling genuine need, cause harm to health, and threaten health system sustainability.2-5 Necessary tests, treatments, and diagnoses are vital, and manufacturers have rights to make profits. But it’s time to ensure the scientific evaluation of tests and treatments, and dissemination of the resulting evidence, are conducted as independently as possible from industries profiting from their use. Perspectives differ on the financial relationships between industry and health professionals, and debate is ongoing about where to draw the line between valuable collaboration and relationships that don’t serve patients or the public.6-8 Some see transparency as the best strategy, while others regard it as necessary but insufficient. We argue that endemic financial entanglement is distorting the production and use of healthcare evidence, causing harm to individuals and waste for health systems. Building on the evidence and practical examples cited below, we propose pathways towards financial independence from industry across healthcare decision making. We hope that our proposals will catalyse and inform development of more detailed recommendations for fundamental reform within research, education, and practice.

• Foroutan, Farid; Guyatt, Gordon H.; Zuk, Victoria; Vandvik, Per Olav; Alba, Ana C. & Mustafa, Reem A. [Show all 17 contributors for this article] (2020). GRADE Guidelines 28: Use of GRADE for the assessment of evidence about prognostic factors: rating certainty in identification of groups of patients with different absolute risks. Journal of Clinical Epidemiology. ISSN 0895-4356. 121, p. 62–70. doi: 10.1016/j.jclinepi.2019.12.023. Full text in Research Archive
• Vandvik, Per Olav & Brandt, Linn (2020). Future of Evidence Ecosystem Series: Evidence ecosystems and learning health systems: why bother? Journal of Clinical Epidemiology. ISSN 0895-4356. 123, p. 166–170. doi: 10.1016/j.jclinepi.2020.02.008. Full text in Research Archive
• Lamontagne, Francois; Agoritsas, Thomas; MacDonald, Helen; Leo, Yee-Sin; DIaz, Janet & Agarwal, Arnav [Show all 40 contributors for this article] (2020). A living WHO guideline on drugs for covid-19. The BMJ. 370. doi: 10.1136/bmj.m3379. Full text in Research Archive
• Rochwerg, Bram; Agarwal, Arnav; Zeng, Linan; Leo, Yee-Sin; Appiah, John Adabie & Agoritsas, Thomas [Show all 27 contributors for this article] (2020). Remdesivir for severe covid-19: A clinical practice guideline. The BMJ. 370. doi: 10.1136/bmj.m2924. Full text in Research Archive
• Heen, Anja Fog; Vandvik, Per Olav; Brandt, Linn; Montori, Victor M.; Lytvyn, Lyubov & Guyatt, Gordon [Show all 8 contributors for this article] (2020). A framework for practical issues was developed to inform shared decision-making tools and clinical guidelines. Journal of Clinical Epidemiology. ISSN 0895-4356. 129, p. 104–113. doi: 10.1016/j.jclinepi.2020.10.002. Full text in Research Archive Show summary

  Objectives: The objective of the study was to develop and test feasibility of a framework of patient-important practical issues. Study design and setting: Guidelines and shared decision-making tools help facilitate discussions about patient-important outcomes of care alternatives, but typically ignore practical issues patients consider when implementing care into their daily routines. Using grounded theory, practical issues in the HealthTalk.org registry and in Option Grids were identified and categorized into a framework. We integrated the framework into the MAGIC authoring and publication platform and digitally structured authoring and publication platform and appraised its use in The BMJ Rapid Recommendations. Results: The framework included the following 15 categories: medication routine, tests and visits, procedure and device, recovery and adaptation, coordination of care, adverse effects, interactions and antidote, physical well-being, emotional well-being, pregnancy and nursing, costs and access, food and drinks, exercise and activities, social life and relationships, work and education, travel and driving. Implementation in 15 BMJ Rapid Recommendations added 283 issues to 35 recommendations. The most frequently used category was procedure and device, and the least frequent was social life and relationship. Conclusion: Adding practical issues systematically to evidence summaries is feasible and can inform guidelines and tools for shared decision-making. How this inclusion can improve patient-centered care remains to be determined. Keywords: Clinical practice guidelines; Decision aids; Patient experience; Patient-important outcomes; Shared decision-making tools. Copyright © 2020 The Authors

• Ye, Zhikang; Blaser, Annika Reintam; Lytvyn, Lyubov; Wang, Ying; Guyatt, Gordon & Mikita, J. Stephen [Show all 20 contributors for this article] (2020). Gastrointestinal bleeding prophylaxis for critically ill patients: a clinical practice guideline. BMJ (Clinical Research Edition). ISSN 0959-8138. 368, p. 1–17. Full text in Research Archive Show summary

  Clinical question: What is the role of gastrointestinal bleeding prophylaxis (stress ulcer prophylaxis) in critically ill patients? This guideline was prompted by the publication of a new large randomised controlled trial. Current practice: Gastric acid suppression with proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) is commonly done to prevent gastrointestinal bleeding in critically ill patients. Existing guidelines vary in their recommendations of which population to treat and which agent to use. Recommendations: This guideline panel makes a weak recommendation for using gastrointestinal bleeding prophylaxis in critically ill patients at high risk (>4%) of clinically important gastrointestinal bleeding, and a weak recommendation for not using prophylaxis in patients at lower risk of clinically important bleeding (≤4%). The panel identified risk categories based on evidence, with variable certainty regarding risk factors. The panel suggests using a PPI rather than a H2RA (weak recommendation) and recommends against using sucralfate (strong recommendation). How this guideline was created: A guideline panel including patients, clinicians, and methodologists produced these recommendations using standards for trustworthy guidelines and the GRADE approach. The recommendations are based on a linked systematic review and network meta-analysis. A weak recommendation means that both options are reasonable. The evidence: The linked systematic review and network meta-analysis estimated the benefit and harm of these medications in 12 660 critically ill patients in 72 trials. Both PPIs and H2RAs reduce the risk of clinically important bleeding. The effect is larger in patients at higher bleeding risk (those with a coagulopathy, chronic liver disease, or receiving mechanical ventilation but not enteral nutrition or two or more of mechanical ventilation with enteral nutrition, acute kidney injury, sepsis, and shock) (moderate certainty). PPIs and H2RAs might increase the risk of pneumonia (low certainty). They probably do not have an effect on mortality (moderate certainty), length of hospital stay, or any other important outcomes. PPIs probably reduce the risk of bleeding more than H2RAs (moderate certainty). Understanding the recommendation: In most critically ill patients, the reduction in clinically important gastrointestinal bleeding from gastric acid suppressants is closely balanced with the possibility of pneumonia. Clinicians should consider individual patient values, risk of bleeding, and other factors such as medication availability when deciding whether to use gastrointestinal bleeding prophylaxis. Visual overviews provide the relative and absolute benefits and harms of the options in multilayered evidence summaries and decision aids available on MAGICapp. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

• Wang, Ying; Ye, Zhikang; Ge, Long; Siemieniuk, Reed A.C.; Wang, Xin & Wang, Yingkai [Show all 14 contributors for this article] (2020). Efficacy and safety of gastrointestinal bleeding prophylaxis in critically ill patients: Systematic review and network meta-analysis. The BMJ. doi: 10.1136/bmj.l6744. Full text in Research Archive
• Helsingen, Lise M.; Vandvik, Per Olav; Jodal, Henriette C.; Agoritsas, Thomas; Lytvyn, Lyubov & Anderson, Joseph C. [Show all 21 contributors for this article] (2019). Colorectal cancer screening with faecal immunochemical testing, sigmoidoscopy or colonoscopy: A clinical practice guideline. The BMJ. 367:I5515, p. 1–16. doi: 10.1136/bmj.l5515. Full text in Research Archive Show summary

  Abstract CLINICAL QUESTION: Recent 15-year updates of sigmoidoscopy screening trials provide new evidence on the effectiveness of colorectal cancer screening. Prompted by the new evidence, we asked: "Does colorectal cancer screening make an important difference to health outcomes in individuals initiating screening at age 50 to 79? And which screening option is best?" CURRENT PRACTICE: Numerous guidelines recommend screening, but vary on recommended test, age and screening frequency. This guideline looks at the evidence and makes recommendations on screening for four screening options: faecal immunochemical test (FIT) every year, FIT every two years, a single sigmoidoscopy, or a single colonoscopy. RECOMMENDATIONS: These recommendations apply to adults aged 50-79 years with no prior screening, no symptoms of colorectal cancer, and a life expectancy of at least 15 years. For individuals with an estimated 15-year colorectal cancer risk below 3%, we suggest no screening (weak recommendation). For individuals with an estimated 15-year risk above 3%, we suggest screening with one of the four screening options: FIT every year, FIT every two years, a single sigmoidoscopy, or a single colonoscopy (weak recommendation). With our guidance we publish the linked research, a graphic of the absolute harms and benefits, a clear description of how we reached our value judgments, and linked decision aids. HOW THIS GUIDELINE WAS CREATED: A guideline panel including patients, clinicians, content experts and methodologists produced these recommendations using GRADE and in adherence with standards for trustworthy guidelines. A linked systematic review of colorectal cancer screening trials and microsimulation modelling were performed to inform the panel of 15-year screening benefits and harms. The panel also reviewed each screening option's practical issues and burdens. Based on their own experience, the panel estimated the magnitude of benefit typical members of the population would value to opt for screening and used the benefit thresholds to inform their recommendations. THE EVIDENCE: Overall there was substantial uncertainty (low certainty evidence) regarding the 15-year benefits, burdens and harms of screening. Best estimates suggested that all four screening options resulted in similar colorectal cancer mortality reductions. FIT every two years may have little or no effect on cancer incidence over 15 years, while FIT every year, sigmoidoscopy, and colonoscopy may reduce cancer incidence, although for FIT the incidence reduction is small compared with sigmoidoscopy and colonoscopy. Screening related serious gastrointestinal and cardiovascular adverse events are rare. The magnitude of the benefits is dependent on the individual risk, while harms and burdens are less strongly associated with cancer risk. UNDERSTANDING THE RECOMMENDATION: Based on benefits, harms, and burdens of screening, the panel inferred that most informed individuals with a 15-year risk of colorectal cancer of 3% or higher are likely to choose screening, and most individuals with a risk of below 3% are likely to decline screening. Given varying values and preferences, optimal care will require shared decision making.

• Jenum, Anne Karen; Brekke, Idunn; Mdala, Ibrahimu; Muilwijk, Mirthe; Ramachandran, Ambady & Kjøllesdal, Marte Karoline Råberg [Show all 19 contributors for this article] (2019). Effects of dietary and physical activity interventions on the risk of type 2 diabetes in South Asians: meta-analysis of individual participant data from randomised controlled trials. Diabetologia. ISSN 0012-186X. 62(8), p. 1337–1348. doi: 10.1007/s00125-019-4905-2. Full text in Research Archive
• Bekkering, Geertruida E.; Agoritsas, Thomas; Lytvyn, Lyubov; Heen, Anja Fog; Feller, Martin & Moutzouri, Elisavet [Show all 21 contributors for this article] (2019). Thyroid hormones treatment for subclinical hypothyroidism: A clinical practice guideline. The BMJ. 365. doi: 10.1136/bmj.l2006. Full text in Research Archive Show summary

  ABSTRACT Clinical question What are the benefits and harms of thyroid hormones for adults with subclinical hypothyroidism (SCH)? This guideline was triggered by a recent systematic review of randomised controlled trials, which could alter practice. Current practice Current guidelines tend to recommend thyroid hormones for adults with thyroid stimulating hormone (TSH) levels >10 mIU/L and for people with lower TSH values who are young, symptomatic, or have specific indications for prescribing. Recommendation The guideline panel issues a strong recommendation against thyroid hormones in adults with SCH (elevated TSH levels and normal free T4 (thyroxine) levels). It does not apply to women who are trying to become pregnant or patients with TSH >20 mIU/L. It may not apply to patients with severe symptoms or young adults (such as those ≤30 years old). How this guideline was created A guideline panel including patients, clinicians, and methodologists produced this recommendation in adherence with standards for trustworthy guidelines using the GRADE approach. The evidence The systematic review included 21 trials with 2192 participants. For adults with SCH, thyroid hormones consistently demonstrate no clinically relevant benefits for quality of life or thyroid related symptoms, including depressive symptoms, fatigue, and body mass index (moderate to high quality evidence). Thyroid hormones may have little or no effect on cardiovascular events or mortality (low quality evidence), but harms were measured in only one trial with few events at two years’ follow-up. Understanding the recommendation The panel concluded that almost all adults with SCH would not benefit from treatment with thyroid hormones. Other factors in the strong recommendation include the burden of lifelong management and uncertainty on potential harms. Instead, clinicians should monitor the progression or resolution of the thyroid dysfunction in these adults. Recommendations are made actionable for clinicians and their patients through visual overviews. These provide the relative and absolute benefits and harms of thyroid hormones in multilayered evidence summaries and decision aids available in MAGIC (https://app.magicapp.org/) to support shared decisions and adaptation of this guideline.

• Hao, Quikui; Devji, Tahira; Zeraatkar, Dena; Wang, Yuting; Qasim, Anila & Siemieniuk, Reed A.C. [Show all 11 contributors for this article] (2019). Minimal important differences for improvement in shoulder condition patient-reported outcomes: A systematic review to inform a BMJ Rapid Recommendation. BMJ Open. 9:e028777(2), p. 1–10. doi: 10.1136/bmjopen-2018-028777. Full text in Research Archive Show summary

  OBJECTIVES: To identify credible anchor-based minimal important differences (MIDs) for patient-reported outcome measures (PROMs) relevant to a BMJ Rapid Recommendations addressing subacromial decompression surgery for shoulder pain. DESIGN: Systematic review. OUTCOME MEASURES: Estimates of anchor-based MIDs, and their credibility, for PROMs judged by the parallel BMJ Rapid Recommendations panel as important for informing their recommendation (pain, function and health-related quality of life (HRQoL)). DATA SOURCES: MEDLINE, EMBASE and PsycINFO up to August 2018. STUDY SELECTION AND REVIEW METHODS: We included original studies of any intervention for shoulder conditions reporting estimates of anchor-based MIDs for relevant PROMs. Two reviewers independently evaluated potentially eligible studies according to predefined selection criteria. Six reviewers, working in pairs, independently extracted data from eligible studies using a predesigned, standardised, pilot-tested extraction form and independently assessed the credibility of included studies using an MID credibility tool. RESULTS: We identified 22 studies involving 5562 patients that reported 74 empirically estimated anchor-based MIDs for 10 candidate instruments to assess shoulder pain, function and HRQoL. We identified MIDs of high credibility for pain and function outcomes and of low credibility for HRQoL. We offered median estimates for the systematic review team who applied these MIDs in Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence summaries and in their interpretations of results in the linked systematic review addressing the effectiveness of surgery for shoulder pain. CONCLUSIONS: Our review provides anchor-based MID estimates, as well as a rating of their credibility, for PROMs for patients with shoulder conditions. The MID estimates inform the interpretation for a linked systematic review and guideline addressing subacromial decompression surgery for shoulder pain, and could also prove useful for authors addressing other interventions for shoulder problems.

• Lamontagne, François; Rochwerg, Bram; Lytvyn, Lyubov; Guyatt, Gordon H.; Møller, Morten Hylander & Annane, Djillali [Show all 24 contributors for this article] (2019). Corticosteroid therapy for sepsis: A clinical practice guideline. The BMJ. 362:k3284 , p. 1–8. doi: 10.1136/bmj.k3284. Full text in Research Archive Show summary

  Do corticosteroids reduce death or improve recovery in people with sepsis or septic shock? Our panel make a weak recommendation to give corticosteroids to people with all types and severity of sepsis, based on new evidence. Because we are not certain that they are beneficial, it is also reasonable not to prescribe them. Patients’ values and preferences may guide this decision-making process. This rapid recommendation was triggered by two trials, with differing conclusions whose results might change practice: • ADRENAL (3658 patients who had septic shock) found no statistically significant difference in 90 day mortality between the hydrocortisone and placebo groups.1 • APROCCHSS (1241 patients who had septic shock) found that hydrocortisone plus fludrocortisone reduced 90 day mortality.2 The trials are incorporated into a linked systematic review comparing corticosteroids with placebo.3 This BMJ Rapid Recommendation promptly and transparently translates this evidence using GRADE methodology for trustworthy guidelines. Sepsis is a life threatening organ dysfunction from infection. C urrently most guidelines advise against WHAT YOU NEED TO KNOW • Sepsis is a syndrome of life threatening infection with organ dysfunction, and most guidelines do not advise use of corticosteroids to treat it in the absence of refractory shock • Two new trials of corticosteroid treatment for sepsis came to differing conclusions • Corticosteroids may reduce the risk of death by a small amount and increase neuromuscular weakness by a small amount, but the evidence is not definitive • This guideline makes a weak recommendation for corticosteroids in patients with sepsis; both steroids and no steroids are reasonable management options • Fully informed patients who value avoiding death over quality of life and function would likely choose corticosteroids No commercial reuse: See rights and reprints http://www.bmj.com/permissions giving corticosteroids in sepsis in the absence of refractory shock, but these guidelines have not taken into account the new evidence. We do not anticipate that new clinical trials will substantively alter the evidence suggesting a small but uncertain mortality reduction. The box below shows publications linked in this Rapid Recommendation package. The main infographic provides an overview of the absolute benefits and harms. The table at the end of the article shows any evidence that has emerged since the publication of this guideline.

• Rochwerg, Bram; Almenawer, Saleh A.; Siemieniuk, Reed Alexander C.; Vandvik, Per Olav; Agoritsas, Thomas & Lytvyn, Lyubov [Show all 22 contributors for this article] (2019). Atraumatic (pencil-point) versus conventional needles for lumbar puncture: A clinical practice guideline. The BMJ. 361. doi: 10.1136/bmj.k1920. Full text in Research Archive
• Lähdeoja, Tuomas; Karjalainen, Teemu; Jokihaara, Jarkko; Salamh, Paul; Kavaja, Lauri & Agarwal, Arnav [Show all 11 contributors for this article] (2019). Subacromial decompression surgery for adults with shoulder pain: A systematic review with meta-analysis. British Journal of Sports Medicine. ISSN 0306-3674. p. 1–10. doi: 10.1136/bjsports-2018-100486. Full text in Research Archive
• Vandvik, Per Olav; Lähdeoja, Tuomas; Ardern, Clare; Buchbinder, Rachelle; Moro, Jaydeep & Brox, Jens Ivar [Show all 20 contributors for this article] (2019). Subacromial decompression surgery for adults with shoulder pain: A clinical practice guideline. The BMJ. 364:I294, p. 1–8. doi: 10.1136/bmj.l294. Full text in Research Archive
• Jodal, Henriette C.; Helsingen, Lise M.; Anderson, Joseph C.; Lytvyn, Lyubov; Vandvik, Per Olav & Emilsson, Louise (2019). Colorectal cancer screening with faecal testing, sigmoidoscopy or colonoscopy: a systematic review and network meta-analysis. BMJ Open. 9(10), p. 1–18. doi: 10.1136/bmjopen-2019-032773. Full text in Research Archive
• Agoritsas, Thomas; Farhoumand, Pauline Darbellay; Siemieniuk, Reed; Heen, Anja Fog; Lytvyn, Lyubov & MacDonald, Helen [Show all 9 contributors for this article] (2019). The BMJ rapid recommendations: Towards a new model for the production of clinical practice guidelines. Revue Medicale Suisse. ISSN 1660-9379. 15(634), p. 149–155. Full text in Research Archive
• Buskermolen, Maaike; Cenin, Dayna R; Helsingen, Lise M.; Guyatt, Gordon; Vandvik, Per Olav & Haug, Ulrike [Show all 8 contributors for this article] (2019). Colorectal cancer screening with faecal immunochemical testing, sigmoidoscopy or colonoscopy: a microsimulation modelling study. The BMJ. 367, p. 1–11. doi: 10.1136/bmj.l5383. Full text in Research Archive
• Dreesens, Dunja; Stiggelbout, Anne; Agoritsas, Thomas; Elwyn, Glyn; Flottorp, Signe Agnes & Grimshaw, Jeremy [Show all 17 contributors for this article] (2019). A conceptual framework for patient-directed knowledge tools to support patient-centred care: Results from an evidence-informed consensus meeting. Patient Education and Counseling. ISSN 0738-3991. 102(10), p. 1898–1904. doi: 10.1016/j.pec.2019.05.003. Full text in Research Archive
• Siemieniuk, Reed A.C.; Chu, Derek K.; Kim, Lisa Ha-Yeon; Güell-Rous, Maria-Rosa; Alhazzani, Waleed & Soccal, Paola M. [Show all 19 contributors for this article] (2019). Oxygen therapy for acutely ill medical patients: A clinical practice guideline. The BMJ. 363:k4169, p. 1–10. doi: 10.1136/bmj.k4169. Full text in Research Archive
• Tikkinen, Kari A.O.; Dahm, Philipp; Lytvyn, Lyubov; Heen, Anja Fog; Vernooij, Robin W.M. & Siemieniuk, Reed A.C. [Show all 19 contributors for this article] (2019). Prostate cancer screening with prostate-specific antigen (PSA) test: A clinical practice guideline. The BMJ. 362:k3581. doi: 10.1136/bmj.k3581. Full text in Research Archive Show summary

  What is the role of prostate-specific antigen (PSA) screening in prostate cancer? An expert panel produced these recommendations based on a linked systematic review.1 The review was triggered by a large scale, cluster randomised trial on PSA screening in men without a previous diagnosis of prostate cancer published in 2018 (box 1).2 It found no difference between one-time PSA screening and standard practice in prostate cancer mortality but found an increase in the detection of low risk prostate cancer after a median follow-up of 10 years. Although the results of this study suggest screening is not worthwhile, several guidelines advocate offering screening in some cases. The study was much larger than previous studies, and existing trials had published more extended follow-up results, and the BMJ Rapid Recommendations team felt these merited a new appraisal of the body of evidence. This guideline aims to promptly and transparently translate potentially practice-changing evidence to usable recommendations for clinicians and patients, based on the GRADE framework and following standards for trustworthy guidelines. The panel suggests against systematic PSA screening (weak recommendation). The panel members judged that most men will decline screening because the benefit is small and uncertain and there are clear harms. However, there is likely considerable variation in values and preferences. Men with family history of prostate cancer, African descent or of lower socioeconomic status, having higher baseline risk of prostate cancer death, may be more likely to choose PSA screening. Shared decision-making is needed for men considering screening. Box 2 shows all of the articles and evidence linked in this Rapid Recommendation package. The main infographic provides an overview of the absolute benefits and harms of PSA screening. The table at the end of the article shows any evidence that has emerged since the publication of this guideline.

• Sun, Xin; Li, Ling; Li, Sheyu; Hao, Qiukui; Wu, Hongmei & Deng, Ke [Show all 14 contributors for this article] (2019). Promoting the rapid creation and effective use of high-quality clinical practice guidelines: MAGIC system and China initiative. Zhongguo Xunzheng Yixue Zazhi. ISSN 1672-2531. 19(1), p. 2–6. doi: 10.7507/1672-2531.201909110. Full text in Research Archive
• Du, Heyue; Li, Xiaodan; Su, Na; Li, Ling; Hao, Xiaoting & Gao, Haihui [Show all 18 contributors for this article] (2019). Proprotein convertase subtilisin/kexin 9 inhibitors in reducing cardiovascular outcomes: A systematic review and meta-analysis. Heart. ISSN 1355-6037. 105(15), p. 1149–1159. doi: 10.1136/heartjnl-2019-314763. Full text in Research Archive
• Karjalainen, Teemu V.; Jain, Nitin B.; Page, Cristina M.; Lähdeoja, Tuomas A.; Johnston, Renea V. & Salamh, Paul [Show all 11 contributors for this article] (2019). Subacromial decompression surgery for rotator cuff disease. Cochrane Database of Systematic Reviews. 2019:CD005619(1), p. 1–87. doi: 10.1002/14651858.CD005619.pub3. Full text in Research Archive
• Fei, Yutong; Guyatt, Gordon Henry; Alexander, Paul Elias; Dib, Regina El; Siemieniuk, Reed A.C. & Vandvik, Per Olav [Show all 13 contributors for this article] (2018). Addition of Ezetimibe to statins for patients at high cardiovascular risk: Systematic review of patient-important outcomes. Journal of Evaluation In Clinical Practice. ISSN 1356-1294. 24(1), p. 222–231. doi: 10.1111/jep.12663. Full text in Research Archive
• Velde, Stijn Rita Patrick van de; Kortteisto, Tiina; Spitaels, David; Jamtvedt, Gro; Roshanov, Pavel & Kunnamo, Ilkka [Show all 9 contributors for this article] (2018). Development of a tailored intervention with computerized clinical decision support to improve quality of care for patients with knee osteoarthritis: Multi-method study. JMIR Research Protocols. 7(6). doi: 10.2196/resprot.9927. Full text in Research Archive Show summary

  Background: Clinical practice patterns greatly diverge from evidence-based recommendations to manage knee osteoarthritis conservatively before resorting to surgery. Objective: This study aimed to tailor a guideline-based computerized decision support (CDS) intervention that facilitates the conservative management of knee osteoarthritis. Methods: Experts with backgrounds in clinical medicine, research, implementation, or health informatics suggested the most important recommendations for implementation, how to develop an implementation strategy, and how to form the CDS algorithms. In 6 focus group sessions, 8 general practitioners and 22 patients from Norway, Belgium, and Finland discussed the suggested CDS intervention and identified factors that would be most critical for the success of the intervention. The focus group moderators used the GUideline Implementation with DEcision Support checklist, which we developed to support consideration of CDS success factors. Results: The experts prioritized 9 out of 22 recommendations for implementation. We formed the concept for 6 CDS algorithms to support implementation of these recommendations. The focus group suggested 59 unique factors that could affect the success of the presented CDS intervention. Five factors (out of the 59) were prioritized by focus group participants in every country, including the perceived potential to address the information needs of both patients and general practitioners; the credibility of CDS information; the timing of CDS for patients; and the need for personal dialogue about CDS between the general practitioner and the patient. Conclusions: The focus group participants supported the CDS intervention as a tool to improve the quality of care for patients with knee osteoarthritis through shared, evidence-based decision making. We aim to develop and implement the CDS based on these study results. Future research should address optimal ways to (1) provide patient-directed CDS, (2) enable more patient-specific CDS within the context of patient complexity, and (3) maintain user engagement with CDS over time.

• Johnston, Bradley C.; Alonso-Coello, Pablo; Bala, Malgorzata M.; Zeraatkar, Dena; Rabassa, Montserrat & Valli, Claudia [Show all 11 contributors for this article] (2018). Methods for trustworthy nutritional recommendations NutriRECS (Nutritional Recommendations and accessible Evidence summaries Composed of Systematic reviews): A protocol. BMC Medical Research Methodology. 18:162, p. 1–11. doi: 10.1186/s12874-018-0621-8. Full text in Research Archive
• Kahale, Lara A.; Diab, Batoul; Brignardello-Petersen, Romina; Agarwal, Arnav; Mustafa, Reem A. & Kwong, Joey [Show all 16 contributors for this article] (2018). Systematic reviews do not adequately report or address missing outcome data in their analyses: a methodological survey. Journal of Clinical Epidemiology. ISSN 0895-4356. 99, p. 14–23. doi: 10.1016/j.jclinepi.2018.02.016. Full text in Research Archive
• Mir, Hassan; Siemieniuk, Reed Alexander C.; Ge, Long Cruz; Foroutan, Farid; Fralick, Michael & Syed, Talha [Show all 12 contributors for this article] (2018). Patent foramen ovale closure, antiplatelet therapy or anticoagulation in patients with patent foramen ovale and cryptogenic stroke: a systematic review and network meta-analysis incorporating complementary external evidence. BMJ Open. 8(7). doi: 10.1136/bmjopen-2018-023761. Full text in Research Archive Show summary

  OBJECTIVE: To examine the relative impact of three management options in patients aged <60 years with cryptogenic stroke and a patent foramen ovale (PFO): PFO closure plus antiplatelet therapy, antiplatelet therapy alone and anticoagulation alone. DESIGN: Systematic review and network meta-analysis (NMA) supported by complementary external evidence. DATA SOURCES: Medline, EMBASE and Cochrane CENTRAL. STUDY SELECTION: Randomised controlled trials (RCTs) addressing PFO closure and/or medical therapies in patients with PFO and cryptogenic stroke. REVIEW METHODS: We conducted an NMA complemented with external evidence and rated certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS: Ten RCTs in eight studies proved eligible (n=4416). Seven RCTs (n=3913) addressed PFO closure versus medical therapy. Of these, three (n=1257) addressed PFO closure versus antiplatelet therapy, three (n=2303) addressed PFO closure versus mixed antiplatelet and anticoagulation therapies and one (n=353) addressed PFO closure versus anticoagulation. The remaining three RCTs (n=503) addressed anticoagulant versus antiplatelet therapy. PFO closure versus antiplatelet therapy probably results in substantial reduction in ischaemic stroke recurrence (risk difference per 1000 patients over 5 years (RD): -87, 95% credible interval (CrI) -100 to -33; moderate certainty). Compared with anticoagulation, PFO closure may confer little or no difference in ischaemic stroke recurrence (low certainty) but probably has a lower risk of major bleeding (RD -20, 95% CrI -27 to -2, moderate certainty). Relative to either medical therapy, PFO closure probably increases the risk of persistent atrial fibrillation (RD 18, 95% CI +5 to +56, moderate certainty) and device-related adverse events (RD +36, 95% CI +23 to +50, high certainty). Anticoagulation, compared with antiplatelet therapy, may reduce the risk of ischaemic stroke recurrence (RD -71, 95% CrI -100 to +17, low certainty), but probably increases the risk of major bleeding (RD +12, 95% CrI -5 to +65, moderate certainty). CONCLUSIONS: In patients aged <60 years, PFO closure probably confers an important reduction in ischaemic stroke recurrence compared with antiplatelet therapy alone but may make no difference compared with anticoagulation. PFO closure incurs a risk of persistent atrial fibrillation and device-related adverse events. Compared with alternatives, anticoagulation probably increases major bleeding. PROSPERO REGISTRATION NUMBER: CRD42017081567.

• Busse, Jason W; Wang, Li; Kamaleldin, Mostafa; Craigie, Samantha; Riva, John J. & Montoya, Luis [Show all 36 contributors for this article] (2018). Opioids for chronic noncancer pain: A systematic review and meta-analysis. JAMA Network Open. 320(23), p. 2448–2460. doi: 10.1001/jama.2018.18472. Full text in Research Archive
• Velde, Stijn Rita Patrick van de; Kunnamo, Ilkka; Roshanov, Pavel; Kortteisto, Tiina; Aertgeerts, Bert & Vandvik, Per Olav [Show all 7 contributors for this article] (2018). The GUIDES checklist: development of a tool to improve the successful use of guideline-based computerised clinical decision support. Implementation Science. 13. doi: 10.1186/s13012-018-0772-3. Full text in Research Archive Show summary

  Background Computerised decision support (CDS) based on trustworthy clinical guidelines is a key component of a learning healthcare system. Research shows that the effectiveness of CDS is mixed. Multifaceted context, system, recommendation and implementation factors may potentially affect the success of CDS interventions. This paper describes the development of a checklist that is intended to support professionals to implement CDS successfully. Methods We developed the checklist through an iterative process that involved a systematic review of evidence and frameworks, a synthesis of the success factors identified in the review, feedback from an international expert panel that evaluated the checklist in relation to a list of desirable framework attributes, consultations with patients and healthcare consumers and pilot testing of the checklist. Results We screened 5347 papers and selected 71 papers with relevant information on success factors for guideline-based CDS. From the selected papers, we developed a 16-factor checklist that is divided in four domains, i.e. the CDS context, content, system and implementation domains. The panel of experts evaluated the checklist positively as an instrument that could support people implementing guideline-based CDS across a wide range of settings globally. Patients and healthcare consumers identified guideline-based CDS as an important quality improvement intervention and perceived the GUIDES checklist as a suitable and useful strategy. Conclusions The GUIDES checklist can support professionals in considering the factors that affect the success of CDS interventions. It may facilitate a deeper and more accurate understanding of the factors shaping CDS effectiveness. Relying on a structured approach may prevent that important factors are missed.

• Vermandere, Mieke; Aertgeerts, Bert; Agoritsas, Thomas; Liu, Catherine; Burgers, Jako & Merglen, Arnaud [Show all 21 contributors for this article] (2018). Antibiotics after incision and drainage for uncomplicated skin abscesses: A clinical practice guideline. BMJ (Clinical Research Edition). ISSN 0959-8138. 360. doi: 10.1136/bmj.k243. Full text in Research Archive
• Neumann, Ignacio; Alonso-Coello, Pablo; Vandvik, Per Olav; Agoritsas, Thomas; Mas, Gemma & Akl, Elie A. [Show all 27 contributors for this article] (2018). Do clinicians want recommendations? A multicenter study comparing evidence summaries with and without GRADE recommendations. Journal of Clinical Epidemiology. ISSN 0895-4356. 99, p. 33–40. doi: 10.1016/j.jclinepi.2018.02.026. Full text in Research Archive
• Prasad, Kameshwar; Siemieniuk, Reed Alexander C.; Hao, Quikui; Guyatt, Gordon H.; O'Donnell, Martin & Lytvyn, Lyubov [Show all 20 contributors for this article] (2018). Dual antiplatelet therapy with aspirin and clopidogrel for acute high risk transient ischaemic attack and minor ischaemic stroke: a clinical practice guideline. BMJ - General Practice Edition. ISSN 0959-8154. 363(k5130). doi: 10.1136/bmj.k5130. Full text in Research Archive
• Velde, Stijn Rita Patrick van de; Heselmans, Annemie; Delvaux, Nicolas; Brandt, Linn; Ruiz, Luis Marco & Spitaels, David [Show all 13 contributors for this article] (2018). A systematic review of trials evaluating success factors of interventions with computerised clinical decision support. Implementation Science. 13. doi: 10.1186/s13012-018-0790-1. Full text in Research Archive Show summary

  BACKGROUND: Computerised clinical decision support (CDS) can potentially better inform decisions, and it can help with the management of information overload. It is perceived to be a key component of a learning health care system. Despite its increasing implementation worldwide, it remains uncertain why the effect of CDS varies and which factors make CDS more effective. OBJECTIVE: To examine which factors make CDS strategies more effective on a number of outcomes, including adherence to recommended practice, patient outcome measures, economic measures, provider or patient satisfaction, and medical decision quality. METHODS: We identified randomised controlled trials, non-randomised trials, and controlled before-and-after studies that directly compared CDS implementation with a given factor to CDS without that factor by searching CENTRAL, MEDLINE, EMBASE, and CINAHL and checking reference lists of relevant studies. We considered CDS with any objective for any condition in any healthcare setting. We included CDS interventions that were either displayed on screen or provided on paper and that were directed at healthcare professionals or targeted at both professionals and patients. The reviewers screened the potentially relevant studies in duplicate. They extracted data and assessed risk of bias in independent pairs or individually followed by a double check by another reviewer. We summarised results using medians and interquartile ranges and rated our certainty in the evidence using the GRADE system. RESULTS: We identified 66 head-to-head trials that we synthesised across 14 comparisons of CDS intervention factors. Providing CDS automatically versus on demand led to large improvements in adherence. Displaying CDS on-screen versus on paper led to moderate improvements and making CDS more versus less patient-specific improved adherence modestly. When CDS interventions were combined with professional-oriented strategies, combined with patient-oriented strategies, or combined with staff-oriented strategies, then adherence improved slightly. Providing CDS to patients slightly increased adherence versus CDS aimed at the healthcare provider only. Making CDS advice more explicit and requiring users to respond to the advice made little or no difference. The CDS intervention factors made little or no difference to patient outcomes. The results for economic outcomes and satisfaction outcomes were sparse. CONCLUSION: Multiple factors may affect the success of CDS interventions. CDS may be more effective when the advice is provided automatically and displayed on-screen and when the suggestions are more patient-specific. CDS interventions combined with other strategies probably also improves adherence. Providing CDS directly to patients may also positively affect adherence. The certainty of the evidence was low to moderate for all factors. TRIAL REGISTRATION: PROSPERO, CRD42016033738.

• Alonso-Coello, Pablo; Oxman, Andrew David; Moberg, Jenny; Brignardello-Petersen, Romina; Akl, Elie A. & Davoli, Marina [Show all 12 contributors for this article] (2018). Marcos GRADE de la evidencia a la decision (EtD): un enfoque sistematico y transparente para tomar decisiones sanitarias bien informadas. 2: Guias de practica clinica. GACETA SANITARIA JOURNAL. ISSN 0213-9111. 32(2), p. 167.e1–167.e10. doi: 10.1016/j.gaceta.2017.03.008. Full text in Research Archive
• Agoritsas, Thomas; Merglen, Arnaud; Heen, Anja Fog; Kristiansen, Annette; Neumann, Ignacio & Brito, Juan Pablo [Show all 11 contributors for this article] (2018). UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 7(11). doi: 10.1136/bmjopen-2017-018593. Full text in Research Archive
• Kuijpers, Ton; Spencer, Frederick A.; Siemieniuk, Reed A.C.; Vandvik, Per Olav; Otto, Catherine M. & Lytvyn, Lyubov [Show all 20 contributors for this article] (2018). Patent foramen ovale closure, antiplatelet therapy or anticoagulation therapy alone for management of cryptogenic stroke? A clinical practice guideline. The BMJ. 362. doi: 10.1136/bmj.k2515. Full text in Research Archive
• Rochwerg, Bram; Oczkowski, Simon; Siemieniuk, Reed Alexander; Menon, Kusum; Szczeklik, Wojciech & English, Shane [Show all 17 contributors for this article] (2017). Corticosteroids in sepsis: An updated systematic review and meta-analysis (protocol). BMJ Open. 7(6). doi: 10.1136/bmjopen-2017-016847. Full text in Research Archive
• Poolman, Rudolf W.; Agoritsas, Thomas; Siemieniuk, Reed A.C.; Harris, Ian A.; Schipper, Inger B. & Mollon, Brent [Show all 16 contributors for this article] (2017). Low intensity pulsed ultrasound (LIPUS) for bone healing: A clinical practice guideline. The BMJ. 356:j576, p. 1–6. doi: 10.1136/bmj.j576. Full text in Research Archive
• Hylands, Mathieu; Toma, Augustin; Beaudoin, Nicolas; Frenette, Anne-Julie; D'Aragon, Frederick & Belley-Côté, Emilie [Show all 22 contributors for this article] (2017). Vasopressor use following traumatic injury: Protocol for a systematic review. BMJ Open. 7:e014166(2), p. 1–6. doi: 10.1136/bmjopen-2016-014166. Full text in Research Archive
• Foroutan, Farid; Guyatt, Gordon H; Otto, Catherine M.; Siemieniuk, Reed A.; Schandelmaier, Stefan & Agoritsas, Thomas [Show all 9 contributors for this article] (2017). Structural valve deterioration after transcatheter aortic valve implantation. Heart. ISSN 1355-6037. 103(23), p. 1899–1905. doi: 10.1136/heartjnl-2017-311329. Full text in Research Archive
• Hylands, Mathieu; Møller, Morten Hylander; Asfar, Pierre; Toma, Augustin; Frenette, Anne-Julie & Beaudoin, Nicolas [Show all 17 contributors for this article] (2017). A systematic review of vasopressor blood pressure targets in critically ill adults with hypotension [Une revue systematique des cibles de tension arterielle sous vasopresseurs chez des adultes gravement malades atteints d'hypotension]. Canadian Journal of Anesthesia. ISSN 0832-610X. 64(7), p. 703–715. doi: 10.1007/s12630-017-0877-1. Full text in Research Archive
• Liu, Jiali; Li, Ling; Deng, Ke; Xu, Chang; Busse, Jason W. & Vandvik, Per Olav [Show all 9 contributors for this article] (2017). Incretin based treatments and mortality in patients with type 2 diabetes: Systematic review and meta-analysis. The BMJ. 357(j2499), p. 1–9. doi: 10.1136/bmj.j2499. Full text in Research Archive Show summary

  Objective To assess the impact of incretin based treatment on all cause mortality in patients with type 2 diabetes. Design Systematic review and meta-analysis of randomised trials. Data sources Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov. Eligibility criteria Randomised controlled trials that compared glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors with placebo or active anti-diabetic drugs in patients with type 2 diabetes. Data collection and analysis Paired reviewers independently screened citations, assessed risk of bias of included studies, and extracted data. Peto’s method was used as the primary approach to pool effect estimates from trials, sensitivity analyses were carried out with other statistical approaches, and meta-regression was applied for six prespecified hypotheses to explore heterogeneity. The GRADE approach was used to rate the quality of evidence. Results 189 randomised controlled trials (n=155 145) were included, all of which were at low to moderate risk of bias; 77 reported no events of death and 112 reported 3888 deaths among 151 614 patients. Meta-analysis of 189 trials showed no difference in all cause mortality between incretin drugs versus control (1925/84 136 v 1963/67 478; odds ratio 0.96, 95% confidence interval 0.90 to 1.02, I2=0%; risk difference 3 fewer events (95% confidence interval 7 fewer to 1 more) per 1000 patients over five years; moderate quality evidence). Results suggested the possibility of a mortality benefit with GLP-1 agonists but not DPP-4 inhibitors, but the subgroup hypothesis had low credibility. Sensitivity analyses showed no important differences in the estimates of effects. Conclusions Current evidence does not support the suggestion that incretin based treatment increases all cause mortality in patients with type 2 diabetes. Further studies are warranted to examine if the effect differs between GLP-1 agonists versus DPP-4 inhibitors.

• Busse, Jason W.; Craigie, Samantha; Juurlink, David N; Buckley, D. Norman; Li, Wang & Couban, Rachel J [Show all 20 contributors for this article] (2017). Guideline for opioid therapy and chronic noncancer pain. CMAJ - Canadian Medical Association Journal. ISSN 0820-3946. 189(18), p. E659–E666. doi: 10.1503/cmaj.170363. Full text in Research Archive
• Kasper, Jürgen; Lager, Anne Regine; Rumpsfeld, Markus; Kienlin, Simone Maria; Smestad, Kristine Hoel & Bråthen, Tone [Show all 15 contributors for this article] (2017). Statusbericht aus Norwegen: Implementierung von Patientenbeteiligung im norwegischen Gesundheitswesen [Status report from Norway: Implementation of patient involvement in Norwegian health care]. Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen. ISSN 1865-9217. 123-124, p. 75–80. doi: 10.1016/j.zefq.2017.05.015. Full text in Research Archive
• Rochwerg, Bram; Hylands, Mathieu; Møller, Morten; Asfar, Pierre; Cohen, Dian & Khadaroo, Rachel G. [Show all 13 contributors for this article] (2017). CCCS-SSAI WikiRecs Clinical Practice Guideline: vasopressor blood pressure targets in critically ill adults with hypotension. Canadian Journal of Anesthesia. ISSN 0832-610X. 64(7), p. 763–765. doi: 10.1007/s12630-017-0878-0. Full text in Research Archive
• Rochwerg, Bram; Hylands, Mathieu; Møller, Morten; Asfar, Pierre; Cohen, Dian & Khadaroo, Rachel G. [Show all 13 contributors for this article] (2017). CCCS-SSAI WikiRecs Clinical Practice Guideline: vasopressors in early traumatic shock. Canadian Journal of Anesthesia. ISSN 0832-610X. 64(7), p. 766–768. doi: 10.1007/s12630-017-0879-z. Full text in Research Archive
• Sadeghirad, Behnam; Siemieniuk, Reed A C; Brignardello-Petersen, Romina; Papola, Davide; Lytvyn, Lyubov & Vandvik, Per Olav [Show all 9 contributors for this article] (2017). Corticosteroids for treatment of sore throat: systematic review and meta-analysis of randomised trials. The BMJ. 358, p. j3887–j3887. doi: 10.1136/bmj.j3887. Full text in Research Archive
• Doust, Jenny; Vandvik, Per Olav; Qaseem, Amir; Mustafa, Reem A.; Horvath, Andrea R. & Frances, Allen [Show all 13 contributors for this article] (2017). Guidance for modifying the definition of diseases: A checklist. JAMA Internal Medicine. ISSN 2168-6106. 177(7), p. 1020–1025. doi: 10.1001/jamainternmed.2017.1302. Full text in Research Archive
• Devji, Tahira; Guyatt, Gordon H; Lytvyn, Lyubov; Brignardello-Petersen, Romina; Foroutan, Farid & Sadeghirad, Behnam [Show all 12 contributors for this article] (2017). Application of minimal important differences in degenerative knee disease outcomes: A systematic review and case study to inform BMJ Rapid Recommendations. BMJ Open. 7(5). doi: 10.1136/bmjopen-2016-015587. Full text in Research Archive
• Brandt, Linn; Vandvik, Per Olav; Alonso-Coello, Pablo; Akl, Elie A.; Thornton, Judith & Rigau, David [Show all 10 contributors for this article] (2017). Multilayered and digitally structured presentation formats of trustworthy recommendations: a combined survey and randomised trial. BMJ Open. 7(2), p. 1–10. doi: 10.1136/bmjopen-2016-011569. Full text in Research Archive Show summary

  Objectives To investigate practicing physicians' preferences, perceived usefulness and understanding of a new multilayered guideline presentation format—compared to a standard format—as well as conceptual understanding of trustworthy guideline concepts. Design Participants attended a standardised lecture in which they were presented with a clinical scenario and randomised to view a guideline recommendation in a multilayered format or standard format after which they answered multiple-choice questions using clickers. Both groups were also presented and asked about guideline concepts. Setting Mandatory educational lectures in 7 non-academic and academic hospitals, and 2 settings involving primary care in Lebanon, Norway, Spain and the UK. Participants 181 practicing physicians in internal medicine (156) and general practice (25). Interventions A new digitally structured, multilayered guideline presentation format and a standard narrative presentation format currently in widespread use. Primary and secondary outcome measures Our primary outcome was preference for presentation format. Understanding, perceived usefulness and perception of absolute effects were secondary outcomes. Results 72% (95% CI 65 to 79) of participants preferred the multilayered format and 16% (95% CI 10 to 22) preferred the standard format. A majority agreed that recommendations (multilayered 86% vs standard 91%, p value=0.31) and evidence summaries (79% vs 77%, p value=0.76) were useful in the context of the clinical scenario. 72% of participants randomised to the multilayered format vs 58% for standard formats reported correct understanding of the recommendations (p value=0.06). Most participants elected an appropriate clinical action after viewing the recommendations (98% vs 92%, p value=0.10). 82% of the participants considered absolute effect estimates in evidence summaries helpful or crucial. Conclusions Clinicians clearly preferred a novel multilayered presentation format to the standard format. Whether the preferred format improves decision-making and has an impact on patient important outcomes merits further investigation.

• Bagur, Rodrigo; Solo, Karla; Alghofaili, Saleh; Nombela-Franco, Luis; Kwok, Chun Shing & Hayman, Samual [Show all 12 contributors for this article] (2017). Cerebral embolic protection devices during transcatheter aortic valve implantation: systematic review and meta-analysis. Stroke. ISSN 0039-2499. 48(5), p. 1306–1315. doi: 10.1161/STROKEAHA.116.015915. Full text in Research Archive
• Schandelmaier, Stefan; Tomonaga, Yuki; Bassler, Dirk; Meerpohl, Jörg J.; Elm, Erik von & You, John J. [Show all 39 contributors for this article] (2017). Premature discontinuation of pediatric randomized controlled trials: a retrospective cohort study. Journal of Pediatrics. ISSN 0022-3476. 184, p. 209–214.e1. doi: 10.1016/j.jpeds.2017.01.071. Full text in Research Archive
• Brignardello-Petersen, Romina; Guyatt, Gordon H.; Buchbinder, Rachelle; Poolman, Rudolf W.; Schandelmaier, Stefan & Chang, Yaping [Show all 9 contributors for this article] (2017). Knee arthroscopy versus conservative management in patients with degenerative knee disease: A systematic review. BMJ Open. 7(5), p. 1–13. doi: 10.1136/bmjopen-2017-016114. Full text in Research Archive
• Hylands, Mathieu; Toma, Augustin; Beaudoin, Nicolas; Frenette, Anne Julie; D'Aragon, Frédérick & Belley-Côté, Émilie [Show all 22 contributors for this article] (2017). Early vasopressor use following traumatic injury: A systematic review. BMJ Open. 7(11). doi: 10.1136/bmjopen-2017-017559. Full text in Research Archive
• Johnston, Bradley C.; Alonso-Coello, Pablo; Friedrich, Jan O.; Mustafa, Reem A.; Tikkinen, Kari A.O. & Neumann, Ignacio [Show all 16 contributors for this article] (2016). Do clinicians understand the size of treatment effects? A randomized survey across 8 countries. CMAJ - Canadian Medical Association Journal. ISSN 0820-3946. 188(1), p. 25–32. doi: 10.1503/cmaj.150430. Full text in Research Archive
• Carrasco-Labra, Alonso; Brignardello-Petersen, Romina; Santesso, Nancy; Neumann, Ignacio; Mustafa, Reem A. & Mbuagbaw, Lawrence [Show all 23 contributors for this article] (2016). Improving GRADE evidence tables part 1: A randomized trial shows improved understanding of content in summary of findings tables with a new format. Journal of Clinical Epidemiology. ISSN 0895-4356. 74, p. 7–18. doi: 10.1016/j.jclinepi.2015.12.007. Full text in Research Archive
• Alexander, Paul E.; Barty, Rebecca L.; Fei, Yutong; Vandvik, Per Olav; Pai, Menaka & Siemieniuk, Reed A.C. [Show all 12 contributors for this article] (2016). Transfusion of fresher vs older red blood cells in hospitalized patients: A systematic review and meta-analysis. Blood. ISSN 0006-4971. 127(4), p. 400–410. doi: 10.1182/blood-2015-09-670950. Full text in Research Archive
• Li, Ling; Li, Sheyu; Deng, Ke; Liu, Jiali; Vandvik, Per Olav & Zhao, Pujing [Show all 19 contributors for this article] (2016). Dipeptidyl peptidase-4 inhibitors and risk of heart failure in type 2 diabetes: Systematic review and meta-analysis of randomised and observational studies. The BMJ. 352. doi: 10.1136/bmj.i610. Full text in Research Archive Show summary

  Objectives To examine the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and the risk of heart failure or hospital admission for heart failure in patients with type 2 diabetes. Design Systematic review and meta-analysis of randomised and observational studies. Data sources Medline, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov searched up to 25 June 2015, and communication with experts. Eligibility criteria Randomised controlled trials, non-randomised controlled trials, cohort studies, and case-control studies that compared DPP-4 inhibitors against placebo, lifestyle modification, or active antidiabetic drugs in adults with type 2 diabetes, and explicitly reported the outcome of heart failure or hospital admission for heart failure. Data collection and analysis Teams of paired reviewers independently screened for eligible studies, assessed risk of bias, and extracted data using standardised, pilot tested forms. Data from trials and observational studies were pooled separately; quality of evidence was assessed by the GRADE approach. Results Eligible studies included 43 trials (n=68 775) and 12 observational studies (nine cohort studies, three nested case-control studies; n=1 777 358). Pooling of 38 trials reporting heart failure provided low quality evidence for a possible similar risk of heart failure between DPP-4 inhibitor use versus control (42/15 701 v 33/12 591; odds ratio 0.97 (95% confidence interval 0.61 to 1.56); risk difference 2 fewer (19 fewer to 28 more) events per 1000 patients with type 2 diabetes over five years). The observational studies provided effect estimates generally consistent with trial findings, but with very low quality evidence. Pooling of the five trials reporting admission for heart failure provided moderate quality evidence for an increased risk in patients treated with DPP-4 inhibitors versus control (622/18 554 v 552/18 474; 1.13 (1.00 to 1.26); 8 more (0 more to 16 more)). The pooling of adjusted estimates from observational studies similarly suggested (with very low quality evidence) a possible increased risk of admission for heart failure (adjusted odds ratio 1.41, 95% confidence interval 0.95 to 2.09) in patients treated with DPP-4 inhibitors (exclusively sitagliptin) versus no use. Conclusions The relative effect of DPP-4 inhibitors on the risk of heart failure in patients with type 2 diabetes is uncertain, given the relatively short follow-up and low quality of evidence. Both randomised controlled trials and observational studies, however, suggest that these drugs may increase the risk of hospital admission for heart failure in those patients with existing cardiovascular diseases or multiple risk factors for vascular diseases, compared with no use.

• Claesson, Jonas; Freundlich, Morten; Gunnarsson, Ivar; Laake, Jon Henrik; Møller, Morten Hylander & Vandvik, Per Olav [Show all 8 contributors for this article] (2016). Scandinavian clinical practice guideline on fluid and drug therapy in adults with acute respiratory distress syndrome. Acta Anaesthesiologica Scandinavica. ISSN 0001-5172. 60(6), p. 697–709. doi: 10.1111/aas.12713. Full text in Research Archive
• Sallinen, V; Akl, EA; You, JJ; Agarwal, A; Shoucair, S & Vandvik, Per Olav [Show all 10 contributors for this article] (2016). Meta‐analysis of antibiotics versus appendicectomy for non‐perforated acute appendicitis. British Journal of Surgery. ISSN 0007-1323. 103(6), p. 656–667. doi: 10.1002/bjs.10147. Full text in Research Archive
• Blümle, Anette; Schandelmaier, Stefan; Oeller, Patrick; Kasenda, Benjamin; Briel, Matthias & Elm, Erik von [Show all 40 contributors for this article] (2016). Premature discontinuation of prospective clinical studies approved by a research ethics committee - A comparison of randomised and non-randomised studies. PLOS ONE. 11(10). doi: 10.1371/journal.pone.0165605. Full text in Research Archive
• Dib, Regina El; Spencer, Frederick Alan; Suzumura, Erica Aranha; Goma, Huda; Kwong, Joey & Guyatt, Gordon Henry [Show all 7 contributors for this article] (2016). Aspiration thrombectomy prior to percutaneous coronary intervention in ST-elevation myocardial infarction: A systematic review and meta-analysis. BMC Cardiovascular Disorders. 16:121. doi: 10.1186/s12872-016-0285-4. Full text in Research Archive
• Foroutan, Farid; Guyatt, Gordon H.; O'Brien, Kathleen; Bain, Eva; Stein, Madeleine & Bhagra, Sai [Show all 18 contributors for this article] (2016). Prognosis after surgical replacement with a bioprosthetic aortic valve in patients with severe symptomatic aortic stenosis: Systematic review of observational studies. The BMJ. 354. doi: 10.1136/bmj.i5065. Full text in Research Archive Show summary

  Abstract Objective To determine the frequency of survival, stroke, atrial fibrillation, structural valve deterioration, and length of hospital stay after surgical replacement of an aortic valve (SAVR) with a bioprosthetic valve in patients with severe symptomatic aortic stenosis. Design Systematic review and meta-analysis of observational studies. Data sources Medline, Embase, PubMed (non-Medline records only), Cochrane Database of Systematic Reviews, and Cochrane CENTRAL from 2002 to June 2016. Study selection Eligible observational studies followed patients after SAVR with a bioprosthetic valve for at least two years. Methods Reviewers, independently and in duplicate, evaluated study eligibility, extracted data, and assessed risk of bias for patient important outcomes. We used the GRADE system to quantify absolute effects and quality of evidence. Published survival curves provided data for survival and freedom from structural valve deterioration, and random effect models provided the framework for estimates of pooled incidence rates of stroke, atrial fibrillation, and length of hospital stay. Results In patients undergoing SAVR with a bioprosthetic valve, median survival was 16 years in those aged 65 or less, 12 years in those aged 65 to 75, seven years in those aged 75 to 85, and six years in those aged more than 85. The incidence rate of stroke was 0.25 per 100 patient years (95% confidence interval 0.06 to 0.54) and atrial fibrillation 2.90 per 100 patient years (1.78 to 4.79). Post-SAVR, freedom from structural valve deterioration was 94.0% at 10 years, 81.7% at 15 years, and 52% at 20 years, and mean length of hospital stay was 12 days (95% confidence interval 9 to 15). Conclusion Patients with severe symptomatic aortic stenosis undergoing SAVR with a bioprosthetic valve can expect only slightly lower survival than those without aortic stenosis, and a low incidence of stroke and, up to 10 years, of structural valve deterioration. The rate of deterioration increases rapidly after 10 years, and particularly after 15 years.

• Schandelmaier, Stefan; Elm, Erik von; You, JJ; Blümle, Anette; Tomonaga, Yuki & Lamontagne, Francois [Show all 40 contributors for this article] (2016). Premature discontinuation of randomized trials in critical and emergency care: A retrospective cohort study. Critical Care Medicine. ISSN 0090-3493. 44(1), p. 130–137. doi: 10.1097/CCM.0000000000001369. Full text in Research Archive
• Lytvyn, Lyubov; Guyatt, Gordon H; Manja, Veena; Siemieniuk, Reed A.; Zhang, Yuan & Agoritsas, Thomas [Show all 7 contributors for this article] (2016). Patient values and preferences on transcatheter or surgical aortic valve replacement therapy for aortic stenosis: a systematic review. BMJ Open. 6(9). doi: 10.1136/bmjopen-2016-014327. Full text in Research Archive
• Vandvik, Per Olav & Guyatt, Gordon H (2016). Review: In severe aortic stenosis, TAVI and conventional surgery do not differ for ≤ 30-day or ≤ 1-year mortality. Annals of Internal Medicine. ISSN 0003-4819. 165(6). doi: 10.7326/ACPJC-2016-165-6-031. Full text in Research Archive
• Velde, Stijn Van De; Roshanov, Paul; Kortteisto, Tiina; Kunnamo, Ilkka; Aertgeerts, Bert & Vandvik, Per Olav [Show all 7 contributors for this article] (2016). Tailoring implementation strategies for evidence-based recommendations using computerised clinical decision support systems: protocol for the development of the GUIDES tools. Implementation Science. 11:29, p. 1–8. doi: 10.1186/s13012-016-0393-7. Full text in Research Archive
• Li, L; Li, S; Liu, J; Deng, K; Busse, JW & Vandvik, Per Olav [Show all 19 contributors for this article] (2016). Glucagon-like peptide-1 receptor agonists and heart failure in type 2 diabetes: systematic review and meta-analysis of randomized and observational studies. BMC Cardiovascular Disorders. 16. doi: 10.1186/s12872-016-0260-0. Full text in Research Archive
• Agarwal, Arnav; Johnston, Bradley C.; Vernooij, Robin W.M.; Carrasco-Labra, Alonso; Brignardello-Petersen, Romina & Neumann, Ignacio [Show all 28 contributors for this article] (2016). Authors seldom report the most patient-important outcomes and absolute effect measures in systematic review abstracts. Journal of Clinical Epidemiology. ISSN 0895-4356. 81, p. 3–12. doi: 10.1016/j.jclinepi.2016.08.004. Full text in Research Archive
• Alonso-Coello, Pablo; Carrasco-Labra, Alonso; Brignardello-Petersen, Romina; Neumann, Ignacio; Akl, Elie A. & Vernooij, Robin W.M. [Show all 27 contributors for this article] (2016). Systematic reviews experience major limitations in reporting absolute effects. Journal of Clinical Epidemiology. ISSN 0895-4356. 72, p. 16–26. doi: 10.1016/j.jclinepi.2015.11.002. Full text in Research Archive
• Alonso-Coello, Pablo; Oxman, Andrew David; Moberg, Jenny; Brignardello-Petersen, Romina; Akl, Elie A & Davoli, Marina [Show all 12 contributors for this article] (2016). GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ (Clinical Research Edition). ISSN 0959-8138. 353. doi: 10.1136/bmj.i2089. Full text in Research Archive
• Neumann, Ignacio; Santesso, Nancy; Akl, Elie A.; Rind, David M.; Vandvik, Per Olav & Alonso-Coello, Pablo [Show all 11 contributors for this article] (2016). A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. Journal of Clinical Epidemiology. ISSN 0895-4356. 72, p. 45–55. doi: 10.1016/j.jclinepi.2015.11.017. Full text in Research Archive
• Kasenda, Benjamin; Elm, Erik von; You, John J.; Blümle, Anette; Tomonaga, Yuki & Saccilotto, Ramon [Show all 38 contributors for this article] (2016). Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. PLoS Medicine. ISSN 1549-1277. 13:e1002046(6), p. 1–14. doi: 10.1371/journal.pmed.1002046. Full text in Research Archive
• Mulla, Sohail M.; Maqbool, Amna; Sivananthan, Laxsanaa; Lopes, Luciane Cruz; Schandelmaier, Stefan & Kamaleldin, Mostafa [Show all 21 contributors for this article] (2015). Reporting of IMMPACT-recommended core outcome domains among trials assessing opioids for chronic non-cancer pain. Pain. ISSN 0304-3959. 156(9), p. 1615–1619. doi: 10.1097/j.pain.0000000000000241. Full text in Research Archive
• Berntsen, Christopher Friis; Kristiansen, Annette; Akl, Elie A; Sandset, Per Morten; Jacobsen, Eva-Marie & Guyatt, Gordon [Show all 7 contributors for this article] (2015). Compression Stockings for Preventing the Postthrombotic Syndrome in Patients with Deep Vein Thrombosis. American Journal of Medicine. ISSN 0002-9343. 129(4), p. 447.e1–447.e20. doi: 10.1016/j.amjmed.2015.11.031. Full text in Research Archive Show summary

  OBJECTIVE: We conducted a systematic review and meta-analysis to address benefits and harms of using elastic compression stockings after lower-extremity deep vein thrombosis. METHODS: We searched 7 electronic databases through January 15, 2015, including randomized controlled trials (RCTs)/quasi-randomized trials reporting on elastic compression stocking efficacy on postthrombotic syndrome incidence, recurrent venous thromboembolism, mortality, and acute pain after deep vein thrombosis. Two reviewers independently screened records, extracted data, assessed risk of bias, and assessed confidence in effect estimates using Grading of Recommendations Assessment, Development, and Evaluation methodology. We applied random-effects meta-analysis models. RESULTS: We included 5 RCTs (n = 1418) reporting on postthrombotic syndrome. The hazard ratio (HR) for postthrombotic syndrome with elastic compression stockings was 0.69 (95% confidence interval [CI], 0.47-1.02). We have very low confidence in this estimate due to heterogeneity and inclusion of unblinded studies at high risk of bias. Excluding high risk of bias studies, a single large RCT at low risk of bias provided moderate-quality evidence of no effect on postthrombotic syndrome (HR 1.00; 95% CI, 0.81-1.24). Moderate-quality evidence including all 5 studies suggests no effect of elastic compression stockings on recurrent venous thromboembolism (relative risk [RR] 0.88; 95% CI, 0.63-1.24) or mortality (RR 1.00; 95% CI, 0.73-1.37, 5 studies). Moderate-quality evidence from one large RCT does not suggest effect on acute pain after deep vein thrombosis. CONCLUSIONS: The highest-quality evidence available suggests no effect of elastic compression stockings on postthrombotic syndrome or pain relief, from a single large RCT. However, results for preventing postthrombotic syndrome differ substantially across studies, and future guideline updates should reflect uncertainty about treatment effects. Elastic compression stockings are unlikely to prevent death or recurrent venous thromboembolism.

• Rosenthal, Rachel; Kasenda, Benjamin; Dell-Kuster, Salome; Elm, Erik B. von; You, John & Blümle, Anette [Show all 40 contributors for this article] (2015). Completion and Publication Rates of Randomized Controlled Trials in Surgery: An Empirical Study. Annals of Surgery. ISSN 0003-4932. 262(1), p. 68–73. doi: 10.1097/SLA.0000000000000810. Full text in Research Archive Show summary

  Objective: To investigate the prevalence of discontinuation and nonpublication of surgical versus medical randomized controlled trials (RCTs) and to explore risk factors for discontinuation and nonpublication of surgical RCTs. Background: Trial discontinuation has significant scientific, ethical, and economic implications. To date, the prevalence of discontinuation of surgical RCTs is unknown. Methods: All RCT protocols approved between 2000 and 2003 by 6 ethics committees in Canada, Germany, and Switzerland were screened. Baseline characteristics were collected and, if published, full reports retrieved. Risk factors for early discontinuation for slow recruitment and nonpublication were explored using multivariable logistic regression analyses. Results: In total, 863 RCT protocols involving adult patients were identified, 127 in surgery (15%) and 736 in medicine (85%). Surgical trials were discontinued for any reason more often than medical trials [43% vs 27%, risk difference 16% (95% confidence interval [CI]: 5%-26%); P = 0.001] and more often discontinued for slow recruitment [18% vs 11%, risk difference 8% (95% CI: 0.1%-16%); P = 0.020]. The percentage of trials not published as full journal article was similar in surgical and medical trials (44% vs 40%, risk difference 4% (95% CI: -5% to 14%); P = 0.373). Discontinuation of surgical trials was a strong risk factor for nonpublication (odds ratio = 4.18, 95% CI: 1.45-12.06; P = 0.008). Conclusions: Discontinuation and nonpublication rates were substantial in surgical RCTs and trial discontinuation was strongly associated with nonpublication. These findings need to be taken into account when interpreting surgical literature. Surgical trialists should consider feasibility studies before embarking on full-scale trials.

• Kristiansen, Annette; Brandt, Linn; Alonso-Coello, Pablo; Agoritsas, Thomas; Akl, Elie A. & Conboy, Tara [Show all 16 contributors for this article] (2015). Development of a novel, multilayered presentation format for clinical practice guidelines. Chest. ISSN 0012-3692. 147(3), p. 754–763. doi: 10.1378/chest.14-1366. Full text in Research Archive Show summary

  Background: Bridging the gap between clinical research and everyday healthcare practice requires effective communication strategies. To address current shortcomings in conveying practice recommendations and supporting evidence, we are creating and testing presentation formats for clinical practice guidelines (CPGs). Methods: We carried out multiple cycles of brainstorming and sketching, developing a prototype. Physicians participating in the user testing viewed CPG formats linked to clinical scenarios and engaged in semi-structured interviews applying a think-aloud method for exploring important aspects of user experience. Results: We developed a multilayered presentation format that allows clinicians to successively view more in depth information. Starting with the recommendations clinicians can on demand access a rationale and a key information section containing statements on quality of the evidence, balance between desirable and undesirable consequences, values and preferences, and resource considerations. We collected feedback from 27 stakeholders and performed user testing with 47 practicing physicians from six countries. Advisory group feedback and user testing of the first version revealed problems with conceptual understanding of underlying CPG methodology, as well as difficulties with the complexity of the layout and content. Extensive revisions made before the second round of user testing resulted in most participants expressing overall satisfaction with the final presentation format. Conclusion: We have developed an electronic multilayered CPG format that enhances the usability of CPGs for front-line clinicians. We have implemented the format in electronic guideline tools which guideline organizations can now use when authoring and publishing their guidelines.

• Carrasco-Labra, Alonso; Brignardello-Petersen, Romina; Santesso, Nancy; Neumann, Ignacio; Mustafa, Reem A. & Mbuagbaw, Lawrence [Show all 22 contributors for this article] (2015). Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users: Study protocol for a randomized controlled trial. Trials. 16(1). doi: 10.1186/s13063-015-0649-6. Full text in Research Archive
• Claesson, J.; Freundlich, M.; Gunnarsson, I.; Laake, Jon Henrik; Vandvik, Per Olav & Varpula, T. [Show all 7 contributors for this article] (2015). Scandinavian clinical practice guideline on mechanical ventilation in adults with the acute respiratory distress syndrome. Acta Anaesthesiologica Scandinavica. ISSN 0001-5172. 59(3), p. 286–297. doi: 10.1111/aas.12449. Full text in Research Archive
• Michaelsen, Vilde Lehne; Vandvik, Per Olav & Farup, Per Grønaas (2015). Predictors of health-related quality of life in patients with irritable bowel syndrome. A cross-sectional study in Norway. Health and Quality of Life Outcomes. 13(1). doi: 10.1186/s12955-015-0311-8. Full text in Research Archive Show summary

  Background: Reduced quality of life (QoL) is often the main problem for patients with irritable bowel syndrome (IBS). This study aimed at finding predictors of reduced physical and mental quality of life (QoL) accessible for intervention. Methods: Consecutive patients with IBS (according to the Rome II criteria) visiting a general practitioner were included in a prospective cohort study and followed up for 6−9 months. At the last visit, information about sociodemographic characteristics, abdominal complaints, QoL and a range of physical and mental comorbidities were collected. Physical and mental QoL were measured with the generic QoL instrument Short Form-12 Physical Component Score (SF-12 PCS) and Short Form-12 Mental Component Score (SF-12 MCS) respectively. The normal scores are 50. This cross-sectional study used data from the last visit. Results: Out of 208 patients included in the cohort study, 149 (female/male: 105/44) with a mean age of 52 years (SD 15.3) were available for the analyses. Physical and mental QoL were reduced, the mean SF-12 PCS and SF-12 MCS scores were 38.4 (SD 11.9) and 45.0 (SD 11.3) respectively. The main independent predictors of low SF-12 PCS and SF-12 MCS were subjective health complaints and organic diseases, and affective disorders respectively. The severity of IBS symptoms was of minor clinical importance. Conclusions: To help patients with IBS and reduced QoL, treatment should focus on QoL and not on relief of IBS symptoms. The different causes of reduced physical and mental QoL make an individually directed treatment necessary.

• Spencer, Frederick A.; Prasad, Manya; Vandvik, Per Olav; Chetan, Devin; Zhou, Qi & Guyatt, Gordon (2015). Longer-versus shorter-duration dual-antiplatelet therapy after drug-eluting stent placement a systematic review and meta-analysis. Annals of Internal Medicine. ISSN 0003-4819. 163(2), p. 118–126. doi: 10.7326/M15-0083. Full text in Research Archive
• Akl, Elie A.; Kahale, Lara A.; Agoritsas, Thomas; Brignardello-Petersen, Romina; Busse, Jason W. & Carrasco-Labra, Alonso [Show all 15 contributors for this article] (2015). Handling trial participants with missing outcome data when conducting a meta-analysis: A systematic survey of proposed approaches. Systematic Reviews. 4:98. doi: 10.1186/s13643-015-0083-6. Full text in Research Archive
• Akl, Elie A.; Carrasco-Labra, Alonso; Brignardello-Petersen, Romina; Neumann, Ignacio; Johnston, Bradley C. & Sun, Xin [Show all 25 contributors for this article] (2015). Reporting, handling and assessing the risk of bias associated with missing participant data in systematic reviews: A methodological survey. BMJ Open. 5:e009368(9). doi: 10.1136/bmjopen-2015-009368. Full text in Research Archive
• Akl, Elie A.; Shawwa, Khaled; Kahale, Lara A.; Agoritsas, Thomas; Brignardello-Petersen, Romina & Busse, Jason W. [Show all 16 contributors for this article] (2015). Reporting missing participant data in randomised trials: Systematic survey of the methodological literature and a proposed guide. BMJ Open. 5:e008431(12). doi: 10.1136/bmjopen-2015-008431. Full text in Research Archive
• Schandelmaier, Stefan; Conen, Katrin L.; Elm, Erik von; You, John J.; Blümle, Anette & Tomonaga, Yuki [Show all 10 contributors for this article] (2015). Planning and reporting of quality-of-life outcomes in cancer trials. Annals of Oncology. ISSN 0923-7534. 26(9), p. 1966–1973. doi: 10.1093/annonc/mdv283. Full text in Research Archive
• Agoritsas, Thomas; Heen, Anja Fog; Brandt, Linn; Alonso-Coello, Pablo; Kristiansen, Annette & Akl, Elie A. [Show all 13 contributors for this article] (2015). Decision aids that really promote shared decision making: the pace quickens. The BMJ. doi: 10.1136/bmj.g7624. Full text in Research Archive
• Iorio, Alfonso; Spencer, Frederick A.; Falavigna, Maicon; Alba, Carolina; Lang, Eddie & Burnand, Bernard [Show all 17 contributors for this article] (2015). Use of GRADE for assessment of evidence about prognosis: Rating confidence in estimates of event rates in broad categories of patients. The BMJ. 350;h870. doi: 10.1136/bmj.h870. Full text in Research Archive
• Elwyn, Glyn; Quinlan, Casey; Mulley, A.; Agoritsas, Thomas; Vandvik, Per Olav & Guyatt, Gordon (2015). Trustworthy guidelines - excellent; customized care tools - even better. BMC Medicine. 13(1). doi: 10.1186/s12916-015-0436-y. Full text in Research Archive
• Perner, Anders; Junttila, Eija K.; Haney, Michael F.; Hreinsson, Kári; Kvåle, Reidar & Vandvik, Per Olav [Show all 7 contributors for this article] (2015). Scandinavian clinical practice guideline on choice of fluid in resuscitation of critically ill patients with acute circulatory failure. Acta Anaesthesiologica Scandinavica. ISSN 0001-5172. 59(3), p. 274–285. doi: 10.1111/aas.12429. Full text in Research Archive Show summary

  Background The task force on Acute Circulatory Failure of the Scandinavian Society of Anaesthesiology and Intensive Care Medicine produced this guideline with recommendations concerning the use of crystalloid vs. colloid solutions in adult critically ill patients with acute circulatory failure. Methods Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to grade the quality of evidence and to determine the strengths of the recommendations. As efficacy and harm may vary in different subpopulations of patients with acute circulatory failure, we produced recommendations for general intensive care unit (ICU) patients and those with sepsis, trauma and burn injury. Results For general ICU patients and those with sepsis, we recommend using crystalloids for resuscitation rather than hydroxyethyl starch and we suggest using crystalloids rather than gelatin and albumin. For patients with trauma we recommend to use crystalloids for resuscitation rather than colloid solutions. For patients with burn injury we provide no recommendations as there are very limited data from randomised trials on fluid resuscitation in this patient population. Conclusions We recommend using crystalloid solutions rather than colloid solutions for resuscitation in the majority of critically ill patients with acute circulatory failure.

• Vandvik, Per Olav; Heen, Anja Fog & Brandt, Linn (2014). Una nueva generación de guías de práctica clínica confiables a través de Magic. Revista Peruana de Medicina de Experimental y Salud Publica. ISSN 1726-4642. 31(1), p. 118–126. doi: 10.17843/rpmesp.2014.311.17. Full text in Research Archive
• Kristiansen, Annette; Brandt, Linn; Agoritsas, Thomas; Akl, Elie A.; Berge, Eivind & Bondi, Johan Fridtjof [Show all 19 contributors for this article] (2014). Adaptation of trustworthy guidelines developed using the GRADE methodology: a novel five-step process. Chest. ISSN 0012-3692. 146(3), p. 727–734. doi: 10.1378/chest.13-2828. Full text in Research Archive Show summary

  BACKGROUND: Adaptation of guidelines for use at the national or local level can facilitate their implementation. We developed and evaluated an adaptation process in adherence with standards for trustworthy guidelines and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, aiming for efficiency and transparency. This article is the first in a series describing our adaptation of Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines for a Norwegian setting. METHODS: Informed by the ADAPTE framework, we developed a five-step adaptation process customized to guidelines developed using GRADE: (1) planning, (2) initial assessment of the recommendations, (3) modification, (4) publication, and (5) evaluation. We developed a taxonomy for describing how and why recommendations from the parent guideline were modified and applied a mixed-methods case study design for evaluation of the process. RESULTS: We published the adapted guideline in November 2013 in a novel multilayered format. The taxonomy for adaptation facilitated transparency of the modification process for both the guideline developers and the end users. We excluded 30 and modified 131 of the 333 original recommendations according to the taxonomy and developed eight new recommendations. Unforeseen obstacles related to acquiring a licensing agreement and procuring a publisher resulted in a 9-month delay. We propose modifications of the adaptation process to overcome these obstacles in the future. CONCLUSIONS: This case study demonstrates the feasibility of a novel guideline adaptation process. Replication is needed to further validate the usefulness of the process in increasing the organizational and methodologic efficiency of guideline adaptation.

• Vartdal, Trond; Fetveit, Arne; Kristiansen, Annette; Brandt, Linn; Halvorsen, Sigrun & Berge, Eivind [Show all 9 contributors for this article] (2014). Antitrombotisk behandling og profylakse: - ny generasjon retningslinjer for allmennleger. Utposten. ISSN 0800-5680. 3, p. 41–43. Full text in Research Archive
• Kasenda, Benjamin; Elm, Erik B. von; You, John; Blümle, Anette; Tomonaga, Yuki & Saccilotto, Ramon [Show all 38 contributors for this article] (2014). Prevalence, Characteristics, and Publication of Discontinued Randomized Trials. Journal of the American Medical Association (JAMA). ISSN 0098-7484. 311(10), p. 1045–1051. doi: 10.1001/jama.2014.1361. Full text in Research Archive Show summary

  Importance The discontinuation of randomized clinical trials (RCTs) raises ethical concerns and often wastes scarce research resources. The epidemiology of discontinued RCTs, however, remains unclear. Objectives To determine the prevalence, characteristics, and publication history of discontinued RCTs and to investigate factors associated with RCT discontinuation due to poor recruitment and with nonpublication. Design and Setting Retrospective cohort of RCTs based on archived protocols approved by 6 research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics and planned recruitment from included protocols. Last follow-up of RCTs was April 27, 2013. Main Outcomes and Measures Completion status, reported reasons for discontinuation, and publication status of RCTs as determined by correspondence with the research ethics committees, literature searches, and investigator surveys. Results After a median follow-up of 11.6 years (range, 8.8-12.6 years), 253 of 1017 included RCTs were discontinued (24.9% [95% CI, 22.3%-27.6%]). Only 96 of 253 discontinuations (37.9% [95% CI, 32.0%-44.3%]) were reported to ethics committees. The most frequent reason for discontinuation was poor recruitment (101/1017; 9.9% [95% CI, 8.2%-12.0%]). In multivariable analysis, industry sponsorship vs investigator sponsorship (8.4% vs 26.5%; odds ratio [OR], 0.25 [95% CI, 0.15-0.43]; P < .001) and a larger planned sample size in increments of 100 (−0.7%; OR, 0.96 [95% CI, 0.92-1.00]; P = .04) were associated with lower rates of discontinuation due to poor recruitment. Discontinued trials were more likely to remain unpublished than completed trials (55.1% vs 33.6%; OR, 3.19 [95% CI, 2.29-4.43]; P < .001). Conclusions and Relevance In this sample of trials based on RCT protocols from 6 research ethics committees, discontinuation was common, with poor recruitment being the most frequently reported reason. Greater efforts are needed to ensure the reporting of trial discontinuation to research ethics committees and the publication of results of discontinued trials. Conducting high-quality randomized clinical trials (RCTs) is challenging and resource-demanding. Trials are often not conducted as planned or are even prematurely discontinued, eg, for reasons of unexpected harm from the intervention, early superiority, futility, administrative problems, or poor recruitment of participants. Trial discontinuation poses ethical concerns, particularly if results remain unreported, and may represent a considerable waste of scarce research resources.1- 3 Currently, little is known about the epidemiology and publication history of discontinued trials. Although studies have highlighted frequent recruitment problems in RCTs, few have empirically addressed factors associated with failure (or success) of patient recruitment, yielding uncertain results.4- 6 We established an international retrospective cohort of RCT protocols to determine: (1) the prevalence of RCT discontinuation and its reasons, (2) differences between RCTs with investigator sponsorship or industry sponsorship, (3) the publication history of discontinued RCTs, (4) factors associated with trial discontinuation due to poor recruitment, and (5) factors associated with nonpublication.

• Ohldieck, Annabel Eide; Nordrehaug, Jan Erik; Vandvik, Per Olav; Schaufel, Margrethe Aase & Norheim, Ole Frithjof (2014). Implementation of transcatheter aortic valve insertion (TAVI) in clinical practice: An ethical analysis. Clinical Ethics. ISSN 1477-7509. 9(2), p. 96–103. doi: 10.1177/1477750914546761. Full text in Research Archive
• Akl, Elie A.; Kahale, Lara A.; Agarwal, Arnav; Al-Matari, Nada; Ebrahim, Shanil & Alexander, Paul E. [Show all 21 contributors for this article] (2014). Impact of missing participant data for dichotomous outcomes on pooled effect estimates in systematic reviews: A protocol for a methodological study. Systematic Reviews. 3:137. doi: 10.1186/2046-4053-3-137. Full text in Research Archive
• Li, Ling; Shen, Jiantong; Bala, Malgorzata M.; Busse, Jason W.; Ebrahim, Shanil & Vandvik, Per Olav [Show all 12 contributors for this article] (2014). Incretin treatment and risk of pancreatitis in patients with type 2 diabetes mellitus: Systematic review and meta-analysis of randomised and non-randomised studies. BMJ. British Medical Journal. ISSN 0959-8146. 348>g2366. doi: 10.1136/bmj.g2366. Full text in Research Archive Show summary

  Objective: To investigate the risk of pancreatitis associated with the use of incretin-based treatments in patients with type 2 diabetes mellitus. Design: Systematic review and meta-analysis. Data sources: Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov. Eligibility criteria: Randomised and non-randomised controlled clinical trials, prospective or retrospective cohort studies, and case-control studies of treatment with glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors in adults with type 2 diabetes mellitus compared with placebo, lifestyle modification, or active anti-diabetic drugs. Data collection and analysis: Pairs of trained reviewers independently screened for eligible studies, assessed risk of bias, and extracted data. A modified Cochrane tool for randomised controlled trials and a modified version of the Newcastle-Ottawa scale for observational studies were used to assess bias. We pooled data from randomised controlled trials using Peto odds ratios, and conducted four prespecified subgroup analyses and a post hoc subgroup analysis. Because of variation in outcome measures and forms of data, we describe the results of observational studies without a pooled analysis. Results: 60 studies (n=353 639), consisting of 55 randomised controlled trials (n=33 350) and five observational studies (three retrospective cohort studies, and two case-control studies; n=320 289) were included. Pooled estimates of 55 randomised controlled trials (at low or moderate risk of bias involving 37 pancreatitis events, raw event rate 0.11%) did not suggest an increased risk of pancreatitis with incretins versus control (odds ratio 1.11, 95% confidence interval 0.57 to 2.17). Estimates by type of incretin suggested similar results (1.05 (0.37 to 2.94) for GLP-1 agonists v control; 1.06 (0.46 to 2.45) for DPP-4 inhibitors v control). Analyses according to the type of control, mode, duration of treatment, and individual incretin agents suggested no differential effect by subgroups, and sensitivity analyses by alternative statistical modelling and effect measures did not show important differences in effect estimates. Three retrospective cohort studies (moderate to high risk of bias, involving 1466 pancreatitis events, raw event rate 0.47%) also did not suggest an increased risk of pancreatitis associated with either exenatide (adjusted odds ratios 0.93 (0.63 to 1.36) in one study and 0.9 (0.6 to 1.5) in another) or sitagliptin (adjusted hazard ratio 1.0, 0.7 to 1.3); a case-control study at moderate risk of bias (1003 cases, 4012 controls) also suggested no significant association (adjusted odds ratio 0.98, 0.69 to 1.38). Another case-control study (1269 cases, 1269 controls) at moderate risk of bias, however, suggested that the use of either exenatide or sitagliptin was associated with significantly increased odds of acute pancreatitis (use within two years v no use, adjusted odds ratio 2.07, 1.36 to 3.13). Conclusions: The available evidence suggests that the incidence of pancreatitis among patients using incretins is low and that the drugs do not increase the risk of pancreatitis. Current evidence, however, is not definitive, and more carefully designed and conducted observational studies are warranted to definitively establish the extent, if any, of increased risk.

• Kristiansen, Annette; Brandt, Linn; Agoritsas, Thomas; Akl, Elie A; Berge, Eivind & Jacobsen, Anne Flem [Show all 10 contributors for this article] (2014). Applying new strategies for the national adaptation, updating and dissemination of trustworthy guidelines: Results from the Norwegian adaptation of the American College of chest physicans evidence-based guidelines on antithrombotic therapy and the prevention of thrombosis, 9th edidion. Chest. ISSN 0012-3692. 146(3), p. 735–761. doi: 10.1378/chest.13-2993. Full text in Research Archive Show summary

  BACKGROUND: The Antithrombotic Therapy and the Prevention of Thrombosis, 9th Edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (AT9) represent trustworthy international guidelines for antithrombotic treatment and thromboprophylaxis. We describe major changes to the format and content resulting from applying new strategies for guideline adaptation and dissemination. METHODS: A Norwegian guideline panel of 46 experts completed a structured and systematic adaptation process, updated the recommendations based on new evidence, and rewrote the recommendations in an electronic multilayered presentation format. We published the adapted guideline using the web-based Making GRADE the Irresistible Choice Guideline Authoring and Publication Platform. RESULTS: We applied a novel presentation format to 333 recommendations from 11 of the 15 management chapters in AT9 and condensed and restructured them into 249 recommendations in a multilayered format. We added additional relevant information, such as 29 best-practice statements about new oral anticoagulants and practical information sections for 121 recommendations. Common reasons for modifications included feasibility of the recommendations in a national context, disagreement with applied baseline risk estimates, and reevaluation of the balance between the benefits and harms of interventions in relation to assumed typical patient preferences and values. The adapted guideline was published and disseminated online in November 2013. CONCLUSIONS: New strategies for adapting, updating, and disseminating trustworthy guidelines proved feasible and will provide Norwegian health-care professionals and patients with up-to-date guidance tailored to national circumstances.

• Alonso-Coello, Pablo; Carrasco-Labra, Alonso; Brignardello-Petersen, Romina; Neumann, Ignacio; Akl, Elie A. & Sun, Xin [Show all 27 contributors for this article] (2014). Correction: A methodological survey of the analysis, reporting and interpretation of Absolute Risk ReductiOn in systematic revieWs (ARROW): A study protocol. Systematic Reviews. 3:76. doi: 10.1186/2046-4053-3-76. Full text in Research Archive
• Treweek, Shaun; Oxman, Andrew David; Alderson, Philip; Bossuyt, Patrick M.; Brandt, Linn & Brozek, Jan [Show all 17 contributors for this article] (2013). Developing and evaluating communication strategies to support informed decisions and practice based on evidence (DECIDE): protocol and preliminary results. Implementation Science. 8. doi: 10.1186/1748-5908-8-6. Full text in Research Archive
• Guyatt, Gordon H; Vandvik, Per Olav & Alonso-Coello, Pablo (2013). Experience with GRADE. Journal of Clinical Epidemiology. ISSN 0895-4356. 65(12), p. 1243–1244. doi: 10.1016/j.jclinepi.2012.07.013. Full text in Research Archive
• Lam, Jason; Schulman, Sam; Witt, Daniel M.; Vandvik, Per Olav; Qayyum, Fareeha & Holbrook, Anne M. (2013). Anticoagulation control with daily low-dose vitamin K to reduce clinically adverse outcomes and international normalized ratio variability: a systematic review and meta-analysis. Pharmacotherapy. ISSN 0277-0008. 33(11), p. 1184–1190. doi: 10.1002/phar.1302. Full text in Research Archive
• Vandvik, Per Olav; Bretthauer, Michael & Kongerud, Ingrid Charlotte (2013). Fra kliniske spørsmål til troverdige svar. Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 133(15), p. 1611–1614. doi: 10.4045/tidsskr.13.0650. Full text in Research Archive
• Vist, Gunn Elisabeth; Sæterdal, Ingvil von Mehren; Vandvik, Per Olav & Flottorp, Signe Agnes (2013). Gradering av kvalitet på dokumentasjonen. Norsk Epidemiologi. ISSN 0803-2491. 23(2), p. 151–156. Full text in Research Archive
• Goldenberg, Joshua Z.; Ma, Stephanie S.Y.; Saxton, Jane D.; Martzen, Mark R.; Vandvik, Per Olav & Thorlund, Kristian [Show all 8 contributors for this article] (2013). Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children. Cochrane Database of Systematic Reviews. doi: 10.1002/14651858.CD006095.pub3. Full text in Research Archive
• Vist, Gunn Elisabeth; Sæterdal, Ingvil von Mehren; Vandvik, Per Olav & Flottorp, Signe Agnes (2013). Gradering av kvaliteten på dokumentasjonen. Norsk Epidemiologi. ISSN 0803-2491. 23(2), p. 151–156. doi: 10.5324/nje.v23i2.1637. Full text in Research Archive
• Vandvik, Per Olav; Berg, Rigmor C. & Vist, Gunn Elisabeth (2013). En ny generasjon troverdige kliniske retningslinjer. Norsk Epidemiologi. ISSN 0803-2491. 23(2), p. 197–204. doi: 10.5324/nje.v23i2.1644. Full text in Research Archive
• Kongerud, Ingrid Charlotte & Vandvik, Per Olav (2013). Arbeidsfiler som læringsverktøy i kunnskapshåndtering. Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 133(15), p. 1587–1590. doi: 10.4045/tidsskr.12.1441. Full text in Research Archive
• Vandvik, Per Olav; Brandt, Linn; Alonso-Coello, Pablo; Treweek, Shaun; Akl, Elie A. & Kristiansen, Annette [Show all 10 contributors for this article] (2013). Creating clinical practice guidelines we can trust, use, and share : a new era is imminent. Chest. ISSN 0012-3692. 144(2), p. 381–389. doi: 10.1378/chest.13-0746. Full text in Research Archive
• Bala, Malgorzata M.; Akl, Elie A.; Sun, Xin; Bassler, Dirk; Mertz, Dominik & Mejza, Filip [Show all 20 contributors for this article] (2013). Randomized trials published in higher vs. lower impact journals differ in design, conduct, and analysis. Journal of Clinical Epidemiology. ISSN 0895-4356. 66(3), p. 286–295. doi: 10.1016/j.jclinepi.2012.10.005. Full text in Research Archive
• Garcia, Laura Martinez; Arevalo-Rodriguez, Ingrid; Sola, I.; Haynes, R. B.; Vandvik, Per Olav & Alonso-Coello, Pablo (2012). Strategies for monitoring and updating clinical practice guidelines: a systematic review. Implementation Science. 7. doi: 10.1186/1748-5908-7-109. Full text in Research Archive Show summary

  Abstract Scientific knowledge is in constant change. The flow of new information requires a frequent re-evaluation of the available research results. Clinical practice guidelines (CPGs) are not exempted from this phenomenon and need to be kept updated to maintain the validity of their recommendations. The objective of our review is to systematically identify, describe and assess strategies for monitoring and updating CPGs. Study design and setting We conducted a systematic review of studies evaluating one or more methods of updating (with or without monitoring) CPGs or recommendations. We searched MEDLINE (PubMed) and The Cochrane Methodology Register (The Cochrane Library) from 1966 to June 2012. Additionally, we hand-searched reference lists of the included studies and the Guidelines International Network book of abstracts. If necessary, we contacted study authors to obtain additional information. Results We included a total of eight studies. Four evaluated if CPGs were out of date, three updated CPGs, and one continuously monitored and updated CPGs. The most detailed reported phase of the process was the identification of new evidence. As opposed to studies updating guidelines, studies evaluating if CPGs were out of date applied restricted searches. Only one study compared a restricted versus an exhaustive search suggesting that a restricted search is sufficient to assess recommendations’ Validity. One study analyzed the survival time of CPGs and suggested that these should be reassessed every three years. Conclusions There is limited evidence about the optimal strategies for monitoring and updating clinical practice guidelines. A restricted search is likely to be sufficient to monitor new evidence and assess the need to update, however, more information is needed about the timing and type of search. Only the exhaustive search strategy has been assessed for the update of CPGs. The development and evaluation of more efficient strategies is needed to improve the timeliness and reduce the burden of maintaining the validity of CPGs. Keywords: Clinical practice guidelines; Diffusion of innovation; Evidence-based medicine; Information storage and retrieval; Methodology; Updating; Implementation science; Dissemination and implementation; Knowledge translation

• Kasenda, Benjamin; Elm, Erik B. von; You, John; Blümle, Anette; Tomonaga, Yuki & Saccilotto, Ramon [Show all 33 contributors for this article] (2012). Learning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study). BMC Medical Research Methodology. 12. doi: 10.1186/1471-2288-12-131. Full text in Research Archive Show summary

  Abstract Background Randomized controlled trials (RCTs) may be discontinued because of apparent harm, benefit, or futility. Other RCTs are discontinued early because of insufficient recruitment. Trial discontinuation has ethical implications, because participants consent on the premise of contributing to new medical knowledge, Research Ethics Committees (RECs) spend considerable effort reviewing study protocols, and limited resources for conducting research are wasted. Currently, little is known regarding the frequency and characteristics of discontinued RCTs. Methods/Design Our aims are, first, to determine the prevalence of RCT discontinuation for specific reasons; second, to determine whether the risk of RCT discontinuation for specific reasons differs between investigator- and industry-initiated RCTs; third, to identify risk factors for RCT discontinuation due to insufficient recruitment; fourth, to determine at what stage RCTs are discontinued; and fifth, to examine the publication history of discontinued RCTs. We are currently assembling a multicenter cohort of RCTs based on protocols approved between 2000 and 2002/3 by 6 RECs in Switzerland, Germany, and Canada. We are extracting data on RCT characteristics and planned recruitment for all included protocols. Completion and publication status is determined using information from correspondence between investigators and RECs, publications identified through literature searches, or by contacting the investigators. We will use multivariable regression models to identify risk factors for trial discontinuation due to insufficient recruitment. We aim to include over 1000 RCTs of which an anticipated 150 will have been discontinued due to insufficient recruitment. Discussion Our study will provide insights into the prevalence and characteristics of RCTs that were discontinued. Effective recruitment strategies and the anticipation of problems are key issues in the planning and evaluation of trials by investigators, Clinical Trial Units, RECs and funding agencies. Identification and modification of barriers to successful study completion at an early stage could help to reduce the risk of trial discontinuation, save limited resources, and enable RCTs to better meet their ethical requirements. Keywords: Randomized controlled trial; Trial discontinuation; Slow recruitment; Ethics committees; Trial protocols

• Brottveit, Margit; Vandvik, Per Olav; Wojniusz, Slawomir Donat; Løvik, Astrid; Lundin, Knut E A & Boye, Turid Birgitte (2012). Absence of somatization in non-coeliac gluten sensitivity. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 47(7), p. 770–777. doi: 10.3109/00365521.2012.679685. Full text in Research Archive
• Sun, Xin; Briel, Matthias; Busse, Jason W.; You, John J.; Akl, Elie A. & Mejza, Filip [Show all 22 contributors for this article] (2012). Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ. British Medical Journal. ISSN 0959-8146. 344. doi: 10.1136/bmj.e1553. Full text in Research Archive
• Ford, Alexander Charles & Vandvik, Per Olav (2012). Irritable bowel syndrome. Clinical Evidence. ISSN 1752-8526. 01(410). Full text in Research Archive
• Vandvik, Per Olav; Santesso, Nancy; Akl, Elie A.; You, John; Mulla, Sohail & Spencer, Frederick A. [Show all 13 contributors for this article] (2012). Formatting modifications in GRADE evidence profiles improved guideline panelists comprehension and accessibility to information. A randomized trial. Journal of Clinical Epidemiology. ISSN 0895-4356. 65(7), p. 748–755. doi: 10.1016/j.jclinepi.2011.11.013. Full text in Research Archive
• Guyatt, Gordon H.; Norris, Susan L.; Schulman, Sam; Hirsh, Jack; Eckman, Mark H. & Akl, Elie A. [Show all 14 contributors for this article] (2012). Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. ISSN 0012-3692. 141(2), p. 53S–70S. doi: 10.1378/chest.11-2288. Full text in Research Archive
• Vandvik, Per Olav; Lincoff, A. Michael; Gore, Joel M.; Guttermann, David D.; Sonnenberg, Frank A. & Alonso-Coello, Pablo [Show all 10 contributors for this article] (2012). Primary and secondary prevention of cardiovaskular disease. Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicans evidence-based clinical practice guidelines. Chest. ISSN 0012-3692. 141(2), p. e637S–e668S. doi: 10.1378/chest.11-2306. Full text in Research Archive
• MacLean, Samantha; Mulla, Sohail; Akl, Elie A.; Jankowski, Milosz; Vandvik, Per Olav & Ebrahim, Shanil [Show all 9 contributors for this article] (2012). Patient values and preferences in desicion making for antithrombotic therapy: a systematic review. Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. ISSN 0012-3692. 141(2 Suppl), p. 1S–23S. doi: 10.1378/chest.11-2290. Full text in Research Archive
• Spencer, Frederick A.; Lorio, Alfonso; You, John; Murad, M. Hassad; Schünemann, Holger J. & Vandvik, Per Olav [Show all 13 contributors for this article] (2012). Uncertainties in baseline risk estimates and confidence in treatment effects. BMJ. British Medical Journal. ISSN 0959-8146. 345. doi: 10.1136/bmj.e7401. Full text in Research Archive Show summary

  The GRADE system provides a framework for evaluating how risk of bias, publication bias, imprecision, inconsistency, and indirectness may reduce confidence in estimates of relative effects of interventions on outcomes. However, GRADE and all other systems for rating confidence in effect estimates do not fully address uncertainty in baseline risk and its impact on confidence in absolute estimates of treatment effect. In this article the authors examine factors that may reduce confidence in estimates of baseline risk and thus estimates of absolute treatment benefit.

• Johnston, Bradley C.; Ma, Stephanie S Y; Goldenberg, Joshua Z.; Thorlund, Kristian; Vandvik, Per Olav & Loeb, Mark [Show all 7 contributors for this article] (2012). Probiotics for the Prevention of Clostridium difficile-Associated Diarrhea A Systematic Review and Meta-analysis. Annals of Internal Medicine. ISSN 0003-4819. 157(12), p. 878–U225. doi: 10.7326/0003-4819-157-12-201212180-00563. Full text in Research Archive
• Sun, Xin; Briel, Matthias; Busse, Jason W.; You, John J.; Akl, Elie A & Mejza, Filip [Show all 24 contributors for this article] (2011). The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review. BMJ. British Medical Journal. ISSN 0959-8146. 342. doi: 10.1136/bmj.d1569. Full text in Research Archive
• Johnston, Bradley C.; Goldenberg, Joshua Z.; Vandvik, Per Olav; Sun, Xin & Guyatt, Gordon H. (2011). Probiotics for the prevention of pediatric antibiotic-associated diarrhea. Cochrane Database of Systematic Reviews. doi: 10.1002/14651858.CD004827.pub3. Full text in Research Archive
• Johansson, Per A; Farup, Per Grønaas; Bracco, Andrea & Vandvik, Per Olav (2010). How does comorbidity affect cost of health care in patients with irritable bowel syndrome? A cohort study in general practice. BMC Gastroenterology. 10(31). doi: 10.1186/1471-230X-10-31. Full text in Research Archive
• Sun, X; Briel, M; Busse, JW; Akl, Ellie A; You, JJ & Mejza, F [Show all 23 contributors for this article] (2009). Subgroup Analysis of Trials Is Rarely Easy (SATIRE): a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials. Trials. 10. doi: 10.1186/1745-6215-10-101. Full text in Research Archive
• Helgeland, Helene; Flagstad, Gro; Grøtta, Jon; Vandvik, Per Olav; Kristensen, Hanne & Markestad, Trond (2009). Diagnosing Pediatric Functional Abdominal Pain in Children (4-15 Years Old) According to the Rome III Criteria: Results From a Norwegian Prospective Study. Journal of Pediatric Gastroenterology and Nutrition - JPGN. ISSN 0277-2116. 49(3), p. 309–315. doi: 10.1097/MPG.0b013e31818de3ab. Full text in Research Archive Show summary

  Objectives: To determine the proportion of referred children with nonorganic abdominal pain who meet the criteria for 1 or more diagnoses of functional gastrointestinal disorders (FGID), explore the distribution of diagnoses according to the revised pediatric Rome III criteria (PRC-III), and to investigate reasons for failure to meet these criteria. Materials and Methods: We recruited children (4-15 years) consecutively referred by general practitioners to 4 general pediatric outpatient clinics for the evaluation of recurrent abdominal pain. FGID diagnoses were based on the Questionnaire on Pediatric Gastrointestinal Symptoms-Rome III version, completed by parents. To exclude organic disease, all patients underwent medical investigations and were reevaluated at follow-up after 6 to 9 months. Results: Of the 152 patients included, 142 (93%) had functional abdominal pain. Of these, 124 (87%) met the criteria for 1 or more diagnoses according to the PRC-III: 66% met the criteria for 1, 29% for 2, and 5% for 3 diagnoses. Irritable bowel syndrome was the most common diagnosis (43%) and overlapped with aerophagia in 16 children (38% of the children with overlapping diagnoses) and with abdominal migraine in 14 (33%). In the 18 patients (13%) not fulfilling the PRC-III for any FGID diagnosis, the main reason was insufficient pain frequency (83%). Conclusions: Of the referred children with functional abdominal pain, 87% met the PRC-III for specific diagnoses. This supports the use of these criteria as a diagnostic tool. The significant overlap between different FGIDs, however, makes it unclear whether some of the diagnoses represent distinct disorders or artificial categories.

• Furunes, Håvard & Vandvik, Per Olav (2009). Gips ved mistanke om skafoidfraktur. Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 129(3), p. 177–179. Full text in Research Archive
• Oxman, Andy; Vandvik, Per Olav; Lavis, John; Fretheim, Atle & Lewin, Simon (2009). SUPPORT Tools for evidence-informed health Policymaking (STP) 2: Improving how your organisation supports the use of research evidence to inform policymaking. Health Research Policy and Systems. 7. Full text in Research Archive

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• Agarwal, Arnav; Mustafa, Reem; Manja, Veena; Agoritsas, Thomas; MacDonald, Helen & Li, Sheyu [Show all 24 contributors for this article] (2025). Cardiovascular, kidney related, and weight loss effects of therapeutics for type 2 diabetes: A living clinical practice guideline. The BMJ. 390. doi: 10.1136/bmj-2024-082071. Full text in Research Archive
• Helsingen, Lise Mørkved; Langeland, Eline Aurvoll; Pisani, Synne Eline Rotihaug; Vandvik, Per Olav; Haavardsholm, Espen A. & Malt, Ulrik Fredrik [Show all 10 contributors for this article] (2024). Glansbilder av nasjonale faglige retningslinjer fra Helsedirektoratet. Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 144(5). doi: 10.4045/tidsskr.24.0141. Full text in Research Archive
• Kunøe, Nikolaj; Indregard, Anne Marthe Rustad; Nussle, Hans Martin; Tesli, Martin Steen; Vandvik, Per Olav & Gather, Jakov (2024). A pragmatic randomised controlled non-inferiority trial of open-door policy versus treatment as usual in urban psychiatric inpatient wards. Full text in Research Archive
• Hunskaar, Birk Bårdson Stokke; Løvsletten, Per Olav; Agoritsas, Thomas; Heen, Anja Fog; Achille, Frankie Alexander Spencer & Vandvik, Per Olav (2023). User-testing of a decision support tool for multiple treatment options with NMA data to facilitate guideline development: A qualitative study. Full text in Research Archive Show summary

  Background: While network meta-analysis (NMA) presents unprecedented opportunities for comparative effectiveness research, data output from NMAs is often overwhelming, even for researchers. Little is known on how to best present NMA data to guideline panelists. Objectives: To employ and user test the MATCH-IT tool – an interactive Summary of Findings table (iSoF) presenting data from NMA for multiple interventions – in guideline panels to further answer their information needs and facilitate guideline development. Methods: We performed user testing sessions with semi-structured interviews of panel members in preparation for or after panel meetings in 4 different guideline panels. We also observed the use of the MATCH-IT tool during panel meetings. Interviews and meetings were transcribed, coded and analyzed using directed content analysis to capture the user experience and use of the tool. The analysis informed iterative developments of the tool. Results: User-testing of 15 panel members (3 chairs, 9 clinical experts, 3 patient partners) and 3 observed panel meetings resulted in 4 iterations of the tool including both new features and refinements from the initial prototype. Key improvements included adding color coding as well as new data elements such as 95 % confidence intervals. In the final two rounds of development, chairs and participating panelists expressed that the tool contributed significantly to facilitating the meeting. Conclusions: This study suggests that iSoFs, in this case the MATCH-IT tool, can facilitate guideline development by making data from NMA in systematic reviews easier to understand and navigate.

• Løvsletten, Per Olav; Hunskaar, Birk Bårdson Stokke; Bekkering, Geertruida; Poel, Louise Vanden; Zeraatkar, Dena & Busse, Jason W. [Show all 10 contributors for this article] (2023). Evaluation and development of a novel interactive Summary of Findings table for network meta-analysis. A qualitative user-testing study with clinicians. Full text in Research Archive Show summary

  Background: Clinicians often need to evaluate comparative effectiveness of relevant treatment options for their patients. Network meta-analyses (NMAs) provide an important resource for clinicians to guide decision-making; however, these analyses are complex, and interpretation may prove challenging for users. Objectives: To evaluate and develop a novel interactive Summary of Findings table (the MATCH-IT tool) for network meta-analysis results, to support clinicians in interpreting and applying comparative effectiveness evidence into decision-making. Methods: We performed qualitative user-testing with a convenience sample of practicing physicians working in hospitals and general practice in Norway, Belgium, and Canada. User testing entailed a brief introduction with a clinical scenario, which was a think aloud session with participant-tool-interaction followed by a semi-structured interview. The tests were recorded, transcribed, and analysed using directed content analysis. The results informed the iterative development process of the MATCH-IT tool. Results: Five rounds of user-testing, with 26 participants in total, have resulted in four iterations with updates in the tutorial, layout, navigation functionality, and interphase, as well as the practical-issues-section. We have also added an FAQ section. Clinicians who participated in user-testing had been in clinical practice from 0 to 30 years (median 6, IQR 3-11). Most had little or no prior experience with interpretation of NMA results and sparse knowledge about GRADE methodology. Most clinicians perceived MATCH-IT as easy to interpret and navigate and appreciated its ability to provide overview of the evidence, although some of the interactive features proved to be difficult to discover intuitively. They perceived pictograms and inclusion of practical-issues-information as potentially useful features when interacting with patients. Categorization of results with colour coding to indicate both certainty of evidence and relative effectiveness of interventions was appreciated, and filtering functionality allowed participants to efficiently browse and focus in on the interventions believed to be most relevant for a given clinical scenario. Conclusions: MATCH-IT shows promise in supporting decision-making for clinicians when presented with results from NMAs. The tool has already been published within Cochrane systematic reviews and clinical practice guidelines. Patient, public, and/or healthcare consumer involvement: Clinicians were the subject for user testing, ensuring user friendliness for this key consumer group. Network meta-analysis

• Løvsletten, Per Olav; Wang, Xiaoqin; Pitre, Tyler; Ødegaard, Marte; Veroniki, Areti Angeliki & Lunny, Carole [Show all 9 contributors for this article] (2023). Reporting of network meta-analysis results in systematic reviews: a cross- sectional sample of evidence summary presentation formats. Full text in Research Archive Show summary

  Background: Systematic reviews (SRs) with network meta-analysis (NMA) are essential in informing treatment decisions in health policy and practice. However, it is challenging to communicate evidence summaries visually in comprehensible presentation formats. Objective: To map and describe current reporting practices of NMA evidence summaries in SRs, with a specific focus on presentation formats´ reporting of estimates of effect, certainty of the evidence and ranking/categorization. Methods: We searched in MEDLINE for SRs with NMA published 01.01.2020 – 31.12.2021. Presentation formats were labelled and categorized according to whether they reported: 1) effect estimates, 2) certainty of the evidence and/or 3) ranking/categorization of interventions. Results: 200 SRs with 1133 presentation formats from 158 different journals were included. Internal medicine (46 SRs, 23.0%) were the most frequent topic and Forest plots (429, 37.9%) and league tables (188, 16.6%) were the most frequent presentation formats. 76 SRs (38.0%) reported both benefits and harms in presentation formats, 26 SRs (13.0%) reported GRADE or CINeMA certainty ratings and 144 SRs (72.0%) reported ranking/categorization. Focusing on evidence summaries reporting absolute effects across benefits and harms, with GRADE or CINeMA certainty ratings and ranking/categorization of interventions, 3 SRs (1.5%) reported this in presentation formats. Of these, 2 SRs (1.0%) reported such evidence summaries for multiple outcomes within the same (single) presentation format. Discussion: This study demonstrates current challenges and shortcomings in reporting of evidence summaries in presentation formats. Only a small fraction of SRs reported absolute effects across benefits and harms, with certainty ratings and ranking/categorization in tables/figures.

• Besnier, Elodie Anne Suzanne; Lewin, Simon Arnold; Kredo, Tamara; Oliver, Joy; Leong, Trudy & Durão, Solange [Show all 44 contributors for this article] (2023). Enhancing evidence-informed guideline recommendations for newborn and child health in sub-Saharan Africa. Full text in Research Archive
• Gantzel, Rasmus; Wieszczy, Paulina; Refsum, Erle; Jess, Tine; Larsen, Lone & Bretthauer, Michael [Show all 11 contributors for this article] (2023). Prognostic models for colorectal cancer incidence and mortality in patients with inflammatory bowel disease. Cochrane Database of Systematic Reviews. doi: 10.1002/14651858.CD015434. Full text in Research Archive
• Løvsletten, Per Olav; Hunskaar, Birk Bårdson Stokke; Zeraatkar, Dena; Bekkering, Geertruida; Busse, Jason W. & Agoritsas, Thomas [Show all 8 contributors for this article] (2022). Making Alternative Treatment CHoices Intuitive and Trustworthy (MATCH-IT) for Clinicians: Development of a new decision support tool for multiple comparisons from network meta-analyses. Preliminary results from qualitative user-testing. Full text in Research Archive Show summary

  Background The massive increase in published network meta-analyses (NMAs) over the last decade provide new opportunities to empower clinicians and their patients to evaluate comparative effectiveness of relevant treatment options. The amount and complexity of evidence from NMAs present challenges for condensing results into interpretable formats for clinicians. Objective To evaluate and improve a new interactive presentation format for multiple comparisons (the MATCH- IT tool), to support clinicians in interpreting and applying NMA evidence in decision-making. Methods We performed qualitative user-testing with a convenience sample of clinicians working in hospitals and general practice in Norway, Belgium and Canada. User-testing entailed; brief introduction, a think aloud session with participant-tool-interaction followed by a semi-structured interview. The tests were recorded, transcribed and analysed applying directed content analysis. The results informed the iterative development process of the MATCH-IT tool. Results We have completed 21 user-tests. Most participants had little or no prior experience with interpretation of NMA results. The tool is perceived by most as easy interpretable and its ability to provide overview of the evidence were positively appraised. Pictograms and inclusion of practical-issues-information were perceived as potentially useful features when interacting with patients. The testing has led to updates in tutorial, practical-issues-section and interactive features of the tool. Key challenges remain, such as how to best cope with > 10 interventions and ranking of interventions. Discussion The MATCH-IT tool shows promise in supporting decision-making for clinicians when presented with results from NMAs. Future studies will explore its role in shared decision-making and guideline development.

• Song, Yang; Alonso-Coello, Pablo; Ballesteros, Monica; Cluzeau, Francoise; Vernooij, Robin & Arayssi, Thurayya [Show all 36 contributors for this article] (2022). A Reporting Tool for Adapted Guidelines in Health Care: The RIGHT-Ad@pt Checklist. Annals of Internal Medicine. ISSN 0003-4819. 175(5), p. 710–719. doi: 10.7326/M21-4352. Full text in Research Archive
• Schnell, Oliver; Battelino, Tadej; Bergenstal, Richard; Blüher, Matthias; Böhm, Michael & Brosius, Frank [Show all 29 contributors for this article] (2022). Report from the CVOT Summit 2021: new cardiovascular, renal, and glycemic outcomes. Cardiovascular Diabetology. 21(1), p. 50–50. doi: 10.1186/s12933-022-01481-0. Full text in Research Archive
• Vandvik, Per Olav; Elliott, Julian; Lawrence, R; Minx, JC; Oladapo, Olufemi T. & Ravaud, P [Show all 10 contributors for this article] (2021). Decision makers need constantly updated evidence synthesis. Full text in Research Archive
• Løvsletten, Per Olav; Veroniki, Areti Angeliki; Lunny, Carole; Vandvik, Per Olav; Agoritsas, Thomas & Tricco, Andrea C. [Show all 7 contributors for this article] (2021). Evidence summaries in systematic reviews with network meta-analysis: protocol of a systematic survey of existing approaches and presentation formats. Open Science Framework (OSF). doi: 10.17605/OSF.IO/Y3JER. Full text in Research Archive
• Vandvik, Per Olav; Askie, Lisa; Glen, Fiona; Tendal, Britta & Agoritsas, Thomas (2021). COVID-19: living guidelines help fix cracks in evidence pipeline. Nature. ISSN 0028-0836. 595(7866), p. 172–172. doi: 10.1038/d41586-021-01821-2. Full text in Research Archive
• Munn, Zachary; Twaddle, Sara; Service, Duncan; Harrow, Elaine; Okwen, Patrick Mbah & Schünemann, Holger J. [Show all 7 contributors for this article] (2020). Developing guidelines before, during, and after the COVID-19 pandemic. Annals of Internal Medicine. ISSN 0003-4819. 173(12), p. 1012–1014. doi: 10.7326/M20-4907. Full text in Research Archive
• Bretthauer, Michael; Helsingen, Lise Mørkved; Kalager, Mette; Vandvik, Per Olav; Agoritsas, Thomas & Guyatt, Gordon (2020). The future of colorectal cancer screening: Parentalism or shared decision-making? CMAJ - Canadian Medical Association Journal. ISSN 0820-3946. 192(18), p. E484–E484. doi: 10.1503/cmaj.74839. Full text in Research Archive
• Helsingen, Lise M.; Vandvik, Per Olav; Jodal, Henriette C.; Murphy, Silje Bjerkelund; Heen, Anja Fog & Kalager, Mette [Show all 7 contributors for this article] (2019). Tarmkreftscreening, eller ikke? 139(15). doi: 10.4045/tidsskr.19.0323. Full text in Research Archive
• Johnston, Bradley C.; Alonso-Coello, Pablo; Bala, Malgorzata M.; Zeraatkar, Dena; Rabassa, Montserrat & Valli, Claudia [Show all 11 contributors for this article] (2019). Correction to: Methods for trustworthy nutritional recommendations NutriRECS (Nutritional Recommendations and accessible Evidence summaries Composed of Systematic reviews): A protocol (BMC Medical Research Methodology (2018) 18 (162) DOI: 10.1186/s12874-018-0621-8). BMC Medical Research Methodology. 19(1). doi: 10.1186/s12874-019-0888-4. Full text in Research Archive
• Vandvik, Per Olav (2018). Do we have trustworthy guidelines for clinical practice in Norway? Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 138(4). doi: 10.4045/tidsskr.18.0102. Full text in Research Archive
• Heen, Anja Fog; Vandvik, Per Olav & Agoritsas, Thomas (2018). Including practical issues and patient perspectives in Rapid Recommendations. BMJ. British Medical Journal. ISSN 0959-8146. 363. doi: 10.1136/bmj.k4871. Full text in Research Archive
• Jenum, Anne Karen; Brekke, Idunn; Mdala, Ibrahimu; Muilwijk, Mirthe; Ramachandran, Ambady & Kjøllesdal, Marte Karoline Råberg [Show all 15 contributors for this article] (2018). Effects of dietary and physical activity interventions on the risk of type 2 diabetes in South Asians: individual participant data meta-analysis of randomsed controlled trials. Full text in Research Archive
• Vandvik, Per Olav; Alhazzani, Waleed & Møller, Morten Hylander (2018). Understanding conflicts of interest. 44(10), p. 1738–1740. doi: 10.1007/s00134-018-5338-y. Full text in Research Archive
• Bretthauer, Michael; Vandvik, Per Olav; Skjeldestad, Finn Egil; Frich, Jan C; Lange, Thomas de & Løberg, Magnus (2017). Ny spesialistutdanning for leger – fra sveitserost til kraftkar? Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 137(17), p. 1270–1271. doi: 10.4045/tidsskr.17.0637. Full text in Research Archive
• Schandelmaier, Stefan; Siemieniuk, Reed A.C.; Agoritsas, Thomas; Vandvik, Per Olav; Guyatt, Gordon H. & Busse, Jason W. (2017). Authors' reply to Farrar. BMJ. British Medical Journal. ISSN 0959-8146. 356:j1483, p. 1–1. doi: 10.1136/bmj.j1483. Full text in Research Archive
• Rochwerg, Bram; Hylands, Mathieu; Møller, Morten Hylander; Asfar, Pierre; Cohen, Dian & Khadaroo, Rachel G. [Show all 13 contributors for this article] (2017). CCCS-SSAI WikiRecs clinical practice guideline: vasopressor blood pressure targets in critically ill adults with hypotension and vasopressor use in early traumatic shock. Intensive Care Medicine. ISSN 0342-4642. 43(7), p. 1062–1064. doi: 10.1007/s00134-016-4539-5. Full text in Research Archive
• Siemieniuk, Reed A.; Dilmitis, Sophie; Ion, Allyson; Chang, Yaping; Bala, Malgorzata M. & Manja, Veena [Show all 13 contributors for this article] (2017). Values and preferences of women living with HIV who are pregnant, postpartum or considering pregnancy on choice of antiretroviral therapy during pregnancy. 7(9). doi: 10.1136/bmjopen-2017-019023. Full text in Research Archive
• Siemieniuk, Reed A C; Lytvyn, Lyubov; Ming, J.; Mullen, Rhonda Marama; Anam, Florence & Otieno, Teresia [Show all 19 contributors for this article] (2017). Antiretroviral therapy in pregnant women living with HIV: a clinical practice guideline. BMJ Open. 358(j3961). doi: 10.1136/bmj.j3961. Full text in Research Archive
• Alonso-Coello, Pablo; Vernooij, Robin W.M.; Carrasco-Labra, Alonso; Vandvik, Per Olav & Guyatt, Gordon Henry (2017). RE: Which estimates comprise optimal reporting in systematic reviews? Journal of Clinical Epidemiology. ISSN 0895-4356. 81, p. 140–141. doi: 10.1016/j.jclinepi.2017.01.001. Full text in Research Archive
• Otto, Catherine M.; Spencer, Frederick A. & Vandvik, Per Olav (2017). Evidence, experts, trustworthy guidelines and WikiRecs. Heart. ISSN 1355-6037. 103(1), p. 3–5. doi: 10.1136/heartjnl-2016-310353. Full text in Research Archive
• Vandvik, Per Olav; Otto, Catherine M.; Siemieniuk, Reed A.; Bagur, Rodrigo; Guyatt, Gordon H. & Lytvyn, Lyubov [Show all 15 contributors for this article] (2016). Transcatheter or surgical aortic valve replacement for patients with severe, symptomatic, aortic stenosis at low to intermediate surgical risk: a clinical practice guideline. The BMJ. 354:i5085. doi: 10.1136/bmj.i5085. Full text in Research Archive
• Dib, Regina El; Spencer, Frederick Alan; Suzumura, Erica Aranha; Gomaa, Huda; Kwong, Joey & Guyatt, Gordon Henry [Show all 7 contributors for this article] (2016). Erratum to: Aspiration thrombectomy prior to percutaneous coronary intervention in ST-elevation myocardial infarction: A systematic review and meta-analysis [BMC Cardiovasc Disord., 16, (2016), (121) 10.1186/s12872-016-0285-4. BMC Cardiovascular Disorders. 16:121, p. 1–1. doi: 10.1186/s12872-016-0332-1. Full text in Research Archive
• Schandelmaier, S; Conen, K; Elm, Erik von; You, JJ; Blümle, Anette & Tomonaga, Yuki [Show all 40 contributors for this article] (2016). Planning and reporting of quality-of-life outcomes in cancer trials. Annals of Oncology. ISSN 0923-7534. 27(1), p. 209–209. doi: 10.1093/annonc/mdv559. Full text in Research Archive
• Siemieniuk, Reed A.; Agoritsas, Thomas; Macdonald, Helen; Guyatt, Gordon H; Brandt, Linn & Vandvik, Per Olav (2016). Introduction to BMJ Rapid Recommendations. The BMJ. 354(i5191). doi: 10.1136/bmj.i5191. Full text in Research Archive
• Vandvik, Per Olav; Brignardello-Petersen, Romina & Guyatt, Gordon Henry (2016). Living cumulative network meta-analysis to reduce waste in research: A paradigmatic shift for systematic reviews? BMC Medicine. 14(59). doi: 10.1186/s12916-016-0596-4. Full text in Research Archive
• Berntsen, Christopher Friis; Kristiansen, Annette; Brandt, Linn; Agoritsas, Thomas; Alonso-Coello, Pablo & Martínez-García, Laura [Show all 9 contributors for this article] (2015). Evaluating a process for living trustworthy guidelines. Full text in Research Archive
• Vandvik, Per Olav; Brandt, Linn; Kristiansen, Annette; Heen, Anja Fog & Berntsen, Christopher Friis (2014). Relating clinical decisions to the evidence. Full text in Research Archive
• Vandvik, Per Olav; Heen, Anja Fog; Berntsen, Christopher Friis; Brandt, Linn & Kristiansen, Annette (2014). Workshop: Development of decision aids linked to guidelines (SHARE- IT). Full text in Research Archive
• Vandvik, Per Olav; Berntsen, Christopher Friis; Heen, Anja Fog; Kristiansen, Annette & Brandt, Linn (2014). Workshop: Intro to MAGIC platform - Developing a top layer for health professionals. Full text in Research Archive
• Brandt, Linn; Kristiansen, Annette; Berntsen, Christopher Friis; Heen, Anja Fog & Vandvik, Per Olav (2014). Workshop: Intro to MAGIC platform. Full text in Research Archive
• Gulbrandsen, Pål; Ofstad, Eirik Hugaas; Holmøy, Trygve & Vandvik, Per Olav (2014). Pasientmedvirkning ved beslutninger om behandling. 134(17), p. 1670–1672. doi: 10.4045/tidsskr.14.0239. Full text in Research Archive
• Brandt, Linn; Kristiansen, Annette; Vandvik, Per Olav & Kunnamo, Ilkka (2014). Workshop: Decision support for healthcare professionals. Experiences from the Finnish and Norwegian systems. Full text in Research Archive
• Brandt, Linn; Kristiansen, Annette & Vandvik, Per Olav (2014). PLUGGED-IN: Providing Likeable and Understandable Guidelines using GRADE in the EMR with Direct links to INdividual patient data. phase 3. Full text in Research Archive
• Brandt, Linn; Vandvik, Per Olav & Kristiansen, Annette (2014). Implementing multilayered presentation formats in a new generation of trustworthy clinical practice guidelines. Full text in Research Archive
• Brandt, Linn; Vandvik, Per Olav & McCallum, Simon (2014). GAME-IT: explore peoples choices and facilitate teaching by turning evidence processing into a game. Full text in Research Archive
• Brandt, Linn; Vandvik, Per Olav; Kristiansen, Annette; Heen, Anja Fog & Berntsen, Christopher Friis (2014). Workshop og foredrag: Udvikling af evidensbaserede retningslinjer. Full text in Research Archive
• Brandt, Linn & Vandvik, Per Olav (2014). linkedPICO project - how to make different tools and platforms in the Medical Knowledge ecosystem talk past their silos. Full text in Research Archive
• Vandvik, Per Olav & Brandt, Linn (2014). Workshop: Producing and using generic decision aids linked to evidence summaries and guideline recommendations to enhance shared-decision making in clinical consultations. Full text in Research Archive
• Kristiansen, Annette; Brandt, Linn; Berge, Eivind; Dahm, Anders Erik A; Halvorsen, Sigrun & Sandset, Per Morten [Show all 7 contributors for this article] (2014). Nye retningslinjer for antitrombotisk behandling og tromboseprofylakse. Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 134(9), p. 921–922. doi: 10.4045/tidsskr.13.1582. Full text in Research Archive Show summary

  Nye retningslinjer med 250 anbefalinger for antitrombotisk behandling og tromboseprofylakse er nå tilgjengelig på nett. Retningslinjene fra Norsk selskap for trombose og hemostase imøtekommer nye standarder for troverdige retningslinjer og benytter seg av innovative teknologiske løsninger.

• Vandvik, Per Olav; Kristiansen, Annette; Heen, Anja Fog; Berntsen, Christopher Friis; Brandt, Linn & Agoritsas, Thomas (2014). Workshop: Producing and Using Generic Decision Aids Linked to Guideline Recommendations to Enhance Shared-Decision Making in Clinical Consultations. Full text in Research Archive
• Brandt, Linn; Kristiansen, Annette & Vandvik, Per Olav (2014). PLUGGED-IN (Providing Likeable and Understandable Guidelines using GRADE in the EMR with Direct links to INdividual patient data ) phase 3. Full text in Research Archive
• Brandt, Linn; Kristiansen, Annette & Vandvik, Per Olav (2014). TRUST-IT - Can we trust the advice given in clinical decision support systems. Full text in Research Archive
• Brandt, Linn; Kristiansen, Annette & Vandvik, Per Olav (2014). GAME-IT : Explore peoples choices and facilitate teaching by turning Guideline-making into a game. A MAGIC project. Full text in Research Archive
• Brandt, Linn; Kristiansen, Annette & Vandvik, Per Olav (2014). linkedPICO project: how to make different tools and platforms in the medical knowledge ecosystem talk past their silos. Full text in Research Archive
• Brandt, Linn; Kristiansen, Annette & Vandvik, Per Olav (2014). Hvordan kommuniserer retningslinjer med IT-systemene. Prosjekt MAGIC - Making GRADE the Irresistible choice. Full text in Research Archive
• Thorvaldsen, Signe Nome & Vandvik, Per Olav (2014). Irritabel tarmsyndrom. Kasuspresentasjon/diskusjon. Full text in Research Archive
• Guyatt, G.; Eikelboom, J.; Crowther, M.; Akl, E.; Francis, C. & Garcia, D. [Show all 13 contributors for this article] (2013). A response to There's madness in their methods. Journal of Thrombosis and Haemostasis. ISSN 1538-7933. 11(4), p. 785–786. doi: 10.1111/jth.12142. Full text in Research Archive
• Bates, Shannon M.; Greer, Ian A.; Middeldorp, Saskia; Veenstra, David L.; Prabulos, Anne-Marie & Vandvik, Per Olav (2013). Recommendations for prophylaxis of pregnancy-related venous thromboembolism in carriers of inherited thrombophilia. Comment on the 2012 ACCP guidelines: a rebuttal. Journal of Thrombosis and Haemostasis. ISSN 1538-7933. 11(9), p. 1782–1784. doi: 10.1111/jth.12347. Full text in Research Archive
• Brandt, Linn; Kristiansen, Annette & Vandvik, Per Olav (2013). GAME-IT (GAMEs for Improving Treatment-recommendations). Full text in Research Archive
• Guyatt, Gordon & Vandvik, Per Olav (2013). Creating Clinical Practice Guidelines Problems and Solutions. Chest. ISSN 0012-3692. 144(2), p. 365–367. doi: 10.1378/chest.13-0463. Full text in Research Archive
• Vandvik, Per Olav (2013). Creating clinical practice guidelines: problems and solutions. Chest. ISSN 0012-3692. doi: 10.1378/chest.13-0463. Full text in Research Archive
• Brandt, Linn & Vandvik, Per Olav (2013). PLUGGED-IN Providing Likeable and Understandable Guidelines using GRADE in the EMR with Direct links to INdividual patient data. Phase 2. Full text in Research Archive
• Vandvik, Per Olav & Brandt, Linn (2013). CLICK-IT: How do clinicians like and understand trustworthy guidelines? Randomized controlled trial using Clickers in educational sessions. Full text in Research Archive
• Vandvik, Per Olav & Brandt, Linn (2013). Electronic multilayered guideline format: a novel structure and presentation of trustworthy guidelines at the point of care. Full text in Research Archive
• Vandvik, Per Olav & Brandt, Linn (2013). SHARE-IT: Decision Aids linked to GRADE Guidelines to improve Shared-Decision Making in the Clinical Encounter. Full text in Research Archive
• Brandt, Linn; Kristiansen, Annette & Vandvik, Per Olav (2013). PLUGGED-IN: Providing Likeable and Understandable Guidelines using GRADE in the EMR with Direct links to INdividual patient data. phase 2. Full text in Research Archive
• Vandvik, Per Olav; Bretthauer, Michael & Kongerud, Ingrid Charlotte (2013). From clinical questions to trustworthy answers. 133(15), p. 1611–1614. Full text in Research Archive
• Frich, Jan C; Gran, Sarah Frandsen; Vandvik, Per Olav; Gulbrandsen, Pål & Hjortdahl, Per (2012). Kunnskap, ledelse og kvalitet i studiet. 132(15), p. 1768–1770. doi: 10.4045/tidsskr.12.0511. Full text in Research Archive
• Brandt, Linn & Vandvik, Per Olav (2012). MAGIC (Making GRADE the Irresistible Choice): Research program for optimal authoring, dissemination and dynamic updating of electronically structured GRADE guidelines. Full text in Research Archive
• Vandvik, Per Olav & Brandt, Linn (2012). Novel adaptation process and taxonomy for modifying recommendations customized to GRADE Guidelines. Full text in Research Archive
• Bates, Shannon M.; Greer, Ian A.; Middeldorp, Saskia; Veenstra, David L.; Prabulos, Anne-Marie & Vandvik, Per Olav (2012). VTE, thrombophilia, antithrombotic therapy, and pregnancy. Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicans evidence-based clinical practice guidelines. Chest. ISSN 0012-3692. 141(2), p. e691S–e736S. doi: 10.1378/chest.11-2300. Full text in Research Archive
• Sæterdal, Ingvil von Mehren; Vandvik, Per Olav & Brandt, Linn (2012). “The great diamond hunt” – Fun teaching GRADE to EBM naïve hospital physicians. Newsletter of the international society for evidence-based health care. Full text in Research Archive
• Brandt, Linn & Vandvik, Per Olav (2012). MAGIC. Full text in Research Archive
• Brandt, Linn & Vandvik, Per Olav (2012). SHARE-IT and related work in MAGIC. Full text in Research Archive
• Brandt, Linn & Vandvik, Per Olav (2012). Oral presentation of PLUGGED-IN at the GIN conference, Berlin 2012. Full text in Research Archive
• Brandt, Linn & Vandvik, Per Olav (2012). DECIDE WP1 user testing - Poster. Full text in Research Archive
• Vandvik, Per Olav; Eiring, Øystein; Jamtvedt, Gro & Nylenna, Magne (2011). Ja til kunnskapsbasert praksis. Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 131(17), p. 1637–1638. Full text in Research Archive
• Vandvik, Per Olav & Eiring, Øystein (2011). Kunnskapsbasert praksis for norske leger? Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 131(18), p. 1755–1755. Full text in Research Archive
• Frich, Jan C & Vandvik, Per Olav (2011). Kunnskapen om kunnskapen. Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 131, p. 1540–1540. Full text in Research Archive
• Eiring, Øystein & Vandvik, Per Olav (2011). The Hospital Trust project: Towards evidence-based clinical practice in Norwegian hospitals. Full text in Research Archive
• Vandvik, Per Olav (2009). Når tarmen slår seg vrang. Tidsskrift for Den norske legeforening (Tidsskriftet). ISSN 0029-2001. 129(7), p. 661–661. Full text in Research Archive
• Olsen, Nina Rydland; Vandvik, Per Olav; Larun, Lillebeth & Kirkhei, Ingvild (2009). An EBP tool for teaching and assessment. Full text in Research Archive Show summary

  Background: Teaching and learning of evidence-based practice (EBP) should be interactive and related to clinical questions. Furthermore, students need tools to help them organize the learning process, and EBP educators need instruments to assess the competence of individual students, and to evaluate study programs. Existing critical appraisal tools are available. However, we have not identified a generic tool that covers all EBP steps and assess EBP behaviour. Aim: To develop a generic EBP tool for learning and assessment purposes. Methods: Characteristics of the tool: The tool is designed for health care students and professionals. It requires participants to document all EBP steps, based on real clinical questions. Thus, the tool allows assessment of self-reported EBP behaviour. Testing of the tool: The tool was tested in different settings; in the curriculum for medical students in their 5th year (n=90); in a post-graduate course for clinical physiotherapy instructors (n=14) and in continuous medical education (CME) for physiotherapists (n=8). Usability and layout of the tool was improved on the basis of feedback from teachers and students, as well as the researchers own experience. Development of a scoring instrument: To assess self-reported EBP behaviour a system for assessment was developed. The Adapted Fresno Test and its grading rubric were used as point of reference. Results: The tool and scoring instrument will be presented at the conference. Feedback from participants and our informal evaluation suggests that the tool is easy to use, structures the learning process and enhances EBP skills and EBP behaviour. Scoring criteria were negotiated between teachers until consensus was reached. Using a standarised scoring instrument may give more accurate scores. Conclusion: The EBP tool shows promise for students? learning and teachers? assessment. However, both the tool and the scoring instrument need to be further tested and evaluated for feasibility, reliability and validity.

• Olsen, Nina Rydland; Vandvik, Per Olav & Larun, Lillebeth (2009). An EBP tool. Full text in Research Archive
• Hilt, Karl Ulvan; Hetlevik, Irene; Kristensen, Pål; Getz, Linn & Vandvik, Per Olav (2008). Validation of Calprotectin rapid test in general practice. Full text in Research Archive
• Johansson, P.A.; Farup, Per Grønaas & Vandvik, Per Olav (2007). Irritable bowel syndrome in general practice: cohort study of health resources, costs and comorbidity. Gut. ISSN 0017-5749. 56(A335). Full text in Research Archive
• Vandvik, Per Olav & Farup, Per Grønaas (2007). Jo høyere man klatrer i helsevesenet, jo mer vondt gjør i tarm, kropp og sjel? Studie av komorbiditet og legesøkning ved Irritabel tarm syndrom (IBS). Full text in Research Archive
• Hagen, Gunhild; Huitfeldt, Anders & Vandvik, Per Olav (2019). Patent foramen ovale closure, antiplatelet therapy or anticoagulation therapy alone for management of cryptogenic stroke. Folkehelseinstituttet. ISSN 9788280829931. Full text in Research Archive
• Frønsdal, Katrine & Vandvik, Per Olav (2014). Behandlingsretningslinjer for håndleddsbrudd hos voksne. Norsk Ortopedisk Forening. Full text in Research Archive
• Vandvik, Per Olav & Eiring, Øystein (2011). Foretaksprosjektet: Mot kunnskapsbasert praksis i spesialisthelsetjenesten. Folkehelseinstituttet. ISSN 9788281214217. Full text in Research Archive Show summary

  Kunnskapsbasert praksis er å integrere forskningskunnskap med klinisk ekspertise og pasientens verdier og preferanser. Kunnskapssenteret fikk i 2005 forespørsel fra Helse Øst RHF om støtte til bedre kunnskapshåndtering i spesialisthelsetjenesten. Denne rapporten oppsummerer resultater fra Foretaksprosjektet, et samarbeid mellom Kunnskapssenteret og Sykehuset Innlandet HF. Vi gir eksempler på eksisterende systemer og verktøy for kunnskapsbasert praksis og presenterer våre erfaringer fra arbeid med kunnskapsbasert praksis innen et rammeverk med fire hovedområder: Kompetanse, organisering, teknologisk infrastruktur og verktøy for kunnskapsstøtte.  Nye og bedre verktøy og systemer for kunnskapsstøtte kan gi helsepersonell tilgang til forskningsbasert kunnskap.  Helsebiblioteket (www.helsebiblioteket.no) er en portal for helsearbeidere med fri tilgang til retningslinjer, tidsskrifter og databaser.  Kunnskapspyramiden (6 S-modellen) kan hjelpe helsearbeidere til å forstå hvor de enkelt kan finne gyldig, forskningsbasert kunnskap.  Kunnskapsraffineriet McMaster PLUS identifiserer nye, viktige studier og serverer disse som e-postvarsler eller gjennom en egen søkemotor.  Vårt forslag til rammeverk for kunnskapsbasert praksis, basert på erfaringer fra Sykehuset Innlandet, beskriver et stort behov for kompetanseheving, organisasjonsendring i eget foretak, bedre teknologi og verktøy for kunnskapsstøtte.  Kompetanseheving er mulig blant annet gjennom nettkurset www.kunnskapsbasertpraksis.no, arbeidsfiler for klinisk integrert loering, loerebøker og ulike kurs.  Like viktig som forankring i toppledelse, strategidokumenter og budsjett er lokale initiativ i sykehusene som involverer klinikere med faglig engasjement ("ildsjeler) og mellomledere.  Arbeidet med å forbedre kunnskapsgrunnlaget i fagprosedyrer er nybrottsarbeid som samler helseforetakene i et nasjonalt nettverk.  Målrettet og omfattende nasjonal og regional innsats er nødvendig for å implementere kunnskapsbasert praksis i spesialisthelsetjenesten.

• Holte, Therese Opsahl; Vandvik, Per Olav; Elvsaas, Ida-Kristin Ørjasæter & Norderhaug, Inger Natvig (2009). Diagnostisk nøyaktighet av øre-, munnhule-, armhule- og pannetermometer sammenliknet med rektaltermometer for å identifisere feber hos voksne pasienter innlagt i sykehus eller sykehjem. Folkehelseinstituttet. ISSN 9788281212848. Full text in Research Archive Show summary

  Bruk av øretermometer er blitt en vanlig metode for å måle kroppstemperatur hos pasienter ved norske sykehus. Denne rapporten oppsummerer kunnskapen om diagnostisk nøyaktighet av øremåling sammenliknet med rektalmåling for å identifisere og utelukke feber hos voksne pasienter i sykehus eller sykehjem. I tillegg har vi søkt etter studier som sammenlikner munnhule-, armhule- og pannemåling med rektalmåling.

• Flottorp, Signe; Eiring, Øystein; Vandvik, Per Olav & Johansen, Marit (2007). Kunnskapsgrunnlaget for behandlingslinjer – en foreløpig oversikt. Folkehelseinstituttet. ISSN 9788281211742. Full text in Research Archive

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