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• Omdal, Roald; Grimstad, Tore Bjørn; Jonsson, Grete; Kvaløy, Jan Terje; Gibbs, Charlotte Christine & Reitsma, Laurens Cornelus [Show all 8 contributors for this article] (2026). Interleukin−1 receptor antagonist and heat shock protein 90alfa are independently associated with fatigue and general health in euthyroid Hashimoto’s thyroiditis. Frontiers in Endocrinology. 17. doi: 10.3389/fendo.2026.1862441. Full text in Research Archive Show summary

  Background Patients with Hashimoto’s thyroiditis frequently experience fatigue and impaired health-related quality of life (HRQOL) despite biochemical euthyroidism, suggesting that immune-mediated mechanisms beyond thyroid hormone deficiency contribute to symptom generation. The role of specific inflammatory mediators - including interleukin-1 receptor antagonist (IL-1Ra), heat shock protein 90α (HSP90α), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and anti-TPO antibodies - in relation to patient-reported outcomes (PROMs) has not been systematically examined. Methods In a cross-sectional study of 36 euthyroid patients with confirmed Hashimoto’s thyroiditis, serum/plasma levels of IL-1Ra, HSP90α, IL-6, and TNF-α were measured alongside anti-TPO. PROMs included the SF-36 General Health subscale (inverted; iGH), the Fatigue Visual Analog Scale (fVAS), and the Fatigue Severity Scale (FSS). Spearman correlations, univariable and multivariable linear regression, and principal component analysis (PCA) were applied. Results The cohort displayed severe fatigue at baseline (median fVAS 85, FSS 6.7, SF-36 GH 16). IL-1Ra was the most consistent biomarker correlate of symptom burden, independently associated with poorer general health and more fatigue across all regression models. HSP90α showed an inverse and independent association with fatigue in multivariable models, suggesting a potentially protective role. IL-6 contributed in correlation analysis only, while TNF-α and anti-TPO were not significantly associated with any PROM in any analytical approach. Conclusion IL-1Ra and HSP90α, but not anti-TPO, are independently associated with fatigue and general health in euthyroid Hashimoto’s thyroiditis, pointing to IL-1 pathway activity as associated with symptom burden and potentially playing a key role in this condition.

• Nilsson, Per Rasmus; Myklebust, Tor Åge; Næss-Andresen, Thomas Fredrik; Bernklev, Tomm; Kersten, Hege & Haug, Erik Skaaheim (2026). In pathological T2-prostate cancers a positive surgical margin is associated with adverse psychological outcomes. Scandinavian Journal of Urology. ISSN 2168-1805. 61, p. 15–21. doi: 10.2340/sju.v61.45306. Full text in Research Archive Show summary

  Objective: A positive surgical margin (PSM) after radical prostatectomy (RP) is considered an adverse surgical feature, but the clinical implications have been debated. Further motive to aim for negative margins (NSM) may be patient anxiety due to PSM, but studies on psychological consequences are lacking. We explored associations between psychological factors and PSM on a consecutive group of men after RP. Material and methods: Men with suspected prostate cancer were invited to a study on psychological factors. Patient reported outcome measurement questionnaires were collected before diagnosis, and at 6, 12 and 24 months from those who underwent RP. Multivariable mixed models and post hoc pairwise comparisons were used to explore associations between PSM and psychological outcomes. Results: In total, 387 men had RP and 94 (24%) had PSM. General psychological outcomes were not associated with margin status. At 12 months, men with PSM considered their personal risk of recurrence 6% (30% vs. 24%) points higher and had clinical fear of recurrence (FoR) 14% (47% vs. 33%) more often than men with NSM. In adjusted and stratified analyses, men with pathological (p-)T2-stage and NSM had less FoR than the rest of the sample. In pT3-disease, PSM had no additional impact on FoR. A limitation was the small size of the pT2 group with PSM and the lack of information on how patients were informed. Conclusions: After RP, PSM was associated with higher FoR, particularly in men with pT2-cancer. Improved counselling and further research into causes and mitigation of FoR, is warranted.

• Holten, Kristina Ingeborg Aass; Bernklev, Tomm; Opheim, Randi; Olsen, Bjørn Christian Elias Grova; Johansen, Ingunn & Strande, Vibeke [Show all 19 contributors for this article] (2026). Fatigue Trajectory During the First Year of an Inflammatory Bowel Disease Diagnosis, Results from the IBSEN III study. Digestive Diseases and Sciences. ISSN 0163-2116. 71, p. 2476–2487. doi: 10.1007/s10620-025-09661-0. Full text in Research Archive Show summary

  Background: Fatigue is common in Crohn's disease (CD) and ulcerative colitis (UC), but the pathogenesis remains poorly understood. Aims: This study aimed to assess changes in fatigue prevalence during the first year after diagnosis and examine the association between disease course and substantial fatigue (SF) at the 1-year follow-up. Methods: Adults with newly diagnosed CD or UC were recruited from the population-based IBSEN III cohort. Fatigue was assessed at diagnosis and the 1-year follow-up using the Fatigue Questionnaire. Associations between SF at the 1-year follow-up and disease-related factors were quantified using multivariate logistic regression adjusted for sex, age and comorbidities. Results: In total, 596 patients were included (CD: 196, UC: 400). SF was present at both baseline and after one year of disease for 46.9% (n = 92/196) and 40.5% (n = 162/400) of patients with CD and UC, respectively. In CD, development of endoscopically non-passable stricture and/or surgically treated stricture within first year of disease (OR = 4.52, 95%CI [1.61;12.68]), self-reported flares since diagnosis (OR = 2.55, 95%CI [1.26;5.16]), female sex (OR = 3.12, 95%CI [1.53;6.37]) and comorbidities (OR = 4.05, 95%CI [1.89;8.69]) were independently associated with SF at the 1-year follow-up. In UC, SF was associated with current biological treatment (OR = 5.14, 95%CI [1.56;16.96]), increasing Mayo endoscopic score at the 1-year follow-up (OR = 1.54, 95%CI [1.01;2.35]), self-reported flares since diagnosis (OR = 2.66, 95%CI [1.24;5.72]) and female sex (OR = 2.20, 95%CI [1.06;4.57]). Conclusions: Fatigue frequently persists through the first year after IBD diagnosis. Clinical factors reflecting a more severe disease course were associated with SF one year after diagnosis in both CD and UC.

• Andersen, Svend; Bernklev, Tomm; Størdal, Ketil; Hagen, Milada; Kristensen, Vendel Ailin & Opheim, Randi [Show all 13 contributors for this article] (2025). Specific phenotypes may drive an increased incidence of pediatric inflammatory bowel disease in South‐Eastern Norway. Journal of Pediatric Gastroenterology and Nutrition - JPGN. ISSN 0277-2116. 81(5), p. 1227–1236. doi: 10.1002/jpn3.70148. Full text in Research Archive Show summary

  Abstract Objectives Pediatric inflammatory bowel disease (PIBD) incidence has increased in recent decades but may be stabilizing, prompting exploration of incidence changes, disease distribution, and severity. Methods From 2017 to 2019, patients under 18 years with PIBD symptoms were recruited from nine hospitals in South‐Eastern Norway for Inflammatory Bowel Disease in South‐Eastern Norway III (IBSEN III), a population‐based inception cohort study. The primary outcome was a diagnosis of any PIBD subtype as defined by revised Porto criteria. Paris classification system defined disease phenotypes, and descriptions of covariates were gathered from patients in IBSEN III. Results We identified 324 PIBD patients, with 216 consenting to the IBSEN III study. The crude incidence rate was 17.8 per 100,000 person‐years (PY) (95% confidence interval [CI]: 15.9–19.8). Crohn's disease (CD) was found in 118 patients (54.6%); 48% had ileocolonic distribution, 40% had upper gastrointestinal disease, and 12.8% had perianal disease. Complications (stricturing and/or penetrating) were noted in 18%. Ulcerative colitis (UC) was diagnosed in 78 patients (36.1%), predominantly pancolitis (41%), with 30% having proctitis. One in five suffered severe disease. IBD unclassified was found in 20 patients (9.3%). PIBD incidence in those under 16 was 13.6/100,000 PY, up from 4.7 in the IBSEN study 27 years ago. Terminal ileitis (11%–23%) and proctitis (14%–25%) rose from IBSEN (1990–1993) to IBSEN III, while stricturing/penetrating disease changed insignificantly (17%–16%). Conclusions The incidence of PIBD has risen in South‐Eastern Norway, with increased cases of terminal ileitis in CD, unchanged stricturing/penetrating disease, and increased proctitis in UC compared to the original IBSEN study. Trial registration ClinicalTrials.gov identifier: NCT02727959.

• Olsen, Bjørn Christian Elias Grova; Opheim, Randi; Kristensen, Vendel Ailin; Høivik, Marte Lie; Lund, Charlotte & Aabrekk, Tone Bergene [Show all 22 contributors for this article] (2025). Prevalence of Irritable Bowel Syndrome Based on Rome IV Criteria in Patients in Biochemical and Endoscopic Remission From Newly Diagnosed Inflammatory Bowel Disease: One- and Three-Year Results (the IBSEN III Cohort). Inflammatory Bowel Diseases. ISSN 1078-0998. 31(10), p. 2704–2713. doi: 10.1093/ibd/izaf047. Full text in Research Archive Show summary

  Background: Distinguishing irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD) flare-ups is challenging. This study used objective remission markers to accurately determine IBS prevalence in a population-based cohort of patients with IBD. Methods: Adults with ulcerative colitis and Crohn’s disease were recruited from the IBD in South-Eastern Norway III cohort study. Irritable bowel-like symptoms were assessed using the Rome IV criteria for patients in remission from IBD at 1- and 3-year follow-ups. Remission was defined objectively using the biochemical marker fecal calprotectin (FC) ≤ 250 μg/g, and comparisons to remission based on endoscopic indices were made at 1-year follow-up. Results: Among patients with FC ≤ 250 μg/g, IBS prevalences were 21.9% (n = 62/283) and 16.1% (n = 49/304) at the 1- and 3-year follow-ups, respectively, which were higher than that in the Norwegian population (9.5%; P < .005). Of patients in endoscopic remission at 1-year follow-up, 19.2% (n = 43/224) reported IBS-like symptoms, which was not significantly different from IBS prevalence for patients with FC ≤ 250 μg/g. Irritable bowel syndrome was independently associated with substantial fatigue (odds ratio: 3.05 [95% CI, 1.48-6.27]) and female sex (odds ratio: 2.67 [95% CI, 1.34-5.32]) at the 1-year follow-up. Patients with IBS reported significantly reduced health-related quality of life (HRQoL) scores. Conclusions: The prevalence of IBS among patients in remission from IBD was approximately twice as common as that in the Norwegian population. Irritable bowel syndrome was independently associated with substantial fatigue, female sex, and reduced HRQoL.

• Hoff, Geir Svein; Bernklev, Tomm; Kvaløy, Jan Terje; Gibbs, Charlotte Christine & Reitsma, Laurens Cornelus (2025). Patients With Persistent Hashimoto-Related Symptoms. Dilemmas in Advice-Giving and Self-Selection for Thyroidectomy. An Observational Study. Endocrine Practice. ISSN 1530-891X. 31(7), p. 906–912. doi: 10.1016/j.eprac.2025.04.007. Full text in Research Archive Show summary

  Objective Some Hashimoto-related symptoms, persistent despite medically obtained euthyroidism, are believed to be related to autoimmunity. Total thyroidectomy has proved beneficial for patient-reported outcome measures (PROMs), but with a certain risk of complications. Selection criteria for surgery have not been defined. Molecular evidence supporting an autoimmune cause is lacking, and a placebo effect of surgery cannot be excluded. Short of selection criteria for thyroidectomy and no pathophysiologic model to adequately explain persistent symptoms, we wanted to look into factors that may be related to patients’ decision for surgery, thus aiming to facilitate patient-physician communication on treatment for persistent Hashimoto-related symptoms. Methods A total of 177 patients with persistent Hashimoto disease-related symptoms and highly motivated for thyroidectomy completed an 18-month watchful waiting period with biannual consultations before being offered thyroidectomy. PROMs were monitored before and after surgery. Results After 18 months of watchful waiting, 131 (74%) of 177 patients proceeded to thyroidectomy whereas 46 declined surgery. There was no difference between the surgery and no-surgery groups regarding sex, age, and thyroid peroxidase antibody levels at 18 months watchful waiting. Compared with the no-surgery group, PROM scores were consistently poorer in the surgery group for all domains in the PROM questionnaires used. Conclusions A grace period of 18 months with biannual follow-up before thyroidectomy may be useful to modify exposure to surgery carrying a certain risk of complications. At 18 months, the fatigue score stands out as the most important factor influencing the odds for maintaining a choice to have surgery.

• Hoff, Geir Svein; Bernklev, Tomm; Johnsen, Lene; Reitsma, Laurens Cornelus; Sina, Dirk & Lauzike, Andromeda [Show all 13 contributors for this article] (2024). Thyroidectomy for Euthyroid Patients with Hashimoto Disease and Persistent Symptoms: An Observational, Postrandomization Study. Journal of Thyroid Research. ISSN 2090-8067. 2024(1). doi: 10.1155/2024/5518720. Full text in Research Archive Show summary

  Background: Despite adequate hormone substitution in Hashimoto disease, some patients may have persistent symptoms with a possible autoimmune pathophysiology. A recent randomized trial (RCT) using patient-reported outcome measures as the primary endpoint showed benefit in total thyroidectomy, but at a cost of high complication rates. Objective: To verify results from the RCT in an observational study including a wider range of patients and explore means of predicting who may benefit from such surgery. Design: A total of 154 patients with Hashimoto disease, euthyroid with or without thyroid hormone substitution, and persistent Hashimoto-related symptoms were subjected to total thyroidectomy and followed for 18 months after surgery. The primary outcome was the General Health (GH) dimensional score in the Short Form-36 Health Survey (SF-36). Results: Eighteen months after surgery, a clinically significant improvement in GH was seen, similar to the findings in the previous RCT. Anti-TPO antibody titers were markedly reduced after surgery, but preoperative titers or other preoperative parameters could not predict the outcome of surgery. Three (1.9%) of 154 patients experienced permanent unilateral recurrent nerve palsy and six (3.9%) experienced hypoparathyroidism after surgery. Conclusions: Thyroidectomy had a beneficial symptom-reducing effect in euthyroid patients with Hashimoto disease and persistent symptoms. The pathophysiology of residual symptoms remains unclear, and surgical complication rates are high. If thyroidectomy is considered as a treatment option, it should be performed in dedicated centers with experienced endocrine surgeons and as part of further studies on persistent symptoms. This trial is registered with NCT-02319538.

• Lukina, Polina; Andersen, Ina Lervåg; Eggen, Petter Tinbod; Mjønes, Patricia Gjertrud; Rønne, Elin & Bolstad, Nils [Show all 18 contributors for this article] (2024). Coeliac disease in the Trøndelag Health Study (HUNT), Norway, a population-based cohort of coeliac disease patients. BMJ Open. 14:e077131(1), p. 1–7. doi: 10.1136/bmjopen-2023-077131. Full text in Research Archive Show summary

  Purpose - Coeliac disease (CD) is a common disorder and affects about 1% of the population worldwide. CD in the Trøndelag Health Study (HUNT) is a population-based cohort study which was established to provide new knowledge about CD that can improve the diagnostics and management, prevent the onset or progression and expand the knowledge about the role of genetics of the disease. Participants - The cohort is based on the fourth wave of the population-based HUNT study (HUNT4), Norway, performed during 2017–2019, also including linkage to hospital records and the Norwegian Patient Registry (NPR). A total of 54 541 HUNT4 participants with available sera were screened for CD by serology. All seropositive participants were invited to a clinical assessment, including endoscopy with duodenal biopsies, during 2019–2023. Findings to date - A total of 1107 HUNT4 participants (2%) were seropositive for CD and 1048 were eligible for clinical assessment, including biopsy. Of these, 724 participants attended the clinical assessment and 482 were identified with CD. In addition, 371 participants with CD were identified through the hospital records and NPR. In total, 853 participants in HUNT4 with biopsy-verified CD diagnosis were identified. Future plans - All participants in the study will be invited to a follow-up assessment after at least 1 year, including repeated standard serological testing, endoscopy and tissue sampling. The collected data and material will be used to establish the true population-based prevalence of CD. The consequences of CD, including symptoms, deficiencies and comorbidity, will be investigated and possible triggers and predictors, will be studied. With access to serum samples from the previous HUNT surveys in HUNT Biobank, serological signs of CD in prediagnostic samples of seropositive individuals will be used. Genetic studies will identify new CD markers, assess genotype–phenotype links and explore gene–environment correlations.

• Andersen, Svend; Hestetun, Sigrid Valen; Bernklev, Tomm; Perminow, Gøri Margrete & Størdal, Ketil (2024). Fetal and Early-Life Antibiotics and Risk of Pediatric Inflammatory Bowel Disease: A Population-Based Nationwide Register Study. The Journal of Pediatrics: Clinical Practice. 12, p. 1–8. doi: 10.1016/j.jpedcp.2024.200096. Full text in Research Archive Show summary

  To assess whether antibiotic exposure prenatally and before 2 years of age is associated with subsequent pediatric inflammatory bowel disease (PIBD), as earlier studies diverge substantially in risk estimations or do not include prenatal exposure. Methods We performed a register-based cohort study including all children in Norway born 2004-2012 until study’s end on December 31, 2020. Exposures were defined as dispensed antibiotics to mothers during pregnancy and to children before 2 years of age. Main outcome was International Classification of Diseases, Tenth Revision, code registrations consistent with PIBD. Results Among 536 819 children, 797 PIBD cases were identified. The aOR for developing PIBD if exposed to antibiotics before 2 years of age compared with no exposure was 1.33 (95% CI 1.15-1.53), adjusted for sex and prenatal antibiotic exposure. An adjustment for maternal smoking during pregnancy increased the aOR to 1.42 (1.22-1.66), but with minimal changes after further adjustments for potential confounders related to pregnancy, birth, or socioeconomic status. A dose-response association was observed in those receiving more than 2 antibiotic courses (aOR 1.47, 1.25-1.73), and with greater effect estimates for broad-spectrum antibiotics (aOR 2.57, 1.82-3.63). Antibiotic exposure during pregnancy was numerically but not significantly associated with offspring PIBD (aOR 1.15, 0.99-1.34). Conclusions Children exposed to antibiotics before 2 years of age were more likely to develop pediatric IBD than controls. Exposure prenatally to maternal antibiotics was numerically but not statistically significant associated to subsequent PIBD.

• Holten, Kristina Ingeborg; Bernklev, Tomm; Opheim, Randi; Olsen, Bjørn Christian Elias Grova; Detlie, Trond Espen & Strande, Vibeke [Show all 18 contributors for this article] (2024). Fatigue in Patients with Inflammatory Bowel Disease in Remission One Year after Diagnosis (the IBSEN III Study). Journal of Crohn's and Colitis. ISSN 1873-9946. 19(4). doi: 10.1093/ecco-jcc/jjae170. Full text in Research Archive Show summary

  Background and aims: Fatigue is commonly observed in Crohn's disease (CD) and ulcerative colitis (UC), but its association to achieving remission is not clearly established. In this study we describe the odds for fatigue in patients with CD/UC one year after diagnosis based on different definitions of remission and identified factors associated with chronic fatigue (CF) among patients in endoscopic/radiological remission. Methods: Patients ≥18 years with CD/UC were recruited from the IBSEN III cohort. Using the Fatigue Questionnaire, and dichotomizing the score, CF was defined as the presence of substantial fatigue (SF) for ≥6 months. Remission was divided into symptomatic (CD: HBI score<5/UC: SCCAI score<3), biochemical (faecal calprotectin ≤250µg/g), endoscopic/radiological (CD: normal intestinal MRI/CT combined with normal endoscopy/UC: Mayo endoscopic score 0) and histological (normal mucosal biopsies). Both the likelihood of SF/CF, depending on the definition of remission, and associations between CF an

• Nilsson, Per Rasmus; Næss-Andresen, Thomas Fredrik; Myklebust, Tor Åge; Bernklev, Tomm; Kersten, Hege & Haug, Erik Skaaheim (2024). The association between pre-diagnostic levels of psychological distress and adverse effects after radical prostatectomy. BJUI Compass. 5(5), p. 616–625. doi: 10.1002/bco2.334. Full text in Research Archive Show summary

  Objectives: To prospectively analyse the associations between pre-diagnostic levels of anxiety and depression and patient-reported urinary and sexual adverse effects after radical prostatectomy in a population-based setting. Patients and Methods: In three Norwegian county hospitals, men referred with a suspicion of prostate cancer were asked to fill out a patient-reported outcome measurement (PROM) questionnaire prior to prostate biopsy. Those who later underwent radical prostatectomy were stratified into three distress groups according to their Hopkins Symptom Checklist 5-score. Additional PROM questionnaires, including the EPIC-26 to measure adverse effects, were collected at 6 and 12 months postoperatively. Multivariable mixed models were estimated and post hoc pairwise comparisons performed to explore differences in adverse effects between distress groups. Results: A total of 416 men were included at baseline and of those, 365 (88%)returned questionnaires at 6 months and 360 (87%) at 12 months. After adjusting for confounders, men with high distress at baseline had worse urinary incontinence domain score (58.9 vs. 66.8, p = 0.028), more urinary bother (64.7 vs. 73.6, p = 0.04) and a higher risk of using incontinence pads (70.6% vs. 54.2%, p = 0.034) at 6 months than those with low distress. There was no difference in the sexual domain scores between distress groups postoperatively, but the high-distress group expressed more sexual bother (24.9 vs. 37.5, p = 0.015) and the intermediate-distress group had a greater probability of using sexual medications or devices (63.8% vs. 50.0%, p = 0.015) than the low-distress group at 6 months. At 12 months scores generally improved slightly and differences between distress groups were less evident. Conclusion: Men with higher levels of anxiety and depression before prostate biopsy report more urinary and sexual adverse effects after radical prostatectomy. This should be considered both in treatment decision-making and during follow-up after radical prostatectomy.

• Holten, Kristina Ingeborg; Bernklev, Tomm; Opheim, Randi; Johansen, Ingunn; Olsen, Bjørn Christian Elias Grova & Lund, Charlotte [Show all 22 contributors for this article] (2023). Fatigue in Patients with Newly Diagnosed Inflammatory Bowel Disease: Results from a Prospective Inception Cohort, the IBSEN III Study. Journal of Crohn's and Colitis. ISSN 1873-9946. 17(11), p. 1781–1790. doi: 10.1093/ecco-jcc/jjad094. Full text in Research Archive Show summary

  Background and aims: Although fatigue is common in inflammatory bowel disease (IBD), its pathogenesis remains unclear. This study aimed to determine the prevalence of fatigue and its associated factors in a cohort of patients newly diagnosed with IBD. Methods: Patients ≥18 years were recruited from the Inflammatory Bowel Disease South-Eastern Norway (IBSEN III) study, a population-based, observational inception cohort. Fatigue was assessed using the Fatigue Questionnaire and compared with data from a Norwegian general population. Univariate and multivariate linear and logistic regression analyses were performed to evaluate the associations of total fatigue (TF) (continuous score) and substantial fatigue (SF) (dichotomized score ≥4) with sociodemographic, clinical, endoscopic, laboratory, and other relevant patient data. Results: In total, 983/1509 (65.1%) patients with complete fatigue data were included (ulcerative colitis (UC), 68.2%; Crohn's disease (CD), 31.8%). The prevalence of SF was higher in CD (69.6%) compared with UC (60.2%) (p<0.01), and in both diagnoses when compared to the general population (p<0.001).In the multivariate analyses, depressive symptoms, pain intensity, and sleep disturbances were associated with increased TF for both diagnoses. In addition, increased clinical disease activity and Mayo endoscopic score were significantly associated with TF in UC, whereas all disease-related variables were insignificant in CD. Similar findings were observed for SF, except regarding the Mayo endoscopic score. Conclusions: SF affects approximately two-thirds of patients newly diagnosed with IBD. Fatigue was associated with depressive symptoms, sleep disturbances, and increased pain intensity in both diagnoses, while clinical and endoscopic activity were associated factors only in UC.

• Olsen, Bjørn Christian Elias Grova; Opheim, Randi; Høivik, Marte Lie; Lund, Charlotte; Aabrekk, Tone Bergene & Johansen, Ingunn [Show all 15 contributors for this article] (2023). Health-related quality of life in patients with newly diagnosed inflammatory bowel disease: an observational prospective cohort study (IBSEN III). Quality of Life Research. ISSN 0962-9343. 32(10), p. 2951–2964. doi: 10.1007/s11136-023-03435-9. Full text in Research Archive Show summary

  Purpose This unselected, population-based cohort study aimed to determine the level of health-related quality of life (HRQoL) in patients with Crohn’s disease (CD) and ulcerative colitis (UC) at the time of diagnosis compared with a reference population and identify the demographic factors, psychosocial measures, and disease activity markers associated with HRQoL. Methods Adult patients newly diagnosed with CD or UC were prospectively enrolled. HRQoL was measured using the Short Form 36 (SF-36) and Norwegian Inflammatory Bowel Disease Questionnaires. Clinical significance was assessed using Cohen’s d effect size and further compared with a Norwegian reference population. Associations between HRQoL and symptom scores, demographic factors, psychosocial measures, and disease activity markers were analyzed. Results Compared with the Norwegian reference population, patients with CD and UC reported significantly lower scores in all SF-36 dimensions, except for physical functioning. Cohen’s d effect sizes for men and women in all SF-36 dimensions were at least moderate, except for bodily pain and emotional role for men with UC and physical functioning for both sexes and diagnoses. In the multivariate regression analysis, depression subscale scores ≥ 8 on the Hospital Anxiety and Depression Scale, substantial fatigue, and high symptom scores were associated with reduced HRQoL. Conclusion Patients newly diagnosed with CD and UC reported statistically and clinically significantly lower scores in seven of the eight SF-36 dimensions than the reference population. Symptoms of depression, fatigue, and elevated symptom scores were associated with poorer HRQoL.

• Hoff, Geir Svein; Bernklev, Tomm; Johnsen, Lene; Reitsma, Laurens Cornelus; Sina, Dirk & Lauzike, Andromeda [Show all 14 contributors for this article] (2023). Thyroidectomy for Euthyroid Patients With Hashimoto Disease and Persisting Symptoms. Annals of Internal Medicine. ISSN 0003-4819. 177(1), p. 101–103. doi: 10.7326/M23-1593. Full text in Research Archive
• Botteri, Edoardo; Hoff, Geir; Randel, Kristin Ranheim; Holme, Øyvind; Lange, Thomas de & Bernklev, Tomm [Show all 16 contributors for this article] (2022). Characteristics of nonparticipants in a randomised colorectal cancer screening trial comparing sigmoidoscopy and faecal immunochemical testing. International Journal of Cancer. ISSN 0020-7136. 151(3), p. 361–371. doi: 10.1002/ijc.34025. Full text in Research Archive Show summary

  Public health systems should guarantee universal access to health care services, including cancer screening. We assessed whether certain population subgroups were underrepresented among participants in colorectal cancer screening with sigmoidoscopy and faecal immunochemical testing (FIT). Between 2012 and 2019, about 140 000 individuals aged 50 to 74 years were randomly invited to once-only sigmoidoscopy or first round of FIT screening. Our study included 46 919 individuals invited to sigmoidoscopy and 70 019 to FIT between 2012 and 2017. We used logistic regression models to evaluate if demographic and socioeconomic factors and use of certain drugs were associated with participation. Twenty-four thousand one hundred and fifty-nine (51.5%) individuals attended sigmoidoscopy and 40 931 (58.5%) FIT screening. Male gender, young age, low education and income, being retired or unemployed, living alone, being an immigrant, long driving time to screening centre, and use of antidiabetic and psychotropic drugs were associated with low participation in both screening groups. Many of these factors also predicted low acceptance of colonoscopy after positive FIT. While male gender, young age and living alone were more strongly associated with nonparticipation in FIT than sigmoidoscopy, low education and income, being retired or immigrant and long driving time were more strongly associated with nonparticipation in sigmoidoscopy than FIT. In conclusion, participation was lower in sigmoidoscopy than FIT. Predictors of nonparticipation were similar between arms. However, low socioeconomic status, being an immigrant and long driving time affected participation more in sigmoidoscopy screening, suggesting that FIT may guarantee more equal access to screening services than sigmoidoscopy.

• Kirkøen, Benedicte; Berstad, Paula; Hoff, Geir; Bernklev, Tomm; Randel, Kristin Ranheim & Holme, Øyvind [Show all 9 contributors for this article] (2022). Type and Severity of Mental Illness and Participation in Colorectal Cancer Screening. American Journal of Preventive Medicine. ISSN 0749-3797. 64(1), p. 76–85. doi: 10.1016/j.amepre.2022.08.011. Full text in Research Archive Show summary

  Introduction: The effectiveness of colorectal cancer screening programs depends on the participation rate. This study examined the association between type and severity of mental illness and colorectal cancer screening participation. Methods: Between 2012 and 2017, a total of 46,919 individuals were invited to sigmoidoscopy screening in Norway, and 70,019 were invited to fecal immunochemical testing. In 2022, logistic regression was used to evaluate the association between the use of antipsychotics, anxiolytics, hypnotics, and antidepressants in the year preceding the screening invitation and screening participation, adjusted for demographic and socioeconomic factors. Defined daily doses of individual drugs were used to assess dose‒response relationships. Results: Overall, 19.2% (24.8% of women, 13.4% of men) of all invitees used at least 1 psychotropic medication. Nonparticipation in the 2 arms combined was associated with the use of anxiolytics (60.7% in users vs 43.2% in nonusers; OR=1.53; 95% CI=1.45, 1.62) and antipsychotics (64.3% vs 43.8%; OR=1.41; 95% CI=1.30, 1.53) and increased with higher doses for both drugs. Hypnotics and antidepressants were only weakly associated with nonparticipation in higher doses. Participation rates were 57.3%, 52.3%, 42.9%, and 35.4% in those prescribed 0, 1, 2, and 3-4 classes of psychotropic medications, respectively. The associations between the use of psychotropic medications and nonparticipation were similar for the 2 screening tests. Conclusions: These findings show significant disparities in colorectal cancer screening participation for individuals with mental illness, independent of the screening method. Moreover, screening participation varied depending on the type and severity of mental illness. Targeted interventions are warranted to ensure that people with mental illness are supported to access the benefits of colorectal cancer screening.

• Tsarpali, Vasiliki; Midtvedt, Karsten; Lønning, Kjersti; Bernklev, Tomm; Åsberg, Anders & Fawad, Haris [Show all 10 contributors for this article] (2022). A Comorbidity Index and Pretransplant Physical Status Predict Survival in Older Kidney Transplant Recipients: A National Prospective Study. Transplantation direct. 8(4), p. e1307–e1307. doi: 10.1097/TXD.0000000000001307. Full text in Research Archive Show summary

  Kidney transplantation (KT) is considered the best treatment for end-stage kidney disease (ESKD). In the increasing elderly ESKD population, KT should be reserved for carefully selected candidates who are expected to experience favorable outcomes. We aimed to prospectively evaluate pretransplant recipient factors that may predict patient survival and can eventually guide therapeutic decisions in elderly with ESKD. Methods: Recipient factors were evaluated in KT candidates aged ≥65 y. Comorbidity was assessed at waitlisting according to the Liu comorbidity index (LCI). Health-related quality of life outcomes were measured using the Kidney Disease Quality of Life Short Form, version 1.3. The Cox proportional hazard regression was used to evaluate predictors of patient survival. Results: We included 192 recipients, with a mean age of 72.1 (4.1) y, who were transplanted with kidneys from deceased brain-dead donors. During a median observation period of 4.6 (3.2-6.3) y, 66 recipients died. Elevated LCI consistently predicted poor patient survival. In recipients with LCI ≥4, dialysis >2 y comprised a 2.5-fold increase in mortality risk compared with recipients on dialysis ≤2 y. Self-reported pretransplant physical function was also proven to be a significant positive predictor of survival. Conclusion: The implementation of LCI and a physical function score during the evaluation of older kidney transplant candidates may improve the selection and thereby optimize posttransplant outcomes.

• Berge, Jarle; Hjelmesæth, Jøran Sture; Kolotkin, Ronette Loganzo; Støren, Øyvind; Bratland-Sanda, Solfrid & Hertel, Jens Kristoffer [Show all 10 contributors for this article] (2022). Effect of aerobic exercise intensity on health-related quality of life in severe obesity: a randomized controlled trial. Health and Quality of Life Outcomes. 20. doi: 10.1186/s12955-022-01940-y. Full text in Research Archive Show summary

  Background Aerobic exercise is an important part of obesity treatment and may improve health-related quality of life (HRQOL). The objective of this study was to compare the effect of two different exercise programs on health-related quality of life in patients with severe obesity. Methods This was a single-center, open-label, randomized, parallel-group study comparing the effects of a 24-week moderate-intensity continuous training (MICT) program and a combined high-intensity interval training program with MICT (HIIT/MICT). The primary objective (specified secondary outcome) was to assess HRQOL by using the general health dimension of the Short Form Health Survey (SF-36). The secondary objectives were to assess other dimensional SF-36 scores, the impact of weight on the physical and psychosocial aspects of quality of life (IWQOL-Lite), and the burden of obesity-specific weight symptoms (WRSM). Results 73 patients were enrolled and reported patient reported outcome measures, with 71 patients (55% females) allocated to either MICT (n = 34) or HIIT/MICT (n = 37). In the intention-to-treat analysis, general health scores increased between baseline and 24-week follow-up in both the HIIT/MICT group and the MICT group, with a mean change of 13 (95% CI 6–21) points and 11 (95% CI 5–17) points, respectively, with no difference between the groups. The effect sizes of these changes were moderate. The vitality and social functioning scores of SF-36, and the physical function and self-esteem scores of IWQOL-Lite increased moderately in both groups, with no difference between groups. The tiredness, back pain, and physical stamina scores based on WRSM showed moderate to strong changes in both the groups. Conclusions Patients who had completed a combined HIIT/MICT program did not experience larger improvements in general health compared with those completing a clean 24-week MICT program. Exercise may confer general health benefits independent of intensity.

• Jelsness-Jørgensen, Lars-Petter; Moum, Bjørn Allan; Grimstad, Tore Bjørn; Jahnsen, Jørgen; Hovde, Øistein & Frigstad, Svein Oskar [Show all 7 contributors for this article] (2022). The multidimensional fatigue inventory (MFI-20): psychometrical testing in a Norwegian sample of inflammatory bowel disease (IBD) patients. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. p. 1–7. doi: 10.1080/00365521.2022.2029939. Full text in Research Archive Show summary

  OBJECTIVES To evaluate the psychometric properties of the Norwegian version of the multidimensional fatigue inventory (MFI-20) in patients with inflammatory bowel disease. METHODS Participants were recruited from nine hospitals in the southeastern and western parts of Norway. Clinical and sociodemographic data were collected, and participants completed the MFI-20, as well as the Fatigue Questionnaire (FQ). In addition to a confirmatory factor analysis, validity, reliability, test-retest and responsiveness were evaluated. RESULTS In total, 410 patients were included. The Norwegian MFI-20 had an acceptable model fit when compared to the original five-dimensional structure. A positive correlation was observed between the dimensions of MFI-20 and the FQ. MFI-20 scores increased according to subjective disease activity, but no differences were observed when using a calprotectin cut-off < or > =250 µg/g mg/kg. All MFI-20 dimensions except ‘reduced motivation’ in both ulcerative colitis (UC) and Crohn’s disease (CD) patients had alpha Cronbach alpha values ≥70, and test-retest reliability revealed good to excellent values. Merely one dimension (Reduced activity) in UC patients reporting improvement did not reach the threshold for acceptable responsiveness according to Guyatt statistics. CONCLUSIONS The Norwegian version of MFI-20 is valid, reliable and responsive. The instrument can safely be used in studies using fatigue as an endpoint.

• Tsarpali, Vasiliki; Midtvedt, Karsten; Lønning, Kjersti; Bernklev, Tomm; Åsberg, Anders & Lippe, Nanna von der [Show all 8 contributors for this article] (2022). Poor physical function trajectory predicts impaired patient survival in older recipients of deceased donor kidneys: A prospective cohort study. Transplantation direct. 8(11), p. e1374–e1374. doi: 10.1097/TXD.0000000000001374. Full text in Research Archive Show summary

  Optimized health-related quality of life (HRQOL) at the time of kidney transplantation (KT) is associated with improved survival. In older KT recipients, we aimed to prospectively evaluate if HRQOL evolution during the first posttransplant year was associated with long-term patient survival. Methods: Recipients older than 65 y at KT who received an organ from a deceased brain-dead donor and survived >12 mo posttransplant were eligible. HRQOL was assessed pre-KT, at 10 wk, 6 mo, and 12 mo post-KT, using the Kidney Disease Quality of Life Short Form version 1.3 survey. A mixed-effect model was used to explore HRQOL evolution during the first posttransplant year in long-term survivors compared with nonsurvivors. Distinct HRQOL clusters were identified using a group-based trajectory modeling and their association with patient survival was investigated with Cox proportional hazard regression models. Results: We included 192 elderly recipients of deceased brain-dead donor kidneys who were transplanted from 2013 to 2020. Eleven died during the first year leaving 181 for evaluation (male, 125; mean age at KT, 72 y [65-84 y]). During a median observation time post-KT of 4.9 y (11.1-8.5 y), 57 recipients died. In survivors, all the generic and kidney-specific HRQOL domains substantially improved during the first year, whereas in nonsurvivors HRQOL deteriorated. Three longitudinal HRQOL trajectories indicating poor, fair, and good HRQOL evolution were identified. Poor physical function trajectory was significantly associated with higher mortality risk independent of covariates, as compared with good physical trajectory (hazard ratio, 2.38; 95% confidence interval, 1.15-5.01). Conclusions: In elderly KT recipients, detection of declining posttransplant physical function may imply impaired survival. Systematic HRQOL monitoring following KT provides added value when evaluating mortality and may guide therapeutic decisions.

• Tsarpali, Vasiliki; Midtvedt, Karsten; Lønning, Kjersti; Bernklev, Tomm; Lippe, Nanna von der & Reisæter, Anna Varberg [Show all 8 contributors for this article] (2021). Health-Related Quality of Life in Older Kidney Transplant Recipients: A National Cohort Study of Short- and Longer-Term Outcomes. Kidney Medicine. 3(6), p. 974–983. doi: 10.1016/j.xkme.2021.05.007. Full text in Research Archive Show summary

  Rationale & Objective Assessing the optimal therapy for older patients (aged ≥65 years) with end-stage kidney disease requires knowledge of longevity and health-related quality of life (HRQoL) outcomes. Kidney transplantation prolongs survival but its long-term impact on HRQoL in older recipients is not well defined. We aimed to prospectively evaluate HRQoL changes from enlisting until 3 years posttransplantation and examine pretransplantation predictors of posttransplantation outcomes. Study Design Prospective cohort study. Setting & Participants Patients 65 years and older enlisted at the Norwegian National Transplant Center between January 2013 and November 2016. Predictors Kidney transplantation, dialysis vintage, and pretransplantation comorbidity assessed using the Liu Comorbidity Index. Outcomes HRQoL, assessed using the Kidney Disease Quality of Life Short Form, version 1.3. Analytical Approach HRQoL scores obtained at 3 years posttransplantation were compared with those obtained pretransplantation and after 1 year using a paired-sample t test. Multivariable linear mixed-effect models were used to identify possible predictors of HRQoL changes over time. Results Among 289 patients included, 220 (mean age, 71.5 years) had undergone transplantation and 136 had completed the 3-year HRQoL follow-up by October 2020. Posttransplant HRQoL, both generic and kidney specific, substantially improved and the benefit persisted for 3 years. For wait-listed candidates remaining on dialysis, HRQoL gradually deteriorated, and recipients who died within 3 years posttransplantation experienced no improvement during the first year. Moderately elevated pretransplantation comorbidity scores and prolonged dialysis vintage independently predicted poor HRQoL outcomes posttransplantation. Recipients receiving dialysis for 1 year or longer with pretransplantation comorbidity scores ≥ 7 experienced a marked and sustained physical deterioration after transplantation. Limitations Homogenous and highly selected population. Conclusions Transplantation is associated with a sustained HRQoL improvement and should be the preferred treatment for selected older patients. The value of a pretransplant comorbidity score to predict posttransplantation outcomes warrants further evaluation and may improve the selection process.

• Astrup, Guro Lindviksmoen; Rohde, Gudrun E.; Rimehaug, Stein Arne; Andersen, Marit Helen; Bernklev, Tomm & Bjordal, Kristin [Show all 11 contributors for this article] (2021). Comparing the use of patient-reported outcomes in clinical studies in Europe in 2008 and 2018: a literature review. Quality of Life Research. ISSN 0962-9343. 31. doi: 10.1007/s11136-021-02946-7. Full text in Research Archive Show summary

  Purpose Several guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specifc criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted. Methods A literature search was conducted in MEDLINE to identify eligible publications. To assess the number of publications, all abstracts were screened for eligibility by pairs of reviewers. Compliance with PRO-specifc criteria and other key characteristics was assessed in a random sample of 150 eligible full-text publications from each year. Randomized controlled trials (RCTs) were assessed according to the full CONSORT-PRO checklist. Results The search identifed 1692 publications in 2008 and 4290 in 2018. After screening of abstracts, 1240 from 2008 and 2869 from 2018 were clinical studies using PROs. By full-text review, the proportion of studies discussing PRO-specifc limitations and implications was higher in 2018 than in 2008, but there were no diferences in the other selected PRO-specifc criteria. In 2018, a higher proportion of studies were longitudinal/cohort studies, included≥300 patients, and used electronic administration of PRO than in 2008. The most common patient groups studied were those with cancer or diseases of the musculoskeletal system or connective tissue. Conclusion The number of clinical studies from Europe using PROs was higher in 2018 than in 2008, but there was little diference in compliance with the PRO-specifc criteria. The studies varied in terms of study design and PRO instruments used in both publication years.

• Nilsson, Rasmus; Næss-Andresen, Thomas Fredrik; Myklebust, Tor Åge; Bernklev, Tomm; Kersten, Hege & Haug, Erik Skaaheim (2021). Fear of Recurrence in Prostate Cancer Patients: A Cross-sectional Study After Radical Prostatectomy or Active Surveillance. European Urology Open Science. ISSN 2666-1691. 25, p. 44–51. doi: 10.1016/j.euros.2021.01.002. Full text in Research Archive Show summary

  Background: Fear of recurrence (FoR) is a distressing consequence of cancer. Little is known about the prevalence of FoR in different treatment groups and factors associated with FoR among prostate cancer (PCa) survivors. Objective: To investigate the prevalence of high FoR among PCa survivors after radical prostatectomy (RP) or under active surveillance (AS) and to explore clinical and psychological factors potentially associated with FoR. Design, setting, and participants: This is a retrospective cross-sectional study of 606 patients with PCa, treated with either RP (n = 442) or AS (n = 164) at two Norwegian regional hospitals. The 440 patients (73%) who gave consent to participate were invited in 2017 to complete a questionnaire measuring FoR, self-rated health, adverse effects, and psychological factors at a mean of 4.1 yr (standard deviation 1.7) after their treatment decision. Clinical data were retrieved from medical records. Outcome measurements and statistical analysis: FoR was measured using the Concerns About Recurrence Questionnaire, with high FoR defined as a sum score of ≥12 points (range 0–40). Using multivariable logistic regression analyses, factors associated with high FoR were identified. Results and limitations: One-third of the participants had high FoR; scores were higher in the AS group and in the RP group with treatment failure. Younger age was significantly associated with high FoR in the AS group, while high prostate-specific antigen at diagnosis, biochemical recurrence, positive surgical margin, higher fatigue, and a type D personality were significantly associated with high FoR in the RP group. Conclusions: At 4 yr after a diagnosis of PCa, high FoR was common, especially among AS patients and among RP patients with treatment failure. Patient summary: In this study, we examined fear that their disease will return or progress among prostate cancer survivors. We found that such fear was common, especially among young patients under active surveillance and among radical prostatectomy patients with treatment failure or with certain psychological features.

• Opheim, Randi; Moum, Bjørn; Grimstad, Tore; Jahnsen, Jørgen; Berset, Ingrid Prytz & Hovde, Øistein [Show all 9 contributors for this article] (2020). Self-esteem in patients with inflammatory bowel disease. Quality of Life Research. ISSN 0962-9343. 29(7), p. 1839–1846. doi: 10.1007/s11136-020-02467-9. Full text in Research Archive Show summary

  Purpose The purpose of this study was to explore self-esteem and associations between self-esteem and sociodemographic, clinical, and psychological factors in patients with infammatory bowel disease (IBD), a disease of chronic relapsing infammation of the gastrointestinal tract. IBD symptoms, including pain, fatigue, and diarrhea, as well as potential life-long medical treatment and surgery, may be demanding, cause signifcant challenges, and infuence self-esteem. Methods In this cross-sectional multicenter study, participants were recruited from nine hospitals in the southeastern and western regions of Norway from March 2013 to April 2014. Data were collected using self-report questionnaires. Selfesteem was assessed by the Rosenberg Self-Esteem Scale, fatigue was assessed by the Fatigue Questionnaire, self-efcacy was assessed by the General Self-Efcacy Scale, and disease activity was assessed by the Simple Clinical Colitis Activity Index for ulcerative colitis (UC) and Harvey Bradshaw Index for Crohn’s disease (CD). Multiple linear regression analysis was applied to examine associations between self-esteem and sociodemographic, clinical, and psychological factors. Results In total, 411 of 452 (91%) patients had evaluable data and were included in this study. The mean scores on selfesteem, self-efcacy, total fatigue, anxiety, and depression were similar between UC patients and CD patients. Male gender, being employed, and higher self-efcacy were independently associated with higher self-esteem, whereas anxiety and depression were independently associated with lower self-esteem. Neither disease activity nor fatigue were associated with self-esteem in the fnal multiple regression analyses. Conclusion Patient-centered interventions that improve self-esteem and reduce anxiety and depression seem to be important to optimize IBD management. Keywords Self-esteem · Self-efcacy · Coping · Infammatory bowel disease · Ulcerative colitis · Crohn’s disease · Health psychology · Chronic disease · Health-related quality of life

• Klepp, Pasquale Catherine; Brackmann, Stephan; Småstuen, Milada Cvancarova; Høivik, Marte Lie; Hovde, Øistein & Henriksen, Magne [Show all 15 contributors for this article] (2020). Risk of colorectal cancer in a population-based study 20 years after diagnosis of ulcerative colitis: results from the IBSEN study. BMJ open gastroenterology. 7. doi: 10.1136/bmjgast-2019-000361. Full text in Research Archive Show summary

  Objective The association between ulcerative colitis (UC) and colorectal cancer (CRC) is widely accepted, although attenuated risk has been reported in recent years. Colonoscopic surveillance is recommended with intervals based on established clinical risk factors. Nevertheless, a significant number of patients develop interval cancers, indicating the need of improved individualised assessment. In the present study, we evaluated clinical risk factors associated with CRC during a prescheduled follow-up 20 years after diagnosis, the IBSEN study. Design A population-based inception cohort of patients diagnosed with inflammatory bowel disease from 1 January 1990 until 31 December 1993, prospectively followed at 1, 5, 10 and 20 years after diagnosis. A total of 517 patients with UC were included; 264 (51 %) men; median age at inclusion 37.4 years (4–88). Results The overall incidence of CRC was 1.6% (8/517) at a 20-year follow-up. The total lifetime risk of CRC prior to or after UC diagnosis was 2.3%. (12/517). Patients older than 70 years at diagnosis had a 15-fold higher risk of CRC compared with those diagnosed when younger than 40 years, with HR 15.68 (95% CI: 1.31 to 187.92). Neither sex, first-degree relative with CRC, extent of colitis nor primary sclerosing cholangitis affected the risk of CRC. Conclusion The risk of CRC in UC was low and comparable with the risk of CRC in the background population of Norway.

• Normann, Cathrine Olaussen; Opheim, Randi; Kulle, Bettina; Bernklev, Tomm & Haug, Erik Skaaheim (2020). Health-related quality-of-life after radical cystectomy among Norwegian men and women compared to the general population. Scandinavian Journal of Urology. ISSN 2168-1805. 54(3), p. 181–187. doi: 10.1080/21681805.2020.1754906. Full text in Research Archive Show summary

  Objective: The aim of this study was to assess health-related quality-of-life (HRQoL) in men and women operated on with radical cystectomy, compared to the general Norwegian population. Materials and methods: All patients with bladder cancer who had undergone radical cystectomy (RC) between 2011–2017 and either received ileal conduit (IC) or orthotopic neobladder (ONB) as urinary diversion were included in a cross-sectional study. HRQoL and sociodemographic data was collected and measured with a questionnaire consisting of the generic EORTC QLQ-C30.v3 and the cancer specific EORTC QLQ-BLM30 and compared to a general population sample. Results: Of the 220 invited patients, 173 patients (78.6%) returned the questionnaires. The global quality-of-life (QoL) score was comparable with the general population. Women had significantly higher fatigue score, worse future perspective and symptoms like bloating, compared to male patients. Men had significantly lower social functioning, more constipation, diarrhoea and sleep disturbance compared to the general male population. There was no significant difference in HRQoL domains between female patients and the general female population. A follow-up (FU) period longer than 37 months since surgery was associated with significantly improved physical- and role-functioning, less fatigue and fewer problems with the urostoma, compared to a shorter FU time. Conclusion: This study found a high global QoL score after radical cystectomy, comparable with the general Norwegian population. Symptoms seem to improve over time. Difference in HRQoL outcomes between men and woman in the study population was comparable with the difference found in the general population.

• Frigstad, Svein Oskar; Høivik, Marte Lie; Jahnsen, Jørgen; Småstuen, Milada C; Grimstad, Tore & Berset, Ingrid Prytz [Show all 11 contributors for this article] (2020). Pain Severity and Vitamin D Deficiency in IBD Patients. Nutrients. 12(1), p. 1–12. doi: 10.3390/nu12010026. Full text in Research Archive Show summary

  Background: Pain and vitamin D deficiency are common in inflammatory bowel disease (IBD). Disease activity, fatigue, frequent relapses, prior surgery and psychological factors all seem to influence the experience of pain in IBD. Vitamin D deficiency has been associated with muscle and skeletal pain. This study aimed to determine whether there is an association between vitamin D deficiency and severity of pain in patients with IBD, and to investigate the influence of other socio-demographic and psychological variables on the experience of pain. Methods: Patients with IBD were recruited from nine hospitals in Norway in a multicenter cross-sectional study. The Brief Pain Inventory (BPI) questionnaire was used to measure pain. Disease activity was assessed using clinical disease activity indices, C-reactive protein (CRP) and fecal calprotectin. Regression models were fitted to explore a possible association between 25-hydroxyvitamin D and pain severity. Results: Of 407 patients included in the analyses, 229 (56%) had Crohn's disease (CD) and 178 (44%) had ulcerative colitis (UC). Vitamin D deficiency was present in half (203/407) of patients. Presence of pain was reported by 76% (309/407). More severe pain was associated with female gender and increased disease activity scores, but not with increased CRP or fecal calprotectin. In CD, patients without prior intra-abdominal surgery reported more severe pain. In multivariate analyses, there was no association between 25-hydroxyvitamin D and pain severity. Conclusions: In this study, no significant association between pain severity and vitamin D deficiency was revealed in patients with IBD. Keywords: pain severity; patient reported outcomes; vitamin D deficiency.

• Nilsson, Per Rasmus; Dahl, Alv A; Bernklev, Tomm; Kersten, Hege & Haug, Erik S. (2020). Work status and work ability after radical prostatectomy or active surveillance for prostate cancer. Scandinavian Journal of Urology. ISSN 2168-1805. 54(3), p. 194–200. doi: 10.1080/21681805.2020.1750473. Full text in Research Archive
• Ossum, Alvilde Maria; Palm, Øyvind; Småstuen, Milada C; Bernklev, Tomm; Jahnsen, Jørgen & Moum, Bjørn [Show all 7 contributors for this article] (2020). The Impact of Spondyloarthritis and Joint Symptoms on Health-Related Quality of Life and Fatigue in IBD Patients. Results from a Population-Based Inception Cohort (20-Year Follow-up in the Ibsen Study). Inflammatory Bowel Diseases. ISSN 1078-0998. doi: 10.1093/ibd/izz105. Full text in Research Archive Show summary

  Background: Patients with inflammatory bowel disease (IBD) often suffer from musculoskeletal manifestations. Health-related quality of life (HRQoL) and fatigue are known to be associated with IBD activity and musculoskeletal complaints. The aim of this study was to determine the association between spondyloarthritis, arthralgia, or back pain and the patient-reported outcomes of HRQoL and fatigue in IBD patients 20 years after their diagnosis. Methods: The IBSEN cohort was followed prospectively for 20 years. At the 20-year follow-up, the patients answered detailed questionnaires regarding rheumatological manifestations, intestinal symptoms, HRQoL, and fatigue. Multiple regression analyses were used to evaluate associations between spondyloarthritis or joint symptoms and HRQoL or fatigue. Sex, IBD diagnosis, and age were included in all the multiple regression models, in addition to other clinically relevant confounders. Results: In total, 441 patients (94%) completed the questionnaires at the 20-year follow-up. The criteria for spondyloarthritis (axial or peripheral) were fulfilled in 158 patients (36%), current back pain during the previous 3 months was reported by 79 patients (18%), and current arthralgia was reported by 178 patients (40%). Current back pain and arthralgia were independently associated with lower HRQoL, higher levels of fatigue, and chronic fatigue. A diagnosis of spondyloarthritis was not associated with reduced HRQoL or fatigue when adjusted for possible confounders. Conclusions: Current joint symptoms in IBD patients 20 years after diagnosis were associated with poorer HRQoL, higher levels of fatigue, and chronic fatigue, whereas spondyloarthritis did not impact HRQoL or fatigue negatively in this cohort.

• Heldal, Kristian; Midtvedt, Karsten; Lønning, Kjersti; Iversen, Tor; Hernæs, Kjersti Helene & Tsarpali, Vasiliki [Show all 8 contributors for this article] (2019). Kidney transplantation: an attractive and cost-effective alternative for older patients?—a cost–utility study. Clinical Kidney Journal (CKJ). ISSN 2048-8505. 12(6), p. 888–894. doi: 10.1093/ckj/sfz018. Full text in Research Archive Show summary

  In the elderly, kidney transplantation is associated with increased survival and improved health-related quality of life compared with dialysis treatment. We aimed to study the short-term health economic effects of transplantation in a population of elderly kidney transplant candidates. Self-perceived health, quality-adjusted life years (QALYs) and costs were evaluated and compared 1 year before and 1 year after kidney transplantation in patients included in a single-centre prospective study of 289 transplant candidates ≥65 years of age. Self-perceived health and QALYs both significantly improved after transplantation. At 1 year, the costs per QALY were substantially higher for transplantation (€88 100 versus €76 495), but preliminary analyses suggest a favourable long-term health economic effect. Kidney transplantation in older kidney transplant recipients is associated with improved health but also with increased costs the first year after engraftment when compared with remaining on the waiting list. Any long-term cost-effectiveness needs to be confirmed in studies with longer observation times.

• Guldvog, Ivar; Reitsma, Laurens Cornelus; Johnsen, Lene Cathrin; Lauzike, Andromeda; Gibbs, Charlotte Christine & Carlsen, Eivind [Show all 13 contributors for this article] (2019). Thyroidectomy Versus Medical Management for Euthyroid Patients With Hashimoto Disease and Persisting Symptoms: A Randomized Trial. Annals of Internal Medicine. ISSN 0003-4819. 170(7), p. 453–464. doi: 10.7326/M18-0284. Full text in Research Archive Show summary

  Background: Hashimoto disease is a chronic autoimmune thyroiditis. Despite adequate hormone substitution, some patients have persistent symptoms that may be the result of immunologic pathophysiology. Objective: To determine whether thyroidectomy improves symptoms in patients with Hashimoto thyroiditis who still have symptoms despite having normal thyroid gland function while receiving medical therapy. Design: Randomized trial. (ClinicalTrials.gov: NCT02319538) Setting: Secondary care hospital in Norway. Patients: 150 patients aged 18 to 79 years with persistent Hashimoto-related symptoms despite euthyroid status while receiving hormone replacement therapy and with serum antithyroid peroxidase (anti-TPO) antibody titers greater than 1000 IU/mL. Intervention: Total thyroidectomy or medical management with hormone substitution to secure euthyroid status in both groups. Measurements: The primary outcome was general health score on the Short Form-36 Health Survey (SF-36) at 18 months. Secondary outcomes were adverse effects of surgery, the other 7 SF-36 subscores, fatigue questionnaire scores, and serum anti-TPO antibody titers at 6, 12, and 18 months. Results: During follow-up, only the surgical group demonstrated improvement: Mean general health score increased from 38 to 64 points, for a between-group difference of 29 points (95% CI, 22 to 35 points) at 18 months. Fatigue score decreased from 23 to 14 points, for a between-group difference of 9.3 points (CI, 7.4 to 11.2 points). Chronic fatigue frequency decreased from 82% to 35%, for a between-group difference of 39 percentage points (CI, 23 to 53 percentage points). Median serum anti-TPO antibody titers decreased from 2232 to 152 IU/mL, for a between-group difference of 1148 IU/mL (CI, 1080 to 1304 IU/mL). In multivariable regression analyses, the adjusted treatment effects remained similar to the unadjusted effects. Limitation: Results are applicable only to a subgroup of patients with Hashimoto disease, and follow-up was limited to 18 months. Conclusion: Total thyroidectomy improved health-related quality of life and fatigue, whereas medical therapy did not. This improvement, along with concomitant elimination of serum anti-TPO antibodies, may elucidate disease mechanisms.

• Nøstdal, Torkjell; Bernklev, Tomm; Fredheim, Olav Magnus; Paddison, Johanna S. & Ræder, Johan (2018). Defining the cut-off point of clinically significant postoperative fatigue in three common fatigue scales. Quality of Life Research. ISSN 0962-9343. doi: 10.1007/s11136-018-2068-0. Full text in Research Archive Show summary

  Purpose Postoperative fatigue (POF) is an often underestimated problem after surgery. Studies on POF often report fatigue scores without relating this to the clinical relevance for the patients. The aim of this study was to define the cut-off point for clinically significant POF in three commonly applied fatigue scales; the Postoperative Fatigue Scale, Christensen’s Fatigue Scale, and the Chalder Fatigue Questionnaire. The identification of cut-off points will make it possible to indicate whether statistically significant findings of increased fatigue are of clinical relevance. Methods We combined data from day 0 (pre-operatively) and day 1, 3, 6, and 30 after surgery in two fatigue-related studies with 442 patients. In order to define clinically significant fatigue, a key question was added in each questionnaire; “Given your current description of fatigue, would you say it has been of considerable significance to you?”; “Yes/No”. We analysed each scale’s ability to identify clinically significant fatigue, by performing receiver-operating characteristics (ROC) analyses, and calculated the optimal cut-off point between Sensitivity and Specificity. Results The average weighted cut-off point for clinically significant POF when measured with the Postoperative Fatigue Scale was ≥ 50 (scale range 0–100), with Christensen’s Fatigue Scale ≥ 6 (scale range 1–10) and with the Chalder Fatigue Questionnaire ≥ 16 (scale range 0–33). Conclusion In three commonly used fatigue scales, we have identified cut-off points for clinically significant fatigue among patients recovering from surgery. This can be particularly valuable for diagnostic purposes and in treatment evaluation. Further, it may be possible to analyse and review data from earlier studies in light of clinical relevance.

• Frigstad, Svein Oskar; Høivik, Marte Lie; Jahnsen, Jørgen; Småstuen, Milada Cvancarova; Grimstad, Tore & Berset, Ingrid Prytz [Show all 11 contributors for this article] (2018). Fatigue is not associated with vitamin D deficiency in inflammatory bowel disease patients. World Journal of Gastroenterology (WJG). ISSN 1007-9327. 24(29), p. 3293–3301. doi: 10.3748/wjg.v24.i29.3293. Full text in Research Archive Show summary

  AIM To investigate if vitamin D deficiency is associated with fatigue in patients with inflammatory bowel disease (IBD). METHODS IBD patients were recruited from nine hospitals in the southeastern and western regions of Norway to participate in a multicenter cross-sectional study lasting from March 2013 to April 2014. Data were collected by interviews, from medical records and laboratory tests. The Fatigue Questionnaire (FQ) was used to measure fatigue. Linear and logistic regression models were applied to explore the possible association between vitamin D deficiency and total fatigue scores and chronic fatigue, respectively. The analyses were adjusted for age, gender, disease activity, depressive symptoms and sleep disturbance. RESULTS In total, 405 patients were included in the analyses, of which 227 (56%) had Crohn’s disease (CD) and 178 (44%) had ulcerative colitis (UC). Vitamin D deficiency (< 50 nmol/L) was present in half (203/405) of the patients. Chronic fatigue was reported by 116 (29%) of all included patients with substantial fatigue reported by 194 (48%). Vitamin D levels were neither associated with total fatigue nor with chronic fatigue. Higher total fatigue scores and chronic fatigue were both associated with increased disease activity scores in patients with UC and CD, but not with increased CRP or fecal calprotectin. In UC patients, female gender was associated with fatigue in the univariate analysis, but no such difference was found when adjusted for elevated disease activity scores. Sleep disturbance and more depressive symptoms were associated with total fatigue scores in both UC and CD patients, but with chronic fatigue only in CD patients. CONCLUSION In this study, no significant association between fatigue and vitamin D deficiency in IBD patients was revealed. Key Words: Inflammatory bowel disease, Crohn’s disease, Ulcerative colitis, Fatigue, Chronic fatigue, Vitamin D deficiency Core tip: Fatigue is common in inflammatory bowel diseases (IBD) and is especially prevalent in active disease. We wanted to investigate if vitamin D deficiency was associated to fatigue in IBD as this is a common belief among both patients and physicians. To the best of our knowledge, no previous studies have investigated this possible association in IBD patients. We also wanted to take into account the multidimensional approach in understanding fatigue making it difficult to single out any one contributing factor. In this study, no significant association between fatigue and vitamin D deficiency in IBD patients was revealed.

• Jelsness-Jørgensen, Lars-Petter; Jensen, Øystein; Gibbs, Charlotte Christine; Moe, Ragnar Bekkhus; Hofsø, Dag & Bernklev, Tomm (2018). Psychometric testing of the Norwegian Diabetes Health Profile (DHP-18) in patients with type 1 diabetes. BMJ Open Diabetes Research & Care. 6(1), p. 1–9. doi: 10.1136/bmjdrc-2018-000541. Full text in Research Archive Show summary

  Objective: The Diabetes Health Profile-18 (DHP-18) was developed to measure disease-specific health-related quality of life. It has been translated into Norwegian but remains invalidated. The purpose of this paper was to examine the psychometric properties of the Norwegian DHP-18. Research design and methods: Participants with type 1 diabetes were recruited from three outpatient clinics in Norway. Clinical and sociodemographic data were collected, and participants completed the DHP-18 and the Short-Form 36 (SF-36). Descriptive analysis, frequencies, t-tests and the chi-squared tests were used. Principal axis factoring (PAF) and confirmatory factor analysis (CFA) were used. Convergent validity was tested using Spearman’s correlation between the DHP-18 and SF-36. Reliability was tested using Cronbach’s alpha and intraclass correlation coefficient. Results: In total, 288 patients were included. No floor and ceiling effects were found. A forced PAF analysis revealed that three questions had an eigenvalue below 0.40. In the unforced PAF analysis, one question loaded below 0.40, while three questions loaded into a fourth factor. The correlation between the DHP-18 and SF-36 dimensions was low to moderate. Problematic internal consistency was observed for the disinhibited eating dimension in the forced PAF and in the suggested fourth dimension in the unforced PAF. CFA revealed poor fit. The test–retest reliability displayed good to excellent values, but responsiveness was limited. Conclusions: Problematic issues were identified regarding factor structure, item loadings, internal consistency and responsiveness. Further evaluation of responsiveness is particularly recommended, and using a revised 14-item DHP version is suggested.

• Jelsness-Jørgensen, Lars-Petter; Bernklev, Tomm & Lundin, Knut Erik Aslaksen (2018). Fatigue as an extra-intestinal manifestation of celiac disease: A systematic review. Nutrients. 10:1652(11). doi: 10.3390/nu10111652. Full text in Research Archive Show summary

  Celiac disease may present with a range of different symptoms, including abdominal problems in a broader sense, iron deficiency and “constant tiredness”. All of these symptoms should consequently lead the clinicians to consider celiac disease as a potential etiopathogenetic cause. Although the pathophysiology of celiac disease is well documented, the actual mechanisms for disease presentation(s) are less well understood. We here address the topic of fatigue in celiac disease. A systematic literature search identified 298 papers of which five met the criteria for full evaluation. None of the reviewed papers were of high quality and had several methodological weaknesses. We conclude that there is an unmet need to study the contributing factors and management of fatigue in celiac disease.

• Lønning, Kjersti; Heldal, Kristian; Bernklev, Tomm; Brunborg, Cathrine; Andersen, Marit Helen & Lippe, Nanna von der [Show all 10 contributors for this article] (2018). Improved Health-Related Quality of Life in Older Kidney Recipients 1 Year After Transplantation. Transplantation direct. doi: 10.1097/TXD.0000000000000770. Full text in Research Archive Show summary

  Background: We aimed to evaluate changes in health-related quality of life (HRQoL) in patients 65 years or older from time of kidney transplantation (KTx) until 1 year postengraftment. Methods: A single-center prospective study was conducted. HRQoL was measured pre-KTx and at 2, 6, and 12 months postengraftment using self-reported Kidney Disease and Quality of Life shortform version 1.3. Intraindividual scores before and after KTx were evaluated. Liu Comorbidity Index was registered at enlisting. short-form-36 scores were additionally compared with scores from an age-matched population. Results: From January 1, 2013, until November 30, 2016, a total of 289 waitlisted patients were included. By September 1, 2017, 134 had reached 1 year postengraftment, and valid questionnaires were available in 120 (90%) patients. Mean age at KTx was 71.6 years (±4.3 years), 71% were male. Living donor was used in 21%, and preemptive KTx was performed in 30% of the recipients. Median waiting time for KTx from deceased donor was 16 months (range, 0.6-50.5 months). A total of 79 (66%) recipients had a Liu Comorbidity Index score of 3 or less. All HRQoL scores except the domain social function improved at 2 months postengraftment and remained stable or continued to improve at 1 year. HRQoL scores 12 months postengraftment were similar to those described in an age-matched general population except for the domain social function which remained at a significantly lower level. Time in dialysis was the most important variable associated with impaired HRQoL postengraftment. Conclusions: HRQoL scores showed clinically significant improvement in older KTx recipients 1 year posttransplant.

• Jensen, Øystein; Bernklev, Tomm; Gibbs, Charlotte Christine; Moe, Ragnar Bekkhus; Hofsø, Dag & Jelsness-Jørgensen, Lars-Petter (2018). Fatigue in type 1 diabetes, prevalence, predictors and comparison with the background population. Diabetes Research and Clinical Practice. ISSN 0168-8227. 143, p. 71–78. doi: 10.1016/j.diabres.2018.06.012. Full text in Research Archive
• Lønning, Kjersti; Midtvedt, Karsten; Bernklev, Tomm; Brunborg, Cathrine; Andersen, Marit Helen & Lippe, Nanna von der [Show all 10 contributors for this article] (2018). Changes in health related quality of life in older candidates waiting for kidney transplantation. Nephrology. ISSN 1320-5358. 23(10), p. 948–956. doi: 10.1111/nep.13117. Full text in Research Archive
• Knudsen, Markus Dines; Hjartåker, Anette; Olsen, Marie Kristin Ek; Hoff, Geir; Lange, Thomas de & Bernklev, Tomm [Show all 7 contributors for this article] (2018). Changes in health behavior 1 year after testing negative at a colorectal cancer screening: a randomized-controlled study. European Journal of Cancer Prevention. ISSN 0959-8278. 27(4), p. 316–322. doi: 10.1097/CEJ.0000000000000328. Full text in Research Archive
• Frigstad, Svein Oskar; Høivik, Marte; Jahnsen, Jørgen; Dahl, Sandra Rinne; Småstuen, Milada C & Grimstad, Tore [Show all 13 contributors for this article] (2017). Vitamin D deficiency in inflammatory bowel disease: Prevalence and predictors in a Norwegian outpatient population. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 52(1), p. 100–106. doi: 10.1080/00365521.2016.1233577. Full text in Research Archive Show summary

  Background and aim: Vitamin D deficiency is common in inflammatory bowel disease (IBD). The aims of the present study were to determine the prevalence of vitamin D deficiency and to identify clinical and epidemiological variables associated with vitamin D deficiency in an outpatient population with IBD. Methods: Participants were recruited from nine hospitals in the southeastern and western regions of Norway as part of an observational, multicentre study from March 2013 to April 2014. Clinical and epidemiological data were collected by interview and from medical records. All analyses of serum 25-hydroxyvitamin D (25-OH-D) were performed in the same laboratory. Results: In total, 49% (200/408) of the patients had a 25-OH-D concentration <50 nmol/L, including 53% (122/230) of the Crohn’s disease (CD) patients and 44% (78/178) of the ulcerative colitis (UC) patients. In CD patients, disease activity, measured as the HBI, was inversely associated with vitamin D deficiency. No such association was observed with the Simple Clinical Colitis Activity Index (SCCAI) scores in UC, but in UC patients, vitamin D deficiency was associated with elevated faecal calprotectin >100 mg/kg. In patients with CD, there were significantly more relapses during the previous year in patients with vitamin D deficiency. Conclusions: Vitamin D deficiency was common, especially in CD, and was associated with increased disease activity, a relapsing disease course and higher inflammatory activity.

• Andersen, Randi D.; Langius-Eklöf, Ann; Nakstad, Britt; Bernklev, Tomm & Jylli, Leena (2017). The measurement properties of pediatric observational pain scales: A systematic review of reviews. International Journal of Nursing Studies. ISSN 0020-7489. 73(August), p. 93–101. doi: 10.1016/j.ijnurstu.2017.05.010. Full text in Research Archive Show summary

  Background: Valid observational pain scales are needed to assess pain and ensure sufficient treatment of pain in children that lack the verbal ability to self-report pain. Published reviews attempt to synthesize results from primary studies validating these scales and based on the findings recommendations may be given, for example which pain scales are the most appropriate for use in different pediatric populations. Objectives: The aims of this review were to describe how systematic reviews have evaluated and recommended observational pain scales for use in children aged 0–18 years and appraise the evidence underlying these recommendations. Design: Systematic review of reviews. Data sources: The Cochrane Library, PubMed/MEDLINE, CINAHL, Web of Science, and PsychINFO were searched from inception to September 2016. Reference lists and gray literature were searched for additional studies. Review methods: Study selection and data extraction were performed by two reviewers independently with a disagreement procedure in place. Methodological quality or study validity was measured using the Assessment of Multiple Systematic Reviews (AMSTAR) checklist and risk of bias or internal validity was measured using the Risk of Bias in Systematic Reviews (ROBIS) tool. The review protocol was registered with PROSPERO: registration number CRD42016035264. Results: Twelve reviews met the inclusion criteria. Together; they included 65 different observational pain scales for use in children, of which 28 were recommended at least once. Face, Legs, Activity, Cry, Consolability (FLACC)/revised version of Face, Legs, Activity, Cry, Consolability (rFLACC), COMFORT/COMFORT behavioral scale and Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) were evaluated and recommended most frequently. Few of the included reviews assessed the methodological quality of the studies included in the review. The narrative analysis consisted mostly of a reiteration of the results from the primary studies. In general, more recent reviews showed a lower risk of bias than older ones. Conclusions: Included reviews exhibited low quality of evidence; thus, their recommendations regarding pain scales for use in clinical practice or research with children that lack the verbal ability to self-report pain should be interpreted with caution.

• Jelsness-Jørgensen, Lars-Petter; Frigstad, Svein Oskar; Moum, Bjørn; Grimstad, Tore; Opheim, Randi & Jahnsen, Jørgen [Show all 7 contributors for this article] (2017). Pain may be an important factor to consider in inflammatory bowel disease patients troubled by fatigue. United European Gastroenterology Journal (UEG Journal). ISSN 2050-6406. 5(5), p. 687–693. doi: 10.1177/2050640616674654. Full text in Research Archive
• Kirkøen, Benedicte; Berstad, Paula Marianna; Botteri, Edoardo; Dalén, Eirin; Nilsen, Jens Aksel & Hoff, Geir [Show all 8 contributors for this article] (2017). Acceptability of two colorectal cancer screening tests: pain as a key determinant in sigmoidoscopy. Endoscopy. ISSN 0013-726X. 49(11), p. 1075–1086. doi: 10.1055/s-0043-117400. Full text in Research Archive
• Knudsen, Markus Dines; Berstad, Paula Marianna; Hjartåker, Anette; Gulichsen, Elisabeth Haagensen; Hoff, Geir & Lange, Thomas de [Show all 8 contributors for this article] (2017). Lifestyle predictors for non-participation and outcome in the second round of faecal immunochemical test in colorectal cancer screening. British Journal of Cancer. ISSN 0007-0920. 117(4), p. 461–469. doi: 10.1038/bjc.2017.189. Full text in Research Archive Show summary

  Background: To reduce colorectal cancer (CRC) mortality through population-based screening programmes using faecal tests, it is important that individuals continue to participate in the repeated rounds of screening. We aimed to identify lifestyle predictors for discontinuation of faecal immunochemical test (FIT) screening after the first round, as well as lifestyle predictors for colorectal neoplasia detected in the second-round FIT screening. Methods: In this longitudinal study, we invited 6959 individuals aged 50–74 years from south-east Norway for a first round of FIT screening and to complete a self-reported lifestyle questionnaire on demographic factors, body mass index (BMI, kg m−2), smoking habits, physical activity, consumption of alcohol and dietary items. Two years later, we estimated the associations between these factors, non-participation and screening results in the second round of FIT screening using adjusted odds ratios (ORs) and 95% confidence intervals (CIs). Results: Of the 3114 responders to the questionnaire who completed the first-round FIT and who were invited to participate in second-round FIT screening, 540 (17%) did not participate. The OR and (95% CI) for discontinuation of FIT screening after the first round was 1.61 (1.24–2.10) for current smoking compared with non-smoking; 2.01 (1.25–3.24) for BMI ≥ 35 kg m−2 compared with BMI 16.9–24.9 kg m−2 and 0.70 (0.52–0.94) for physical activity in the third quartile vs the first. Among participants, smoking, high BMI and high alcohol consumption were associated with an increased odds of detecting colorectal neoplasia (n=107). Conclusions: These results may indicate that Norwegian FIT screening participants who discontinue after the first round have lifestyle behaviours associated with increased risk of CRC.

• Huppertz-Hauss, Gert; Høivik, Marte; Jelsness-Jørgensen, Lars-Petter; Opheim, Randi; Henriksen, Magne & Høie, Ole Ingebreth [Show all 13 contributors for this article] (2017). Fatigue in a population-based cohort of patients with inflammatory bowel disease 20 years after diagnosis: The IBSEN study. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 52(3), p. 351–358. doi: 10.1080/00365521.2016.1256425. Full text in Research Archive
• Jensen, Øystein; Bernklev, Tomm & Jelsness-Jørgensen, Lars-Petter (2017). Fatigue in type 1 diabetes: A systematic review of Observational studies. Diabetes Research and Clinical Practice. ISSN 0168-8227. 123, p. 63–74. doi: 10.1016/j.diabres.2016.11.002. Full text in Research Archive Show summary

  Aim To systematically review the literature on fatigue in people with type 1diabetes. Methods In the period from April - June 2015 and with an updated search in May 2016, eight electronic databases as well as the grey literature were searched. Studies of all types of design were included if they reported data on fatigue in adult people with type 1 diabetes. All studies were assessed for quality. Results Out of 4259 references (including grey literature), 10 papers were reviewed in full. Three of these papers investigated fatigue as the primary endpoint, and one was assessed to be high quality. Two papers provided a definition of fatigue. Prevalence estimates ranged from 23-40%, dependent on the cut-off used. Six different questionnaires were used to measure fatigue/vitality and these were only validated to a limited extent in a diabetes population. Several demographic, personal and clinical factors were associated with fatigue, but the results were conflicting. Conclusions Few studies have been published that investigate fatigue in type 1 diabetes and there is a large variability in findings due to different measurement methods and factors investigated. There is still an unmet need to understand what contributes to fatigue in these patients through rigorous research.

• Nøstdal, Torkjell; Fredheim, Olav Magnus; Bernklev, Tomm; Doksrød, Tron Simen; Mohus, Randi Marie & Ræder, Johan (2017). A randomised controlled trial of propofol vs. thiopentone and desflurane for fatigue after laparoscopic cholecystectomy. Anaesthesia. ISSN 0003-2409. 72(7), p. 864–869. doi: 10.1111/anae.13909. Full text in Research Archive
• Jelsness-Jørgensen, Lars-Petter; Moum, Bjørn; Grimstad, Tore; Jahnsen, Jørgen; Opheim, Randi & Berset, Ingrid Prytz [Show all 11 contributors for this article] (2016). Validity, reliability, and responsiveness of the brief pain inventory in inflammatory bowel disease. Canadian Journal of Gastroenterology and Hepatology. ISSN 2291-2789. 2016:5624261. doi: 10.1155/2016/5624261. Full text in Research Archive
• Jelsness-Jørgensen, Lars-Petter; Bernklev, Tomm; Hovde, Øistein; Berset, Ingrid Prytz; Huppertz-Hauss, Gert & Moum, Bjørn [Show all 7 contributors for this article] (2016). Patients’ perceptions of quality of care and follow-up in inflammatory bowel disease. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 51(4), p. 434–441. doi: 10.3109/00365521.2015.1102319. Full text in Research Archive
• Opheim, Randi; Høivik, Marte; Bernklev, Tomm; Jelsness-Jørgensen, Lars-Petter & Moum, Bjørn (2016). The use of complementary and alternative medicine (CAM) among patients with inflammatory bowel disease (IBD) is associated with reduced health-related quality of life (HRQoL). Gastroenterology Research and Practice. ISSN 1687-6121. 2016. doi: 10.1155/2016/6453657. Full text in Research Archive
• Knudsen, Markus Dines; Lange, Thomas de; Botteri, Edoardo; Nguyen, Dung-Hong; Evensen, Helge & Steen, Chloe Beate [Show all 10 contributors for this article] (2016). Favorable lifestyle before diagnosis associated with lower risk of screen-detected advanced colorectal neoplasia. World Journal of Gastroenterology (WJG). ISSN 1007-9327. 22(27), p. 6276–6286. doi: 10.3748/wjg.v22.i27.6276. Full text in Research Archive
• Nøstdal, Torkjell; Bernklev, Tomm; Ræder, Johan; Sandvik, Leiv & Fredheim, Olav Magnus (2016). Postoperative fatigue translation and validation of a revised 10-item short form of the Identity-Consequence Fatigue Scale (ICFS). Journal of Psychosomatic Research. ISSN 0022-3999. 84, p. 1–7. doi: 10.1016/j.jpsychores.2016.03.002. Full text in Research Archive
• Kirkøen, Benedicte; Berstad, Paula Marianna; Botteri, Edoardo; Bernklev, Linn; El-Safadi, Badboni & Hoff, Geir [Show all 8 contributors for this article] (2016). Psychological effects of colorectal cancer screening: Participants vs individuals not invited. World Journal of Gastroenterology (WJG). ISSN 1007-9327. 22(43), p. 9631–9641. doi: 10.3748/wjg.v22.i43.9631. Full text in Research Archive
• Huppertz-Hauss, Gert; Høivik, Marte; Jelsness-Jørgensen, Lars-Petter; Henriksen, Magne; Høie, Ole Ingebreth & Jahnsen, Jørgen [Show all 9 contributors for this article] (2016). Health-related quality of life in patients with inflammatory bowel disease 20 years after diagnosis: results from the IBSEN study. Inflammatory Bowel Diseases. ISSN 1078-0998. 22(7), p. 1679–1687. doi: 10.1097/MIB.0000000000000806. Full text in Research Archive
• Hovde, Øistein; Småstuen, Milada C; Høivik, Marte; Bernklev, Tomm; Huppertz-Hauss, Gert & Høie, Ole Ingebreth [Show all 11 contributors for this article] (2016). Mortality and Causes of Death in Ulcerative Colitis: Results from 20 Years of Follow-up in the IBSEN Study. Inflammatory Bowel Diseases. ISSN 1078-0998. 22(1), p. 141–145. doi: 10.1097/MIB.0000000000000582. Full text in Research Archive
• Kirkøen, Benedicte; Berstad, Paula Marianna; Botteri, Edoardo; Åvitsland, Tone Lise; Ossum, Alvilde Maria & Lange, Thomas de [Show all 8 contributors for this article] (2016). Do no harm: No psychological harm from colorectal cancer screening. British Journal of Cancer. ISSN 0007-0920. 114(5), p. 497–504. doi: 10.1038/bjc.2016.14. Full text in Research Archive
• Huppertz-Hauss, Gert; Aas, Eline; Høivik, Marte; Langholz, Ebbe; Odes, Selwyn & Småstuen, Milada C [Show all 10 contributors for this article] (2016). Comparison of the Multiattribute Utility Instruments EQ-5D and SF-6D in a Europe-Wide Population-Based Cohort of Patients with Inflammatory Bowel Disease 10 Years after Diagnosis. Gastroenterology Research and Practice. ISSN 1687-6121. 2016:5023973, p. 1–9. doi: 10.1155/2016/5023973. Full text in Research Archive
• Huppertz-Hauss, Gert; Høivik, Marte; Langholz, E; Odes, Selwyn; Småstuen, Milada Cvancarova & Stockbrügger, Reinhold [Show all 9 contributors for this article] (2015). Health-related Quality of Life in Inflammatory Bowel Disease in a European-wide Population-based Cohort 10 Years After Diagnosis. Inflammatory Bowel Diseases. ISSN 1078-0998. 21(2), p. 337–344. doi: 10.1097/MIB.0000000000000272. Full text in Research Archive
• Andersen, Randi D.; Bernklev, Tomm; Langius-Eklöf, Ann; Nakstad, Britt & Jylli, Leena (2015). The COMFORT behavioural scale provides a useful assessment of sedation, pain and distress in toddlers undergoing minor elective surgery. Acta Paediatrica. ISSN 0803-5253. 104(9), p. 904–909. doi: 10.1111/apa.13045. Full text in Research Archive Show summary

  Aim: The COMFORT behavioural scale was developed to assess sedation, pain and distress in children unable to report pain. Our aims were to test construct validity of the scale in toddlers undergoing minor surgery and determine the inter-rater reliability of the scale. Methods: We consecutively enrolled 45 children aged 12–36 months from a Norwegian surgical outpatient care unit. The level of sedation, pain and distress was assessed before and after surgery with the COMFORT behavioural scale. Inter-rater reliability was estimated and construct validity was tested based on a priori defined hypotheses. A 2.5-point (15%) change in the scale was considered clinically important. Results: We obtained 307 scores covering most of the scale’s range, but a floor effect was clearly present. Inter-rater reliability was high between assessors (intraclass correlation coefficient = 0.96; 95% CI 0.92–0.98). Clinically important differences were seen between baseline and light sedation (3.1 points, p < 0.001) and between light and deep sedation (4.6 points, p = 0.002). The difference between baseline and our definition of a pain/distress state was not clinically important (1.5 points, p = 0.039). Conclusion: The COMFORT behavioural scale can provide one aspect of an overall clinical assessment of sedation, and probably pain and distress, in toddlers before and after surgery.

• Risstad, Hilde; Søvik, Torgeir Thorson; Hewitt, Stephen I; Kristinsson, Jon Adalsteinn; Fagerland, Morten & Bernklev, Tomm [Show all 7 contributors for this article] (2015). Changes in Health-Related Quality of Life After Gastric Bypass in Patients With and Without Obesity-Related Disease. Obesity Surgery. ISSN 0960-8923. 25(12), p. 2408–2416. doi: 10.1007/s11695-015-1717-4. Full text in Research Archive
• Jelsness-Jørgensen, Lars-Petter; Bernklev, Tomm & Moum, Bjørn (2014). Coexisting irritable bowel-like symptoms in inflammatory bowel disease in remission is associated with impaired social functioning and increased bodily pain. Gastroenterology Nursing. ISSN 1042-895X. 37(4), p. 280–287. doi: 10.1097/SGA.0000000000000055. Full text in Research Archive
• Aftab, Hira; Risstad, Hilde; Søvik, Torgeir Thorson; Bernklev, Tomm; Hewitt, Stephen & Kristinsson, Jon Adalsteinn [Show all 7 contributors for this article] (2014). Five-year outcome after gastric bypass for morbid obesity in a Norwegian cohort. Surgery for Obesity and Related Diseases. ISSN 1550-7289. 10(1), p. 71–78. doi: 10.1016/j.soard.2013.05.003. Full text in Research Archive
• Isene, Rune; Bernklev, Tomm; Høie, Ole Ingebreth; Langholz, Ebbe; Tsianos, Epameinondas V. & Stockbrügger, Reinhold [Show all 9 contributors for this article] (2014). Thromboembolism in inflammatory bowel disease: results from a prospective, population-based European inception cohort. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 49(7), p. 820–825. doi: 10.3109/00365521.2014.910545. Full text in Research Archive
• Opheim, Randi; Fagermoen, May Solveig; Jelsness-Jørgensen, Lars-Petter; Bernklev, Tomm & Moum, Bjørn (2014). Sense of coherence in patients with inflammatory bowel disease. Gastroenterology Research and Practice. ISSN 1687-6121. 2014:989038. doi: 10.1155/2014/989038. Full text in Research Archive
• Isene, Rune; Bernklev, Tomm; Høie, Ole Ingebreth; Munkholm, Pia; Tsianos, Epameinondas V. & Stockbrügger, Reinhold [Show all 10 contributors for this article] (2014). Extraintestinal manifestations in Crohn’s disease and ulcerative colitis: results from a prospective, population based European inception cohort. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 50(3), p. 300–305. doi: 10.3109/00365521.2014.991752. Full text in Research Archive
• Opheim, Randi; Fagermoen, May Solveig; Bernklev, Tomm; Jelsness-Jørgensen, Lars-Petter & Moum, Bjørn (2014). Fatigue interference with daily living among patients with inflammatory bowel disease. Quality of Life Research. ISSN 0962-9343. 23(2), p. 709–719. doi: 10.1007/s11136-013-0508-4. Full text in Research Archive
• Jelsness-Jørgensen, Lars-Petter; Bernklev, Tomm & Moum, Bjørn (2013). Calprotectin Is a Useful Tool in Distinguishing Coexisting Irritable Bowel-Like Symptoms from That of Occult Inflammation among Inflammatory Bowel Disease Patients in Remission. Gastroenterology Research and Practice. ISSN 1687-6121. doi: 10.1155/2013/620707. Full text in Research Archive
• Høivik, Marte; Moum, Bjørn; Solberg, Inger Camilla; Henriksen, Magne; Småstuen, Milada C & Bernklev, Tomm (2012). Work disability in inflammatory bowel disease patiens 10 years after disease onset: results from the IBSEN Study. Gut. ISSN 0017-5749. 62(3), p. 368–375. doi: 10.1136/gutjnl-2012-302311. Full text in Research Archive
• Jelsness-Jørgensen, Lars-Petter; Bernklev, Tomm & Moum, Bjørn (2012). Quality of life in patients with inflammatory bowel disease: translation, validity, reliability and sensitivity to change of the Norwegian version of the Short Health Scale (SHS). Quality of Life Research. ISSN 0962-9343. 21(9), p. 1671–1676. doi: 10.1007/s11136-011-0081-7. Full text in Research Archive
• Jelsness-Jørgensen, Lars-Petter; Bernklev, Tomm & Moum, Bjørn (2012). Fatigue and disease-related worries among inflammatory bowel disease patients in remission; is it a reflection of coexisting IBS-like symptoms? A short report. Journal of Psychosomatic Research. ISSN 0022-3999. 73(6), p. 469–472. doi: 10.1016/j.jpsychores.2012.08.009. Full text in Research Archive
• Opheim, Randi; Bernklev, Tomm; Fagermoen, May Solveig; Småstuen, Milada C & Moum, Bjørn (2012). Use of complementary and alternative medicine in patients with inflammatory bowel disease: results of a cross-sectional study in Norway. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 47(12), p. 1436–1447. doi: 10.3109/00365521.2012.725092. Full text in Research Archive

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• Andersen, Svend; Bernklev, Tomm; Størdal, Ketil; Perminow, Gøri & Høivik, Marte Lie (2022). Paediatric IBD incidence increases in South-East Norway. Full text in Research Archive
• Lukina, Polina; Andersen, Ina Lervåg; Hjort, Rebecka; Eggen, Petter Tinbod; Næss, Marit & Mjønes, Patricia [Show all 20 contributors for this article] (2022). Cøliaki i HUNT. Forekomst, konsekvenser og årsaker. Full text in Research Archive
• Søiland, Håvard; Janssen, Emiel; Helland, Thomas; Eliassen, Finn Magnus; Hagland, Magnus & Nordgård, Oddmund [Show all 30 contributors for this article] (2022). Liquid biopsies and patient-reported outcome measures for integrative monitoring of patients with early-stage breast cancer: a study protocol for the longitudinal observational Prospective Breast Cancer Biobanking (PBCB) study. BMJ Open. 12(4). doi: 10.1136/bmjopen-2021-054404. Full text in Research Archive
• Astrup, Guro Lindviksmoen; Rohde, Gudrun E.; Rimehaug, Stein Arne; Andersen, Marit Helen; Bernklev, Tomm & Bjordal, Kristin [Show all 10 contributors for this article] (2020). Comparing the use of patient-reported outcomes in clinical studies in Europe in 2008 and 2018; a literature review. Full text in Research Archive
• Jensen, Øystein; Bernklev, Tomm; Gibbs, Charlotte Christine; Moe, Ragnar Bekkhus; Hofsø, Dag & Jelsness-Jørgensen, Lars-Petter (2019). Chronic Fatigue is associated with impared Health-Related Quality of Life in Type 1 Diabetes. Full text in Research Archive
• Tsarpali, Vasiliki; Lønning, Kjersti; Midtvedt, Karsten; Bernklev, Tomm; Lippe, Nanna Von der & Andersen, Marit Helen [Show all 7 contributors for this article] (2019). Getting Life Back »-Kidney Transplantation in the Elderly Patient. Full text in Research Archive
• Tsarpali, Vasiliki; Lønning, Kjersti; Midtvedt, Karsten; Bernklev, Tomm; Lippe, Nanna Von der & Andersen, Marit Helen [Show all 7 contributors for this article] (2019). « Getting Life Back »-Kidney Transplantation in the Elderly Patient. Full text in Research Archive
• Opheim, Randi; Jahnsen, Jørgen; Bernklev, Tomm; Høie, Ole Ingebreth; Huppertz-Hauss, Gert & Moum, Bjørn (2019). Complementary and alternative medicine in patients with inflammatory bowel disease 20 years after diagnosis: Results from the IBSEN study. American Journal of Gastroenterology. ISSN 0002-9270. 114, p. S12–S13. doi: 10.14309/01.ajg.0000578256.56976.23. Full text in Research Archive
• Opheim, Randi; Bernklev, Tomm; Jahnsen, Jørgen; Grimstad, Tore; Hovde, Øistein & Berset, Ingrid Prytz [Show all 8 contributors for this article] (2018). Chronic fatigue in patients with inflammatory bowel disease is associated with lower health–related quality of life, low self-esteem, increased anxiety and depression. Full text in Research Archive
• Jensen, Øystein; Bernklev, Tomm; Gibbs, Charlotte Christine; Moe, Ragnar Bekkhus; Hofsø, Dag & Jelsness-Jørgensen, Lars-Petter (2018). Chronic Fatigue is associated with a significant reduction of Health-Related Quality of life (HRQoL) in type 1 diabetes. Full text in Research Archive
• Lundin, Knut Erik Aslaksen; Jelsness-Jørgensen, Lars-Petter & Bernklev, Tomm (2018). Cøliaki og fatigue - en vanlig kombinasjon. NGF-nytt. ISSN 0809-6570. Full text in Research Archive
• Enden, Tone Rønnaug; Bernklev, Tomm; Jelsness-Jørgensen, Lars-Petter & Amdal, Cecilie Delphin (2018). Pasientene kjenner best egen helse. 138(8), p. 716–718. doi: 10.4045/tidsskr.17.1054. Full text in Research Archive
• Frigstad, Svein Oskar; Bernklev, Tomm; Dahl, Sandra Rinne; Hovde, Øistein; Jahnsen, Jørgen & Grimstad, Tore [Show all 10 contributors for this article] (2017). Vitamin D deficiency is not associated with chronic fatigue in inflammatory bowel disease. Full text in Research Archive
• Frigstad, Svein Oskar; Høivik, Marte Lie; Småstuen, Milada C; Jahnsen, Jørgen; Dahl, Sandra Rinne & Berset, Ingrid Prytz [Show all 13 contributors for this article] (2017). Fatigue er ikke assosiert med vitamin D mangel hos IBD pasienter. Full text in Research Archive
• Knudsen, Markus Dines; Berstad, Paula Marianna; Hjartåker, Anette; Gulichsen, Elisabeth Haagensen; Hugin, Silje & Hoff, Geir [Show all 9 contributors for this article] (2017). People discontinuing colorectal cancer screening is properly the ones benefiting the most from screening. Full text in Research Archive
• Jensen, Øystein; Bernklev, Tomm; Gibbs, Charlotte; Moe, Ragnar Bekkhus; Hofsø, Dag & Jelsness-Jørgensen, Lars-Petter (2017). Chronic fatigue is more prevalent in patients with type 1 diabetes than in the background populasjon: a cross-sectional study. Full text in Research Archive
• Frigstad, Svein Oskar; Høivik, Marte Lie; Moum, Bjørn; Dahl, Sandra Rinne; Jahnsen, Jørgen & Småstuen, Milada Cvancarova [Show all 12 contributors for this article] (2017). Vitamin D deficiency is not associated with depression in IBD patients. Full text in Research Archive
• Knudsen, Markus Dines; Berstad, Paula Marianna; Hjartåker, Anette; Gulichsen, Elisabeth Haagensen; Hoff, Geir & Lange, Thomas de [Show all 8 contributors for this article] (2017). Lifestyle predictors for non-participation and outcome in the second round of faecal immunochemical test in colorectal cancer screening. Norsk Epidemiologi, Supplement. ISSN 0803-4206. Full text in Research Archive
• Frigstad, Svein Oskar; Høivik, Marte Lie; Jahnsen, Jørgen; Dahl, Sandra Rinne; Cvancarova, Milada & Grimstad, Tore [Show all 13 contributors for this article] (2017). Vitamin D deficiency is not associated with depression in IBD patients. Journal of Crohn's and Colitis. ISSN 1873-9946. 11, p. 444–445. doi: 10.1093/ecco-jcc/jjx002.834. Full text in Research Archive
• Frigstad, Svein Oskar; Høivik, Marte Lie; Jahnsen, Jørgen; Småstuen, Milada C; Grimstad, Tore & Berset, Ingrid Prytz [Show all 12 contributors for this article] (2017). Fatigue is not Associated with Vitamin D Deficiency in IBD Patients. Gastroenterology. ISSN 0016-5085. 152(5), p. S945–S945. doi: 10.1016/S0016-5085(17)33218-3. Full text in Research Archive
• Bernklev, Tomm; Huppertz-Hauss, Gert; Opheim, Randi; Høivik, Marte; Moum, Bjørn & Jelsness-Jørgensen, Lars-Petter [Show all 7 contributors for this article] (2016). Co-existing Irritable Bowel Syndrome (IBS) in Inflammatory Bowel Disease (IBD) is associated with increased risk of chronic fatigue (CF), especially in females. Full text in Research Archive
• Knudsen, Markus Dines; Hjartåker, Anette; Hoff, Geir; Lange, Thomas de; Bernklev, Tomm & Berstad, Paula Marianna (2016). Differences in health behavior at 1-year follow-up between attendees of two screening modalities having a negative screening test result, and controls. Full text in Research Archive
• Jelsness-Jørgensen, Lars-Petter; Høivik, Marte Lie; Moum, Bjørn; Opheim, Randi; Huppertz-Hauss, Gert & Grimstad, Tore [Show all 10 contributors for this article] (2015). Fatigue is associated with increased pain intensity and interference in IBD. Inflammatory Bowel Diseases. ISSN 1078-0998. doi: 10.1080/00365521. Full text in Research Archive
• Knudsen, Markus Dines; Botteri, Edoardo; Steen, Chloe Beate; Hoff, Geir; Lange, Thomas de & Bernklev, Tomm [Show all 8 contributors for this article] (2015). Baseline lifestyle characteristics in participants in bowel cancer screening in Norway and in controls. Full text in Research Archive
• Opheim, Randi; Lie, Marte Høivik; Bernklev, Tomm; Jelsness-Jørgensen, Lars-Petter & Moum, Bjørn (2015). Relationship between use of complementary and alternative medicine (CAM) and health-related quality of life (HRQoL) among patients with inflammatory bowel disease. Journal of Crohn’s and Coltis Supplements. ISSN 1873-9954. 9. Full text in Research Archive
• Bernklev, Tomm; Huppertz-Hauss, Gert; Jelsness-Jørgensen, Lars-Petter; Høivik, Marte; Opheim, Randi & Jahnsen, Jørgen [Show all 7 contributors for this article] (2014). Chronic Fatigue Twenty Years After Diagnosis. Results from the IBSEN-Study. Inflammatory Bowel Diseases. ISSN 1078-0998. 20(12), p. 31–32. doi: 10.1097/01.MIB.0000456782.03905.38. Full text in Research Archive
• Jelsness-Jørgensen, Lars-Petter; Bernklev, Tomm; Henriksen, Magne; Torp, Roald & Moum, Bjørn (2012). Is patient reported outcome (PRO) affected by different follow-up regimens in inflammatory bowel disease (IBD)? Full text in Research Archive
• Nordvåg, Bjørn-Yngvar; Bernklev, Tomm; Slevolden, Ellen Margrethe; Myhr, Kjell-Morten & Stensland, Eva (2012). Norwegian quality registry for biological drugs: the NOKBIL project. Scandinavian Journal of Rheumatology. ISSN 0300-9742. 41, p. 50–50. Full text in Research Archive
• Andersen, Randi D.; Jylli, Leena; Langius-Eklöf, Ann; Bernklev, Tomm & Nakstad, Britt (2018). Do you see my pain? Aspects of pain assessment in hospitalized preverbal children. Karolinska Institutet. ISSN 9789178310159. Full text in Research Archive Show summary

  Background and aim: Pain in hospitalized preverbal children is underassessed and undermanaged. According to the Social Communication Model of Pain, pain is both a personal experience and a social construction, influenced not only by the child in pain, but by the observer and the context. Nurses’ pain assessment is biased towards underestimation. The use of structured pain scales is strongly advocated, but pain scales have been difficult to implement into clinical practice. To improve clinical pain assessment and reduce unnecessary pain for hospitalized preverbal children, a better understanding of aspects concerning these scales is needed, and nurses’ views regarding clinical pain assessment and their understanding and practical use of structured pain scales need to be further explored. The overall aim of this thesis was to contribute to knowledge regarding how to reduce unnecessary pain and suffering in hospitalized preverbal children by exploring aspects that influence nurses' assessment of pain in the clinical setting. Material and Methods: This PhD thesis consists of four different studies using both qualitative and quantitative methods. In study I the COMFORT behavioral scale was translated into Norwegian using the forward-back-translation method and culturally adapted in 12 cognitive interviews with clinicians who would later be using the scale in clinical practice. The translated scale’s responsiveness to change and inter-rater reliability were tested in study II, based on repeated measurements from 45 preverbal children before and after minor outpatient surgery. Study III was a systematic review appraising the evidence underlying the recommendations presented in 14 systematic reviews on the measurement properties of observational pain scales. Study IV was a semi-structured interview study with 22 nurses in Norway and Canada and examined their pain assessment practices based on self-selected clinical examples. Results: Cognitive interviews identified several problems with the content validity of the Norwegian and original versions of the COMFORT behavioral scale. The responsiveness of the translated version was supported for assessment of sedation, but not for assessment of pain/distress. Scale recommendations given in systematic reviews addressing the measurement properties of observational pain scales had low evidence value and should be interpreted with caution. Observational pain scales were infrequently used in clinical practice and pain scores were not considered pain –specific. Instead; nurses expressed strong preferences for pain assessment based on clinical judgment and individually tailored to the child and the situation. When assessing pain, nurses combined experience-based and childspecific knowledge with one or more specific strategies to interpret observations of and information from the child. Described strategies included identifying a probable cause for pain, eliminating other sources of distress, evaluating behavioral change and/or effect of interventions on behavior, using a personal and contextual approach, and using behavioral pain scores. Conclusions: A preverbal child’s pain will probably be better seen, evaluated and managed if nurses apply a systematic and comprehensive assessment approach that integrates clinical judgement and structured pain scales.

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