Publications
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Skøyeneie, Sigrid Cecilie Tinglum; Fauske, Lena; Wik, Hilde Skuterud; Tjønnfjord, Geir Erland; Gedde-Dahl, Tobias & Myhre, Anders Eivind
(2025).
Patients’ Experiences With Hospital at Home Following Allogenic Hematopoietic Stem Cell Transplantation: A Qualitative Study.
Cancer Nursing.
ISSN 0162-220X.
doi:
10.1097/NCC.0000000000001504.
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Background
Hospital at Home (HaH) models aim to deliver hospital-level care to patients in a home setting. In the context of allogeneic hematopoietic stem cell transplantation (HSCT), HaH is intended to improve patients’ quality of life and reduce symptom burden. However, limited research exists on patients’ perceptions of this innovative care model.
Objective
This study aimed to explore how patients experienced HaH following HSCT.
Methods
A qualitative exploratory research design was employed, utilizing semistructured individual interviews. Sixteen patients who received HaH care following HSCT were interviewed. Reflexive thematic analysis was used to identify themes representing patterns of meaning across the dataset.
Results
The following 3 themes were identified: (1) actively working through the illness experience: participants needed to engage in active coping mechanisms, emphasizing the crucial role of their informal caregivers, (2) recognition of normality in the illness situation: experiencing autonomy and living in a homelike environment enhanced their sense of normality, and (3) fundamental aspects of daily life that promote recovery: psychological and emotional benefits of the private setting, including improved rest, calmness, relaxation, increased physical activity, and the opportunities to engage in familiar daily activities, facilitated recovery in ways that differed from the traditional hospital setting.
Conclusion
This study suggests that HaH positively influences recovery and well-being among HSCT patients and has the potential to improve patient outcomes.
Implications for Practice
HaH offers a viable alternative to traditional hospitalization, promoting a more personalized approach to care.
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Quist-Paulsen, Petter; Horvei, Lars Daae; Dalgaard, Jakob; Moksnes, Magnus; Eilertsen, Anette Løken & Paulson, Martin
[Show all 9 contributors for this article]
(2025).
Improved outcomes in elderly patients with acute lymphoblastic leukaemia using a paediatric‐based protocol — A prospective study.
British Journal of Haematology.
ISSN 0007-1048.
207(6),
p. 2434–2440.
doi:
10.1111/bjh.70159.
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Summary Population data have shown that the prognosis for elderly patients with acute lymphoblastic leukaemia (ALL) is poor, even in the modern era and despite improvements in the outcome for younger patients. In this Norwegian prospective population‐based study, the feasibility and effectiveness of a paediatric‐based regimen in newly diagnosed patients above 65 years of age with ALL were assessed. Patients who were Philadelphia chromosome (Ph) negative were assigned to unmodified doses of pegylated asparaginase starting on day 30, while Ph‐positive patients were treated with imatinib. For frail patients, dose reductions were allowed at the discretion of the treating physician. A total of 52 patients were enrolled, 32 of whom were Ph negative. The median age was 70 years (range 65–82). Forty‐nine attained remission, of which four did not receive further treatment and died. Six patients died while in remission and three died from a second malignancy. Among the remaining 36 patients, only six relapsed. The 2‐year and 5‐year overall survival rates, with a median follow‐up of 3.2 years (Interquartile range 1.3–6.3), were 0.60 (95% confidence interval 0.46–0.74) and 0.50 (0.34–0.66) respectively. In conclusion, this paediatric‐based protocol was well tolerated and effective, with low relapse rates and 50% long‐term survival.
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Svalastoga, Marte; Larsen, Trine-Lise; Brekke, Jorunn; Enden, Tone Rønnaug; Frøen, Hege & Garresori, Herish
[Show all 15 contributors for this article]
(2025).
Effect of drug interactions with apixaban on clinical outcomes in cancer patients with venous thromboembolism.
Frontiers in Oncology.
15.
doi:
10.3389/fonc.2025.1520725.
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Introduction: It is unclear how drug-interaction with apixaban influences recurrent venous thromboembolism (VTE) and bleedings in cancer patients.
Methods: A post-hoc analysis of a single-arm interventional clinical trial on apixaban treatment of cancer patients with VTE to investigate whether the occurrence of any of the endpoints could be associated with the concurrent use of an interacting drug. Drugs taken by the patients during the trial period were categorized as either increasing bleeding risk, increasing thrombosis risk, both or neither.
Results: 298 patients were divided into groups based on whether they used no interacting drugs (controls, n=74), drugs increasing bleeding risk (n=55), drugs increasing thrombosis risk (n=8), or both (n=161). Odds ratios (OR) were calculated for recurrent VTE, clinically relevant non-major bleeding (CRNMB), and major bleeding during the 36-month follow-up period. Each patient took a median of 13 different drugs over the study period. 67% of the patients used drugs expected to both increase bleeding and thrombosis. The use of fluconazole appeared associated with CRNMB (OR 3.6, 95% confidence interval (CI) 0.99-13), but not with major bleeding (OR 0.56, 95% CI 0.06 - 4.8). Non-steroid anti-inflammatory drugs were not associated with CRNMB (OR 1.0, 95% CI 0.25-4.1) or major bleedings (OR 0.72, 95% CI 0.14 - 3.6). Use of antiplatelet therapy was not associated with CRNMB (OR 0.75, 95% CI, 0.22 - 2.58) or major bleeding (OR 0.2, 95% CI, 0.02-1.6). There were no major bleedings in 23 patients using aprepitant nor in the 10 patients taking macrolides. We found no association between drugs and recurrent VTE, except that there were no recurrent VTE in 19 patients using bevacizumab.
Conclusions: Despite the high number of drugs taken that could potentially interact with apixaban, none were found to clearly influence clinical outcomes, except that fluconazole may increase the risk of CRNMB.
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Skøyeneie, Sigrid Cecilie Tinglum; Wik, Hilde Skuterud; Tjønnfjord, Geir Erland; Fauske, Lena; Gedde-Dahl, Tobias & Myhre, Anders Eivind
(2025).
Family Caregivers’ Experiences of Hospital at Home Following Allogeneic Haematopoietic Stem Cell Transplantation: A Qualitative Study.
European Journal of Cancer Care.
ISSN 0961-5423.
2025(1).
doi:
10.1155/ecc/7043910.
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Purpose: The use of Hospital at Home (HaH) is expanding globally, including in the context of allogeneic haematopoietic stem cell transplantation (HSCT), as an innovative care model that delivers hospital-equivalent care to patients in a home setting. The HaH model designed for HSCT relies on informal caregivers, such as next of kin or friends. Given the limited research on caregivers’ perceptions of HaH, this study aimed to explore how informal caregivers of patients undergoing HSCT experienced HaH.
Method: Using a phenomenological interpretive approach, semistructured individual interviews were conducted with 14 family caregivers. Data were analysed using reflexive thematic analysis.
Results: The analysis identified three themes: (1) On the inside as a caregiver, (2) Variation in caregiver burden and (3) Appreciating normality. Caregivers valued the opportunity to be physically present and involved in caring for the patient during HSCT. Although most had to undertake an active caregiving role, they reported varying levels of involvement and distress. Caregivers also highlighted the sensation of normality that HaH fostered, emphasising that maintaining a familiar routine in the home setting was less exhausting than traditional hospital care.
Conclusion: This study found that family caregivers appreciated being physically present in HaH, experiencing a sensation of being ‘on the inside’ and closely sharing the patient’s treatment journey, in contrast to during hospitalisation. The findings revealed diverse experiences of caregiving and associated distress, underscoring the importance of adequately preparing caregivers for their role and ensuring appropriate support.
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Panagopoulos, Ioannis; Andersen, Kristin; Wik, Hilde Skuterud & Tandsæther, Maren Randi
(2024).
Acute Lymphoblastic Leukemia With Near-haploid Karyotype and Philadelphia Chromosome.
Anticancer Research.
ISSN 0250-7005.
44(4),
p. 1389–1397.
doi:
10.21873/anticanres.16935.
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Podgorica, Mirjam; Drivet, Elsa Maria Caroline; Viken, Jonas Krag; Richman, Alyssa; Vestbøstad, Johanne Bonsaksen & Szodoray, Peter
[Show all 12 contributors for this article]
(2024).
Transcriptome analysis of primary adult B-cell lineage acute lymphoblastic leukemia identifies pathogenic variants and gene fusions, and predicts subtypes for in depth molecular diagnosis.
European Journal of Haematology.
ISSN 0902-4441.
112(5),
p. 731–742.
doi:
10.1111/ejh.14164.
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Background B-cell acute lymphoblastic leukemia (B-ALL) is classified into subgroups based on known driver oncogenes and molecular lesions, including translocations and recurrent mutations. However, the current diagnostic tests do not identify subtypes or oncogenic lesions for all B-ALL samples, creating a heterogeneous B-ALL group of unknown subtypes. Methods We sorted primary adult B-ALL cells and performed transcriptome analysis by bulk RNA sequencing (RNA-seq). Results Transcriptomic analysis of an adult B-ALL cohort allowed the classification of four patient samples with subtypes that were not previously revealed by standard gene panels. The leukemia of two patients were of the DUX4 subtype and two were CRLF2+ Ph-like B-ALL. Furthermore, single nucleotide variant analysis detected the oncogenic NRAS-G12D, KRAS-G12D, and KRAS-G13D mutations in three of the patient samples, presenting targetable mutations. Additional oncogenic variants and gene fusions were uncovered, as well as multiple variants in the PDE4DIP gene across five of the patient samples. Conclusion We demonstrate that RNA-seq is an effective tool for precision medicine in B-ALL by providing comprehensive molecular profiling of leukemia cells, identifying subtype and oncogenic lesions, and stratifying patients for appropriate therapy.
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Panagopoulos, Ioannis; Andersen, Kristin; Wik, Hilde Skuterud; Tandsæther, Maren Randi; Micci, Francesca & Heim, Sverre
(2023).
Acute Undifferentiated Leukemia With a Balanced t(5;10)(q35;p12) Resulting in Fusion of HNRNPH1 With MLLT10.
Cancer Genomics & Proteomics.
ISSN 1109-6535.
20(4),
p. 354–362.
doi:
10.21873/cgp.20387.
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Larsen, Trine-Lise; Garresori, Herish; Brekke, Jorunn; Enden, Tone Rønnaug; Frøen, Hege & Jacobsen, Eva-Marie
[Show all 15 contributors for this article]
(2022).
Low dose apixaban as secondary prophylaxis of venous thromboembolism in cancer patients – 30 months follow-up.
Journal of Thrombosis and Haemostasis.
ISSN 1538-7933.
20(5),
p. 1166–1181.
doi:
10.1111/jth.15666.
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Background
There are no data on the effect of low-dose anticoagulation as secondary prophylaxis for venous thromboembolism (VTE) in cancer patients. We assessed the efficacy and safety of low-dose apixaban for 30 months, after initial 6 months of full-dose treatment.
Methods
We included 298 patients with cancer and any type of VTE in a single arm interventional clinical trial. All patients were treated with full-dose apixaban (5 mg twice daily) for 6 months. Total 196 patients with active cancer after 6 months treatment continued with apixaban 2.5 mg twice daily for another 30 months. The main endpoints were recurrent VTE, major bleeding and clinically relevant non-major bleeding.
Results
During the 30 months of treatment with low-dose apixaban 14 (7.6%; 95% confidence interval (CI) 4.0%–11.7%) patients experienced recurrent VTE, six (3.1%; 95% CI 1.1%–6.5%) experienced major bleeding and 16 (8.1%, 95% CI: 4.7%–12.8%) experienced clinically relevant non-major bleeding. The incidence rate per person month of recurrent VTE was 0.8% (95% CI 0.41–1.6) at 2–6 months with full-dose apixaban, and 1.0% (95% CI 0.5–1.9) at 7–12 months with low-dose apixaban. The incidence rate of major bleeding was 1.1% (95% CI 0.6–2.0) at 2–6 months, and 0.3% (95% CI 0.1–1.0) at 7–12 months. Between 12 and 36 months the incidence rate of recurrent VTE and major bleedings remained low.
Conclusion
Dose reduction of apixaban to 2.5 mg twice daily seems safe after 6 months of full-dose treatment. After 12 months the incidence rate of recurrent VTE and major bleeding remained low.
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Bistervels, Ingrid M.; Bavalia, Roisin; Beyer-Westendorf, Jan; Cate-Hoek, Arina J. ten; Schellong, Sebastian M. & Kovacs, Michael J.
[Show all 34 contributors for this article]
(2022).
Postthrombotic syndrome and quality of life after deep vein thrombosis in patients treated with edoxaban versus warfarin.
Research and Practice in Thrombosis and Haemostasis (RPTH).
6(5).
doi:
10.1002/rth2.12748.
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Background Postthrombotic syndrome (PTS) is a long‐term complication after deep vein thrombosis (DVT) and can affect quality of life (QoL). Pathogenesis is not fully understood but inadequate anticoagulant therapy with vitamin K antagonists is a known risk factor for the development of PTS. Objectives To compare the prevalence of PTS after acute DVT and the long‐term QoL following DVT between patients treated with edoxaban or warfarin. Methods We performed a long‐term follow‐up study in a subset of patients with DVT who participated in the Hokusai‐VTE trial between 2010 and 2012 (NCT00986154). Primary outcome was the prevalence of PTS, defined by the Villalta score. The secondary outcome was QoL, assessed by validated disease‐specific (VEINES‐QOL) and generic health‐related (SF‐36) questionnaires. Results Between 2017 and 2020, 316 patients were enrolled in 26 centers in eight countries, of which 168 (53%) patients had been assigned to edoxaban and 148 (47%) to warfarin during the Hokusai‐VTE trial. Clinical, demographic, and thrombus‐specific characteristics were comparable for both groups. Mean (SD) time since randomization in the Hokusai‐VTE trial was 7.0 (1.0) years. PTS was diagnosed in 85 (51%) patients treated with edoxaban and 62 (42%) patients treated with warfarin (adjusted odds ratio 1.6, 95% CI 1.0–2.6). Mean differences in QoL scores between treatment groups were not clinically relevant. Conclusion Contrary to our hypothesis, the prevalence of PTS tended to be higher in patients treated with edoxaban compared with warfarin. No differences in QoL were observed. Further research is warranted to unravel the role of anticoagulant therapy on development of PTS.
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Tavoly, Mazdak; Asady, Elia; Wik, Hilde Skuterud & Ghanima, Waleed
(2022).
Measuring Quality of Life after Venous Thromboembolism: Who, When, and How?
Seminars in Thrombosis and Hemostasis.
ISSN 0094-6176.
doi:
10.1055/s-0042-1754390.
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Engeseth, Marit; Enden, Tone Rønnaug; Sandset, Per Morten & Wik, Hilde Skuterud
(2021).
Predictors of long-term post-thrombotic syndrome following high proximal deep vein thrombosis: a cross-sectional study.
Thrombosis Journal.
19:3,
p. 1–7.
doi:
10.1186/s12959-020-00253-8.
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Background Post-thrombotic syndrome (PTS) is a frequent chronic complication of proximal deep vein thrombosis (DVT) of the lower limb, but predictors of PTS are not well established. We aimed to examine predictors of PTS in patients with long-term PTS following proximal DVT. Methods During 2006–09, 209 patients with a first time acute upper femoral or iliofemoral DVT were randomized to receive either additional catheter-directed thrombolysis or conventional therapy alone. In 2017, the 170 still-living participants were invited to participate in a cross-sectional follow-up study. In the absence of a gold standard diagnostic test, PTS was defined in line with clinical practice by four mandatory, predefined clinical criteria: 1. An objectively verified DVT; 2. Chronic complaints (> 1 month) in the DVT leg; 3. Complaints appeared after the DVT; and 4. An alternative diagnosis was unlikely. Possible predictors of PTS were identified with multivariate logistic regression. Results Eighty-eight patients (52%) were included 8–10 years following the index DVT, and 44 patients (50%) were diagnosed with PTS by the predefined clinical criteria. Younger age and higher baseline Villalta score were found to be independent predictors of PTS, i.e., OR 0.96 (95% CI, 0.93–0.99), and 1.23 (95% CI, 1.02–1.49), respectively. Lack of iliofemoral patency at six months follow-up was significant in the bivariate analysis, but did not prove to be significant after the multivariate adjustments. Conclusions In long-term follow up after high proximal DVT, younger age and higher Villalta score at DVT diagnosis were independent predictors of PTS.
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Bavalia, Roisin; Bistervels, Ingrid M.; Boersma, Wim G.; Quere, Isabelle; Brisot, Dominique & Falvo, Nicolas
[Show all 33 contributors for this article]
(2021).
Quality of life patients with pulmonary embolism treated with edoxaban versus warfarin.
Research and Practice in Thrombosis and Haemostasis (RPTH).
doi:
10.1002/rth2.12566.
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Background Long-term sequelae of acute pulmonary embolism (PE) include decreased quality of life (QoL). Evidence suggests that adequacy of initial anticoagulant treatment in the acute phase of venous thrombosis has a key impact on late postthrombotic complications. We hypothesize that patients with acute PE treated with edoxaban for acute PE experience have improved QoL compared to those treated with warfarin. Methods Patients with PE who participated in the Hokusai-VTE trial were contacted between June 2017 and September 2020 for a single long-term follow-up visit. Main outcomes were the generic and disease-specific QoL measured by the 36-Item Short Form Health Survey (SF-36) and Pulmonary Embolism Quality of Life questionnaire. Results We included 251 patients from 26 centers in eight countries, of which 129 (51%) had been assigned to edoxaban and 122 (49%) to warfarin. Patient- and thrombus-specific characteristics were similar in both groups. Mean time since randomization in the Hokusai-VTE trial was 7.0 years (standard deviation, 1.0). No relevant or statistical differences were observed in the QoL for patients treated with edoxaban compared to patients treated with warfarin. The mean difference between patients treated with edoxaban and patients with PE treated with warfarin was 0.8 (95% confidence interval [CI]. −1.6 to 3.2) for the SF-36 summary mental score and 1.6 (95% CI, −0.9 to 4.1) for summary physical score. Conclusion Our findings indicate that patients with an index PE treated with edoxaban or warfarin have a similar long-term QoL. Since our study was a follow-up study from a well-controlled clinical trial setting, future studies should be designed in a daily clinical practice setting. We suggest a longitudinal design for investigation of changes in QoL over time.
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Asady, Elia; Ghanima, Waleed; Jelsness-Jørgensen, Lars-Petter; Klok, Erik; Kahn, Susan R. & Strømme, Hilde
[Show all 7 contributors for this article]
(2021).
Health-related quality-of-life questionnaires for deep vein thrombosis and pulmonary embolism: A systematic review on questionnaire development and methodology.
Research and Practice in Thrombosis and Haemostasis (RPTH).
5(5).
doi:
10.1002/rth2.12556.
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To improve the quality and accuracy of the patient-reported outcome measures that assess health-related quality of life (HRQoL), guidelines have been developed to standardize the development and validation process. Considering the increasing importance of HRQoL questionnaires in research, we set out to review the literature and evaluate whether existing questionnaires developed for deep vein thrombosis (DVT) and pulmonary embolism (PE) fulfill state-of-the-art requirements. The literature search was conducted in March 2019 and updated in September 2020. Seven databases were searched. No time limit was set for the search to include all available questionnaires. The inclusion criteria were original publications describing the development of disease-specific HRQoL questionnaires specific to DVT or PE in adults and available in English. The questionnaires were assessed to determine whether they fulfill the requirements in the latest guidelines. A total of 3826 references were identified. After the exclusion process, 15 papers were reviewed in full, of which 7 were included. Four questionnaires were developed for chronic venous disease, two were specific to DVT, and one was specific to PE. Most questionnaires we found in this review, fulfilled some but none fulfilled all recommendations in existing guidelines. Because the development of current available HRQoL questionnaires specific to DVT or PE do not fulfil all recommendations of existing guidelines, there is room for improvements within this field. Such improvements could likely enhance the quality associated with the use of these end points in clinical trials and practice.
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Wik, Hilde Skuterud; Kahn, Susan; Eriksson, Henry; Morrison, David; Ghanima, Waleed & Schulman, Sam
[Show all 7 contributors for this article]
(2021).
Post-thrombotic syndrome in patients with venous thromboembolism treated with dabigatran or warfarin: A long-term cross-sectional follow-up of RE-COVER study patients.
Journal of Thrombosis and Haemostasis.
ISSN 1538-7933.
p. 1–9.
doi:
10.1111/jth.15449.
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Background Studies suggest that the direct factor Xa inhibitor rivaroxaban compared to warfarin reduces the risk of post-thrombotic syndrome (PTS) after deep vein thrombosis (DVT), but this has not been evaluated for oral direct thrombin inhibitors. Objectives To compare the long-term prevalence of PTS, recurrent venous thromboembolism (VTE), and health-related quality of life (HRQoL) in patients with acute DVT and/or pulmonary embolism (PE), randomized to treatment with dabigatran or warfarin in the phase III RE-COVER studies. Methods We conducted a cross-sectional follow-up study of patients randomized in Canada, Norway, and Sweden. PTS was assessed by the patient-reported Villalta scale (PRV) and HRQoL by EQ-5D and VEINES-QOL/Sym. Results We included 349 patients between December 2015 and November 2018; 166 were treated with dabigatran and 183 with warfarin. DVT (+/− PE) was index event in 255 patients, whereas 94 patients had PE only. Mean time from index event was 8.7 (standard deviation 1.4) years. PTS was diagnosed in 63% of patients with DVT and in 46% of patients with PE only, and did not differ between the treatment groups; the crude odds ratio (OR) for PTS in patients treated with dabigatran compared with warfarin was 1.1 (95% confidence interval [CI] 0.6–1.8) after DVT and 1.2 (95% CI 0.5–2.6) after PE only. The prevalence of recurrent VTE was 21% in both treatment groups. HRQoL scores did not differ between groups. Conclusion In this long-term cross-sectional study, the prevalence of PTS, recurrent VTE, and HRQoL were similar in patients treated with dabigatran and warfarin.
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Frønæs, Synne Grønvold; Jørgensen, Camilla Tøvik; Dahm, Anders Erik A; Wik, Hilde Skuterud; Gleditsch, Jostein & Raouf, Nezar
[Show all 9 contributors for this article]
(2020).
Safety of a strategy combining D-dimer testing and whole-leg ultrasonography to rule out deep vein thrombosis.
Blood Advances.
ISSN 2473-9529.
4(20),
p. 5002–5010.
doi:
10.1182/BLOODADVANCES.2020002173.
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Abstract Guidelines for the diagnostic workup of deep vein thrombosis (DVT) recommend assessing the clinical pretest probability before proceeding to D-dimer testing and/or compression ultrasonography (CUS) if the patient has high pretest probability or positive D-dimer. Referring only patients with positive D-dimer for whole-leg CUS irrespective of pretest probability may simplify the workup of DVT. In this prospective management outcome study, we assessed the safety of such a strategy. We included consecutive outpatients referred to the Emergency Department at Østfold Hospital, Norway, with suspected DVT between February 2015 and November 2018. STA-Liatest D-Di Plus D-dimer was analyzed for all patients, and only patients with levels ≥0.5 µg/mL were referred for CUS. All patients with negative D-dimer or negative CUS were followed for 3 months to assess the venous thromboembolic rate. One thousand three hundred ninety-seven patients were included. Median age was 64 years (interquartile range, 52-73 years), and 770 patients (55%) were female. D-dimer was negative in 415 patients (29.7%) and positive in 982 patients (70.3%). DVT was diagnosed in 277 patients (19.8%). Six patients in whom DVT was ruled out at baseline were diagnosed with DVT within 3 months of follow-up for a thromboembolic rate of 0.5% (95% confidence interval, 0.2-1.2). A simple diagnostic approach with initial stand-alone D-dimer followed by a single whole-leg CUS in patients with positive D-dimer safely ruled out DVT. We consider this strategy to be a valuable alternative to the conventional workup of DVT in outpatients. This trial was registered at www.clinicaltrials.gov as #NCT02486445.
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Hannevik, Trine-Lise; Brekke, Jorunn; Enden, Tone Rønnaug; Frøen, Hege; Ahmed, Herish & Jacobsen, Eva-Marie
[Show all 15 contributors for this article]
(2020).
Thrombosis and bleedings in a cohort of cancer patients treated with apixaban for venous thromboembolism.
Thrombosis Research.
ISSN 0049-3848.
196,
p. 238–244.
doi:
10.1016/j.thromres.2020.08.042.
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Introduction: The direct oral anti-coagulants (DOAC) edoxaban and rivaroxaban are suggested treatment alternatives for cancer-associated venous thromboembolism (VTE) together with low molecular-weight heparins. New studies indicate that the DOAC apixaban also is an option for cancer-associated VTE. The current study assessed recurrent VTE, arterial thrombosis, bleedings and adverse events in a cohort of apixaban treated cancer patients with VTE. Materials and methods: Single-arm, interventional study of apixaban as treatment of cancer-associated VTE. Inclusion criteria were cancer with objectively verified VTE. Patients received apixaban 10 mg bid for seven days, then 5 mg bid for six months. Primary efficacy and safety outcomes were recurrent VTE and bleeding respectively. This trial is registered with ClinicalTrials.gov identifier NCT02581176. Results: We recruited 298 cancer patients with VTE. During six months treatment, recurrent VTE or death related to VTE occurred in 12 patients (4.0%, 95% confidence interval (CI) 2.1–6.9%). Major bleeding occurred in 16 patients (5.4%, 95% CI 2.8–7.9), most frequently gastrointestinal bleeding. There were no overrepresentation of major bleedings among patients with gastrointestinal cancer (7/126, 5.5%, 95% CI 2.3–11%). Twenty-six patients experienced one or more clinically relevant non-major bleedings (8.9%, 95% CI 5.5–12%). Twelve patients had arterial thrombosis (4.0%, 95% CI 2.1–6.9%), of which the majority were strokes in patients with pancreatic cancer. Death occurred in 35 patients (12%, 95% CI 8.3–16%). Conclusion: The frequency of recurrent VTE and major bleedings are in line with other studies on apixaban in cancer-associated VTE. Arterial thrombosis was a frequent serious adverse event.
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Frønæs, Synne Grønvold; Dahm, Anders Erik Astrup; Wik, Hilde Skuterud; Jørgensen, Camilla Tøvik; Gleditsch, Jostein & Raouf, Nezar
[Show all 9 contributors for this article]
(2020).
Safety and feasibility of rivaroxaban in deferred workup of patients with suspected deep vein thrombosis.
Blood Advances.
ISSN 2473-9529.
4(11),
p. 2468–2476.
doi:
10.1182/bloodadvances.2020001556.
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Abstract Guidelines suggest using empiric low-molecular-weight heparin if the diagnostic workup of deep vein thrombosis (DVT) is expected to be delayed. The role of direct oral anticoagulants for deferred compression ultrasound imaging (CUS) in patients with suspected DVT remains unexplored. The main objective of the study was to assess the safety of deferring CUS with therapeutic doses of rivaroxaban. We prospectively included consecutive outpatients referred to the Emergency Department at Østfold Hospital, Norway, with suspected first or recurrent lower-extremity DVT between February 2015 and November 2018. Patients were discharged with rivaroxaban 15 mg twice daily while awaiting CUS within 24 hours if D-dimer level was ≥0.5 mg/L fibrinogen-equivalent units. The primary outcome was the rate of major bleeding incidents from study inclusion until DVT was confirmed and anticoagulation therapy continued, or otherwise up to 48 hours following administration of the last tablet of rivaroxaban. The secondary outcome was the rate of progressive DVT symptoms or symptoms or signs of pulmonary embolism between hospital discharge until venous thromboembolism was diagnosed. Six hundred twenty-four of 1653 patients referred with suspected DVT were included (37.7%; 95% confidence interval [CI], 35.4-40.1). DVT was diagnosed in 119 patients (19.1%; 95% CI, 16.1-22.3). There were no major bleeding incidents, yielding an observed major bleeding rate of 0% (1-sided 95% CI <0.4). No patients experienced major complications in the interval that CUS was deferred (0%; 95% CI, 0.0-0.6). Deferring CUS for up to 24 hours in patients with suspected DVT with therapeutic doses of rivaroxaban is a safe strategy. This trial was registered at www.clinicaltrials.gov as #NCT02486445.
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Engeseth, Marit; Enden, Tone Rønnaug; Andersen, Marit Helen; Sandset, Per Morten & Wik, Hilde Skuterud
(2019).
Does the Villalta scale capture the essence of postthrombotic syndrome? A qualitative study of patient experience and expert opinion.
Journal of Thrombosis and Haemostasis.
ISSN 1538-7933.
p. 1–8.
doi:
10.1111/jth.14557.
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Background The Villalta scale is recommended for diagnosing and grading of postthrombotic syndrome (PTS) in clinical studies, but with limitations in specificity and sensitivity. Objectives To explore the typical complaints of PTS through patients experience and expert opinion and relate this to the items of the Villalta scale. Patients/Methods A qualitative study design with focus group interviews including patients with PTS and health care workers experienced in PTS patient care. Results Typical PTS complaints were reflected within four main domains: (a) agonizing discomforts; patients without venous ulcers often described other discomforts than pain; (b) skin changes; these were common and sometimes present before deep vein thrombosis (DVT). Except for venous ulcers, skin changes were considered of less importance; (c) fluctuating heaviness and swelling during the day and with activity; (d) post‐DVT concerns; fear of DVT recurrence, health services failing to meet the patients’ expectations, and psychological and social restrictions. These findings are not necessarily captured or well reflected in the Villalta scale. Conclusion Our findings indicate that the Villalta scale does not capture typical PTS complaints or their importance to the patients. A revision of the diagnosis and grading should be considered.
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Engeseth, Marit; Enden, Tone Rønnaug; Sandset, Per Morten & Wik, Hilde Skuterud
(2019).
Limitations of the Villalta scale in diagnosing post-thrombotic syndrome.
Thrombosis Research.
ISSN 0049-3848.
184,
p. 62–66.
doi:
10.1016/j.thromres.2019.10.018.
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Introduction The Villalta scale is currently the recommended tool for diagnosing post-thrombotic syndrome (PTS) in clinical studies, but there is concern that the sensitivity and specificity of the scale might be low. We aimed to evaluate the diagnostic accuracy of the Villata scale using criteria in line with clinical practice as a reference. Material and methods We invited patients with a history of proximal DVT during 2006–09 to participate in a cross-sectional follow-up study of long-term complications after DVT. PTS was diagnosed by the Villalta scale, and by the following four mandatory and predefined clinical criteria used as a reference for PTS: 1. Objectively verified DVT; 2. chronic complaints (>1 month) in the DVT leg; 3. complaints appeared after the DVT; and 4. an alternative diagnosis was unlikely. Results We included 88 of 170 eligible patients (52%). With our clinical criteria as a reference the sensitivity and specificity of the Villalta scale for diagnosing PTS were 75% (95% CI 60–87%) and 66% (95% CI 50–80%), respectively. Fifteen patients were diagnosed with PTS by the Villalta scale only. These patients more often experienced pain or had comorbidity that could explain their leg symptoms and signs. Eleven patients diagnosed with PTS by the clinical criteria only, had more fluctuating heaviness and edema. Conclusions Our findings indicate that the diagnostic accuracy of the Villalta scale has limitations. Incorporating chronicity, whether the leg problems appeared following the DVT, fluctuations of heaviness and edema, and comorbidity in PTS assessment may improve the diagnostic accuracy.
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Dahm, Anders Erik A; Jacobsen, Eva-Marie; Wik, Hilde Skuterud; Jacobsen, Anne Flem; Mollnes, Tom Eirik & Kanse, Sandip
[Show all 7 contributors for this article]
(2019).
Elevated complement C3 and C4 levels are associated with postnatal pregnancy-related venous thrombosis.
Thrombosis and Haemostasis.
ISSN 0340-6245.
119(9),
p. 1481–1488.
doi:
10.1055/s-0039-1692426.
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High levels of complement C3 are associated with venous thrombosis (VT) in the general population. We investigated if high C3 and C4 levels were associated with pregnancy-related VT. We undertook the Norwegian VIP study, a case–control study of VT in pregnancy or within 3 months postpartum (cases, n = 313) and women without pregnancy-related VT (controls, n = 353). Determinants of C3 and C4 in the control women were investigated with linear regression and the odds ratio (OR) for pregnancy-related VT was calculated with logistic regression. We found that levels of C3 and C4 were associated with body mass index (BMI), C-reactive protein (CRP); with the coagulation factors (F) fibrinogen, FVIII, and FIX; and with the coagulation inhibitors antithrombin, protein C, protein S, and tissue factor pathway inhibitor. These associations were influenced by CRP levels. The crude OR for pregnancy-related VT was 1.8 (95% confidence interval [CI], 1.1–3.0) for C3 above the 90th percentile and 2.0 (95% CI, 1.2–3.2) for C4 above the 90th percentile. Stratification in antenatal and postnatal VT showed that C3 and C4 were only associated with postnatal VT with an OR for high C3 of 3.0 (95% CI, 1.8–5.0), and for high C4 of 2.6 (95% CI, 1.5–4.6). Adjustment for high FIX and BMI reduced the ORs. We conclude that the association between postnatal VT and C3 and C4 suggests that there is clinically relevant crosstalk between the complement and the coagulation system.
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Frønæs, Synne Grønvold; Wik, Hilde Skuterud; Dahm, Anders Erik A; Jørgensen, Camilla Tøvik; Gleditsch, Jostein & Raouf, Nezar
[Show all 8 contributors for this article]
(2018).
Safety of D-dimer testing as a stand-alone test for the exclusion of deep vein thrombosis as compared with other strategies.
Journal of Thrombosis and Haemostasis.
ISSN 1538-7933.
16(12),
p. 2471–2481.
doi:
10.1111/jth.14314.
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Background: Several strategies for safely
excluding deep vein thrombosis (DVT) while limiting the
number of imaging tests have been explored. Objectives:
To determine whether D-dimer testing could safely and
efficiently exclude DVT as a stand-alone test, and evalu-
ate its performance as compared with strategies that
incorporate the Wells score and age-adjusted D-dimer.
Patients/Methods: We included consecutive outpatients
referred with suspected DVT to the Emergency Depart-
ment at Østfold Hospital, Norway. STA-Liatest D-Di
PLUS D-dimer was analyzed for all patients. Patients
with a D-dimer level of ≥ 0.5 lgmL
1
were referred for
compression ultrasonography (CUS). In patients with a
D-dimer level of < 0.5 lgmL
1
, no further testing was
performed and anticoagulation was withheld. Patients were followed for 3 months for venous thromboembolism
(VTE). Results: Of the 913 included patients, 298 (33%)
had a negative D-dimer result. One hundred and seventy-
three patients (18.9%) were diagnosed with DVT at
baseline. One of 298 patients had DVT despite having a
negative D-dimer result, resulting in a failure rate of
0.3% (95% confidence interval [CI] 0.1–1.9%). Adding
the modified Wells score would have yielded a failure rate
of 0.0% (95% CI 0.0–1.8%) while necessitating 87 more
CUS examinations. Age-adjusted D-dimer as a stand-
alone test would have necessitated 80 fewer CUS exami-
nations than fixed D-dimer as a stand-alone test, at the
cost of a failure rate of 1.6% (95% CI 0.7– 3.4%). Con-
clusions: This outcome study shows that a negative
high-sensitivity D-dimer result safely excludes DVT in an
outpatient population, and necessitates fewer CUS than if
used in combination with Wells score. The safety of
stand-alone age-adjusted D-dimer needs further assess-
ment in prospective outcome studies.
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Utne, Kristin Kornelia; Dahm, Anders Erik A; Wik, Hilde Skuterud; Jelsness-Jørgensen, Lars-Petter; Sandset, Per Morten & Ghanima, Waleed Khalid
(2018).
Rivaroxaban versus warfarin for the prevention of post-thrombotic syndrome.
Thrombosis Research.
ISSN 0049-3848.
163,
p. 6–11.
doi:
10.1016/j.thromres.2018.01.013.
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Wik, Hilde Skuterud; Enden, Tone Rønnaug; Ghanima, Waleed Khalid; Engeseth, Marit; Kahn, Susan R. & Sandset, Per Morten
(2018).
Diagnostic scales for the post-thrombotic syndrome.
Thrombosis Research.
ISSN 0049-3848.
164,
p. 110–115.
doi:
10.1016/j.thromres.2017.10.022.
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Ghanima, Waleed Khalid; Wik, Hilde Skuterud; Tavoly, Mazdak; Enden, Tone Rønnaug & Jelsness-Jørgensen, Lars-Petter
(2018).
Late consequences of venous thromboembolism: Measuring quality of life after deep vein thrombosis and pulmonary embolism.
Thrombosis Research.
ISSN 0049-3848.
164,
p. 170–176.
doi:
10.1016/j.thromres.2017.07.025.
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Wik, Hilde Skuterud; Ghanima, Waleed Khalid; Sandset, Per Morten & Kahn, Susan R
(2017).
Scoring Systems for Postthrombotic Syndrome.
Seminars in Thrombosis and Hemostasis.
ISSN 0094-6176.
43(5),
p. 500–504.
doi:
10.1055/s-0037-1599142.
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Utne, Kristin Kornelia; Ghanima, Waleed Khalid; Foyn, Siv Lindholm; Kahn, Susan; Sandset, Per Morten & Wik, Hilde Skuterud
(2016).
Development and validation of a tool for patient reporting of symptoms and signs of the post-thrombotic syndrome.
Thrombosis and Haemostasis.
ISSN 0340-6245.
115(2),
p. 233–463.
doi:
10.1160/TH15-04-0318.
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Post-thrombotic syndrome (PTS) is a long-term complication of deep-vein thrombosis (DVT). The Villalta scale is the recommended tool for diagnosing PTS, but requires a clinician’s assessment in addition to patient self-assessment. In the present study, we validated a self-administered tool for patient reporting of leg symptoms and signs as a mean to assess PTS. We first validated a form for patient self-reported Villalta (PRV1), then developed and validated a visually assisted form (PRV2). The validity of PRV1 and PRV2 was assessed in patients diagnosed with DVT between 2004 and 2012. Median time from DVT to inclusion was 5.1 and 3.5 years for PRV1 (n=162) and PRV2 (n=94), respectively. Patients were requested to complete the PRV form before a scheduled visit. PTS diagnosed by the original Villalta scale during the visit served as the reference method. PRV1 showed only moderate agreement for diagnosing PTS compared with the original Villalta scale (kappa agreement 0.60, 95 % CI 0.48–0.72), whereas PRV2 showed very good agreement (0.82, 95 % CI 0.71–0.94). In the validation of PRV2, PTS was diagnosed in 54 (57 %) patients according to the original Villalta scale and in 60 (64 %) by PRV2. The sensitivity of PRV2 to detect PTS was 98 % and the specificity was 83 %. We conclude that the visually assisted form for PRV is a valid and sensitive tool for diagnosing PTS. Such a tool could be applied in further clinical studies of PTS, making studies less resource demanding by reducing the need for in-person clinic visits.
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Wik, Hilde Skuterud; Jacobsen, Anne Flem; Mowinckel, Marie-Christine & Sandset, Per Morten
(2016).
The role of inflammation in post-thrombotic syndrome after pregnancy-related deep vein thrombosis: A population-based, cross-sectional study.
Thrombosis Research.
ISSN 0049-3848.
138,
p. 16–21.
doi:
10.1016/j.thromres.2015.12.014.
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Utne, Kristin Kornelia; Tavoly, Mazdak; Wik, Hilde Skuterud; Jelsness-Jørgensen, Lars-Petter; Holst, René & Sandset, Per Morten
[Show all 7 contributors for this article]
(2016).
Health-related quality of life after deep vein thrombosis.
SpringerPlus.
5(1).
doi:
10.1186/s40064-016-2949-z.
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Background Health-related quality of life (HRQoL) is known to be impaired in patients who develop post-thrombotic syndrome (PTS) following deep vein thrombosis (DVT). However, there is limited knowledge of the long-term HRQoL after DVT compared to controls without DVT. The objectives of this study were to evaluate long-term HRQoL following DVT and to compare that with age and sex matched control group and to population norms as well as to investigate possible predictors for reduced HRQoL. Methods HRQoL was evaluated in 254 patients with confirmed DVT using the generic EQ-5D and the diseases specific VEINES-QOL/Sym questionnaire, whereas PTS was assessed by the Villalta scale. Patients were asked to give the EQ-5D questionnaire to two friends of same age- (±5 years) and sex (buddy controls). Results Patients scored significantly lower on all dimensions of EQ-5D compared to controls. EQ-5D index value was lower in patients compared with buddy controls; mean 0.79 (SD 0.17; IQR 0.72–1.00) versus 0.9 (SD 0.12; IQR 0.80–1.00), p < 0.001. EQ-5D index value was also significantly lower than age- and sex-adjusted population norms (p < 0.001). PTS and obesity (BMI >30/m2) were significantly associated with impaired HRQoL assessed by EQ-5D index value (odds ratio [OR] 11.0: 95 % confidence interval [CI] 4.6–29.7; and 2.3: 95 % CI 1.1–4.8, respectively) and VEINES-QOL (OR 28.2: 95 % CI 10.6–75.0; and OR 4.1: 95 % CI 1.7–9.7, respectively). Conclusion Long-term HRQoL was significantly impaired in DVT patients compared with buddy controls and population norms. PTS and obesity were independently associated with impaired HRQoL.
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Tavoly, Mazdak; Jelsness-Jørgensen, Lars-Petter; Wik, Hilde Skuterud; Roaldsnes, Christina; Sandset, Per Morten & Ghanima, Waleed Khalid
(2014).
Quality of life after pulmonary embolism: first cross-cultural evaluation of the pulmonary embolism quality-of-life (PEmb-QoL) questionnaire in a Norwegian cohort.
Quality of Life Research.
ISSN 0962-9343.
24(2),
p. 417–425.
doi:
10.1007/s11136-014-0779-4.
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Wik, Hilde Skuterud; Jacobsen, Anne Flem; Fagerland, Morten; Sandvik, Leiv & Sandset, Per Morten
(2013).
Long-term mortality and incidence of cancer after pregnancy-related venous thrombosis: Results of a population-based cohort study.
Thrombosis Research.
ISSN 0049-3848.
131(6),
p. 497–501.
doi:
10.1016/j.thromres.2013.04.035.
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Enden, Tone Rønnaug; Wik, Hilde Skuterud; Kvam, Ann Kristin; Klow, Nils-Einar & Sandset, Per Morten
(2013).
Health-related quality of life after catheter-directed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study.
BMJ Open.
3(8).
doi:
10.1136/bmjopen-2013-002984.
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Enden, Tone Rønnaug; Resch, S.; White, Christopher; Wik, Hilde Skuterud; Klow, Nils-Einar & Sandset, Per Morten
(2013).
Cost-effectiveness of additional catheter-directed thrombolysis for deep vein thrombosis.
Journal of Thrombosis and Haemostasis.
ISSN 1538-7933.
11(6),
p. 1032–1042.
doi:
10.1111/jth.12184.
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Wik, Hilde Skuterud; Jacobsen, Anne Flem; Sandvik, Leiv & Sandset, Per Morten
(2012).
Long-term impact of pregnancy-related venous thrombosis on quality-of-life, general health and functioning: results of a cross-sectional, case–control study.
BMJ Open.
2.
doi:
10.1136/bmjopen-2012-002048.
Full text in Research Archive
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Wik, Hilde Skuterud; Jacobsen, Anne Flem; Sandvik, Leiv & Sandset, Per Morten
(2012).
Prevalence and predictors for post-thrombotic syndrome 3 to 16 years after pregnancy-related venous thrombosis: a population-based, cross-sectional, case-control study.
Journal of Thrombosis and Haemostasis.
ISSN 1538-7933.
10(5),
p. 840–847.
doi:
10.1111/j.1538-7836.2012.04690.x.
Full text in Research Archive
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Wik, Hilde Skuterud; Enden, Tone Rønnaug; Jacobsen, Anne Flem & Sandset, Per Morten
(2011).
Long-term quality of life after pregnancy-related deep vein thrombosis and the influence of socioeconomic factors and comorbidity.
Journal of Thrombosis and Haemostasis.
ISSN 1538-7933.
9(10),
p. 1931–1936.
doi:
10.1111/j.1538-7836.2011.04468.x.
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Toksvang, Linea Natalie; Als-Nielsen, Bodil; Bacon, Christopher; Bertasiute, Ruta; Duarte, Ximo & Escherich, Gabriele
[Show all 24 contributors for this article]
(2022).
Thiopurine Enhanced ALL Maintenance (TEAM): study protocol for a randomized study to evaluate the improvement in disease-free survival by adding very low dose 6-thioguanine to 6-mercaptopurine/methotrexate-based maintenance therapy in pediatric and adult patients (0–45 years) with newly diagnosed B-cell precursor or T-cell acute lymphoblastic leukemia treated according to the intermediate risk-high group of the ALLTogether1 protocol.
BMC Cancer.
22(1).
doi:
10.1186/s12885-022-09522-3.
Full text in Research Archive
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Holme, Pål Andre; Ghanima, Waleed; Wik, Hilde Skuterud; Jacobsen, Eva-Marie & Fløisand, Yngvar
(2022).
Koagulasjonsforstyrrelser.
In Birkeland, Kåre Inge; Gullestad, Lars & Aabakken, Lars (Ed.),
Indremedisin I.
Fagbokforlaget.
ISSN 9788245043365.
p. 447–458.
Full text in Research Archive
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Dahm, Anders Erik A; Jacobsen, Eva-Marie; Jacobsen, Anne Flem; Wik, Hilde Skuterud & Sandset, Per Morten
(2017).
High complement C3 increases the risk for postnatal venous thrombosis.
Full text in Research Archive
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Wik, Hilde Skuterud; Jacobsen, Anne Flem; Sandvik, Leiv & Sandset, Per Morten
(2011).
Prevalence and predictors for post-thrombotic syndrome (PTS) three to 16 years after first-time pregnancy related venous thrombosis - a population-based case-control study.
Thrombosis Research.
ISSN 0049-3848.
127,
p. S127–S127.
Full text in Research Archive
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Mar. 20, 2025 1:30 PM
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Apr. 9, 2025 9:20 AM
