Publications by authors named "Heidi Zangi"

23 Publications

  • Page 1 of 1

Effects of a mindfulness-based and acceptance-based group programme followed by physical activity for patients with fibromyalgia: a randomised controlled trial.

BMJ Open 2021 06 29;11(6):e046943. Epub 2021 Jun 29.

Division of Rheumatology and Research, Diakonhjemmet Hospital, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Oslo, Norway.

Introduction: Non-pharmacological approaches are recommended as first-line treatment for patients with fibromyalgia. This randomised controlled trial investigated the effects of a multicomponent rehabilitation programme for patients with recently diagnosed fibromyalgia in primary and secondary healthcare.

Methods: Patients with widespread pain ≥3 months were referred to rheumatologists for diagnostic clarification and assessment of study eligibility. Inclusion criteria were age 20-50 years, engaged in work or studies at present or during the past 2 years, and fibromyalgia diagnosed according to the American College of Rheumatology 2010 criteria. All eligible patients participated in a short patient education programme before inclusion and randomisation. The multicomponent programme, a 10-session mindfulness-based and acceptance-based group programme followed by 12 weeks of physical activity counselling was evaluated in comparison with treatment as usual, that is, no treatment or any other treatment of their choice. The primary outcome was the Patient Global Impression of Change (PGIC). Secondary outcomes were self-reported pain, fatigue, sleep quality, psychological distress, physical activity, health-related quality of life and work ability at 12-month follow-up.

Results: In total, 170 patients were randomised, 1:1, intervention:control. Overall, the multicomponent rehabilitation programme was not more effective than treatment as usual; 13% in the intervention group and 8% in the control group reported clinically relevant improvement in PGIC (p=0.28). No statistically significant between-group differences were found in any disease-related secondary outcomes. There were significant between-group differences in patient's tendency to be mindful (p=0.016) and perceived benefits of exercise (p=0.033) in favour of the intervention group.

Conclusions: A multicomponent rehabilitation programme combining patient education with a mindfulness-based and acceptance-based group programme followed by physical activity counselling was not more effective than patient education and treatment as usual for patients with recently diagnosed fibromyalgia at 12-month follow-up.

Trial Registration Number: BMC Registry (ISRCTN96836577).
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http://dx.doi.org/10.1136/bmjopen-2020-046943DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8245472PMC
June 2021

The referral of patients with fibromyalgia to a rheumatological specialist care unit. Is it necessary?

Clin Exp Rheumatol 2021 May-Jun;39 Suppl 130(3):194. Epub 2021 May 13.

Department of Rheumatology, National Resource Centre for Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

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July 2021

Trajectories of change in symptom severity in patients with fibromyalgia: exploratory analyses of a randomised controlled trial.

Rheumatol Int 2021 Apr 15;41(4):691-697. Epub 2021 Feb 15.

Division of Rheumatology and Research, Diakonhjemmet Hospital, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Vinderen, PO Box 23, 0319, Oslo, Norway.

The clinical picture of fibromyalgia (FM) symptoms fluctuates, and the symptom severity varies within and between patients. The current study aimed to identify groups of PDS trajectories and to explore differences in baseline characteristics between the potential groups of trajectories. We included patients from a completed randomised controlled trial, in total 170 patients diagnosed with FM according to the ACR 2010 criteria. The mean age was 40 years, and 94% were women. Symptom severity was assessed by the Polysymptomatic distress scale (PDS) [range 0 (no symptoms) to 31] at four timepoints over 13-18 months. Latent class growth analysis was used to identify patient trajectories based on their response pattern on the PDS. Potential differences in baseline characteristics between the trajectories were compared using appropriate statistical tests. Two distinct PDS trajectories were identified with 110 patients (65%) classified as the "no improvement" group and 60 (35%) as the "some improvement" group. Mean PDS scores at pre-baseline were ≥ 20 in both groups. At 12 months, the groups diverged, mean (SD) PDS score was 14 (3.82) in the "some improvement" group and 21 (4.12) in the "no improvement" group. There were no significant differences in baseline characteristics between the groups of PDS trajectories. We identified one group of FM patients that improved slightly during the study period and one group that not improved. There were no differences in baseline characteristics between the two groups.
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http://dx.doi.org/10.1007/s00296-021-04801-xDOI Listing
April 2021

Mobile App to Help People With Chronic Illness Reflect on Their Strengths: Formative Evaluation and Usability Testing.

JMIR Form Res 2020 Mar 4;4(3):e16831. Epub 2020 Mar 4.

Department for Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.

Background: Supporting patient engagement and empowerment is increasingly seen as essential in providing person-centered health care to people with chronic illness. Mobile apps helping patients reflect on their concerns as preparation for consultations with their health care providers can have beneficial effects on the consultation quality. However, apps focusing on empowerment and personal strengths are still scarce.

Objective: This study aimed to (1) develop a mobile app to support patients with rheumatic diseases in reflecting on their strengths in preparation for consultations with health care providers and (2) explore patients' perceived usability of the app in a nonclinical test setting.

Methods: A prototype app was developed based on input from patients and health care providers, as reported in previous studies. The app was designed for use in self-management support settings aiming to promote awareness of strengths and to focus attention on strengths in the patient-health care provider dialogue. The features included in the prototype were as follows: (1) introduction to the topic of strengths, (2) list of examples of strengths to promote reflection and registration of own strengths, (3) summary of registered strengths, (4) value-based goal setting, (5) linking of strengths to goals, (6) summary of all registrations, and (7) options to share summary digitally or as a print version. In this study, the app was refined through a formative evaluation with patients and health care providers recruited from a specialized rheumatology hospital unit. Patients' perceptions of the app's usability were explored in a test setting with self-report measurements and semistructured interviews. The interviews were audiotaped, transcribed, and analyzed with directed content analysis. Data from questionnaires were analyzed with descriptive statistics.

Results: Developmental and formative evaluation included 18 patients and 7 health care providers. The evaluation resulted in minor adjustments to the prototype but no major changes in features. The usability testing included 12 patients. All participants found the usability acceptable; the median score on the System Usability Scale was 86.3 (range 70-100). All reported that it was meaningful and relevant to use the app. Out of 12 participants, 9 (75%) reported becoming more aware of their own strengths by using the app; 1 (8%) disagreed and 2 (17%) provided a neutral response. The results on the goal-related feature were mixed, with half of the patients finding it useful to link strengths to concrete goals. A statistically significant positive change from pre- to postintervention was identified on measures of self-efficacy and negative emotions.

Conclusions: In this formative evaluation of a mobile app to promote patients' reflections on their strengths, patients perceived the app as meaningful and supporting awareness. The results suggest the usefulness of building in functionality to support use of strengths and goal attainment. Further studies on efficacy and usability in a clinical setting, including health care providers, are needed.
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http://dx.doi.org/10.2196/16831DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7081135PMC
March 2020

Outcomes in patient education programmes for people with rheumatic diseases: Results from a Delphi process and a study of feasibility and responsiveness.

Musculoskeletal Care 2020 06 28;18(2):195-203. Epub 2020 Jan 28.

National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

Background: Patient education (PE) is recommended as an integral part of disease management for people with chronic inflammatory arthritis (IA). There is no consensus on how PE should be evaluated and which outcome measures should be used.

Objectives: This study had three aims: (a) to identify core aspects that PE for patients with IA may impact on; (b) to identify outcome measures to assess changes in these aspects; (c) to test the feasibility and responsiveness of the identified outcome measures.

Methods: A Delphi process was conducted to identify core aspects and outcome measures. Feasibility and responsiveness were tested in a pre-/post-test study with 3 months follow-up, including 104 patients attending PE programmes.

Results: Seven core aspects were identified: communication with health professionals, coping strategies, empowerment, knowledge about healthy life style, self-efficacy, understanding disease and treatment, and sharing experiences. Four outcome measures were identified; Arthritis Self Efficacy Scale (ASES-11), Effective Consumer scale (EC-17), Health Education Impact Questionnaire (heiQ) and Patient Activation Measure (PAM). At baseline, all measures had low rates of missing data. All measures except two heiQ subscales exhibited ceiling effects. Internal consistency was acceptable. At follow-up, statistically significant, but small improvements were found in EC-17 and three heiQ subscales.

Conclusion: ASES and EC-17 were found to be the most valid and feasible outcome measures to evaluate the identified core aspects of PE and can be recommended as outcome measures to assess PE programmes for patients with IA.
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http://dx.doi.org/10.1002/msc.1456DOI Listing
June 2020

A User-Centered Approach to an Evidence-Based Electronic Health Pain Management Intervention for People With Chronic Pain: Design and Development of EPIO.

J Med Internet Res 2020 01 21;22(1):e15889. Epub 2020 Jan 21.

Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.

Background: Chronic pain conditions are complicated and challenging to live with. Electronic health (eHealth) interventions show promise in helping people cope with chronic illness, including pain. The success of these interventions depends not only on the technology and intervention content but also on the users' acceptance and adherence. Involving all stakeholders (eg, patients, spouses, health care providers, designers, software developers, and researchers) and exploring their input and preferences in the design and development process is an important step toward developing meaningful interventions and possibly strengthening treatment outcomes.

Objective: The aim of this study was to design and develop a user-centered, evidence-based eHealth self-management intervention for people with chronic pain.

Methods: The study employed a multidisciplinary and user-centered design approach. Overall, 20 stakeholders from the project team (ie, 7 researchers, 5 editors, 7 software developers, and 1 user representative), together with 33 external stakeholders (ie, 12 health care providers, 1 health care manger, 1 eHealth research psychologist, and 17 patients with chronic pain and 2 of their spouses) participated in a user-centered development process that included workshops, intervention content development, and usability testing. Intervention content was developed and finalized based on existing evidence, stakeholder input, and user testing. Stakeholder input was examined through qualitative analyses with rapid and in-depth analysis approaches.

Results: Analyses from stakeholder input identified themes including a need for reliable, trustworthy, and evidence-based content, personalization, options for feedback, behavioral tracking, and self-assessment/registration as factors to include in the intervention. Evidence-based intervention content development resulted in one face-to-face introduction session and 9 app-based educational and exercise-based modules. Usability testing provided further insight into how to optimize the design of the intervention to the user group, identifying accessibility and a simple design to be essential.

Conclusions: The design and development process of eHealth interventions should strive to combine well-known evidence-based concepts with stakeholder input. This study, designing and developing the pain management intervention EPIO, illustrates how a stakeholder-centered design approach can provide essential input in the development of an eHealth self-management intervention for people with chronic pain.

Trial Registration: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.
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http://dx.doi.org/10.2196/15889DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7001051PMC
January 2020

Revision of the Norwegian effective consumer scale using a dual-panel approach.

Musculoskeletal Care 2020 03 5;18(1):81-83. Epub 2019 Dec 5.

National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

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http://dx.doi.org/10.1002/msc.1432DOI Listing
March 2020

Implementation Strategies to Enhance the Implementation of eHealth Programs for Patients With Chronic Illnesses: Realist Systematic Review.

J Med Internet Res 2019 09 27;21(9):e14255. Epub 2019 Sep 27.

Center for Shared Decision Making and Collaborative Care Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.

Background: There is growing evidence of the positive effects of electronic health (eHealth) interventions for patients with chronic illness, but implementation of such interventions into practice is challenging. Implementation strategies that potentially impact implementation outcomes and implementation success have been identified. Which strategies are actually used in the implementation of eHealth interventions for patients with chronic illness and which ones are the most effective is unclear.

Objective: This systematic realist review aimed to summarize evidence from empirical studies regarding (1) which implementation strategies are used when implementing eHealth interventions for patients with chronic illnesses living at home, (2) implementation outcomes, and (3) the relationship between implementation strategies, implementation outcomes, and degree of implementation success.

Methods: A systematic literature search was performed in the electronic databases MEDLINE, Embase, PsycINFO, Scopus, Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Library. Studies were included if they described implementation strategies used to support the integration of eHealth interventions into practice. Implementation strategies were categorized according to 9 categories defined by the Expert Recommendations for Implementing Change project: (1) engage consumers, (2) use evaluative and iterative strategies, (3) change infrastructure, (4) adapt and tailor to the context, (5) develop stakeholder interrelationships, (6) use financial strategies, (7) support clinicians, (8) provide interactive assistance, and (9) train and educate stakeholders. Implementation outcomes were extracted according to the implementation outcome framework by Proctor and colleagues: (1) acceptability, (2) adoption, (3) appropriateness, (4) cost, (5) feasibility, (6) fidelity, (7) penetration, and (8) sustainability. Implementation success was extracted according to the study authors' own evaluation of implementation success in relation to the used implementation strategies.

Results: The implementation strategies management support and engagement, internal and external facilitation, training, and audit and feedback were directly related to implementation success in several studies. No clear relationship was found between the number of implementation strategies used and implementation success.

Conclusions: This is the first review examining implementation strategies, implementation outcomes, and implementation success of studies reporting the implementation of eHealth programs for patients with chronic illnesses living at home. The review indicates that internal and external facilitation, audit and feedback, management support, and training of clinicians are of importance for eHealth implementation. The review also points to the lack of eHealth studies that report implementation strategies in a comprehensive way and highlights the need to design robust studies focusing on implementation strategies in the future.

Trial Registration: PROSPERO CRD42018085539; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=85539.
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http://dx.doi.org/10.2196/14255DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6789428PMC
September 2019

Mindfulness- and acceptance-based interventions for patients with fibromyalgia - A systematic review and meta-analyses.

PLoS One 2019 3;14(9):e0221897. Epub 2019 Sep 3.

Department of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

Objectives: To analyze health effects of mindfulness- and acceptance-based interventions, including mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy (ACT). Additionally, we aimed to explore content and delivery components in terms of procedure, instructors, mode, length, fidelity and adherence in the included interventions.

Methods: We performed a systematic literature search in the databases MEDLINE, PsychINFO, CINAHL, EMBASE, Cochrane Central and AMED from 1990 to January 2019. We included randomized and quasi-randomized controlled trials analyzing health effects of mindfulness- and acceptance-based interventions for patients with fibromyalgia compared to no intervention, wait-list control, treatment as usual, or active interventions. MBSR combined with other treatments were included. Predefined outcomes were pain, fatigue, sleep quality, psychological distress, depression, anxiety, mindfulness, health-related quality of life and work ability. The Template for Intervention Description and Replication (TIDieR) checklist and guide was used to explore content and delivery components in the interventions. Meta-analyses were performed, and GRADE was used to assess the certainty in the evidence.

Results: The search identified 4430 records, of which nine original trials were included. The vast majority of the participants were women. The analyses showed small to moderate effects in favor of mindfulness- and acceptance-based interventions compared to controls in pain (SMD -0.46 [95% CI -0.75, -0.17]), depression (SMD -0.49 [95% CI -0.85, -0.12]), anxiety (SMD -0.37 [95% CI -0.71, -0.02]), mindfulness (SMD -0.40 [-0.69, -0.11]), sleep quality (SMD -0.33 [-0.70, 0.04]) and health-related quality of life (SMD -0.74 [95% CI -2.02, 0.54]) at end of treatment. The effects are uncertain due to individual study limitations, inconsistent results and imprecision.

Conclusion: Health effects of mindfulness- and acceptance-based interventions for patients with fibromyalgia are promising but uncertain. Future trials should consider investigating whether strategies to improve adherence and fidelity of mindfulness- and acceptance-based interventions can improve health outcomes.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0221897PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6719827PMC
March 2020

2018 update of the EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis.

Ann Rheum Dis 2020 01 12;79(1):61-68. Epub 2019 Jul 12.

Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands.

To update the European League Against Rheumatism (EULAR) recommendations for the role of the nurse in the management of chronic inflammatory arthritis (CIA) using the most up to date evidence. The EULAR standardised operating procedures were followed. A task force of rheumatologists, health professionals and patients, representing 17 European countries updated the recommendations, based on a systematic literature review and expert consensus. Higher level of evidence and new insights into nursing care for patients with CIA were added to the recommendation. Level of agreement was obtained by email voting. The search identified 2609 records, of which 51 (41 papers, 10 abstracts), mostly on rheumatoid arthritis, were included. Based on consensus, the task force formulated three overarching principles and eight recommendations. One recommendation remained unchanged, six were reworded, two were merged and one was reformulated as an overarching principle. Two additional overarching principles were formulated. The overarching principles emphasise the nurse's role as part of a healthcare team, describe the importance of providing evidence-based care and endorse shared decision-making in the nursing consultation with the patient. The recommendations cover the contribution of rheumatology nursing in needs-based patient education, satisfaction with care, timely access to care, disease management, efficiency of care, psychosocial support and the promotion of self-management. The level of agreement among task force members was high (mean 9.7, range 9.6-10.0). The updated recommendations encompass three overarching principles and eight evidence-based and expert opinion-based recommendations for the role of the nurse in the management of CIA.
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http://dx.doi.org/10.1136/annrheumdis-2019-215458DOI Listing
January 2020

Effects of a community-based multicomponent rehabilitation programme for patients with fibromyalgia: protocol for a randomised controlled trial.

BMJ Open 2018 06 4;8(6):e021004. Epub 2018 Jun 4.

Department of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

Introduction: People with fibromyalgia (FM) suffer from symptoms such as widespread pain, non-refreshing sleep, fatigue and reduced quality of life. Effects of pharmacological treatment are questionable and non-pharmacological treatments are recommended as first-line therapy. To date the majority of patients with FM in Norway are not offered any targeted treatment. The aim of this randomised controlled trial is to investigate the effects of a community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling.

Materials And Methods: General practitioners refer potential participants to a rheumatologist in specialist healthcare for diagnostic clarification and assessment of comorbidities. Inclusion criteria are widespread pain/FM ≥3 months, age 20-50 and work participation (minimum part-time) within the last 2 years. The intervention group attends the VTP comprising 10 weekly 4 hour group sessions plus a booster session after 6 months. Thereafter, they receive 12 weeks of individually tailored physical exercise counselled by physiotherapists at community-based Healthy Life Centers. The control group follows treatment as usual. The primary outcome is Patient Global Impression of Change. Secondary outcomes include self-reported pain, fatigue and sleep quality, psychological distress, mindfulness, health-related quality of life, physical activity, work ability and exercise beliefs and habits. To achieve a power of 80% and allow for 10% dropout, 70 participants are needed in each arm. All analyses will be conducted on intention-to-treat bases and measured as differences between groups at 12 months follow-up.

Ethics And Dissemination: The study is approved and granted by the Norwegian South-Eastern Regional Health Authority (reference 2016015). Ethics approval was obtained from Regional Committee for Medical and Health Research Ethics (reference 2015/2447/REK sør-øst A). Results will be submitted to appropriate journals and presented in relevant conferences and social media.

Trial Registration: ISRCTN 96836577.
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http://dx.doi.org/10.1136/bmjopen-2017-021004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5988178PMC
June 2018

Vitality training-A mindfulness- and acceptance-based intervention for chronic pain.

Patient Educ Couns 2017 Nov 19;100(11):2095-2097. Epub 2017 Jun 19.

Chronic non-malign pain has a substantial impact on all parts of an individual's life. Mindfulness- and acceptance- based interventions are increasingly offered to help people manage their pain and strengthening their health promoting resources. In this paper, we present a mindfulness- and acceptance-based intervention, the Vitality Training Programme (VTP), to mitigating pain and accompanying symptoms and increasing pain coping abilities. Based on a clinical case presentation, we discuss how the VTP can help individuals to live a better life with pain. The VTP has been evaluated in two randomised controlled trials and two qualitative studies. Existing evidence is presented. Finally, based on a recently published theoretical model, we present some possible common explanatory mechanisms across various mindfulness- and acceptance-based interventions that might also apply to the VTP.
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http://dx.doi.org/10.1016/j.pec.2017.05.032DOI Listing
November 2017

Patients' Perspectives on Information and Communication About Sexual and Relational Issues in Rheumatology Health Care.

Musculoskeletal Care 2017 06 13;15(2):131-139. Epub 2016 Jul 13.

National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

Introduction: Men and women with rheumatic diseases report a significantly negative impact on multiple areas of life, including sexuality. Research indicates that patients want to discuss sexual issues with health professionals (HPs) in rheumatology care but these issues are rarely addressed in consultations.

Aim: The objective of the present study was to explore patients' experiences of communication with HPs about disease-related sexual issues, their perceptions of the relevance of these issues in rheumatology care and their preferences for how these topics should be handled.

Methods: A qualitative design was used and 18 semi-structured interviews were performed, including eight women and ten men with inflammatory rheumatic joint diseases, aged 29-62 years. The interviews were recorded and transcribed verbatim. Data were analysed thematically.

Results: Four main themes were derived from the interviews: (i) relevance of sexual issues; (ii) vital conditions for communication; (iii) individual preferences in mode and timing of information and communication; and (iv) benefits of information and communication. The participants expressed that, although sexual issues are relevant, necessary conditions for good communication are largely lacking. HPs' knowledge, experience and personal skills, as well as having sufficient time were essential. HPs lack of initiating sexual topics contributed to uncertainty about whether their sexual challenges were disease related and whether it was a legitimate topic to discuss in rheumatology care.

Conclusion: Patients wanted HPs to possess knowledge about possible disease-related challenges in sexual life and intimate relationships, and to facilitate communication about these aspects. There is a need to develop practice guidelines to enable HPs to integrate sexual issues as an aspect of healthcare delivery in a patient-friendly manner. Copyright © 2016 John Wiley & Sons, Ltd.
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http://dx.doi.org/10.1002/msc.1149DOI Listing
June 2017

Predictors of Fatigue in Rheumatoid Arthritis Patients in Remission or in a Low Disease Activity State.

Arthritis Care Res (Hoboken) 2016 07;68(7):1043-8

Diakonhjemmet Hospital, Oslo, Norway.

Objective: Fatigue is a frequently occurring symptom in patients with rheumatoid arthritis (RA). Our aims were to assess the level of reported fatigue in RA patients who had achieved remission or low disease activity after 6 months of treatment with disease-modifying antirheumatic drugs (DMARDs), and to explore associations between fatigue and demographics, disease activity, and other patient-reported outcomes in this patient group.

Methods: A total of 2,193 RA patients (ages ≥18 years) starting either methotrexate (MTX) monotherapy or a tumor necrosis factor inhibitor in combination with MTX were retrieved from the Norwegian Disease-Modifying Antirheumatic Drugs Register (NOR-DMARD). At the 6-month followup, 699 patients (31.9%) were in remission or in a low disease activity state. Bivariate and multivariate linear regression analyses were conducted, with the fatigue visual analog scale (VAS) at 6 months as the dependent variable. Age, sex, disease duration, treatment group, erythrocyte sedimentation rate (ESR), the swollen and tender joint count in 28 joints, the pain VAS score, and disability at baseline and at 6 months were tested as predictors of fatigue at 6 months.

Results: At 6 months, the median (25th, 75th percentile) level of fatigue was 20.0 mm (6.0, 43.0), and a fatigue VAS score of ≥40 mm was reported by 27.9% of patients. In the multivariate analysis, lower ESR and higher pain at baseline were statistically significant predictors of higher levels of fatigue (P < 0.001). In the multivariate cross-sectional analysis at 6 months, younger age and greater pain were significantly associated with higher levels of fatigue (P < 0.001).

Conclusion: Pain levels at baseline and at 6 months were associated with a higher level of fatigue. Patients in remission or in a low disease activity state may need nonpharmacologic interventions to manage their pain and fatigue.
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http://dx.doi.org/10.1002/acr.22787DOI Listing
July 2016

EULAR recommendations for patient education for people with inflammatory arthritis.

Ann Rheum Dis 2015 Jun 3;74(6):954-62. Epub 2015 Mar 3.

Department of Medicine, Division of Rheumatology, Maastricht University Medical Center, Maastricht, The Netherlands.

Objectives: The task force aimed to: (1) develop evidence-based recommendations for patient education (PE) for people with inflammatory arthritis, (2) identify the need for further research on PE and (3) determine health professionals' educational needs in order to provide evidence-based PE.

Methods: A multidisciplinary task force, representing 10 European countries, formulated a definition for PE and 10 research questions that guided a systematic literature review (SLR). The results from the SLR were discussed and used as a basis for developing the recommendations, a research agenda and an educational agenda. The recommendations were categorised according to level and strength of evidence graded from A (highest) to D (lowest). Task force members rated their agreement with each recommendation from 0 (total disagreement) to 10 (total agreement).

Results: Based on the SLR and expert opinions, eight recommendations were developed, four with strength A evidence. The recommendations addressed when and by whom PE should be offered, modes and methods of delivery, theoretical framework, outcomes and evaluation. A high level of agreement was achieved for all recommendations (mean range 9.4-9.8). The task force proposed a research agenda and an educational agenda.

Conclusions: The eight evidence-based and expert opinion-based recommendations for PE for people with inflammatory arthritis are intended to provide a core framework for the delivery of PE and training for health professionals in delivering PE across Europe.
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http://dx.doi.org/10.1136/annrheumdis-2014-206807DOI Listing
June 2015

Validation of the educational needs assessment tool as a generic instrument for rheumatic diseases in seven European countries.

Ann Rheum Dis 2014 Dec 6;73(12):2122-9. Epub 2013 Aug 6.

Academic & Clinical Unit for Musculoskeletal Nursing (ACUMeN), Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.

Objectives: To validate the educational needs assessment tool (ENAT) as a generic tool for assessing the educational needs of patients with rheumatic diseases in European Countries.

Methods: A convenience sample of patients from seven European countries was included comprising the following diagnostic groups: ankylosing spondylitis, psoriatic arthritis, systemic sclerosis, systemic lupus erythematosus, osteoarthritis (OA) and fibromyalgia syndrome. Translated versions of the ENAT were completed through surveys in each country. Rasch analysis was used to assess the construct validity of the adapted ENATs including differential item functioning by culture (cross-cultural DIF). Initially, the data from each country and diagnostic group were fitted to the Rasch model separately, and then the pooled data from each diagnostic group.

Results: The sample comprised 3015 patients; the majority, 1996 (66.2%), were women. Patient characteristics (stratified by diagnostic group) were comparable across countries except the educational background, which was variable. In most occasions, the 39-item ENAT deviated significantly from the Rasch model expectations (item-trait interaction χ(2) p<0.05). After correction for local dependency (grouping the items into seven domains and analysing them as 'testlets'), fit to the model was satisfied (item-trait interaction χ(2) p>0.18) in all pooled disease group datasets except OA (χ(2)=99.91; p=0.002). The internal consistency in each group was high (Person Separation Index above 0.90). There was no significant DIF by person characteristics. Cross-cultural DIF was found in some items, which required adjustments. Subsequently, interval-level scales were calibrated to enable transformation of ENAT scores when required.

Conclusions: The adapted ENAT is a valid tool with high internal consistency providing accurate estimation of the educational needs of people with rheumatic diseases. Cross-cultural comparison of educational needs is now possible.
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http://dx.doi.org/10.1136/annrheumdis-2013-203461DOI Listing
December 2014

Patient satisfaction with nursing consultations in a rheumatology outpatient clinic: a 21-month randomised controlled trial in patients with inflammatory arthritides.

Ann Rheum Dis 2013 Jun 7;72(6):836-43. Epub 2013 Feb 7.

Department of Rheumatology, University Hospital of Trondheim, Trondheim, Norway.

Objective: To study the effect of individual nursing consultations in patients treated with disease-modifying antirheumatic drugs (DMARDs) in a rheumatology outpatient setting.

Methods: Patients with inflammatory arthritides (IA) who had started with a DMARD regimen 3 months before were randomised to two different follow-up consultation systems: either follow-up by a clinical nurse specialist (CNS) or by a medical doctor (MD) in rheumatology 3, 9 and 21 months after randomisation. The primary outcome was patient satisfaction measured by Leeds Satisfaction Questionnaire (LSQ). Secondary outcomes included coping, disease activity, pain, fatigue, patient's global assessment of disease activity and health related quality of life. Effects at 9 and 21 months were estimated by Least Square means calculated from the final mixed model.

Results: Of 68 patients randomised, 65 patients completed assessments at 21 months. Statistically significant improvements in favour of the CNS group were found in all LSQ subscales (all p values<0.001) and in overall satisfaction at 9 months (adjusted mean between-group difference 0.74, 95% CI -0.96 to -0.52) and at 21 months (-0.69, 96% CI -0.87 to -0.50). Disease activity Score 28 joint count (DAS-28) was improved from baseline to 9 months in both groups and improvement was maintained at 21 months, but without any group difference. No statistically significant between-group differences were found in any of the other secondary outcomes.

Conclusions: Patients with IA are likely to benefit from nurse consultations in terms of increased satisfaction with care compared with MD consultations and without loss of efficacy in terms of clinical outcomes. The study is registered as a clinical trial at the ClinicalTrials.gov (NCT00403676).
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http://dx.doi.org/10.1136/annrheumdis-2012-202296DOI Listing
June 2013

Two to five repeated measurements per patient reduced the required sample size considerably in a randomized clinical trial for patients with inflammatory rheumatic diseases.

BMC Res Notes 2013 Feb 1;6:37. Epub 2013 Feb 1.

National Resource Centre for Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, 0319, Norway.

Background: Patient reported outcomes are accepted as important outcome measures in rheumatology. The fluctuating symptoms in patients with rheumatic diseases have serious implications for sample size in clinical trials. We estimated the effects of measuring the outcome 1-5 times on the sample size required in a two-armed trial.

Findings: In a randomized controlled trial that evaluated the effects of a mindfulness-based group intervention for patients with inflammatory arthritis (n=71), the outcome variables Numerical Rating Scales (NRS) (pain, fatigue, disease activity, self-care ability, and emotional wellbeing) and General Health Questionnaire (GHQ-20) were measured five times before and after the intervention. For each variable we calculated the necessary sample sizes for obtaining 80% power (α=.05) for one up to five measurements.Two, three, and four measures reduced the required sample sizes by 15%, 21%, and 24%, respectively. With three (and five) measures, the required sample size per group was reduced from 56 to 39 (32) for the GHQ-20, from 71 to 60 (55) for pain, 96 to 71 (73) for fatigue, 57 to 51 (48) for disease activity, 59 to 44 (45) for self-care, and 47 to 37 (33) for emotional wellbeing.

Conclusions: Measuring the outcomes five times rather than once reduced the necessary sample size by an average of 27%. When planning a study, researchers should carefully compare the advantages and disadvantages of increasing sample size versus employing three to five repeated measurements in order to obtain the required statistical power.
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http://dx.doi.org/10.1186/1756-0500-6-37DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3571945PMC
February 2013

A mindfulness-based group intervention to reduce psychological distress and fatigue in patients with inflammatory rheumatic joint diseases: a randomised controlled trial.

Ann Rheum Dis 2012 Jun 20;71(6):911-7. Epub 2011 Dec 20.

National Resource Center for Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

Objective: To evaluate the effects of a mindfulness-based group intervention, the Vitality Training Programme (VTP), in adults with inflammatory rheumatic joint diseases.

Methods: In a randomised controlled trial, the VTP-a 10-session mindfulness-based group intervention including a booster session after 6 months-was compared with a control group that received routine care plus a CD for voluntary use with mindfulness-based home exercises. The primary outcome was psychological distress measured by the General Health Questionnaire-20. Self-efficacy (pain and symptoms) and emotion-focused coping (emotional processing and expression) were used as co-primary outcomes. Secondary outcomes included pain, fatigue, patient global disease activity, self-care ability and well-being. Effects were estimated by mixed models repeated measures post-intervention and at 12-month follow-up.

Results: Of 73 participants randomised, 68 completed assessments post-intervention and 67 at 12 months. Significant treatment effects in favour of the VTP group were found post-treatment and maintained at 12 months in psychological distress (adjusted mean between-group difference -3.7, 95% CI -6.3 to -1.1), self-efficacy pain (9.1, 95% CI 3.4 to 14.8) and symptoms (13.1, 95% CI 6.7 to 19.3), emotional processing (0.3, 95% CI 0.02 to 0.5), fatigue (-1.1, 95% CI -1.8 to -0.4), self-care ability (1.0, 95% CI 0.5 to 1.6) and overall well-being (0.6, 95% CI 0.1 to 1.2). No significant group differences were found in emotional expression, pain or disease activity.

Conclusion: The VTP improved most primary and secondary outcomes compared with individual use of CD exercises. Improvements were maintained at 12 months, suggesting that the VTP is a beneficial complement to existing treatments for patients with inflammatory rheumatic joint diseases.
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http://dx.doi.org/10.1136/annrheumdis-2011-200351DOI Listing
June 2012

EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis.

Ann Rheum Dis 2012 Jan 28;71(1):13-9. Epub 2011 Oct 28.

Department of Integrated Care, Maastricht University Medical Centre, Postbox 5800, 6202 AZ Maastricht, The Netherlands.

Objectives: The authors aim to develop European League Against Rheumatism recommendations for the role of the nurse in the management of patients with chronic inflammatory arthritis, to identify a research agenda and to determine an educational agenda.

Methods: A task force made up of a multidisciplinary expert panel including nurses, rheumatologists, occupational therapist, physiotherapist, psychologist, epidemiologist and patient representatives, representing 14 European countries, carried out the development of the recommendations, following the European League Against Rheumatism standardised operating procedures. The task force met twice. In the first meeting, the aims of the task force were defined, and eight research questions were developed. This was followed by a comprehensive, systematic literature search. In the second meeting, the results from the literature review were presented to the task force that subsequently formulated the recommendations, research agenda and educational agenda.

Results: In total, 10 recommendations were formulated. Seven recommendations covered the contribution of nurses to care and management: education, satisfaction with care, access to care, disease management, psychosocial support, self-management and efficiency of care. Three recommendations focused on professional support for nurses: availability of guidelines or protocols, access to education and encouragement to undertake extended roles. The strength of the recommendations varied from A to C, dependent on the category of evidence (1A-3), and a high level of agreement was achieved. Additionally, the task force agreed upon 10 topics for future research and an educational agenda.

Conclusion: 10 recommendations for the role of the nurse in the management of chronic inflammatory arthritis were developed using a combination of evidence-based and expert consensus approach.
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http://dx.doi.org/10.1136/annrheumdis-2011-200185DOI Listing
January 2012

Cross-cultural validation of the Educational Needs Assessment Tool in RA in 7 European countries.

BMC Musculoskelet Disord 2011 May 24;12:110. Epub 2011 May 24.

Academic & Clinical Unit for Musculoskeletal Nursing (ACUMeN), Section of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK.

Background: The Educational Needs Assessment Tool (the ENAT) is a 39-item patient questionnaire originally developed in the UK to assess educational needs of patients with rheumatoid arthritis (RA). The objective of this study was to assess the cross-cultural validity of the ENAT in 7 European countries.

Methods: The ENAT was translated into Dutch, Finnish, Norwegian, Portuguese, Spanish and Swedish versions by using Beaton's cross-cultural adaptation process, and was completed by a convenience sample of patients with RA in each country. The generated country-specific data were assessed for construct validity and were then pooled and assessed for cross-cultural invariance using Rasch analysis.

Results: Individual country-specific analysis showed adequate fit to the Rasch model after adjustment for local dependency within domains. When data from the different countries were pooled, the 39 items deviated significantly from Rasch model's expectations (X(2)=977.055, DF=351, p=0.000, PSI=0.976). Again, most items within domains were found to be locally dependent, significantly affecting the fit. Consequently each domain was treated as a unit (i.e. testlet) and the ENAT was re-analysed as a seven-testlet scale resulting into a good fit to the Rasch model (X(2)=71.909; DF=63; p=0.207, PSI=0.951). A test of strict unidimensionality confirmed that all domains contributed to measuring a single construct. Cross-cultural non-invariance was discounted by splitting domains for DIF maintaining an excellent fit to the Rasch model. This allowed calibration of the ENAT into an interval scale.

Conclusion: The ENAT is a simple tool, which is a valid measure of educational needs of people with RA. Adjustment for cross-cultural non-invariance is available if data from the 7 European countries are to be pooled or compared.
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http://dx.doi.org/10.1186/1471-2474-12-110DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3126763PMC
May 2011

"I am not only a disease, I am so much more". Patients with rheumatic diseases' experiences of an emotion-focused group intervention.

Patient Educ Couns 2011 Dec 5;85(3):419-24. Epub 2011 Feb 5.

National Resource Center for Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

Objective: To obtain understanding of how patients with rheumatic diseases experienced participation in an emotion-focused group intervention in terms of influences on their emotional well-being and coping behavior and the processes whereby these influences arose.

Methods: The intervention, Vitality Training (VTP), was conducted in 10 group sessions over 4 months. Qualitative data were collected from 10 focus group interviews (n=69) two weeks after the intervention. Data were analyzed with a qualitative content analysis approach.

Results: Five categories were identified from the analyses: (1) recognizing oneself as both ill and healthy, (2) recognizing own emotions, (3) awareness of own needs, (4) being part of a community and (5) being recognized as a credible patient.

Conclusion: The VTP addressed participants' awareness of emotional and bodily reactions in a process-oriented and supportive group. The program had enhanced participants' recognition of their disease-related emotions and helped them to more actively relate to their own needs.

Practical Implications: This study has highlighted how a process-oriented group intervention that combines topics related to life, rather than disease, and learning methods that enhance emotional awareness and adaptive emotional expression can enhance emotional well-being and coping behavior in patients with rheumatic diseases.
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http://dx.doi.org/10.1016/j.pec.2010.12.032DOI Listing
December 2011

Emotion regulation in patients with rheumatic diseases: validity and responsiveness of the Emotional Approach Coping Scale (EAC).

BMC Musculoskelet Disord 2009 Sep 3;10:107. Epub 2009 Sep 3.

National Resource Center for Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Pb, 23 Vinderen, Oslo, Norway.

Background: Chronic rheumatic diseases are painful conditions which are not entirely controllable and can place high emotional demands on individuals. Increasing evidence has shown that emotion regulation in terms of actively processing and expressing disease-related emotions are likely to promote positive adjustment in patients with chronic diseases. The Emotional Approach Coping Scale (EAC) measures active attempts to acknowledge, understand, and express emotions. Although tested in other clinical samples, the EAC has not been validated for patients with rheumatic diseases. This study evaluated the data quality, internal consistency reliability, validity and responsiveness of the Norwegian version of the EAC for this group of patients.

Methods: 220 patients with different rheumatic diseases were included in a cross-sectional study in which data quality and internal consistency were assessed. Construct validity was assessed through comparisons with the Brief Approach/Avoidance Coping Questionnaire (BACQ) and the General Health Questionnaire (GHQ-20). Responsiveness was tested in a longitudinal pretest-posttest study of two different coping interventions, the Vitality Training Program (VTP) and a Self-Management Program (SMP).

Results: The EAC had low levels of missing data. Results from principal component analysis supported two subscales, Emotional Expression and Emotional Processing, which had high Cronbach's alphas of 0.90 and 0.92, respectively. The EAC had correlations with approach-oriented items in the BACQ in the range 0.17-0.50. The EAC Expression scale had a significant negative correlation with the GHQ-20 of -0.13. As hypothesized, participation in the VTP significantly improved EAC scores, indicating responsiveness to change.

Conclusion: The EAC is an acceptable and valid instrument for measuring emotional processing and expression in patients with rheumatic diseases. The EAC scales were responsive to change in an intervention designed to promote emotion regulation. The instrument has not yet been tested for test-retest reliability, which is recommended in future studies.
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http://dx.doi.org/10.1186/1471-2474-10-107DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2749806PMC
September 2009
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