Assessing acceptability and identifying barriers and facilitators to implementation of the EULAR recommendations for patient education in inflammatory arthritis: a mixed-methods study with rheumatology professionals in 23 European and Asian countries.

OBJECTIVES: To disseminate and assess the level of acceptability and applicability of the European Alliance of Associations for Rheumatology (EULAR) recommendations for patient education among professionals in rheumatology across Europe and three Asian countries and identify potential barriers and facilitators to their application. METHODS: A parallel convergent mixed-methods design with an inductive approach was used. A web-based survey, available in 20 different languages, was distributed to health professionals by non-probability sampling. The level of agreement and applicability of each recommendation was assessed by (0-10) rating scales. Barriers and facilitators to implementation were assessed using free-text responses. Quantitative data were analysed descriptively and qualitative data by content analysis and presented in 16 categories supported by quotes. RESULTS: A total of 1159 completed the survey; 852 (73.5%) were women. Most of the professionals were nurses (n=487), rheumatologists (n=320), physiotherapists (n=158). For all recommendations, the level of agreement was high but applicability was lower. The four most common barriers to application were lack of time, lack of training in how to provide patient education, not having enough staff to perform this task and lack of evaluation tools. The most common facilitators were tailoring patient education to individual patients, using group education, linking patient education with diagnosis and treatment and inviting patients to provide feedback on patient education delivery. CONCLUSIONS: This project has disseminated the EULAR recommendations for patient education to health professionals across 23 countries. Potential barriers to their application were identified and some are amenable to change, namely training patient education providers and developing evaluation tools.

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

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.

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

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.

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

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.

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

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.

EULAR recommendations for patient education for people with inflammatory arthritis.

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.

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

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.

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

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).

The WebRA study: Opportunities and challenges in digital patient education from the perspective of patients with rheumatoid arthritis: A qualitative study.

OBJECTIVE: To explore patients' perceptions of digital patient education (PE), and how this contributes to self-management of rheumatoid arthritis (RA). METHODS: Individual interviews based on 'interpretive description' methodology. The patients were purposively selected from a randomized controlled trial that investigated the effects of digital PE. The analysis included a descriptive section, followed by the interpretation and extraction of the main messages. RESULTS: Overall, participants had positive perceptions of the e-learning program. Advantages were flexibility, the possibility for repetition, entertainment, availability, and learning in familiar surroundings. Disadvantages were unmet relational support needs due to missing dialogue with health care providers (HCPs). For the majority, a need for insight into the condition led to an active approach to using e-learning. The e-learning program facilitated knowledge acquisition about RA, but relational support from HCPs and a positive attitude toward living with RA were also important for achieving self-management. CONCLUSION: Digital PE is useful for self-management support in RA, however different forms and combinations of PE must be offered in the future to accommodate various needs throughout the disease course. PRACTICE IMPLICATIONS: These results may inform future development and implementation of digital PE that adequately takes individual preferences for self-management support into account.

Educational readiness among health professionals in rheumatology: low awareness of EULAR offerings and unfamiliarity with the course content as major barriers-results of a EULAR-funded European survey.

BACKGROUND: Ongoing education of health professionals in rheumatology (HPR) is critical for high-quality care. An essential factor is education readiness and a high quality of educational offerings. We explored which factors contributed to education readiness and investigated currently offered postgraduate education, including the European Alliance of Associations for Rheumatology (EULAR) offerings. METHODS AND PARTICIPANTS: We developed an online questionnaire, translated it into 24 languages and distributed it in 30 European countries. We used natural language processing and the Latent Dirichlet Allocation to analyse the qualitative experiences of the participants as well as descriptive statistics and multiple logistic regression to determine factors influencing postgraduate educational readiness. Reporting followed the Checklist for Reporting Results of Internet E-Surveys guideline. RESULTS: The questionnaire was accessed 3589 times, and 667 complete responses from 34 European countries were recorded. The highest educational needs were 'professional development', 'prevention and lifestyle intervention'. Older age, more working experience in rheumatology and higher education levels were positively associated with higher postgraduate educational readiness. While more than half of the HPR were familiar with EULAR as an association and the respondents reported an increased interest in the content of the educational offerings, the courses and the annual congress were poorly attended due to a lack of awareness, comparatively high costs and language barriers. CONCLUSIONS: To promote the uptake of EULAR educational offerings, attention is needed to increase awareness among national organisations, offer accessible participation costs, and address language barriers.

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

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.

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

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.

Disseminating and assessing implementation of the EULAR recommendations for patient education in inflammatory arthritis: a mixed-methods study with patients' perspectives.

OBJECTIVES: To explore patients' agreement and reasons for agreement or disagreement with the EULAR recommendations for patient education (PE) for people with inflammatory arthritis (IA). METHODS: This mixed-method survey collected data using snowball sampling. The survey had been translated into 20 languages by local healthcare professionals, researchers and patient research partners. It explored the degree to which patients with IA agreed with each recommendation for PE (0=do not agree at all and 10=agree completely) and their rationale for their agreement level in free text questions. Descriptive statistics summarised participants' demographics and agreement levels. Qualitative content analysis was used to analyse the free text data. Sixteen subcategories were developed, describing the reasons for agreement or disagreement with the recommendations, which constituted the categories. RESULTS: The sample comprised 2779 participants (79% female), with a mean (SD) age 55.1 (13.1) years and disease duration 17.1 (13.3) years. Participants strongly agreed with most recommendations (median 10 (IQR: 9-10) for most recommendations). Reasons for agreement with the recommendations included the benefit of using PE to facilitate collaborative care and shared decision making, the value of flexible and tailored PE, and the value of gaining support from other patients. Reasons for disagreement included lack of resources for PE, not wanting information to be tailored by healthcare professionals and a reluctance to use telephone-based PE. CONCLUSION: The EULAR recommendations for PE have been disseminated among patients with IA. Overall, agreement levels were very high, suggesting that they reflect patients' preferences for engaging in collaborative clinical care and using PE to facilitate and supplement their own understanding of IA. Reasons for not completely agreeing with the recommendations can inform implementation strategies and education of healthcare professionals.

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

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.

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

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).

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

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.

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

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.

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

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.

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

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.