Translation and validation of the Dutch version of the Effective Consumer Scale (EC-17)

PURPOSE: The Effective Consumer Scale (EC-17) measures the skills of musculoskeletal patients in managing their own healthcare. The objectives of this study were to translate the EC-17 into Dutch and to further evaluate its psychometric properties. METHODS: The EC-17 was translated and cognitively pretested following cross-cultural adaptation guidelines. Two hundred and thirty-eight outpatients (52 % response rate) with osteoarthritis or fibromyalgia completed the EC-17 along with other validated measures. Three weeks later, 101 patients completed the EC-17 again. RESULTS: Confirmatory factor analysis supported the unidimensional structure of the scale. The items adequately fit the Rasch model and only one item demonstrated differential item functioning. Person reliability was high (0.92), but item difficulty levels tended to cluster around the middle of the scale, and measurement precision was highest for moderate and lower levels of skills. The scale demonstrated adequate test-retest reliability (ICC = 0.71), and correlations with other measures were largely as expected. CONCLUSION: The results supported the validity and reliability of the Dutch version of the EC-17, but suggest that the scale is best targeted at patients with relatively low levels of skills. Future studies should further examine its sensitivity to change in a clinical trial specifically aimed at improving effective consumer skills

Establishing the values for patient engagement (PE) in health-related quality of life (HRQoL) research: an international, multiple-stakeholder perspective

PurposeActive patient engagement is increasingly viewed as essential to ensuring that patient-driven perspectives are considered throughout the research process. However, guidance for patient engagement (PE) in HRQoL research does not exist, the evidence-base for practice is limited, and we know relatively little about underpinning values that can impact on PE practice. This is the first study to explore the values that should underpin PE in contemporary HRQoL research to help inform future good practice guidance. MethodsA modified ‘World Café’ was hosted as a collaborative activity between patient partners, clinicians and researchers: self-nominated conference delegates participated in group discussions to explore values associated with the conduct and consequences of PE. Values were captured via post-it notes and by nominated note-takers. Data were thematically analysed: emergent themes were coded and agreement checked. Association between emergent themes, values and the Public Involvement Impact Assessment Framework were explored. ResultsEighty participants, including 12 patient partners, participated in the 90-min event. Three core values were defined: (1) building relationships; (2) improving research quality and impact; and (3) developing best practice. Participants valued the importance of building genuine, collaborative and deliberative relationships—underpinned by honesty, respect, co-learning and equity—and the impact of effective PE on research quality and relevance. Conclusions An explicit statement of values seeks to align all stakeholders on the purpose, practice and credibility of PE activities. An innovative, flexible and transparent research environment was valued as essential to developing a trustworthy evidence-base with which to underpin future guidance for good PE practice.Peer reviewe

Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation

Stakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for the meaningful and equitable engagement of multiple stakeholders in guideline development and implementation. METHODS: This will be a multi-stage project. The first stage is to conduct a series of four systematic reviews. These will (1) describe existing guidance and methods for stakeholder engagement in guideline development and implementation, (2) characterize barriers and facilitators to stakeholder engagement in guideline development and implementation, (3) explore the impact of stakeholder engagement on guideline development and implementation, and (4) identify issues related to conflicts of interest when engaging multiple stakeholders in guideline development and implementation. DISCUSSION: We will collaborate with our multiple and diverse stakeholders to develop guidance for multi-stakeholder engagement in guideline development and implementation. We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders. An invited group of representatives from all stakeholder groups will discuss the results of the survey at a consensus meeting which will inform the development of the final guidance papers. Our overall goal is to improve the development of guidelines through meaningful and equitable multi-stakeholder engagement, and subsequently to improve health outcomes and reduce inequities in health

Personal non-commercial use only

ABSTRACT. Objective. To develop an innovative stepped patient decision aid (StDA) comparing the benefits and harms of 13 nonsurgical treatment options for managing osteoarthritis (OA) and to evaluate its acceptability and effects on informed decision making. Methods. Guided by the Ottawa Decision Support Framework and the International Patient Decision Aid Standards, the process involved (1) developing a decision aid with evidence on 13 nonsurgical treatments from the 2012 American College of Rheumatology OA clinical practice guidelines; and (2) interviewing patients with OA and healthcare providers to test its acceptability and effects on knowledge and decisional conflict. Results. The StDA helped make the decision explicit, and presented evidence on 13 OA treatments clustered into 5 steps or levels according to their benefits and harms. Probabilities of benefits and harms were presented using pictograms of 100 faces formatted to allow comparisons across sets of options. It also included a values clarification exercise and knowledge test. Feedback was obtained from 49 patients and 7 healthcare providers. They found that the StDA presented evidence in a clear manner, and helped patients clarify their values and make an informed decision. Some participants found that there was too much information and others said that there was not enough on each treatment option. Conclusion. This innovative StDA allows patients to consider both the evidence and their values for multiple options. The findings are being used to revise and plan future evaluation. The StDA is an example of how research evidence in guidelines can be implemented in practice

Identifying flares in rheumatoid arthritis: Reliability and construct validation of the OMERACT RA Flare Core Domain Set

Objective: To evaluate the reliability of concurrent flare identification using 3 methods (patient, rheumatologist and Disease Activity Score (DAS)28 criteria), and construct validity of candidate items representing the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA Flare Core Domain Set. Methods: Candidate flare questions and legacy measures were administered at consecutive visits to Canadian Early Arthritis Cohort (CATCH) patients between November 2011 and November 2014. The American College of Rheumatology (ACR) core set indicators were recorded. Concordance to identify flares was assessed using the agreement coefficient. Construct validity of flare questions was examined: convergent (Spearman's r); discriminant (mean differences between flaring/non-flaring patients); and consequential (proportions with prior treatment reductions and intended therapeutic change postflare). Results: The 849 patients were 75% female, 81% white, 42% were in remission/low disease activity (R/LDA), and 16-32% were flaring at the second visit. Agreement of flare status was low-strong (κ's 0.17-0.88) and inversely related to RA disease activity level. Flare domains correlated highly (r's≥0.70) with each other, patient global (r's≥0.66) and corresponding measures (r's 0.49-0.92); and moderately highly with MD and patient-reported joint counts (r's 0.29-0.62). When MD/patients agreed the patient was flaring, mean flare domain between-group differences were 2.1-3.0; 36% had treatment reductions prior to flare, with escalation planned in 61%. Conclusions: Flares are common in rheumatoid arthritis (RA) and are often preceded by treatment reductions. Patient/MD/DAS agreement of flare status is highest in patients worsening from R/LDA. OMERACT RA flare questions can discriminate between patients with/without flare and have strong evidence of construct and consequential validity. Ongoing work will identify optimal scoring and cut points to identify RA flares

Stiffness Is the Cardinal Symptom of Inflammatory Musculoskeletal Diseases, Yet Still Variably Measured: Report from the OMERACT 2016 Stiffness Special Interest Group

Objective: The objectives of the Outcome Measures in Rheumatology (OMERACT) Stiffness special interest group (SIG) are to characterize stiffness as an outcome in rheumatic disease and to identify and validate a stiffness patient-reported outcome (PRO) in rheumatology. Methods: At OMERACT 2016, international groups presented and discussed results of several concurrent research projects on stiffness: a literature review of rheumatoid arthritis (RA) stiffness PRO measures, a qualitative investigation into the RA and polymyalgia rheumatica patient perspective of stiffness, data-driven stiffness conceptual model development, development and testing of an RA stiffness PRO measure, and a quantitative work testing stiffness items in patients with RA and psoriatic arthritis. Results: The literature review identified 52 individual stiffness PRO measures assessing morning or early morning stiffness severity/intensity or duration. Items were heterogeneous, had little or inconsistent psychometric property evidence, and did not appear to have been developed according to the PRO development guidelines. A poor match between current stiffness PRO and the conceptual model identifying the RA patient experience of stiffness was identified, highlighting a major flaw in PRO selection according to the OMERACT filter 2.0. Conclusion: Discussions within the Stiffness SIG highlighted the importance of further research on stiffness and defined a research agenda