scholarly journals Addressing Challenges in Developing a Core Domain Set in Adherence Interventions in Rheumatology: A Report from the OMERACT-Adherence Group

2019 ◽  
Vol 46 (9) ◽  
pp. 1202-1206
Author(s):  
Ayano Kelly ◽  
Susan J. Bartlett ◽  
Maarten P. de Wit ◽  
Dorcas E. Beaton ◽  
Therese Dawson ◽  
...  

Objective.The OMERACT-Adherence meeting was convened to discuss the conceptual and methodological challenges in developing a core domain set (Adherence-CDS) for trials of interventions for medication adherence in rheumatology.Methods.Forty participants from nine countries participated.Results.Four ideas emerged: for adherence trials, the Adherence-CDS could include adherence and the condition-specific CDS; many factors affect adherence and are intervention targets, contextual factors, or outcome domains; adherence is a critical factor in drug trials; and standardized adherence measures are needed.Conclusion.Despite the challenges, the meeting clarified an approach to developing an Adherence-CDS that complements existing OMERACT work and methodology.

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Shahrzad Salmasi ◽  
Ayano Kelly ◽  
Susan J. Bartlett ◽  
Maarten de Wit ◽  
Lyn March ◽  
...  

Abstract Background Research on adherence interventions in rheumatology is limited by methodological issues, particularly heterogeneous outcomes. We aimed to describe researchers’ experiences with conducting interventional studies targeting medication adherence in rheumatology and their perspectives on establishing core outcomes. Methods Semi-structured interviews using audio conference were conducted with researchers who had conducted an adherence study of any design in the past 10 years. Data collection and thematic analysis were performed iteratively, until saturation. Results We interviewed 13 researchers, most of whom worked in academia and specialized in epidemiology and/or health services research. We identified three themes: 1) improving measurement of adherence (considering all phases of adherence, using appropriate and relevant measures, and establishing clinically meaningful thresholds); 2) challenges in designing and appraising adherence intervention studies (considering the confusion over a plethora of outcomes, difficulties with powering studies to demonstrate meaningful changes, and suboptimal descriptions of adherence interventions in published studies); and 3) advancing outcome assessment in adherence intervention studies (capturing rationale for developing a core domain set as well as recommendations and anticipated challenges by participants). Conclusions Uniquely gathering perspectives from international adherence researchers, our findings led to researcher-informed recommendations for improving adherence research including specifying the targeted adherence phase in designing interventions and studies and providing a glossary of terms to promote consistency in reporting. We also identified recommendations for developing a core domain set for interventional studies targeting medication adherence including involvement of patients, clinicians, and other stakeholders and methodological and practical considerations to establish rigor and support uptake.


2017 ◽  
Vol 44 (11) ◽  
pp. 1723-1726 ◽  
Author(s):  
Jasvinder A. Singh ◽  
Michelle M. Dowsey ◽  
Michael Dohm ◽  
Susan M. Goodman ◽  
Amye L. Leong ◽  
...  

Objective.Discussion and endorsement of the OMERACT total joint replacement (TJR) core domain set for total hip replacement (THR) and total knee replacement (TKR) for endstage arthritis; and next steps for selection of instruments.Methods.The OMERACT TJR working group met at the 2016 meeting at Whistler, British Columbia, Canada. We summarized the previous systematic reviews, the preliminary OMERACT TJR core domain set and results from previous surveys. We discussed preliminary core domains for TJR clinical trials, made modifications, and identified challenges with domain measurement.Results.Working group participants (n = 26) reviewed, clarified, and endorsed each of the inner and middle circle domains and added a range of motion domain to the research agenda. TJR were limited to THR and TKR but included all endstage hip and knee arthritis refractory to medical treatment. Participants overwhelmingly endorsed identification and evaluation of top instruments mapping to the core domains (100%) and use of subscales of validated multidimensional instruments to measure core domains for the TJR clinical trial core measurement set (92%).Conclusion.An OMERACT core domain set for hip/knee TJR trials has been defined and we are selecting instruments to develop the TJR clinical trial core measurement set to serve as a common foundation for harmonizing measures in TJR clinical trials.


2016 ◽  
Vol 110 ◽  
pp. 34-45 ◽  
Author(s):  
Melinde R.S. Boland ◽  
Job F.M. van Boven ◽  
Annemarije L. Kruis ◽  
Niels H. Chavannes ◽  
Thys van der Molen ◽  
...  

2012 ◽  
Vol 52 (3) ◽  
pp. 381-397 ◽  
Author(s):  
Sarah L. Cutrona ◽  
Niteesh K. Choudhry ◽  
Michael A. Fischer ◽  
Amber D. Servi ◽  
Margaret Stedman ◽  
...  

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Nathan A. Pearson ◽  
Elizabeth Tutton ◽  
Alexander Joeris ◽  
Stephen Gwilym ◽  
Richard Grant ◽  
...  

Abstract Background Ankle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogeneity in outcome reporting and consequently, restricted the contribution of evidence syntheses. Over the past decade, core outcome sets have been developed to address this issue and are available for several common fractures, including those of the hip, distal radius, and open tibial fractures. This protocol describes the process to co-produce—with patient partners and other key stakeholders—a multi-stakeholder derived Core Outcome Set for distal Tibia and Ankle fractures (COSTA). The scope of COSTA will be for clinical trials. Methods The study will have five-stages which will include the following: (i) systematic reviews of existing qualitative studies and outcome reporting in randomised controlled trial studies to inform a developing list of potential outcome domains; (ii) qualitative interviews (including secondary data) and focus groups with patients and healthcare professionals to explore the impact of ankle fracture and the outcomes that really matter; (iii) generation of meaningful outcome statements with the study team, international advisory group and patient partners; (iv) a multi-round, international e-Delphi study to achieve consensus on the core domain set; and (v) an evidence-based consensus on a core measurement set will be achieved through a structured group consensus meeting, recommending best assessment approaches for each of the domains in the core domain set. Discussion Development of COSTA will provide internationally endorsed outcome assessment guidance for clinical trials for distal tibia and ankle fractures. This will enhance comparative reviews of interventions, potentially reducing reporting bias and research waste.


Author(s):  
Nimmy Elizabeth George ◽  
Smrithy Sunny ◽  
Anitta Mariyam Sam ◽  
Aleena Susan Sabu ◽  
Prudence A Rodrigues

  Objectives: To assess the patient medication adherence using 8 item morisky medication adherence scale (MMAS). To categorize patients based on their adherence to antidiabetic medications into low, medium, and high adherent. To provide educational interventions such as patient counseling using teach-back method, patient medication information leaflet, and audio-visual aids and thus to improve the patient medication adherence.Methods: After obtaining informed consent from the patients, data of the patients were recorded in data collection forms. Their adherence to antidiabetic medication was evaluated using 8 item MMAS and patients were categorized into low, medium, and high adherence groups based on the score. Counseling was done based on the categorization (high, medium, and low). During review, again adherence was rechecked using 8 item MMAS.Results: Medication adherence was measured using 8 item MMAS on review and adherence was found to be improved using different patient counseling methods according to their adherence category. Improvement in score within low adherence group was found to be 83.87%; improvement of the low adherence group to medium adherence group was 16.12%. Improvement within the medium adherence group was 82.14% and from medium adherence to high adherence group was 17.85%.Conclusion: Patient counseling can improve adherence in type 2 diabetes mellitus patients, which in turn help patients in achieving optimal glycemic control.


RMD Open ◽  
2016 ◽  
Vol 2 (1) ◽  
pp. e000225 ◽  
Author(s):  
Vivian P Bykerk ◽  
Clifton O Bingham ◽  
Ernest H Choy ◽  
Daming Lin ◽  
Rieke Alten ◽  
...  

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