Engaging Stakeholders and Promoting Uptake of OMERACT Core Outcome Instrument Sets

Tunis, Sean; Maxwell, Lara; Graham, Ian D.; Shea, Beverley; Beaton, Dorcas; Bingham, Clifton O.; Brooks, Peter; Conaghan, Philip G.; D'Agostino, Maria Antonietta; Wit, Maarten de; Gossec, Laure; March, Lyn; Simon, Lee S.; Singh, Jasvinder A.; Strand, Vibeke; Wells, George; Tugwell, Peter

doi:10.3899/jrheum.161273

Cited by 33 publications

(20 citation statements)

References 24 publications

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“…The implementation of core outcomes requires extensive stakeholder engagement, and specifically, end-users (eg, triallists who use them and clinicians who apply the results) need to be involved in the process of establishing core outcomes. 15 In recent studies, developers of core outcome sets have been interviewed to inform guidance for the conduct of core outcomes studies. 2 15 However, the perspectives of end-users on the concept, identification and expected impact of core outcomes remain largely unknown.…”

Section: Introductionmentioning

confidence: 99%

Clinicians’ and researchers’ perspectives on establishing and implementing core outcomes in haemodialysis: semistructured interview study

Tong

Crowe²,

Gill

et al. 2018

BMJ Open

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ObjectivesTo describe the perspectives of clinicians and researchers on identifying, establishing and implementing core outcomes in haemodialysis and their expected impact.DesignFace-to-face, semistructured interviews; thematic analysis.StettingTwenty-seven centres across nine countries.ParticipantsFifty-eight nephrologists (42 (72%) who were also triallists).ResultsWe identified six themes: reflecting direct patient relevance and impact (survival as the primary goal of dialysis, enabling well-being and functioning, severe consequences of comorbidities and complications, indicators of treatment success, universal relevance, stakeholder consensus); amenable and responsive to interventions (realistic and possible to intervene on, differentiating between treatments); reflective of economic burden on healthcare; feasibility of implementation (clarity and consistency in definition, easily measurable, requiring minimal resources, creating a cultural shift, aversion to intensifying bureaucracy, allowing justifiable exceptions); authoritative inducement and directive (endorsement for legitimacy, necessity of buy-in from dialysis providers, incentivising uptake); instituting patient-centredness (explicitly addressing patient-important outcomes, reciprocating trial participation, improving comparability of interventions for decision-making, driving quality improvement and compelling a focus on quality of life).ConclusionsNephrologists emphasised that core outcomes should be relevant to patients, amenable to change, feasible to implement and supported by stakeholder organisations. They expected core outcomes would improve patient-centred care and outcomes.

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Section: Introductionmentioning

confidence: 99%

Clinicians’ and researchers’ perspectives on establishing and implementing core outcomes in haemodialysis: semistructured interview study

Tong

Crowe²,

Gill

et al. 2018

BMJ Open

Self Cite

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“…To ensure proper representation, inviting at least two PRPs is recommended [ 55 ]. Finally, acknowledgement of input and feedback to patients is essential, and integrated knowledge translation is desirable [ 56 ].…”

Section: Conclusion: Principles For Engaging With Patientsmentioning

confidence: 99%

Practical guidance for engaging patients in health research, treatment guidelines and regulatory processes: results of an expert group meeting organized by the World Health Organization (WHO) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)

Wit¹,

Cooper

Tugwell

et al. 2019

Aging Clin Exp Res

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There is increasing emphasis on patient-centred research to support the development, approval and reimbursement of health interventions that best meet patients’ needs. However, there is currently little guidance on how meaningful patient engagement may be achieved. An expert working group, representing a wide range of stakeholders and disciplines, was convened by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the World Health Organization (WHO). Through a structured, collaborative process the group generated practical guidance to facilitate optimal patient engagement in clinical development and regulatory decisions. Patient engagement is a relational process. The principles outlined in this report were based on lessons learned through applied experience and on an extensive dialogue among the expert participants. This practice guidance forms a starting point from which tailoring of the approach to suit different chronic diseases may be undertaken.

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“…The number of COS studies being published is increasing, but uptake of these cos in research has been variable. However, the importance of COS uptake has been acknowledged amongst key stakeholders including trialists [4], trial funders [5], clinical guideline developers [6], regulative authorities [7], payers [8] and industry [9]. Development of the COS-STAR (Core Outcome Set-STAndards for Reporting) guideline aims to improve the quality of reporting COS development studies [10].…”

Section: Introductionmentioning

confidence: 99%

Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement

Kirkham

Gorst

Altman

et al. 2019

Trials

187

173

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BackgroundSeveral hundred core outcome set (COS) projects have been systematically identified to date which, if adopted, ensure that researchers measure and report those outcomes that are most likely to be relevant to users of their research. The uptake of a COS by COS users will depend in part on the transparency and robustness of the methods used in the COS development study, which would be increased by the use of a standardised protocol. This article describes the development of the COS-STAP (Core Outcome Set-STAndardised Protocol Items) Statement for the content of a COS development study protocol.MethodsThe COS-STAP Statement was developed following the Enhancing the Quality and Transparency Of Health Research (EQUATOR) Network’s methodological framework for guideline development. This included an initial item generation stage, a two-round Delphi survey involving more than 150 participants representing three stakeholder groups (COS developers, journal editors and patient and public involvement researchers interested in COS development), followed by a consensus meeting with eight voting participants.ResultsThe COS-STAP Statement consists of a checklist of 13 items considered essential documentation in a protocol, outlining the scope of the COS, stakeholder involvement, COS development plans and consensus processes.ConclusionsJournal editors and peer reviewers can use the guidance to assess the completeness of a COS development study protocol submitted for publication. By providing guidance for key content, the COS-STAP Statement will enhance the drafting of high-quality protocols and determine how the COS development study will be carried out.Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3230-x) contains supplementary material, which is available to authorized users.

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Engaging Stakeholders and Promoting Uptake of OMERACT Core Outcome Instrument Sets

Cited by 33 publications

References 24 publications

Clinicians’ and researchers’ perspectives on establishing and implementing core outcomes in haemodialysis: semistructured interview study

Clinicians’ and researchers’ perspectives on establishing and implementing core outcomes in haemodialysis: semistructured interview study

Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement

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