Standardising outcomes for clinical trials and systematic reviews

Clarke, Michael

doi:10.1186/1745-6215-8-39

Cited by 404 publications

(337 citation statements)

References 11 publications

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“…However, authors of these reviews report that outcomes are inconsistently measured and reported across trials [11][12][13]. This inconsistency may limit the comparison of findings among trials and hinder statistical pooling [14]. In addition, inconsistent reporting can be due to selective reporting bias (e.g.…”

Section: Introductionmentioning

confidence: 97%

Core outcome domains for clinical trials in non-specific low back pain

et al. 2015

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Purpose Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP.Methods An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions.

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Section: Introductionmentioning

confidence: 97%

Core outcome domains for clinical trials in non-specific low back pain

et al. 2015

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“…In an effort to reduce heterogeneity in outcomes measured across clinical trials, the development of core outcome sets (COSs) in specific health conditions has been recommended [2]. A COS is defined as an agreed minimum selection of outcomes that should be measured and reported in all clinical trials for a particular health condition [3].…”

Section: What Is Newmentioning

confidence: 99%

A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group

Buchbinder

Page²,

Huang

et al. 2017

J Rheumatol

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Objective.The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders.Methods.In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps.Results.There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated.Conclusion.Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.

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“…Standardising outcomes has been proposed as a solution to the problems of inappropriate and non-uniform outcome selection in clinical trials [13]. OMERACT advocates use of core outcome sets in clinical trials designed using consensus techniques [14] which formed the basis of the current process for a provisional MCD, albeit focussed on LOS in RA.…”

Section: Discussionmentioning

confidence: 99%

Achieving consensus on minimum data items (including core outcome domains) for a longitudinal observational cohort study in rheumatoid arthritis

et al. 2016

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Objectives: To obtain consensus on minimum data items for an observational cohort study in rheumatoid arthritis (RA) in the UK and to make available the process for similar studies and other rheumatic conditions.Methods: Individuals with a diverse range of expertise and backgrounds were invited to participate in a process to propose a minimal core dataset (MCD) for research studies, items for inclusion into a MCD. Workshops were undertaken for two essential items which required further exploration: work/social participation and co-morbidity. Conclusions:Consensus for proposed minimal data items for long-term observational cohort studies of RA in the UK posed novel challenges and opportunities, and was largely successful.Further work is needed to select instruments for two important items and to achieve compatibility with other UK national initiatives, and more widely across Europe.

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Standardising outcomes for clinical trials and systematic reviews

Cited by 404 publications

References 11 publications

Core outcome domains for clinical trials in non-specific low back pain

Core outcome domains for clinical trials in non-specific low back pain

A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group

Achieving consensus on minimum data items (including core outcome domains) for a longitudinal observational cohort study in rheumatoid arthritis

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