Core Outcome Sets (COS) for clinical trials in health- and nursing science: the case of Incontinence-Associated Dermatitis (IAD)

Abstract Background Temporomandibular Disorder (TMD) is a generic term applied to describe musculoskeletal disorders that affect the temporomandibular joint (TMJ), the masticatory muscles and the related structures. TMD comprises two groups of disorders, namely intra-articular TMD and masticatory muscle disorders. There is still difficulty in establishing the effectiveness of different therapeutic modalities for TMD with robust evidence, despite the large volume of publications in the area. The lack of outcomes standardization may represent a limiting factor in the search for scientific evidence. Objective This study aims to develop a core outcome sets (COS) for clinical trials in intra-articular TMD and masticatory muscle disorders. Methods The protocol for determining the COS-TMD will consist of three phases: 1. Synthesis of TMD Management Intervention Outcomes. The identification of outcomes will be carried out through a systematic review, which will include randomized clinical trials that evaluated the effectiveness of interventions used in TMD management. 2. Through a two-round international Delphi survey, the list of outcomes will be scored by three panels of stakeholders. 3. A representative sample of key stakeholders will be invited to participate in a face-to-face meeting where they can discuss the results of the Delphi survey and determine the final core set. Conclusions The implementation of this protocol will determine the COS-TMD, which will be made available for use in all TMD clinical studies. The use of COS when planning and reporting TMD clinical trials will reduce the risk of publication bias and enable proper comparison of results found by different studies.

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Core Outcome Sets for Clinical Trials in Dry Eye Disease

JAMA Ophthalmology ◽

10.1001/jamaophthalmol.2018.3361 ◽

2018 ◽

Vol 136 (10) ◽

pp. 1180 ◽

Cited By ~ 4

Author(s):

Michael T. M. Wang ◽

Jennifer P. Craig

Keyword(s):

Clinical Trials ◽

Dry Eye ◽

Dry Eye Disease ◽

Eye Disease ◽

Core Outcome ◽

Core Outcome Sets

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Core Outcome Sets for Psoriasis Clinical Trials

JAMA Dermatology ◽

10.1001/jamadermatol.2018.1166 ◽

2018 ◽

Vol 154 (10) ◽

pp. 1135

Author(s):

Bruce E. Strober ◽

Kenneth B. Gordon

Keyword(s):

Clinical Trials ◽

Core Outcome ◽

Core Outcome Sets

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Developing core outcome sets for clinical trials: issues to consider

Trials ◽

10.1186/1745-6215-13-132 ◽

2012 ◽

Vol 13 (1) ◽

Cited By ~ 712

Author(s):

Paula R Williamson ◽

Douglas G Altman ◽

Jane M Blazeby ◽

Mike Clarke ◽

Declan Devane ◽

...

Keyword(s):

Clinical Trials ◽

Core Outcome ◽

Core Outcome Sets

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Pain Measurement in Rheumatic and Musculoskeletal Diseases: Where To Go from Here? Report from a Special Interest Group at OMERACT 2018

The Journal of Rheumatology ◽

10.3899/jrheum.181099 ◽

2019 ◽

Vol 46 (10) ◽

pp. 1355-1359 ◽

Cited By ~ 1

Author(s):

Alessandro Chiarotto ◽

Ulrike Kaiser ◽

Ernest Choy ◽

Robin Christensen ◽

Philip G. Conaghan ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Pain Measurement ◽

Research Agenda ◽

Online Survey ◽

Musculoskeletal Diseases ◽

Core Outcome ◽

Core Outcome Sets ◽

Pain Experience ◽

Key Questions

Objective.Establishing a research agenda on standardizing pain measurement in clinical trials in rheumatic and musculoskeletal diseases (RMD).Methods.Discussion during a meeting at the Outcome Measures in Rheumatology (OMERACT) 2018, prepared by a systematic review of existing core outcome sets and a patient online survey.Results.Several key questions were debated: Is pain a symptom or a disease? Are pain core (sub)domains consistent across RMD? How to account for pain mechanistic descriptors (e.g., central sensitization) in pain measurement?Conclusion.Characterizing and assessing the spectrum of pain experience across RMD in a standardized fashion is the objective of the OMERACT Pain Working Group.

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Use of Core Outcome Sets was Low in Clinical Trials Published in Major Medical Journals

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2021.10.012 ◽

2021 ◽

Author(s):

Karen Matvienko-Sikar ◽

Kerry Avery ◽

Jane Blazeby ◽

Declan Devane ◽

Susanna Dodd ◽

...

Keyword(s):

Clinical Trials ◽

Core Outcome ◽

Medical Journals ◽

Core Outcome Sets

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How well are the ASAS/OMERACT Core Outcome Sets for Ankylosing Spondylitis implemented in randomized clinical trials? A systematic literature review

Clinical Rheumatology ◽

10.1007/s10067-014-2728-6 ◽

2014 ◽

Vol 33 (9) ◽

pp. 1313-1322 ◽

Cited By ~ 25

Author(s):

Wilson Bautista-Molano ◽

Victoria Navarro-Compán ◽

Robert B. M. Landewé ◽

Maarten Boers ◽

Jamie J. Kirkham ◽

...

Keyword(s):

Clinical Trials ◽

Ankylosing Spondylitis ◽

Literature Review ◽

Systematic Literature Review ◽

Randomized Clinical Trials ◽

Core Outcome ◽

Core Outcome Sets

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coreSCD: multi-stakeholder consensus on core outcomes for sickle cell disease clinical trials

BMC Medical Research Methodology ◽

10.1186/s12874-021-01413-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Ellen Tambor ◽

Matoya Robinson ◽

Lewis Hsu ◽

Hsing-Yuan Chang ◽

Jennifer Al Naber ◽

...

Keyword(s):

Decision Making ◽

Clinical Trials ◽

Sickle Cell Disease ◽

Delphi Panel ◽

Core Outcome ◽

Cell Disease ◽

Consensus Process ◽

Core Outcome Sets ◽

Multi Stakeholder ◽

Stakeholder Consensus

Abstract Background With the dramatic increase in the pipeline for new sickle cell disease (SCD) therapies in recent years, the time is ripe to ensure a robust body of evidence is available for decision making by regulators, payers, clinicians, and patients. Harmonization of the outcomes selected across interventional trials enables optimal post-trial appraisal and decision making through valid pooled analyses and indirect comparisons. We employed a structured, multi-stakeholder consensus process to develop core outcome sets (COS) for use in clinical trials of SCD interventions. Methods CoreSCD utilized a modified Delphi method adapted from the standards recommended by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. An initial list of candidate outcomes was developed through a targeted literature review and input from an 11-member advisory committee. A 44-member multi-stakeholder Delphi Panel was established and included patients and family members, advocates, clinicians, researchers, payers, health technology assessors, representatives from government agencies, and industry representatives. Patients/advocates comprised 25% of the Delphi Panel and orientation and training was provided prior to the consensus process to ensure all were prepared to participate meaningfully. Panelists completed three rounds of an online survey to rate the importance of candidate outcomes for inclusion in the COS. Summary data was provided between each voting round and an in-person consensus meeting was held between the second and third round of voting. Consensus rules were applied following each round of voting to eliminate outcomes that did not meet predetermined criteria for retention. Results Consensus was reached for two core outcome sets. The final COS for trials of disease-modifying therapies includes ten outcomes and the COS for trials of acute interventions includes six outcomes. Both core sets include clinical outcomes as well as outcomes related to functioning/quality of life, resource utilization, and survival/mortality. Conclusions Use of the COS in clinical development programs for SCD will help to ensure that relevant, consistent outcomes are available for decision making across the product lifecycle.

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