O039 / #863: DEVELOPMENT OF A CORE OUTCOME SET FOR PEDIATRIC CRITICAL CARE RESEARCH: AN INTERNATIONAL, MODIFIED DELPHI CONSENSUS STUDY

Abstract Purpose Faecal incontinence (FI) is estimated to affect around 7.7% of people. There is a lack of uniformity in outcome definitions, measurement and reporting in FI studies. Until now, there is no general consensus on which outcomes should be assessed and reported in FI research. This complicates comparison between studies and evidence synthesis, potentially leading to recommendations not evidence-based enough to guide physicians in selecting an FI therapy. A solution for this lack of uniformity in reporting of outcomes is the development of a Core Outcome Set (COS) for FI. This paper describes the protocol for the development of a European COS for FI. Methods Patient interviews and a systematic review of the literature will be performed to identify patient-, physician- and researcher-oriented outcomes. The outcomes will be categorised using the COMET taxonomy and put forward to a group of patients, physicians (i.e. colorectal surgeons, gastroenterologists and general practitioners) and researchers in a Delphi consensus exercise. This exercise will consist of up to three web-based rounds in which participants will prioritise and condense the list of outcomes, which is expected to result in consensus. A consensus meeting with participants from all stakeholder groups will take place to reach a final agreement on the COS. Discussion This study protocol describes the development of a European COS to improve reliability and consistency of outcome reporting in FI studies, thereby improving evidence synthesis and patient care. Trial registration This project has been registered in the COMET database on the 1st of April 2020, available at http://www.comet-initiative.org/Studies/Details/1554. The systematic review has been registered on the PROSPERO database on the 31st of August 2020, available at https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=1381336.

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A multi-stakeholder Delphi consensus core outcome set for clinical trials in moderate-to-severe asthma (coreASTHMA)

Annals of Allergy Asthma & Immunology ◽

10.1016/j.anai.2021.03.022 ◽

2021 ◽

Author(s):

Vickram Tejwani ◽

Hsing-Yuan Chang ◽

Annie P. Tran ◽

Jennifer Al Naber ◽

Florian S. Gutzwiller ◽

...

Keyword(s):

Clinical Trials ◽

Severe Asthma ◽

Core Outcome Set ◽

Core Outcome ◽

Delphi Consensus ◽

Outcome Set ◽

Multi Stakeholder

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Core Outcome Set for Reporting Outcomes of Interventions for Velopharyngeal Dysfunction: Final Results of the COS-VPD Initiative

The Cleft Palate-Craniofacial Journal ◽

10.1177/10556656211035026 ◽

2021 ◽

pp. 105566562110350

Author(s):

Catherine de Blacam ◽

Adriane L. Baylis ◽

Richard E. Kirschner ◽

Susan Smith ◽

Debbie Sell ◽

...

Keyword(s):

Core Outcome Set ◽

A Priori ◽

Delphi Panel ◽

Core Outcome ◽

Delphi Consensus ◽

Assessment Development ◽

Comparison Of Results ◽

Outcome Set ◽

Patient Reported ◽

Panel Rating

Objective To date, the recording of outcomes of interventions for velopharyngeal dysfunction (VPD) has not been standardized. This makes a comparison of results between studies challenging. The aim of this study was to develop a core outcome set (COS) for reporting outcomes in studies examining the management of VPD. Design A two-round Delphi consensus process was used to develop the COS. Patients, Participants The expert Delphi panel comprised patients and caregivers of patients with VPD, surgeons and speech and language therapists specializing in cleft palate, and researchers with expertise in VPD. Interventions A long list of outcomes was derived from the published literature. In each round of a Delphi survey, participants were asked to score outcomes using the Grading of Recommendations, Assessment, Development, and Evaluations scale of 1 to 9, with 1 to 3 labeled “not important,” 4 to 6 labeled “important but not critical,” and 7 to 9 labeled “critical.” Main outcome measure Consensus criteria were specified a priori. Outcomes with a rating of 75% or more of the panel rating 7 to 9 and 25% or fewer rating 1 to 3 were included in the COS. Results A total of 31 core outcomes were identified from the Delphi process. This list was condensed to combine topic areas to produce a final COS of 10 outcomes, including both processes of care and patient-reported outcomes that should be considered for reporting in future studies of VPD. Conclusions Implementation of the COS-VPD will facilitate consistency of outcomes data collection and comparison of results across studies.

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Systematic review of clinical outcome reporting in randomised controlled trials of burn care

BMJ Open ◽

10.1136/bmjopen-2018-025135 ◽

2019 ◽

Vol 9 (2) ◽

pp. e025135 ◽

Cited By ~ 4

Author(s):

Amber E Young ◽

Anna Davies ◽

Sophie Bland ◽

Sara Brookes ◽

Jane M Blazeby

Keyword(s):

Randomised Controlled Trials ◽

Core Outcome Set ◽

Controlled Trials ◽

Free Text ◽

Core Outcome ◽

Care Research ◽

Burn Care ◽

Outcome Reporting ◽

Outcome Set ◽

Randomised Controlled

IntroductionSystematic reviews collate trial data to provide evidence to support clinical decision-making. For effective synthesis, there must be consistency in outcome reporting. There is no agreed set of outcomes for reporting the effect of burn care interventions. Issues with outcome reporting have been identified, although not systematically investigated. This study gathers empirical evidence on any variation in outcome reporting and assesses the need for a core outcome set for burn care research.MethodsElectronic searches of four search engines were undertaken from January 2012 to December 2016 for randomised controlled trials (RCTs), using medical subject headings and free text terms including ‘burn’, ‘scald’ ‘thermal injury’ and ‘RCT’. Two authors independently screened papers, extracted outcomes verbatim and recorded the timing of outcome measurement. Duplicate outcomes (exact wording ± different spelling), similar outcomes (albumin in blood, serum albumin) and identical outcomes measured at different times were removed. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included trials. Outcomes were classified into domains. Bias was reduced using five researchers and a patient working independently and together.Results147 trials were included, of which 127 (86.4%) were RCTs, 13 (8.8%) pilot studies and 7 (4.8%) RCT protocols. 1494 verbatim clinical outcomes were reported; 955 were unique. 76.8% of outcomes were measured within 6 months of injury. Commonly reported outcomes were defined differently. Numbers of unique outcomes per trial varied from one to 37 (median 9; IQR 5,13). No single outcome was reported across all studies demonstrating inconsistency of reporting. Outcomes were classified into 54 domains. Numbers of outcomes per domain ranged from 1 to 166 (median 11; IQR 3,24).ConclusionsThis review has demonstrated heterogeneity in outcome reporting in burn care research which will hinder amalgamation of study data. We recommend the development of a Core Outcome Set.PROSPERO registration numberCRD42017060908.

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Consensus Building in OMERACT: Recommendations for Use of the Delphi for Core Outcome Set Development

The Journal of Rheumatology ◽

10.3899/jrheum.181094 ◽

2019 ◽

Vol 46 (8) ◽

pp. 1041-1046 ◽

Cited By ~ 3

Author(s):

Susan Humphrey-Murto ◽

Richard Crew ◽

Beverley Shea ◽

Susan J. Bartlett ◽

Lyn March ◽

...

Keyword(s):

Clinical Trials ◽

Outcome Measures ◽

Core Outcome Set ◽

Delphi Process ◽

Consensus Building ◽

Core Outcome ◽

Delphi Consensus ◽

International Consensus ◽

Work In Progress ◽

Outcome Set

Objective.Developing international consensus on outcome measures for clinical trials is challenging. The following paper will review consensus building in Outcome Measures in Rheumatology (OMERACT), with a focus on the Delphi.Methods.Based on the literature and feedback from delegates at OMERACT 2018, a set of recommendations is provided in the form of the OMERACT Delphi Consensus Checklist.Results.The OMERACT delegates generally supported the use of the checklist as a guide. The checklist provides guidance for clearly outlining the multiple aspects of the Delphi process.Conclusion.OMERACT is deeply committed to consensus building and these recommendations should be considered a work in progress.

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