scholarly journals Development of a core outcome set for behavioural weight management programmes for adults with overweight and obesity: protocol for obtaining expert consensus using Delphi methodology

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025193 ◽  
Author(s):  
Ruth M Mackenzie ◽  
Louisa J Ells ◽  
Sharon Anne Simpson ◽  
Jennifer Logue
Keyword(s):  
Weight Management ◽  
Core Outcome Set ◽  
Health Department ◽  
Evidence Base ◽  
Overweight And Obesity ◽  
Delphi Process ◽  
Core Outcome ◽  
Management Interventions ◽  
Outcome Set ◽  
Scottish Government

IntroductionWeight management interventions in research studies and in clinical practice differ in length, advice, frequency of meetings, staff and cost. Very few real-world programmes have published patient-related outcomes, and those that have published used different ways of reporting the information, making it impossible to compare interventions and further develop the evidence base. Developing a core outcome set for behavioural weight management programmes (BWMPs) for adults with overweight and obesity will allow different BWMPs to be compared and reveal which interventions work best for which members of the population.Methods and analysisAn expert group, comprised of 40 people who work in, refer to, or attend BWMPs for adults with overweight and obesity, will be asked to decide which outcomes services should report. An online Delphi process will be employed to help the group reach consensus as to which outcomes should be measured and reported, and which definitions/instruments should be used in order to do so. The first stage of the Delphi process (three rounds of questionnaires) will focus on outcomes while the second stage (three additional rounds of questionnaires) will focus on definition/instrument selection.Ethics and disseminationEthical approval for this study has been received from the University of Glasgow College of Medical, Veterinary and Life Sciences Ethics Committee. With regard to disseminating results, a report will be submitted to our funding body, the Chief Scientist Office of the Scottish Government Health Department. In addition, early findings will be shared with Public Health England and Health Scotland, and results communicated via conference presentations, peer review publication and our institutions’ social media platforms.

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

2019 ◽  
Vol 46 (8) ◽  
pp. 1041-1046 ◽  
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.

scholarly journals A protocol for developing, disseminating, and implementing a core outcome set for adenomyosis research

2021 ◽  
Vol 13 (3) ◽  
pp. 203-209
Author(s):  
T Tellum ◽  
J Naftalin ◽  
M Hirsch ◽  
E Saridogan ◽  
D Jurkovic
Keyword(s):  
Outcome Measures ◽  
Core Outcome Set ◽  
Delphi Process ◽  
Core Outcome ◽  
Data Synthesis ◽  
The Core ◽  
Steering Group ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Meta Analyses

Background: Adenomyosis is a common benign gynaecological condition that has been associated with heavy and/or painful periods, subfertility and poor obstetric outcomes including miscarriage and preterm delivery. Studies evaluating treatments for adenomyosis have reported a wide range of outcomes and outcome measures. This variation in outcomes and outcome measures prevents effective data synthesis, thereby hampering the ability of meta-analyses to draw useful conclusions and inform clinical practice. Objectives: Our aim is to develop a minimum set of outcomes to be reported in all future studies that investigate any uterus-sparing intervention for treating uterine adenomyosis. Wide adoption of ‘core outcomes’ into research on adenomyosis would reduce the heterogeneity of studies and make data synthesis easier. This will ultimately lead to comparable, prioritised, and patient-centred conclusions from meta-analyses and guidelines. Materials and Methods: Outcomes identified from a systematic review of the literature will form a long list, agreed by an international steering group representing key stakeholders, including healthcare professionals, researchers, and public research partners. Through a modified Delphi process, key stakeholders will score outcomes from the agreed long list on a nine-point Likert scale that ranges from 1 (not important) to 9 (critical). Following the Delphi process, the refined outcome set will be finalised by the steering group. Finally, the steering group will develop recommendations for high-quality measures for each outcome. The study was prospectively registered with Core Outcome Measures in Effectiveness Trials Initiative; number 1649. Conclusion: The implementation of the core outcome set for adenomyosis in future trials will enhance the availability of comparable data to facilitate more patient-centred evidence-based care. What is new? The core outcome set will facilitate the generation of clinically important and patient centred outcomes for studies evaluating treatments for adenomyosis.

scholarly journals The development of a Core Outcome Set for medicines management interventions for people with dementia in primary care

2018 ◽  
Vol 48 (2) ◽  
pp. 260-266 ◽  
Author(s):  
Mairead McGrattan ◽  
Heather E Barry ◽  
Cristín Ryan ◽  
Janine A Cooper ◽  
A Peter Passmore ◽  
...  
Keyword(s):  
Primary Care ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Medicines Management ◽  
Management Interventions ◽  
People With Dementia ◽  
Outcome Set

scholarly journals Core outcome research measures in anal cancer (CORMAC): protocol for systematic review, qualitative interviews and Delphi survey to develop a core outcome set in anal cancer

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e018726 ◽  
Author(s):  
Rebecca Fish ◽  
Caroline Sanders ◽  
Paula R Williamson ◽  
Andrew G Renehan
Keyword(s):  
Systematic Review ◽  
Side Effects ◽  
Anal Cancer ◽  
Core Outcome Set ◽  
Delphi Process ◽  
Phase Iii ◽  
Core Outcome ◽  
Anal Squamous Cell Carcinoma ◽  
Outcome Set

IntroductionThe incidence of anal squamous cell carcinoma (ASCC) has increased threefold in the last 30 years. Initial treatment is chemoradiotherapy, associated with short-term and long-term side effects. Future therapy innovations aim to reduce morbidity in treatment of early tumours while maintaining treatment efficacy, and to escalate treatment intensity in locally advanced tumours with acceptable quality of life (QoL). However, all phase III randomised controlled trials to-date have utilised different primary outcomes, which hinders evidence synthesis and presents challenges to the selection of optimal outcomes in future trials. No trial comprehensively assessed long-term side effects and QoL, suggesting outcomes reflecting issues important to patients are under-represented. This project aims to determine the priority outcomes for all stakeholders and reach agreement on a standardised core set of outcomes to be measured and reported on in all future ASCC trials.Methods and analysisA systematic review will identify all outcomes reported in trials and observational studies of chemoradiotherapy as primary treatment for ASCC. Outcomes of importance to patients will be identified through patient interviews. The long list of outcomes generated from the systematic review and interviews will be used to create a two-round Delphi process, including key stakeholders (patients and healthcare professionals). The results of the Delphi will be discussed at a face-to-face consensus meeting. Discussion will focus on outcomes that did not achieve consensus through the Delphi process and conclude with anonymous voting to ratify the final core outcome set (COS).Ethics and disseminationThe final COS will feed directly into the PersonaLising Anal cancer radioTherapy dOse (PLATO) national anal cancer trials and the Association of coloproctologists of Great Britain and Ireland (ACPGBI) supported national anal cancer database. Utilisation of the COS will increase the relevance of research output to all stakeholders and increase the capacity for data synthesis between trials. This study has ethical approval and is registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative.Trial registration numberPROSPERO registration ID:CRD42016036540

scholarly journals What to measure in biliary atresia research: study protocol for developing a core outcome set

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e047224
Author(s):  
Christopher Maguire ◽  
Zephanie Tyack ◽  
Roy M Kimble ◽  
Bronwyn Ruth Griffin ◽  
Helen Joanna Yesberg ◽  
...  
Keyword(s):  
Biliary Atresia ◽  
Core Outcome Set ◽  
Evidence Base ◽  
Future Research ◽  
Core Outcome ◽  
Allied Health Professionals ◽  
Human Research Ethics ◽  
Delphi Approach ◽  
Outcome Set

AimExtrahepatic biliary atresia is a rare disorder. This creates challenges in the quality and quantity of research conducted. This issue is exacerbated by the potential heterogeneity in the reported outcomes in research examining the management of biliary atresia. A core outcome set is required to standardise reporting on the management of biliary atresia in research, facilitate systematic reviews that include outcomes of greatest importance to patients and clinicians, and to evaluate the quality of the existing evidence base on the management of biliary atresia.MethodsA list of all potential outcomes will be developed through a systematic review of the literature. This list will be refined through a three-stage Delphi approach, involving key stakeholders in the management of biliary atresia. This will include patients and their parents, clinicians, nurses and allied health professionals. In this way, outcomes will be prioritised into a set of consensus core outcomes.ConclusionThe development of a core outcome set in biliary atresia management is needed to guide future research and assist in evaluating the quality of existing research.Ethics and disseminationEthical approval has been granted by the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC), Ref: HREC/20/QCHQ/62448. Results of the study will be published in an open access format.

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