Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynaecological Interventions (Preprint)

2021 ◽  
Author(s):  
Stergios D Doumouchtsis ◽  
Vivek Nama ◽  
Gabriele Falconi ◽  
Maria Patricia Rada ◽  
Jittima Manonai ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Delphi Survey ◽  
Dissemination And Implementation ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
International Context ◽  
Literature Reviews ◽  
Registration Number ◽  
Survey Results ◽  
Core Outcome Measures

BACKGROUND Studies evaluating cosmetic gynecological interventions have followed variable methodology and reported a diversity of outcomes. Such variations limit the comparability of studies and the value of research-based evidence. The development of core outcome sets (COS) and core outcome measures sets (COMS) would help address these issues, ensuring outcomes important to all stakeholders, primarily women requesting or with experience of cosmetic gynecological interventions. OBJECTIVE N/A METHODS An international steering group, within the CHORUS Collaboration, including healthcare professionals, researchers and women with experience in cosmetic gynecological interventions will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. COS and COMS will be entered into an international, multi-perspective online Delphi survey. The Delphi survey results will be evaluated in subsequent stakeholder group consensus meetings in the process of establishing ‘core’ outcomes. RESULTS Dissemination and implementation of the resulting COS and COMS within an international context will be promoted and reviewed. CONCLUSIONS Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to the enhancement of the value of research and improving overall patient care. CLINICALTRIAL Core Outcome Measures in Effectiveness Trials [COMET] initiative, registration number 1592

Controversy and Debate Series on Core Outcome Sets. Paper 4: Debate on Paper 1 from the perspective of COMET [Core Outcome Measures in Effectiveness Trials]

2020 ◽  
Vol 125 ◽  
pp. 222-224 ◽  
Author(s):  
Paula R. Williamson ◽  
Jane M. Blazeby ◽  
Sara T. Brookes ◽  
Mike Clarke ◽  
Caroline B. Terwee ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Core Outcome Measures ◽  
Effectiveness Trials

scholarly journals Study protocol: a core outcome set for perinatal interventions for congenital diaphragmatic hernia

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Simen Vergote ◽  
Felix De Bie ◽  
Jan Bosteels ◽  
Holly Hedrick ◽  
James Duffy ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Congenital Diaphragmatic Hernia ◽  
Outcome Measures ◽  
Diaphragmatic Hernia ◽  
Systematic Reviews ◽  
Core Outcome ◽  
The Core ◽  
Registration Number ◽  
Core Outcome Measures ◽  
Effectiveness Trials

Abstract Background Congenital diaphragmatic hernia (CDH) is, depending of the severity, a birth defect associated with significant mortality and morbidity. Prenatal screening by ultrasound may detect this condition and comprehensive assessment of severity is possible, allowing for in utero referral to an experienced centre for planned delivery. In an effort to improve outcomes, prenatal interventions to stimulate lung development were proposed. Along the same lines, new postnatal management strategies are being developed. In order to enable proper comparison of novel perinatal interventions as well as outcomes, a set of uniform and relevant outcome measures is required. Core outcome sets (COS) are agreed, clearly defined sets of outcomes to be measured in a standardised manner and reported consistently. Herein we aim to describe the methodology we will use to define a COS for perinatal and neonatal outcomes of foetuses and newborns with congenital diaphragmatic hernia and to draft a dissemination and implementation plan. Methods We will use the methodology described in the Core Outcome Measures in Effectiveness Trials (COMET) Initiative Handbook. An international steering group will be created to guide the development of the COS. We are systematically reviewing the literature to identify all potential relevant pre- and neonatal outcomes previously used in studies on perinatal interventions for CDH. We will build a consensus on these core outcomes in a stakeholder group using the Delphi method. After completion, a stakeholder meeting will decide on a final COS, using a modified Nominal Group Technique. Thereafter, we will review potential definitions and measurements of these outcomes, and again a consensus meeting will be organised, to finalise the COS before dissemination. Discussion We have started a procedure to develop a COS for studies on perinatal interventions for congenital diaphragmatic hernia, with the purpose of improving the quality of research, guide clinical practice and improve patient care and eventual use in future clinical trials, systematic reviews and clinical practice guidelines. Trial registration We prospectively registered this study in the International Prospective Register of Systematic Reviews (PROSPERO) (registration number: CRD42019124399) and The Core Outcome Measures in Effectiveness Trials (COMET) Initiative (registration number:1296).

scholarly journals A Protocol for the Development of Core Outcome Sets in Pelvic Organ Prolapse Research

2019 ◽  
Author(s):  
Stergios Doumouchtsis ◽  
Maria Patricia Rada ◽  
Vasilios Pergialiotis ◽  
Gabriele Falconi ◽  
Jorge Milhem Haddad ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Pelvic Organ Prolapse ◽  
Women’S Health ◽  
Women's Health ◽  
Outcome Measures ◽  
Randomized Trials ◽  
Pelvic Organ ◽  
Delphi Survey ◽  
Core Outcome ◽  
Core Outcome Sets

Abstract Background The high prevalence of symptomatic pelvic organ prolapse (POP) and the women's lifetime risk of requiring surgery, as well as the significant impact of POP on women’s health related quality of life has resulted in a variety of studies on POP interventions. A wide variety of outcomes have been reported across randomized trials evaluating interventions for POP and various outcome measures have been used. Such variation leads to a limited value of research to provide reliable evidence-based data for clinical practice guidance. The development and use of a core outcome set (COS) would help to address these issues ensuring outcomes important to all stakeholders, primarily women with POP. We aim to produce, disseminate and implement a COS for POP. Methods A steering group within the CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health will guide the development of this COS. Systematic reviews of trials that reported outcomes and outcome measures on interventions for POP will form the basis for the creation of an outcome inventory. Core outcome selection process will be performed using an international, multi-perspective, online Delphi survey. The modified Delphi method encourages stakeholder group agreement towards consensus core outcomes through repeated reflection and rescoring of items. Discussion Dissemination and implementation of the resulting COS within an international context will be promoted. An embedded COS for POP within future studies will most likely be reflected by an increased value of research that provides guidance for clinical practice. The paradigm of the COS development could further inform research priorities in POP treatments, and support clinical guidelines development and better patient care. KEYWORDS: core outcome sets, outcome measures, pelvic organ prolapse, Delphi survey, randomized trials.

scholarly journals Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynaecological Interventions: a protocol (Preprint)

10.2196/28032 ◽  
2021 ◽  
Author(s):  
Stergios D Doumouchtsis ◽  
Vivek Nama ◽  
Gabriele Falconi ◽  
Maria Patricia Rada ◽  
Jittima Manonai ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Core Outcome Measures

Core outcome sets and core outcome measures: a primer

2020 ◽  
Author(s):  
Murad Alam ◽  
Sarah A. Ibrahim ◽  
Bianca Y. Kang ◽  
Arianna F. Yanes ◽  
Bharat B. Mittal ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Core Outcome Measures

scholarly journals Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations

Pain ◽  
2012 ◽  
Vol 153 (12) ◽  
pp. 2315-2324 ◽  
Author(s):  
Sandra D. Comer ◽  
James P. Zacny ◽  
Robert H. Dworkin ◽  
Dennis C. Turk ◽  
George E. Bigelow ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Abuse Liability ◽  
Opioid Abuse ◽  
Core Outcome ◽  
Laboratory Assessment ◽  
Core Outcome Measures

Implementation of the Core Outcome Measures CPG: Assessing the Know-Do Gap

2021 ◽  
Vol 102 (10) ◽  
pp. e94
Author(s):  
Amy Yorke ◽  
Suzanne Trojanowski ◽  
Nora Fritz
Keyword(s):  
Outcome Measures ◽  
Core Outcome ◽  
The Core ◽  
Core Outcome Measures
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