scholarly journals Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS)

2022 ◽  
Author(s):  
Reem Moussa ◽  
Maria Patricia Rada ◽  
Constantin Durnea ◽  
Gabriele Falconi ◽  
Cornelia Betschart ◽  
...  
Keyword(s):  
Adverse Events ◽  
Outcome Measures ◽  
Methodological Quality ◽  
Reporting Quality ◽  
Adult Women ◽  
Core Outcome ◽  
Pharmacological Management ◽  
Core Outcome Sets ◽  
Outcome Reporting ◽  
Management Interventions

Abstract Introduction and hypothesis Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). Methods RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. Results Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman’s rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. Conclusions Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.

scholarly journals Quality assessment of outcome reporting, publication characteristics and overall methodological quality in trials on synthetic mesh procedures for the treatment of pelvic organ prolapse for development of core outcome sets

2021 ◽  
Author(s):  
Thais Regina de Mattos Lourenço ◽  
◽  
Vasilis Pergialiotis ◽  
Constantin M. Durnea ◽  
Abdullatif Elfituri ◽  
...  
Keyword(s):  
Methodological Quality ◽  
Reporting Quality ◽  
Pelvic Organ ◽  
Synthetic Mesh ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Outcome Reporting ◽  
Randomized Controlled ◽  
The Mean

Abstract Introduction and hypothesis Variations in outcome measures and reporting of outcomes in trials on surgery for pelvic organ prolapse (POP) using synthetic mesh have been evaluated and reported. However, the quality of outcome reporting, methodology of trials and their publication parameters are important considerations in the process of development of Core Outcome Sets. We aimed to evaluate these characteristics in randomized controlled trials on surgery for POP using mesh. Methods Secondary analysis of randomized controlled trials on surgical treatments using synthetic mesh for POP previously included in a systematic review developing an inventory of reported outcomes and outcome measures. The methodological quality was investigated with the modified Jadad criteria. Outcome reporting quality was evaluated with the MOMENT criteria. Publication parameters included publishing journal, impact factor and year of publication. Results Of the 71 previously reviewed studies published from 2000 to 2017, the mean JADAD score was 3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT) was related to methodological quality (JADAD) (rho = 0.662; p = 0.000) and to year of publication (rho = 0.262; p = 0.028). Conclusions Methodological quality and outcome reporting quality appear correlated. However, publication characteristics do not have strong associations with the methodological quality of the studies. Evaluation of the quality of outcomes, methodology and publication characteristics are all an indispensable part of a staged process for the development of Core Outcome and Outcome Measure Sets.

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

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

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 Barriers to uptake of the hip fracture core outcome set: An international survey of 80 hip fracture trialists

2020 ◽  
Vol 17 (6) ◽  
pp. 712-716
Author(s):  
Jessica Fletcher ◽  
Katie Jane Sheehan ◽  
Toby O Smith
Keyword(s):  
Hip Fracture ◽  
Outcome Measures ◽  
Research Training ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Mean Values ◽  
Surgical Interventions ◽  
Outcome Set ◽  
Randomised Controlled

Background: Core outcome sets are an agreed recommendation to inform the selection of outcome measures in clinical trials. There has been low uptake of the 2014 hip fracture core outcome set. The reasons for this remain unclear. The aim of this study was to understand the reasons for the non-adoption and approaches to increase adoption of the hip fracture core outcome set. Methods: Randomised controlled trials from PubMed (2017–2019) and ClinicalTrials.gov (2015–2019) were identified. Corresponding authors for each identified trial (n = 302) were surveyed using five questions on awareness of the hip fracture core outcome set, reasons for non-adoption and approaches to increase adoption. Data were analysed descriptively using frequencies, mean values and standard deviations. Results: Fifty-four percent of the respondents (n = 43) were aware of the concept of core outcome set. Only 15% (n = 12) based the outcome measure selection on the 2014 hip fracture core outcome set. Key reasons for non-adoption included the following: authors being unaware and perceived inappropriateness to their trial design. Eighty-six percent (n = 69) of respondents agreed to the need for increased awareness of core outcome sets through research training, academic and clinical journal requirements, and funding or publication stipulations. Eighty-eight percent (n = 70) of respondents indicated the current core outcome set required revision to focus on trials investigating people with cognitive impairment, caregivers, rehabilitation, surgical interventions and anaesthetic trial designs. Conclusion: Barriers to the adoption of the hip fracture core outcome set centre on education, awareness of the core outcome sets and applicability to the breath of hip fracture trial designs. Further consideration should be made to address these, to improve the harmonisation of outcome measures across hip fracture trials.

Sign in / Sign up

Export Citation Format

Share Document