Outcome reporting for reconstructive breast surgery: The need for consensus, consistency and core outcome sets

2012 ◽  
Vol 38 (11) ◽  
pp. 1020-1021 ◽  
Author(s):  
J.A. Ward ◽  
S. Potter ◽  
J.M. Blazeby
Keyword(s):  
Breast Surgery ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Outcome Reporting

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.

scholarly journals Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery

Trials ◽  
2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Shelley Potter ◽  
Sara T. Brookes ◽  
Christopher Holcombe ◽  
Joseph A. Ward ◽  
Jane M. Blazeby
Keyword(s):  
Breast Surgery ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Stakeholder Views

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 Engaging Stakeholders and Promoting Uptake of OMERACT Core Outcome Instrument Sets

2017 ◽  
Vol 44 (10) ◽  
pp. 1551-1559 ◽  
Author(s):  
Sean R. Tunis ◽  
Lara J. Maxwell ◽  
Ian D. Graham ◽  
Beverley J. Shea ◽  
Dorcas E. Beaton ◽  
...  
Keyword(s):  
Knowledge Translation ◽  
Core Outcome Set ◽  
Healthcare Providers ◽  
Stakeholder Involvement ◽  
Decision Makers ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Regulatory Decision ◽  
Outcome Instrument ◽  
Outcome Domain

Objective.While there has been substantial progress in the development of core outcomes sets, the degree to which these are used by researchers is variable. We convened a special workshop on knowledge translation at the Outcome Measures in Rheumatology (OMERACT) 2016 with 2 main goals. The first focused on the development of a formal knowledge translation framework and the second on promoting uptake of recommended core outcome domain and instrument sets.Methods.We invited all 189 OMERACT 2016 attendees to the workshop; 86 attended, representing patient research partners (n = 15), healthcare providers/clinician researchers (n = 52), industry (n = 4), regulatory agencies (n = 4), and OMERACT fellows (n = 11). Participants were given an introduction to knowledge translation and were asked to propose and discuss recommendations for the OMERACT community to (1) strengthen stakeholder involvement in the core outcome instrument set development process, and (2) promote uptake of core outcome sets with a specific focus on the potential role of post-regulatory decision makers.Results.We developed the novel “OMERACT integrated knowledge translation” framework, which formalizes OMERACT’s knowledge translation strategies. We produced strategies to improve stakeholder engagement throughout the process of core outcome set development and created a list of creative and innovative ways to promote the uptake of OMERACT’s core outcome sets.Conclusion.The guidance provided in this paper is preliminary and is based on the views of the participants. Future work will engage OMERACT groups, “post-regulatory decision makers,” and a broad range of different stakeholders to identify and evaluate the most useful methods and processes, and to revise guidance accordingly.

scholarly journals Core outcome sets and systematic reviews

2016 ◽  
Vol 5 (1) ◽  
Author(s):  
Mike Clarke ◽  
Paula R. Williamson
Keyword(s):  
Systematic Reviews ◽  
Core Outcome ◽  
Core Outcome Sets

The evolution of instrument selection for inclusion in core outcome sets at OMERACT: Filter 2.2

2021 ◽  
Author(s):  
Lara J Maxwell ◽  
Dorcas E Beaton ◽  
Maarten Boers ◽  
Maria Antonietta D'Agostino ◽  
Philip G Conaghan ◽  
...  
Keyword(s):  
Core Outcome ◽  
Core Outcome Sets ◽  
Instrument Selection ◽  
Selection For

Substantial heterogeneity found in reporting mortality in Cochrane Systematic Reviews and Core Outcome Sets in COMET Database

2022 ◽  
Author(s):  
Eve Tomlinson ◽  
Jordi Pardo Pardo ◽  
Susanna Dodd ◽  
Torunn Sivesind ◽  
Mindy D. Szeto ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Substantial Heterogeneity
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