Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review, and Delphi surveys

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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The outcomes of Perthes’ disease of the hip: a study protocol for the development of a core outcome set

Trials ◽

10.1186/s13063-018-2695-3 ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 4

Author(s):

Donato Giuseppe Leo ◽

Wei Yee Leong ◽

Tina Gambling ◽

Andrew Long ◽

Rebecca Murphy ◽

...

Keyword(s):

Study Protocol ◽

Core Outcome Set ◽

Perthes Disease ◽

Core Outcome ◽

Outcome Set

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Core outcome set in paediatric sepsis in low- and middle-income countries: a study protocol

BMJ Open ◽

10.1136/bmjopen-2019-034960 ◽

2020 ◽

Vol 10 (4) ◽

pp. e034960

Author(s):

Gavin Wooldridge ◽

Srinivas Murthy ◽

Niranjan Kissoon

Keyword(s):

Study Protocol ◽

Core Outcome Set ◽

Core Outcome ◽

High Quality ◽

Middle Income ◽

Ongoing Research ◽

Middle Income Countries ◽

Outcome Set ◽

Low Middle Income Countries ◽

Low And Middle Income

IntroductionSepsis is the leading cause of death in children worldwide and has recently been declared a major global health issue. New interventions and a concerted effort to enhance our understanding of sepsis are required to address the huge burden of disease, especially in low- and middle-income countries (LMIC) where it is highest. An opportunity therefore exists to ensure that ongoing research in this area is relevant to all stakeholders and is of consistently high quality. One method to address these issues is through the development of a core outcome set (COS).Methods and analysisThis study protocol outlines the phases in the development of a core outcome set for paediatric sepsis in LMIC. The first step involves performing a systematic review of all outcomes reported in the research of paediatric sepsis in low middle-income countries. A three-stage international Delphi process will then invite a broad range of participants to score each generated outcome for inclusion into the COS. This will include an initial two-step online survey and finally, a face-to-face consensus meeting where each outcome will be reviewed, voted on and ratified for inclusion into the COS.Ethics and disseminationNo core outcome sets exist for clinical trials in paediatric sepsis. This COS will serve to not only highlight the heavy burden of paediatric sepsis in this setting and aid collaboration and participation between all stakeholders, but to promote ongoing essential high quality and relevant research into the topic. A COS in paediatric sepsis in LMIC will advocate for a common language and facilitate interpretation of findings from a variety of settings. A waiver for ethics approval has been granted by University of British Columbia Children’s and Women’s Research Ethics Board.

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