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

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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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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Core outcomes in periodontal trials: study protocol for core outcome set development

Trials ◽

10.1186/s13063-017-2169-z ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 3

Author(s):

Thomas J. Lamont ◽

Jan E. Clarkson ◽

David N. J. Ricketts ◽

Peter A. Heasman ◽

Craig R. Ramsay

Keyword(s):

Study Protocol ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set ◽

Core Outcomes

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Development of a core outcome set for medication review in older patients with multimorbidity and polypharmacy: a study protocol

Clinical Interventions in Aging ◽

10.2147/cia.s135481 ◽

2017 ◽

Vol Volume 12 ◽

pp. 1379-1389 ◽

Cited By ~ 4

Author(s):

Jean Baptiste Beuscart ◽

Olivia Dalleur ◽

Benoit Boland ◽

Stefanie Thevelin ◽

Wilma Knol ◽

...

Keyword(s):

Study Protocol ◽

Medication Review ◽

Older Patients ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set

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A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey

Trials ◽

10.1186/s13063-018-3082-9 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 2

Author(s):

Geng Li ◽

Li Zhou ◽

Wenwei Ouyang ◽

Meiling Xuan ◽

Liming Lu ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Chinese Medicine ◽

Study Protocol ◽

Core Outcome Set ◽

Delphi Survey ◽

Core Outcome ◽

Outcome Set

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Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol

Trials ◽

10.1186/s13063-018-3072-y ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 6

Author(s):

Karoline Kragelund Nielsen ◽

Sharleen O’Reilly ◽

Nancy Wu ◽

Kaberi Dasgupta ◽

Helle Terkildsen Maindal

Keyword(s):

Study Protocol ◽

Core Outcome Set ◽

Pregnancy Prevention ◽

Core Outcome ◽

Outcome Set ◽

Prevention Interventions

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Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set

Trials ◽

10.1186/s13063-018-2805-2 ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 5

Author(s):

Nicola L. Harman ◽

◽

John Wilding ◽

Dave Curry ◽

James Harris ◽

...

Keyword(s):

Type 2 Diabetes ◽

Study Protocol ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set ◽

Core Outcomes ◽

Effectiveness Trials

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Creation of a core outcome set for clinical trials of people with shoulder pain: a study protocol

Trials ◽

10.1186/s13063-017-2054-9 ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 12

Author(s):

Joel J. Gagnier ◽

Matthew J. Page ◽

Hsiaomin Huang ◽

Arianne P. Verhagen ◽

Rachelle Buchbinder

Keyword(s):

Clinical Trials ◽

Shoulder Pain ◽

Study Protocol ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set

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CONSIDER - Core Outcome Set in IAD Research: study protocol for establishing a core set of outcomes and measurements in incontinence-associated dermatitis research

Journal of Advanced Nursing ◽

10.1111/jan.13165 ◽

2016 ◽

Vol 73 (10) ◽

pp. 2473-2483 ◽

Cited By ~ 9

Author(s):

Karen Van den Bussche ◽

Dorien De Meyer ◽

Nele Van Damme ◽

Jan Kottner ◽

Dimitri Beeckman

Keyword(s):

Study Protocol ◽

Research Study ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set ◽

Core Set

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Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol

ERJ Open Research ◽

10.1183/23120541.00193-2020 ◽

2020 ◽

Vol 6 (3) ◽

pp. 00193-2020

Author(s):

Alexander G. Mathioudakis ◽

Fekri Abroug ◽

Alvar Agusti ◽

Per Bakke ◽

Konstantinos Bartziokas ◽

...

Keyword(s):

Study Protocol ◽

Task Force ◽

Core Outcome Set ◽

Measurement Instrument ◽

Chronic Obstructive ◽

Core Outcome ◽

European Respiratory Society ◽

Copd Exacerbations ◽

Outcome Set ◽

Multi Stakeholder

Randomised controlled trials (RCTs) on the management of COPD exacerbations evaluate heterogeneous outcomes, often omitting those that are clinically important and patient relevant. This limits their usability and comparability. A core outcome set (COS) is a consensus-based minimum set of clinically important outcomes that should be evaluated in all RCTs in specific areas of health care. We present the study protocol of the COS-AECOPD ERS Task Force, aiming to develop a COS for COPD exacerbation management, that could remedy these limitations.For the development of this COS we follow standard methodology recommended by the COMET initiative. A comprehensive list of outcomes is assembled through a methodological systematic review of the outcomes reported in relevant RCTs. Qualitative research with patients with COPD will also be conducted, aiming to identify additional outcomes that may be important to patients, but are not currently addressed in clinical research studies. Prioritisation of the core outcomes will be facilitated through an extensive, multi-stakeholder Delphi survey with a global reach. Selection will be finalised in an international, multi-stakeholder meeting. For every core outcome, we will recommend a specific measurement instrument and standardised time points for evaluation. Selection of instruments will be based on evidence-informed consensus.Our work will improve the quality, usability and comparability of future RCTs on the management of COPD exacerbations and, ultimately, the care of patients with COPD. Multi-stakeholder engagement and societal support by the European Respiratory Society will raise awareness and promote implementation of the COS.

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