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

2016 ◽  
Vol 73 (10) ◽  
pp. 2473-2483 ◽  
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

scholarly journals The development of a faecal incontinence core outcome set: an international Delphi study protocol

2021 ◽  
Vol 36 (3) ◽  
pp. 617-622
Author(s):  
Sadé Assmann ◽  
Daniel Keszthelyi ◽  
Jos Kleijnen ◽  
Merel Kimman ◽  
Foteini Anastasiou ◽  
...  
Keyword(s):  
Systematic Review ◽  
Study Protocol ◽  
Faecal Incontinence ◽  
Delphi Study ◽  
Evidence Synthesis ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Delphi Consensus ◽  
Link Type ◽  
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.

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

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
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

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

BMJ Open ◽  
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.

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

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
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

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

2017 ◽  
Vol Volume 12 ◽  
pp. 1379-1389 ◽  
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

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

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
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

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

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
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

scholarly journals Development of a Core Set of Patient-Reported Outcomes for Population-Based Cancer Survivorship Research: Protocol for an Australian Consensus Study

10.2196/14544 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e14544 ◽  
Author(s):  
Imogen Ramsey ◽  
Nadia Corsini ◽  
Amanda D Hutchinson ◽  
Julie Marker ◽  
Marion Eckert
Keyword(s):  
Cancer Survivors ◽  
Cancer Survivorship ◽  
Phase Ii ◽  
Core Outcome Set ◽  
Population Based ◽  
Core Outcome ◽  
The Core ◽  
Outcome Set ◽  
Core Set

Background Core outcome sets seek to improve the consistency and quality of research by providing agreed-upon recommendations regarding what outcomes should be measured as a minimum for a population and setting. The problems arising from a lack of outcome standardization in population-based cancer survivorship research indicate the need for agreement on a core set of patient-reported outcomes (PROs) to enhance data quality, consistency, and comparability. Objective This study aims to identify a core set of PROs, representing the most important issues impacting on cancer survivors' long-term health, functioning and quality of life, to inform population-based research on cancer survivorship. Methods In Phase I, a list of all potentially important outcomes will be generated through focus group discussions with cancer survivors and a review of measures for assessing quality of life in cancer survivorship. The consolidated list will be advanced to Phase II, where a stakeholder consensus process will be conducted with national experts in cancer survivorship to refine and prioritize the outcomes into a core outcome set. The process will consist of a two-round Delphi survey and a consensus meeting. Cancer survivors, oncology health care professionals, and potential end users of the core outcome set with expertise in cancer survivorship research or policy will be invited to participate. In Phase III, recommended measures for assessment of the core outcome set will be selected with advice from experts on the assessment, analysis, and interpretation of PROs. Results As of April 2019, data collection for Phase I is complete and data analysis is underway. These data will inform the list of outcomes to be advanced into Phase II. Recruitment for Phase II will commence in June 2019, and it is anticipated that it will take 6 months to complete the three-step consensus process and identify a provisional core outcome set. The study results are expected to be published in early 2020. Conclusions Expert consensus-driven recommendations on outcome measurement will facilitate the inclusion of survivorship outcomes considered important by cancer survivors and health professionals in future research. Adoption of the core outcome set will enable comparison and synthesis of evidence across studies and enhance the quality of PRO data collected in cancer survivorship research, particularly when applied to address macro-level questions. International Registered Report Identifier (IRRID) DERR1-10.2196/14544

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