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

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
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

scholarly journals Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes (SCORE-IT): a patient and healthcare professional consensus on a core outcome set for type 2 diabetes

2019 ◽  
Vol 7 (1) ◽  
pp. e000700 ◽  
Author(s):  
Nicola L Harman ◽  
John P H Wilding ◽  
Dave Curry ◽  
James Harris ◽  
Jennifer Logue ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Healthcare Professionals ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Core Outcome ◽  
Outcome Set ◽  
Core Outcomes ◽  
Effectiveness Trials

ObjectivesHeterogeneity in outcomes measured across trials of glucose-lowering interventions for people with type 2 diabetes impacts on the ability to compare findings and may mean that the results have little importance to healthcare professionals and the patients that they care for. The SCORE-IT study (Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes) has addressed this issue by establishing consensus on the most important outcomes for non-surgical interventions for hyperglycemia in type 2 diabetes.Research design and methodsA comprehensive list of outcomes was developed from registered clinical trials, online patient resources, qualitative literature and long-term studies in the field. This list was then scored in a two-round online Delphi survey completed by healthcare professionals, people with type 2 diabetes, researchers in the field and healthcare policymakers. The results of this online Delphi were discussed and ratified at a face-to-face consensus meeting.Results173 people completed both rounds of the online survey (116 people with type 2 diabetes, 37 healthcare professionals, 14 researchers and 6 policymakers), 20 of these attended the consensus meeting (13 people with type 2 diabetes and 7 healthcare professionals). Consensus was reached on 18 core outcomes across five domains, which include outcomes related to diabetes care, quality of life and long-term diabetes-related complications.ConclusionsImplementation of the core outcome set in future trials will ensure that outcomes of importance to all stakeholders are measured and reported, enhancing the relevance of trial findings and facilitating the comparison of results across trials.

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 COSUMO: study protocol for the development of a core outcome set for efficacy and effectiveness trials in posterior segment-involving uveitis

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Mohammad O. Tallouzi ◽  
Jonathan M. Mathers ◽  
David J. Moore ◽  
Philip I. Murray ◽  
Nicholas Bucknall ◽  
...  
Keyword(s):  
Study Protocol ◽  
Core Outcome Set ◽  
Posterior Segment ◽  
Core Outcome ◽  
Outcome Set ◽  
Effectiveness Trials

scholarly journals Incorporating patients’ perspectives into the initial stages of core outcome set development: a rapid review of qualitative studies of type 2 diabetes

2019 ◽  
Vol 7 (1) ◽  
pp. e000615 ◽  
Author(s):  
Sarah L Gorst ◽  
Bridget Young ◽  
Paula R Williamson ◽  
John P H Wilding ◽  
Nicola L Harman
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Development Process ◽  
Core Outcome Set ◽  
Qualitative Studies ◽  
Patient Perspectives ◽  
Rapid Review ◽  
Core Outcome ◽  
Outcome Set

Conducting systematic reviews of qualitative studies to incorporate patient perspectives within the early stages of core outcome set (COS) development can be resource intensive. We aimed to identify an expedited approach to be used as part of the wider COS development process. Specifically, we undertook a rapid review of qualitative studies of patients’ views and experiences of type 2 diabetes. We searched MEDLINE from inception to June 2017 to identify studies reporting qualitative empirical findings of perspectives of people with type 2 diabetes. Qualitative methodological filters were used to minimize irrelevant references. Drawing on content analysis, data synthesis involved identifying text in eligible studies relevant to outcomes of type 2 diabetes and interpreting and categorizing this according to the 38 core domains of the Core Outcome Measures in Effectiveness Trials taxonomy. Of 146 studies screened, 26 were included. Four hundred and fifty-eight outcomes were derived from the included studies. In comparison to the outcomes extracted from clinical trials, more life impact outcomes were derived from the qualitative studies, but fewer physiological/clinical outcomes. Outcomes relating to ‘mortality/survival’ and ‘role functioning’ were more prevalent in studies conducted in low/middle-income countries. This rapid review and synthesis of qualitative studies identified outcomes that had not previously been identified by a systematic review of clinical trials. It also identified differences in the types of outcomes given prominence to in the clinical trials and qualitative literatures. Incorporating qualitative evidence on patient perspectives from the outset of the COS development process can help to ensure outcomes that matter to patients are not overlooked. Our method provides a pragmatic and resource-efficient way to do this. For those developing international COS, our method has potential for incorporating the perspectives of patients from diverse countries in the early stages of COS development.

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 A protocol for developing a core outcome set for ectopic pregnancy

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Krystle Y. Chong ◽  
Sarah Solangon ◽  
James Kemper ◽  
Kurt Barnhart ◽  
Pamela Causa Andrieu ◽  
...  
Keyword(s):  
Ectopic Pregnancy ◽  
Randomised Controlled Trials ◽  
Core Outcome Set ◽  
Future Research ◽  
Controlled Trials ◽  
Core Outcome ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Core Outcomes ◽  
Randomised Controlled

Abstract Background Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. Study aim To develop and implement a core outcome set to guide future research in ectopic pregnancy. Methods and analysis We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus ‘core’ outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. Trial registration COMET 1492. Registered in November 2019.

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
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