scholarly journals The Core Outcome DEvelopment for Carrier Screening (CODECS) study: protocol for development of a core outcome set

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ebony Richardson ◽  
Alison McEwen ◽  
Toby Newton-John ◽  
Karine Manera ◽  
Chris Jacobs
Keyword(s):  
Systematic Review ◽  
Genetic Testing ◽  
Core Outcome Set ◽  
Carrier Screening ◽  
Core Outcome ◽  
The Core ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Methods Of Measurement ◽  
Genetic Carrier Screening

Abstract Background Reproductive genetic carrier screening is a type of genetic testing available to those planning a pregnancy, or during their first trimester, to understand their risk of having a child with a severe genetic condition. There is a lack of consensus for ‘what to measure’ in studies on this intervention, leading to heterogeneity in choice of outcomes and methods of measurement. Such outcome heterogeneity has implications for the quality and comparability of these studies and has led to a lack of robust research evidence in the literature to inform policy and decision-making around the offer of this screening. As reproductive genetic carrier screening becomes increasingly accessible within the general population, it is timely to investigate the outcomes of this intervention. Objectives The development of a core outcome set is an established methodology to address issues with outcome heterogeneity in research. We aim to develop a core outcome set for reproductive genetic carrier screening to clarify and standardise outcomes for research and practice. Methods In accordance with guidance from the COMET (Core Outcome Measures in Effectiveness Trials) Initiative, this study will consist of five steps: (i) a systematic review of quantitative studies, using narrative synthesis to identify previously reported outcomes, their definitions, and methods of measurement; (ii) a systematic review of qualitative studies using content analysis to identify excerpts related to patient experience and perspectives that can be interpreted as outcomes; (iii) semi-structured focus groups and interviews with patients who have undertaken reproductive genetic carrier screening to identify outcomes of importance to them; (iv) Delphi survey of key stakeholders, including patients, clinicians, and researchers, to refine and prioritise the list of outcomes generated from the previous steps; and (v) a virtual consensus meeting with a purposive sample of key stakeholders to finalise the core outcome set for reporting. Discussion This protocol outlines the core outcome set development process and its novel application in the setting of genetic testing. This core outcome set will support the standardisation of outcome reporting in reproductive carrier screening research and contribute to an evolving literature on outcomes to evaluate genetic testing and genetic counselling as health interventions. COMET core outcome set registration http://www.comet-initiative.org/Studies/Details/1381.

scholarly journals The Core Outcome Development for Carrier Screening (CODECS) Study: Protocol for Development of a Core Outcome Set

2020 ◽  
Author(s):  
Ebony Joanne Richardson ◽  
Alison McEwen ◽  
Toby Newton-John ◽  
Karine Manera ◽  
Chris Jacobs
Keyword(s):  
Systematic Review ◽  
Genetic Testing ◽  
Core Outcome Set ◽  
Carrier Screening ◽  
Core Outcome ◽  
The Core ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Methods Of Measurement ◽  
Genetic Carrier Screening

Abstract Background: Reproductive genetic carrier screening is a type of genetic testing available to those planning a pregnancy, or during their first trimester, to understand their risk of having a child with a severe genetic condition. There is a lack of consensus for ‘what to measure’ in studies on this intervention, leading to heterogeneity in choice of outcomes and methods of measurement. Such outcome heterogeneity has implications for the quality and comparability of these studies and has led to a lack of robust research evidence in the literature to inform policy and decision-making around the offer of this screening. As reproductive genetic carrier screening becomes increasingly accessible within the general population, it is timely to investigate the outcomes of this intervention. Objectives: The development of a core outcome set is an established methodology to address issues with outcome heterogeneity in research. We aim to develop a core outcome set for reproductive genetic carrier screening to clarify and standardise outcomes for research and practice.Methods: In accordance with guidance from the COMET (Core Outcome Measures in Effectiveness Trials) Initiative, this study will consist of five steps: i) A systematic review of quantitative studies, using narrative synthesis to identify previously reported outcomes, their definitions, and methods of measurement ii) A systematic review of qualitative studies using content analysis to identify excerpts related to patient experience and perspectives that can be interpreted as outcomes iii) Semi-structured focus groups and interviews with patients who have undertaken reproductive genetic carrier screening to identify outcomes of importance to them iv) Delphi survey of key stakeholders, including patients, clinicians, and researchers, to refine and prioritise the list of outcomes generated from the previous steps v) A virtual consensus meeting with a purposive sample of key stakeholders to finalise the core outcome set for reporting.Discussion: This protocol outlines the core outcome set development process and its novel application in the setting of genetic testing. This core outcome set will support the standardisation of outcome reporting in reproductive carrier screening research and contribute to an evolving literature on outcomes to evaluate genetic testing and genetic counselling as health interventions. COMET core outcome set registration: http://www.comet-initiative.org/Studies/Details/1381

scholarly journals A protocol for developing, disseminating, and implementing a core outcome set for adenomyosis research

2021 ◽  
Vol 13 (3) ◽  
pp. 203-209
Author(s):  
T Tellum ◽  
J Naftalin ◽  
M Hirsch ◽  
E Saridogan ◽  
D Jurkovic
Keyword(s):  
Outcome Measures ◽  
Core Outcome Set ◽  
Delphi Process ◽  
Core Outcome ◽  
Data Synthesis ◽  
The Core ◽  
Steering Group ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Meta Analyses

Background: Adenomyosis is a common benign gynaecological condition that has been associated with heavy and/or painful periods, subfertility and poor obstetric outcomes including miscarriage and preterm delivery. Studies evaluating treatments for adenomyosis have reported a wide range of outcomes and outcome measures. This variation in outcomes and outcome measures prevents effective data synthesis, thereby hampering the ability of meta-analyses to draw useful conclusions and inform clinical practice. Objectives: Our aim is to develop a minimum set of outcomes to be reported in all future studies that investigate any uterus-sparing intervention for treating uterine adenomyosis. Wide adoption of ‘core outcomes’ into research on adenomyosis would reduce the heterogeneity of studies and make data synthesis easier. This will ultimately lead to comparable, prioritised, and patient-centred conclusions from meta-analyses and guidelines. Materials and Methods: Outcomes identified from a systematic review of the literature will form a long list, agreed by an international steering group representing key stakeholders, including healthcare professionals, researchers, and public research partners. Through a modified Delphi process, key stakeholders will score outcomes from the agreed long list on a nine-point Likert scale that ranges from 1 (not important) to 9 (critical). Following the Delphi process, the refined outcome set will be finalised by the steering group. Finally, the steering group will develop recommendations for high-quality measures for each outcome. The study was prospectively registered with Core Outcome Measures in Effectiveness Trials Initiative; number 1649. Conclusion: The implementation of the core outcome set for adenomyosis in future trials will enhance the availability of comparable data to facilitate more patient-centred evidence-based care. What is new? The core outcome set will facilitate the generation of clinically important and patient centred outcomes for studies evaluating treatments for adenomyosis.

scholarly journals A Core Outcome Set for Clinical Trials of First- and Second-Segree Perineal Tears Prevention and Treatment: A Study Protocol for a Systematic Review and a Delphi Survey

2021 ◽  
Author(s):  
Lin Xiao ◽  
Lei Shi ◽  
Suting Liu ◽  
yuan yuan Luo ◽  
Jin hui Tian ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Vaginal Delivery ◽  
Core Outcome Set ◽  
Delphi Survey ◽  
Core Outcome ◽  
Perineal Tears ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Prevention And Treatment

Abstract Background Perineal tear is a common consequence of vaginal births affecting females globally. Even mild perineal tears could cause short- and long-term complications for females. Though many studies of interventions to prevent or treat perineal tears to minimize the consequences have been conducted, however, there is significant heterogeneity in the outcomes measured and reported in existing studies, which makes meaningful comparison difficult and makes the generalizability to clinical practice challenging. Developing a core outcome set (COS) could solve these methodological concerns. In this paper, we report a protocol to develop a COS for clinical trials of mild perineal tears, which shall assist in establishing the evidence base and implementation of effective measures to reduce the incidence and minimize the consequences of mild perineal tears. Methods /Design: The development of this COS will be guided by a study advisory group composed of obstetricians, midwives, nursing managers, service users and methodologists. This study will include four stages: (1) a systematic review of the literature to identify outcomes reported in prior studies; (2) a semi-structured interview with key stakeholders to collect their opinions on important outcomes; (3) a panel of experts will be invited to conduct a three-round Delphi survey to prioritize these outcomes; (4) a consensus meeting with key stakeholders to determine the list of outcomes included in the final COS. Discussion The development of this COS will provide an international standards for the outcomes to be collected and reported in all clinical trials and audits of practice, that involve prevention and treatment of first- and second-degree perineal tears for women with vaginal delivery. This will facilitate comparing and contrasting of studies and allow for combining of appropriate studies with the ultimate goal of improved perineal care for women choosing vaginal delivery.

scholarly journals Development of the CORE-Kids core set of outcome domains for studies of childhood limb fractures

2021 ◽  
pp. 1-10
Author(s):  
Ben A. Marson ◽  
Joseph C. Manning ◽  
Marilyn James ◽  
Simon Craxford ◽  
Sandeep R. Deshmukh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Lower Limb ◽  
Policy Development ◽  
Core Outcome Set ◽  
Delphi Survey ◽  
Core Outcome ◽  
The Core ◽  
Outcome Set ◽  
Core Set ◽  
Limb Fractures

Aims The aim of this study is to develop a core set of outcome domains that should be considered and reported in all future trials of childhood limb fractures. Methods A four-phase study was conducted to agree a set of core outcome domains. Identification of candidate outcome domains were identified through systematic review of trials, and outcome domains relevant to families were identified through semi-structured interviews with 20 families (parent-child pairing or group). Outcome domains were prioritized using an international three-round Delphi survey with 205 panellists and then condensed into a core outcome set through a consensus workshop with 30 stakeholders. Results The systematic review and interviews identified 85 outcome domains as relevant to professionals or families. The Delphi survey prioritized 30 upper and 29 lower limb outcome domains at first round, an additional 17 upper and 18 lower limb outcomes at second round, and four additional outcomes for upper and lower limb at the third round as important domains. At the consensus workshop, the core outcome domains were agreed as: 1) pain and discomfort; 2) return to physical and recreational activities; 3) emotional and psychosocial wellbeing; 4) complications from the injury and treatment; 5) rturn to baseline activities daily living; 6) participation in learning; 7) appearance and deformity; and 8) time to union. In addition, 9a) recovery of mobility and 9b) recovery of manual dexterity was recommended as a core outcome for lower and upper limb fractures, respectively. Conclusion This set of core outcome domains is recommended as a minimum set of outcomes to be reported in all trials. It is not an exhaustive set and further work is required to identify what outcome tools should be used to measure each of these outcomes. Adoption of this outcome set will improve the consistency of research for these children that can be combined for more meaningful meta-analyses and policy 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.

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