A core outcome set for localised prostate cancer effectiveness trials: protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey

Aims To identify a suite of the key physical, emotional, and social outcomes to be employed in clinical practice and research concerning Perthes' disease in children. Methods The study follows the guidelines of the COMET-Initiative (Core Outcome Measures in Effectiveness Trials). A systematic review of the literature was performed to identify a list of outcomes reported in previous studies, which was supplemented by a qualitative study exploring the experiences of families affected by Perthes’ disease. Collectively, these outcomes formed the basis of a Delphi survey (two rounds), where 18 patients with Perthes’ disease, 46 parents, and 36 orthopaedic surgeons rated each outcome for importance. The International Perthes Study Group (IPSG) (Dallas, Texas, USA (October 2018)) discussed outcomes that failed to reach any consensus (either ‘in’ or ‘out’) before a final consensus meeting with representatives of surgeons, patients, and parents. Results In total, 23 different outcome domains were identified from the systematic review, and a further ten from qualitative interviews. After round one of the Delphi survey, participants suggested five further outcome domains. A total of 38 outcomes were scored in round two of the Delphi. Among these, 16 outcomes were scored over the prespecified 70% threshold for importance (divided into six main categories: adverse events; life impact; resource use; pathophysiological manifestations; death; and technical considerations). Following the final consensus meeting, 14 outcomes were included in the final Core Outcome Set (COS). Conclusion Core Outcome Sets (COSs) are important to improve standardization of outcomes in clinical research and to aid communication between patients, clinicians, and funding bodies. The results of this study should be a catalyst to develop high-quality clinical research in order to determine the optimal treatments for children with Perthes’ disease. Cite this article: Bone Joint J 2020;102-B(5):611–617.

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Development of a core outcome set for clinical trials in basal cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Trials ◽

10.1186/s13063-017-2244-5 ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 16

Author(s):

Daniel I. Schlessinger ◽

Sanjana Iyengar ◽

Arianna F. Yanes ◽

Jake M. Lazaroff ◽

Victoria Godinez-Puig ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Basal Cell Carcinoma ◽

Cell Carcinoma ◽

Study Protocol ◽

Basal Cell ◽

Core Outcome Set ◽

Core Outcome ◽

Review Of The Literature ◽

Outcome Set

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A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey

Trials ◽

10.1186/s13063-016-1666-9 ◽

2016 ◽

Vol 17 (1) ◽

Cited By ~ 17

Author(s):

Lauren E. Kelly ◽

Lauren M. Jansson ◽

Wendy Moulsdale ◽

Jodi Pereira ◽

Sarah Simpson ◽

...

Keyword(s):

Systematic Review ◽

Study Protocol ◽

Core Outcome Set ◽

Delphi Survey ◽

Neonatal Abstinence Syndrome ◽

Core Outcome ◽

Abstinence Syndrome ◽

Outcome Set

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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

10.21203/rs.3.rs-625834/v1 ◽

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.

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