The key elements and application of a master protocol in the development of the core outcome set

Qiu, Ruijin; Wan, Siqi; Guan, Zhiyue; Zhang, Xinyi; Han, Seongwook; Li, Min; Hu, Jian; Chen, Zhao; Chen, Lingxin; Chen, Jing; Shang, Hongcai

doi:10.1111/jebm.12500

Cited by 2 publications

(3 citation statements)

References 46 publications

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“…The generation of a COS can enhance intervention evaluation and evidence synthesis, reduce methodological issues in clinical trials (such as selective outcome reporting, outcome heterogeneity and research waste), and improve research transparency (Chalmers & Glasziou, 2009; Qiu et al., 2022; Schmitt et al., 2019; Williamson et al., 2017); and the additional benefit of developing COS for clinical practice has been emphasized (Clarke, 2008). These benefits support the development of a COS for each health condition or specialty.…”

Section: Discussionmentioning

confidence: 99%

“…The GRADE (Grading of Recommendations Assessment, Development and Evaluation) group, supported by Cochrane and the World Health Organization (WHO), for the development of guideline recommendations (Rosenbaum et al., 2010) has acknowledged the need to identify a relevant COS for use in the research that will underpin those recommendations. Where a COS does not exist, the development requires rigorous, established methodology involving appropriate stakeholders, including patients (Qiu et al., 2022; Williamson et al., 2012).…”

Section: Introductionmentioning

confidence: 99%

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An international consensus study to identify “what” outcomes should be included in a core outcome set for endodontic treatments (COSET) for utilization in clinical practice and research

El Karim,

Duncan,

Cushley

et al. 2023

Int Endodontic J

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BackgroundDevelopment of a standardized set of topic‐specific outcomes known as a Core Outcome Set (COS) is important to address issues of heterogeneity in reporting research findings in order to streamline evidence synthesis and clinical decision making.AimThe aim of the current international consensus study is to identify “what” outcomes to include in the Core Outcome Set for Endodontic Treatments (COSET). Outcomes of various endodontic treatments (non‐surgical root canal treatment, surgical endodontics, vital pulp treatment and revitalization procedures) performed on permanent teeth were considered.MethodsA standard validated methodology for COS development and reporting was adopted. The process involved identification of existing outcomes through four published scoping reviews. This enabled creation of a list of outcomes to be prioritized via semi‐structured patient interviews, e‐Delphi process and a consensus meeting with a range of relevant global stakeholders. Outcomes were prioritized using a 1–9 Likert scale, with outcomes rated 7–9 considered critical, 4–6 are important and 1–3 are less important. Outcomes rated 7–9 by ≥70% and 1–3 by <15% of participants were considered to achieve consensus for inclusion in the COS. The outcomes that did not achieve consensus in the first round were considered for further prioritization in the second Delphi round and consensus meeting. Final decisions about the outcomes to include in COSET were made by voting during the consensus panel meeting using the Zoom Poll function.ResultsA total of 95 participants including patients contributed to the COS development process. The consensus panel recommended, with strong consensus, eight outcomes shared across all treatment modalities for inclusion in COSET: pain; signs of infection (swelling, sinus tract); further intervention/exacerbation; tenderness to percussion/palpation; radiographic evidence of disease progression/healing; function; tooth survival; and patient satisfaction. Additional treatment specific outcomes were also recommended.DiscussionMany of the outcomes included in COSET are patient reported. All should be included in future outcomes studies.ConclusionCOSET identified outcomes that are important for patients and clinicians and validated these using a rigorous methodology. Further work is ongoing to determine “how” and “when” these outcomes should be measured.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

An international consensus study to identify “what” outcomes should be included in a core outcome set for endodontic treatments (COSET) for utilization in clinical practice and research

El Karim,

Duncan,

Cushley

et al. 2023

Int Endodontic J

View full text Add to dashboard Cite

show abstract

“…Te COS is a collection of the smallest and most important outcomes that should be measured and reported in a trial in the same health problem or social care area [27,28]. It aims to improve research utility by involving stakeholders' perspectives and reducing inconsistency, reporting bias, and research waste [29][30][31][32]. In recent years, with the continuous application of new technologies in nursing education, implementing new RCTs requires the standardisation of outcomes.…”

Section: Introductionmentioning

confidence: 99%

Development of a Core Outcome Set for Randomised Controlled Trials of Nursing Education: A Methodological Framework

Chen

Luo

Yang

et al. 2023

Journal of Nursing Management

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Background. Nursing educational research is very important for the development of the nursing discipline. There have been many randomised controlled trials (RCTs) of nursing education, and the outcomes are highly heterogeneous and waste resources. The study aims to report the methodological framework to establish a core outcome set (COS) for RCTs of nursing education. Methods. The study will be conducted in the following five steps: (a) establish nursing education COS working groups; (b) develop an initial list of outcomes of nursing education by systematic review and semistructured interview; (c) Delphi survey with different stakeholders to reach a preliminary consensus on the core outcome of nursing education; (d) expert consultation to form the outcome pool; (e) expert consensus meeting to form the nursing education COS. Results. The goal is to develop a COS that includes stakeholders’ interest in nursing education to determine which outcomes should be reported and how they should be measured. Conclusions. By performing the study, the nursing education COS will be established, which will help to reduce reporting bias and resource waste, and provide enough results for nursing education systematic reviews.

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The key elements and application of a master protocol in the development of the core outcome set

Cited by 2 publications

References 46 publications

An international consensus study to identify “what” outcomes should be included in a core outcome set for endodontic treatments (COSET) for utilization in clinical practice and research

An international consensus study to identify “what” outcomes should be included in a core outcome set for endodontic treatments (COSET) for utilization in clinical practice and research

Development of a Core Outcome Set for Randomised Controlled Trials of Nursing Education: A Methodological Framework

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