Development of a core outcome set for effectiveness studies of breech birth at term (Breech-COS): a systematic review on variations in outcome reporting

IntroductionMyocardial infarction (MI) is the most dangerous complication in patients with coronary heart disease. In China, there is an increasing number of randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating MI. However, the inconsistency of outcome reporting means that a large number of clinical trials cannot be included in systematic reviews to provide the best evidence for clinical practice. The aim of this study is to develop a core outcome set (COS) for future TCM clinical trials of MI, which may improve the consistency of outcome reporting and facilitate the synthesis of data across studies in systematic reviews.Methods and analysisWe will conduct a systematic review of MI clinical trials with any intervention. Semistructured interviews will be conducted to obtain the perspectives of patients with MI. The outcomes from the systematic review and semistructured interviews will be grouped and used to develop a questionnaire. The questionnaire will be developed as a supplement for the TCM syndromes of MI and will be constructed from the results of a systematic review, existing medical records and a cross-sectional study. Then two rounds of the Delphi survey will be conducted with different stakeholders (TCM experts and Western medicine experts in cardiovascular disease, methodologists, magazine editors and patients) to determine the importance of the outcomes. Only the TCM experts will need to response to the questionnaire for core TCM syndromes. A face-to-face consensus meeting will be conducted to create a final COS and recommend measurement time for each outcome.Ethics and disseminationThis project has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine. The final COS will be published and freely available.Trial registration numberThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1243 (available at:http://www.comet-initiative.org/studies/details/1243).

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Development of a Core Outcome Set for Effectiveness Studies of Breech Birth at Term (Breech-COS)- An International Multi-Stakeholder Delphi Study: Study Protocol

10.21203/rs.3.rs-210164/v1 ◽

2021 ◽

Author(s):

Shawn Walker ◽

Tisha Dasgupta ◽

Andrew Shennan ◽

Jane Sandall ◽

Catey Bunce ◽

...

Keyword(s):

Literature Review ◽

Core Outcome Set ◽

Delphi Survey ◽

Neonatal Outcomes ◽

Core Outcome ◽

Care Providers ◽

Outcome Set ◽

Increased Risk ◽

Breech Birth ◽

Effectiveness Studies

Abstract Background: Women pregnant with a breech-presenting foetus at term are at increased risk of adverse pregnancy outcomes. The most common intervention used to improve neonatal outcomes is planned delivery by caesarean section. But this is not always possible, and some women prefer to plan a vaginal birth. A number of providers have proposed alternative interventions, such as delivery protocols or specialist teams, but heterogeneity in reported outcomes and their measurements prevents meaningful comparisons. The aim of this paper is to present a protocol for a study to develop a Breech Core Outcome Set (Breech-COS) for studies evaluating the effectiveness of interventions to improve outcomes associated with term breech birth.Methods: The development of a Breech-COS includes three phases. First, a systematic literature review will be conducted to identify outcomes previously used in effectiveness studies of breech birth at term. A focus group discussion will be conducted with the study’s pre-established Patient and Public Involvement (PPI) group, to enable service user perspectives on the results of literature review to influence the design of Delphi survey instrument. Second, an international Delphi survey will be conducted to prioritize outcomes for inclusion in the Breech-COS from the point of view of key stakeholders, including perinatal care providers and families who have experienced a term breech pregnancy. Finally, a consensus meeting will be held with stakeholders to ratify the Breech-COS and disseminate findings for application in future effectiveness studies.Discussion: The expectation is that the Breech-COS will always be collected in all clinical trials, audits of practice and other forms of observation research that concern breech birth at term, along with other outcomes of interest. This will facilitate comparing, contrasting and combining studies with the ultimate goal of improved maternal and neonatal outcomes. Trial registration: Core Outcome Measures in Effectiveness Trials (COMET): #1749; Core Outcomes in Women’s and Newborn Health (CROWN) Initiative.

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Developing a core outcome set for traumatic brachial plexus injuries: a systematic review of outcomes

BMJ Open ◽

10.1136/bmjopen-2020-044797 ◽

2021 ◽

Vol 11 (7) ◽

pp. e044797

Author(s):

Caroline Miller ◽

Jane Cross ◽

Joel O'Sullivan ◽

Dominic M Power ◽

Derek Kyte ◽

...

Keyword(s):

Systematic Review ◽

Brachial Plexus ◽

Meta Analysis ◽

Core Outcome Set ◽

Core Outcome ◽

Range Of Movement ◽

Outcome Reporting Bias ◽

Outcome Reporting ◽

Outcome Set ◽

Patient Reported

ObjectiveTo identify what outcomes have been assessed in traumatic brachial plexus injury (TBPI) research to inform the development of a core outcome set for TBPI.DesignSystematic review.MethodMedline (OVID), EMBASE, CINAHL and AMED were systematically searched for studies evaluating the clinical effectiveness of interventions in adult TBPIs from January 2013 to September 2018 updated in May 2021. Two authors independently screened papers. Outcome reporting bias was assessed. All outcomes were extracted verbatim from studies. Patient-reported outcomes or performance outcome measures were extracted directly from the instrument. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included studies. Outcomes were categorised into domains using a prespecified taxonomy.ResultsVerbatim outcomes (n=1491) were extracted from 138 studies including 32 questionnaires. Unique outcomes (n=157) were structured into 4 core areas and 11 domains. Outcomes within the musculoskeletal domain were measured in 86% of studies, physical functioning in 25%, emotional functioning in 25% and adverse events in 33%. We identified 63 different methods for measuring muscle strength, 16 studies for range of movement and 63 studies did not define how they measured movement. More than two-thirds of the outcomes were incompletely reported in prospective studies.ConclusionThis review of outcome reporting in TBPI research demonstrated an impairment focus and heterogeneity. A core outcome set would ensure standardised and relevant outcomes are reported to facilitate future systematic review and meta-analysis.PROSPERO registration numberCRD42018109843.

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Developing a core outcome set in interventions to prevent stillbirth: a systematic review on variations of outcome reporting

European Journal of Obstetrics & Gynecology and Reproductive Biology ◽

10.1016/j.ejogrb.2020.12.036 ◽

2020 ◽

Author(s):

Bobae V. Kim ◽

Edoardo C Aromataris ◽

Willem de Lint ◽

Philippa Middleton ◽

Rosemary Townsend ◽

...

Keyword(s):

Systematic Review ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Reporting ◽

Outcome Set

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Do we need a core outcome set for childbirth perineal trauma research? A systematic review of outcome reporting in randomised trials evaluating the management of childbirth trauma

BJOG An International Journal of Obstetrics & Gynaecology ◽

10.1111/1471-0528.15408 ◽

2018 ◽

Vol 125 (12) ◽

pp. 1522-1531 ◽

Cited By ~ 16

Author(s):

V Pergialiotis ◽

C Durnea ◽

A Elfituri ◽

JMN Duffy ◽

SK Doumouchtsis ◽

...

Keyword(s):

Systematic Review ◽

Core Outcome Set ◽

Perineal Trauma ◽

Core Outcome ◽

Randomised Trials ◽

Trauma Research ◽

Outcome Reporting ◽

Childbirth Trauma ◽

Outcome Set

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Outcome Reporting Variability in Trials of Chinese Medicine for Hyperlipidemia: A Systematic Review for Developing a Core Outcome Set

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/8822215 ◽

2021 ◽

Vol 2021 ◽

pp. 1-9

Author(s):

Geng Li ◽

Ruxue Han ◽

Wencong Cao ◽

Zehuai Wen ◽

Xiankun Chen

Keyword(s):

Systematic Review ◽

Chinese Medicine ◽

Total Effective Rate ◽

Core Outcome Set ◽

Density Lipoprotein ◽

Effective Rate ◽

Lipoprotein Cholesterol ◽

Core Outcome ◽

Outcome Reporting ◽

Outcome Set

Introduction. Hyperlipidemia is an underlying process behind cardiovascular disease. Chinese medicine (CM) may be effective in treating hyperlipidemia, but there is a lack of studies with high methodological quality. A major reason for this is heterogeneity in outcome reporting. Therefore, this study explores the degree of outcome reporting variation in CM trials for hyperlipidemia. It then generates a list of potentially important outcomes for developing a core outcome set (COS). Methods. A systematic review of literature focusing on studies of CM for hyperlipidemia was conducted. Outcomes were listed verbatim and grouped into 8 domains. Outcome frequency and definition uniformity were analyzed. Results. 3,702 studies and 452 individual outcomes were identified. These outcomes were reported 27,328 times, of which 1.6% were reported as primary outcomes, and 13.3% were defined. The most frequent outcome was total triglyceride, represented in 86.7% of the studies, followed by total cholesterol (86.0%), total effective rate (75.1%), high-density lipoprotein cholesterol (73.2%), and low-density lipoprotein cholesterol (60.5%). However, 43.6% of outcomes were reported only once. The largest outcome domain was “pathological or pathophysiological outcomes,” which included 67.0% of outcomes. Of the “response rate related outcomes” domain, total effective rate was the most frequently reported outcome (n = 2,780), and 95.3% of the studies gave a clear definition. However, these definitions were often contradictory. Only 10 papers reported cardiovascular events, 3 of which referred to them as primary outcomes. Moreover, ten patient-reported outcomes were reported in the retrieved literature 19 times in total. The majority of the outcomes did not report measurement instruments (MIs) (269/453, 59.4%). MIs of the surrogate outcomes were reported more frequently. Conclusion. Outcome reporting in CM trials for hyperlipidemia is inconsistent and ill-defined, creating barriers to data synthesis and comparison. Thus, we propose and are developing a COS for CM trials for hyperlipidemia.

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