Outcome reporting in trials on conservative interventions for Pelvic Organ Prolapse: A systematic review for the development of a core outcome set

2021 ◽  
Author(s):  
Kimmee Khan ◽  
Maria Rada ◽  
Abdullatif Elfituri ◽  
Cornelia Betschart ◽  
Gabriele Falconi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Pelvic Organ Prolapse ◽  
Core Outcome Set ◽  
Pelvic Organ ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Outcome Set

scholarly journals Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032256 ◽  
Author(s):  
Ruijin Qiu ◽  
Changming Zhong ◽  
Songjie Han ◽  
Tianmai He ◽  
Ya Huang ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Systematic Review ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Outcome Set ◽  
Semistructured Interviews

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).

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

BMJ Open ◽  
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.

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

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.

scholarly journals Heterogeneous outcome reporting in adult slow‐transit constipation studies: Systematic review towards a core outcome set

2019 ◽  
Vol 35 (2) ◽  
pp. 192-203
Author(s):  
Stella C M Heemskerk ◽  
Adriënne H Rotteveel ◽  
Jarno Melenhorst ◽  
Stéphanie O Breukink ◽  
Merel L Kimman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Core Outcome Set ◽  
Slow Transit Constipation ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Outcome Set ◽  
Slow Transit ◽  
Transit Constipation

scholarly journals Heterogeneity in outcome selection, definition and measurement in studies assessing the treatment of cryptoglandular anal fistula: findings from a systematic review

2021 ◽  
Author(s):  
A. J. H. M. Machielsen ◽  
N. Iqbal ◽  
M. L. Kimman ◽  
K. Sahnan ◽  
S. O. Adegbola ◽  
...  
Keyword(s):  
Systematic Review ◽  
Anal Fistula ◽  
Outcome Measurement ◽  
Core Outcome Set ◽  
Adult Patients ◽  
Cochrane Library ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Outcome Reporting ◽  
Outcome Set

Abstract Background Treatment for cryptoglandular anal fistula (AF) is challenging and a lack of uniform outcomes in the literature prevents direct comparison of treatments. This can be addressed by developing a core outcome set, a standardised set of outcomes reported in all interventional studies for a specific condition. The aim of this systematic review is to assess the range of outcomes, their definitions, and the measurement instruments currently utilised in interventional studies for adult patients with AF. This will inform the development of an AF core outcome set. Methods Medline, Embase and The Cochrane Library were searched to identify all patient- and clinician-reported outcomes in studies assessing medical, surgical or combination treatment of adult patients with AF published from January 2008 to May 2020. The resulting outcomes were categorized according to the Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to better understand their distribution. Results In total, 155 studies were included, 552 outcomes were extracted, with a median of three outcomes (interquartile range 2–5) per study. Only 25% of studies demonstrated high-quality outcome reporting. The outcomes were merged into 52 unique outcomes and structured into four core areas and 14 domains, with the majority in the domain of physiological or clinical (gastrointestinal) outcomes. The most commonly reported outcomes were healing (77%), incontinence (63%), and recurrence (40%), with no single outcome assessed across all studies. There was a wide variation in outcome definitions and measurement instruments used. Conclusions There is substantial heterogeneity in outcomes, definitions, and measurement instruments reported in interventional studies for cryptoglandular anal fistula. This emphasises the need for standardised outcome reporting and measurement.

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