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.

scholarly journals Outcomes and outcomes measurements used in intervention studies of pelvic girdle pain and lumbopelvic pain: a systematic review

2019 ◽  
Vol 27 (1) ◽  
Author(s):  
Francesca Wuytack ◽  
Maggie O’Donovan
Keyword(s):  
Systematic Review ◽  
Intervention Studies ◽  
Core Outcome Set ◽  
Pelvic Girdle ◽  
Pelvic Girdle Pain ◽  
Cochrane Library ◽  
Core Outcome ◽  
Outcome Set ◽  
Pregnancy And Postpartum

Abstract Background Pelvic girdle pain is a common problem during pregnancy and postpartum with significant personal and societal impact and costs. Studies examining the effectiveness of interventions for pelvic girdle pain measure different outcomes, making it difficult to pool data in meta-analysis in a meaningful and interpretable way to increase the certainty of effect measures. A consensus-based core outcome set for pelvic girdle pain can address this issue. As a first step in developing a core outcome set, it is essential to systematically examine the outcomes measured in existing studies. Objective The objective of this systematic review was to identify, examine and compare what outcomes are measured and reported, and how outcomes are measured, in intervention studies and systematic reviews of interventions for pelvic girdle pain and for lumbopelvic pain (which includes pelvic girdle pain). Methods We searched PubMed, Cochrane Library, PEDro and Embase from inception to the 11th May 2018. Two reviewers independently selected studies by title/abstract and by full text screening. Disagreement was resolved through discussion. Outcomes reported and their outcome measurement instruments were extracted and recorded by two reviewers independently. We assessed the quality of reporting with two independent reviewers. The outcomes were grouped into core domains using the OMERACT filter 2.0 framework. Results A total of 107 studies were included, including 33 studies on pelvic girdle pain and 74 studies on lumbopelvic pain. Forty-six outcomes were reported across all studies, with the highest amount (26/46) in the ‘life impact’ domain. ‘Pain’ was the most commonly reported outcome in both pelvic girdle pain and lumbopelvic pain studies. Studies used different instruments to measure the same outcomes, particularly for the outcomes pain, function, disability and quality of life. Conclusions A wide variety of outcomes and outcome measurements are used in studies on pelvic girdle pain and lumbopelvic pain. The findings of this review will be included in a Delphi survey to reach consensus on a pelvic girdle pain - core outcome set. This core outcome set will allow for more effective comparison between future studies on pelvic girdle pain, allowing for more effective translation of findings to clinical practice.

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 A Core Outcome Set for Nonpharmacological Community-Based Interventions for People Living With Dementia at Home: A Systematic Review of Outcome Measurement Instruments

2020 ◽  
Author(s):  
Andrew J E Harding ◽  
Hazel Morbey ◽  
Faraz Ahmed ◽  
Carol Opdebeeck ◽  
Ruth Elvish ◽  
...  
Keyword(s):  
Outcome Measurement ◽  
Core Outcome Set ◽  
Face Validity ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Community Based Interventions ◽  
Community Based ◽  
Key Stakeholders ◽  
Outcome Set ◽  
Dementia Research

Abstract Background and Objectives It is questionable whether existing outcome measurement instruments (OMIs) in dementia research reflect what key stakeholders’ value. We attained consensus from more than 300 key stakeholders, including people living with dementia, and identified 13 core outcome items for use in nonpharmacological and community-based interventions for people with dementia living at home. In this systematic review, we review OMIs that have previously been used in dementia care research to determine how, or even if, the 13 core outcome items can be measured. Research Design and Methods We extracted self-reported OMIs from trials, reviews, and reports of instrument development. Searches were undertaken in the ALOIS database, MEDLINE, PsycINFO, CINAHL, SocINDEX, and COSMIN databases. We aimed to assess the psychometric properties of OMI items for face validity with the core outcome items, content validity, internal consistency, and responsiveness. We held a coresearch workshop involving people living with dementia and care partners in order to ratify the findings. Results In total 347 OMIs were located from 354 sources. Of these, 76 OMIs met the inclusion criteria. No OMIs were deemed to have sufficient face validity for the core outcome set (COS) items, and no OMIs proceeded to further assessment. The “best” available OMI is the Engagement and Independence in Dementia Questionnaire. Discussion and Implications This study provides a practical resource for those designing dementia research trials. Being able to measure the COS items would herald a paradigm shift for dementia research, be responsive to what key stakeholders value and enhance the ability to make comparisons.

scholarly journals How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

Trials ◽  
2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Cecilia A. C. Prinsen ◽  
Sunita Vohra ◽  
Michael R. Rose ◽  
Maarten Boers ◽  
Peter Tugwell ◽  
...  
Keyword(s):  
Outcome Measurement ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Practical Guideline ◽  
Outcome Set

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 Developing a core outcome set for paediatric wrist fractures: a systematic review of prior outcomes

2020 ◽  
Vol 1 (5) ◽  
pp. 121-130
Author(s):  
Benjamin Thomas Crosby ◽  
Abolfazl Behbahani ◽  
Olivia Olujohungbe ◽  
Ben Cottam ◽  
Daniel Perry
Keyword(s):  
Outcome Measures ◽  
Core Outcome Set ◽  
Clinical Effectiveness ◽  
Wrist Fracture ◽  
Cochrane Library ◽  
Core Outcome ◽  
Measurement Instruments ◽  
Range Of Movement ◽  
Wrist Fractures ◽  
Outcome Set

Objectives This review aims to summarize the outcomes used to describe effectiveness of treatments for paediatric wrist fractures within existing literature. Method We searched the Cochrane Library, Scopus, and Ovid Medline for studies pertaining to paediatric wrist fractures. Three authors independently identified and reviewed eligible studies. This resulted in a list of outcome domains and outcomes measures used within clinical research. Outcomes were mapped onto domains defined by the COMET collaborative. Results Our search terms identified 4,262 different papers. Screening of titles excluded 2,975, leaving 1,287 papers to be assessed for eligibility. Of this 1,287, 30 studies were included for full analysis. Overall, five outcome domains, 16 outcome measures, and 28 measurement instruments were identified as outcomes within these studies. 24 studies used at least one measurement pertaining to the physiological/clinical outcome domain. The technical, life impact, and adverse effect domains were recorded in 23, 20, and 11 of the studies respectively. Within each domain it was common for different measurement instruments to be used to assess each outcome measure. The most commonly reported outcome measures were range of movement, a broad array of “radiological measures” and pain intensity, which were used in 24, 23, and 12 of the 30 studies. Conclusion This study highlights the heterogeneity in outcomes reported within clinical effectiveness studies of paediatric wrist fractures. We provided an overview of the types of outcomes reported in paediatric wrist fracture studies and identified a list of potentially relevant outcomes required for the development of a core outcome set.

scholarly journals Establishing a core outcome set for mucopolysaccharidoses (MPS) in children: study protocol for a rapid literature review, candidate outcomes survey, and Delphi surveys

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alison H. Howie ◽  
Kylie Tingley ◽  
Michal Inbar-Feigenberg ◽  
John J. Mitchell ◽  
Nancy J. Butcher ◽  
...  
Keyword(s):  
Literature Review ◽  
Health Care Providers ◽  
Metabolic Diseases ◽  
Outcome Measurement ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Care Providers ◽  
Measurement Instruments ◽  
Two Phase ◽  
Outcome Set

Abstract Background Mucopolysaccharidoses (MPS) are a group of inherited metabolic diseases characterized by chronic, progressive multi-system manifestations with varying degrees of severity. Disease-modifying therapies exist to treat some types of MPS; however, they are not curative, underscoring the need to identify and evaluate co-interventions that optimize functioning, participation in preferred activities, and quality of life. A Canadian pediatric MPS registry is under development and may serve as a platform to launch randomized controlled trials to evaluate such interventions. To promote the standardized collection of patient/family-reported and clinical outcomes considered important to patients/families, health care providers (HCPs), and policymakers, the choice of outcomes to include in the registry will be informed by a core outcome set (COS). We aim to establish a patient-oriented COS for pediatric MPS using a multi-stakeholder approach. Methods In step 1 of the six-step process to develop the COS, we will identify relevant outcomes through a rapid literature review and candidate outcomes survey. A two-phase screening approach will be implemented to identify eligible publications, followed by extraction of outcomes and other pre-specified data elements. Simultaneously, we will conduct a candidate outcomes survey with children with MPS and their families to identify outcomes most important to them. In step 2, HCPs experienced in treating patients with MPS will be invited to review the list of outcomes generated in step 1 and identify additional clinically relevant outcomes. We will then ask patients/families, HCPs, and policymakers to rate the outcomes in a set of Delphi Surveys (step 3), and to participate in a subsequent consensus meeting to finalize the COS (step 4). Step 5 involves establishing a set of outcome measurement instruments for the COS. Finally, we will disseminate the COS to knowledge users (step 6). Discussion The proposed COS will inform the choice of outcomes to include in the MPS registry and, more broadly, promote the standardized collection of patient-oriented outcomes for pediatric MPS research. By involving patients/families from the earliest stage of the research, we will ensure that the COS will be relevant to those who will ultimately benefit from the research. Trial registration PROSPERO CRD42021267531, COMET

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