Can a core outcome set improve the quality of systematic reviews? – a survey of the Co-ordinating Editors of Cochrane review groups

ObjectivesA core outcome set (COS) is an agreed standardised minimum collection of outcomes that should be measured and reported in research in a specific area of health. Cochrane systematic reviews (‘reviews’) are rigorous reviews on health-related topics conducted under the auspices of Cochrane. This study examines the use of existing COS to inform the choice of outcomes in Cochrane systematic reviews (‘reviews’) and investigates the views of the coordinating editors of Cochrane Review Groups (CRGs) on this topic.MethodsA cohort of 100 recently published or updated Cochrane reviews were assessed for reference to a COS being used to inform the choice of outcomes for the review. Existing COS, published 2 or more years before the review publication, were then identified to assess how often a reviewer could have used a relevant COS if it was available. We asked 52 CRG coordinating editors about their involvement in COS development, how outcomes are selected for reviews in their CRG and their views of the advantages and challenges surrounding the standardisation of outcomes within their CRG.ResultsIn the cohort of reviews from 2019, 40% (40/100) of reviewers noted problems due to outcome inconsistency across the included studies. In 7% (7/100) of reviews, a COS was referenced in relation to the choice of outcomes for the review. Relevant existing COS could be considered for a review update in 35% of the others (33/93). Most editors who responded (31/36, 86%) thought that COS should definitely or possibly be used to inform the choice of outcomes in a review.ConclusionsSystematic reviewers are continuing to note outcome heterogeneity but are starting to use COS to inform their reviews. There is potential for greater uptake of COS in Cochrane reviews.

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Patient-Reported Outcomes in Inflammatory Bowel Disease: A Measurement of Effect in Research and Clinical Care

Gastroenterology Insights ◽

10.3390/gastroent12020020 ◽

2021 ◽

Vol 12 (2) ◽

pp. 225-237

Author(s):

Jane Fletcher ◽

Sheldon C. Cooper ◽

Amelia Swift

Keyword(s):

Inflammatory Bowel Disease ◽

Systematic Reviews ◽

Bowel Disease ◽

Core Outcome Set ◽

Core Outcome ◽

Health Measurement ◽

Outcome Set ◽

Patient Reported ◽

Inflammatory Bowel ◽

Selection Of

The measurement of outcomes is key in evaluating healthcare or research interventions in inflammatory bowel disease (IBD). In patient-centred care, patient-reported outcome measures (PROMs) are central to this evaluation. In this review, we provide an overview of validated, adult disease-specific PROMs developed for use in IBD. Our aim is to assist clinicians and researchers in selection of PROMs to measure outcomes in their patient cohort. The Consensus-based Standards for the Selection of Health Measurement Instruments database of systematic reviews was the primary resource used to identify PROMs used in IBD. Search terms were ‘Crohn’s disease’, ‘ulcerative colitis’, and ‘IBD’. Seven systematic reviews were identified from this search. In addition, the publication by the IBD Core Outcome Set Working Group was used to identify further PROMs. Three systematic reviews were excluded as they did not meet the inclusion criteria. From the five included systematic reviews, we identified 21 PROMs and their shortened versions. In conclusion, it does not appear that any one PROM is entirely suitable for both research and clinical practice. Overall, the IBDQ-32 is most widely used in research but has the limitation of cost, whereas the IBD-Control has been recommended in the clinical core outcome set.

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Efficacy and Safety Outcomes in Systematic Reviews of Interventions for Postoperative Pain in Children: Comparison Against the Recommended Core Outcome Set

Pain Medicine ◽

10.1093/pm/pnx255 ◽

2017 ◽

Vol 19 (11) ◽

pp. 2316-2321 ◽

Cited By ~ 5

Author(s):

Krste Boric ◽

Svjetlana Dosenovic ◽

Antonia Jelicic Kadic ◽

Matija Boric ◽

Milka Jeric ◽

...

Keyword(s):

Postoperative Pain ◽

Systematic Reviews ◽

Core Outcome Set ◽

Core Outcome ◽

Efficacy And Safety ◽

Outcome Set ◽

Safety Outcomes

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

Chiropractic & Manual Therapies ◽

10.1186/s12998-019-0279-2 ◽

2019 ◽

Vol 27 (1) ◽

Cited By ~ 2

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.

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Outcomes reported on the management of COPD exacerbations: a systematic survey of randomised controlled trials

ERJ Open Research ◽

10.1183/23120541.00072-2019 ◽

2019 ◽

Vol 5 (2) ◽

pp. 00072-2019 ◽

Cited By ~ 6

Author(s):

Alexander G. Mathioudakis ◽

Mia Moberg ◽

Julie Janner ◽

Pablo Alonso-Coello ◽

Jørgen Vestbo

Keyword(s):

Outcome Measures ◽

Systematic Reviews ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Controlled Trials ◽

Significant Heterogeneity ◽

Core Outcome ◽

Copd Exacerbations ◽

Outcome Set ◽

Randomised Controlled

Randomised controlled trials (RCTs) evaluating the management of acute exacerbations of chronic obstructive pulmonary disease (COPD) report heterogeneous outcome measures, thus rendering their results incomparable, complicating their translation into clinical practice. As a first step in the development of a core outcome set that will aim to homogenise outcome measures in future RCTs, we assessed the outcomes reported in recent relevant RCTs and systematic reviews.We conducted a methodological systematic review (https://www.crd.york.ac.uk/prospero/ registration number CRD42016052437) of RCTs and systematic reviews on COPD exacerbation management indexed on Medline and PubMed during the last decade. We evaluated their methodology, specifically focusing on the reported outcome measures.Based on 123 RCTs and 38 systematic reviews, we found significant variability in the outcomes reported and in their definition. Mortality, which was assessed in 82% of the included trials, was the most frequently assessed outcome, followed by the rate of treatment success or failure (63%), adverse events (59%), health status, symptoms and quality of life (59%), lung function (47%), and duration of exacerbations (42%).The significant heterogeneity in the selection and definition of outcome measures in RCTs and systematic reviews limits the interpretability and comparability of their results, and warrants the development of a core outcome set for COPD exacerbations management.

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Development of a Core Set of Patient-Reported Outcomes for Population-Based Cancer Survivorship Research: Protocol for an Australian Consensus Study

JMIR Research Protocols ◽

10.2196/14544 ◽

2020 ◽

Vol 9 (1) ◽

pp. e14544 ◽

Cited By ~ 1

Author(s):

Imogen Ramsey ◽

Nadia Corsini ◽

Amanda D Hutchinson ◽

Julie Marker ◽

Marion Eckert

Keyword(s):

Cancer Survivors ◽

Cancer Survivorship ◽

Phase Ii ◽

Core Outcome Set ◽

Population Based ◽

Core Outcome ◽

The Core ◽

Outcome Set ◽

Core Set

Background Core outcome sets seek to improve the consistency and quality of research by providing agreed-upon recommendations regarding what outcomes should be measured as a minimum for a population and setting. The problems arising from a lack of outcome standardization in population-based cancer survivorship research indicate the need for agreement on a core set of patient-reported outcomes (PROs) to enhance data quality, consistency, and comparability. Objective This study aims to identify a core set of PROs, representing the most important issues impacting on cancer survivors' long-term health, functioning and quality of life, to inform population-based research on cancer survivorship. Methods In Phase I, a list of all potentially important outcomes will be generated through focus group discussions with cancer survivors and a review of measures for assessing quality of life in cancer survivorship. The consolidated list will be advanced to Phase II, where a stakeholder consensus process will be conducted with national experts in cancer survivorship to refine and prioritize the outcomes into a core outcome set. The process will consist of a two-round Delphi survey and a consensus meeting. Cancer survivors, oncology health care professionals, and potential end users of the core outcome set with expertise in cancer survivorship research or policy will be invited to participate. In Phase III, recommended measures for assessment of the core outcome set will be selected with advice from experts on the assessment, analysis, and interpretation of PROs. Results As of April 2019, data collection for Phase I is complete and data analysis is underway. These data will inform the list of outcomes to be advanced into Phase II. Recruitment for Phase II will commence in June 2019, and it is anticipated that it will take 6 months to complete the three-step consensus process and identify a provisional core outcome set. The study results are expected to be published in early 2020. Conclusions Expert consensus-driven recommendations on outcome measurement will facilitate the inclusion of survivorship outcomes considered important by cancer survivors and health professionals in future research. Adoption of the core outcome set will enable comparison and synthesis of evidence across studies and enhance the quality of PRO data collected in cancer survivorship research, particularly when applied to address macro-level questions. International Registered Report Identifier (IRRID) DERR1-10.2196/14544

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Development of a Core Outcome Set for Fetal MyelomenIngoCele (COSMiC): study protocol

10.21203/rs.2.21011/v1 ◽

2020 ◽

Author(s):

Samar Altoukhi ◽

Clare L Whitehead ◽

Greg Ryan ◽

Jan Deprest ◽

Luc Joyeux ◽

...

Keyword(s):

Clinical Practice ◽

Systematic Reviews ◽

Core Outcome Set ◽

Fetal Surgery ◽

Second Phase ◽

Core Outcome ◽

Outcome Reporting ◽

Ventriculoperitoneal Shunting ◽

Outcome Set

Abstract Background: Open spina bifida (OSB) is one of the most common congenital central nervous system defects and leads to long-term physical and cognitive disabilities. Open fetal surgery for OSB improves neurological outcomes and reduces the need for ventriculoperitoneal shunting, compared to postnatal surgery, at the expense of increased prematurity. It however confers significant morbidity to the mother in the index pregnancy and potential risks to future pregnancies. Fetoscopic surgery may prevent maternal morbidity yet the question remains whether the procedure is neuroprotective and reduces prematurity. Comparison of outcomes between different treatment options is challenging due to inconsistent outcome reporting. We aim to develop and disseminate a core outcome set (COS) for fetal OSB, to ensure that outcomes relevant to all stakeholders are collected and reported in a standardised fashion in future studies. Methods: The COS will be developed using a validated Delphi methodology. A systematic literature review will be performed to identify previously reported outcomes focused on prenatally diagnosed OSB. Outcomes assessed will include maternal (primary and subsequent pregnancies), fetal, neonatal and childhood to adolescence. In a second phase, semi-structured interviews with stakeholders will be performed to ensure representation of additional relevant outcomes that may not have been reported in the literature. We will include patients and parents, as well as health professionals involved in the care of these pregnancies and children (fetal medicine specialists, fetal surgeons, neonatologists/paediatricians, and allied health). Subsequently, an international group of key stakeholders will rate the importance of the identified outcomes using three sequential, online, rounds of a modified Delphi Survey. Final agreement on outcomes to be included in the COS, their definition and measurement will be achieved through a final face-to-face consensus meeting with all stakeholder groups represented. Dissemination of the final COS will be ensured through different media and relevant societies. Discussion: Development and implementation of a COS for fetal OSB will ensure consistent outcome reporting in future clinical trials, systematic reviews, and clinical practice guidelines. This will lead to higher quality research, better evidence-based clinical practice and ultimately improved maternal, fetal and long term childhood outcomes. Trial registration: Core Outcome Measures in Effectiveness Trials (COMET): 1187. International Prospective Register of Systematic Reviews (PROSPERO): CRD42018104880.

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Treatment of Chronic Pulmonary Heart Disease with Traditional Chinese Medicine: A Protocol for the Development of a Core Outcome Set (COS-TCM-CPHD)

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/5559883 ◽

2021 ◽

Vol 2021 ◽

pp. 1-7

Author(s):

Bohan Niu ◽

Mingyan Zhang ◽

Hui Zi Chua ◽

Kai Li ◽

Junhua Zhang

Keyword(s):

Decision Making ◽

Heart Disease ◽

Core Outcome Set ◽

Evidence Based ◽

Core Outcome ◽

Stakeholder Groups ◽

Pulmonary Heart Disease ◽

Outcome Set ◽

Chronic Pulmonary Heart Disease

Background. Treatment of chronic pulmonary heart disease (CPHD), a common disease, has over recent years been studied using traditional Chinese medicine (TCM) due to many high-profile benefits. These can be evaluated by the measurement and analysis of related outcomes. Because of selective reporting bias and the heterogeneity of study outcomes, it is not possible to combine similar studies in a meta-analysis. Consequently, not only does the low quality of original studies fails to support evidence-based decision-making, but also the value of those clinical studies cannot be evaluated. To solve these problems, the development of a core outcome set for traditional Chinese medicines for the treatment of chronic pulmonary heart disease (COS-TCM-CPHD) is required. Methods. The development is conducted in five steps: (1) a library of outcomes through systematic review, the retrieval of libraries from two clinical trials registries, and semistructured interviews is established; (2) following data extraction and analysis of the library of outcomes, each outcome can be classified into seven outcome domains, including TCM disease, symptoms/signs, physical and chemical testing, quality of life, long-term prognosis, economic evaluation, and adverse events to form a preliminary list of outcomes; (3) stakeholder groups for participation are selected; (4) stakeholder groups are invited to participate in two rounds of Delphi surveys to score outcomes and provide additional outcomes; (5) a consensus meeting is organized to produce the final COS-TCM-CPHD. Discussion. The protocol is consistent with the guidelines defined by the Core Outcome Set-STAndardised Protocol (COS-STAP) statement and formulated with reference to Core Outcome Set-STAndards for development (COS-STAD). The COS-TCM-CPHD will improve the consistency of study reports and reduce publication bias, thereby improving the quality of TCM clinical trials and decision-making for evidence-based medicine. The study has been registered on the COMET website (http://www.comet-initiative.org/Studies/Details/1677).

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Development of a Core Outcome Set for Fetal MyelomenIngoCele (COSMiC): study protocol

10.21203/rs.2.21011/v2 ◽

2020 ◽

Author(s):

Samar Altoukhi ◽

Clare L Whitehead ◽

Greg Ryan ◽

Jan Deprest ◽

Luc Joyeux ◽

...

Keyword(s):

Clinical Practice ◽

Systematic Reviews ◽

Maternal Morbidity ◽

Core Outcome Set ◽

Significant Risk ◽

Second Phase ◽

Core Outcome ◽

Outcome Reporting ◽

Outcome Set

Abstract Background: Open spina bifida (OSB) is one of the most common congenital central nervous system defects and leads to long-term physical and cognitive disabilities. Open fetal surgery for OSB improves neurological outcomes and reduces the need for ventriculoperitoneal shunting, compared to postnatal surgery, but is associated with a significant risk of prematurity and maternal morbidity. Fetoscopic surgery comes with less maternal morbidity yet the question remains whether the procedure is neuroprotective and reduces prematurity. Comparison of outcomes between different treatment options is challenging due to inconsistent outcome reporting. We aim to develop and disseminate a core outcome set (COS) for fetal OSB, to ensure that outcomes relevant to all stakeholders are collected and reported in a standardised fashion in future studies. Methods: The COS will be developed using a validated Delphi methodology. A systematic literature review will be performed to identify outcomes previously reported for prenatally diagnosed OSB. We will assess will maternal (primary and subsequent pregnancies), fetal, neonatal and childhood outcomes until adolescence. In a second phase, we will conduct semi-structured interviews with stakeholders, to ensure representation of additional relevant outcomes that may not have been reported in the literature. We will include patients and parents, as well as health professionals involved in the care of these pregnancies and children (fetal medicine specialists, fetal surgeons, neonatologists/paediatricians, and allied health). Subsequently, an international group of key stakeholders will rate the importance of the identified outcomes using three sequential online rounds of a modified Delphi Survey. Final agreement on outcomes to be included in the COS, their definition and measurement will be achieved through a face-to-face consensus meeting with all stakeholder groups. Dissemination of the final COS will be ensured through different media and relevant societies. Discussion: Development and implementation of a COS for fetal OSB will ensure consistent outcome reporting in future clinical trials, systematic reviews, and clinical practice guidelines. This will lead to higher quality research, better evidence-based clinical practice and ultimately improved maternal, fetal and long term childhood outcomes.Trial registration: Core Outcome Measures in Effectiveness Trials (COMET): 1187. International Prospective Register of Systematic Reviews (PROSPERO): CRD42018104880.

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