scholarly journals Assessing the relevance and uptake of core outcome sets (an agreed minimum collection of outcomes to measure in research studies) in Cochrane systematic reviews: a review

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036562
Author(s):  
Paula R Williamson ◽  
Ricardo de Ávila Oliveira ◽  
Mike Clarke ◽  
Sarah L Gorst ◽  
Karen Hughes ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Core Outcome Set ◽  
Cochrane Review ◽  
Specific Area ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Cochrane Reviews ◽  
Outcome Set ◽  
Health Related ◽  
Research Studies

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.

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

Trials ◽  
2013 ◽  
Vol 14 (1) ◽  
pp. 21 ◽  
Author(s):  
Jamie J Kirkham ◽  
Elizabeth Gargon ◽  
Mike Clarke ◽  
Paula R Williamson
Keyword(s):  
Systematic Reviews ◽  
Core Outcome Set ◽  
Cochrane Review ◽  
Core Outcome ◽  
Outcome Set

scholarly journals Core Outcome Sets (COS) related to pregnancy and childbirth: a systematic review

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marie Österberg ◽  
Christel Hellberg ◽  
Ann Kristine Jonsson ◽  
Sara Fundell ◽  
Frida Trönnberg ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Core Outcome Set ◽  
Specific Area ◽  
Consensus Method ◽  
Future Research ◽  
Core Outcome ◽  
Pregnancy And Childbirth ◽  
Ovid Medline ◽  
Outcome Set ◽  
Academic Search

Abstract Background Systematic reviews often conclude low confidence in the results due to heterogeneity in the reported outcomes. A Core Outcome Set (COS) is an agreed standardised collection of outcomes for a specific area of health. The outcomes included in a COS are to be measured and summarized in clinical trials as well as systematic reviews to counteract this heterogeneity. Aim The aim is to identify, compile and assess final and ongoing studies that are prioritizing outcomes in the area of pregnancy and childbirth. Methods All studies which prioritized outcomes related to pregnancy and childbirth using consensus method, including Delphi surveys or consensus meetings were included. Searches were conducted in Ovid MEDLINE, EMBASE, PsycINFO, Academic Search Elite, CINAHL, SocINDEX and COMET databases up to June 2021. For all studies fulfilling the inclusion criteria, information regarding outcomes as well as population, method, and setting was extracted. In addition, reporting in the finalized studies was assessed using a modified version of the Core Outcome Set–STAndards for Reporting. Results In total, 27 finalized studies and 42 ongoing studies were assessed as relevant and were included. In the finalized studies, the number of outcomes included in the COS ranged from 6 to 51 with a median of 13 outcomes. The majority of the identified COS, both finalized as well as ongoing, were relating to physical complications during pregnancy. Conclusion There is a growing number of Core Outcome Set studies related to pregnancy and childbirth. Although several of the finalized studies follow the proposed reporting, there are still some items that are not always clearly reported. Additionally, several of the identified COS contained a large number (n > 20) outcomes, something that possibly could hinder implementation. Therefore, there is a need to consider the number of outcomes which may be included in a COS to render it optimal for future research.

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

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.

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

Pain Medicine ◽  
2017 ◽  
Vol 19 (11) ◽  
pp. 2316-2321 ◽  
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

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

2019 ◽  
Vol 5 (2) ◽  
pp. 00072-2019 ◽  
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.

scholarly journals Towards core outcome set (COS) development: a follow-up descriptive survey of outcomes in Cochrane reviews

2015 ◽  
Vol 4 (1) ◽  
Author(s):  
Francesca Wuytack ◽  
Valerie Smith ◽  
Mike Clarke ◽  
Paula Williamson ◽  
Elizabeth Gargon
Keyword(s):  
Core Outcome Set ◽  
Core Outcome ◽  
Cochrane Reviews ◽  
Outcome Set ◽  
Descriptive Survey

scholarly journals Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group

2016 ◽  
Vol 44 (12) ◽  
pp. 1916-1919 ◽  
Author(s):  
Louise Klokker ◽  
Peter Tugwell ◽  
Daniel E. Furst ◽  
Dan Devoe ◽  
Paula Williamson ◽  
...  
Keyword(s):  
Working Group ◽  
Qualitative Data ◽  
Safety Issue ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Randomized Controlled ◽  
Outcome Set ◽  
Rheumatic Conditions ◽  
Consistent Approach

Objective.Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions.Methods.The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved.Results.Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions.Conclusion.The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

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

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.

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

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.

Facilitating International Participation in Core Outcome Set Development: A Proposed Approach for Multi-language Delphi Surveys, a Review of Current Practice and Issues to Consider

2020 ◽  
Author(s):  
Bilal Alkhaffaf ◽  
Paula Williamson ◽  
Jane M Blazeby ◽  
Anne-Marie Glenny ◽  
Ademola Adeyeye ◽  
...  
Keyword(s):  
Current Practice ◽  
Stakeholder Participation ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Key Stakeholders ◽  
Outcome Set ◽  
International Participation ◽  
Methodological Approaches ◽  
Improve Planning

Abstract Background Core outcome sets (COS) should be relevant to key stakeholders and widely applicable so that researchers are willing to use them when designing trials. Many COS developers have utilised online Delphi surveys which enable wider international stakeholder participation. Despite broader participation, most international COS projects have restricted Delphi surveys to a single language potentially excluding important opinion from those who are not fluent in the survey language.Methods A structured review of current approaches to translating Delphi surveys for COS development was undertaken. We present a proposed methodology adapted from international guidance. Results Four studies were identified from our structured review. Wide variation exists in the methodological approaches to translating Delphi surveys for the developing of COS. Issues which arise when developing multi-language Delphi surveys include establishing translation groups, timelines, financial implications, strategies to maximise recruitment and regulatory approvals.Conclusion Consideration of the issues described will improve planning by other COS developers and can be used to widen international participation from both patients and healthcare professionals.

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