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 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 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 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.

scholarly journals Adding value to core outcome set development using multimethod systematic reviews

2020 ◽  
Vol 11 (2) ◽  
pp. 248-259
Author(s):  
Ginny Brunton ◽  
James Webbe ◽  
Sandy Oliver ◽  
Chris Gale
Keyword(s):  
Systematic Reviews ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Set

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 COHESION: core outcomes in neonatal encephalopathy (protocol)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fiona A. Quirke ◽  
Patricia Healy ◽  
Elaine Ní Bhraonáin ◽  
Mandy Daly ◽  
Linda Biesty ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Evidence Synthesis ◽  
Core Outcome Set ◽  
Treatment Options ◽  
Delphi Survey ◽  
Core Outcome ◽  
Randomised Trials ◽  
Neonatal Encephalopathy ◽  
Outcome Set ◽  
The Brain

Abstract Background Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or complications later in life, including seizures, movement disorders and cerebral palsy. Treatment options for neonatal encephalopathy are limited mainly to therapeutic hypothermia, although other potential treatments are emerging. However, evaluations of the effectiveness of treatments are challenging because of heterogeneity and inconsistency in outcomes measured and reported between trials. In this paper, we detail how we will develop a core outcome set to standardise outcomes measured and reported upon for interventions for the treatment of neonatal encephalopathy. Methods We will systematically review the literature to identify outcomes reported previously in randomised trials and systematic reviews of randomised trials. We will identify outcomes important to parents or caregivers of infants diagnosed with and who have received treatment for neonatal encephalopathy. We will do this by conducting in person or by video teleconferencing interviews with parents or caregivers in high-income and low- to middle-income countries. Stakeholders with expertise in neonatal encephalopathy (parents/caregivers, healthcare providers and researchers) will rate the importance of identified outcomes in an online Delphi survey using either a three-round Delphi survey or a “Real-Time” Delphi survey to which stakeholders will be allocated at random. Consensus meetings will take place by video conference to allow for an international group of stakeholder representatives to discuss and vote on the outcomes to include in the final core outcome set (COS). Discussion More research is needed on treatments for neonatal encephalopathy. Standardising outcomes measured and reported in evaluations of the effectiveness of interventions for the treatment of neonatal encephalopathy will improve evidence synthesis and improve results reported in systematic reviews and meta-analysis in this area. Overall, this COS will allow for improved treatments to be identified, heterogeneity in research to be reduced, and overall patient care to be enhanced. Trial registration This study is registered in the Core Outcome Measures for Effectiveness (COMET) database http://www.comet-initiative.org/Studies/Details/1270.

scholarly journals Development of a Core outcome set for fetal Myelomeningocele (COSMiC): study protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Samar Altoukhi ◽  
Clare L. Whitehead ◽  
Greg Ryan ◽  
Jan Deprest ◽  
Luc Joyeux ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Systematic Reviews ◽  
Maternal Morbidity ◽  
Core Outcome Set ◽  
Second Phase ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Link Type ◽  
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 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 International Prospective Register of Systematic Reviews (PROSPERO) CRD42018104880. Registered on December 5, 2018. Core Outcome Measures in Effectiveness Trials (COMET): 1187

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