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

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.

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Core outcome sets (COS) related to pregnancy and childbirth: a systematic review

10.22541/au.160876858.83048752/v1 ◽

2020 ◽

Author(s):

Marie Österberg ◽

Christel Hellberg ◽

AnnKristine Jonsson ◽

Sara Fundell ◽

Frida Trönnberg ◽

...

Keyword(s):

Systematic Review ◽

Core Outcome Set ◽

Obstetric Care ◽

Consensus Method ◽

Future Research ◽

Core Outcome ◽

Pregnancy And Childbirth ◽

Ovid Medline ◽

Outcome Set ◽

Data Collection And Analysis

Background: Systematic reviews of clinical trials frequently reveal heterogeneity in the number and types of outcomes reported. To counteract this, a Core Outcome Set (COS) may be applied. Objectives: A systematic review of all completed and ongoing COS related to pregnancy and childbirth Search strategy: COMET up to January 2020, Ovid MEDLINE, EMBASE, PsycINFO, Academic Search Elite, CINAHL and SocINDEX up to June 2019. Selection criteria: Studies which prioritized outcomes using some form of consensus method (such as the Delphi technique) were included. Data collection and analysis: All included studies were checked for compliance with the Core Outcome Set–STAndards for Reporting. Information about population, setting, method and outcomes was extracted. Main results: Nineteen completed studies and thirty-nine ongoing studies were included. The number of outcomes included in various COS ranged from 6 to 48. Most COS were for conditions related to physical complications during pregnancy. No COS were identified for perinatal mental health. Conclusion: This review discloses a growing number of COS within the field of pregnancy and childbirth. Many of the completed studies follow the proposed reporting. However, several of the COS included a large number of outcomes. There is a need to consider the number of outcomes which may be included in a COS while retaining its applicability in future research. Funding This article is adapted from a report undertaken by the SBU, who provided funding for the study. Keywords: Childbirth, Core outcome set, Maternal health, Obstetric care, Pregnancy

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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 ◽

10.1136/bmjopen-2019-036562 ◽

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.

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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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A protocol for developing a core outcome set for ectopic pregnancy

Trials ◽

10.1186/s13063-021-05772-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Krystle Y. Chong ◽

Sarah Solangon ◽

James Kemper ◽

Kurt Barnhart ◽

Pamela Causa Andrieu ◽

...

Keyword(s):

Ectopic Pregnancy ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Future Research ◽

Controlled Trials ◽

Core Outcome ◽

Key Stakeholders ◽

Outcome Set ◽

Core Outcomes ◽

Randomised Controlled

Abstract Background Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. Study aim To develop and implement a core outcome set to guide future research in ectopic pregnancy. Methods and analysis We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus ‘core’ outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. Trial registration COMET 1492. Registered in November 2019.

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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 outcome set for evaluative research into paediatric cerebral visual impairment (CVI), in the UK and Eire

BMJ Open ◽

10.1136/bmjopen-2021-051014 ◽

2021 ◽

Vol 11 (9) ◽

pp. e051014

Author(s):

Anna Pease ◽

Trudy Goodenough ◽

Cath Borwick ◽

Rose Watanabe ◽

Christopher Morris ◽

...

Keyword(s):

Literature Review ◽

Visual Impairment ◽

Qualitative Interviews ◽

Core Outcome Set ◽

Well Being ◽

Consensus Meeting ◽

Future Research ◽

Core Outcome ◽

Outcome Set ◽

Cerebral Visual Impairment

ObjectivesCerebral visual impairment (CVI) comprises a heterogeneous group of brain-related vision problems. A core outcome set (COS) represents the most important condition-specific outcomes according to patients, carers, professionals and researchers. We aimed to produce a COS for studies evaluating interventions for children with CVI, to increase the relevance of research for families and professionals and thereby to improve outcomes for affected children.DesignWe used methods recommended by the Core Outcome Measures in Effectiveness Trials Initiative. These included a proportionate literature review of outcomes used in previous studies; qualitative interviews with children and families; a two-round Delphi survey involving parents, children and professionals and a consensus meeting to ratify the most important outcomes.SettingTelephone interviews and online Delphi surveys of participants who all lived in UK or Eire.ParticipantsEighteen parents and six young people were interviewed. Delphi participants (n=80 did both rounds) included professionals working with children who have CVI (teachers, orthoptists, ophthalmologists, optometrists, qualified teachers for visually impaired, family members (parents and siblings) and affected children.ResultsThe literature review included 13 studies yielding 37 outcomes. Qualitative interviews provided 22 outcomes. After combining and refining similar items, the first round contained 23 outcomes and the second 46. At the consensus meeting, 5 attendees recommended 27 outcomes for inclusion in the CVI COS, of which 15 were ratified as most important, including 4 related to vision; 1 to family well-being; 1 to adults around the child being informed about CVI and the rest to the child’s abilities to engage with people and surroundings.ConclusionsGood engagement from participants led to the development of a COS. Future research will be useful to identify the best ways to measure COS items and potentially to update this COS as more interventions for CVI are developed.Trial registration numberISRCTN13762177.

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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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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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