Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol

D’Souza, Rohan; Hall, Chelsea; Sermer, Mathew; Siu, Samuel C.; Silversides, Candice

doi:10.1186/s13063-020-04233-1

Cited by 13 publications

(16 citation statements)

References 21 publications

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Section: Methods and Analysismentioning

confidence: 99%

“…As described in protocols for other core outcome sets being developed by the OROS group, all outcomes identified through the above process, will be presented in tabular form, separating maternal from fetal/neonatal outcomes, each stratified by the five main core outcome areas, and an online supplementary table highlighting all outcomes, their Delphi scores and the stages at which they were excluded will also be presented, for greater transparency. 12 Step 5: Mmeasuring/defining core outcomes On selection of a final list of core outcomes, we will employ the COnsensus-based Standards for the selection of health Measurement INstruments to assess measurement tools/definitions for included outcomes based on four criteria: validity, responsiveness, reliability and interpretability. 25 We will begin the process by listing measurement instruments and/or definitions for outcomes where universal agreement exists.…”

Section: Open Accessmentioning

confidence: 99%

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Core outcome set for studies on pregnant women with vasa previa (COVasP): a study protocol

et al. 2020

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IntroductionVasa previa is a condition where fetal blood vessels run unprotected in the membranes, outside the umbilical cord, and cross the internal opening of the cervix. During rupture of membranes, these vessels can rupture and put the baby at serious risk of severe blood loss and death. Numerous studies are being conducted to improve diagnostic modalities and establish clear management plans to improve pregnancy outcomes. However, the lack of a standardised set of outcomes for studies on vasa previa makes it difficult to compare study findings and draw meaningful conclusions. Through this project, we will be developing a core outcome set for studies on pregnant women with vasa previa (COVasP).Methods and analysisThe development of COVasP will involve five steps. The first will be a systematic review, in which we will generate a long list of outcomes based on published studies in pregnancies complicated with vasa previa. The second will involve in-depth interviews with current and former patients, their family members and healthcare providers who care for these patients. This will be followed by a two-round Delphi survey, which will aim to narrow down the long list of outcomes into those considered important by four groups of ‘stakeholders’: (1) patients, family members and patient advocates/representatives, (2) healthcare providers, (3) researchers, epidemiologists and methodologists and (4) other stakeholders directly or indirectly involved in the management of these pregnancies such as administrators, guideline developers and policymakers. The fourth step will involve a face-to-face consensus meeting using a nominal group approach to establish a finalised core outcome set. The final step will involve measuring and defining the identified outcomes using a combination of systematic reviews and Delphi surveys.Ethics and disseminationThis study as well as consent forms for stakeholder participation have received approval from the Mount Sinai Hospital Research Ethics Board (REB number 18-0173-E) on 05 September 2018 and the Human Research Ethics Committee at The University of Technology Sydney, Australia on 30 July 2019 (UTS HREC reference number ETH19-3718). All progress will be documented on the international prospective register of systematic reviews and Core Outcome Measures in Effectiveness Trials databases.Registration detailshttp://www.comet-initiative.org/studies/details/1117.

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Section: Methods and Analysismentioning

confidence: 99%

Section: Open Accessmentioning

confidence: 99%

Core outcome set for studies on pregnant women with vasa previa (COVasP): a study protocol

et al. 2020

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“…We have adopted the approach of COS developers in the obstetric setting. (46) Equal representation of patient and professional perspectives is desirable; as such, we will aim to recruit at a minimum 50 patient participants and 50 participants from other professional stakeholder groups to the rst round of the Delphi survey. In recognising natural rates of attrition in subsequent rounds, this number should allow su cient representation through the three rounds of the Delphi process.…”

Section: Participants and Recruitmentmentioning

confidence: 99%

The Core Outcome Development for Carrier Screening (CODECS) Study: Protocol for Development of a Core Outcome Set

Richardson

McEwen

Newton‐John

et al. 2020

Preprint

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Background: Reproductive genetic carrier screening is a type of genetic testing available to those planning a pregnancy, or during their first trimester, to understand their risk of having a child with a severe genetic condition. There is a lack of consensus for ‘what to measure’ in studies on this intervention, leading to heterogeneity in choice of outcomes and methods of measurement. Such outcome heterogeneity has implications for the quality and comparability of these studies and has led to a lack of robust research evidence in the literature to inform policy and decision-making around the offer of this screening. As reproductive genetic carrier screening becomes increasingly accessible within the general population, it is timely to investigate the outcomes of this intervention. Objectives: The development of a core outcome set is an established methodology to address issues with outcome heterogeneity in research. We aim to develop a core outcome set for reproductive genetic carrier screening to clarify and standardise outcomes for research and practice.Methods: In accordance with guidance from the COMET (Core Outcome Measures in Effectiveness Trials) Initiative, this study will consist of five steps: i) A systematic review of quantitative studies, using narrative synthesis to identify previously reported outcomes, their definitions, and methods of measurement ii) A systematic review of qualitative studies using content analysis to identify excerpts related to patient experience and perspectives that can be interpreted as outcomes iii) Semi-structured focus groups and interviews with patients who have undertaken reproductive genetic carrier screening to identify outcomes of importance to them iv) Delphi survey of key stakeholders, including patients, clinicians, and researchers, to refine and prioritise the list of outcomes generated from the previous steps v) A virtual consensus meeting with a purposive sample of key stakeholders to finalise the core outcome set for reporting.Discussion: This protocol outlines the core outcome set development process and its novel application in the setting of genetic testing. This core outcome set will support the standardisation of outcome reporting in reproductive carrier screening research and contribute to an evolving literature on outcomes to evaluate genetic testing and genetic counselling as health interventions. COMET core outcome set registration: http://www.comet-initiative.org/Studies/Details/1381

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“…Reporting measures for studies of cardiac disease in pregnancy are currently in development as part of the Core Outcomes in Women's and Newborn Health (CROWN) initiative, but there is no known equivalent for RHD‐P, which has specific risks related to its epidemiology.…”

Section: Introductionmentioning

confidence: 99%

Standardizing clinical care measures of rheumatic heart disease in pregnancy: A qualitative synthesis

Vaughan

Dawson

Peek

et al. 2019

Birth

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Background Rheumatic heart disease (RHD) is a preventable cardiac condition that escalates risk in pregnancy. Models of care informed by evidence‐based clinical guidelines are essential to optimal health outcomes. There are no published reviews that systematically explore approaches to care provision for pregnant women with RHD and examine reported measures. The review objective was to improve understanding of how attributes of care for these women are reported and how they align with guidelines. Methods A search of 13 databases was supported by hand‐searching. Papers that met inclusion criteria were appraised using CASP/JBI checklists. A content analysis of extracted data from the findings sections of included papers was undertaken, informed by attributes of quality care identified previously from existing guidelines. Results The 43 included studies were predominantly conducted in tertiary care centers of low‐income and middle‐income countries. Cardiac guidelines were referred to in 25 of 43 studies. Poorer outcomes were associated with higher risk scores (detailed in 36 of 41 quantitative studies). Indicators associated with increased risk include anticoagulation during pregnancy (28 of 41 reported) and late booking (gestation documented in 15 of 41 studies). Limited access to cardiac interventions was discussed (19 of 43) in the context of poorer outcomes. Conversely, early assessment and access to regular multidisciplinary care were emphasized in promoting optimal outcomes for women and their babies. Conclusions Despite often complex care requirements in challenging environments, pregnancy provides an opportunity to strengthen health system responses and address whole‐of‐life health for women with RHD. A standard set of core indicators is proposed to more accurately benchmark care pathways, outcomes, and burden.

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Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol

Cited by 13 publications

References 21 publications

Core outcome set for studies on pregnant women with vasa previa (COVasP): a study protocol

Core outcome set for studies on pregnant women with vasa previa (COVasP): a study protocol

The Core Outcome Development for Carrier Screening (CODECS) Study: Protocol for Development of a Core Outcome Set

Standardizing clinical care measures of rheumatic heart disease in pregnancy: A qualitative synthesis

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