Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity

IntroductionIncreasingly more pregnant women are living with pre-existing multimorbidity (≥two long-term physical or mental health conditions). This may adversely affect maternal and offspring outcomes. This study aims to develop a core outcome set (COS) for maternal and offspring outcomes in pregnant women with pre-existing multimorbidity. It is intended for use in observational and interventional studies in all pregnancy settings.Methods and analysisWe propose a four stage study design: (1) systematic literature search, (2) focus groups, (3) Delphi surveys and (4) consensus group meeting. The study will be conducted from June 2021 to August 2022. First, an initial list of outcomes will be identified through a systematic literature search of reported outcomes in studies of pregnant women with multimorbidity. We will search the Cochrane library, Medline, EMBASE and CINAHL. This will be supplemented with relevant outcomes from published COS for pregnancies and childbirth in general, and multimorbidity. Second, focus groups will be conducted among (1) women with lived experience of managing pre-existing multimorbidity in pregnancy (and/or their partners) and (2) their healthcare/social care professionals to identify outcomes important to them. Third, these initial lists of outcomes will be prioritised through a three-round online Delphi survey using predefined score criteria for consensus. Participants will be invited to suggest additional outcomes that were not included in the initial list. Finally, a consensus meeting using the nominal group technique will be held to agree on the final COS. The stakeholders will include (1) women (and/or their partners) with lived experience of managing multimorbidity in pregnancy, (2) healthcare/social care professionals involved in their care and (3) researchers in this field.Ethics and disseminationThis study has been approved by the University of Birmingham’s ethical review committee. The final COS will be disseminated through peer-reviewed publication and conferences and to all stakeholders.

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Development of a core outcome set for trials investigating the long-term management of bronchiectasis

Chronic Respiratory Disease ◽

10.1177/1479972318804167 ◽

2018 ◽

Vol 16 ◽

pp. 147997231880416 ◽

Cited By ~ 2

Author(s):

Maureen Spargo ◽

Cristín Ryan ◽

Damian Downey ◽

Carmel Hughes

Keyword(s):

Core Outcome Set ◽

Delphi Panel ◽

Core Outcome ◽

Outcome Set ◽

Overview Of Systematic Reviews ◽

Outcome Selection ◽

Accurate Comparison ◽

Initial List ◽

Selection Of

Heterogeneity in outcomes measured in trials limits accurate comparison of bronchiectasis studies. A core outcome set (COS) is an agreed, standardized set of outcomes that should be measured in trials for specific clinical areas. A COS for bronchiectasis could encourage consistency in future studies. An overview of systematic reviews and qualitative study on outcome selection in bronchiectasis informed an initial list of outcomes. A Delphi panel ( n = 86) rated the importance of each outcome from 1 to 9 in 3 sequential questionnaires, as a means to achieve consensus: 1–3 = ‘of limited importance’; 4–6 = ‘important, but not critical’; and 7–9 = ‘critical’. Outcomes rated ‘critical’ by ≥70% of the panel were added to the COS. Eighty-two participants responded to the first questionnaire. Attrition between each questionnaire was 5%. After 3 rounds of questioning, 18 outcomes exceeded the threshold for consensus and were included in the COS. This study has achieved consensus on 18 outcomes that should be measured in trials of interventions for bronchiectasis. Selection of the highest ranked outcomes may represent a pragmatic means for comparison. Further research is required to condense the number of outcomes selected and to determine its relevance to interventions.

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Developing a core outcome set for people living with dementia at home in their neighbourhoods and communities: study protocol for use in the evaluation of non-pharmacological community-based health and social care interventions

Trials ◽

10.1186/s13063-018-2584-9 ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 15

Author(s):

Andrew J. E. Harding ◽

Hazel Morbey ◽

Faraz Ahmed ◽

Carol Opdebeeck ◽

Ying-Ying Wang ◽

...

Keyword(s):

Study Protocol ◽

Social Care ◽

Core Outcome Set ◽

Core Outcome ◽

Community Based ◽

Outcome Set ◽

Health And Social Care ◽

At Home

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BJOG commentary for BJOG‐21‐0466 A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study

BJOG An International Journal of Obstetrics & Gynaecology ◽

10.1111/1471-0528.16823 ◽

2021 ◽

Author(s):

Sanne J Gordijn ◽

Wessel Ganzevoort

Keyword(s):

Pregnant Women ◽

Core Outcome Set ◽

Core Outcome ◽

Pregestational Diabetes ◽

International Consensus ◽

Outcome Set

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Development of a core outcome set for epilepsy in pregnancy (E-CORE): a national multi-stakeholder modified Delphi consensus study

BJOG An International Journal of Obstetrics & Gynaecology ◽

10.1111/1471-0528.14430 ◽

2016 ◽

Vol 124 (4) ◽

pp. 661-667 ◽

Cited By ~ 25

Author(s):

BH Al Wattar ◽

K Tamilselvan ◽

R Khan ◽

A Kelso ◽

A Sinha ◽

...

Keyword(s):

Core Outcome Set ◽

Core Outcome ◽

Delphi Consensus ◽

Modified Delphi ◽

Outcome Set ◽

Multi Stakeholder ◽

In Pregnancy

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‘Getting back to normal’: using patients’ lived experience to inform a core outcome set for cardiac arrest clinical trials

Trials ◽

10.1186/1745-6215-16-s3-p3 ◽

2015 ◽

Vol 16 (S3) ◽

Cited By ~ 1

Author(s):

Laura Whitehead ◽

Gavin Perkins ◽

Kirstie Haywood

Keyword(s):

Clinical Trials ◽

Cardiac Arrest ◽

Lived Experience ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set

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Developing a core outcome set for the treatment of pregnant women with pregestational diabetes—a study protocol

Trials ◽

10.1186/s13063-020-04910-1 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Oratile Kgosidialwa ◽

◽

Delia Bogdanet ◽

Aoife Egan ◽

Paula M. O’Shea ◽

...

Keyword(s):

Systematic Review ◽

Pregnant Women ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Consensus Meeting ◽

Controlled Trials ◽

Core Outcome ◽

Pregestational Diabetes ◽

Outcome Set ◽

Randomised Controlled

Abstract Background Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes including increased rates of caesarean section birth, macrosomia, congenital malformation, prematurity, admission to the neonatal intensive care unit and stillbirth. As a result, there has been an increase in interventions to improve outcomes in both mother and infant. To date, meaningful comparisons between these studies are limited due to heterogeneity in outcome selection and reporting. The aim of this study is to develop a core outcome set (COS) for randomised controlled trials evaluating the effectiveness of interventions for the treatment of pregnant women with PGDM. Methods The study consists of three steps. The first step is a systematic review of the literature to assess outcomes reported in randomised controlled trials assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. The second step is a three round, online Delphi survey to prioritise these outcomes. In this step, stakeholders (including women with PGDM, healthcare workers, researchers and policymakers) will be asked to rank the importance of outcomes for inclusion in the COS using a 9-point Likert type scale. Outcomes that meet the inclusion criteria after completion of the Delphi surveys will be brought to the consensus meeting. The consensus meeting will be the third and final step, where the COS will be finalised. The consensus meeting will include members from each stakeholder group. Discussion This paper describes the process used to develop a COS for the reporting of studies evaluating the effectiveness of interventions in pregnant women with PGDM. The COS will enable greater comparison between and information synthesis across RCTs in the treatment of PGDM. In addition, this COS will also help improve trial reporting and minimise research waste by prioritising the collection and reporting of outcomes that matter to all relevant stakeholder groups. Trial registration This COS has been registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative (http://www.comet-initiative.org/studies/details/1425) on the 4th of November 2019. The systematic review component of this study has also been registered with the International Prospective Register of Systematic Reviews (PROSPERO) (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020173549).

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The Development of a Core Outcome Set for Trials and Evaluative Studies in Adult Social Care

Journal of Long-Term Care ◽

10.31389/jltc.98 ◽

2021 ◽

pp. 438-445

Author(s):

Thavapriya Sugavanam ◽

James Caiels ◽

Michele Peters ◽

Ray Fitzpatrick

Keyword(s):

Social Care ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set

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Development of a core outcome set for immunomodulation in pregnancy (COSIMPREG): a protocol for a systematic review and Delphi study

BMJ Open ◽

10.1136/bmjopen-2018-021619 ◽

2018 ◽

Vol 8 (8) ◽

pp. e021619 ◽

Cited By ~ 1

Author(s):

Jelmer R Prins ◽

Floor Holvast ◽

Janneke van ’t Hooft ◽

Arend F Bos ◽

Jan Willem Ganzevoort ◽

...

Keyword(s):

Systematic Review ◽

Immune System ◽

Delphi Study ◽

Immune Modulation ◽

Core Outcome Set ◽

Core Outcome ◽

Reproductive Immunology ◽

Maternal Immune System ◽

Outcome Set ◽

In Pregnancy

IntroductionTo establish pregnancy, the maternal immune system must adapt to tolerate the semiallogenic fetus. Less than optimal adaptation of the maternal immune system during (early) pregnancy is implicated in several complications of pregnancy. The development of effective immune modulation interventions as preventive or therapeutic strategies for pregnancy complications holds promise. Several studies sought to evaluate the safety and effectiveness of various approaches. However, a limitation is the high variability in clinical and immune outcomes that are reported. We, therefore, aim to develop a core outcome set for application to studies of immune modulation in pregnancy (COSIMPREG).Methods and analysisWe will use a stepwise approach to develop a COSIMPREG. First, we will perform a systematic review to identify reported outcomes. For this review, Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. Second, we will use the Delphi method to develop a preliminary COSIMPREG. In three rounds, the outcomes of the systematic review will be scored. A panel comprising experts from relevant disciplines and diverse geographical locations will be assembled until a sufficient quality of the panel is reached. We will use predefined decision rules for outcomes. After each round outcomes, including scores, will be returned to the panel for further refinement. The outcomes not excluded after the third round will be taken to a consensus meeting. In this meeting, experts from all relevant disciplines will discuss and finalise the COSIMPREG.Ethics and disseminationFor this study ethical approval is not required. The systematic review will be published in an appropriate open access reproductive immunology journal. Once the COSIMPREG is finalised, it will be published in an open access reproductive immunology journal, and disseminated at appropriate international meetings, as well as through relevant research and scientific societies. Experts involved in the Delphi study will be asked to give informed consent.

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

BMJ Open ◽

10.1136/bmjopen-2019-034018 ◽

2020 ◽

Vol 10 (7) ◽

pp. e034018 ◽

Cited By ~ 1

Author(s):

Rohan D’Souza ◽

Linda Villani ◽

Chelsea Hall ◽

Meron Seyoum ◽

John Kingdom ◽

...

Keyword(s):

Pregnant Women ◽

Research Ethics ◽

Systematic Reviews ◽

Core Outcome Set ◽

Healthcare Providers ◽

Family Members ◽

Nominal Group ◽

Core Outcome ◽

Outcome Set ◽

Vasa Previa

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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