Core outcome set for three ophthalmic conditions: a healthcare professional and patient consensus on core outcome sets for amblyopia, ocular motility and strabismus (COSAMS Study)

ObjectivesAmblyopia, strabismus and ocular motility disorders are common conditions with significant impact on visual function, appearance and quality of life. We aimed to establish a core set of outcomes for each of the three conditions for use in clinical trials and routine clinical practice.DesignA comprehensive databank of outcomes was developed from a systematic review of the literature and a series of focus groups with healthcare professionals, researchers, patients and carers. The databank of outcomes was scored in a two-round Delphi Survey completed by two stakeholder groups: healthcare professionals/researchers and patients/carers. Results of the online Delphi were discussed at a face-to-face consensus meeting where the core outcome sets were finalised.SettingUK-wide consultation.ParticipantsResearchers, clinicians, patients and carers.Outcome measuresCore outcome sets.ResultsFor amblyopia, strabismus and ocular motility, 40/42/33 participants contributed to both rounds of the Delphi; six/nine/seven members attended consensus meetings, respectively. Consensus was reached on ten core outcomes for both amblyopia and ocular motility and nine for strabismus. All three conditions shared the core outcomes: adverse events, cost, vision-related quality of life and ocular alignment. The strabismus and ocular motility disorder core sets included, in addition, measuring the deviation, binocular vision, ocular movement, patient satisfaction and symptoms. The amblyopia set, distinct from the sets for the other two conditions, included best corrected distance and near visual acuity, spherical and cylindrical refraction, compliance and treatment-related and functionality/long-term impacts.ConclusionsThe study used robust consensus methods to develop a core outcome set for three ophthalmic conditions. Implementation of these core outcome sets in clinical trials and routine clinical practice will ensure that the outcomes being measured and reported are relevant to all stakeholders. This will enhance the relevance of study findings and enable comparison of results from different studies.

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Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative

BMJ Open ◽

10.1136/bmjopen-2020-043242 ◽

2021 ◽

Vol 11 (11) ◽

pp. e043242

Author(s):

Kirstie Haywood ◽

Rachel Potter ◽

Robert Froud ◽

Gemma Pearce ◽

Barbara Box ◽

...

Keyword(s):

Quality Of Life ◽

Healthcare Professionals ◽

Core Outcome Set ◽

Episodic Migraine ◽

Consensus Meeting ◽

Good Representation ◽

Core Outcome ◽

The Core ◽

Outcome Set

ObjectiveTypically, migraine prevention trials focus on reducing migraine days. This narrow focus may not capture all that is important to people with migraine. Inconsistency in outcome selection across trials limits the potential for data pooling and evidence synthesis. In response, we describe the development of core outcome set for migraine (COSMIG).DesignA two-stage approach sought to achieve international, multistakeholder consensus on both the core domain set and core measurement set. Following construction of a comprehensive list of outcomes, expert panellists (patients, healthcare professionals and researchers) completed a three-round electronic-Delphi study to support a reduction and prioritisation of core domains and outcomes. Participants in a consensus meeting finalised the core domains and methods of assessment. All stages were overseen by an international core team, including patient research partners.ResultsThere was a good representation of patients (episodic migraine (n=34) and chronic migraine (n=42)) and healthcare professionals (n=33) with high response and retention rates. The initial list of domains and outcomes was reduced from >50 to 7 core domains for consideration in the consensus meeting, during which a 2-domain core outcome set was agreed.ConclusionInternational and multistakeholder consensus emerged to describe a two-domain core outcome set for reporting research on preventive interventions for chronic and episodic migraine: migraine-specific pain and migraine-specific quality of life. Intensity of migraine pain assessed with an 11-point Numerical Rating Scale and the frequency as the number of headache/migraine days over a specified time period. Migraine-specific quality of life assessed using the Migraine Functional Impact Questionnaire.

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Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes (SCORE-IT): a patient and healthcare professional consensus on a core outcome set for type 2 diabetes

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2019-000700 ◽

2019 ◽

Vol 7 (1) ◽

pp. e000700 ◽

Cited By ~ 3

Author(s):

Nicola L Harman ◽

John P H Wilding ◽

Dave Curry ◽

James Harris ◽

Jennifer Logue ◽

...

Keyword(s):

Type 2 Diabetes ◽

Healthcare Professionals ◽

Core Outcome Set ◽

Consensus Meeting ◽

Core Outcome ◽

Outcome Set ◽

Core Outcomes ◽

Effectiveness Trials

ObjectivesHeterogeneity in outcomes measured across trials of glucose-lowering interventions for people with type 2 diabetes impacts on the ability to compare findings and may mean that the results have little importance to healthcare professionals and the patients that they care for. The SCORE-IT study (Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes) has addressed this issue by establishing consensus on the most important outcomes for non-surgical interventions for hyperglycemia in type 2 diabetes.Research design and methodsA comprehensive list of outcomes was developed from registered clinical trials, online patient resources, qualitative literature and long-term studies in the field. This list was then scored in a two-round online Delphi survey completed by healthcare professionals, people with type 2 diabetes, researchers in the field and healthcare policymakers. The results of this online Delphi were discussed and ratified at a face-to-face consensus meeting.Results173 people completed both rounds of the online survey (116 people with type 2 diabetes, 37 healthcare professionals, 14 researchers and 6 policymakers), 20 of these attended the consensus meeting (13 people with type 2 diabetes and 7 healthcare professionals). Consensus was reached on 18 core outcomes across five domains, which include outcomes related to diabetes care, quality of life and long-term diabetes-related complications.ConclusionsImplementation of the core outcome set in future trials will ensure that outcomes of importance to all stakeholders are measured and reported, enhancing the relevance of trial findings and facilitating the comparison of results across trials.

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Development of a Core Set of Patient-Reported Outcomes for Population-Based Cancer Survivorship Research: Protocol for an Australian Consensus Study

JMIR Research Protocols ◽

10.2196/14544 ◽

2020 ◽

Vol 9 (1) ◽

pp. e14544 ◽

Cited By ~ 1

Author(s):

Imogen Ramsey ◽

Nadia Corsini ◽

Amanda D Hutchinson ◽

Julie Marker ◽

Marion Eckert

Keyword(s):

Cancer Survivors ◽

Cancer Survivorship ◽

Phase Ii ◽

Core Outcome Set ◽

Population Based ◽

Core Outcome ◽

The Core ◽

Outcome Set ◽

Core Set

Background Core outcome sets seek to improve the consistency and quality of research by providing agreed-upon recommendations regarding what outcomes should be measured as a minimum for a population and setting. The problems arising from a lack of outcome standardization in population-based cancer survivorship research indicate the need for agreement on a core set of patient-reported outcomes (PROs) to enhance data quality, consistency, and comparability. Objective This study aims to identify a core set of PROs, representing the most important issues impacting on cancer survivors' long-term health, functioning and quality of life, to inform population-based research on cancer survivorship. Methods In Phase I, a list of all potentially important outcomes will be generated through focus group discussions with cancer survivors and a review of measures for assessing quality of life in cancer survivorship. The consolidated list will be advanced to Phase II, where a stakeholder consensus process will be conducted with national experts in cancer survivorship to refine and prioritize the outcomes into a core outcome set. The process will consist of a two-round Delphi survey and a consensus meeting. Cancer survivors, oncology health care professionals, and potential end users of the core outcome set with expertise in cancer survivorship research or policy will be invited to participate. In Phase III, recommended measures for assessment of the core outcome set will be selected with advice from experts on the assessment, analysis, and interpretation of PROs. Results As of April 2019, data collection for Phase I is complete and data analysis is underway. These data will inform the list of outcomes to be advanced into Phase II. Recruitment for Phase II will commence in June 2019, and it is anticipated that it will take 6 months to complete the three-step consensus process and identify a provisional core outcome set. The study results are expected to be published in early 2020. Conclusions Expert consensus-driven recommendations on outcome measurement will facilitate the inclusion of survivorship outcomes considered important by cancer survivors and health professionals in future research. Adoption of the core outcome set will enable comparison and synthesis of evidence across studies and enhance the quality of PRO data collected in cancer survivorship research, particularly when applied to address macro-level questions. International Registered Report Identifier (IRRID) DERR1-10.2196/14544

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Developing a core outcome set for interventions to improve discharge from mental health inpatient services: a survey, Delphi and consensus meeting with key stakeholder groups

BMJ Open ◽

10.1136/bmjopen-2019-034215 ◽

2020 ◽

Vol 10 (5) ◽

pp. e034215

Author(s):

Natasha Tyler ◽

Nicola Wright ◽

Andrew Grundy ◽

Justin Waring

Keyword(s):

Mental Health ◽

Health Services ◽

Healthcare Professionals ◽

Core Outcome Set ◽

Consensus Meeting ◽

Service Users ◽

Core Outcome ◽

Stakeholder Groups ◽

The Core ◽

Outcome Set

ObjectiveTo develop a core set of outcomes to be used in all future studies into discharge from acute mental health services to increase homogeneity of outcome reporting.DesignWe used a cross-sectional online survey with qualitative responses to derive a comprehensive list of outcomes, followed by two online Delphi rounds and a face-to-face consensus meeting.SettingThe setting the core outcome set applies to is acute adult mental health.ParticipantsParticipants were recruited from five stakeholder groups: service users, families and carers, researchers, healthcare professionals and policymakers.InterventionsThe core outcome set is intended for all interventions that aim to improve discharge from acute mental health services to the community.ResultsNinety-three participants in total completed the questionnaire, 69 in Delphi round 1 and 68 in round 2, with relatively even representation of groups. Eleven participants attended the consensus meeting. Service users, healthcare professionals, researchers, carers/families and end-users of research agreed on a four-item core outcome set: readmission, suicide completed, service user-reported psychological distress and quality of life.ConclusionImplementation of the core outcome set in future trials research will provide a framework to achieve standardisation, facilitate selection of outcome measures, allow between-study comparisons and ultimately enhance the relevance of trial or research findings to healthcare professionals, researchers, policymakers and service users.

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A Core Outcome Set for Trials in Glomerular Disease

Clinical Journal of the American Society of Nephrology ◽

10.2215/cjn.07840621 ◽

2021 ◽

pp. CJN.07840621

Author(s):

Simon A. Carter ◽

Liz Lightstone ◽

Dan Cattran ◽

Allison Tong ◽

Arvind Bagga ◽

...

Keyword(s):

United States ◽

Core Outcome Set ◽

Glomerular Disease ◽

Core Outcome ◽

Potential Core ◽

Content Type ◽

The Core ◽

Care Partners ◽

Outcome Set ◽

Core Outcomes

Background and objectivesOutcomes reported in trials in adults with glomerular disease are often selected with minimal patient input, are heterogeneous, and may not be relevant for clinical decision making. The Standardized Outcomes in Nephrology–Glomerular Disease (SONG-GD) initiative aimed to establish a core outcome set to help ensure that outcomes of critical importance to patients, care partners, and clinicians are consistently reported.Design, setting, participants, and measurementsWe convened two 1.5-hour workshops in Melbourne, Australia, and Washington, DC, United States. Attendees were identified purposively with 50 patients/care partners and 88 health professionals from 19 countries; 51% were female. Patients and care partners were from the United States, Australia, and Canada, and had experience of a glomerular disease with systemic features (n=9), kidney-limited nephrotic disease (n=9), or other kidney-limited glomerular disease (n=8). Attendees reviewed the results of the SONG-GD Delphi survey and aims of the workshop and then discussed potential core outcomes and their implementation in trials among moderated breakout groups of eight to 12 people from diverse backgrounds. Transcripts of discussions were analyzed thematically.ResultsThree themes were identified that supported the proposed core outcomes: limiting disease progression, stability and control, and ensuring universal relevance (i.e., applicable across diverse populations and settings). The fourth theme, preparedness for implementation, included engaging with funders and regulators, establishing reliable and validated measures, and leveraging existing endorsements for patient-reported outcomes.ConclusionsWorkshop themes demonstrated support for kidney function, disease activity, death, life participation, and cardiovascular disease, and these were established as the core outcomes for trials in adults with glomerular disease. Future work is needed to establish the core measures for each domain, with funders and regulators central to the uptake of the core outcome set in trials.

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Updating the OMERACT Filter at OMERACT 11

The Journal of Rheumatology ◽

10.3899/jrheum.131306 ◽

2014 ◽

Vol 41 (5) ◽

pp. 975-977 ◽

Cited By ~ 16

Author(s):

John R. Kirwan ◽

Maarten Boers ◽

Peter Tugwell

Keyword(s):

First Principles ◽

Core Outcome Set ◽

Controlled Trials ◽

Core Outcome ◽

Core Outcome Sets ◽

Randomized Controlled ◽

Outcome Set ◽

Core Outcomes ◽

Working Groups ◽

Broad Consensus

The Outcome Measures in Rheumatology (OMERACT) community strives to develop core outcome sets for rheumatologic conditions to specify, for each condition, the minimum set of outcomes necessary to provide consistent estimates of the benefits of an intervention. The original and successful OMERACT filter of “truth, discrimination, and feasibility” requires development and updating because of application to a widening range of conditions by an expanding group, particularly patients. It should more explicitly identify the relevant core outcomes that might be universal to all randomized controlled trials within rheumatology. Working from first principles, comparing proposals against actual procedures adopted by OMERACT working groups, and seeking a broad consensus over several major sessions at the OMERACT 11 meeting, a new version has emerged, OMERACT Filter 2.0, which will form the central theme of the intended OMERACT handbook and offers an approach to core outcome set development in many areas of healthcare.

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Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations

Health Technology Assessment ◽

10.3310/hta21260 ◽

2017 ◽

Vol 21 (26) ◽

pp. 1-192 ◽

Cited By ~ 12

Author(s):

Lucy Webster ◽

Derek Groskreutz ◽

Anna Grinbergs-Saull ◽

Rob Howard ◽

John T O’Brien ◽

...

Keyword(s):

Quality Of Life ◽

Core Outcome Set ◽

Core Outcome ◽

Disease Modification ◽

The Core ◽

Moderate Dementia ◽

Outcome Set ◽

Core Set ◽

And Biological Markers

BackgroundThere is currently no disease-modifying treatment available to halt or delay the progression of the disease pathology in dementia. An agreed core set of the best-available and most appropriate outcomes for disease modification would facilitate the design of trials and ensure consistency across disease modification trials, as well as making results comparable and meta-analysable in future trials.ObjectivesTo agree a set of core outcomes for disease modification trials for mild to moderate dementia with the UK dementia research community and patient and public involvement (PPI).Data sourcesWe included disease modification trials with quantitative outcomes of efficacy from (1) references from related systematic reviews in workstream 1; (2) searches of the Cochrane Dementia and Cognitive Improvement Group study register, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Latin American and Caribbean Health Sciences Literature and PsycINFO on 11 December 2015, and clinical trial registries [International Standard Randomised Controlled Trial Number (ISRCTN) and clinicaltrials.gov] on 22 and 29 January 2016; and (3) hand-searches of reference lists of relevant systematic reviews from database searches.Review methodsThe project consisted of four workstreams. (1) We obtained related core outcome sets and work from co-applicants. (2) We systematically reviewed published and ongoing disease modification trials to identify the outcomes used in different domains. We extracted outcomes used in each trial, recording how many used each outcome and with how many participants. We divided outcomes into the domains measured and searched for validation data. (3) We consulted with PPI participants about recommended outcomes. (4) We presented all the synthesised information at a conference attended by the wider body of National Institute for Health Research (NIHR) dementia researchers to reach consensus on a core set of outcomes.ResultsWe included 149 papers from the 22,918 papers screened, referring to 125 individual trials. Eighty-one outcomes were used across trials, including 72 scales [31 cognitive, 12 activities of daily living (ADLs), 10 global, 16 neuropsychiatric and three quality of life] and nine biological techniques. We consulted with 18 people for PPI. The conference decided that only cognition and biological markers are core measures of disease modification. Cognition should be measured by the Mini Mental State Examination (MMSE) or the Alzheimer’s Disease Assessment Scale – Cognitive subscale (ADAS-Cog), and brain changes through structural magnetic resonance imaging (MRI) in a subset of participants. All other domains are important but not core. We recommend using the Neuropsychiatric Inventory for neuropsychiatric symptoms: the Disability Assessment for Dementia for ADLs, the Dementia Quality of Life Measure for quality of life and the Clinical Dementia Rating scale to measure dementia globally.LimitationsMost of the trials included participants with Alzheimer’s disease, so recommendations may not apply to other types of dementia. We did not conduct economic analyses. The PPI consultation was limited to members of the Alzheimer’s Society Research Network.ConclusionsCognitive outcomes and biological markers form the core outcome set for future disease modification trials, measured by the MMSE or ADAS-Cog, and structural MRI in a subset of participants.Future workWe envisage that the core set may be superseded in the future, particularly for other types of dementia. There is a need to develop an algorithm to compare scores on the MMSE and ADAS-Cog.Study registrationThe project was registered with Core Outcome Measures in Effectiveness Trials [www.comet-initiative.org/studies/details/819?result=true(accessed 7 April 2016)]. The systematic review protocol is registered as PROSPERO CRD42015027346.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Harmonising research outcomes for polycystic ovary syndrome: an international multi-stakeholder core outcome set

Human Reproduction ◽

10.1093/humrep/dez272 ◽

2020 ◽

Vol 35 (2) ◽

pp. 404-412 ◽

Cited By ~ 6

Author(s):

Bassel H Al Wattar ◽

Helena Teede ◽

Rhonda Garad ◽

Steve Franks ◽

Adam Balen ◽

...

Keyword(s):

Polycystic Ovary ◽

Evidence Synthesis ◽

Core Outcome Set ◽

Core Outcome ◽

Ovary Syndrome ◽

Outcome Set ◽

Core Outcomes ◽

Competing Interest

Abstract STUDY QUESTION What are the key core outcomes to be reported in studies on polycystic ovary syndrome (PCOS)? SUMMARY ANSWER We identified 3 generic and 30 specific core outcomes in 6 specialist domains: metabolic (8), reproductive (7), pregnancy (10), oncological (1), psychological (1) and long-term outcomes (1). WHAT IS KNOWN ALREADY Research reporting PCOS is heterogeneous with high variation in outcome selection, definition and quality. STUDY DESIGN, SIZE, DURATION Evidence synthesis and a modified Delphi method with e-surveys were used as well as a consultation meeting. PARTICIPANTS/MATERIALS, SETTING, METHODS Overall, 71 health professionals and 123 lay consumers (women with lived experience of PCOS and members of advocacy and peer support groups) from 17 high-, middle- and low-income countries were involved in this analysis. MAIN RESULTS AND THE ROLE OF CHANCE The final core outcome set included 3 generic outcomes (BMI, quality of life, treatment satisfaction) that are applicable to all studies on women with PCOS and 30 specific outcomes that were categorised into six specialist domains: 8 metabolic outcomes (waist circumference, type 2 diabetes, insulin resistance, impaired glucose tolerance, hypertension, coronary heart disease, lipid profile, venous thromboembolic disease); 7 reproductive outcomes [viable pregnancy (confirmed by ultrasound including singleton, twins and higher multiples), clinical and biochemical hyperandrogenism, menstrual regularity, reproductive hormonal profile, chronic anovulation, ovulation stimulation success including the number of stimulated follicles ≥ 12 mm, incidence and severity of ovarian hyperstimulation syndrome]; 10 pregnancy outcomes (live birth, miscarriage, stillbirth, neonatal mortality, gestational weight gain, gestational diabetes, preterm birth, hypertensive disease in pregnancy, baby birth weight, major congenital abnormalities); 3 psychological outcomes (depression, anxiety, eating disorders); 1 oncological (abnormal endometrial proliferation including atypical endometrial hyperplasia and endometrial cancer); and 1 outcome in the long-term domain (long-term offspring metabolic and developmental outcomes). LIMITATIONS, REASONS FOR CAUTION We involved lay consumers in all stages of study through e-surveys but not through focus groups, thereby limiting our understanding of their choices. We did not address the variations in the definitions and measurement tools for some of the core outcomes. WIDER IMPLICATIONS OF THE FINDINGS Implementing this core outcome set in future studies on women with PCOS will improve the quality of reporting and aid evidence synthesis. STUDY FUNDING/COMPETING INTEREST(S) Evidence synthesis was funded through the Australian government, National Health and Medical Research Council (NHMRC) Centre for Research Excellence in PCOS, and H.T. is funded through an NHMRC fellowship. B.H.A. is funded through an NIHR lectureship. All authors have no competing interest to declare.

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Development of a Core Set of Patient-Reported Outcomes for Population-Based Cancer Survivorship Research: Protocol for an Australian Consensus Study (Preprint)

10.2196/preprints.14544 ◽

2019 ◽

Author(s):

Imogen Ramsey ◽

Nadia Corsini ◽

Amanda D Hutchinson ◽

Julie Marker ◽

Marion Eckert

Keyword(s):

Cancer Survivors ◽

Cancer Survivorship ◽

Phase Ii ◽

Core Outcome Set ◽

Population Based ◽

Core Outcome ◽

The Core ◽

Outcome Set ◽

Core Set

BACKGROUND Core outcome sets seek to improve the consistency and quality of research by providing agreed-upon recommendations regarding what outcomes should be measured as a minimum for a population and setting. The problems arising from a lack of outcome standardization in population-based cancer survivorship research indicate the need for agreement on a core set of patient-reported outcomes (PROs) to enhance data quality, consistency, and comparability. OBJECTIVE This study aims to identify a core set of PROs, representing the most important issues impacting on cancer survivors' long-term health, functioning and quality of life, to inform population-based research on cancer survivorship. METHODS In Phase I, a list of all potentially important outcomes will be generated through focus group discussions with cancer survivors and a review of measures for assessing quality of life in cancer survivorship. The consolidated list will be advanced to Phase II, where a stakeholder consensus process will be conducted with national experts in cancer survivorship to refine and prioritize the outcomes into a core outcome set. The process will consist of a two-round Delphi survey and a consensus meeting. Cancer survivors, oncology health care professionals, and potential end users of the core outcome set with expertise in cancer survivorship research or policy will be invited to participate. In Phase III, recommended measures for assessment of the core outcome set will be selected with advice from experts on the assessment, analysis, and interpretation of PROs. RESULTS As of April 2019, data collection for Phase I is complete and data analysis is underway. These data will inform the list of outcomes to be advanced into Phase II. Recruitment for Phase II will commence in June 2019, and it is anticipated that it will take 6 months to complete the three-step consensus process and identify a provisional core outcome set. The study results are expected to be published in early 2020. CONCLUSIONS Expert consensus-driven recommendations on outcome measurement will facilitate the inclusion of survivorship outcomes considered important by cancer survivors and health professionals in future research. Adoption of the core outcome set will enable comparison and synthesis of evidence across studies and enhance the quality of PRO data collected in cancer survivorship research, particularly when applied to address macro-level questions. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/14544

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Development of a Core Outcome Set for research on critically ill obstetric patients: A study protocol

Obstetric Medicine ◽

10.1177/1753495x18772996 ◽

2018 ◽

Vol 11 (3) ◽

pp. 132-136 ◽

Cited By ~ 4

Author(s):

Julien Viau-Lapointe ◽

Rohan D’Souza ◽

Louise Rose ◽

Stephen E Lapinsky

Keyword(s):

Systematic Review ◽

Critical Illness ◽

Critically Ill ◽

Core Outcome Set ◽

Current Data ◽

Future Research ◽

Core Outcome ◽

Core Outcome Sets ◽

Outcome Set ◽

Core Outcomes

Background Current data on critical illness during pregnancy are insufficient for evidence-based decision making. Core outcome sets are promoted to improve reporting of outcomes important to decision makers. We aim to develop a Core Outcome Set for research on critically ill obstetric patients (COSCO study). Methods We will perform a systematic review of studies on critical illness in pregnancy and focus groups or interviews with women who were critically ill while being pregnant. These data will inform an international Delphi survey where stakeholders will rank proposed outcomes. Selected outcomes will be brought forward to a consensus meeting where core outcomes will be defined. We will then complete a second consensus process to define measures for each core outcome. Conclusion The Core Outcome Set on Critically ill Obstetric patients study aims to develop a set of core outcomes to be part of all studies on critically ill obstetric patients. Implementation of this core outcome set will help improve future research efforts. Trial registration: This study is registered on the COMET-initiative website (COS #916). This systematic review is registered on PROSPERO (CRD #42017071944).

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