Core Outcome Sets

Core Outcome Sets

We list any COS highlighted to us providing it has been registered with the COMET initiative. The projects are grouped as follows:

1. COS endorsed by CROWN
Health problemFull titleDescriptionCOMET registration numberLinks Funding Body
Epilepsy in pregnancyDefining core outcomes for clinical trials in pregnant women with epilepsy (E-core): A Delphi surveyThe aim of this project is to develop a core outcome set for clinical trials on the management of epilepsy in pregnant women.
The objectives are: a) to perform a systematic literature review to produce a comprehensive list of all maternal and neonatal outcomes reported in recent studies of pregnant women with epilepsy; b) to use the Delphi technique to refine the outcome list into a core outcome set agreed by key stakeholders.
393Full article: Al Wattar BH , Tamilselvan K, Khan KS et al. for Antiepileptic Drug Management in Pregnancy (EMPIRE) Collaborative Network.BJOG 2016; doi: 10.1111/1471-0528.14430None
Preterm birthCore outcome set for studies on primary prevention of preterm birthThe Core outcomes set on primary Prevention Of Preterm birth (COPOP) project used an international multidisciplinary Delphi method to develop consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women. A total of 228 participants from five stakeholder groups from 10 lower-middle-income and 17 high-income countries scored 31 outcomes. Consensus was reached on 13 core outcomes.

Read the summary here
603Full article: van ʼt Hooft J, Duffy JM, Daly M, et al. for Global Obstetrics Network (GONet). Obs & Gyn. 2016;127(1):49-58None
Maternity CareEvaluating Maternity Care: A Core Set of Outcome MeasuresThe aim of this project was to identify a minimum set of outcome measures for evaluating models of maternity care.

A 3-round, electronic Delphi survey including a wide range of key, international stakeholders. Members of the panel self-assessed their expertise in evaluating models of maternity care.
108
Full article: Devane D, Begley CM, Clarke M, et al.Birth 2007; 34(2): 164–172Not stated
2. COS working towards CROWN endorsement
a) with external funding
Health problemFull titleDescriptionCOMET registration numberFunding Body
AbortionSTandardizing Abortion Research outcomes (STAR)Complications of unsafe abortion are one of the main causes of maternal mortality globally. The aim of this project is to develop a core outcome set for the studies with the most common procedures performed on women worldwide to improve the applicability of their findings.
The protocol is available here
779World Health Organization
Cervical cancerCore outcomes for clinical trials of fertility sparing surgery for cervical cancer: a Core Outcome sets for Gynaecological conditions (COGS) project
COGS
Our aim is to develop a core outcome set that can be used in future studies investigating fertility sparing surgical techniques for cervical cancer.791The British Medical Association's Strutt and Harper Grant
EndometriosisDeveloping a Core Outcome Set in Endometriosis
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The International Collaboration to Harmonise Outcomes in Endometriosis (iHOME) aims to produce, disseminate, and implement a core outcome set for endometriosis.
The protocol is available here
691Catalyst Fund - Royal Society of New Zealand &
Endometriosis Millennium Fund, Royal College of Obstetricians and Gynaecologists
Endometrial cancerDevelopment of core outcomes sets to standardise reporting in endometrial cancer and atypical endometrial hyperplasiaThe aim of this project is to develop core outcome sets (COS) for studies concerning the management of endometrial cancer and atypical endometrial hyperplasia.

This project will produce three overarching COS:
  • COS for endometrial cancer

  • COS for atypical endometrial hyperplasia

  • COS for fertility-sparing treatment of endometrial cancer and endometrial hyperplasia
to be registeredCancer Research UK Population Research Scheme (recently awarded)
GastroschisisDeveloping a core outcome set for infants born with gastroschisisThe key objectives of this project are: to determine which outcomes are currently reported in studies comparing surgical treatments for gastroschisis and assess the quality of reporting; Prioritise outcomes from patient/parent, paediatric surgical and non-surgical clinician perspectives; Achieve consensus between key stakeholders on a core outcome set for assessing how successful the overall treatment of an infant with gastroschisis has bee; and compare and contrast outcomes prioritised by patients/parents, surgeons and non-surgical clinicians. Study protocol is available here746NIHR Doctoral Research Fellowship
Gestational diabetes mellitusDeveloping a core outcome set for clinical studies of prepregnancy care for women with pregestational diabetes mellitusThe aim is to develop a Core Outcome Set for trials and other studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes mellitus.

Protocol available here
692Health Research Board (Ireland)
Hirschsprung’s DiseaseDevelopment of a Core Outcome Set for use in Infants with Hirschsprung’s DiseaseA core outcome set will be developed for assessing key outcomes, both short and long term in infants who have undergone surgical intervention for Hirschsprung's Disease.
Study protocol available here
787National Institute for Health Research
Heavy menstrual bleedingCore outcomes for clinical trials of heavy menstrual bleeding: a Core Outcome sets for Gynaecological conditions (COGS) project
COGS
Heavy menstrual bleeding (HMB) is one of the most common reasons for referral to secondary care and affects up to 1 in 5 women of reproductive age. It is a common condition that has a large impact on women’s physical, psychological and social wellbeing and an economic impact due to time taken away from employment and cost to the NHS.

There are many different treatments for HMB including hormonal, medical and surgical interventions. Our aim is to develop a COS that covers all aspects of the condition.
789The Academy of Medical Sciences Starter Grant
Hypertensive disorders in pregnancyInternational Collaboration to Harmonise Outcomes for Pre-Eclampsia (iHOPE)
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iHOPE is working to improve pre-eclampsia research to enable doctors and midwives to provide better treatments and care for pregnant women and their babies.

We invite you to sign up to become an iHOPE collaborator:
  • Deciding which outcomes should be measured involves seeking many different opinions and utilising different methods to reach an agreement.

  • Patients, healthcare professionals, and researchers from all backgrounds and locations are invited to contribute.

  • As an iHOPE collaborator we would invite you to read three short, informative e-mails and take part in an online survey.
The protocol is available here
588The National Institute for Health Research Doctoral Fellowship & The EGA Hospital Charity Travelling Fellowship in Memory of Anne Boutwood, Royal College of Obstetricians and Gynaecologists
Intimate partner violenceForming Core Outcome Sets to Unify Studies on Domestic Violence and Abuse (FoCUS DVA)Domestic violence and abuse (DVA) affects one in four women and is a major public health issue. Recent Cochrane reviews highlight that synthesising evidence on addressing DVA in healthcare settings is limited because of enormous variation in the measurement of effectiveness of intervention. To address this problem, we aim to develop a core outcome set for (a) screening interventions on DVA and (b) advocacy interventions on DVA. This will be achieved via systematic review, stakeholder engagement, qualitative interviews with survivors, and a 2-stage Delphi process.823The Barts Health Charity Academic Clinical Fellowship grant
Intrapartum fetal assessment Developing a core outcome set for intrapartum fetal assessmentThe use of the COS as a minimum across the field of intrapartum fetal assessment would allow for the results of trials and other studies to be effectively compared, contrasted and combined, as appropriate.741Health Research Board (Ireland)
Intrauterine growth restriction Developing a core outcome set for clinical trials in intrauterine growth restrictionDeveloping a COS for use in all studies of the screening, prevention and treatment of intrauterine growth restriction is timely and important. This use of the COS as a minimum across an entire research area would allow for the results of trials and other studies to be effectively compared, contrasted and combined, as appropriate.689Health Research Board (Ireland)
MiscarriageCore outcome measures for prevention of miscarriage trials The aim of this study will be to develop core outcome measures for trials in the prevention of miscarriage.815The National Institute for Health Research Post doctoral Fellowship
MiscarriageCore outcome measures for medical management of miscarriageThe aim of this study will be to develop core outcome measures for the medical management of miscarriage816The National Institute for Health Research Post doctoral Fellowship
MiscarriageCore outcome measures for surgical management of miscarriageThe aim of this study will be to develop core outcome measures for the surgical management of miscarriage.679The National Institute for Health Research Post doctoral Fellowship
NeonatologyCore Outcomes in Neonatology (COIN)
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The aim of this study is to develop a neonatal Core Outcome Set that are linked to data that are routinely recorded during clinical care. Development and use of a core outcome set will ensure that outcomes of importance to all stakeholders, including patients and parents, are collected and reported in a standard way.842Imperial College Doctoral Fellowship
ObesityNetwork for Preconception and early Pregnancy Randomised Controlled TrialsThis project will:
  • Identify core neonatal outcomes for preconception and early pregnancy randomised controlled trials that aim to break the intergenerational cycle of obesity (and diabetes)

  • Build a network of studies to improve pregnancy in overweight and obese women through preconception and early gestation lifestyle programs.
784The University of Western Australia Research Collaboration Award
Postpartum haemorrhageCore outcome sets for the prevention and treatment of postpartum haemorrhagePostpartum Haemorrhage (PPH) is the leading cause of maternal mortality worldwide, but evidence around prevention and treatment interventions is difficult to interpret due to heterogeneity in endpoints.

This project will develop Core Outcomes Sets (COS) for (1) prevention and (2) treatment of PPH by consulting relevant stakeholders using a Delphi survey and face to face meeting.

To explore best methodology for development of COS, we will do one Delphi on a small group of experts and a second Delphi on a larger stakeholder group and agree the final COS at the face to face consensus meeting.
706The British Medical Association's Strutt and Harper Grant
b) without external funding or awaiting funding
Health problemFull titleDescriptionCOMET registration numberStatus
Breast cancerValidated Outcomes in the Grafting of Fat to the Breast (VOGUE)The objective is to develop a core outcome set (COS) for AFG to the breast. Study protocol is available here860Ongoing
Cardiovascular DiseasePrimary endpoints in cohort studies evaluating cardiovascular disease risk after reproductive disordersThe study aims to systematically review relevant CVD endpoints used in prognostic research among women with reproductive disorders and to develop a core outcome set.701Ongoing
Cardiovascular DiseaseDeveloping a core outcome set for pregnant women with cardiac diseaseTrials and cohort studies evaluating therapeutic interventions in women with cardiac disease report many different outcomes resulting in significant outcome reporting bias and an inability to compare results across studies. The development and use of core outcome sets would help to address these issues.834Ongoing
Gestational diabetes mellitusDeveloping a core outcome set for clinical trials in Gestational diabetes mellitusTo develop a COS for use in studies on screening, prevention and treatment of GDM.686Planning
(status to be confirmed)
Hyperemesis gravidarumDevelopment of a definition and core outcome set for studies in hyperemesis gravidarumThe aim is to develop a consensus definition of hyperemesis gravidarum and core outcome set for use in future trials, systematic reviews and guidelines on the management of the condition.805Ongoing
Immune thrombocytopenic purpuraConstructing a core outcome set for Immune Thrombocytopenia in PregnancyThe objective of this project is to generate a core outcome set for studies focusing on the evolution and management of Immune thrombocytopenic purpura in pregnancy. 840Planning
(status to be confirmed)
Induction of LabourDevelopment of a Core Outcome Set for trials on Induction of Labour
COSIOL
The objectives are:
a) to identify all relevant obstetric, fetal and neonatal outcomes in randomised studies of IOL; b) to develop a set of core outcomes for reporting on IOL using the Delphi technique.
You can learn more about the project here.
695Ongoing
Intrauterine death/ stillbirthDefining a core outcome set for bereavement care interventions following intrauterine death, stillbirth and neonatal lossWe aim to define a core outcome set for bereavement care interventions following intrauterine death, stillbirth and neonatal loss, that is evidence-based, relevant and appropriate for patients and researchers alike.775Planning
(status to be confirmed)
Iron Deficiency AnaemiaConstructing a core outcome set for Iron Deficiency Anaemia in PregnancyThe objective of this project is to produce a core outcome set for studies focusing on the identification, assessment and management of iron deficiency anaemia in pregnancy and postpartum.836Ongoing
Maternity careDeveloping a core outcome set for caesarean delivery maternal infectious outcomesObjective: to review all Cochrane Reviews and contributing trials in the area to devise a common core outcome set to propose to the CROWN initiative for use in any newly published clinical trials.763Ongoing
MenopauseCore outcome set in Menopause (COMMA)The aim of this project is to develop, disseminate, and implement a core outcome set for menopause engaging with key stakeholders, including healthcare professionals, researchers, and women who have experienced the menopause transition917Ongoing
Multiple pregnanciesDeveloping a core outcome set for research in multiple pregnanciesThe aim is to develop a core outcome set for research in multiple pregnancies, irrespective of chorionicity.844Planning
(status to be confirmed)
Neonatal Abstinence SyndromeA core outcome set for neonatal abstinence syndrome (NAS)The NAS core outcome set is a first step in facilitating high-quality evidence that will ease the comparability between studies and foster meta-analysis. The synthesis of NAS effectiveness evidence informs clinical decision making, improves health outcomes and saves resources808Ongoing
Obstetric Anal Sphincter InjuryThe CO-OPT Study: Core Outcomes in Obstetric Anal Sphincter Injury Prevention and TreatmentThe objective of this project is to develop a core outcome set for studies evaluating interventions for the prevention and treatment of Obstetric Anal Sphincter Injuries (OASIS).844Planning
Reduced fetal movements/ StillbirthDeveloping a core outcome set (COS) for clinical trials on interventions for the detection and management of reduced fetal movements in pregnancyThe aim is to develop a COS for use in future trials on the topic of reduced fetal movements in pregnancy.928Planning
Venous thromboembolism Constructing a core outcome set for Venous Thromboembolism in PregnancyThe objective of this project is to produce a core outcome set for studies focusing on the identification, assessment and management of VTE in pregnancy.839Ongoing

Please contact us if you would like your core outcome set listed on this page.