Table 1 Characteristics of included studies
From: Core Outcome Sets (COS) related to pregnancy and childbirth: a systematic review
Author, Year Ref | Subject | Study objective | N outcomes in COS | Methods | Consensus criteria for inclusion in the COS | Stakeholders included | Participants: N included, % answering all surveys, N at meeting | Protocol (Y/N) Comet Registration number | Compliance with COS-STAR |
|---|---|---|---|---|---|---|---|---|---|
Pregnancy | |||||||||
Bashir et al. 2021 [12] | Gestational diabetes for treatment trials | A Core Outcome Set | 11a | Five round Delphi survey and consensus meetings | Agreement by three-quarters of those present | Researchers and clinicians from Qatar, North America, Europe, and Australiab | Not stated | N 1790 | Some details not reported |
Meissner et al. 2021 [31] | Pregnancy registries in rheumatology | A Core data set for registries | 51a | A two-round Delphi survey and consensus meeting | > 70% scored as critically important in Delphi and > 50% of votes in meeting | Multidisciplinary stakeholders from 14 different countriesb | 64, 88%, 12 | N 1710 | Some details not reported |
Duffy et al. 2020 [19] | Pre-eclampsia research | A Core Outcome Set | 22a | A Three-round Delphi survey and consensus meetingc | 70%/ 15%d in each stakeholder group | Patients, clinicians, researchers from 56 nations | 432, 63%,11 | Ye 588 | Good |
Egan et al. 2020 [20] | Gestational diabetes mellitus prevention and treatment | A Core Outcome Set | 14 | A three-round Delphi survey and consensus meeting | 70%/ 15%d in each stakeholder group and ≥ 70% voted ‘yes in meeting | Patient representatives, researchers and clinicians from 27 countries | 173f, 59%, 23 | Ye 686 | Good |
Jansen et al. 2020 [27] | Hyperemesis gravidarum research | A Core Outcome Set | 24 | A two-round Delphi survey and consensus meetingc | 70%/ 15%d in each stakeholder group | Patient representatives, researchers and clinicians from 22 countries | 277, 45%,20 | N 805 | Good |
Bogdanet et al. 2019 [14] | Follow-up at 1 year and beyond of women with gestational diabetes | A Core Outcome Set | 9 | A three-round Delphi survey and consensus meeting | 70%/ 15%d | Patients, clinicians, researchers, policy makers and others from 33 nations | 835, 20%, 20 | Ye 1031 | Good |
Bunch et al. 2018 ( [16] | Monitor the quality of maternity care | Developing a set of consensus indicators | 14 | A two-round Delphi survey and consensus meeting | 70%/ 15%d | Service designers, providers and users from Englandb | 101, 71%, 19 | N | Some details not reportedg |
Nijagal et al. 2018 [32] | Pregnancy and childbirth | Standardized outcome measures | 23 | A series of nine teleconferences, incorporating a modified Delphi process | Outcome domains thought to be “critical” (7–9) by at least 70% | Consumer representatives and international experts, researchers and patient advocacy from 8 nations | 21, 73%, NA | N 875 | Some details not reported |
Egan et al. 2017 [21] | Pre-pregnancy care for women with pregestational diabetes | A Core Outcome Set | 17 | A three-round Delphi survey and consensus meeting | 70%/ 15%d | Clinicians’ patient’s policy makers, researchers, advocates on behalf of those with diabetes and others from 24 nations | 151f, 67%, 14 | Ye 692 | Good |
Al Wattar et al. 2016 [11] | Epilepsy in pregnancy | A Core Outcome Set | 31 | A three-round Delphi survey and consultation meetingi | 70%/ 15%d (used a 5-point scale) | Healthcare professionals, and patient representatives from UK.b | 99f, 49%, 15 | Yh 393 | Good |
Rogozinska et al. 2016 [34] | The effects of diet and lifestyle in pregnancy | Composite outcomes for individual patient data (IPD) meta-analysis | Maternal: 6 Neonatal: 4 | A two-round Delphi survey | Considered to be critically important by the (score > 7) by the panel | Researchers from the International Weight Management in Pregnancy collaborative network from 11 nationsb | 26, 96%, NA | N | Significant details not reported |
van ʼt Hooft et al. 2016 [37] | Interventions to Prevent Preterm Birth | A Core Outcome Set | 13 | A two-round Delphi survey and consensus meeting | 70%/ 15%d in each stakeholder group | Parents, clinicians, and researcher from 25 nations | 228, 76%, 29 | Yh 603 | Good |
Fong et al. 2014 [23] | Management of late-onset pre-eclampsia | Maternal and neonatal composite outcomes | Maternal: 7 Neonatal: 3 | A two-round Delphi survey | A median score of ≤4 and indicated consensus (IQR ≤2) for evaluation in the third stage. (5-point scale) | Practising senior clinicians and clinical academics from the United Kingdomb | 44, 90% maternal outcomes 75% neonatal outcomes, NA | N 716 | Significant details not reported |
Saldanha et al. 2013 [35] | Gestational diabetes mellitus | Identify research needs, including which outcomes to measure, from a systematic review | Maternal: 17 Neonatal:13 | Delphi method | Not specified | Clinicians, primary researchers, research funders, insurers, and patients or patient representatives from 1 nation | 9 | N | Significant details not reported |
Bennett et al. 2012 [13] | Gestational diabetes mellitus | Identify research needs, including which outcomes to measure | Medication: 8 Delivery:8 | One- survey | Appearing in the top 3 list of two or more of the nine stakeholders | Clinical expertsb | 20, NA, NA | N 527 | Significant details not reported |
Mehra et al. 2012 [30] | Weight management interventions in pregnancy | Prioritisation of outcomes | Presents the top 5 | A two-round Delphi survey | Not enough information provided | 20 Consultants from 2 nationsb | 20 participants | N | Significant details not reported |
Devane et al. 2007 [17] | Evaluating maternity care | A Core Outcome Set | 48 | A three-round Delphi survey | Both a mean above the overall group mean for all outcomes combined and rated 4–5 by at least 70% | Healthcare professionals and patients from 28 nations. | 320, 48%, NA | N 108 | Some details not reportedg |
Misscarriage, abortion and stillbirth | |||||||||
Kim et al. 2021 828) | Interventions to prevent stillbirth | A Core Outcome Set | 11 | A two-round Delphi survey and consensus meetingc | 70%/ 15%d | Clinicians, researchers and parents | 129f 69%, 20 | Yh 982 | Some details not reported |
Fiala et al. 2018 [22] | First trimester medical termination of pregnancy | Definitions of outcomes | NA | Consensus meeting | Not specified | Clinicians, researchers and members of the pharmaceutical industry from Europeb | Number of participants not clearly stated | N | Significant details not reportedg |
Mental Health | |||||||||
Hellberg et al. 2021 [26] | Treatment studies of perinatal depression | A Core Outcome Set | 9 | A three-round Delphi survey and consensus meetingc | 70%/ 15%d in each stakeholder group | Clinicians, researchers and patients from 13 countries | 222, 55%,13 | Y 1421 | Goodj |
Labour and delivery and complications | |||||||||
Gachon et al. 2021 [24] | Mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery | A Core Outcome Set for a one-year observational French study | 51 outcomes 63 variables | A three-round Delphi surveyi | at least 50% of respondents considered the item as essential | Obstetricians and women in the community | Clinicians: 109, 37%, NA Women: 24, 63%, NA | N | Some details not reportedg |
Briscoe et al. 2019 [15] | Cesarean deliveries with infectious morbidity outcomes | A Core Outcome Set | 6 | A two-round Delphi survey | Majority of respondents | Systematic review authorsb | 41, 34%, NA | N 763 | Significant details not reported |
Dos Santos et al. 2018 [18] | Induction of labour | A Core Outcome Set | 28 | A two-round Delphi survey and consensus meeting | 70%/ 15%d | Midwives, obstetricians, neonatologists, and women’s representatives | 159, 45%, 20 | Yh 695 | Good |
Meher et al. 2019 [29] | Prevention and treatment of postpartum haemorrhage | Two Core Outcome Sets | Prevention: 9 Treatment: 12 | A two-round Delphi survey and consensus meeting | 70%/ 15%d in each stakeholder group | Healthcare professionals and women’s representatives from 36 nations | Prevention: 205, 74%, 36 Treatment: 197, 73%, 36 | Yh 706 | Good |
Fetal / neonatal | |||||||||
Healy et al. 2019 [25] | Prevention and treatment of fetal growth restriction | A Core Outcome Set | 22 | A three-round Delphi survey and consensus meeting | 70%/ 15%d | Healthcare providers, researchers/academics, members of the public from 36 nations | 238, 45%, not specified | Ye 689 | Good |
Perry et al. 2019 [33] | Treatments for twin-twin transfusion syndrome. | A Core Outcome Set | 12 | A three-round Delphi survey and consensus meetingc | 70%/ 15%d | Healthcare professionals, researchers and patients or relatives of patients from 29 nations | 103f, 85%, 16 | Ye 1392 | Good |
Townsend et al. 2019 [36] | Management of selective fetal growth restriction in twins. | A Core Outcome Set | 11 | A three-round Delphi survey and consensus meetingc | A median score of 8 after the third round were taken forwards for discussion | Clinicians, obstetricians, fetal medicine specialists, neonatologists, and midwives, researchers, and parents or patients from 23 nations. | 102f, 86%, 19 | Ye 998 | Good |