Core outcome sets (COS) related to pregnancy and childbirth: a systematic review

Marie Österberg1, Christel Hellberg1, Ann Kristine Jonsson1, Sara Fundell1, Frida Trönnberg2, Alkistis Skalkidou3, Maria Jonsson3
1 Swedish Agency for Health Technology Assessment and Assessment of Social Services, Stockholm, Sweden
2Patient representative
3 Dept. of Women’s and Children’s Health, Uppsala university, Sweden
Corresponding author: Marie Österberg, Ph.D., Swedish Agency for Health Technology Assessment and Assessment of Social Services, Stockholm, Sweden. Marie.Osterberg@sbu.se
Running title: Core outcome sets (COS) related to pregnancy and childbirth
Abbreviations
COMET Core Outcome Measures in Effectiveness Trials Initiative
COS Core outcome set/ sets
COS-STAD The Core Outcome Set-STAndards for Development
COS-STAR Core Outcome Set–STAndards for Reporting
CROWN Core Outcomes in Women’s and Newborn Health
RCT Randomised Controlled Trial
SBU Swedish agency for health technology assessment and assessment of social services
HTA Health technology assessment

Abstract

Background: Systematic reviews of clinical trials frequently reveal heterogeneity in the number and types of outcomes reported. To counteract this, a Core Outcome Set (COS) may be applied.
Objectives: A systematic review of all completed and ongoing COS related to pregnancy and childbirth
Search strategy: COMET up to January 2020, Ovid MEDLINE, EMBASE, PsycINFO, Academic Search Elite, CINAHL and SocINDEX up to June 2019.
Selection criteria: Studies which prioritized outcomes using some form of consensus method (such as the Delphi technique) were included.
Data collection and analysis: All included studies were checked for compliance with the Core Outcome Set–STAndards for Reporting. Information about population, setting, method and outcomes was extracted.
Main results: Nineteen completed studies and thirty-nine ongoing studies were included. The number of outcomes included in various COS ranged from 6 to 48. Most COS were for conditions related to physical complications during pregnancy. No COS were identified for perinatal mental health.
Conclusion: This review discloses a growing number of COS within the field of pregnancy and childbirth. Many of the completed studies follow the proposed reporting. However, several of the COS included a large number of outcomes. There is a need to consider the number of outcomes which may be included in a COS while retaining its applicability in future research.