PREgnancy Nutrition: A protocol for the development of a Core Outcome Set (PRENCOS)

Abstract

Objective: To develop a Core Outcome Set (COS) for pregnancy nutrition research that is relevant to varied stakeholders and resource settings. Methods:This study has three distinct phases. The first phase involves generating a list of outcomes for consideration for the COS. This includes a systematic review of studies evaluating nutrition during pregnancy where all outcomes reported in relevant literature will be extracted. Qualitative interviews with currently or previously pregnant women will also be conducted. This step will supplement the findings of the systematic review by identifying additional outcomes of importance to this stakeholder group. In the second phase of the study, healthcare professionals, researchers, and mothers from various international resource settings will be invited to participate in a two-round modified Delphi survey. The aim of the survey is to gain consensus on which outcomes are most important to include in the COS. Finally, a face-face consensus meeting will be held with a select group of participants to finalize the COS. Conclusion:This COS will support standardization of outcome reporting in pregnancy nutrition research and ensure that selected outcomes are considered important by a variety of stakeholders. This will enhance the evidence behind nutrition interventions in pregnancy to improve outcomes for pregnant women. K E Y W O R D S

Effect of an Antenatal Lifestyle Intervention on Dietary Inflammatory Index and Its Associations with Maternal and Fetal Outcomes: A Secondary Analysis of the PEARS Trial

“…There is no core outcome set for pregnancy nutrition research. However, our group is developing this through the PRENCOS study [ 33 ]. The Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP) is also relevant to this group [ 34 ].…”

UsingFIGONutrition Checklist counselling in pregnancy: A review to support healthcare professionals

“… 112 The FIGO Nutrition Checklist can also be used to assess response to a dietary intervention in pregnancy and appropriate core outcomes for nutritional studies are being developed. 113 Dietary interventions also show promise in terms of cost‐effectiveness. 114 For further insights on how the FIGO Nutrition Checklist can be used, see Figures 2 , 3 , 4 .…”

Pregnancy Nutrition Core Outcome Set (PRENCOS): A core outcome set development study

“…The systematic review was prospectively registered with the International Prospective Register of Systematic Reviews (PROSPERO) in April 2020 (CRD42020135052) and took place on 27 February 2020. 40 Results are reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (Appendix S2; Figure 2). 41 The protocol was published previously.…”

“…The understanding of the Delphi survey process and lay definitions for candidate outcomes were tested during the interviews. 36 Feedback was incorporated into the remaining study material activities. The interviews were digitally recorded and transcribed verbatim.…”

“…56 Participants could select 1-3 or 'not essential' for inclusion, 4-6 or 'important but not critical', 7-9 or 'critically important for inclusion' or 'unable to score'. 36 Participants received two reminder emails, spaced 2 weeks apart, to encourage completion. Participants were provided with their scores from round one and the median score per stakeholder group for each outcome.…”