Developing a core outcome set for the treatment of pregnant women with pregestational diabetes—a study protocol

Abstract

Background Pregestational diabetes mellitus (PGDM) is associated with adverse pregnancy outcomes including increased rates of caesarean section birth, macrosomia, congenital malformation, prematurity, admission to the neonatal intensive care unit and stillbirth. As a result, there has been an increase in interventions to improve outcomes in both mother and infant. To date, meaningful comparisons between these studies are limited due to heterogeneity in outcome selection and reporting. The aim of this study is to develop a core outcome set (COS) for randomised controlled trials evaluating the effectiveness of interventions for the treatment of pregnant women with PGDM. Methods The study consists of three steps. The first step is a systematic review of the literature to assess outcomes reported in randomised controlled trials assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. The second step is a three round, online Delphi survey to prioritise these outcomes. In this step, stakeholders (including women with PGDM, healthcare workers, researchers and policymakers) will be asked to rank the importance of outcomes for inclusion in the COS using a 9-point Likert type scale. Outcomes that meet the inclusion criteria after completion of the Delphi surveys will be brought to the consensus meeting. The consensus meeting will be the third and final step, where the COS will be finalised. The consensus meeting will include members from each stakeholder group. Discussion This paper describes the process used to develop a COS for the reporting of studies evaluating the effectiveness of interventions in pregnant women with PGDM. The COS will enable greater comparison between and information synthesis across RCTs in the treatment of PGDM. In addition, this COS will also help improve trial reporting and minimise research waste by prioritising the collection and reporting of outcomes that matter to all relevant stakeholder groups. Trial registration This COS has been registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative (http://www.comet-initiative.org/studies/details/1425) on the 4th of November 2019. The systematic review component of this study has also been registered with the International Prospective Register of Systematic Reviews (PROSPERO) (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020173549).

Quality of patient-reported outcome reporting in trials of diabetes in pregnancy: A systematic review

“…The need for more patient representation in COSs has also been specifically addressed in the area of diabetes in pregnancy [81]. While a number of well-defined diabetes specific COSs have already been developed for diabetes in pregnancy, they focus predominately on physiological outcomes and contain no PROs [82][83][84].…”

A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study

“…Ethical approval for this study was granted by the Clinical Research Ethics Committee, Galway 21 has been published elsewhere 22 . This study consisted of 3 components:…”

“…The systematic review component of the study was registered with the International Prospective Register of Systematic Reviews (PROSPERO) database (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020173549). A detailed study protocol prepared in line with the COS‐STAndardised Protocol Items Statement recommendations 21 has been published elsewhere 22 …”

“…A detailed study protocol prepared in line with the COS-STAndardised Protocol Items Statement recommendations 21 has been published elsewhere. 22 This study consisted of three components: 1 A systematic literature review to identify a list of all outcomes reported in prior or ongoing RCTs of interventions for the treatment of pregnant women with PGDM. 2 A three-round eDelphi survey where key stakeholders prioritised these outcomes.…”

A systematic review on outcome reporting in randomised controlled trials assessing treatment interventions in pregnant women with pregestational diabetes

“…The protocol for this systematic review has been published. 16 This systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO) database (Registration number CRD42020173549). The study was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement guidelines.…”