Variation in outcome reporting in studies on obesity in pregnancy-A systematic review.

Although considerable research is being conducted with a view to improve outcomes for pregnant women with obesity and their babies, much of this research is compromised by the quality of outcome reporting. Our aim is to determine how outcomes have been reported and measured in obesity in pregnancy studies, as a first step towards developing a core outcome set to standardize outcome reporting in future trials. We conducted a systematic review of clinical trials and systematic reviews on obesity in pregnancy in accordance with the Preferred Reporting in Systematic Reviews and Meta-analyses guidelines. We searched Medline, Embase, controlled register of trials, World Health Organization International Clinical Trials Registry, www.clinicaltrials.gov and Google Scholar, for relevant studies and extracted study characteristics, outcome reporting and measurement. Reporting quality was assessed using previously published criteria. Outcomes were grouped using a published taxonomy and variations in outcome reporting and measurement were descriptively presented. Seventy included studies yielded a total of 135 outcomes. Foetal/neonatal outcomes were not reported in 53.3% of studies where an intervention could have implications to both, mother and baby. Reported outcomes were mostly physiological/clinical (74.8%), with very limited representation of outcomes related to mortality/survival (5.2%), life impact (7.4%), adverse events (5.9%) and resource utilization (6.7%).

Development of a Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP): a study protocol.

BACKGROUND: Maternal obesity is a risk factor for adverse maternal, fetal, and neonatal events. Numerous clinical trials are currently exploring the effectiveness of antenatal and peripartum interventions in improving pregnancy outcomes that can in future inform clinical practice. However, the heterogeneity in outcome reporting limits our ability to compare outcomes across studies, and there is a lack of stakeholder representation in outcome choice. A pragmatic solution to this problem is the development of a core outcome set (COS) that defines the minimum criteria for outcome reporting in clinical trials undertaken in this population, arrived at by the involvement of relevant stakeholders. METHODS: The development of a COS for studies on obesity in pregnant patients (COSSOPP) will comprise five steps. First, a systematic review of published literature will identify the long list of outcomes, their definitions and measurements if applicable, and outcome reporting quality. This will be followed by a meta-synthesis of qualitative studies with patients, and qualitative interviews in Toronto with patients, clinicians, researchers, hospital administrators, and policy-makers, to identify novel outcomes that were not obtained through systematic review. Third, the long list of outcomes will be narrowed down through online Delphi surveys involving an international group of patients and relevant stakeholders. This will be followed by a face-to-face consensus meeting with representatives of all stakeholder groups to arrive at a consensus on the final COS. Finally, in order to determine how the identified core outcomes should be measured, we will conduct another literature review and Delphi process. DISCUSSION: COSSOPP will engage patients, clinicians, researchers, and other relevant stakeholders in determining the core set of outcomes that should be reported and measured in order to harmonize outcome reporting in studies evaluating the effectiveness of antepartum and peripartum interventions in obese pregnant women. This protocol provides a detailed overview of the steps involved in the development of a COS, to guide researchers in developing COS within their areas of specialization. COMET CORE OUTCOME SET REGISTRATION: http://www.comet-initiative.org/studies/details/939 .