Complex interventions and composite outcomes in Individual Participant Data (IPD) meta-analysis: double challenge in i-WIP IPD

Article type
Authors
Rogozinska E1, Marlin N2, Thangaratinam S1
1Women's Health Research Unit, Queen Mary University of London, United Kingdom
2Pragmatic Clinical Trials Unit, Queen Mary University of London, United Kingdom
Abstract
Background: i-WIP (International Weight management In Pregnancy) is an IPD meta-analysis of randomised controlled trials looking at the differential effect of diet and physical activity based interventions on maternal and fetal outcomes in pregnancy.
The interventions used in the studies eligible for the IPD involve a range of weight management methods aiming to improve diet, level of physical activity and lifestyle. The interventions were delivered with various frequencies, for different lengths of time and formats (group sessions and individual consultations). Additionally the effect of interventions was evaluated using a wide range of maternal, fetal and neonatal outcomes.
Objective: To discuss the solutions adopted in i-WIP project to deal with a double challenge of complexity of evaluated interventions with a multitude of clinical outcomes.
Complex interventions: Building on the work of Hill et al (2013), we developed an 18-item questionnaire (Table 1) breaking down the intervention into standard components. We asked the trials’ Principal Investigators (PIs) to fill out the questionnaire and specify which of the items were present in their interventions.
Outcomes: We conducted a two-stage Delphi survey to prioritize the outcomes for their importance to clinical care. Secondly, using a validated method we developed maternal composite, and fetal and neonatal composite outcomes (Table 2).
Discussion: The IPD meta-analysis gives the researchers greater power than the aggregated one, however it comes with certain challenges. If our abstract is accepted, we will provide a detailed description of the solutions applied in the i-WIP IPD; their strengths, limitations and recommendation for future research.