The Cooking and Pneumonia Study (CAPS) in Malawi: Implementation of Remote Source Data Verification

Area of Science:

• Clinical research methodology
• Public health surveillance
• Digital health interventions

Background:

• Traditional Source Data Verification (SDV) is resource-intensive, requiring multiple on-site visits.
• The Cooking And Pneumonia Study (CAPS) is a village-level trial in Malawi assessing cook-stove intervention effectiveness.
• CAPS utilized smartphones for electronic Case Report Forms (eCRFs) and digital record imaging.

Purpose of the Study:

• To evaluate the feasibility and efficiency of electronic data capture with remote SDV in a challenging rural research setting.
• To assess the use of mobile technology for data collection and verification in a public health trial.
• To report on the experience of remote SDV in the CAPS trial in Malawi.

Main Methods:

• Fieldworkers captured pneumonia data and digital images of original records onto eCRFs.
• Data and images were uploaded via a web-based application for remote SDV.
• Remote SDV compared eCRF data against digital images of original records for pneumonia occurrence, severity, and clinical indicators.

Main Results:

• After 6 months, 664 pneumonia episodes were recorded, with 92% confirmed by original records.
• All captured digital images of original records were clear and legible.
• Remote SDV was successfully conducted from the UK.

Conclusions:

• Electronic data capture with mobile technology is feasible in rural Malawi.
• Digital imaging facilitates efficient and secure remote SDV, eliminating the need for additional field visits.
• This approach is recommended for similar settings, particularly for studies with health endpoints.