Challenges with study procedure fidelity when conducting household survey: reports from the field.

OBJECTIVES

The aim of the study was to identify reasons for protocol deviations during conduct of large epidemiological surveys despite training of field workers, validating clinicians, and providing field supervisory support. Enquiries focused on breaches of recruitment procedures, privacy, confidentiality, and informed consent. The case study was a household survey conducted in Ile-Ife, Nigeria.

RESULTS

The study reveals that despite training of field workers, providing supervisory support, and conducting validation exercises, protocol deviation still occurred. Measures to improve internal research validity during the conduct of surveys can minimise but not eliminate protocol deviations. Individual and environmental factors increase the risk for protocol deviation. Individual factors include personal bias against adherence to elements of the protocols, and pressure to meet personal recruitment targets to maximise remuneration. These pressures increase the risk of breaching study participants' recruitment process. Environmental pressures resulted from low research literacy that made it possible for field workers not to consent participants and for participants not to prioritise privacy. The use of electronic data collection enhanced data security. A key recommendation from the study was that improved field supervision will reduce the risk for protocol violation.