Estimating study visit burden: An important planning tool for community-based research

Background: In preparation for a multi-country, community-based research study with a complex combination of home and clinic visits (burden analysis assumes that there is not a rigid schedule), we conducted an analysis of visit burden to: 1) estimate time needed to complete home and clinic visits; 2) compare several accrual scenarios and their impact on staffing. The analysis was used to develop accrual strategies for the implementation and monitoring of the study intervention.

Methods: Three variables were used as inputs in the analysis: 1) frequency of home and clinic visits; 2) estimates of time per type of visit; and 3) duration of the intervention. Scenarios based upon varying accrual rates were input into an electronic spreadsheet. Descriptive statistics and line graphs were generated to compare each accrual scenario. Taking into consideration constraints of budget, staffing, and setting, research sites reviewed the analysis to develop strategies to monitor implementation and participant compliance.

Results: For the 3 accrual scenarios examined, average visits per day ranged from 4.5 to 7.0, the maximum number of visits ranged from 11 to 18, and the time spent with participants per day ranged from 3.46 to 5.43 hours. An optimal recruitment scenario was selected for each country team. Strategies to meet demand included the support of community health workers and volunteers.

Conclusions: Country teams found that the burden analysis was a useful tool to plan for the optimal use of human resources. This simple analysis is recommended in preparation for community-based research with demanding study visit schedules.