Sample size considerations for studies of intervention efficacy in the occupational setting.

OBJECTIVE Due to a shared environment and similarities among workers within a worksite, the strongest analytical design to evaluate the efficacy of an intervention to reduce occupational health or safety hazards is to randomly assign worksites, not workers, to the intervention and comparison conditions. Statistical methods are well described for estimating the sample size when the unit of assignment is a group but these methods have not been applied in the evaluation of occupational health and safety interventions. We review and apply the statistical methods for group-randomized trials in planning a study to evaluate the effectiveness of technical/behavioral interventions to reduce wood dust levels among small woodworking businesses. METHODS We conducted a pilot study in five small woodworking businesses to estimate variance components between and within worksites and between and within workers. In each worksite, 8 h time-weighted dust concentrations were obtained for each production employee on between two and five occasions. With these data, we estimated the parameters necessary to calculate the percent change in dust concentrations that we could detect (alpha = 0.05, power = 80%) for a range of worksites per condition, workers per worksite and repeat measurements per worker. RESULTS The mean wood dust concentration across woodworking businesses was 4.53 mg/m3. The measure of similarity among workers within a woodworking business was large (intraclass correlation = 0.5086). Repeated measurements within a worker were weakly correlated (r = 0.1927) while repeated measurements within a worksite were strongly correlated (r = 0.8925). The dominant factor in the sample size calculation was the number of worksites per condition, with the number of workers per worksite playing a lesser role. We also observed that increasing the number of repeat measurements per person had little benefit given the low within-worker correlation in our data. We found that 30 worksites per condition and 10 workers per worksite would give us 80% power to detect a reduction of approximately 30% in wood dust levels (alpha = 0.05). CONCLUSIONS Our results demonstrate the application of the group-randomized trials methodology to evaluate interventions to reduce occupational hazards. The methodology is widely applicable and not limited to the context of wood dust reduction.