Abstract
BackgroundAchieving adequate follow-up in clinical trials is essential to establish the validity of the findings. Achieving adequate response rates reduces bias and increases probability that the findings can be generalized to the population of interest. Therefore, the purpose of this study was to determine the influence of attention, demographic, psychological, and health status factors on web-based response rates in the ongoing Prevention of Low Back Pain in the Military (POLM) trial.MethodsTwenty companies of Soldiers (n = 4,325) were cluster randomized to complete a traditional exercise program including sit-ups (TEP) with or without a psychosocial educational program (PSEP) or a core stabilization exercise program (CSEP) with or without PSEP. A subgroup of Soldiers (n = 371) was randomized to receive an additional physical and ultrasound imaging (USI) examination of key trunk musculature. As part of the surveillance program, all Soldiers were encouraged to complete monthly surveys via email during the first year. Descriptive statistics of the predictor variables were obtained and compared between responders and non-responders using two sample t-tests or chi-square test, as appropriate. Generalized linear mixed models were subsequently fitted for the dichotomous outcomes to estimate the effects of the predictor variables. The significance level was set at .05 a priori.ResultsThe overall response rate was 18.9% (811 subjects) for the first year. Responders were more likely to be older, Caucasian, have higher levels of education and income, reservist military status, non smoker, lower BMI, and have received individualized attention via the physical/USI examination (p < .05). Age, race/ethnicity, education, military status, smoking history, BMI, and whether a Soldier received the physical/USI examination remained statistically significant (p < .05) when considered in a full multivariate model.ConclusionThe overall web based response rate during the first year of the POLM trial was consistent with studies that used similar methodology, but lower when compared to rates expected for standard clinical trials. One year response rate was significantly associated with demographic characteristics, health status, and individualized attention via additional testing. These data may assist for planning of future trials that use web based response systems.Trial RegistrationThis study has been registered at reports at http://clinicaltrials.gov (NCT00373009).
Highlights
Achieving adequate follow-up in clinical trials is essential to establish the validity of the findings
Non-responders and responders significantly differed in age, race/ethnicity, education, income, military status, length of service, depression, back beliefs, anxiety, health status, smoking history, body mass index (BMI), and whether a Soldier received individual attention from the physical/ultrasound imaging (USI) examination
The above effects remained statistically significant in the second generalized linear mixed model that included the quadratic time effect, which indicated that the response rates significantly decreased over the first 12 months of the trial (p < .001, Figure 2). The results of this analysis demonstrated that response rate to the web-based survey was significantly associated with demographic characteristics, health status, and individualized attention via additional testing
Summary
Achieving adequate follow-up in clinical trials is essential to establish the validity of the findings. Achieving adequate response rates reduces bias and increases probability that the findings can be generalized to the population of interest. Achieving adequate follow-up in clinical trials is essential to establish the validity of study findings and reduce bias, helping to insure that the findings can be generalized to the population of interest and more accurately inform clinical decision-making. Even small losses to follow-up can bias a study’s results if few individuals have the outcome of interest. These issues make it imperative that clinical trials be conducted in a manner to maximize retention
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