title: Predictors of web-based follow-up response in the Prevention Of Low Back Pain In The Military Trial (POLM).
abstract: BACKGROUND
  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. 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.
  
  
  METHODS
  Twenty 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  This study has been registered at reports at http://clinicaltrials.gov (NCT00373009).
authors.affiliation: US Army-Baylor University Doctoral Program in Physical Therapy (MCCS-HMT), Army Medical Department Center and School, Fort Sam Houston, TX 78234, USA. childsjd@gmail.com
authors.forename: John D
authors.initials: JD
authors.lastname: Childs
authors.forename: Deydre S
authors.initials: DS
authors.lastname: Teyhen
authors.forename: Joshua J
authors.initials: JJ
authors.lastname: Van Wyngaarden
authors.forename: Brett F
authors.initials: BF
authors.lastname: Dougherty
authors.forename: Bryan J
authors.initials: BJ
authors.lastname: Ladislas
authors.forename: Gary L
authors.initials: GL
authors.lastname: Helton
authors.forename: Michael E
authors.initials: ME
authors.lastname: Robinson
authors.forename: Samuel S
authors.initials: SS
authors.lastname: Wu
authors.forename: Steven Z
authors.initials: SZ
authors.lastname: George
mesh_terms: D000293:Adolescent; D000328:Adult; D001288:Attention; D016009:Chi-Square Distribution; D005081:Exercise Therapy; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006304:Health Status; D006801:Humans; D020407:Internet; D016014:Linear Models; D017116:Low Back Pain / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control* / Q000523:psychology; D008297:Male; D008887:Military Medicine; D008889:Military Personnel / Q000523:psychology; D009784:Occupational Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control* / Q000523:psychology; D016017:Odds Ratio; D010147:Pain Measurement; D010349:Patient Compliance; D010353:Patient Education as Topic; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult