BACKGROUND: For intervention studies that require the use of @entity1 self-reports, the quality and accuracy of recorded data and variability in @entity1 adherence rates to the treatment can cause significant outcome bias. PURPOSE: To assess the quality and accuracy of @entity1 documentation of daily self-monitoring of leg skin temperature, adherence to a graduated cooling treatment protocol to prevent @entity3179 , and the potential for bias in treatment effect in a randomized controlled trial that included a population with chronic @entity66 . METHODS: Individuals were randomized to a leg cooling intervention or placebo treatment group to daily self-monitor and record lower leg skin temperature over a 9-month period on monthly paper study logs. Returned study logs for the first 100 completed @entity1 (n=54 cooling intervention, n=46 control) were reviewed for quality and accuracy. Adherence was determined from evaluating the accuracy of @entity1 documentation. To examine potential outcome bias in treatment effect, mean between group and within group comparisons of the before and after treatment differences were conducted using an intention-to-treat (ITT) versus a modified intention-to-treat (mITT) analysis approach with an 85% accuracy cut-off rate. Data were collected in 2011-2014. RESULTS: Of the expected 900 study logs, 91.8% (826/900) were returned and 8.2% (74/900) were not. Non-mutually exclusive main error types in returned documentation included: 59.2% (489/826) white-outs, cross-off and/or overwrites, 34.9% (288/826) entries omitted, 29.4% (243/826) no performance of daily self-monitoring, 28.7% (237/826) no performance of the treatment intervention per the prescribed protocol regime, 26.8% (221/826) extraneous data, 8.6% (71/826) suspected fabrication, and 7.6% (63/826) questionable validity. Under ITT analysis, 38.4% (346/900) of all returned logs were <85% accurate, 25.0% (225/900) were 85%-99% accurate, and 36.6% (329/900) were 100% accurate. Mean overall @entity1 adherence rates were: 22.0% at <85% accuracy, 53.0% at 85%-99% accuracy, and 25.0% at 100% accuracy. Under the mITT analysis, 54.0% (483/900) of returned logs were deemed adherent with >= 85% accuracy. CONCLUSION: This study found good rates of adherence. Under ITT analysis, 78.0% of @entity1 were deemed adherent to the study protocol with >= 85% accuracy in documenting daily self-monitoring of skin temperatures in response to a topically applied experimental cooling cuff intervention for the prevention of @entity3179 .

Self-monitoring of lower leg skin temperature: accuracy of self-reported data and adherence to a cooling protocol for the prevention of XXXX .

@entity1 :: ('9606', 'Species') :: ['participants', 'participant'] @entity66 :: ('MESH:D004194', 'Disease') :: ['venous disease'] @entity3179 :: ('MESH:D014647', 'Disease') :: ['venous leg ulcers']
@entity3179 :: (MESH:D014647,Disease) :: ['venous leg ulcers']
