Introduction: In clinical trials, a treatment policy strategy is often used to handle treatment nonadherence. However, estimation in this context is complicated when data are missing after treatment deviation. Reference-based multiple imputation has been developed for the analysis of a longitudinal continuous outcome in this setting.
View Article and Find Full Text PDFLongitudinal studies are frequently used in medical research and involve collecting repeated measures on individuals over time. Observations from the same individual are invariably correlated and thus an analytic approach that accounts for this clustering by individual is required. While almost all research suffers from missing data, this can be particularly problematic in longitudinal studies as participation often becomes harder to maintain over time.
View Article and Find Full Text PDFTreatment switching is common in randomised controlled trials (RCTs). Participants may switch onto a variety of different treatments, all of which may have different treatment effects. Adjustment analyses that target hypothetical estimands - estimating outcomes that would have been observed in the absence of treatment switching - have focused primarily on a single type of switch.
View Article and Find Full Text PDFWith this short communication, which contains a new case report on diabetic ulcer, we summarize our research progress in treating several complex conditions at a point where currently available treatments were failing to help the affected patients. We review the first case of lower back pain due to severe spondylitis (T12-L1) treated with intravenous injections of a sterile fraction of human purified amniotic fluid (ViX001) obtained from thoroughly screened volunteers at the time of planned c-section at the term of normal pregnancies. Then, we review the first case of recalcitrant diabetic ulcer treated successfully by twice-daily applications of ViX001 directly on the wound and describe another case of diabetic ulcer treated successfully with ViX001.
View Article and Find Full Text PDFBackground: Data from randomized trials evaluating the effectiveness of tuberculosis (TB) preventive treatment for contacts of multidrug-resistant (MDR)-TB are lacking. Two recently published randomized trials that did not achieve statistical significance provide the opportunity for a meta-analysis.
Methods: We conducted combined analyses of two phase 3 trials of levofloxacin MDR-TB preventive treatment - Levofloxacin for the Prevention of Multidrug-Resistant Tuberculosis (VQUIN) trial and the Levofloxacin preventive treatment in children exposed to MDR-TB (TB-CHAMP) trial.