Enhancing clarity of clinical trial safety reports for data monitoring committees.

A Data Monitoring Committee (DMC) evaluates patient safety in a clinical trial of an investigational intervention through periodic review of adverse events (AEs) and clinical safety assessments. Our aim was to construct DMC report displays to enhance the DMC safety review through use of graphics and clear identification and adjustment for missing data caused by early discontinuations and ongoing study participation. Suggested displays include a study snapshot graph, enhanced adverse event incidence tables including the incidence density and plotted incidence proportions, line graphs in place of by-patient listings, and trend plots in place of tables for continuous assessments.

Bone mineral density, body mass index, postmenopausal period and outcomes of low back pain treatment in Korean postmenopausal women.

Women going through menopause experience bone loss and increased musculoskeletal pain, including low back pain. This study explored the relationships between bone mineral density (BMD) and body mass index (BMI), postmenopausal period and outcomes of treatment for low back pain in postmenopausal Korean women. On examining the medical records of 78 postmenopausal women hospitalized for low back pain, investigators found that women with low BMD were older and had been postmenopausal for longer periods than women with normal BMD. Postmenopausal length was positively correlated with pain scores at day 15 and 20 post-admission (P = 0.011 and 0.006) and negatively correlated with T-scores (P = 0.002). BMI was positively correlated with T-scores (r = 0.283, P = 0.022). In conclusion, age, postmenopausal length and BMI correlate with BMD in Korean women suffering from LBP. Larger studies investigating the associations between menopause, BMD, BMI and LBP seem desirable. Moreover, evidence-based therapeutic approaches should be explored for BMD and LBP management.