Objective: This study aimed to confirm whether the methods for assessing the reported causal relationship between dietary supplement intake and adverse events are reliable in the clinical setting.
Design: The relationships between supplement intake and adverse events were assessed using two algorithms proposed in our previous report, and causal relationships were evaluated.
Methods: Twelve raters with a high probability of handling adverse event information examined 200 records of dialogues with supplement users.  Each rater independently assessed the causal relationship using the two algorithms.  The relationships between supplement intake and adverse events were assessed for all 200 cases.  Variability in the evaluation among raters was analyzed for each occupation and the whole group of raters.  The distributions of evaluation were analyzed, and inter-rater reliability was evaluated using the intraclass correlation coefficient (ICC) and Fleiss’ kappa coefficient.
Results: All events of 200 cases seemed to be slight and within the range of variation in daily life.  Almost all cases were classified into two categories as “Possible” and “Lack of Information” by each rater.  The ICC values for all raters, pharmacists, dieticians, and health care workers were 0.644, 0.573, 0.678, and 0.694, respectively, and the kappa coefficients using the two algorithms were 0.466, 0.426, 0.468, and 0.519 and 0.481, 0.478, 0.465, and 0.517, respectively.  There were moderate levels of agreement based on the kappa coefficients and ICC values.
Conclusion: The two algorithms proposed in our previous report may be reliable in the clinical setting.  Their reliability could be enhanced by establishing a unified method of accumulation and recording adverse events for supplement intake, which should be evaluated by more raters using more cases of adverse events.

BACKGROUND: The Fujiwara-kyo Osteoporosis Risk in Men (FORMEN) study was launched to investigate risk factors for osteoporotic fractures, interactions of osteoporosis with other non-communicable chronic diseases, and effects of fracture on QOL and mortality. METHODS: FORMEN baseline study participants (in 2007 and 2008) included 2012 community-dwelling men (aged 65-93 years) in Nara prefecture, Japan. Clinical follow-up surveys were conducted 5 and 10 years after the baseline survey, and 1539 and 906 men completed them, respectively. Supplemental mail, telephone, and visit surveys were conducted with non-participants to obtain outcome information. Survival and fracture outcomes were determined for 2006 men, with 566 deaths identified and 1233 men remaining in the cohort at 10-year follow-up. COMMENTS The baseline survey covered a wide range of bone health-related indices including bone mineral density, trabecular microarchitecture assessment, vertebral imaging for detecting vertebral fractures, and biochemical markers of bone turnover, as well as comprehensive geriatric assessment items. Follow-up surveys were conducted to obtain outcomes including osteoporotic fracture, cardiovascular diseases, initiation of long-term care, and mortality. A complete list of publications relating to the FORMEN study can be found at https://www.med.kindai.ac.jp/pubheal/FORMEN/Publications.html .
Aged ; Bone Density ; Cardiovascular Diseases/etiology* ; Cohort Studies ; Geriatric Assessment ; Humans ; Independent Living ; Japan/epidemiology* ; Long-Term Care/statistics & numerical data* ; Male ; Middle Aged ; Osteoporosis/etiology* ; Osteoporotic Fractures/etiology* ; Risk Factors