Factors related to volunteer comprehension of informed consent for a clinical trial.

The informed consent process has become a universal requirement for research involving human subjects. Its goal is to inform volunteers regarding research in order to make decision to participate or not. This study aimed to measure volunteers' comprehension levels concerning the clinical trial and to find out factors associated with that comprehension levels. Eighty-one volunteers who enrolled in a malaria clinical trial were recruited into the study. A semi-structured questionnaire was used to collect the information. Non-participant observation was used to observe the process of informed consent. Volunteers were interviewed three days after being recruited into the trial. The results show the volunteers' comprehension was low. Only 44% of volunteers had an acceptable level of comprehension. It also revealed that 20 volunteers were not aware of being volunteers. Most volunteers knew about the benefits of participating in the trial and realized that they had the right to withdraw from the study, but not many knew about the risks of the trial. The results indicated the method of informing about the trial affected the volunteers' comprehension level. No relationship was found between comprehension level and volunteers' socio-demographic characteristics and their attitude toward the consent process. The findings from this study demonstrate volunteers who participated in the clinical trial were not truly informed. Further studies regarding enhancing volunteers' understanding of the trial are needed.

Modified Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) as a screening test for dementia for Thai elderly.

A potential test for early detection of dementia in the elderly is the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), which is based on information from the informant for the elderly about the changes of the elderly in everyday cognitive functioning associated with dementia. The present study aimed to modify and assess the reliability and validity of the modified IQCODE consisting of 32 items. The study consisted of two methods of assessing dementia: DSMIV diagnosis carried out by clinicians, and informants responding to the IQCODE. The subjects were 200 pairs of elderly subjects and their informants who visited the Geriatric Clinic, Ramathibodi Hospital. The optimal cutoff score on the modified IQCODE was 3.42, with 90% sensitivity and 95% specificity. The positive predictive values, negative predictive values, and accuracy were 0.94, 0.90, and 0.92, respectively. The IQCODE items had high internal consistency. The IQCODE associated with the elderly person's age, but not with their gender and educational level; nor were they associated with the demographic characteristics of the informant. Therefore, the IQCODE could be used as an alternative screening test for dementia in Thailand with acceptable sensitivity and specificity. This tool may be useful for dementia screening in the community and the geriatric clinic for early detection of disease.

Gender difference in treatment seeking behaviors of tuberculosis cases in rural communities of Bangladesh.

This descriptive cross-sectional study was conducted to investigate gender differences in the epidemiological factors associated with the treatment seeking behaviors of TB cases in the rural communities of Bangladesh. The study reveals that there is significant gender difference in treatment seeking behaviors of rural TB cases and the majority of them (52%) have taken prior treatment from various traditional healers, 70% of them are females who attended health centers (UZHCs) as the other choice (adjusted OR: 4.2, 95% CI: 2.0-8.4). It was found that the mean patient delay was 63 days (range 14-210 days) where half of the females delayed more than 60 days while they were spreading their disease. The study findings reveal gender differences in treatment seeking behaviors associated with socio-cultural barriers, particularly among females in their access to TB care. Fifty-five percent of cases wanted the diagnosis of TB remain confidential to avoid being labeled as TB patients, where 82.7% were female, 85.6% of female TB patients had problems in their relationships with their spouse (61%) and family members (58%) after being diagnosed with TB. The results of the TB service factors found that 39% of females were not satisfied with their provider's behaviors, which was significantly associated with treatment seeking behavior (adjusted OR: 2.6, 95% CI: 1.0-6.6). The study findings strongly suggest that there was a significant gender difference in treatment seeking behavior in rural Bangladesh. Based on the study findings, we recommend developing an appropriate gender strategy for developing a TB control program, comprised of operational, socio-cultural and community awareness interventions aimed at treating undiscovered reservoirs of female TB cases in rural Bangladesh.