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.

Effects of managerial intervention on drug utilization pattern at King Chulalongkorn Memorial Hospital.

The economic crisis in Thailand since 1997 has a major impact on all sections of the country including health care. There were several suggestions for reducing the drug expenditure budget including restriction of hospital formulary, generic prescribing and generic dispensing. At King Chulalongkorn Memorial hospital, the new hospital formulary was established and implemented in March 1998. The generic dispensing policy was also in place at the same time. This study aimed to evaluate the impact of the new implementation by comparing the prescription patterns in out patient departments (OPDs) of the hospital before and after the new hospital formulary implementation. The prescriptions from several OPDs were systematically stratified samplings 5 weeks before and 5 weeks after March 1st, 1998. The information from the prescriptions including drug category, drug name, amount of dispensed drug, drug cost, etc. was collected and analyzed. The total number of prescriptions and the average number of drug items/prescription before and after the implementation were similar (2,049 vs 2,052, and 2.52 +/- 0.048 vs 2.45 +/- 0.03 respectively). The total cost of the prescription, the cost/prescription and the cost/item seemed to be different (1,690,484 baht vs 1,282,343 baht, 844 +/- 54.04 vs 633 +/- 41.11 and 332.58 +/- 29.59 vs 255.29 +/- 19.98 respectively). After the implementation, physicians in the hospital increasingly prescribed drugs by generic name (37.1% vs 44.85%). Locally made drugs were also prescribed by physicians and received by patients more than before (9.56% vs 84.27% and 28.15% vs 60.72%, respectively). Anti-infective agents were studied in depth as they contribute to significant amount of drug expenditure. The total cost of prescribed anti-infective agents and the cost/prescription were increased after the implementation (223,529 vs 274,435 Baht and 585.38 +/- 102.84 vs 772.71 +/- 147.59). The increased cost mainly came from the cost of anti-HIV drugs. Our data indicate that the new hospital formulary may have played a part on the impact of drug expenditure reduction and may have changed the prescribing attitude of physicians in King Chulalongkorn Memorial Hospital.