Compensation for trial-related injury: does simplicity compromise fairness.

India’s regulatory framework for research ethics is two pronged. Schedule Y of the Drugs and Cosmetics Act, 1940, of the Government of India, lays down the requirements for undertaking clinical trials for drugs and medical devices in India; it also requires compliance with the ICMR’s Ethical guidelines for biomedical research on human participants for such trials. Other health research may use the ICMR’s guidelines but this is not mandatory. The regulatory framework is operationalised through the offices of the Central Drugs Standard Control Organisation. However, the mechanisms of monitoring drug trials using this framework have proved to be rather weak.

Predictors of treatment delays for tuberculosis in Sikkim.

BACKGROUND: This study examined the factors associated with delays (i) between the onset of symptoms and the patient's first visit to a medical facility (patient delay), and (ii) between a patient's visit to a medical facility and the diagnosis of tuberculosis (health system delay). METHODS: A cross-sectional survey was conducted of 323 patients (median age 30 years, men: 190) reporting to 2 tuberculosis units and 4 microscopy centres in East Sikkim using a pre-tested structured interview schedule. Patient records were verified for dates of investigations, diagnosis and treatment. Bivariate and multivariate analyses were done to find out the associations between dependent and independent variables. RESULTS: The median patient and health system delays were 21 and 7 days, respectively. Patient delay >30 days was reported by 17% and health system delay > 7 days by 49% of the participants. Patient delay was associated with self-medication (OR 2.28, 95% CI: 1.0-5.18), choice of government doctors as first contact (OR 2.76, 95% CI: 1.15-6.62), use of traditional healers (OR 2.18, 95% CI: 1.03-4.61) and cost of treatment 3Rs 400 compared with <Rs 100 (OR 2.52, 95% CI: 1.17-5.38). Important predictors of health system delays were first contact with private doctors (OR 33.1, 95% CI: 13.44-81.49) and cost of treatment (OR 2.5; 95% CI: 1.22-5.128). CONCLUSION: Efforts need to be made to eliminate the factors causing a delay in the initiation of treatment of patients with tuberculosis. These should include increasing awareness to avoid self-medication, the availability of free treatment, and training traditional healers and private doctors in the treatment of tuberculosis.

Prevalence-correlates-awareness-treatment and control of hypertension in kumarakom, kerala: baseline results of a community-based intervention program.

BACKGROUND, Hypertension is one of the major causes of cardiovascular morbidity and mortality. However, awareness, treatment, and control of hypertension remain major challenges worldwide. In this article, we present the baseline prevalence of hypertension from an ongoing intervention program for its control in a community-based sample in Kerala, Southern India. METHODS, We measured blood pressure, body weight, and height of 4955 individuals above the age of 30 yers (men;2159:mean-age: 50 years) and collected information on alcohol use, tobacco use, and other demographic variables using a pre-tested structured questionnaire. RESULTS, The overall prevalence of hypertension (JNC-VII) was 36.7% ( 95% CI:35.5-38.0; men: 36.0% and women 37.2% ) in multipile logistic regression analysis, a body mass index of >/=25 kg/m(2) was associated with a 1.65-fold (95% CI:1.37-1.98) prevalence of hypertension compared to a body mass index <25kg/m(2). Individuals with diabetes mellitus had 2.10 higher odds of hypertension prevalence (95% CI: 1.62-2.73) compared to people wihtout diabetes mellitus. Participants with increased waist circumference (90 cm in men, 85 cm in women) were 1.84 times more likely to be hypertensive compared to those with normal waist circumference (95% CI: 1.55-2.19). Among hypertensives, 24% were aware of the condition, 20% were on treatment, and 6.4% achieved effective blood pressure control. CONCLUSION, A higher body mass index, increased waist circumference, and self-reported diabetes mellitus were the important correlates of hypertension in our community-based sample. Our data emphasize the importance of educational interventions and appropriate lifestyle modifications that target increased body mass index and waist circumference to reduce the community burden of hypertension.

Tobacco use in Kerala: findings from three recent studies.

BACKGROUND: We reviewed the literature on tobacco use in Kerala and present data from three recently conducted unpublished studies. METHODS: Three cross-sectional studies were conducted; a community-based study of 1,298 individuals aged 15 years and above (mean age 37.4 years, men 630), a school-based study of 1,323 boys (mean age 14.7 years), and a college-based study of 1,254 male students (mean age 18.2 years). Information on tobacco use and sociodemographic variables was collected using pre-tested, structured interview schedules and questionnaires. RESULTS: In the community study, 72% of men and 6% of women had ever used tobacco. Compared to men with > 12 years of schooling, those with < 5 years of schooling were 7 times more likely to smoke (OR 7, CI 3.2-15.6). The age at initiation of smoking was 19 years among those < 25 years of age compared to 25.5 years among ever smokers > 44 years. In the school study, the age at initiation among boys aged < or = 1 3 years was 10.7 years compared with 13.2 years among > or = 16-year-old boys. Boys whose fathers and friends used tobacco were 2 times and 2.9 times more likely to use tobacco (OR 2.0, CI 1.3-3.1 and OR 2.9, CI 1.6-5.1), respectively, compared with their counterparts. In the college study, 29% of the commerce students used tobacco compared with 5.3% of polytechnic students (p < 0.001). CONCLUSION: Survey data suggest that the age at initiation of tobacco use appears to be falling. A series of cross-sectional studies with larger sample sizes of the youth is required to confirm this impression. Tobacco use habits of fathers and peers are significant influences on youth smoking. There is a need to focus on particular types of colleges as these appear to have high-risk tobacco use environments.