The protective effect of BCG against tuberculosis (TB) estimated in randomized controlled trials and observational studies ranges from negative to close to a 100%. One of the many explanations offered for this is that different immunological mechanisms may be associated with protective effect against different forms and sites of disease. In this investigation, we recalculated vaccine protective effect separately for pulmonary disease and for meningeal/miliary disease in randomized controlled trials and case-control studies, tested for heterogeneity in site-specific estimates of protective effect and calculated a summary measure when appropriate. We found protective effect against pulmonary disease to be heterogeneous to a statistically significant degree, and thus we did not calculate a summary measure of protection. Protective effect against meningeal and miliary TB was higher than against pulmonary disease and, except for a single study with two cases only, appeared to be homogenous. Summary BCG protective effect against miliary or meningeal TB in randomized controlled trials was 86% (95% confidence interval [CI] 65, 95) and in case-control studies 75% (95% CI: 61, 84). The fact that protective effect appeared to be homogeneous against meningitis and miliary TB but not against pulmonary disease may result from the fact that patients with meningitis are on average younger and thus less likely to have been exposed to atypical bacteria; to a waning of the protective effect of BCG; or from the diversity of mechanisms of pathogenesis of pulmonary disease, which can originate from reinfection, reactivation or primary progression.
Summary: Purpose:We studied overall and cause-specific mortality rates in a large cohort of patients with epilepsy compared with mortality rates of the general population in the same geographic area.Methods: The cohort consisted of all patients (N = 9,061) aged >15 years admitted with a diagnosis of epilepsy for inpatient care in Stockholm during the years 1980-1989. All patients were followed in the National Cause-of-Death Register, from which the causes of death were obtained, until December 31, 1992. Thus, 53,520 person-years were observed. Mortality rates were compared with those of the general population of Stockholm.Results: We observed 4,001 deaths in the cohort, compared with an expected number of 1,109 deaths in the general population. This yielded a standardized mortality ratio (SMR) of 3.6[95% confidence interval (CI) 3.5-3.71. Although highest in the younger patients, the SMR was significantly increased in all age groups. The excess mortality rate in the cohort was due to a wide range of causes of death, including malignant neoplasms [SMR 2.6 (2.4-2. Conclusions: Our results demonstrate that this large subgroup of patients with a diagnosis of epilepsy, once hospitalized and discharged, is a population at risk, with an excess mortality rate due to several different causes. Key Words: Epilepsy-Mortality-Standardized mortality ratio-Epidemiology-Cause of death.Patients with epilepsy have consistently been found to have a higher death rate than the general population (1-5). Although overall mortality rate has been analyzed in several studies, few researchers have investigated causespecific mortality rates in patients with epilepsy.In previous studies based on patients in institutions (6,7) and referral centers (3,s) researchers have analyzed a highly selected population with severe epilepsy. Studies (9,lO) based on cause-of-death registers have comprised large cohorts of patients. However, the validity of the diagnosis and the patients selection are uncertain in these studies because epilepsy is seldom entered as a diagnosis on death certificates. On the other hand, population-based studies, which provide valid information representative of the epilepsy population in general, have, on the whole, comprised a comparatively small number of patient-years and deaths (1,2,4). Therefore,
Objective To assess whether customised mobile phone reminders would improve adherence to therapy and thus decrease virological failure among HIV infected patients starting antiretroviral treatment (ART). Design Randomised controlled trial among HIV infected patients initiating antiretroviral treatment.Setting Three diverse healthcare delivery settings in south India: two ambulatory clinics within the Indian national programme and one private HIV healthcare clinic.Participants 631 HIV infected, ART naïve, adult patients eligible to initiate first line ART were randomly assigned to mobile phone intervention (n=315) or standard care (n=316) and followed for 96 weeks.. InterventionThe intervention consisted of customised, interactive, automated voice reminders, and a pictorial message that were sent weekly to the patients' mobile phones for the duration of the study. Main outcome measuresThe primary outcome was time to virological failure (viral load >400 copies/mL on two consecutive measurements). Secondary outcomes included ART adherence measured by pill count, death rate, and attrition rate. Suboptimal adherence was defined as mean adherence <95%. ResultsUsing an intention-to-treat approach we found no observed difference in time to virological failure between the allocation groups: failures in the intervention and standard care arms were 49/315 (15.6%) and 49/316 (15.5%) respectively (unadjusted hazard ratio 0.98, 95% confidence interval 0.67 to 1.47, P=0.95). The rate of virological failure in the intervention and standard care groups were 10.52 and 10.73 per 100 person years respectively. Comparison of suboptimal adherence was similar between both groups (unadjusted incidence rate ratio 1.24, 95% CI 0.93 to 1.65, P=0.14). Incidence proportion of patients with suboptimal adherence was 81/300 (27.0%) in the intervention arm and 65/299 (21.7%) in the standard care arm. The results of analyses adjusted for potential confounders were similar, indicating no significant difference between the allocation groups. Other secondary outcomes such as death and attrition rates, and subgroup analysis also showed comparable results across allocation groups. ConclusionsIn this multicentre randomised controlled trial among ART naïve patients initiating first line ART within the Indian national programme, we found no significant effect of the mobile phone intervention on either time to virological failure or ART adherence at the end of two years of therapy.Trial registration Current Controlled Trials ISRCTN79261738. IntroductionThe current explosion in the use of mobile phone technology in healthcare coupled with decreasing costs of wireless communications worldwide has led to a panoply of promising mobile phone based interventions among patients with chronic conditions, including HIV infection.1 Systematic reviews acknowledge that mobile phone interventions can help improve specific health conditions, but they also underline the need for high quality clinical trials measuring outcomes in real world With an estimated 2.5...
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