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BACKGROUND. Our purpose is to develop a clinical test capable of assessing vision through dense cataracts (and other advanced media opacities) before surgery. Because such anomalies are endemic in the developing world, it was desirable to conduct a clinical study of a prototype India instrument and HyperAcuity Study Protocol (HASP) in such a setting. This investigation, preliminary to a planned clinical study, was conducted at the Aravind (Free) Eye Hospital, Madurai, India. EXPERIMENTAL. The preliminary HASP protocol, developed in Berkeley, was adapted to existing clinical practices in Madurai. Included was a new test of visual acuity, the Gap "VA" test, developed as part of the revised protocol. The rational for this test, methods used, and sample data are presented. A Vernier alignment test (one of the hyperacuities) is used to assess vision through dense ocular media disorders. The task of the patient is to align vertically three high luminance, discrete visual stimuli. The revised HASP protocol and adapted India instrument were tested upon patients with advanced cataracts. The cataract grading system used in these studies (provided by Drs. N. V. Projna and G. Rohini) is defined. Patients were tested before and shortly after surgery. This investigation allowed us to refine the test protocol and instrument design preparatory for a clinical study of HASP. A much simpler/cheaper version of the India instrument will be used in the planned clinical study. Additional experiments are scheduled in order to address issues which require resolution before initiation of next-stage testing. In part, in these papers, we seek to help others understand some problems encountered when conducting research in a developing world environment, even a very good one!
India is experiencing a rapid spread of human immunodeficiency virus type 1 (HIV-1), primarily through heterosexual transmission of subtype C viruses. To delineate the molecular features of HIV-1 circulating in India, we sequenced the V3-V4 region of viral env from 21 individuals attending an HIV clinic in Calcutta, the most populous city in the eastern part of the country, and analyzed these and the other Indian sequences in the HIV database. Twenty individuals were infected with viruses having a subtype C env, and one had viruses with a subtype A env. Analyses of 192 subtype C sequences that included one sequence for each subject from this study and from the HIV database revealed that almost all sequences from India, along with a small number from other countries, form a phylogenetically distinct lineage within subtype C, which we designate C(IN). Overall, C(IN) lineage sequences were more closely related to each other (level of diversity, 10.2%) than to subtype C sequences from Botswana, Burundi, South Africa, Tanzania, and Zimbabwe (range, 15.3 to 20.7%). Of the three positions identified as signature amino acid substitution sites for C(IN) sequences (K340E, K350A, and G429E), 56% of the C(IN) sequences contained all three amino acids while 87% of the sequences contained at least two of these substitutions. Among the non-C(IN) sequences, all three amino acids were present in 2%, while 22% contained two or more of these amino acids. These results suggest that much of the current Indian epidemic is descended from a single introduction into the country. Identification of conserved signature amino acid positions could assist epidemiologic tracking and has implications for the development of a vaccine against subtype C HIV-1 in India.
Anemia among older adults aged ≥ 60 years is a well-described risk factor that increases the risk of falls, cardiovascular diseases, and mortality. In India, objectively measured national estimates of anemia prevalence and the causes of anemia among older adults are lacking. The Harmonized Diagnostic Assessment of Dementia for the Longitudinal Aging Study in India (LASI-DAD) collected venous blood samples from a nationally representative sample of 3,252 individuals in wave 2 of the study. Out of these, 3,009 samples were used to estimate national prevalence and regional differences in anemia prevalence and its underlying causes. Anemia was defined as hemoglobin < 13 mg/dl in males and < 12 mg/dl in females and further categorized into nutritional and non-nutritional anemia based on several nutritional (ferritin, Vitamin B12, and folate), inflammatory (ferritin, C-reactive protein), and renal (serum creatinine) biomarkers. The overall national anemia prevalence was 49.92%. Anemia prevalence was significantly higher among women (53.9%) than men (45.8%). Among those with anemia, nutritional anemia was found in 63.5% of the respondents, with isolated iron deficiency anemia being the most common cause (51.8%). Among the non-nutritional category, anemia of chronic disease was the most common type (31.4%). About 10% of all anemia cases could not be classified into either category using the available data. Regional differences were seen with the highest prevalence of anemia in Assam, West Bengal, Jharkhand, and Odisha, and the lowest prevalence (< 30%) in Jammu & Kashmir and Haryana. Multivariate adjustment showed that age, sex, and region of residence are independently associated with anemia status. The study provides valuable insights into the overall anemia prevalence among older adults in India, its underlying causes, and regional differences to lay a strong foundation for making informed decisions toward anemia control in India.
BACKGROUND: Maternal mortality rates in India are estimated at 560/100,000 live births and postpartum hemorrhage (PPH) accounts for 35-56% of these deaths. Given that 50% of births in rural India occur at home, oral Misoprostol administered by minimally trained midwives may be an effective uterotonic agent for preventing PPH when the use of other uterotonics is not feasible. While the import for testing the effectiveness of this intervention may be readily obvious, the elements essential for the conduct of a scientific study in rural areas served by indigenous health workers may not be as evident. METHODS: We present the design as well as the preparation and development of an ongoing NICHD sponsored U.S.-Indian collaborative randomized, placebo-controlled, clinical trial (RCT) conducted in four Primary Health Center areas of Belgaum District, Karnataka, India. The primary goal of the trial is to assess the effectiveness of Misoprostol 600 microg orally in reducing the incidence of acute PPH (> or = 500 mL) in women delivering at home or in neighboring sub-centers. 1600 pregnant women will be randomized to receive Misoprostol or placebo immediately post-delivery of the infant. However, beyond testing the scientific merit of the RCT, this study also tests the feasibility of having indigenous midwives regularly using Misoprostol in rural areas as well as the willingness of these communities to accept this intervention. In addition, this paper also explores the international and community collaborations necessary for the conduct of this study. FINDINGS: It is necessary to have several critical elements in place, including international collaboration between the Indian and US research sites, funding through a private/public collaboration and trained scientists, as well as commitment from the community for the successful conduct of such a study. In the development and implementation of a RCT, careful attention must be paid to the training of field personnel involved in the delivery process and developing a data collection and monitoring system to ensure that information gathered is valid. CONCLUSIONS: A joint U.S.-Indian collaboration to test the efficacy and the feasibility of an innovative method to reduce PPH can serve as collaborative model to develop additional interventions to improve maternal mortality and morbidity. If Misoprostol is shown to be sufficiently safe and efficacious in the prevention of PPH, the appropriate government agencies will be encouraged to make the drug available to midwives (ANMs) and rurally located physicians for whom parenteral medications are either not permitted or impractical and/or unavailable. Such a project can serve as a model applicable to rural settings throughout the developing world for improving delivery practices and reducing maternal mortality and morbidity. These are important public health concerns in India and other developing nations.
One hundred and twenty-five cases of biopsy proven sarcoidosis have been found during a prospective study since 1972 in Calcutta, Eastern India. The presentation, clinical course and radiological features are considerably different from those seen in the West. Elderly males over 40 years are more prone. Low grade fever, cough, dyspnoea, arthralgia are common symptoms while hepatosplenomegaly, hypercalcaemia, hypercalciuria and hyperglobulinaemia are frequent signs. Nearly 60% are MT negative (up to 100 TU). Serum angiotensin converting enzyme and high lymphocyte count in bronchoalveolar lavage fluid are usual findings in active disease. Chest X-ray usually shows mottled opacities or fibrosis in 60% cases. Clinico-radiological dissociation (i.e. remarkable dissociation between the alarming-looking chest X-ray and scanty physical signs and symptoms in chest) was a very remarkable feature in this series. Treatment with oral steroid or steroid aerosol with oxyphenbutazone and chloroquine give equally good results initially. However, most cases tend to relapse inspite of adequate initial treatment. The pattern of the disease is similar almost all over India with minor regional differences like more erythema nodosum and eye involvement in Chandigarh in the extreme north (which could also have been due to case selection). The pattern from Northern India (Delhi) and Western India is nearly similar to our figures.
This random multistage cross sectional population survey was undertaken to determine the prevalence of diabetes mellitus (DM) and impaired fasting glycemia/glucose (IFG) in subjects aged 25 years and above in India. The study was carried out in 108 centers (49 urban and 59 rural) to reflect the size and heterogeneity of the Indian population. 41,270 (20,534 males and 20,736 females) subjects were studied. 21,516 (10,865 males and 10,651 females) were from urban areas and 19,754 (9669 males and 10,085 females) from rural areas. Blood samples were taken after a fast of 10-12h and the subjects were categorized as having IFG or DM using the 1997 American Diabetes Association criteria. The age and gender standardized prevalence rate for DM and IFG in the total Indian population was 3.3 and 3.6% respectively (P < 0.001). The standardized prevalence of DM and IFG in urban areas was significantly higher than that for the rural population (urban DM prevalence 4.6% versus rural DM prevalence 1.9%, P < 0.001; urban IFG prevalence 4.8% versus rural IFG prevalence 2.5%, P < 0.001). There was no statistically significant difference in the prevalence between DM (4.6%) and IFG (4.8%) in the urban population. The rural prevalence of IFG (2.5%) was significantly (P <0.001) more than the rural prevalence of DM (1.9%). Type 2 diabetes is a major health problem is India.
This random multistage cross-sectional population survey was undertaken to determine the prevalence of diabetes mellitus (DM) and impaired glucose tolerance (IGT) in subjects aged 25 years and above in India. The study was carried out in 77 centers (40 urban and 37 rural). 18363 (9008 males and 9355 females) subjects were studied. 10617 (5379 males and 5238 females) were from urban areas and 7746 (3629 males and 4117 females) from rural areas. Blood samples were taken after a fast of 10-12 h and 2 h after 75 g of oral glucose. Subjects were categorized as having IGT or DM using the World Health Organisation (WHO) (1999) criteria. The standardized prevalence rate for DM in the total Indian, urban and rural populations was 4.3, 5.9 and 2.7%, respectively. The corresponding IGT rates in the three populations was 5.2, 6.3 and 3.7%, respectively. The urban prevalence of DM and IGT was significantly greater than in the rural population (P < 0.001 in both instances). The prevalence of DM was significantly, more than that of IGT (P < 0.001) within both the rural and urban populations. Type 2 diabetes is a major health problem is India.
This study was carried out to estimate the incidence of childhood insulin dependent diabetes mellitus (IDDM) in an urban southern Indian, population. A registry for IDDM has been set up in the city of Madras. South India. Details of newly diagnosed IDDM children, aged less than 15 years, were analysed retrospectively, for a period of 1991-1994. Primary sources were government and service hospitals, large diabetes clinics and secondary sources were diabetes camp, private diabetologists and endocrinologists. A capture-recapture method was used and the estimate of case in the population (1991 census) was calculated. Incidence (case/100,000) was calculated in the total group and then for boys and girls separately. The incidence for the 4 year period was 10.5/100,000/year (CI 5.0). The corresponding values for boys and girls were 12.6 +/- 11 and 9.6 +/- 4.7 respectively. The peak incidence was between 10 and 12 years. This is the first population based incidence data from India and showed that the incidence of childhood IDDM is not low in urban children.
In India are approximately 4 million blind people by advanced or mature cataract. For only 10 US$ one patient can be operated in eye camps in the villages by an intracapsular cataract cryoextraction an + 12.00 dptr. aphakia glasses. Also estimated four million people are blind by xerophthalmia. The project is to examine all the babies and little children in the villages and to give them for 2 years each month vitamin-A-medication. On the other side the parents of children suffering from xerophthalmia are instructed to plant vegetables rich in vitamin A. The goal of both projects is to make a cataract and xerophthalmia free zone in Uttar Pradesh, which should spread over the entire country. Both projects are sponsored by Combat Blindness Foundation, P.O. Box 5, 332 Madison Wisconsin 53705 USA, Professor Suresh Chandra, chairman.
AIM: To investigate the relationship between diabetes control, management and late complications in a subset of urban Indian diabetes population treated at tertiary diabetes care centres and measure the quality of management to set benchmarks for future improvement. METHODOLOGY: The study population consisted of 100 consecutive review patients treated for more than one year at each of the 26 participating centres. HbA1c was estimated centrally by Bio-Rad Variant method. The methods used to diagnose diabetic complications varied among centres, depending on the doctor's standard clinical examination. A more detailed methodology was eschewed for reason of brevity of the data collection form, and lack of standardisation of methods. Similarly, the assessment of renal function was performed via a variety of methods, namely dipstick proteinuria, a 24 hour urinary excretion assay, presence of microalbuminuria and serum creatiine concentration; retinopathy was detected using fundoscopy. Data was collected in a standardized data collection form, entered into an SAS database, validated and descriptive analysis performed. RESULTS: A total of 2,269 subjects with valid relevant data formed the study population. Subjects had a mean age of 53.3 +/- 13 years. The mean age at onset of diabetes was 43.6 +/- 12.2 years, with a mean diabetes duration of 10.0 +/- 6.9 years. Type 2 diabetics constituted 90.6% of the patients. Approximately half the patients had poor control (HbA1c > 2% points above upper limit of normal and FBG > 139 mg/dl). Mean HbA1c (central laboratory) was 8.9 +/- 2.1% and FBG 150 +/- 59 mg/dl. Over 54% patients had severe late complications, apart from a high frequency of associated hyperlipidemia. Mean HbA1c level and frequency of complications was higher in patients with longer diabetes duration. Frequency of self-monitoring was low. Only 4% of patients were on diet therapy, 53.9% were receiving oral hypoglycemic agents (OHAs), 22% were receiving insulin and 19.8% a combination of insulin and OHAs. Frequency of insulin usage was higher amongst patients with longer diabetes duration. CONCLUSIONS: This large multi-centre collaborative observational study shows that type 2 diabetes begins at an early age amongst Indians. With increasing duration of diabetes, glycemic control deteriorates leading to late complications. Diabetes care in India leaves much to be desired. Concerted efforts to increase awareness amongst health professionals to improve diabetes care are urgently needed. The study by increasing awareness about the current status of diabetes care provides a useful benchmark to plan future improvements.
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