Equivalence in Active Pharmaceutical Ingredient of Generic Antihypertensive Medicines Available in Nigeria (EQUIMEDS): A Case for Further Surveillance.

BACKGROUND: Widespread access to good quality antihypertensive medicines is a critical component for reducing premature cardiovascular disease (CVD) mortality. Poor-quality medicines pose serious health concerns; however, there remains a knowledge gap about the quality of cardiovascular medicines available in low- and middle-income countries. OBJECTIVES: The aim of this study was to determine the quality of generic antihypertensive medicines available in the retail market of a developing country. METHODS: Samples of the 2 most commonly prescribed classes of antihypertensive medicines were collected from 3 states in 3 different geopolitical zones in Nigeria following a semirandom sampling framework. Medicine samples were purchased by mystery shoppers from 22 pharmacy outlets from 6 local government areas across the 3 states. Medicine quality was determined by measuring the amount of stated active pharmaceutical ingredient using high-performance liquid chromatography with photodiode array detection and classified according to their compliance to the specified pharmacopeia tolerance limits for each antihypertensive drug. RESULTS: Amlodipine and lisinopril were identified as the most commonly prescribed antihypertensive drugs in Nigeria. In total, 361 samples from 22 pharmacies were collected and tested. In total, 24.6% of amlodipine and 31.9% of lisinopril samples were of substandard quality and significantly more samples purchased in rural (59 of 161, 36.7%) compared with urban (32 of 200, 16%) outlets were found to be of substandard quality (p < 0.001). No falsified samples of either amlodipine or lisinopril were detected. There was large variation in price paid for the antihypertensive medicines (range ₦150 to ₦9,750). Of the 24 pharmacy outlets surveyed, 46% stated that patients did not always require a prescription and 21% had previously reported a medicine as falsified or substandard. CONCLUSIONS: More than one-quarter of some commonly prescribed antihypertensive medicines available in Nigeria may be of substandard quality. Enhanced quality assurance processes in low- and middle-income countries, such as Nigeria, are needed to support optimum management.

Improving Hypertension Outcome Measurement in Low- and Middle-Income Countries.

High blood pressure is the leading modifiable risk factor for mortality, accounting for nearly 1 in 5 deaths worldwide and 1 in 11 in low-income countries. Hypertension control remains a challenge, especially in low-resource settings. One approach to improvement is the prioritization of patient-centered care. However, consensus on the outcomes that matter most to patients is lacking. We aimed to define a standard set of patient-centered outcomes for evaluating hypertension management in low- and middle-income countries. The International Consortium for Health Outcomes Measurement convened a Working Group of 18 experts and patients representing 15 countries. We used a modified Delphi process to reach consensus on a set of outcomes, case-mix variables, and a timeline to guide data collection. Literature reviews, patient interviews, a patient validation survey, and an open review by hypertension experts informed the set. The set contains 18 clinical and patient-reported outcomes that reflect patient priorities and evidence-based hypertension management and case-mix variables to allow comparisons between providers. The domains included are hypertension control, cardiovascular complications, health-related quality of life, financial burden of care, medication burden, satisfaction with care, health literacy, and health behaviors. We present a core list of outcomes for evaluating hypertension care. They account for the unique challenges healthcare providers and patients face in low- and middle-income countries, yet are relevant to all settings. We believe that it is a vital step toward international benchmarking in hypertension care and, ultimately, value-based hypertension management.

Human resources, patient load, and infrastructure at institutions providing diabetic care in India: The India 11-city 9-state study.

BACKGROUND: There is a lack of information on the practice patterns and available human resources and services for screening for eye complications among persons with diabetes in India. OBJECTIVES: The study was undertaken to document existing health care infrastructure and practice patterns for managing diabetes and screening for eye complications. METHODS: This cross-sectional, hospital-based survey was conducted in 11 cities where public and private diabetic care providers were identified. Both multispecialty and standalone diabetic care facilities were included. A semi-structured questionnaire was administered to senior representative(s) of each institution to evaluate parameters using the World Health Organization health systems framework. RESULTS: We interviewed physicians in 73 hospitals (61.6% multispecialty hospitals; 38.4% standalone clinics). Less than a third reported having skilled personnel for direct ophthalmoscopy. About 74% had provision for glycated hemoglobin testing. Only a third had adequate vision charts. Printed protocols on management of diabetes were available only in 31.5% of the facilities. Only one in four facilities had a system for tracking diabetics. Half the facilities reported having access to records from the treating ophthalmologists. Direct observation of the services provided showed that reported figures in relation to availability of patient support services were overestimated by around 10%. Three fourths of the information sheets and half the glycemia monitoring cards contained information on the eye complications and the need for a regular eye examination. CONCLUSIONS: The study highlighted existing gaps in service provision at diabetic care centers in India.

Perceptions and practices related to diabetes reported by persons with diabetes attending diabetic care clinics: The India 11-city 9-state study.

BACKGROUND: India has the second largest population of persons with diabetes and a significant proportion has poor glycemic control and inadequate awareness of management of diabetes. OBJECTIVES: Determine the level of awareness regarding management of diabetes and its complications and diabetic care practices in India. METHODS: The cross-sectional, hospital-based survey was conducted in 11 cities where public and private providers of diabetic care were identified. At each diabetic care facility, 4-6 persons with diabetes were administered a structured questionnaire in the local language. RESULTS: Two hundred and eighty-five persons with diabetes were interviewed. The mean duration since diagnosis of diabetes was 8.1 years (standard deviation ± 7.3). Half of the participants reported a family history of diabetes and 41.7% were hypertensive. Almost 62.1% stated that they received information on diabetes and its management through interpersonal channels. Family history (36.1%), increasing age (25.3%), and stress (22.8%) were the commonest causes of diabetes reported. Only 29.1% stated that they monitored their blood sugar levels at home using a glucometer. The commonest challenges reported in managing diabetes were dietary modifications (67.4%), compliance with medicines (20.5%), and cost of medicines (17.9%). Around 76.5% were aware of complications of diabetes. Kidney failure (79.8%), blindness/vision loss (79.3%), and heart attack (56.4%) were the commonest complications mentioned. Almost 67.7% of the respondents stated that they had had an eye examination earlier. CONCLUSIONS: The findings have significant implications for the organization of diabetes services in India for early detection and management of complications, including eye complications.

Eye care infrastructure and human resources for managing diabetic retinopathy in India: The India 11-city 9-state study.

BACKGROUND: There is a paucity of information on the availability of services for diagnosis and management of diabetic retinopathy (DR) in India. OBJECTIVES: The study was undertaken to document existing healthcare infrastructure and practice patterns for managing DR. METHODS: This cross-sectional study was conducted in 11 cities and included public and private eye care providers. Both multispecialty and stand-alone eye care facilities were included. Information was collected on the processes used in all steps of the program, from how diabetics were identified for screening through to policies about follow-up after treatment by administering a semistructured questionnaire and by using observational checklists. RESULTS: A total of 86 eye units were included (31.4% multispecialty hospitals; 68.6% stand-alone clinics). The availability of a dedicated retina unit was reported by 68.6% (59) facilities. The mean number of outpatient consultations per year was 45,909 per responding facility, with nearly half being new registrations. A mean of 631 persons with sight-threatening-DR (ST-DR) were registered per year per facility. The commonest treatment for ST-DR was laser photocoagulation. Only 58% of the facilities reported having a full-time retina specialist on their rolls. More than half the eye care facilities (47; 54.6%) reported that their ophthalmologists would like further training in retina. Half (51.6%) of the facilities stated that they needed laser or surgical equipment. About 46.5% of the hospitals had a system to track patients needing treatment or for follow-up. CONCLUSIONS: The study highlighted existing gaps in service provision at eye care facilities in India.

Perception of care and barriers to treatment in individuals with diabetic retinopathy in India: 11-city 9-state study.

BACKGROUND: Diabetic retinopathy is a leading cause of visual impairment. Low awareness about the disease and inequitable distribution of care are major challenges in India. OBJECTIVES: Assess perception of care and challenges faced in availing care among diabetics. MATERIALS AND METHODS: The cross-sectional, hospital based survey was conducted in eleven cities. In each city, public and private providers of eye-care were identified. Both multispecialty and standalone facilities were included. Specially designed semi-open ended questionnaires were administered to the clients. RESULTS: 376 diabetics were interviewed in the eye clinics, of whom 62.8% (236) were selected from facilities in cities with a population of 7 million or more. The mean duration of known diabetes was 11.1 (±7.7) years. Half the respondents understood the meaning of adequate glycemic control and 45% reported that they had visual loss when they first presented to an eye facility. Facilities in smaller cities and those with higher educational status were found to be statistically significant predictors of self-reported good/adequate control of diabetes. The correct awareness of glycemic control was significantly high among attending privately-funded facilities and higher educational status. Self-monitoring of glycemic status at home was significantly associated with respondents from larger cities, privately-funded facilities, those who were better educated and reported longer duration of diabetes. Duration of diabetes (41%), poor glycemic control (39.4%) and age (20.7%) were identified as the leading causes of DR. The commonest challenges faced were lifestyle/behavior related. CONCLUSIONS: The findings have significant implications for the organization of diabetes services in India.

Is India's policy framework geared for effective action on avoidable blindness from diabetes?

BACKGROUND: The growing burden of avoidable blindness caused by diabetic retinopathy (DR) needs an effective and holistic policy that reflects mechanisms for early detection and treatment of DR to reduce the risk of blindness. MATERIALS AND METHODS: We performed a comprehensive health policy review to highlight the existing systemic issues that enable policy translation and to assess whether India's policy architecture is geared to address the mounting challenge of DR. We used a keyword-based Internet search for documents available in the last 15 years. Two reviewers independently assessed retrieved policies and extracted contextual and program-oriented information and components delineated in national policy documents. Using a "descriptive analytical" method, the results were collated and summarized as per themes to present status quo, gaps, and recommendations for the future. RESULTS: Lack of focus on building sustainable synergies that require well laid out mechanisms for collaboration within and outside the health sector and poor convergence between national health programs appears to be the weakest links across policy documents. CONCLUSIONS: To reasonably address the issues of consistency, comprehensiveness, clarity, context, connectedness, and sustainability, policies will have to rely more strongly on evidence from operational research to support decisions. There is a need to involve multiple stakeholders from multiple sectors, recognize contributions from not-for-profit sector and private health service providers, and finally bring about a nuanced holistic perspective that has a voice with implementable multiple sector actions.

Estimating the proportion of persons with diabetes developing diabetic retinopathy in India: A systematic review and meta-analysis.

BACKGROUND: Available evidence from India shows that the control of diabetes is poor in majority of the population. This escalates the risk of complications. There is no systematic review to estimate the magnitude of diabetic retinopathy (DR) in India. MATERIALS AND METHODS: A systematic literature search was carried out in Ovid Medline and EMBASE databases using Mesh and key search terms. Studies which reported the proportion of people with diabetes with DR in a representative community population were included. Two independent reviewers reviewed all the retrieved publications. Data were extracted using a predefined form. Review Manager software was used to perform meta-analysis to provide a pooled estimate. Studies included were assessed for methodological quality using selected items from the STROBE checklist. RESULTS: Seven studies (1999-2014; n = 8315 persons with diabetes) were included in the review. In the meta-analysis, 14.9% (95% confidence interval [CI] 10.7-19.0%) of known diabetics aged ≥30 years and 18.1% (95% CI 14.8-21.4) among those aged ≥50 years had DR. Heterogeneity around this estimate ranged from I(2)= 79-87%. No linear trend was observed between age and the proportion with DR. The overall methodological quality of included studies was moderate. CONCLUSIONS: Early detection of DR is currently not prioritized in public health policies for noncommunicable diseases and blindness programs. Methodological issues in studies suggest that the proportion of diabetics with DR is underestimated in the Indian population. Future research should emphasize more robust methodology for assessing diabetes and DR status.

Strengthening diabetes retinopathy services in India: Qualitative insights into providers' perspectives: The India 11-city 9-state study.

CONTEXT: There is a lack of evidence on the subjective aspects of the provider perspective regarding diabetes and its complications in India. OBJECTIVES: The study was undertaken to understand the providers' perspective on the delivery of health services for diabetes and its complications, specifically the eye complications in India. SETTINGS AND DESIGN: Hospitals providing diabetic services in government and private sectors were selected in 11 of the largest cities in India, based on geographical distribution and size. METHODS: Fifty-nine semi-structured interviews conducted with physicians providing diabetes care were analyzed all interviews were recorded, transcribed, and translated. Nvivo 10 software was used to code the transcripts. Thematic analysis was conducted to analyze the data. RESULTS: The results are presented as key themes: "Challenges in managing diabetes patients," "Current patient management practices," and "Strengthening diabetic retinopathy (DR) services at the health systems level." Diabetes affects people early across the social classes. Self-management was identified as an important prerequisite in controlling diabetes and its complications. Awareness level of hospital staff on DR was low. Advances in medical technology have an important role in effective management of DR. A team approach is required to provide comprehensive diabetic care. CONCLUSIONS: Sight-threatening DR is an impending public health challenge that needs a concerted effort to tackle it. A streamlined, multi-dimensional approach where all the stakeholders cooperate is important to strengthening services dealing with DR in the existing health care setup.

Physicochemical equivalence of generic antihypertensive medicines (EQUIMEDS): protocol for a quality of medicines assessment.

BACKGROUND: Prevention and optimal management of hypertension in the general population is paramount to the achievement of the World Heart Federation (WHF) goal of reducing premature cardiovascular disease (CVD) mortality by 25% by the year 2025 and widespread access to good quality antihypertensive medicines is a critical component for achieving the goal. Despite research and evidence relating to other medicines such as antimalarials and antibiotics, there is very little known about the quality of generic antihypertensive medicines in low-income and middle-income countries. The aim of this study was to determine the physicochemical equivalence (percentage of active pharmaceutical ingredient, API) of generic antihypertensive medicines available in the retail market of a developing country. METHODS: An observational design will be adopted, which includes literature search, landscape assessment, collection and analysis of medicine samples. To determine physicochemical equivalence, a multistage sampling process will be used, including (1) identification of the 2 most commonly prescribed classes of antihypertensive medicines prescribed in Nigeria; (2) identification of a random sample of 10 generics from within each of the 2 most commonly prescribed classes; (3) a geographical representative sampling process to identify a random sample of 24 retail outlets in Nigeria; (4) representative sample purchasing, processing to assess the quality of medicines, storage and transport; and (5) assessment of the physical and chemical equivalence of the collected samples compared to the API in the relevant class. In total, 20 samples from each of 24 pharmacies will be tested (total of 480 samples). DISCUSSION: Availability of and access to quality antihypertensive medicines globally is therefore a vital strategy needed to achieve the WHF 25×25 targets. However, there is currently a scarcity of knowledge about the quality of antihypertensive medicines available in developing countries. Such information is important for enforcing and for ensuring the quality of antihypertensive medicines.

Evaluation of effectiveness and cost-effectiveness of a clinical decision support system in managing hypertension in resource constrained primary health care settings: results from a cluster randomized trial.

BACKGROUND: Randomized control trials from the developed world report that clinical decision support systems (DSS) could provide an effective means to improve the management of hypertension (HTN). However, evidence from developing countries in this regard is rather limited, and there is a need to assess the impact of a clinical DSS on managing HTN in primary health care center (PHC) settings. METHODS AND RESULTS: We performed a cluster randomized trial to test the effectiveness and cost-effectiveness of a clinical DSS among Indian adult hypertensive patients (between 35 and 64 years of age), wherein 16 PHC clusters from a district of Telangana state, India, were randomized to receive either a DSS or a chart-based support (CBS) system. Each intervention arm had 8 PHC clusters, with a mean of 102 hypertensive patients per cluster (n=845 in DSS and 783 in CBS groups). Mean change in systolic blood pressure (SBP) from baseline to 12 months was the primary endpoint. The mean difference in SBP change from baseline between the DSS and CBS at the 12th month of follow-up, adjusted for age, sex, height, waist, body mass index, alcohol consumption, vegetable intake, pickle intake, and baseline differences in blood pressure, was -6.59 mm Hg (95% confidence interval: -12.18 to -1.42; P=0.021). The cost-effective ratio for CBS and DSS groups was $96.01 and $36.57 per mm of SBP reduction, respectively. CONCLUSION: Clinical DSS are effective and cost-effective in the management of HTN in resource-constrained PHC settings. CLINICAL TRIAL REGISTRATION URL: http://www.ctri.nic.in. Unique identifier: CTRI/2012/03/002476.

Hypertension in India: a systematic review and meta-analysis of prevalence, awareness, and control of hypertension.

BACKGROUND: A region-specific (urban and rural parts of north, east, west, and south India) systematic review and meta-analysis of the prevalence, awareness, and control of hypertension among Indian patients have not been done before. METHODS: Medline, Web of Science, and Scopus databases from 1950 to 30 April 2013 were searched for 'prevalence, burden, awareness, and control of blood pressure (BP) or hypertension (≥140 SBP and or ≥90 DBP) among Indian adults' (≥18 years). Of the total 3047 articles, 142 were included. RESULTS: Overall prevalence for hypertension in India was 29.8% (95% confidence interval: 26.7-33.0). Significant differences in hypertension prevalence were noted between rural and urban parts [27.6% (23.2-32.0) and 33.8% (29.7-37.8); P = 0.05]. Regional estimates for the prevalence of hypertension were as follows: 14.5% (13.3-15.7), 31.7% (30.2-33.3), 18.1% (16.9-19.2), and 21.1% (20.1-22.0) for rural north, east, west, and south India; and 28.8% (26.9-30.8), 34.5% (32.6-36.5), 35.8% (35.2-36.5), and 31.8% (30.4-33.1) for urban north, east, west, and south India, respectively. Overall estimates for the prevalence of awareness, treatment, and control of BP were 25.3% (21.4-29.3), 25.1% (17.0-33.1), and 10.7% (6.5-15.0) for rural Indians; and 42.0% (35.2-48.9), 37.6% (24.0-51.2), and 20.2% (11.6-28.7) for urban Indians. CONCLUSION: About 33% urban and 25% rural Indians are hypertensive. Of these, 25% rural and 42% urban Indians are aware of their hypertensive status. Only 25% rural and 38% of urban Indians are being treated for hypertension. One-tenth of rural and one-fifth of urban Indian hypertensive population have their BP under control.

Development and validation of a clinical and computerised decision support system for management of hypertension (DSS-HTN) at a primary health care (PHC) setting.

BACKGROUND: Hypertension remains the top global cause of disease burden. Decision support systems (DSS) could provide an adequate and cost-effective means to improve the management of hypertension at a primary health care (PHC) level in a developing country, nevertheless evidence on this regard is rather limited. METHODS: Development of DSS software was based on an algorithmic approach for (a) evaluation of a hypertensive patient, (b) risk stratification (c) drug management and (d) lifestyle interventions, based on Indian guidelines for hypertension II (2007). The beta testing of DSS software involved a feedback from the end users of the system on the contents of the user interface. Software validation and piloting was done in field, wherein the virtual recommendations and advice given by the DSS were compared with two independent experts (government doctors from the non-participating PHC centers). RESULTS: The overall percent agreement between the DSS and independent experts among 60 hypertensives on drug management was 85% (95% CI: 83.61-85.25). The kappa statistic for overall agreement for drug management was 0.659 (95% CI: 0.457-0.862) indicating a substantial degree of agreement beyond chance at an alpha fixed at 0.05 with 80% power. Receiver operator curve (ROC) showed a good accuracy for the DSS, wherein, the area under curve (AUC) was 0.848 (95% CI: 0.741-0.948). Sensitivity and specificity of the DSS were 83.33 and 85.71% respectively when compared with independent experts. CONCLUSION: A point of care, pilot tested and validated DSS for management of hypertension has been developed in a resource constrained low and middle income setting and could contribute to improved management of hypertension at a primary health care level.

Cost effective interventions for the prevention of cardiovascular disease in low and middle income countries: a systematic review.

BACKGROUND: While there is good evidence to show that behavioural and lifestyle interventions can reduce cardiovascular disease risk factors in affluent settings, less evidence exists in lower income settings.This study systematically assesses the evidence on cost-effectiveness for preventive cardiovascular interventions in low and middle-income settings. DESIGN: Systematic review of economic evaluations on interventions for prevention of cardiovascular disease. DATA SOURCES: PubMed, Web of Knowledge, Scopus and Embase, Opensigle, the Cochrane database, Business Source Complete, the NHS Economic Evaluations Database, reference lists and email contact with experts. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: we included economic evaluations conducted in adults, reporting the effect of interventions to prevent cardiovascular disease in low and middle income countries as defined by the World Bank. The primary outcome was a change in cardiovascular disease occurrence including coronary heart disease, heart failure and stroke. DATA EXTRACTION: After selection of the studies, data were extracted by two independent investigators using a previously constructed tool and quality was evaluated using Drummond's quality assessment score. RESULTS: From 9731 search results we found 16 studies, which presented economic outcomes for interventions to prevent cardiovascular disease in low and middle income settings, with most of these reporting positive cost effectiveness results.When the same interventions were evaluated across settings, within and between papers, the likelihood of an intervention being judged cost effective was generally lower in regions with lowest gross national income. While population based interventions were in most cases more cost effective, cost effectiveness estimates for individual pharmacological interventions were overall based upon a stronger evidence base. CONCLUSIONS: While more studies of cardiovascular preventive interventions are needed in low and mid income settings, the available high-level of evidence supports a wide range of interventions for the prevention of cardiovascular disease as being cost effective across all world regions.

The role of Decision Support System (DSS) in prevention of cardiovascular disease: a systematic review and meta-analysis.

BACKGROUND: The potential role of DSS in CVD prevention remains unclear as only a few studies report on patient outcomes for cardiovascular disease. METHODS AND RESULTS: A systematic review and meta-analysis of randomised controlled trials and observational studies was done using Medline, Embase, Cochrane Library, PubMed, Amed, CINAHL, Web of Science, Scopus databases; reference lists of relevant studies to 30 July 2011; and email contact with experts. The primary outcome was prevention of cardiovascular disorders (myocardial infarction, stroke, coronary heart disease, peripheral vascular disorders and heart failure) and management of hypertension owing to decision support systems, clinical decision supports systems, computerized decision support systems, clinical decision making tools and medical decision making (interventions). From 4116 references ten studies met our inclusion criteria (including 16,312 participants). Five papers reported outcomes on blood pressure management, one paper on heart failure, two papers each on stroke, and coronary heart disease. The pooled estimate for CDSS versus control group differences in SBP (mm of Hg) was - 0.99 (95% CI -3.02 to 1.04 mm of Hg; I(2) = 0; p = 0.851). CONCLUSIONS: DSS show an insignificant benefit in the management and control of hypertension (insignificant reduction of SBP). The paucity of well-designed studies on patient related outcomes is a major hindrance that restricts interpretation for evaluating the role of DSS in secondary prevention. Future studies on DSS should (1) evaluate both physician performance and patient outcome measures (2) integrate into the routine clinical workflow with a provision for decision support at the point of care.

'Decision support system (DSS) for prevention of cardiovascular disease (CVD) among hypertensive (HTN) patients in Andhra Pradesh, India'--a cluster randomised community intervention trial.

BACKGROUND: Very few studies having decision support systems as an intervention report on patient outcomes for cardiovascular disease in the Western world. The potential role of decision support system for the management of blood pressure among Indian hypertensives remains unclear. We propose a cluster randomised trial that aims to test the effectiveness and cost effectiveness of DSS among Indian hypertensive patients. METHODS: The trial design is a cluster randomised community intervention trial, in which the participants would be adult male and female hypertensive patients, in the age group of 35 to 64 years, reporting to the Primary Health Care centres of Mahabubnagar district, Andhra Pradesh, India. The objective of the study is to test the effectiveness and compare the cost effectiveness and cost utility among hypertensive subjects randomized to receive either decision support system or a chart based algorithmic support system in urban and rural areas of a district in the state of Andhra Pradesh, India (baseline versus 12 months follow up). The primary outcome would be a comparison of the systolic blood pressure at 0 and 12 months among hypertensive patients randomized to receive the decision support system or the chart based algorithmic support system. Computer generated randomisation and an investigator and analyser blinded method would be followed. 1600 participants; 800 to each arm; each arm having eight clusters of hundred participants each have been recruited between 01 August 2011 - 01 March 2012. A twelve month follow up will be completed by March 2013 and results are expected by April 2013. DISCUSSION: This cluster randomized community intervention trial on DSS will enable policy makers to find out the effectiveness, cost effectiveness and cost utility of decision support system for management of blood pressure among hypertensive patients in India. Most of the previous studies on decision support system have focused on physician performance, adherence and on preventive care reminders. The uniqueness of the proposed study lies in finding out the effectiveness of a decision support system on patient related outcomes. TRIAL REGISTRATION: CTRI/2012/03/002476, Clinical Trial Registry - India.

Are tuberculosis patients in a tertiary care hospital in Hyderabad, India being managed according to national guidelines?

SETTING: A tertiary health care facility (Government General and Chest hospital) in Hyderabad, India. OBJECTIVES: To assess a) the extent of compliance of specialists to standardized national (RNTCP) tuberculosis management guidelines and b) if patients on discharge from hospital were being appropriately linked up with peripheral health facilities for continuation of anti-Tuberculosis (TB) treatment. METHODS: A descriptive study using routine programme data and involving all TB patients admitted to inpatient care from 1(st) January to 30(th) June, 2010. RESULTS AND CONCLUSIONS: There were a total of 3120 patients admitted of whom, 1218 (39%) required anti-TB treatment. Of these 1104 (98%) were treated with one of the RNTCP recommended regimens, while 28 (2%) were treated with non-RNTCP regimens. The latter included individually tailored MDR-TB treatment regimens for 19 patients and adhoc regimens for nine patients. A total of 957 (86%) patients were eventually discharged from the hospital of whom 921 (96%) had a referral form filled for continuing treatment at a peripheral health facility. Formal feedback from peripheral health facilities on continuation of TB treatment was received for 682 (74%) patients. In a tertiary health facility with specialists the great majority of TB patients are managed in line with national guidelines. However a number of short-comings were revealed and measures to rectify these are discussed.

The timing of death in patients with tuberculosis who die during anti-tuberculosis treatment in Andhra Pradesh, South India.

BACKGROUND: India has 2.0 million estimated tuberculosis (TB) cases per annum with an estimated 280,000 TB-related deaths per year. Understanding when in the course of TB treatment patients die is important for determining the type of intervention to be offered and crucially when this intervention should be given. The objectives of the current study were to determine in a large cohort of TB patients in India:- i) treatment outcomes including the number who died while on treatment, ii) the month of death and iii) characteristics associated with "early" death, occurring in the initial 8 weeks of treatment. METHODS: This was a retrospective study in 16 selected Designated Microscopy Centres (DMCs) in Hyderabad, Krishna and Adilabad districts of Andhra Pradesh, South India. A review was performed of treatment cards and medical records of all TB patients (adults and children) registered and placed on standardized anti-tuberculosis treatment from January 2005 to September 2009. RESULTS: There were 8,240 TB patients (5183 males) of whom 492 (6%) were known to have died during treatment. Case-fatality was higher in those previously treated (12%) and lower in those with extra-pulmonary TB (2%). There was an even distribution of deaths during anti-tuberculosis treatment, with 28% of all patients dying in the first 8 weeks of treatment. Increasing age and new as compared to recurrent TB disease were significantly associated with "early death". CONCLUSION: In this large cohort of TB patients, deaths occurred with an even frequency throughout anti-TB treatment. Reasons may relate to i) the treatment of the disease itself, raising concerns about drug adherence, quality of anti-tuberculosis drugs or the presence of undetected drug resistance and ii) co-morbidities, such as HIV/AIDS and diabetes mellitus, which are known to influence mortality. More research in this area from prospective and retrospective studies is needed.