Public Health System's Preparedness to Address Polycystic Ovarian Syndrome: A Rapid Assessment Survey of Health-care Providers in India.

BACKGROUND: Polycystic ovarian syndrome (PCOS) is one of the most common endocrine disorders largely affecting women of reproductive age group. OBJECTIVES: This study aimed to understand the Indian public health-care systems' preparedness in addressing PCOS. MATERIALS AND METHODS: A multicentric rapid assessment cross-sectional study was undertaken among 173 health-care providers serving across various public health-care facilities in India. This study was a component of a larger task force study that aimed to estimate the community-based prevalence of PCOS in India. Information on PCOS cases reported that knowledge about PCOS diagnosis, management practices, availability of diagnostic facilities, and drugs was explored. RESULTS: Irregular menstrual cycle was the most commonly reported PCOS symptom. Most of the health-care providers (HCPs) lacked correct knowledge about diagnostic criteria and investigation needed for the diagnosis of PCOS. Diagnostic facilities and drugs were inadequate. However, some facilities had access to investigations through public-private partnerships. Awareness programs on PCOS in the community were negligible, and PCOS cases were not documented. Training HCPs on PCOS along with the availability of specialists and strengthening diagnostic facilities were some major demands from the HCPs. CONCLUSION: Results suggest the need for training HCPs, strengthening infrastructure with good referral linkages, and adequate supply of drugs to help improve PCOS management at public health-care facilities in India. There is a need to develop national technical and operational guidelines to address PCOS using a multidisciplinary approach across all levels of care. Creating demand for services and advocating healthy lifestyles through community awareness can help early diagnosis and prevention of complications.

Variation in normative values of major clinical biochemistry analytes in healthy reproductive-age women in India: A subset of data from a National Indian Council of Medical Research-Polycystic Ovary Syndrome task force study.

OBJECTIVES: Clinical biochemistry reference intervals (RIs) play a crucial role in interpreting patient test results and making informed clinical decisions. Using data from an ongoing Indian Council of Medical Research-National task force study on healthy women, normative ranges for commonly analyzed biochemical analytes were established. MATERIALS AND METHODS: A.total of 13,181 women of reproductive age (18-40 years) were recruited from different urban and rural regions of the country, of which 9898 women signed an informed consent were included. Among these, women having features of hyperandrogenism, menstrual cycle irregularities, and comorbidities were excluded. RIs of 22 analytes were computed in the remaining 938 women controls. To estimate the 95% range of the reference distribution, the limits of the 2.5th percentile and the 97.5th percentile were used in the study. RESULTS: Mean ± standard deviation of age and body mass index of participants was 30.12 ± 6.32 years and 22.8 ± 3.36 kg/m2 respectively. Centiles (2.5th-97.5th) of liver function parameters, lipid parameters, glycaemic parameters, and renal parameters are presented. No significant difference in analytes was observed in relation to the area of residence, and age groups except in albumin (P = 0.03). The distribution of most of the parameters was consistent with the various RI studies conducted in India as well as other countries. CONCLUSION: This is the first study generating biochemical RIs data among a large representative sample of healthy reproductive-age women recruited using a robust design across the country. The resource may serve as a reference range for common biochemical analytes for future in this age group.

Cost-effectiveness and budget impact of adding tranexamic acid for management of post-partum hemorrhage in the Indian public health system.

BACKGROUND: Postpartum hemorrhage (PPH) is the global leading cause of maternal mortality, affecting nearly 3 to 6 percent of all women giving birth in India. The World Health Organization (WHO) has updated its guidelines to recommend the early use of intravenous (IV) tranexamic acid (TXA) in addition to standard care for all diagnosed PPH cases. This study aimed to assess the cost-effectiveness of introducing TXA for PPH management in the Indian public health system. METHODS: A decision analytic model was built using a decision tree to determine the cost-effectiveness of administering IV TXA to women experiencing PPH within 3 h of birth to existing management with uterotonics and supportive care. Using a disaggregated societal perspective, the costs and consequences for a hypothetical cohort of women experiencing PPH in public health facilities was estimated. The model was populated using probabilities, clinical parameters, and utilities from published literature, while cost parameters were largely derived from a primary economic costing study. The primary outcome of interest was the incremental cost-utility ratio (ICUR). Associated clinical events and net benefits were estimated. One-way and probabilistic sensitivity analysis (PSA) was undertaken. The budget impact was estimated for a national-level introduction. RESULTS: For an estimated annual cohort of 510,915 PPH cases in India, the addition of IV TXA would result in a per-patient disaggregated societal cost of INR 6607 (USD 95.15) with a discounted gain of 20.25 QALYs, as compared to a cost of INR 6486 (USD 93.41) with a discounted gain of 20.17 QALYs with standard care PPH management. At an ICUR value of INR 1470 per QALY gained (USD 21), the addition of IV TXA is cost-effective in Indian public health settings. The intervention is likely to prevent 389 maternal deaths, 177 surgeries, and 128 ICU admissions per 100,000 PPH cases. The findings are robust under uncertainty, with 94.5% of PSA simulations remaining cost-effective. A cumulative increase of 2.3% financial allocation for PPH management over five years will be incurred for TXA introduction. CONCLUSIONS: Addition of tranexamic acid for primary PPH management, as recommended by WHO, is cost-effective in Indian public health settings. Policy guidelines, training manuals, and facility checklists should be updated to reflect this recommendation.

Yoga Intervention Improves the Metabolic Parameters and Quality of Life among Infertile Women with Polycystic Ovary Syndrome in Indian Population.

Background: The heterogenic manifestations of polycystic ovarian syndrome have led to various treatment approaches that include improving hormonal imbalance, weight management, and improving quality of life (QoL). Yoga therapy being a versatile treatment approach benefits physical and mental well-being and can be recommended to women with polycystic ovary syndrome (PCOS). Objective: The objective of this study was to study the effect of structured yoga intervention on anthropometric, metabolic, hormonal, biochemical, ovarian morphology, and infertility-related QoL parameters among infertile women with PCOS. Settings and Design: A prospective, controlled before and after study was conducted at a Multidisciplinary PCOS Clinic in Mumbai, Maharashtra, India. Methodology: Infertile women with PCOS (26 participants in each group which includes intervention and control arm) seeking treatment for infertility at the Multidisciplinary PCOS Clinic at National Institute for Research in Reproductive and Child Health. The intervention group received 90 min of structured yoga intervention for 3 months. Statistical Analysis: The median change in parameters between baseline and after 12 weeks of intervention was analyzed using IBM SPSS software, version 26 to perform descriptive analyses and Wilcoxon test to analyze pre- and postintervention parameters in the intervention and control group. Results: There was a significant difference in the weight, basal metabolic rate, postglucose insulin, anti-Müllerian hormone, cholesterol, high-density lipoprotein, low-density lipoprotein, serum glutamic pyruvic transaminase, ultrasound parameters such as stromal thickness, follicle number per ovary, and QoL in infertility domain in the intervention group compared to the control group. Within 1 year of initiation of the study, 13 participants became pregnant in the yoga intervention group as compared to 7 participants in the control group. Conclusion: The metabolic comorbidities of PCOS have adverse effects on the QoL and pregnancy outcome among infertile women with PCOS. This pilot study demonstrated that a 12-week yoga intervention brought overall improvement in anthropometric, hormonal, biochemical, ovarian morphology, and infertility-related QoL parameters compared to the control group. Integration of yoga in infertility management will help to improve the QoL and to optimize prepregnancy metabolic parameters among infertile women with PCOS.

An integrated multidisciplinary model of care for addressing comorbidities beyond reproductive health among women with polycystic ovary syndrome in India.

Background & objectives: Polycystic Ovary Syndrome (PCOS) is becoming an area of global and national health concern. It requires a life cycle approach from adolescence to menopause. To comprehensively address the wide spectrum of this disorder, a multidisciplinary model of care was established for women with PCOS in a government setting in India with an objective to screen and manage multifaceted manifestations of PCOS and to diagnose and treat associated comorbidities such as metabolic syndrome, dermatologic manifestations and psychological issues. Methods: A model of integrated multidisciplinary PCOS clinic was implemented for services and research at ICMR-National Institute for Research in Reproductive and Child Health (NIRRCH), Mumbai Maharashtra, India. This is a one-stop holistic centre for managing menstrual, cosmetic, infertility, obesity, metabolic and psychological concerns of women affected with PCOS. Two hundred and twenty six women diagnosed with PCOS using the Rotterdam criteria were screened for metabolic comorbidities with anthropometry, ultrasonography, hormonal and biochemical tests and for psychological problems. Analysis was performed using SPSS version 19.0. Results: Mean body mass index (BMI) was 26.1 kg/m2, higher for Asians. Hirsutism was observed in 53.6 per cent of women. Metabolic syndrome was seen among 35.3 per cent and non-alcoholic fatty liver in 18.3 per cent. Psychological issues such as anxiety and depression were identified in majority of the women 31.4 per cent of women could achieve pregnancy at the end of one year of multidisciplinary management. Interpretation & conclusions: The results of the present study suggest that an integrated multidisciplinary approach led to the early identification and treatment of comorbidities of PCOS, especially metabolic syndrome. There is hence an urgent need to implement multidisciplinary PCOS clinics in government health facilities.

Enablers & challenges of tribal women & health system for implementation of screening of non-communicable diseases & common cancers: A mixed-methods study in Palghar district of Maharashtra, India.

Background & objectives: Non-communicable diseases (NCDs) and cancers of breast, oral cavity and cervix contribute to around 5.87 million (60%) deaths in India. Despite this, there is limited evidence on preparedness of the tribal health system in mitigating these conditions. This mixed-methods study aimed at identifying enablers and challenges using a multistakeholder approach for the screening of NCDs and common cancers in a tribal block of Maharashtra, India. Methods: This study was conducted in a tribal community of Dahanu taluka in Palghar district of Maharashtra. A total of nine focus group discussions (FGDs) among tribal women and accredited social health activists (ASHAs), 13 key informant interviews (KIIs) among auxiliary nurse midwives (ANMs) and community health officers (CHO) and facility surveys of five public health facilities were conducted. The FGDs and KIIs were conducted using guides, recorded digitally, transcribed, analyzed and triangulated to identify emerging themes. Results: The tribal women had limited knowledge about NCDs and common cancers. Paucity of health facilities, out-of-pocket expenditure, misconceptions, belief on traditional healers and inability to prioritize health were identified as major challenges. The ASHAs were recognized as a key connecting link between health system and community while provision of culturally appropriate IEC materials and adequate training were recognized as critical enablers by healthcare providers in implementing screening for NCDs and common cancers. Interpretation & conclusions: The study recommends incorporating socioculturally relevant strategies in the tribal population and strengthening health facilities in terms of infrastructure and training with involvement of ASHAs for successful implementation of the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) through health and wellness centres.

Cost-effectiveness of uterine balloon tamponade devices in managing atonic post-partum hemorrhage at public health facilities in India.

OBJECTIVE: Post-partum hemorrhage (PPH) is the leading direct cause of maternal mortality in India. Uterine balloon tamponade (UBT) is recommended for atonic PPH cases not responding to uterotonics. This study assessed cost-effectiveness of three UBT devices used in Indian public health settings. METHODS: A decision tree model was built to assess cost-effectiveness of Bakri-UBT and low-cost ESM-UBT alternatives as compared to the recommended standard of care i.e. condom-UBT intervention. A hypothetical annual cohort of women eligible for UBT intervention after experiencing atonic PPH in Indian public health facilities were evaluated for associated costs and outcomes over life-time horizon using a disaggregated societal perspective. Costs by undertaking primary costing and clinical parameters from published literature were used. Incremental cost per Disability Adjusted Life Years (DALY) averted, number of surgeries and maternal deaths with the interventions were estimated. An India specific willingness to pay threshold of INR 24,211 (USD 375) was used to evaluate cost-effectiveness. Detailed sensitivity analysis and expected value of information analysis was undertaken. RESULTS: ESM-UBT at base-case Incremental Cost-Effectiveness Ratio (ICER) of INR -2,412 (USD 37) per DALY averted is a cost-saving intervention i.e. is less expensive and more effective as compared to condom-UBT. Probabilistic sensitivity analysis however shows an error probability of 0.36, indicating a degree of uncertainty around model results. Bakri-UBT at an ICER value of INR -126,219 (USD -1,957) per DALY averted incurs higher incremental societal costs and is less effective as compared to condom-UBT. Hence, Bakri-UBT is not cost-effective. CONCLUSION: For atonic PPH management in India, condom-UBT offers better value as compared to Bakri-UBT. Given the limited clinical effectiveness evidence and uncertainty in sensitivity analysis, cost-saving result for ESM-UBT must be considered with caution. Future research may focus on generating high quality comparative clinical evidence for UBT devices to facilitate policy decision making.

Cost of managing atonic postpartum haemorrhage with uterine balloon tamponade devices in public health settings of Maharashtra, India: an economic microcosting study.

OBJECTIVE: Postpartum haemorrhage (PPH) is the worldwide leading cause of preventable maternal mortality. India offers free treatment for pregnancy and related complications in its public health facilities. Management with uterine balloon tamponade (UBT) is recommended for refractory atonic PPH cases. As part of health technology assessment to determine the most cost-effective UBT device, this study estimated costs of atonic PPH management with condom-UBT, Every Second Matters (ESM) UBT and Bakri balloon UBT in public health system of Maharashtra, India. DESIGN: Health system cost was estimated using primary economic microcosting, data from Health Management Information System and published literature for event probabilities. SETTINGS: Four public health facilities from the state of Maharashtra, India representing primary, secondary and tertiary level care were chosen for primary costing. OUTCOME MEASURES: Unit, package and annual cost of atonic PPH management with three UBT devices were measured. This included cost of medical treatment, UBT intervention and PPH related surgeries undertaken in public health system of Maharashtra for year 2017-2018. RESULTS: Medical management of atonic PPH cost the health system US$37 (95% CI 29 to 45) per case, increasing to US$44 (95% CI 36 to 53) with condom-UBT and surgical interventions for uncontrolled cases. Similar cost was estimated for ESM-UBT. Bakri-UBT reported a higher cost of US$59 (95% CI 46 to 73) per case. Overall annual cost of managing 27 915 atonic PPH cases with condom-UBT intervention in Maharashtra was US$1 226 610 (95% CI 870 250 to 1 581 596). CONCLUSIONS: Atonic PPH management in public health facilities of Maharashtra with condom-UBT, ESM-UBT or Bakri-UBT accounts to 3.8%, 3.8% or 5.2% of the state's annual spending on reproductive and child health services. These findings can guide policy-makers to include PPH complication management in publicly financed health schemes. Economic evaluation studies can use this evidence to determine cost effectiveness of UBT in Indian settings.

Perspectives of primary healthcare providers on implementing cancer screening services in tribal block of Maharashtra, India.

BACKGROUND: Breast, cervical, and oral cancers contribute to majority of cancer deaths among women in India. However, there is poor implementation of screening programs at primary health care (PHC). There is a need to understand the perspectives of healthcare providers at PHC level for feasibility of implementation of a cost-effective cancer screening program, particularly in the rural and tribal areas that are under served by cancer services. MATERIALS AND METHODS: A continuous medical education (CME) program on "Prevention and early detection of common cancers" was held for all Medical Officers of Palghar District, Maharashtra. A self-administered questionnaire was used to assess the knowledge, attitude, practices, perspectives regarding common cancers, screening methods, and human papilloma virus (HPV) vaccination. A pre- and post-assessment was carried out before the commencement and on completion of the CME among 76 participants. RESULTS: Knowledge about etiology of common cancers was high; however, awareness of risk factors was low. There were knowledge gaps about HPV vaccination. There was overall improvement about the available screening methods and knowledge of HPV vaccine and dosages after the CME (pretest 65% to posttest 95%). Providers had no experience in performing cervical cancer screening on a routine basis. While the majority of the providers (97%) indicated that screening for cancer was essential and feasible at PHC level; however, training (52%) and resources (53%) would be needed. CONCLUSION: Healthcare providers though from the underserved tribal areas, were optimistic to implement screening for common cancers and were willing to take training for the same. This emphasizes the need for educating and training the healthcare providers with simple techniques for effective implementation of cancer screening programs in underserved areas.