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.

Assessment of quality of life in patients having Poly-Cystic Ovarian Syndrome: A cross-sectional facility-based study.

BACKGROUND: Polycystic ovarian syndrome (PCOS) is a complex and heterogeneous disorder affecting various body organs. Menstrual irregularity, anovulation, and many cosmetic issues faced by PCOS patients endanger the essence of being a woman and may have a deleterious impact on their health-related quality of life (HRQOL). This study aimed to assess HRQOL in patients with PCOS and to identify the clinical and socio-demographic factors that might predict poor HRQOL. MATERIALS AND METHODS: This cross-sectional study was carried out in the tertiary care hospital in India. A total of 275 women visiting the same setting and diagnosed with PCOS were included. The participants' quality of life was studied using a disease-specific HRQOL questionnaire. Information regarding clinical and socio-demographics was collected using the interviewer schedule. For evaluating the predictors of HRQOL in PCOS subjects, analysis of variance and independent t-test was applied. For subgroup analysis, the post hoc (Gabriel) test was applied. RESULTS: The average total score of HRQOL of the study participants was 125.41 ± 29.1. The lowest weighted mean score was for menstrual problems. Among the socio-demographic variables, age and educational level influenced the HRQOL scores. Highly educated women reported the poorest HRQOL. The analysis of variance also indicated a significant variation in HRQOL scores among body mass index categories [F (4,270) = 5.09, P = <.001] and hirsutism status [F (2,272) = 14.222, P =<.001]. CONCLUSIONS: Menstrual irregularity, hirsutism, increased body mass index, educational status, and age are critical in altering HRQOL in PCOS cases. Clinicians should inquire about the HRQOL of patients with severe clinical manifestations and appropriate support must be provided during patient care.

Prospective assessment of mental and physical health of maternal near-miss women: A low-middle-income country's experience.

Background: Traumatic birth experience is an unaddressed arena, especially in Asian women, with several societal stigmas lingering around. Aim: A study was undertaken to simultaneously assess the post-partum mental and physical health follow-up of maternal near-miss (MNM) women and compare it with women of uneventful deliveries. Materials and Methods: The prospective cohort study enrolled 88 MNM women (case cohort) and 80 women with an uneventful peri-partum period (control cohort) at the same time. The participants were followed up with Edinburgh Postnatal Depression Scale (EDPS), PTSD Checklist - Civilian Version (PLC-C), and a 36-item short-form-survey form over 6 months after the delivery. Results: The case group had higher mean EPDS and PLC-C scores, with poor quality of life (QOL) performance, compared to the control group at 6 weeks and 3 months, and 6 months follow-up (P < 0.05). At the sixth-week follow-up visit, the study observed that 28 (31.8%) women from the case group required a psychiatry consultation compared to the control group with only two (2.5%) participants (P < 0.001). At 3 months, an evident difference was noted on various QOL parameters, such as limitations due to physical health and emotional problems, energy fatigue, general health, and health change parameters between the two groups (P < 0.05). The difference persisted at 6-month follow-up as well for limitations due to physical health, energy fatigue, and general health parameters only (P < 0.05). Conclusion: There is an urgent need for a multi-departmental collaborative approach at the hospital level and policy-making decisions at higher levels for the mental health of Asian women facing MNM events.

Baseline Assessment of Evidence-Based Intrapartum Care Practices in Medical Schools in 3 States in India: A Mixed-Methods Study.

INTRODUCTION: Implementation research with pre- and post-comparison was planned to improve the quality of evidence-based intrapartum care services in Indian medical schools. We present the baseline study results to assess the status of adherence to intrapartum evidence-based practices (IP-EBP) in study schools in 3 states in India and the perception of the faculty. METHODS: A concurrent mixed-methods approach was used to conduct the baseline assessment in 9 medical schools in Rajasthan, Gujarat, and Union Territory from October 2018 to June 2019. IP-EBP among pregnant women in uncomplicated first (n=135), second (n=120), and third stage (n=120) of labor were observed using a predesigned, pretested checklist quantitatively. We conducted in-depth interviews with 33 obstetrics and gynecology faculty to understand their perceptions of intrapartum practices. Quantitative data were analyzed using SPSS (version 22). COM-B (Capability, Opportunity, and Motivation Behavior) model was used to understand the behaviors, and thematic analysis was done for the qualitative data. FINDINGS: Unindicated augmentation of labor was done in 64.4%, fundal pressure applied in 50.8%, episiotomy done in 58.3%, and delivery in lithotomy position was performed in 86.7% of women in labor. CONCLUSIONS: Intrapartum practices that are not recommended were routinely practiced in the study medical schools due to a lack of staff awareness of evidence-based practices and incorrect beliefs about their impact.

A randomized controlled trial comparing the efficacy, tolerability, and cost of oral iron preparations in iron-deficiency anemia in pregnancy.

OBJECTIVE: To evaluate the efficacy, tolerability, and cost of four commonly prescribed oral iron preparations: ferrous sulfate (FS), ferrous fumarate (FF), ferrous ascorbate (FA), and carbonyl iron (CI) in the treatment of iron-deficiency anemia (IDA) in pregnant women. METHODS: It was a prospective, randomized, open-label, blinded endpoint (PROBE) design with four parallel active control groups: FS, FF, FA, CI. The primary outcome was the proportion of participants becoming non-anemic (Hb ≥ 11 g%) at the end of the study period. The secondary outcomes were the proportion of participants achieving normal red blood corpuscular indices such as mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration; the proportion of participants achieving normal iron indices such as serum iron, serum ferritin, total iron-binding capacity, and transferrin saturation; and comparison of incidence of any adverse events between treatment groups and comparison of costs of individual drug therapy between treatment groups. RESULTS: One hundred and twenty patients were randomized to four different groups (n = 30). The results of the present study show that all the four iron salts at the dose of 200 mg elemental iron per day were equally effective in improving hemoglobin concentration and other hematological parameters. The adverse effects were more common in the FF group (56.7%). The pharmacoeconomic analysis showed that all the drugs are equally cost-effective. CONCLUSION: To conclude from the results of the present study, it can be said that FS, FF, FA, and CI are equally effective in treating IDA and they can be prescribed interchangeably.

Ultrasound-guided fine needle aspiration of ovarian masses: Assessment of diagnostic accuracy and risk stratification using a categorical reporting system.

INTRODUCTION: The present study was undertaken to assess the accuracy of fine needle aspiration cytology (FNAC) and cell-block immunocytochemistry, and to estimate the risk of malignancy, using a categorical reporting system, in the diagnosis of ovarian masses. METHODS: This was a 5-year retrospective study of FNAs of ovarian masses. The cytological diagnoses were categorised as inadequate, non-neoplastic, benign neoplasms, indeterminate for malignancy, suspicious for malignancy and malignant neoplasms. The cytology was correlated with the corresponding histopathology to assess the diagnostic accuracy and risk of malignancy associated with each diagnostic category. RESULTS: Of a total of 66 703 FNAs performed during the study period, 580 (0.9%) were performed on ovarian masses. Of these, 40 (6.9%) were reported as non-neoplastic; 76 (13.1%) as benign neoplasms; 14 (2.4%) as indeterminate for malignancy, 48 (8.3%) as suspicious for malignancy, 337 (58.1%) as malignant neoplasms and 65 (11.2%) as inadequate for interpretation. Immunocytochemistry (ICC) was performed on 99 (17%) aspirates. Subsequent histopathology was available in 208 (35.8%) cases. On cyto-histopathological correlation, 183 (88%) were concordant and 25 (12%) were discordant. The overall sensitivity, specificity, positive and negative predictive values and diagnostic accuracy for diagnosing ovarian malignancy were 88.4%, 85.7%, 96.8%, 60.0% and 88% respectively. Risk of malignancy for each category was 80%, 0%, 4.5%, 66.7%, 88.5% and 98.5% respectively. CONCLUSIONS: Ultrasound-guided FNAC has high specificity and diagnostic accuracy for preoperative diagnosis of ovarian malignancies and hence is a valid diagnostic procedure in certain clinical situations. Reporting using a categorical system imparts uniformity and also provides the clinicians with an associated risk of malignancy to guide further management.

Harnessing genomics to improve outcomes for women with cancer in India: key priorities for research.

Cumulatively, breast, cervical, ovarian, and uterine cancer account for more than 70% of cancers in women in India. Distinct differences in the clinical presentation of women with cancer suggest underlying differences in cancer biology and genetics. The peak age of onset of breast and ovarian cancer appears to be a decade earlier in India (age 45-50 years) than in high-income countries (age >60 years). Understanding these differences through research to develop diagnosis, screening, prevention, and treatment frameworks that ar e specific to the Indian population are critical and essential to improving women's health in India. Since the sequencing of the human genome in 2001, applications of advanced technologies, such as massively parallel sequencing, have transformed the understanding of the genetic and environmental drivers of cancer. How can advanced technologies be harnessed to provide health-care solutions at a scale and to a budget suitable for a country of 1·2 billion people? What research programmes are necessary to answer questions specific to India, and to build capacity for innovative solutions using these technologies? In order to answer these questions, we convened a workshop with key stakeholders to address these issues. In this Series paper, we highlight challenges in tackling the growing cancer burden in India, discuss ongoing genomics research and developments in infrastructure, and suggest key priorities for future research in cancer in India.

Cost-effectiveness of human papillomavirus vaccination for adolescent girls in Punjab state: Implications for India's universal immunization program.

BACKGROUND: Introduction of human papillomavirus (HPV) vaccination for adolescent girls is being considered in the Punjab state of India. However, evidence regarding cost-effectiveness is sought by policy makers when making this decision. The current study was undertaken to evaluate the incremental cost per quality-adjusted life-years (QALYs) gained with introduction of the HPV vaccine compared with a no-vaccination scenario. METHODS: A static progression model, using a combination of decision tree and Markov models, was populated using epidemiological, cost, coverage, and effectiveness data to determine the cost-effectiveness of HPV vaccination. Using a societal perspective, lifetime costs and consequences (in terms of QALYs) among a cohort of 11-year-old adolescent girls in Punjab state were modeled in 2 alternate scenarios with and without vaccination. All costs and consequences were discounted at a rate of 3%. RESULTS: Although immunizing 1 year's cohort of 11-year-old girls in Punjab state costs Indian National Rupees (INR) 135 million (US dollars [USD] 2.08 million and International dollars [Int$] 6.25 million) on an absolute basis, its net cost after accounting for treatment savings is INR 38 million (USD 0.58 million and Int$ 1.76 million). Incremental cost per QALY gained for HPV vaccination was found to be INR 73 (USD 1.12 and Int$ 3.38). Given all the data uncertainties, there is a 90% probability for the vaccination strategy to be cost-effective in Punjab state at a willingness-to-pay threshold of INR 10,000, which is less than one-tenth of the per capita gross domestic product. CONCLUSIONS: HPV vaccination appears to be a very cost-effective strategy for Punjab state, and is likely to be cost-effective for other Indian states. Cancer 2017;123:3253-60. © 2017 American Cancer Society.

Evaluation of effect of isoflavone on thyroid economy & autoimmunity in oophorectomised women: a randomised, double-blind, placebo-controlled trial.

BACKGROUND AND OBJECTIVES: The potential of soy isoflavones to interfere with thyroid function has been reported. However, there are limited data regarding their effect on thyroid function and autoimmunity in surgical menopausal women. The present study aimed to evaluate the effect of isoflavones on thyroid function and autoimmunity, menopausal symptoms, serum follicle stimulating hormone (FSH) and estradiol levels in oophorectomised women. METHODS: A randomized, double blind, placebo-controlled trial was conducted in 43 oophorectomised women to evaluate the effect of soy isoflavones (75 mg/day for 12 wk) on serum thyroid profile (free T3, free T4, TSH, TBG and anti-TPO antibody titres) assessed at baseline, 6 and 12 wk after randomization. Assessment was also done for menopause symptom score (MSS) three weekly, and FSH and estradiol levels at baseline and at study completion. RESULTS: There was a significant alteration in free T3 levels in the group receiving isoflavones (4.05 ± 0.36, 4.12 ± 0.69 and 3.76 ± 0.55 pmol/l at baseline, 6 and 12 wk, respectively; P=0.02). However, the mean change in various thyroid parameters at 12 wk from baseline was not significantly different between the two groups. MSS was also significantly decreased at 9 and 12 wk from baseline with isoflavones (12.47 ± 8.15, 9.35 ± 5.23 and 9 ± 5.14 at baseline, 9 and 12 wk respectively; P=0.004) with significant improvement in urogenital symptoms compared to placebo. Isoflavones did not significantly affect other parameters during study period. There were no serious adverse events reported and the proportion of patients experiencing adverse events was similar between the two groups. INTERPRETATION AND CONCLUSIONS: Modest reduction in serum free T3 levels in the isoflavone group in the absence of any effect on other thyroid parameters might be considered clinically unimportant.

Pre-induction sonographic assessment of the cervix in the prediction of successful induction of labour in nulliparous women.

OBJECTIVE: To compare the efficacy of ultrasonographic cervical assessment with Bishop score before induction of labour in predicting the success of labour induction in nulliparous women. METHODS: This is a prospective study conducted in 138 women who underwent cervical assessment with transvaginal sonography followed by digital cervical assessment using Bishop score before induction of labour. Ultrasonographic parameters evaluated were cervical length, posterior cervical angle and funnelling were blinded to the managing physicians. Statistical analysis was carried out using Mann-Whitney test, chi2 test, receiver operating characteristics curves and logistic regression analysis. RESULTS: Induction of labour was successful in 106 (76.8%) of the women. Multiple logistic regression analysis demonstrated cervical length and posterior cervical angle assessed by transvaginal sonography as independent predictors of successful outcome after induction of labour. Neither Bishop score nor its individual parameters were found to be significant in the regression analysis. The area under the receiver operating characteristic curve for cervical length and posterior cervical angle was greater than that of the Bishop score in predicting a successful labour induction. The best cut-off point for the parameters in receiver operating characteristics curve was 3.0 cm for cervical length and 100 degrees for posterior cervical angle. Cervical length of 3.0 cm had a sensitivity of 84.9%, and a specificity of 90.6% and a posterior cervical angle of 100 degrees with 65% and 72%, respectively. CONCLUSIONS: Transvaginal sonographic assessment of cervical length and posterior cervical angle is better than conventional Bishop score in predicting successful labour induction in nulliparous women.