Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2).

BACKGROUND: Neonatal mortality in India has fallen steadily and was estimated to be 24 per 1000 live births in the year 2017. However, neonatal mortality remains high in rural parts of the country. The Community Health Promotion and Medical Provision and Impact On Neonates (CHAMPION2) trial investigates the effect of a complex health intervention on neonatal mortality in the Satna District of Madhya Pradesh. METHODS/DESIGN: The CHAMPION2 trial forms one part of a cluster-randomised controlled trial with villages (clusters) randomised to receive either a health (CHAMPION2) or education (STRIPES2) intervention. Villages receiving the health intervention are controls for the education intervention and vice versa. The primary outcome is neonatal mortality. The effect of the active intervention on the primary outcome (compared to usual care) will be expressed as a risk ratio, estimated using a generalised estimating equation approach with robust standard errors that take account of clustering at village level. Secondary outcomes include maternal mortality, stillbirths, perinatal deaths, causes of death, health care and knowledge, hospital admissions of enrolled women during pregnancy or in the immediate post-natal care period or of their babies (during the neonatal period), maternal blood transfusions, and the cost effectiveness of the intervention. A total of 196 villages have been randomised and over 34,000 women have been recruited in CHAMPION2. DISCUSSION: This update to the published trial protocol gives a detailed plan for the statistical analysis of the CHAMPION2 trial. TRIAL REGISTRATION: Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2.

Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial.

BACKGROUND: Cornea is the most important refractive media in the eye, and damage to the corneal endothelium is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The role of phaco tip position during phacoemulsification on corneal endothelial damage is ambiguous, and there is no consensus regarding the most cornea-friendly phaco tip position (bevel-up or bevel-down). The objective of the trial is to compare the effect of phaco tip position (bevel-up vs. bevel-down) during phacoemulsification using direct chop technique on corneal endothelial cell count. METHODS AND DESIGN: TIPS is a randomised, multicentre, parallel-group, triple-masked (participant, outcome assessor, and statistician) trial with 1:1 allocation ratio. A total of 480 eligible participants, aged > 18 years with immature cataract, will be randomly allocated into bevel-up and bevel-down groups at two centres. Randomisation will be stratified according to the cataract grade. The primary outcome is postoperative endothelial cell count at 1 month. Secondary outcomes are central corneal thickness on postoperative days 1, 15, and 30 and difference in intraoperative complications. CONCLUSION: In this paper, we describe the detailed statistical analysis plan (SAP) for the TIPS trial, which was prepared prior to database lock. The SAP includes details of planned analyses and unpopulated tables, which will be reported in the publications. We plan to lock the database in July 2023 and publish the results later in the same year. SAP Version 0.1 (dated: 28 April 2023) Protocol version:2.0 TRIAL REGISTRATION: Clinical Trial Registry of India CTRI/2019/02/017464. Registered on 5 February 2019; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=29764&EncHid=&userName=2019/02/017464.

Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2).

BACKGROUND: India has made steady progress in improving rates of primary school enrolment but levels of learning achievement remain low. The Support To Rural India's Public Education System (STRIPES) trial provided evidence that an after-school para-teacher intervention improved numeracy and literacy levels in Telangana, India. The STRIPES2 trial investigates whether such an intervention will have a similar effect on the literacy and numeracy of primary school age children in the Satna District of Madhya Pradesh, India. METHODS/DESIGN: The STRIPES2 trial forms one part of a cluster-randomised controlled trial with villages (clusters) randomised to receive either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The primary outcome is a combined literacy and numeracy score. Secondary outcomes include separate scores for literacy and numeracy; caregivers' engagement with child's learning; expenditure on education; enrolment in school; caregiver's report of school attendance and the cost effectiveness of the intervention. Over 7000 primary school age children have been recruited and randomised in STRIPES2. DISCUSSION: This update to the published trial protocol gives a detailed plan for the statistical analysis of the STRIPES 2 trial. TRIAL REGISTRATION: Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27.

Can ultrasonic biometric indices with optimal cut-offs be a potential screening tool for primary angle closure disease? A case-control study.

BACKGROUND/OBJECTIVES: Despite a significant disease burden and potential to cause blindness, primary angle closure disease (PACD) does not have a population-based screening programme. Biometric indices using ultrasound A-scan is a potential tool for glaucoma case-detection. Given that genetic and environmental factors influence these parameters and paucity of data on their discrimination thresholds in Indian populace, we conducted a matched case-control study to determine the biometric indices and their discrimination thresholds associated with PACD. METHODS: We studied 172 eyes of 86 participants (43 cases; 43 controls). We compared the following biometric parameters of cases (PACD, occludable angle ≥180° ± raised intraocular pressure) with age and gender-matched controls (1:1): Anterior chamber depth (ACD), lens thickness (LT), axial length (AXL), lens position (LP), relative lens position (RLP), lens axial factor (LAF), simple crowding value (Cs), ACD/AXL). We performed conditional logistic regression (to identify factors associated with PACD) and Receiver operating characteristic (ROC) analysis (to determine discrimination thresholds). RESULTS: Reduced ACD (Adj OR 0.01; 95% CI: 0.0003-0.15, p < 0.001) and increased LT (Adj OR 10.3; 95% CI:2.42-43.93, p < 0.001) were associated with PACD. On ROC analysis, ACD, Cs, and ACD/AXL had optimum sensitivity/specificity at ≤3.015, ≥0.056 and ≤0.1303, respectively. ACD (88.4%) and Cs (94.2%) had highest sensitivity and specificity, respectively. CONCLUSION: Ultrasonic biometric parameters differed significantly between PACD and controls. ACD and Cs (at discrimination thresholds of ≤3.015 mm and ≥ 0.056, respectively) using ultrasound A-scan could be a potential tool for PACD case-detection that requires evaluation of its diagnostic yield and cost-effectiveness.

Factors associated with good near vision after cataract surgery with monofocal intraocular lens implantation at a tertiary eye hospital in southern India.

PURPOSE: Although multifocal intraocular lenses (IOLs) are effective methods of dealing with surgical presbyopia, there are associated limitations (cost, technique, and patient-reported symptoms). Given their scalability challenge (due to economic factors), it is imperative to explore alternative low-cost and sustainable solutions to achieve good near vision postcataract surgery. This study aimed to determine the proportion of and the factors associated with good near vision in patients following cataract surgery with monofocal IOL implantation. METHODS: We conducted a hospital-based cross-sectional study at a tertiary eye hospital in southern India from September 2019 to January 2020. Inclusion criteria: Uncomplicated postcataract surgery cases with monofocal IOL at least 30 days ago. Exclusion criteria: patients with any ocular condition (other than refractive errors) that could decrease the vision with best-corrected distance visual acuity < 0.18 Logarithm of the Minimum Angle of Resolution (LogMAR) units. Data collection: we assessed near vision (at 40 cm distance by using near vision card with Early Treatment of Diabetic Retinopathy Study format), distance visual acuity (uncorrected and best-corrected), refractive error (amount and type), type of astigmatism, pupil size, axial length, and contrast sensitivity. We considered a near vision of 0.2 LogMAR units or better as good near vision. RESULTS: Of the 82 patients (82 eyes), 71 (86.59%) had good near vision. Multiple logistic regression analysis found found that the presence of myopia or myopic astigmatism was significantly associated with good near vision (adjusted odds ratio: 72.63; 95% confidence interval: 1.02-5193.5, p = 0.049). CONCLUSION: About eight of every ten participants had good near vision postcataract surgery with monofocal IOL implantation. Myopia/myopic astigmatism was associated with good near vision.

Diagnostic accuracy of screening algorithms to identify persons with active pulmonary tuberculosis at prison entry: protocol of a systematic review and network meta-analysis.

Prison inmates are a high-risk group for tuberculosis (TB) infection and disease due to the increasing number of vulnerable fringe groups, risk factors (e.g., alcohol and drug addictions), contagious diseases (HIV, hepatitis), and their high-risk behavior. Compared to the general population, TB incidence and prevalence rates are significantly higher among prison inmates. Early identification of potentially infectious pulmonary TB (PTB) and targeted care of sick inmates are essential to effectively control TB within the prison system. The WHO recommends combining active and passive case-finding in prisons. No study has been published comparing the broad spectrum of screening tools using a diagnostic accuracy network meta-analysis (NMA). We aim to identify the most accurate TB case-finding algorithm at prison entry that is feasible in resource-limited prisons of high-burden TB countries and ensures continuous comprehensive TB detection services in such settings. Evidence generated by this NMA can provide important decision support in selecting the most (cost-) effective algorithms for screening methods for resource-limited settings in the short, medium, and long terms.

Determinants of healthcare facility utilization for childbirth in Kuantan Singingi regency, Riau province, Indonesia 2017.

BACKGROUND: Reducing maternal mortality ratio (MMR) is a high priority public health issue in developing countries such as Indonesia. The current MMR in Indonesia is 126/100,000 live births. Optimum use of available healthcare facilities for delivery can avert maternal deaths. This study aimed to determine the factors associated with healthcare facility utilization for childbirth in Kuantan Singingi regency, Riau province, Indonesia 2017. METHODS: We conducted a community-based cross-sectional study in 15 sub-districts of Kuantan Singingi regency from May-June 2017. We selected 320 mothers from 15 sub-districts who delivered in the last 3 months (February-April 2017). Trained data enumerators collected the relevant data by using a pre-tested semi-structured questionnaire. We used Cox regression analysis to determine the factors associated with delivery at healthcare facilities. Prevalence Ratio (PR) with a 95% confidence interval (CI) for childbirth at healthcare facilities was the key outcome measure. RESULTS: Only 54.4% (174) of the 320 mothers delivered at healthcare facilities. Knowledge about pregnancy danger signs (PR = 1.59, 95%CI:1.15-2.2), attitude towards healthcare services (PR = 0.79, 95%CI:0.33-1.89), and access to health care services (PR = 0.39, 95%CI:0.18-0.84) were the dominant factors of childbirth at healthcare facilities. There was an interaction between attitude and access to healthcare influencing delivery at healthcare facilities. CONCLUSIONS: Utilization of healthcare facilities for childbirth was low in Kuantan Singingi regency. Knowledge of pregnancy danger signs was an independent correlate of childbirth at healthcare facilities. Also, the interaction between attitude and access to healthcare showed a significant influence on childbirth at healthcare facilities. We recommend strengthening of existing maternal and child health program with a particular emphasis on complete and quality antenatal care, health education on danger signs of pregnancy and childbirth, and promoting positive attitudes towards healthcare facilities.

Protocol for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2).

BACKGROUND: Rural areas of India exhibit high neonatal mortality, and low literacy and numeracy. We assess the effect of a complex package of health interventions on neonatal survival and the effect of out-of-school-hours teaching on children's literacy and numeracy in rural Madhya Pradesh. METHODS/DESIGN: This is a cluster-randomised controlled trial with villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The clusters are 196 villages in Satna district, Madhya Pradesh, India: each is at least 5 km from a Community Health Centre, has a population below 2500, and has at least 15 children eligible for the education intervention. The participants in CHAMPION2 are resident married women younger than 50 years of age who had not undergone a family planning operation, provided they are enumerated pre-randomisation or marry a man enumerated pre-randomisation. The participants in STRIPES2 are resident children born 16 June 2010 to 15 June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020. DISCUSSION: In CHAMPION2, the NICE Foundation will deliver a 3.5-year programme comprising Accredited Social Health Activists or village health workers and midwives promoting health knowledge and providing antenatal, postnatal, and neonatal healthcare; community mobilisation; referrals to appropriate government health facilities; and a health education campaign. In STRIPES2, the Pratham Education Foundation will deliver a programme of village-based, before/after school support focusing on literacy and numeracy. As controls, the CHAMPION2 control villages will receive the usual health services (plus the STRIPES2 intervention). STRIPES2 control villages will receive the usual education services (plus the CHAMPION2 intervention). The primary outcome in CHAMPION2 is neonatal mortality. Secondary outcomes include antenatal, delivery, immediate neonatal and postnatal care practices, maternal mortality, stillbirths, early neonatal deaths, perinatal deaths, health knowledge, hospital admissions, maternal blood transfusions, and cost effectiveness. The primary outcome in STRIPES2 is a composite literacy and numeracy test score. Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness. Independent research and implementation teams will conduct the trial. Trial Steering and Data Monitoring Committees, with independent members, will supervise the trial. TRIAL REGISTRATION: Clinical Trial Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27.

Does mobile phone instructional video demonstrating sputum expectoration improve the sputum sample quality and quantity in presumptive pulmonary TB cases? Protocol for a prospective pragmatic non-randomised controlled trial in Karnataka state, India.

INTRODUCTION: Sputum smear microscopy is the cornerstone of tuberculosis (TB) diagnosis under the Revised National Tuberculosis Control Programme (RNTCP) in India. Instructions on how to produce a good sputum sample are a part of RNTCP training manuals, but its assessment is not emphasised. Healthcare provider's instruction to expectorate a good sputum sample has limitations. Presumptive TB patients often submit inadequate (in quantity and/or quality) sputum samples, which may result in false-negative results. Objectives of the study are, among the selected RNTCP designated microscopy centres in Dakshina Kannada district, Karnataka, India, (a) to assess the effectiveness of mobile phone instructional video demonstrating sputum expectoration on sputum quality and quantity and (b) to explore the mobile phone video implementation challenges as perceived by the healthcare providers. METHODS AND ANALYSIS: This is a pragmatic, prospective, non-randomised controlled trial in two pairs of RNTCP Designated Microscopy Centres (located at secondary and primary healthcare facilities) of Dakshina Kannada district, India. Presumptive pulmonary TB patients aged ≥18 years will be included. We will exclude who are severely ill, blind, hearing impaired, patients who have already brought their sputum for examination, and transported sputum. In the intervention group, participants will watch a mobile phone instructional video demonstrating submission of an adequate sputum sample. The control group will follow the usual ongoing procedure for sputum submission. This study would require 406 participants for each group to achieve a power of 90% for detecting a difference of 15% between the two groups. The participant enrolment started in December 2019. ETHICS AND DISSEMINATION: Yenepoya University Ethics Committee, Mangaluru, India, has approved the study protocol (YEC-1/158/2019). It complies with the Declaration of Helsinki, local laws, and the International Council for Harmonization-good clinical practices. Investigators will present the results in scientific forums, publish in a scientific journal, and share with RNTCP officers. TRIAL REGISTRATION NUMBER: Clinical Trial Registry of India (CTRI/2019/06/019887).

Ergonomic practices and musculoskeletal disorders among ophthalmologists in India: An online appraisal.

INTRODUCTION: Ergonomics in ophthalmology is neither taught during professional training nor does it readily receive consideration or priority in clinical practice. Owing to a high prevalence of musculoskeletal disorders among ophthalmologists, ergonomic awareness, and practices are vital in averting this modern epidemic. OBJECTIVE: To assess the ergonomic practices and prevalence of self-reported musculoskeletal disorders among ophthalmologists in India. METHOD: An online survey was conducted among ophthalmologists who were registered with the All India Ophthalmological Society of India using a pre-tested and validated questionnaire. RESULTS: The prevalence of self-reported musculoskeletal disorder in the 377 participants was 75.3% (284; 95% confidence interval: 70.6-79.5). Low back pain (149, 52.9%) was the most commonly reported symptom. Musculoskeletal disorder-attributed productivity loss was reported by 58.45% (166) of the respondents. Musculoskeletal disorder was most frequently associated with less than 10 years of work experience (odds ratio: 1.2; 95% confidence interval: 1.1-1.3, p = 0.01) and lack of good clinic (odds ratio: 1.7; 95% confidence interval: 1.1-2.7, p = 0.03) and operation room ergonomic practices (odds ratio: 1.8; 95% confidence interval: 1.1-2.9, p = 0.03). Only 27.9% (105) of the respondents had accessed information related to ergonomics in ophthalmic practice. CONCLUSION: The self-reported musculoskeletal disorder among ophthalmologists in India is quite high and significant enough to cause some degree of productivity loss. It is thus imperative to emphasize the implementation of good ergonomic practices, especially among relatively young ophthalmologists.

Does the phaco TIp position during clear corneal Phacoemulsification Surgery adversely affect corneal endothelium? TIPS study protocol for a randomised, triple-masked, parallel-group trial of bevel-up versus bevel-down phacoemulsification.

Introduction: Globally, at least 30 million cataract surgeries are required annually to prevent cataract-related blindness. Corneal endothelial decompensation is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The increasing ageing population and reduced visual impairment threshold for cataract surgery have resulted in rising cataract surgical rates and hence, an increase in corneal endothelial decompensation is expected. The role of phaco tip position on corneal endothelial damage is ambiguous. Previous studies have reported contradictory results and were also underpowered to detect a significant difference due to small sample sizes. With no consensus regarding the most cornea-friendly phaco tip position (bevel-up versus bevel-down) during phacoemulsification, we propose a randomised clinical trial with a robust design using direct chop phaco-technique. Objective: To compare the effect of phaco tip position (bevel-up vs. bevel-down) on corneal endothelial cell count during phacoemulsification. Methods: A randomised, multicentre, parallel-group, triple-masked (participant, outcome assessor, and statistician) trial with 1:1 allocation ratio is proposed. By adopting stratified randomisation (according to cataract grade), we will randomly allocate 480 patients aged >18 years with immature cataract into bevel-up and bevel-down groups at two centres. History of significant ocular trauma, previous intraocular surgery, shallow anterior chamber, low endothelial cell count, pseudoexfoliation syndrome, intraocular inflammation, and corneal endothelial dystrophy are the key exclusion criteria. The primary outcome is postoperative endothelial cell count at one month. Secondary outcomes are central corneal thickness on postoperative days 1, 15, and 30, and intraoperative complications. Trial registration: Clinical Trial Registry of India CTRI/2019/02/017464 (05/02/2019).

Factors associated with pasung (physical restraint and confinement) of schizophrenia patients in Bogor regency, West Java Province, Indonesia 2017.

BACKGROUND: Schizophrenia is a chronic mental disorder affecting more than 21 million worldwide. In Indonesia, 14.3% of households have a patient with a mental disorder, and the majority of these are in rural areas. Family members in Indonesia use repressive social measures like pasung (physical restraint and confinement) for these patients. A study was conducted with the objective to determine the factors associated with pasung among patients with schizophrenia in Bogor Regency, West Java Province, Indonesia 2017. METHODS: A case-control study was conducted in Bogor Regency from May-June 2017. A case subject was defined as a patient with schizophrenia who was ever subjected to pasung and a control subject was defined as a patient with schizophrenia residing in the same geographical area and never subjected to pasung. Multi-stage sampling was used to select case and control subjects from the registered reports of the Health Service of Bogor Regency (2012-16) in 34 sub districts and 59 health centers. Multivariate logistic regression was used to identify the factors associated with pasung. Attributable and population attributable risks (AR, PAR) for pasung were calculated. RESULTS: A total of 114 case and 136 control subjects were studied. Patient's aggressive or violent behavior (AdjOR: 4.49, 95%CI: 2.52-8.0), unemployment (AdjOR: 2.74, 95%CI: 1.09-6.9) and informal employment (AdjOR: 2.5, 95%CI: 1.1-5.84) in the family and negative attitude of the family towards the patient (AdjOR: 2.52, 95%CI: 1.43-4.43) were associated with pasung. Patient's aggressive or violent behavior (PAR = 44.3%) and unemployment in the family (PAR = 49.3%) were the predominant factors of pasung. CONCLUSIONS: Patient's aggressive or violent behavior, negative attitude of the family towards the patient and unemployment in the family were associated with pasung. We recommend health education and encouraging family members to shift patients with schizophrenia exhibiting aggressive or violent behavior to a mental health facility. Strengthening of basic mental health services and involving family members while treating patients with schizophrenia to develop positive attitudes could be considered. Creating employment opportunities and a social support system for treated patients with schizophrenia and family members could further avert pasung.

Perceptions about pasung (physical restraint and confinement) of schizophrenia patients: a qualitative study among family members and other key stakeholders in Bogor Regency, West Java Province, Indonesia 2017.

BACKGROUND: The UN resolution recommends treating all mentally ill patients with humanity and respect. However, social stigma continues to prevail for patients with schizophrenia. Physical restraint and confinement of the mentally ill is a well-known phenomenon in Indonesia and is termed as pasung. OBJECTIVE: To explore the perceptions of family members of patients of schizophrenia and other key stakeholders concerning pasung in Bogor Regency, West Java Province 2017. METHODS: This qualitative exploratory study was conducted in Bogor Regency, West Java Province from May to June 2017. This study involved 12 key stakeholders including family members, neighbors, community leaders, and mental health officers. In-depth interviews were conducted with family members (n = 3) who practiced pasung for patients with schizophrenia and key informant interviews of neighbors, community leaders (two household heads and one from a health cadre) (n = 3) and mental health officers of puskesmas (three midwives). Data triangulation was performed by interviewing residents and mental health workers. Content analysis was conducted and themes were identified based on valid inference and interpretation. RESULTS: Family members and society in general perceived that pasung is necessary for security reasons due to the patient's aggressive behavior such as physical violence to neighbors, stealing food etc. According to community leaders, families often do not respond to patient's request to be released from pasung. Family members had financial constraints to seek mental healthcare and were also dissatisfied with available services. Healthcare providers highlighted the poor knowledge and prevailing misconceptions about schizophrenia in the community. CONCLUSION: Concurrent efforts to strengthen basic mental health services and health education regarding schizophrenia, prevalent misconceptions, and importance of timely and appropriate treatment are needed, especially in rural settings.

Age at diagnosis predicted survival outcome of female patients with breast cancer at a tertiary hospital in Yogyakarta, Indonesia.

INTRODUCTION: Breast cancer is the most common cancer in women in Indonesia. Patients' survival depends on various factors, namely patient-, tumor-, and treatment-related factors. Survival analysis on Indonesian patients has only been reported in a few studies. This study aimed to identify the factors that are associated with five-year overall survival (OS) among patients with breast cancer at a local tertiary hospital in Indonesia. METHODS: A retrospective cohort study was conducted at Dr Sardjito Hospital, Yogyakarta. Female patients diagnosed with breast cancer between January and December 2009 were studied. Socio-demographic and clinicopathological data were collected from the medical and pathological records. The five-year OS rate was assessed using Kaplan Meier method and prognostic factors were analyzed using Cox regression. RESULTS: A total of 213 eligible patients with breast cancer were recruited. The five-year OS probability of the breast cancer patient was 51.07%. The majority of the patients (151, 70.9%) presented an advanced stage at the time of diagnosis. In the bi-variable analysis, cases who were younger, of a lower educational status, at a more advanced stage, with a bigger tumor size, and a central tumor location showed a worse five-year OS compared to their counterparts (p = 0.005, 0.001, 0.004, 0.011 and 0.023, respectively). In the multivariable analysis, age was an independent predictor for the OS (HR = 3.73; 95% CI = 1.0-13.6, p = 0.046). CONCLUSION: The five-year OS of breast cancer patients in the local tertiary hospital was 51.07%. The patients' age at diagnosis was the only significant prognostic factor for the patients' survival.

Occupational exposure to unburnt tobacco and potential risk of toxic optic neuropathy: A cross-sectional study among beedi rollers in selected rural areas of coastal Karnataka, India.

BACKGROUND: Beedi also known as poor man's cigarette is manufactured in almost all major states of India. Beedi workers are exposed to various health risks. There is an increased risk of systemic absorption of tobacco through skin and mucous membrane. The optic nerve is susceptible to damage from several toxic substances including tobacco. This group of disorders is known as toxic optic neuropathy (TON). The association of TON with occupational exposure to unburnt tobacco in beedi rollers has not been explored. OBJECTIVES: Among the beedi rollers in Mangaluru and Bantwal talukas of Dakshina Kannada District, Karnataka, India: to assess the magnitude of potential TON utilizing colour vision and contrast sensitivity as screening tools and to identify the demographic, biological and occupational factors associated with potential TON. METHODS: A community-based cross-sectional study was conducted from April-Sept 2016 in Mangaluru and Bantwal talukas, of Dakshina Kannada district, Karnataka. Beedi rollers from twelve villages (six from each taluka) were included. In each of the selected villages, the investigators identified beedi collection centres and all the eligible beedi rollers were included in the study till the required number of beedi rollers for that village was achieved. Participants were screened at the study site for visual acuity, colour vision and contrast sensitivity and those with abnormal colour and contrast sensitivity in the presence of good visual acuity were considered to have potential TON. RESULTS: A total of 377 beedi rollers were approached; of which 365 consented to take part in the study (response rate: 96.81%). Women constituted the majority of the participants (n = 338, 92.6%). Based on the screening criteria, the prevalence of potential TON was 17.5% (n = 64, 95% CI: 13.5-21.9). On multiple logistic regression analysis, duration of beedi rolling (Adj OR: 1.061; 95% CI 1.015-1.109, p = 0.009), advancing age (Adj OR: 1.096; 95% CI 1.058-1.136, p<0.001) and presence of diabetes (Adj OR: 6.315; 95% CI 1.4572-27.376, p = 0.014) were independent correlates of potential TON. CONCLUSION: In the present study, almost one out of six beedi rollers displayed clinical signs of potential TON. Increased duration of beedi rolling, advancing age and presence of diabetes were the independent correlates of potential TON. However, with this cross-sectional study it is not possible to conclude if these factors play a role individually or collectively or are a serendipitous association, for which large scale analytical studies are required.

Birth preparedness and complication readiness among the women beneficiaries of selected rural primary health centers of Dakshina Kannada district, Karnataka, India.

INTRODUCTION: Birth preparedness and complication readiness (BPCR) is a strategy to promote timely use of skilled maternal and neonatal care during childbirth. According to World Health Organization, BPCR should be a key component of focused antenatal care. Dakshina Kannada, a coastal district of Karnataka state, is categorized as a high-performing district (institutional delivery rate >25%) under the National Rural Health Mission. However, a substantial proportion of women in the district experience complications during pregnancy (58.3%), childbirth (45.7%), and postnatal (17.4%) period. There is a paucity of data on BPCR practice and the factors associated with it in the district. Exploring this would be of great use in the evidence-based fine-tuning of ongoing maternal and child health interventions. OBJECTIVE: To assess BPCR practice and the factors associated with it among the beneficiaries of two rural Primary Health Centers (PHCs) of Dakshina Kannada district, Karnataka, India. METHODS: A facility-based cross-sectional study was conducted among 217 pregnant (>28 weeks of gestation) and recently delivered (in the last 6 months) women in two randomly selected PHCs from June -September 2013. Exit interviews were conducted using a pre-designed semi-structured interview schedule. Information regarding socio-demographic profile, obstetric variables, and knowledge of key danger signs was collected. BPCR included information on five key components: identified the place of delivery, saved money to pay for expenses, mode of transport identified, identified a birth companion, and arranged a blood donor if the need arises. In this study, a woman who recalled at least two key danger signs in each of the three phases, i.e., pregnancy, childbirth, and postpartum (total six) was considered as knowledgeable on key danger signs. Optimal BPCR practice was defined as following at least three out of five key components of BPCR. OUTCOME MEASURES: Proportion, Odds ratio, and adjusted Odds ratio (adj OR) for optimal BPCR practice. RESULTS: A total of 184 women completed the exit interview (mean age: 26.9±3.9 years). Optimal BPCR practice was observed in 79.3% (95% CI: 73.5-85.2%) of the women. Multivariate logistic regression revealed that age >26 years (adj OR = 2.97; 95%CI: 1.15-7.7), economic status of above poverty line (adj OR = 4.3; 95%CI: 1.12-16.5), awareness of minimum two key danger signs in each of the three phases, i.e., pregnancy, childbirth, and postpartum (adj OR = 3.98; 95%CI: 1.4-11.1), preference to private health sector for antenatal care/delivery (adj OR = 2.9; 95%CI: 1.1-8.01), and woman's discussion about the BPCR with her family members (adj OR = 3.4; 95%CI: 1.1-10.4) as the significant factors associated with optimal BPCR practice. CONCLUSION: In this study population, BPCR practice was better than other studies reported from India. Healthcare workers at the grassroots should be encouraged to involve women's family members while explaining BPCR and key danger signs with a special emphasis on young (<26 years) and economically poor women. Ensuring a reinforcing discussion between woman and her family members may further enhance the BPCR practice.

Clinical and paraclinical profile, and predictors of outcome in 90 cases of scrub typhus, Meghalaya, India.

BACKGROUND: India is an integral component of "tsutsugamushi triangle" which depicts a part of the globe endemic to scrub typhus. Owing to frequent outbreaks witnessed in different parts of the country in the recent past, scrub typhus is described as a re-emerging infectious disease in India. The present study aimed to study the clinical and paraclinical profile, complications and predictors of outcome among 90 cases of scrub typhus diagnosed in a hospital of north-eastern India from Sept 2011 to Aug 2012. METHODS: A longitudinal study was conducted in a hospital of Meghalaya, India between Sept 2011 and Aug 2012. Diagnosis of scrub typhus was arrived by SD BIOLINE tsutsugamushi (solid phase immunochromatographic assay) rapid diagnostic test for antibodies (IgM, IgG or IgA). Descriptive analyses of age, gender, geographic area, symptoms and signs, treatment, laboratory findings, complications, and outcome were conducted. Relative risk (RR) with 95 % confidence interval (CI) was computed for Multiple Organ Dysfunction Syndrome (MODS) and mortality. Binary logistic regression was applied to the significant correlates (P < 0.05) on univariate analysis to identify the predictors of MODS and mortality in scrub typhus. RESULTS: As many as 662 clinically suspected scrub typhus patients were tested and 90 (13.6 %) were diagnosed to have scrub typhus. Out of 90 patients, 52.2 % (n = 47) were males and their mean (SD) age was 36.29 (13.38) years. Fever of <7 days (n = 75, 83.3 %), myalgia (n = 56, 62.2 %), pain abdomen (n = 24, 26.7 %), headache (n = 24, 26.7 %), nausea/vomiting (n = 21, 23.3 %), dry cough (n = 21, 23.3 %), hepatomegaly (n = 24, 26.7 %), splenomegaly (n = 22, 24.4 %), and lymphadenopathy (n = 20, 22.2 %) were the predominant clinical features. Eschar was seen in 10 patients (11.1 %). One third (n = 30) of the patients developed at least one systemic complication. Acute hepatitis (n = 15, 16.7 %), pneumonitis (n = 14, 15.6 %), and acute kidney injury (n = 11, 12.2 %) were the common complications. MODS was seen in 14.4 % (n = 13) and 38.5 % (n = 5) of the patients with MODS died. Overall, case fatality rate was 5.15 % (n = 5). On univariate analysis, platelets <100 000/mm3, serum creatinine >1.5 mg/dl, and transaminase (AST, ALT or both) >500 U/L were associated with MODS (P < 0.001) and mortality (P < 0.05). In addition, serum bilirubin >3 mg/dl was also associated with MODS (P < 0.001). On applying binary logistic regression, serum creatinine >1.5 mg/dl was a predictor of MODS (OR: 76.1, 95 % CI: 4.9-1175.6) and mortality (OR: 18.03, 95 % CI: 1.38-235.1). CONCLUSION: In this study setting, approximately one-seventh (13.6 %) of the acute undifferentiated febrile illness were due to scrub typhus. Systemic complications were common (33.3 %). Serum creatinine >1.5 mg/dl was a predictor of MODS and mortality.