Adverse Events among Beneficiaries who Received a Dose of Sputnik V Vaccine at a Tertiary Care Hospital in Coastal Karnataka, India.

Introduction: Vaccination has played a vital role in containing the COVID-19 pandemic. Sputnik V was the third vaccine approved for emergency use in India. The objectives of the present study were to document the adverse events following Sputnik V vaccination and the factors associated with adverse events. Methodology: This cross-sectional study was conducted during September and October 2021 in a teaching hospital of Karnataka. Ethics approval and CTRI registration were obtained before collecting the data. All persons receiving at least one dose of vaccine were invited to participate and baseline information was collected after written informed consent. They were contacted telephonically to enquire about the adverse events. Data were entered in Microsoft Excel and analyzed using SPSS Version 23 to describe percentages and proportions. Results: The median age of 2532 participants was 31 (IQR 25-39) years and 60.4% were males. Minor adverse events were seen among 29.4% participants. Most common symptoms with first dose were fever, vaccination site tenderness, myalgia and headache, and with second dose were fever, myalgia, headache, and vaccination site tenderness. No severe adverse events were reported in our study. The adverse events were seen more among females (P < 0.05) and with the first dose (P < 0.05). Conclusion: Most common adverse events were similar to symptoms suggested by the vaccine manufacturers with fever being the most common one. A follow-up after a longer lag time may be recommended to enquire whether the vaccinees developed serious adverse events.

Factors Associated with Out-of-Pocket Expenditure among Patients Admitted for Cataract Surgery under District Blindness Control Society Scheme: A Cross-Sectional Study from a Private Medical College Hospital of South India.

Background: The National Programme for Control of Blindness and Visual Impairment in India supports the management of various conditions of the eye including cataracts. Objective: The objective of this study is to estimate out-of-pocket expenditure (OOPE) and factors associated with it among patients admitted for cataract surgery under District Blindness Control Society (DBCS) scheme. Materials and Methods: A cross-sectional study was conducted in a Medical College Hospital of Coastal Karnataka, South India. Data were collected using a predesigned semi-structured interview schedule from 100 patients admitted for cataract surgery under DBCS scheme. Costs were reported as median values with interquartile range (IQR) and compared using the Kruskal-Wallis test. Results: Median total cost incurred by the patient was INR 1700 (IQR 1052-2575). Median direct costs (1425, IQR 762.5-2200 INR) included medical expenditure (600, IQR 0-1475 INR), mainly contributed by the treatment of systemic comorbid conditions and nonmedical expenditure toward travel. Median indirect costs (400, IQR 200-600 INR) included loss of wages for the patient and the bystander. Conclusions: OOPE for cataract surgery among DBCS patients was associated with the presence of comorbidity, postponement of surgery, duration of hospital stay, and distance traveled by the patient.

Are Primary Health Centers Prepared for Noncommunicable Disease Management? A Facility-Based Mapping of Gaps in Coastal Karnataka, India.

BACKGROUND: India is in the middle of epidemiological and demographic transitions, with an estimated 63% of the deaths attributed to noncommunicable diseases (NCDs). Primary health centers (PHCs) can deliver a package of services to prevent and control NCDs. OBJECTIVE: The aim of this sudy is to assess the status of health promotion activities and availability of resources for screening and the treatment of NCDs in PHCs of Dakshina Kannada district, Karnataka. MATERIALS AND METHODS: A cross-sectional facility-based assessment of all the 65 functioning PHCs (2016-2017) was conducted for the status of health promotion activities, and availability of resources using a checklist evolved from the World Health Organization Package of Essential NCD Interventions framework and Indian Public Health Standards. RESULTS: Forty-eight (74%) PHCs had displayed materials on the intake of healthy foods and avoiding junk food. Warning signs of cancer were displayed at 43 (66%) PHCs. The availability of drugs for the management of hypertension (Atenolol and Amlodepine) and diabetes mellitus (Metformin) were seen in all the PHCs. Insulin was available in 64 (98%) PHCs. Sorbitrate and Nifedefine were found in 11 (17%) and 7 (11%) PHCs. More than a quarter of the PHCs were not having the medical officer and other health-care professionals to manage NCDs. CONCLUSIONS: Preparedness of the PHCs in the health promotion domain was good. The availability of human resources, laboratory support and emergency drugs for the management of NCDs needs improvement.

Factors associated with awareness and practice about foot care among patients admitted with diabetes mellitus: A cross sectional research from a medical college hospital of southern India.

BACKGROUND: Diabetes Mellitus (DM) causes micro and macro vascular complications. One of the complications of DM is diabetic foot that results in amputations and decreased quality of life. The aim of this study was to assess the awareness and practice about foot care and associated factors among admitted patients in a teaching hospital of coastal Karnataka, India. MATERIAL AND METHODS: A cross-sectional study was conducted in a medical college hospital after obtaining institutional ethics approval from 24th December 2016 to 21st January 2017. Adults with diabetes (N=317) admitted in the hospital were interviewed with a validated structured questionnaire for awareness and practice regarding foot care. The scores obtained were further graded into good and poor. Data was analyzed with SPSS version 22 for descriptive statistics. Bivariate logistic and linear regressions were used to determine the association between variables and awareness/practice scores. RESULTS: Mean age of the participants was 56.98 (±10.54) years with males constituting the majority (63.4%). Good awareness and practice scores were observed among 69.1% and 41.6% participants, respectively. Good awareness scores were associated with male patients (p=0.027), currently not married (p=0.044), below poverty line socioeconomic status (p=0.014) and presence of foot ulcer (p=0.021). Good practice scores was associated with secondary schooling (p=0.003) and receiving insulin (p=0.045). Moderate correlation with coefficient 0.493 (p<0.001) was observed between awareness and practice scores. CONCLUSION: Seven and four out of 10 study participants had good awareness and practice scores about foot care, respectively. A tailor-made health education module addressing the lacunae identified in the awareness and practice domains needs to be provided to the patients with diabetes mellitus.

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).

'I am on treatment since 5 months but I have not received any money': coverage, delays and implementation challenges of 'Direct Benefit Transfer' for tuberculosis patients - a mixed-methods study from South India.

Background: In March 2018, the Government of India launched a direct benefit transfer (DBT) scheme to provide nutritional support for all tuberculosis (TB) patients in line with END TB strategy. Here, the money (@INR 500 [~8 USD] per month) is deposited electronically into the bank accounts of beneficiaries. To avail the benefit, patients are to be notified in NIKSHAY (web-based notification portal of India's national TB programme) and provide bank account details. Once these details are entered into NIKSHAY, checked and approved by the TB programme officials, it is sent to the public financial management system (PFMS) portal for further processing and payment. Objectives: To assess the coverage and implementation barriers of DBT among TB patients notified during April-June 2018 and residing in Dakshina Kannada, a district in South India. Methods: This was a convergent mixed-methods study involving cohort analysis of patient data from NIKSHAY and thematic analysis of in-depth interviews of providers and patients. Results: Of 417 patients, 208 (49.9%) received approvals for payment by PFMS and 119 (28.7%) got paid by 1 December 2018 (censor date). Reasons for not receiving DBT included (i) not having a bank account especially among migrant labourers in urban areas, (ii) refusal to avail DBT by rich patients and those with confidentiality concerns, (iii) lack of knowledge and (iv) perception that money was too little to meet the needs. The median (IQR) delay from diagnosis to payment was 101 (67-173) days. Delays were related to the complexity of processes requiring multiple layers of approval and paper-based documentation which overburdened the staff, bulk processing once-a-month and technological challenges (poor connectivity and issues related to NIKSHAY and PFMS portals). Conclusion: DBT coverage was low and there were substantial delays. Implementation barriers need to be addressed urgently to improve uptake and efficiency. The TB programme has begun to take action.

"Who has to do it at the end of the day? Programme officials or hospital authorities?" Airborne infection control at drug resistant tuberculosis (DR-TB) centres of Karnataka, India: a mixed-methods study.

BACKGROUND: Drug resistant tuberculosis (DR-TB) centers admit patients with DR-TB for initiation of treatment and thereby concentrate the patients under one setting. It becomes imperative to assess the compliance of DR-TB centres to national airborne infection control (AIC) guidelines and explore the provider perspectives into reasons for unsatisfactory compliance. METHODS: This mixed methods study (triangulation design) was carried out across all the six DR-TB centers of Karnataka state, India, between November 2016 and April 2017. Non-participant observation using a structured format was carried out at the DR-TB wards (n = 6), outpatient departments (n = 6), patient waiting areas outside outpatient departments (n = 6) and culture and drug susceptibility testing laboratories (n = 3). Structured interviews of admitted patients (n = 30) were done to assess the knowledge on cough hygiene and sputum disposal. Key informant interviews (KIIs) of health care providers (n = 20) were done. Manual descriptive content analysis was done to analyse the transcripts of KIIs. RESULTS: The findings related to compliance in non-participant observation were corroborated by KIIs. All the laboratories were consistently implementing the AIC guidelines. Compliance to hand hygiene, wet mopping and ventilation measures were satisfactory in four or more DR-TB wards. The non-availability of N95 masks in wards as well as outpatient departments was staggering. Sputum disposal without prior disinfection and the lack of display materials on cough hygiene and patient education was common. Patient fast tracking in outpatient department waiting areas and visitor restrictions in wards were lacking. Trainings on AIC measures were uncommon. About half and one-third of patients admitted had satisfactory knowledge regarding sputum disposal and situations demanding mask respectively. The reasons for unsatisfactory compliance to AIC guidelines were poor coordination between programme and hospital authorities leading to lack of ownership; ineffective or non-existent infection control committees; vacant posts of medical officers; and attitudes of health care delivery staff. CONCLUSION: Compliance with AIC guidelines in DR-TB centers of Karnataka was sub-optimal. The reasons identified require urgent attention of the programme managers and hospital authorities.

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.

Construction site workers' malaria knowledge and treatment-seeking pattern in a highly endemic urban area of India.

BACKGROUND: Construction sites are potential breeding places for some species of mosquitoes. Construction workers usually stay at the construction sites, thus being extremely susceptible to malaria. For malaria control, a special focus on them is warranted as they often seek treatment from unregulated, private vendors, increasing their risk of exposure to substandard drugs. OBJECTIVES: To elicit the socio-demographic factors associated with comprehensive malaria knowledge (symptoms, mode of spread, and preventive measures) and treatment-seeking pattern (preferred source and type of treatment) among the construction workers in Mangaluru, India; and, to study the association among their comprehensive malaria knowledge, past suffering from malaria (within 1 year) and treatment-seeking pattern. METHODS: A community based cross-sectional study was conducted in nine randomly selected construction sites of Mangaluru, a high-risk city for malaria with an annual parasite incidence of >2/1000/year, from June-September 2012. A sample size of 132 was estimated assuming at least 30% of them have satisfactory malaria knowledge, 10% absolute precision, 95% confidence level, design effect of 1.5 and 10% non-responses. A semi-structured interview schedule was used, and knowledge scores were computed. Multivariate linear (for knowledge score) and logistic regressions (for preferred source and type of treatment) were applied. RESULTS: One hundred and nineteen workers participated in the study (total approached-138). 85% (n = 101) of them were males. Mean knowledge score was 9.95 ± 3.19 (maximum possible score-16). The majority of them were aware of the symptoms and the mode of malaria transmission. However, <12% could explain the malaria preventive measures. Females workers (ß = -0.281, p = 0.001), self stated malaria within 1 year (ß = 0.276, p < 0.001) and who preferred allopathic treatment (ß = 0.283, P = 0.001) displayed better knowledge scores. Male workers (AdjOR 7.21, 95% CI 2.3-22.9) and those with self stated malaria within 1 year (AdjOR 11.21, 95% CI 2.38-52.8) showed favorable treatment-seeking pattern. CONCLUSIONS: There is an urgent need of intensifying and streamlining of ongoing malaria prevention activities for construction site workers in Mangaluru, India. Emphasizing the gender equity at every stage of programme implementation and addressing their treatment-seeking pattern is essential. Involvement of labour employers and building contractors in this regard is imperative.

Comparison of Topical Versus Sub-Tenon's Anesthesia in Phacoemulsification at a Tertiary Care Eye Hospital.

PURPOSE: To compare the effectiveness of topical and sub-Tenon's anesthesia in providing pain relief during phacoemulsification. METHODS: This randomized controlled trial was carried out at a tertiary eye care hospital, Coimbatore, Tamil Nadu, India. Patients who underwent phacoemulsification through self-sealing clear corneal incision with foldable intra-ocular lens implantation were randomized into two groups. Group 1 (n = 100) received topical anesthesia with 0.5% proparacaine (Paracaine, Sunways India Pvt. Ltd., India) drops. Group 2 (n = 100) received sub-Tenon's infiltration with 2% lignocaine (Xylocaine, AstraZeneca Pharma India Pvt. Ltd., India). As per study criteria, patients graded the pain during administration of anesthesia, during surgery and after surgery on a visual analogue pain scale. The surgeon graded overall patient co-operation. The complications were also noted. Data analysis was performed using Statistical Package for Social Sciences version 11. Student's t-test and Chi-square test were used for comparison of variables between the groups. RESULTS: Sub-Tenon's anesthesia provided statistically significant better intra-operative pain relief and patient satisfaction than topical anesthesiat. No statistically significant difference was noted between the two groups regarding pain during administration, postoperative pain, and surgeon satisfaction. CONCLUSION: Sub-Tenon's anesthesia provides better pain relief than topical anesthesia during phacoemulsification.