Assessment of prevalence and need for screening of diabetic retinopathy using non-mydriatic fundus camera in rural and tribal diabetic populations in Maharashtra.

PURPOSE: To assess the prevalence of DR and the need for screening and management of DR with medical management of diabetes in rural and tribal population in Maharashtra. METHODS: The known diabetics of rural area and tribal area were screened at corresponding primary health centers, subcenters, and village level with the help of local healthcare workers using a portable non-mydriatic fundus camera. The prevalence of blindness among known diabetics in rural area was 1.29%, and 0.84% in tribal area. RESULTS: In the rural area, the prevalence of diabetic retinopathy (DR) was 5.67% ( n = 776), out of those 18.18% had sight threatening diabetic retinopathy (STDR). The prevalence of DR was 7.73% ( n = 711) in tribal areas, out of those, 30.90% had STDR. CONCLUSIONS: The significant risk factors were identified to be the duration of diabetes and poor glycemic control. Implementation of targeted interventions for screening and management are required to reduce the risk of blindness among known diabetics in rural and tribal areas.

Study of tear function before and after laser-assisted in-situ keratomileusis.

Purpose: This work assesses the change in tear function after LASIK surgery. Methods: This prospective, observational study was conducted in the Refractive Clinic of a tertiary care rural hospital. Tear dysfunction symptoms and the tear function tests were assessed in 269 eyes of 134 patients, OSDI score was used to document the tear dysfunction symptoms. Tear function was assessed by tear meniscus height, tear film break-up time (TBUT), Lissamine green staining, corneal fluorescein staining, Schirmer test 1 without anesthesia before and at 4-6 weeks and 10-12 weeks after LASIK surgery. Results: Preoperatively OSDI score was 8.54 ± 7.71. It increased to 15.11 ± 9.18 postoperatively at 4-6 weeks after LASIK surgery and 13 ± 9.56 at 10-12 weeks after LASIK surgery Mean TBUT preoperatively was 7.82 ± 3.57 sec which decreased to 5.34 ± 2.56 sec at 4-6 weeks and to 4.53 ± 2.63 sec at 10-12 weeks postoperatively. The number of eyes with clear secretion decreased from 40.5% preoperatively to 23.4% at 4-6 weeks and to 22.3% at 10-12 weeks postoperatively, whereas the granular and cloudy secretions increased significantly in eyes after LASIK surgery. The prevalence of eyes with Lissamine green score >3 (dry eye) increased from 17.1% preoperatively to 27.9% at 4-6 weeks and to 30.5% at 10-12 weeks. Similarly, the number of eyes showing positive fluorescein corneal staining increased from 5.6% preoperatively to 19% postoperatively at 4-6 weeks. Mean Schirmer score was 28.83 ± 6.39 mm preoperatively, 22.47 ± 5.38 mm at 4-6 weeks, and 21.27 ± 4.99 mm at 10-12 weeks after LASIK surgery. Conclusion: The prevalence of dry eye increased after LASIK as was assessed by an increase in the tear dysfunction symptoms using OSDI score and the deranged values of various tear function tests after LASIK surgery.

Stimulated Reporting of Adverse Events Following Immunization with COVID-19 Vaccines.

In India, up until December 2021, Covishield and Covaxin vaccines against COVID-19 were being used for mass vaccination programs. In view of the urgency of fighting the ongoing pandemic, many vaccines have been granted emergency use approval while phase 2/3 clinical trials were still underway. Even for vaccines that have completed phase 3 trials, safety data may not be comprehensive. This retrospective observational study was conducted at a designated Regional Training Centre for Pharmacovigilance cum Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India. The data sources were stimulated spontaneous reports of Adverse Events Following Immunization (AEFI) due to the COVID-19 vaccines from 10 January to 31 December 2021. A total of 51,010 COVID vaccine doses were administered during the study period. There were 330 AEFI reported (AEFI rate: 0.65%). Six AEFI were serious events among which three were Adverse Events of Special Interest. The majority of the AEFI were systemic, reported after the first dose, and with an onset between 1 and 24 h after vaccination. On comparing Covishield and Covaxin, there were no statistically significant differences in the AEFI reported with either vaccine in terms of gender, seriousness, lag period, duration, recovery, causality, treatment received for AEFI, presence of co-morbidity, or history of COVID-19 infection. Overall, the rates of AEFI was uncommon, and serious AEFI were rare with both Covishield and Covaxin, with a higher rate after the first dose. Whether immunological tolerance or allayed anxiety was responsible for the lower AEFI risk with the second dose remains to be investigated.

Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions.

BACKGROUND: The Pharmacovigilance Program of India recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, while many clinicians prefer the Naranjo algorithm for its simplicity. In the present study, we assessed agreement between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm. MATERIALS AND METHODS: In this study, 842 individual case safety reports were randomly selected from 1000 spontaneously reported forms submitted to the ADR Monitoring Center at a tertiary healthcare Institute in Central India between 2016 and 2018. Two well-trained independent groups performed the causality assessment. One group performed a causality assessment of the 842 ADRs using the WHO-UMC criteria and the other group performed the same using the Naranjo algorithm. The agreement between two ADR causality scales was assessed using the weighted kappa (κ) test. RESULTS: Cohen's kappa coefficient (κ) statistical test was applied between the two scales (WHO-UMC scale and Naranjo algorithm) to find out the agreement between these two scales. "No" agreement was found between the two scales {Kappa statistic with 95% confidence interval = 0.048 (P < 0.001)}. CONCLUSION: There was no agreement found between the WHO-UMC criteria and the Naranjo algorithm in our study.

Effect of health education and screening location on compliance with diabetic retinopathy screening in a rural population in Maharashtra.

Purpose: To compare the acceptance of diabetic retinopathy (DR) screening by the proximity of care and health education in rural Maharashtra. Methods: Study was done in the public health facilities in four blocks (in two blocks at community health center (CHC) level and in other two blocks at primary health center (PHC) level with the provision of transport from villages to PHCs) over 3 months. Health education was not imparted in one block in each segment. Health education consisted of imparting knowledge on diabetes mellitus (DM) and DR by trained village-level workers. The screening was done using non-mydriatic fundus camera and teleophthalmology supported remote grading of DR. Results: In the study period, 1,472 people with known diabetes were screened in four blocks and 86.6% (n = 1275) gradable images were obtained from them. 9.9% (n = 126) were detected having DR and 1.9% (n = 24) having sight-threatening DR (STDR). More people accepted screening closer to their residence at the PHC than CHC (24.4% vs 11.4%; P < 0.001). Health education improved the screening uptake significantly (14.4% vs 18.7%; P < 0.01) irrespective of the place of screening-at CHC, 9.5% without health education vs 13.1% with health education; at PHC, 20.1% without health education versus 31.6% with health education. Conclusion: Conducting DR screening closer to the place of living at PHCs with the provision of transport and health education was more effective for an increase in the uptake of DR screening by people with known diabetes in rural Maharashtra.

Diabetic retinopathy screening at primary and community health centers in Maharashtra.

In order to integrate and improve eye care in noncommunicable disease (NCD) clinics, screening for diabetic retinopathy (DR) in people with diabetes mellitus (DM) was introduced in primary and secondary-level government health facilities. Initially, the project was carried out at the fixed health facilities at one district hospital (DH), two sub-district hospitals (SDH) and two community health centers (CHCs). This was combined with training of existing health care personnel, information-education-communication (IEC) campaign among patients and service providers along with the provision of essential equipment required for screening. In the revised strategy, NCD nurses were also trained for screening. Of 12,788 DM patients registered in NCD clinics, 63.8% (n = 8159) were screened for DR by trained paramedical ophthalmic assistants and the four trained NCD nurses using non-mydriatic fundus camera and teleophthalmology supported remote grading of retinopathy. DR was detected in 9.45% (n = 771) patients and sight-threatening DR (STDR) was detected in 2.35% (n = 192) in one or both eyes. Of 8,159 people screened, 55% (n = 4481) and 45% (n = 3678) were screened at CHC and mobile screening at primary health centers (PHC), respectively. DR screening in a fixed facility at CHC combined with the mobile screening at PHC level and fixed-day screening strategy provides effective coverage.

Safety and efficacy of alirocumab: A meta analysis of 12 randomized controlled trials.

BACKGROUND AND OBJECTIVE: Hypercholesterolemia is one of the major risk factor for atherosclerotic coronary heart disease, especially coronary heart disease. Most effective class of medications for prevention of cardiovascular events and LDL-C reduction are the statins. Approximately only one fourth of these high risk patients had achieved LDL-C levels <70 mg/dL with statins. Monoclonal antibody targeting PCSK9 is a novel class of drug used in the treatment of Hypercholesterolemia. Alirocumab is one such human monoclonal antibody directed against PCSK9. Binding of PCSK9 to the LDL-R on the hepatocytes promotes LDL-R degradation. Inhibition of PCSK9 binding to LDL-R leads to increased number of LDL-Rs to clear LDL, thus decreasing LDL-C levels. The purpose of this systematic study is to assess the safety and efficacy of Alirocumab in adults with hypercholesterolemia and Familial hypercholesterolemia. MATERIALS AND METHODS: We searched Medline, PubMed Central database, Google scholar, EBSCO, Wiley library, conference proceedings and Clinical trials.gov registry through March 2017. Phase 3 randomized, controlled trials (RCTs) using Alirocumab in adults with hypercholesterolemia and Familial Hypercholesterolemia were selected. RESULTS: In twelve RCTs comprising of 6019 patients included in the meta-analysis, significant favorable changes in LDL-C and HDL-C were found. LIMITATIONS: Results were derived from study level data rather than patient level data. CONCLUSIONS: Alirocumab substantially reduced the LDL-C level by over 50 %, increased the HDL-C level, and resulted in favorable changes in other lipids.