Unreported protocol deviations - The tip of the research-berg.

Introduction: Failure to stay within an ethics committee (EC)-approved protocol limits is termed protocol deviation or violation (PD/PV), depending on the seriousness of the transgression and its attendant risks and/or harms. PD/PVs arise in the post-approval phase of the research and are often missed. Current guidelines expect ECs to detect, report and recommend suitable actions such that research participants' risks and harms are mitigated, to the extent possible. Objective: Yenepoya Ethics Committee-1 conducted an internal audit of ongoing postgraduate dissertations involving human participants to assess the occurrence of PD/PVs. Materials and Methods: 54 out of 80 postgraduates responded to our request for filling out a self-reported checklist. These responses were followed up with physical verification of the protocol-related documents. Results: Protocol transgressions were classified as non-compliance (administrative issues), protocol deviations (minor transgressions with minimal or less than minimal increase in attendant risk to participants) and protocol violations (serious transgressions with more than minimal increase in attendant risk to participants). The non-compliances included non-reporting for audit and non-reporting of PDs. Protocol deviations included non-conformance to EC validity, sample size, approved methodology, informed consent process and documentation and suboptimal data storage. No protocol violations were observed. Conclusion: We report PD/PVs from these 54 protocols - with our assessment on the negative impact it may have on scientific validity, harm to participants, EC functioning and credibility of the institution - in the hope that our readers appreciate this important aspect of the post-approval process in the functioning of an EC.

An empirical study of preprocessing techniques with convolutional neural networks for accurate detection of chronic ocular diseases using fundus images.

Chronic Ocular Diseases (COD) such as myopia, diabetic retinopathy, age-related macular degeneration, glaucoma, and cataract can affect the eye and may even lead to severe vision impairment or blindness. According to a recent World Health Organization (WHO) report on vision, at least 2.2 billion individuals worldwide suffer from vision impairment. Often, overt signs indicative of COD do not manifest until the disease has progressed to an advanced stage. However, if COD is detected early, vision impairment can be avoided by early intervention and cost-effective treatment. Ophthalmologists are trained to detect COD by examining certain minute changes in the retina, such as microaneurysms, macular edema, hemorrhages, and alterations in the blood vessels. The range of eye conditions is diverse, and each of these conditions requires a unique patient-specific treatment. Convolutional neural networks (CNNs) have demonstrated significant potential in multi-disciplinary fields, including the detection of a variety of eye diseases. In this study, we combined several preprocessing approaches with convolutional neural networks to accurately detect COD in eye fundus images. To the best of our knowledge, this is the first work that provides a qualitative analysis of preprocessing approaches for COD classification using CNN models. Experimental results demonstrate that CNNs trained on the region of interest segmented images outperform the models trained on the original input images by a substantial margin. Additionally, an ensemble of three preprocessing techniques outperformed other state-of-the-art approaches by 30% and 3%, in terms of Kappa and F 1 scores, respectively. The developed prototype has been extensively tested and can be evaluated on more comprehensive COD datasets for deployment in the clinical setup.

A narrative review of the challenges, ethical frameworks, and guidelines in the setting of COVID-19 healthcare and research.

The coronavirus disease (COVID)-19 pandemic has ever since its outbreak been perplexing healthcare generally at all levels. There is a need to identify, analyze and address the bioethical dilemmas that have emerged during the pandemic. This paper presents a narrative review of the published literature on the ethical issues, frameworks, and guidelines in COVID-19-related healthcare and research. An electronic search was conducted on PubMed, Google Scholar, and Science Direct using the search terms "COVID- 19" [AND] ethical issues, clinical trials, resource allocation, ethical guidelines, vaccine allocation. Articles between 2019 and 2020 focusing on ethics were included and analyzed. Fifteen full-text articles in English, one workshop summary, and 5 guidelines were identified and are discussed under the following themes: global response to the pandemic, allocation of resources, conduct of clinical trials, and fair distribution of vaccines and individual patient care. Despite the global and collaborative response to guide the healthcare sector throughout the pandemic, there have been some worrying repercussions in the form of increased vulnerabilities, precarious imbalances in resources, priority settings, exclusion of individuals or groups, exhaustions of healthcare professionals, impaired individual patient care, slowing down of non-covid research as well as scientific, ethical and logistic challenges in COVID and non-COVID research. These can be ethically justifiable only considering the seriousness and urgency of the pandemic. This paper presents some tenacious challenges that must be addressed if ethical reflection is to be effectively implemented in response to this pandemic.

6-6-2020: A date that went viral among ophthalmologists.

6-6-2020 was a landmark date for the ophthalmology community, not only because of the normal visual acuity connotation of 6/6 and 20/20, but because it genuinely reflects every ophthalmologist's dream to bring back perfect vision for every patient. The Covid-19 pandemic had forced ophthalmologists to "refuse to operate" albeit for a short period. This narrative describes how, during a telemedicine call, a surgeon experienced the distress of refusing to operate on a mature cataract. It reveals the trauma caused by the disordered goals of eye care during the pandemic, when elective procedures were abandoned and only emergency services were provided.

Multi-Scale Convolutional Neural Network for Accurate Corneal Segmentation in Early Detection of Fungal Keratitis.

Microbial keratitis is an infection of the cornea of the eye that is commonly caused by prolonged contact lens wear, corneal trauma, pre-existing systemic disorders and other ocular surface disorders. It can result in severe visual impairment if improperly managed. According to the latest World Vision Report, at least 4.2 million people worldwide suffer from corneal opacities caused by infectious agents such as fungi, bacteria, protozoa and viruses. In patients with fungal keratitis (FK), often overt symptoms are not evident, until an advanced stage. Furthermore, it has been reported that clear discrimination between bacterial keratitis and FK is a challenging process even for trained corneal experts and is often misdiagnosed in more than 30% of the cases. However, if diagnosed early, vision impairment can be prevented through early cost-effective interventions. In this work, we propose a multi-scale convolutional neural network (MS-CNN) for accurate segmentation of the corneal region to enable early FK diagnosis. The proposed approach consists of a deep neural pipeline for corneal region segmentation followed by a ResNeXt model to differentiate between FK and non-FK classes. The model trained on the segmented images in the region of interest, achieved a diagnostic accuracy of 88.96%. The features learnt by the model emphasize that it can correctly identify dominant corneal lesions for detecting FK.

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.

Knowledge and awareness of informed consent among orthodontists and patients: A pilot study.

AIM: Despite fixed professional opinion of what might constitute optimal treatment, patients must be informed of the various treatment options available in orthodontics to manage their clinical problem. The purpose of this study was to compare and evaluate the knowledge and awareness among practicing orthodontists and patients with regard to informed consent in clinical practice and research. MATERIALS AND METHODS: Twenty-five orthodontists and 25 patients were enrolled in a questionnaire study which was descriptive and cross-sectional in the nature. The questionnaire focused on the following aspects; contents of informed consent, at what age and who can give consent. RESULTS: The study showed a majority of orthodontists (79.14%) were aware of knowledge regarding informed consent when compared to patients(35.14%). CONCLUSION: The overall result showed the huge gap that exists between orthodontists and patients and thus making it categorical for patients to be more involved in the decision-making process.

Glaucoma Awareness and Self-Care Practices among the Health Professionals in a Medical College Hospital.

BACKGROUND: Awareness and self-care practices concerning glaucoma, the silent thief of sight, is poor. This study was conducted to assess the same among health professionals in a medical college. MATERIALS AND METHODS: Institutional Ethics Committee Clearance was obtained and a descriptive semi-structured-questionnaire-based study was conducted. Informed written consent was taken from 114 (convenience sampling) health professionals (doctors/paramedicals) and a questionnaire were administered. Participants were questioned about the awareness of glaucoma, what are the features of glaucoma etc. Non-medical hospital workers were excluded. Data was analysed using Microsoft excel, descriptive statistics and chi-square test. RESULTS: Respondents included clinicians, non-clinician-doctors and paramedicals (36:30:48) {mean age: 37 years, males:females::58:56}. Glaucoma awareness was statistically similar in the three study groups: high IOP (82.4%, p=0.55); optic nerve damage (32.4%, p=0.79); normal/low IOP (38.6%, p=0.2); irreversible blindness (47.1%, p=0.29); risk factors like corticosteroids (57%, p=0.11), family history of glaucoma (74.5%, p=0.17) and diabetes (77.1%, p=0.84). Over 13% thought that screening is done after 60 years. Few had undertaken screening for themselves (16.60%) and family members (21.05%). Few knew tests (41.2%, p=0.04) and treatment modalities (41.2%, p=0.0516). CONCLUSION: The study revealed unsatisfactory awareness and self-care practices concerning glaucoma among health professionals including clinicians despite studying ophthalmology, although it is presumed and predicted to be the contrary. This alarming revelation warrants the need for enrichment of glaucoma awareness programs.

Change-readiness of the blind: a hospital based study in a coastal town of South India.

PURPOSE: Blindness is a devastating condition with psychosocial and economic effects. The shortcomings result in a burden to the blind person, the family and society. Rehabilitation of the blind can transform their lives. The aim of this study was to assess the "change-readiness" of the blind to undergo a "change-management". MATERIALS AND METHODS: The study was a semi-structured pre-tested questionnaire-based study of 50 blind subjects in a medical college hospital. The blind participants were assessed for depression using the Beck Depression Inventory II, for the perceived effect of blindness on family, social life and occupation. The participants were counseled to undergo psychiatric management, vocational training, use blind aids and learn Braille. The willingness of the participants with reasons was assessed using a verbal analogue scale. Pearson Chi-square test, ANOVA and the t-test were used for statistical analysis. RESULTS: Over two-thirds of the subjects were depressed. Family life, social life and occupation were perceived to be affected by 44%, 66% and 74%, respectively. Change-readiness scores were low for low vision and blind aids, vocational training, psychiatric management, change of job and learning Braille. The low score was due to the associated taboo, dependence, lack of skills, embarrassment, etc., The most valuable feature was the family cohesiveness. CONCLUSION: The results suggest that there is a need to modify health policy to include blind rehabilitation, to improve visibility of blind rehabilitation centers, to include family members and co-professionals while managing the blind so that we treat the "blind person" and not a "pair of blind eyes".