Knowledge and awareness of clinical trials among trial participants in India: A multicentric questionnaire-based cross-sectional study.

PURPOSE: The knowledge and attitude of participants toward clinical trials (CTs) are a key determinant in successful recruitment and retention. This study aimed to evaluate knowledge and awareness-attitude among the recruited CT participants about CTs. METHODS: This was a cross-sectional face-to-face survey comprising CT participants involved in the past or currently a part of a CT during this study within the Indian Ophthalmology Clinical Trial Network (IOCTN). A previously validated questionnaire was used, and data regarding demographics, knowledge, and awareness-attitude about CTs were collected. The total awareness-attitude score was used to determine the knowledge and awareness of the participants. RESULTS: A total of 121 subjects had participated in the study who were part of ongoing trials, of which only five participants had prior experience of CTs. The majority (90%) had knowledge about CTs, whereas only 7% had confirmed signing consent forms. The total awareness-attitude score significantly varied across locations (27% for the southern zone, 53% for the central zone, and 52% for the western zone), and this was negatively associated with education. The most negative attitude (38.6%) was observed regarding adequate information sharing among participants, whereas non-disruption of their routine family life (60.7%) and financial stability (67.6%) were the top most positive attitudes revealed during their participation. The participants' pre- and post-participation attitude toward CTs revealed a positive attitude. CONCLUSION: The factors influencing a participant's knowledge and attitudes toward CTs were revealed in the study. Furthermore, the need for awareness regarding benefits of CTs to the public, participant's rights, and their voluntary power were the major highlights.

Attitude and perception toward clinical trials in India among patients and patient bystanders visiting the Indian Ophthalmology Clinical Trial Network: A multi-centric, cross-sectional survey.

Purpose: Advances in patient treatment depend heavily on clinical trials (CTs). Patient volunteers for CT are tougher to recruit and retain. In order to administer CTs effectively, it is necessary to comprehend how the public views and perceives participating in them. The study assessed the perception and attitudes of patients and bystanders toward CTs in India. Methods: This was a multi-centric, cross-sectional study among patients and bystanders using a questionnaire that consisted of socio-demographic characteristics and questions on knowledge and attitude toward participation in CTs. The minimum sample size estimated for the survey was 750. Results: A total of 1260 respondents (patients and bystanders) had participated in the survey. 42% of total respondents were aware about CTs. Unawareness regarding (i) voluntary power of an individual to participate in a CT (only 47%), (ii) entitled benefits of free treatment and medical insurance during enrolment in a CT (only 47%), and (iii) only 16% of the respondents knew involvement of human subjects in CT were the major highlights among those who had prior knowledge about CTs. Education was the most pervasive factor in shaping positive perception among the respondents. Occupation was another ubiquitous factor in shaping their perception regarding CTs. Conclusion: The majority of respondents were not aware of CTs. The major concerns observed were time consumption and harmful nature of CTs that influenced their unwillingness to participate in CTs. Initiatives such as awareness campaigns and survey assessments that would result in scientifically effective health service policies would be strategic methods to enhance CT participation.

Knowledge and perception of health-care professionals on clinical trials in India: A pan-Indian cross-sectional survey.

Purpose: The purpose of the study was to evaluate the knowledge and perception of health-care professionals (HCPs), such as doctors/surgeons, pharmacists, nurses, optometrists, and lab technicians, on clinical trials (CTs) in India. Methods: The study was a pan-Indian cross-sectional survey initiated by the Indian Ophthalmology Clinical Trial Network (IOCTN) by using a previously validated questionnaire for three months of data collection. An online survey was used to record information regarding demographics, CT knowledge, and CT perception among HCPs. Results: A total of 630 responses were recorded from HCPs: 207 doctors and surgeons, 159 pharmacists, and 264 laboratory technicians, nurses, and optometrists across India. Over 90% of HCPs had a clear knowledge on the purpose of CTs, the informed consent (IC) process, ethical approval by the Drugs Controller General of India (DCGI). About 80% and 90% were aware of confidentiality of patients, voluntariness of participation, and good clinical practice. Surprisingly, less than 50% had lesser knowledge regarding monetary incentives of CT participants (CTPs). A slightly positive perception was observed regarding the potential benefits of CTPs, compensation related to injury, and importance of obtaining IC. Less than 50% had a negative perception that monetary compensation to CTPs led to bias and deprivation of standard treatments. However, no significant difference was observed between other aspects of demographics and perception regarding CTs. Conclusion: We observed doctors and surgeons to be having the highest regarding CTs, followed by pharmacists. The survey highlighted the necessity of scheduling awareness programs among the HCPs, which would improve their misconceptions and perception of CTs while interacting with patients for CT enrollment.

Patterns of risk for diabetic retinopathy in the Mumbai slums: The Aditya Jyot Diabetic Retinopathy in Urban Mumbai Slums Study (AJ-DRUMSS) Report 3.

Diabetes onset precedes diabetic retinopathy (DR) by 5-10 years, but many people with diabetes remain free of this microvascular complication. Our aim was to identify risk factors for DR progression in a unique and diverse population, the slums of Mumbai. We performed a nested case-control study of 1163 diabetics over 40 years of age from slums in 18 wards of Mumbai. Data was collected on 33 variables and assessed for association with DR using both univariate and multivariate analyses. Stratified analyses were also performed on males and females, separately. Among hypertensive individuals we also assessed whether duration of hypertension associated with DR. Of 31 non-correlated variables analysed as risk factors for DR, 15 showed evidence of significant association. The most prominent included sex, where being a female associated with decreased odds of DR, while longer duration of diabetes and poor glycaemic control associated with increased odds. The duration of diabetes effect was partially, but significantly, mediated by age of diabetes diagnoses (8.6% of variance explained, p = 0.012). Obesity as measured by several measures, including body mass index (BMI) and measures of central obesity had a negative association with DR; increased measures of obesity consistently reduced odds of DR. As in most earlier studies, DR was associated with the duration of diabetes and glycaemic control. However, other factors, especially obesity related measures were associated with DR, in ways that contrast with most prior studies. These results indicated that the overall pattern of association in the Mumbai slums was novel. Thus, in previously uncharacterized populations, such as the slums that we examined, it is important to evaluate all risk factors de novo to appropriately assess patterns of association as the patterns of association with DR can be complex and population specific.

Mucormycosis in COVID-19 patients.

Mucormycosis, commonly known as 'Black Fungus' which was then a rare fungal infection, has suddenly come to light post the COVID-19- pandemic, more so during the second wave in India. It thus becomes important not only for the medical fraternity but also the general population to build awareness about the same. The present review will focus on the pathophysiology, etiology, outcomes of some case studies, and current treatment methods of mucormycosis infection. Major focus of the current article is on rhino-orbital-cerebral mucormycosis. All the studies included in the present review article was extracted from the PubMed database.

Development of integrated microfluidic platform coupled with Surface-enhanced Raman Spectroscopy for diagnosis of COVID-19.

Corona Virus Disease 19 (COVID-19) pandemic has created an alarming situation across the globe. Varieties of diagnostic protocols are being developed for the diagnosis of COVID-19. Many of these diagnostic protocols however, have limitations such as for example unacceptable no of false-positive and false-negative cases, particularly during the early stages of infection. At present, the real-time (quantitative) reverse transcriptase-polymerase chain reaction (RT-PCR) is considered the gold standard for COVID-19 diagnosis. However, RT-PCR based tests are complex, expensive, time consuming and involve pre-processing of samples. A swift, sensitive, inexpensive protocol for mass screening is urgently needed to contain this pandemic. There is urgent need to harness new powerful technologies for accurate detection not only of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) but also combating the emergence of pandemics of new viruses as well. To overcome the current challenges, the authors propose a diagnostic protocol based on Surface-enhanced Raman Spectroscopy (SERS) coupled with microfluidic devices containing integrated microchannels functionalized either with vertically aligned Au/Ag coated carbon nanotubes or with disposable electrospun micro/nano-filter membranes. These devices have the potential to successfully trap viruses from diverse biological fluids/secretions including saliva, nasopharyngeal, tear etc. These can thus enrich the viral titre and enable accurate identification of the viruses from their respective Raman signatures. If the device is successfully developed and proven to detect target viruses, it would facilitate rapid screening of symptomatic as well as asymptomatic individuals of COVID-19. This would be a valuable diagnostic tool not only for mass screening of current COVID-19 pandemic but also in viral pandemic outbreaks of future.

MYD88 L265P mutation in intraocular lymphoma: A potential diagnostic marker.

PURPOSE: Vitreoretinal lymphoma (VRL) is the most common intraocular lymphoma (IOL). This can be either primary or secondary to the central nervous system lymphoma. The diagnosis of primary intraocular lymphoma (PIOL) currently relies on clinical diagnosis and cytological analysis of the vitreous or subretinal biopsy. Although most cases are diagnosed without much issue, the limited amount of vitreous fluid, subjectivity in cytological reporting, and special expertise in ocular pathology make the diagnosis challenging. MYD88 L265P mutation has been implicated to have diagnostic utility in PIOL. In this study, we screened consecutive vitreous biopsies for the presence of MYD88 L265P mutation to understand its diagnostic utility compared to conventional cytological analysis. METHODS: Cytological analysis and MYD88 L265P mutation by PCR-based sequencing and restriction fragment length polymorphism (RFLP) were carried out on consecutive vitreous and subretinal biopsies collected from 21 patients. The diagnostic utility of the cytology and MYD88 L265P mutation analysis were compared. RESULTS: Out of the 21 patients, 15 had clinical suspicion of having PIOL. Out of these suspected cases of PIOL, nine were confirmed on follow-up, while six were diagnosed as other intraocular pathologies. Diagnostic utility of MYD88 L265P mutation analysis revealed a sensitivity of 88.9%, specificity of 91.6%, positive and negative predictive value of 88.9% and 91.7%, respectively. Diagnostic accuracy of 90.5% was achieved with the mutation analysis that shows the superiority of MYD88 in both ruling in and ruling out PIOL. The diagnostic utility of MYD88 L265P mutation was superior to conventional cytological analysis. CONCLUSION: The analysis of MYD88 L265P mutation is reliable and efficient in the diagnosis of PIOL.

The claw: A novel intraocular foreign body removal forceps.

Removal of intraocular foreign body (IOFB) from the posterior segment of the eye is challenging. In addition to surgical skill, it requires specific instrumentation to grasp and remove the IOFB. Small metallic IOFB can be removed using intraocular rare earth magnets but metallic IOFB larger than 3 mm and nonmetallic IOFBs like shot gun pellets, stones, or large glass fragments require specialized IOFB grasping forceps for removal. We describe the design and case-based clinical applications of a novel IOFB removal forceps, "the claw" that consists of a titanium handle and a 27-mm, 19-G metallic shaft that houses four retractable prongs made of nitinol wire. When completely extended, the prongs measure 14 mm in length and open up to 8-8.5 mm in the widest extent. The four prongs offer a very secure grip without crushing or splintering the IOFB leading to minimal chances of IOFB slippage and inadvertent retinal trauma.

Evaluation of oral health related quality of life in patient with mild periodontitis among young male population of Namakkal district.

AIM: The aim of the study is to assess the impact of oral health related quality of life (QOL) on patients presenting for scaling and oral prophylaxis using a the oral health-related quality of life (OHRQL) questionnaire. MATERIALS AND METHODS: This prospective study includes a total of 100 male patients of age group 25-35 years, who visited private clinic in Namakkal district, South India. They were assessed for their perceptions of oral health using OHRQL questionnaire before initial periodontal therapy including scaling and root planning. RESULTS: A total of 100 patients (mean age:29 years) participated in the study and completed initial periodontal therapy. Before treatment 98% of the patients perceived that their oral health status impacted on their QOL in one or more ways. Bad breath was the most common complaint. Social well-being, personality and psychological function were identified as compromised OHRQL domains. More than 60% of the patients stated their overall general health is affected by periodontal disease. CONCLUSION: Periodontitis negatively affected QOL in this Namakkal district population of young male patients with mild periodontitis. Conventional non-surgical periodontal therapy and personality development counseling has a potential to ameliorate patient perceptions of oral health and improve their QOL.

Intravitreal bevacizumab (avastin) in a pediatric case of pathologic myopia.

PURPOSE: To report the successful consecutive use of intravitreal bevacizumab (Avastin) in a child with myopic choroidal neovascular membrane (mCNVM). METHOD: A 12-year-old child presented with gradual diminution of vision in both eyes. Ocular examination revealed pathologic myopia with mCNVMs in both eyes. Leakage was demonstrated on fluorescein angiography in right eye at the first visit, followed by the left eye 1 week later. A single injection of bevacizumab (Avastin) 1.25 mg (0.05 mL) was administered under aseptic precautions using a 30-G needle in each eye separated by duration of 1 week. There were no complications during or after each procedure RESULTS: : Leakage from the mCNVM was reduced in both eyes within 2 weeks after the injections and there was reduction of macular thickness in both eyes. However, visual acuity change was modest, with the right eye improving from Snellen acuity of 1/60 before injection to 6/60 and the left eye remaining stable at 3/60. CONCLUSION: Intravitreal Avastin was safely injected successively in each eye in a pediatric case of pathologic myopia with mCNVM. Reduction of leakage and macular thickening may not be associated with commensurate visual improvement as in our case. Long-term safety and appropriate dosage of intravitreal bevacizumab needs to be studied before routine use in pediatric cases of neovascularization.