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.

Risk factors for secondary ocular hypertension in silicone oil-filled eyes following transconjunctival sutureless vitrectomy – A prospective cohort study

Purpose: Our aim was to determine the various risk factors for secondary ocular hypertension (OHT) following pars plana vitrectomy (PPV) with silicone oil (SO) injection. Methods: A prospective cohort study was performed on 46 eyes of 42 patients who underwent PPV with SO injection under a single surgeon between January 2020 and July 2021. Complete ophthalmological examination including gonioscopy and Goldmann applanation tonometry was performed preoperatively and on three postoperative visits, that is, day 7, day 30, and day 90. Axial length and lens thickness were measured at baseline using immersion A?scan. Anterior segment optical coherence tomography (OCT) was used for measuring anterior chamber depth (ACD) at baseline and at 3 months. Results: There was a statistically significant increase in intraocular pressure (IOP) (>21 mmHg) on day 7 (4.70 ± 7.754 mmHg), day 30 (5.24 ± 7.481 mmHg), and day 90 (2.39 ± 5.659 mmHg) (P<0.01 for all). Age <50 years, rhegmatogenous retinal detachment (RRD), and pseudophakia had a strong association with short?term OHT on day 7. Preexisting glaucoma was the only independent risk factor for long?term OHT (day 90). Higher baseline IOP and SO emulsification also contributed to long?term OHT. Conclusion: There was a statistically significant elevation in IOP at all postoperative visits. Short?term OHT was associated with younger age (<50 years), RRD, and pseudophakia. Patients with emulsified SO in the anterior chamber, higher baseline IOP, and preexisting glaucoma were at higher risk for long?term OHT.

Effect of dexamethasone implant on intraocular cytokines in diabetic macular edema

Purpose: Our primary aim was to evaluate intraocular cytokines (IC) before and after dexamethasone in diabetic macular edema (DME). Our secondary aim was to study the early and late effects of single dexamethasone implant in DME. Methods: This before and after comparative study was conducted at the Department of Ophthalmology and Centre for Nanosciences at a quaternary referral center in Kerala, India, from September 2016 to September 2018. Patients underwent complete ophthalmological examination and cytokine analysis before and after dexamethasone implant. Levels of cytokines at baseline and repeat sample were studied. Results: Twenty?seven eyes (21 patients) were divided into two groups depending on time from baseline to second injection. Group 1 included patients with <3 months between the two samples – 12 (44.4%). Group 2 included patients with >3 months between the two samples –15 (55.6%). Best corrected visual acuity (BCVA) and central macular thickness (CMT) improved significantly post?dexamethasone in group 1, but not in group 2. Interleukin (IL)?4, IL?6, IL?10, vascular endothelial growth factor (VEGF), IL?1?, interferon?gamma inducible protein?10 (IP?10), monocyte chemoattractant protein?1 (MCP?1), and IL?2 decreased post?injection in group 1. But cytokines increased post?dexamethasone in group 2, except IL?10. When compared to baseline, IL?6 reduced to half in group 1 (P?value 0.814) and it tripled in group 2 ( P?value 0.009). The level of VEGF in the first and second samples was not different in either group. Conclusion: Our study suggests that dexamethasone acts more on IC than VEGF in DME. This is significant in the first 3 months with a rebound effect on IL?6 after 3 months. Our study also suggests that repeat injection of DEX in DME should be done at 3 months to prevent deterioration of visual acuity (VA) and worsening of CMT.

The usage of prior upper gastrointestinal endoscopy among symptomatic patients undergoing cholecystectomy

Background: Cholelithiasis is one of the most common problems encountered in surgery. It is an immense challenge to discriminate between signs and symptoms due to gastrointestinal lesions and gallstones diseases. The objective of this study was to evaluate the usage of pre-operative upper gastrointestinal endoscopy (UGE) as a routine in treating symptomatic gallstone patients.Methods: This prospective hospital based observational study was conducted in the Department of General Surgery at Sri Guru Ram Das Institute of Medical Sciences and Research, Sri Amritsar from January 2018 to June 2019. 60 symptomatic gallstone patients were selected for cholecystectomy and preoperative upper gastrointestinal (GI) endoscopy evaluation was done for any associated upper gastrointestinal problems.Results: Out of the total patients, females constituted 85% of overall study patients and majority of the patients presented with atypical biliary colic symptoms (55%, group 2) whereas 45% presented with typical biliary colic symptoms (group 1) (p value=0.009). Relief rate was highest in group 1 with abnormal UGE than with group 2.Conclusions: The routine use of upper GI endoscopy in patients with symptomatic cholelithiasis prior to cholecystectomy will help reduce post-operative persistence of symptoms and thus, it is a useful investigation in the overall treatment of gallstone diseases.

Toxoplasma retinitis following intravitreal injection of triamcinolone acetonide: A case report and review of literature

The aim of this study was to report a case of atypical toxoplasma retinochoroiditis following intravitreal triamcinolone acetonide (IVTA) injection and to review the literature pertaining to toxoplasma retinochoroiditis following intravitreal injection of corticosteroid. Clinical data were collected from a 64-year-old male who developed toxoplasma retinitis 2 months after IVTA. A review of the literature was conducted to identify additional reports on similar cases. A 64-year-old male, known diabetic with nonproliferative diabetic retinopathy in both the eyes and optic atrophy in the left eye, presented with atypical retinitis inferior to the disc following IVTA. Real-time polymerase chain reaction and serology confirmed the toxoplasma etiology, and the patient was started on anti-toxoplasma therapy along with oral corticosteroid leading to regression of the lesion by 3 months. A high index of suspicion and proper microbiological diagnosis with appropriate antimicrobial therapy can aid in the management of toxoplasma retinochoroiditis following intravitreal injection of corticosteroid.

Protective effect of Ocimum sanctum Linn. leaf extract on ethanol withdrawal syndrome in Wistar rats

Objective:To evaluate the effects of Oscimum sanctum L (O. sanctum), an important medicinal herb, on alcohol withdrawal syndrome in Wistar rats.Methods:Liquid diet with 7.2%, v/v ethanol was administered to the rats for 21 d. Control group animals received sucrose as an isocaloric liquid diet. After alcohol withdrawal, rats were examined at 6th and 24th hour for major withdrawal signs that included anxiety and hyper locomotor activity. Ethanol withdrawal anxiety was tested using elevated plus maze, light and dark model; the hyper locomotor activity using actophotometer. O. sanctum leaf extract (100, 200 and 300 mg/kg, oral) and diazepam (2 mg/kg, i.p) were administered to the treatment group animals 30 min before alcohol withdrawal estimation. Drug treatment was also given 30 min before the second observation at 24th hour. On the last day of the protocol, rats were sacrificed by cervical dislocation liver, kidney and brain were isolated and preserved in formalin for further histopathological examination.Results:Findings from the present study revealed that O. Sanctum leaf extract treatment at doses 100, 200 and 300 mg/kg, oral had a significant protective effect on signs and symptoms of ethanol withdrawal in alcohol-dependent rats. However, no remarkable pathological and microscopic alterations were observed in histopathological examination.Conclusions:O. sanctum seems to be an active drug for the treatment of alcohol abstinence syndrome.

Profile of pancreatic tumors at a tertiary care center.

BACKGROUND: Pancreas, a relatively inaccessible organ, poses diagnostic difficulties with overlapping presentation among benign and malignant tumors. In the present study, pancreatic aspirates obtained by computed tomography (CT) guided procedures were used for cytodiagnosis. Our study aims at correlating clinical, cytological, biochemical, and histopathological results in obtaining a final diagnosis. METHODOLOGY: A retrospective study of 2 years was done which included 32 cases of pancreatic tumors at a tertiary care center. Patient data were retrieved and analyzed. RESULTS: Twenty‑seven of the 32 (84.37%) cases were malignant tumors. Age distribution in malignant tumors was predominantly seen in the fourth to eighth decade, whereas in benign, it ranged in the second to third decade. Thirteen out of the 32 (40.62%) cases reported were females, with male:female ratio of 1.46:1. The most common presenting symptom was abdominal pain followed by jaundice and vomiting. Three of the 32 cases had visceral metastasis at the time of diagnosis. CT‑guided aspirates in most cases yielded diagnostic material. Cytological and histopathological results concurred except for three cases. Cancer Antigen 19-9 was worked up for 14 of 27 malignant cases, 11 of which showed grossly elevated values (700–7000), and three cases showed mildly elevated values (100–300). Three of the four benign cases worked up for CA 19‑9 showed normal values. CONCLUSIONS: Among the mass forming lesions in pancreas, malignancy was more common compared to benign tumors. A multidisciplinary approach in the assessment and diagnosis of pancreatic tumors yields accurate results in spite of the limitations faced in obtaining adequate samples by needle aspirates.

Review: Head and Neck Squamous Cell Carcinoma in Sub-Saharan Africa

Aim.Review the literature from 1990 to 2013 to determine known anatomic sites; risk factors; treatments; and outcomes of head and neck squamous cell carcinoma (HNSCC) in sub-Saharan Africa.Methods.Using a systematic search strategy; literature pertaining to HNSCC in sub-Saharan Africa was reviewed and patient demographics; anatomic sites; histology; stage; treatment; and outcomes were abstracted. The contributions of human immunodeficiency virus (HIV); human papillomavirus (HPV) and behavioural risk factors to HNSCC in the region were assessed. Results of the 342 papers identified; 46 were utilized for review; including 8611 patients. In sub-Saharan Africa; the oropharyngeal/oral cavity was found to be the most common site; with 7750 cases (90% of all cases). Few papers distinguished oropharyngeal from oral cavity; making identification of possible HPV-associated oropharyngeal squamous cell carcinoma (SCC) difficult. SCC of the nasopharynx; nasal cavity; or paranasal sinuses was identified in 410 patients (4.8% of all cases). Laryngeal SCC was found in 385 patients (4.5% of all cases); and only 66 patients (0.8% of all cases) with hypopharyngeal SCC were identified. In 862 patients with data available; 43% used tobacco and 42% used alcohol; and reported use varied widely and was more common in laryngeal SCC than that of the oropharyngeal/oral cavity. Toombak and kola nut use was reported to be higher in patients with HNSCC. Several papers reported HIV-positive patients with HNSCC; but it was not possible to determine HNSCC prevalence in HIV-positive compared to negative patients. Reports of treatment and outcomes were rare.Conclusions The oropharyngeal/oral cavity was by far the most commonly reported site of HNSCC reported in sub-Saharan Africa. The roles of risk factors in HNSCC incidence in sub-Saharan Africa were difficult to delineate from the available studies; but a majority of patients did not use tobacco and alcohol

Clinicomicrobiological analysis of patients with cholangitis.

Acute cholangitis is inflammation of biliary ductal system from infection with an associated biliary obstruction. This retrospective study was done to determine the factors responsible for cholangitis and the microbiological profile of the bile in patients with cholangitis. In the study involving 348 patients, 36.4% had associated malignancy. A total of 54% of the bile samples were positive for aerobic culture. Nearly 66-73% of the Escherichia coli and Klebsiella isolates were Extended spectrum beta lactamases (ESBL) producers. Two isolates of Candida spps were also obtained. Polymicrobial infection was seen in 31.5% of the culture positive cases. Ideal antibiotics in case of cholangitis would be those which are excreted in the bile such as third‑generation cephalosporins, ureidopenicillins, carbapenems and fluoroquinolones to combat resistance and polymicrobial aetiology. Anti‑fungal drugs may also be necessary if the patient is not responding to biliary decompression and antibacterial agents to prevent fungaemia.

Gastric volvulus with perforation in association with congenital diaphragmatic hernia.

Gastric volvulus in children is a rare surgical emergency. We describe 2 cases of gastric volvulus with gastric perforation in association with congenital diaphragmatic hernia. One case presented in infancy after recurrent chest infections with intestinal obstruction. The other case presented in the early neonatal period. Both cases underwent laparotomy with repair of the stomach and diaphragm defect. The first case developed pyoperitoneum postoperatively, was reexplored but succumbed to septicaemia. The second baby had a favourable postoperative outcome.

Palliation of malignant colonic obstruction by self-expandable metal stent.

Advanced obstructive colorectal cancer is routinely treated by surgical colostomy. Self-expandable metal stents are a promising alternative. We report the use of an expandable metal stent to relieve colonic obstruction in an elderly lady with advanced colorectal malignancy.

Hepatic sickling crisis mimicking recurrent cholangitis.

A 22-year-old man with homozygous sickle cell disease presented with recurrent fever, right upper quadrant pain and jaundice. Liver biopsy confirmed the diagnosis of hepatic sickling crisis; the symptoms responded to hydroxyurea therapy. Hepatic vasocclusive crisis can diagnosed on liver biopsy, and need not be a diagnosis of exclusion.

Autoimmune sclerosing cholangitis: an overlap syndrome in a child.

We report an overlap syndrome of autoimmune chronic liver disease and primary sclerosing cholangitis in a young girl. This could be the first such report from India.

Local steroid therapy in cutaneous hemangiomas.

OBJECTIVES: To evaluate the efficacy of intralesional triamcinolone in enhancing regression in various type of hemangiomas. SETTING: Outpatients department of a teaching hospital Subjects: One hundred and five patients with rapidly growing surface hemangioma. The age ranged from 1 month to 15 months (mean 7 months). INTERVENTION: Intralesional triamcinolone administered at monthly intervals, ranging from single injection to 7 injections (mean 3.6 injections). MAIN OUTCOME MEASURE: Regression of the hemangioma. RESULTS: The overall response rate was 88.6% (excellent 51.4%, and good 37.2%). Maximum response was observed in children below 1 year of age (> 90%), lesions over the face (92.8%) and strawberry hemangiomas (99.9%). CONCLUSION: Intralesional administration of triamcinolone devoid of systemic side effects and an effective initial modality for rapidly growing hermangiomas.