Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial.

Importance: Older patients and those with comorbidities who are infected with SARS-CoV-2 may be at increased risk of hospitalization and death. Sotrovimab is a neutralizing antibody for the treatment of high-risk patients to prevent COVID-19 progression. Objective: To evaluate the efficacy and adverse events of sotrovimab in preventing progression of mild to moderate COVID-19 to severe disease. Design, Setting, and Participants: Randomized clinical trial including 1057 nonhospitalized patients with symptomatic, mild to moderate COVID-19 and at least 1 risk factor for progression conducted at 57 sites in Brazil, Canada, Peru, Spain, and the US from August 27, 2020, through March 11, 2021; follow-up data were collected through April 8, 2021. Interventions: Patients were randomized (1:1) to an intravenous infusion with 500 mg of sotrovimab (n = 528) or placebo (n = 529). Main Outcomes and Measures: The primary outcome was the proportion of patients with COVID-19 progression through day 29 (all-cause hospitalization lasting >24 hours for acute illness management or death); 5 secondary outcomes were tested in hierarchal order, including a composite of all-cause emergency department (ED) visit, hospitalization of any duration for acute illness management, or death through day 29 and progression to severe or critical respiratory COVID-19 requiring supplemental oxygen or mechanical ventilation. Results: Enrollment was stopped early for efficacy at the prespecified interim analysis. Among 1057 patients randomized (median age, 53 years [IQR, 42-62], 20% were ≥65 years of age, and 65% Latinx), the median duration of follow-up was 103 days for sotrovimab and 102 days for placebo. All-cause hospitalization lasting longer than 24 hours or death was significantly reduced with sotrovimab (6/528 [1%]) vs placebo (30/529 [6%]) (adjusted relative risk [RR], 0.21 [95% CI, 0.09 to 0.50]; absolute difference, -4.53% [95% CI, -6.70% to -2.37%]; P < .001). Four of the 5 secondary outcomes were statistically significant in favor of sotrovimab, including reduced ED visit, hospitalization, or death (13/528 [2%] for sotrovimab vs 39/529 [7%] for placebo; adjusted RR, 0.34 [95% CI, 0.19 to 0.63]; absolute difference, -4.91% [95% CI, -7.50% to -2.32%]; P < .001) and progression to severe or critical respiratory COVID-19 (7/528 [1%] for sotrovimab vs 28/529 [5%] for placebo; adjusted RR, 0.26 [95% CI, 0.12 to 0.59]; absolute difference, -3.97% [95% CI, -6.11% to -1.82%]; P = .002). Adverse events were infrequent and similar between treatment groups (22% for sotrovimab vs 23% for placebo); the most common events were diarrhea with sotrovimab (n = 8; 2%) and COVID-19 pneumonia with placebo (n = 22; 4%). Conclusions and Relevance: Among nonhospitalized patients with mild to moderate COVID-19 and at risk of disease progression, a single intravenous dose of sotrovimab, compared with placebo, significantly reduced the risk of a composite end point of all-cause hospitalization or death through day 29. The findings support sotrovimab as a treatment option for nonhospitalized, high-risk patients with mild to moderate COVID-19, although efficacy against SARS-CoV-2 variants that have emerged since the study was completed is unknown. Trial Registration: ClinicalTrials.gov Identifier: NCT04545060.

Enhancing COVID-19 Vaccine Uptake among Tribal Communities: A Case Study on Program Implementation Experiences from Jharkhand and Chhattisgarh States, India.

Tribal populations in India have health care challenges marked by limited access due to geographical distance, historical isolation, cultural differences, and low social stratification, and that result in weaker health indicators compared to the general population. During the pandemic, Tribal districts consistently reported lower COVID-19 vaccination coverage than non-Tribal districts. We assessed the MOMENTUM Routine Immunization Transformation and Equity (the project) strategy, which aimed to increase access to and uptake of COVID-19 vaccines among Tribal populations in Chhattisgarh and Jharkhand using the reach, effectiveness, adoption, implementation, and maintenance framework. We designed a qualitative explanatory case study and conducted 90 focus group discussions and in-depth interviews with Tribal populations, community-based nongovernmental organizations that worked with district health authorities to implement the interventions, and other stakeholders such as government and community groups. The active involvement of community leaders, targeted counseling, community gatherings, and door-to-door visits appeared to increase vaccine awareness and assuage concerns about its safety and efficacy. Key adaptations such as conducting evening vaccine awareness activities, holding vaccine sessions at flexible times and sites, and modifying messaging for booster doses appeared to encourage vaccine uptake among Tribal populations. While we used project resources to mitigate financial and supply constraints where they arose, sustaining long-term uptake of project interventions appears dependent on continued funding and ongoing political support.

Long-term outcomes after Bankart shoulder stabilization.

PURPOSE: The purposes of this study were (1) to analyze long-term outcomes in patients who have undergone open or arthroscopic Bankart repair and (2) to evaluate study methodologic quality through validated tools. METHODS: We performed a systematic review of Level I to IV Evidence using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Clinical outcome studies after open or arthroscopic Bankart repair with a minimum of 5 years' follow-up were analyzed. Clinical and radiographic outcomes were extracted and reported. Study methodologic quality was evaluated with Modified Coleman Methodology Scores and Quality Appraisal Tool scores. RESULTS: We analyzed 26 studies (1,781 patients). All but 2 studies were Level III or IV Evidence with low Modified Coleman Methodology Scores and Quality Appraisal Tool scores. Patients analyzed were young (mean age, 28 years) male patients (81%) with unilateral dominant shoulder (61%), post-traumatic recurrent (mean of 11 dislocations before surgery) anterior shoulder instability without significant glenoid bone loss. The mean length of clinical follow-up was 11 years. There was no significant difference in recurrence of instability with arthroscopic (11%) versus open (8%) techniques (P = .06). There was no significant difference in instability recurrence with arthroscopic suture anchor versus open Bankart repair (8.5% v 8%, P = .82). There was a significant difference in rate of return to sport between open (89%) and arthroscopic (74%) techniques (P < .01), whereas no significant difference was observed between arthroscopic suture anchor (87%) and open repair (89%) (P = .43). There was no significant difference in the rate of postoperative osteoarthritis between arthroscopic suture anchor and open Bankart repair (26% and 33%, respectively; P = .059). There was no significant difference in Rowe or Constant scores between groups (P > .05). CONCLUSIONS: Surgical treatment of anterior shoulder instability using arthroscopic suture anchor and open Bankart techniques yields similar long-term clinical outcomes, with no significant difference in the rate of recurrent instability, clinical outcome scores, or rate of return to sport. No significant difference was shown in the incidence of postoperative osteoarthritis with open versus arthroscopic suture anchor repair. Study methodologic quality was poor, with most studies having Level III or IV Evidence. LEVEL OF EVIDENCE: Level IV, systematic review of studies with Level I through IV Evidence.

Systems E-approach for women at risk (SEWA)-A digital health solution for detection of high-risk pregnancies.

BACKGROUND: High-risk pregnancy (HRP) puts current pregnancy at an increased risk of complications. In the absence of pre-existing HRP implementation model of the country, in collaboration with the Government of Himachal Pradesh, a new digital HRP model called the 'SEWA-A System E-approach for Women at risk' was developed. The current article demonstrates a model for the early identification and line listing of high-risk pregnant women (PW) with appropriate referrals and increased engagement with the healthcare workers using a digital tool in the form of the Android App. METHODS: SEWA was implemented as a pilot intervention in two community development blocks of the Chamba district. The key implementation steps included finalizing protocols for the identification of HRPs, defining processes and roles, mapping health facilities, setting up the communication loop, and developing of digital solutions. The digital app, used by the auxiliary nurse midwife (ANM) and program officers, tracked PW for a year from October 19 to October 20 and recorded the ANC visits, referrals, and birth outcomes. A qualitative assessment was conducted among the health workers to find out their level of acceptance. RESULTS: A total of 1,340 high-risk PW were identified. The intervention year saw a rise in the identification of HRP to 27.9% from 3.5% in the previous year. A total of 2,559 conditions were tagged to the identified 1,340 women categorized into current pregnancy (81%), previous pregnancy (16%), and any existing chronic illness (3%). A majority of the women who required urgent referrals were provided referrals. The application recorded 53% of the delivered HRP with a digital birth preparedness plan, prepared and shared with the PW and Accredited Social Health Activists (ASHA), by text message for compliance. CONCLUSION: The SEWA application is a feasible and sustainable solution to complement the competency of the care providers for early identification of the high-risk conditions and reduce the burden of preventable unprecedented deaths around the time of birth.

Experiences From an Implementation Model of ARI Diagnostic Device in Pneumonia Case Management Among Under-5 Children in Peripheral Healthcare Centers in India.

OBJECTIVES: To address pneumonia, a major killer of under-5 children in India, a multimodal pulse oximeter was implemented in Health and Wellness Centers. Given the evidence of pulse oximetry in effective pneumonia management and taking into account the inadequate skills of front-line healthcare workers in case management, the device was introduced to help them readily diagnose and treat a child and to examine usability of the device. DESIGN: The implementation was integrated with the routine OPD of primary health centers for 15 months after healthcare workers were provided with an abridged IMNCI training. Monthly facility data was collected to examine case management with the diagnostic device. Feedback on usefulness of the device was obtained. SETTING: Health and Wellness Centers (19) of 7 states were selected in consultation with state National Health Mission based on patient footfall. PARTICIPANTS: Under-5 children presenting with ARI symptoms at the OPD. RESULTS: Of 4846 children, 0.1% were diagnosed with severe pneumonia and 23% were diagnosed with pneumonia. As per device readings, correct referrals were made of 77.6% of cases of severe pneumonia, and 81% of pneumonia cases were correctly given antibiotics. The Pulse oximeter was highly acceptable among health workers as it helped in timely classification and treatment of pneumonia. It had no maintenance issue and battery was long-lasting. CONCLUSION: Pulse oximeter implementation was doable and acceptable among health workers. Together with IMNCI training, PO in primary care settings is a feasible approach to provide equitable care to under-5 children.

Colchicine for Prevention of Atherothrombotic Events in Patients With Coronary Artery Disease: Review and Practical Approach for Clinicians.

A better understanding of the central role of inflammation in the development of coronary artery disease (CAD) has been the impetus for the evaluation of therapeutic strategies targeting the interleukin-1ß/interleukin-6 cytokine signaling pathway, involved in both chronic atherogenesis and in triggering of atherosclerotic plaque rupture. As an inexpensive pharmacologic agent with relatively few adverse effects that tend to be mild and tolerable, the role of colchicine in secondary prevention of atherothrombotic events has been the focus of multiple recent large-scale randomized controlled trials involving patients with stable CAD (Low-Dose Colchicine [LoDoCo] and LoDoCo2 trials), a recent myocardial infarction (Colchicine Cardiovascular Outcome Trial [COLCOT], Colchicine in Patients With Acute Coronary Syndrome [COPS], and Colchicine and Spironolactone in Patients With Myocardial Infarction/Synergy Stent Registry [CLEAR SYNERGY] trials), and undergoing percutaneous coronary interventions (Colchicine in Percutaneous Coronary Intervention [COLCHICINE-PCI] trial). Based on this evidence, low-dose colchicine (0.5 mg once daily) should be considered in patients with recent myocardial infarctions-within 30 days and, ideally, within 3 days-or with stable CAD to improve cardiovascular outcomes. Colchicine should not be used in patients with severe renal or hepatic disease because of the risk of severe toxicity. No serious adverse effect was associated with the combined use of colchicine and high-intensity statin therapy in large trials. The impact of colchicine in high-risk populations of patients with peripheral arterial disease and in those with diabetes for the primary prevention of CAD remains to be established.

Implementing a skill development program among food handlers in tertiary care hospital to improve their personal hygiene: A pilot study.

INTRODUCTION: Food handlers with poor personal hygiene and lack of awareness in preventing foodborne diseases working in hospitality sectors or hospitals could spread foodborne infections. OBJECTIVE: Our study objective was to ascertain the impact of a video-based educational intervention program and administrative measures on improvement in personal hygiene of food handlers in hospital. METHODOLOGY: We conducted this pilot study among all 103 food handlers who were working in a tertiary care hospital. A checklist-based scoring and physical examination were conducted by the investigator for the food handlers. After baseline scoring S1, intervention 1 and 2 was implemented, and score was obtained as S2 and S3, respectively. Descriptive statistics was calculated, and score was compared by repeated measures ANOVA test using SPSS-22 software. RESULTS: Our study revealed that a total of 19.2% of food handlers had health complaints. More than half (54.8%) admitted that they had suffered from any kind of illness since last 6 months. Common illness was viral fever (40.3%) followed by typhoid (5.7%), dengue (4.8%) and urinary tract infection (3.8%). Most of the food handlers had long hair (62.5%) followed by long nail (57.69%). Nearly, one-fifth (20.1%) of food handlers nail was infected with fungus. Worm was found in 14.4% cases by stool examination. Statistically significant (P < 0.05) improvement in score was observed after each intervention. DISCUSSION: Poor hygiene (Score-1 = 23.76) was observed at baseline study although there was a mechanism in place for a yearly health checkup and regular (6 monthly) hygiene training. After interventions (video-based training and administrative measures), the score was improved to Score-3 (42.57). Statistically significant (P < 0.05) differences in hygiene score were observed for variables such as state of residence, education level, and working experiences (inside or outside the hospital). CONCLUSION: It is possible to improve personal hygiene among food handlers using video-based interactive training methods and administrative measures with no extra or minimal cost. RECOMMENDATIONS: This "piggyback" approach of training can be imparted in addition to routine training measures among the food handlers for improving their personal hygiene in the hospital setting.

A comparison of various minimally invasive techniques for the removal of dental fluorosis stains in children.

CONTEXT: Dental fluorosis is caused by successive exposure to high concentrations of fluoride during tooth development leading to enamel with lower mineral content and increased porosity. AIMS: The aim of the study was to evaluate and compare the effectiveness of minimally invasive techniques for the removal of dental fluorosis stains in children in vivo. DESIGN: Ninety children in the age group of 10-17 years were selected. MATERIALS AND METHODS: The study sample was equally and randomly divided into three groups; Group 1: In-office bleaching with 35% hydrogen peroxide (HP) activated by light-emitting diode (LED) bleaching unit (35% HP), Group 2: Enamel microabrasion (EM) followed by in-office bleaching with 44% carbamide peroxide gel (EM), Group 3: In-office bleaching with 5% sodium hypochlorite (5% NaOCl). Statistical analysis was done using one-way ANOVA test. RESULTS: Bleaching with 35% HP activated by LED bleaching unit and EM followed by bleaching with 44% carbamide peroxide were equally effective for the removal of dental fluorosis stains in children in vivo. However, bleaching with 5% NaOCl could not completely remove moderate to severe stains. It was effective in removing only mild stains. Bleaching and microabrasion procedures caused slight decrease in tooth sensitivity readings by electric pulp vitality tester which continued to increase over time. However, none of the patients reported sensitivity in their teeth at any point of time. Patients were highly satisfied with the treatment outcome postoperatively but reported slight relapse of color in the three groups. CONCLUSIONS: Bleaching and microabrasion techniques can consider as an interesting alternatives to conventional operative treatment options.

Behaviour management of an anxious child.

Children with dental anxiety may refuse treatment, which can lead to dental emergencies. Behavior management is an essential skill and should be acquired by all members of a dental team treating children. Dental surgery staff should be relaxed, welcoming and friendly. Make the child the centre of attention and smile. Use age-appropriate language and avoid the use of jargon. Decide who will talk to the child and when, as he/she may only be able to listen to one person at a time. Avoid non-dental conversations with colleagues during procedures.

Evaluation of the short-term and long-term effect of a short series of hand hygiene campaigns on improving adherence in a tertiary care hospital in India.

Hand hygiene compliance at our institution was monitored by direct observation before and after a series of 2 hand hygiene awareness campaigns across an18-month time period to analyze the effect of these campaigns. A total of 5,059 opportunities for hand hygiene were observed. Compliance increased from 28.1% (95% confidence interval [CI], 18.7%-43.2%) to 42.5% (95% CI, 30.7%-54.8%) after the 2 campaigns (P < .0001) but dropped to 36.4% (95% CI, 30.5%-44.5%) after 2 years (P < .001). Three of the 8 intensive care units that showed a significant increase after the campaigns did not maintain the increased compliance at 2 years' follow-up. We conclude that educational programs should be repeatedly conducted to maintain high adherence to hand hygiene standards in health care settings.

Planning and response to the influenza A (H1N1) pandemic: ethics, equity and justice.

This paper aims to highlight three ethical considerations related to influenza pandemic planning and response: ethical allocation of scarce resources; obligations and duties of healthcare workers to treat patients, and the balance between conflicting individual and community interests. Among these, perhaps the most challenging question facing bioethics is how to allocate scarce, life-saving resources given the devastating social and economic ramifications of a pandemic. In such situations, the identification of clear overall goals for pandemic planning is essential in making difficult choices. The dilemma between the duty to save patients and the right to protect the healthcare personnel's own life and health is a key issue. During the course of a pandemic, civil liberties may also be threatened, requiring limits on individual freedom to protect individuals as well as entire communities. Yet, individual liberty should be restricted with great care, and only when alternative approaches are not effective. Pandemic influenza planning and response should be a cooperative and shared responsibility that balances community and individual interests.

The use of antiplatelet therapy in the outpatient setting: Canadian Cardiovascular Society Guidelines Executive Summary.

Antiplatelet agents are a cornerstone of therapy for patients with atherosclerotic vascular disease. There is presently a lack of comprehensive guidelines focusing on the use of antiplatelet drugs in patients currently manifesting or at elevated risk of cardiovascular disease. The Canadian Antiplatelet Therapy Guidelines Committee reviewed existing disease-based guidelines and subsequently published literature and used expert opinion and review to develop guidelines on the use of antiplatelet therapy in the outpatient setting. This Executive Summary provides an abbreviated version of the principal recommendations. Antiplatelet therapy appears to be generally underused, perhaps in part because of a lack of clear, evidence-based guidance. Here, we provide specific guidelines for secondary prevention in patients discharged from hospital after acute coronary syndromes, percutaneous coronary intervention, or coronary artery bypass grafting; patients with a history of transient cerebral ischemic events or strokes; and patients with peripheral arterial disease. Issues related to primary prevention are also addressed, in addition to special clinical contexts such as diabetes, heart failure, chronic kidney disease, pregnancy or lactation, and perioperative management. Recommendations are provided regarding pharmacologic interactions that may occur during combination therapy with warfarin, clopidogrel, and proton-pump inhibitors, or aspirin and nonsteroidal anti-inflammatory drugs, as well as for the management of bleeding complications. The complete guidelines document is published as a supplementary issue of the Canadian Journal of Cardiology and is available at http://www.ccs.ca/.

Evidence-based medicine in day surgery.

PURPOSE OF REVIEW: To present the evidence available for the management of pain, for the prevention of nausea and vomiting, and for the best anaesthetic technique during ambulatory surgery. RECENT FINDINGS: Paracetamol and nonsteroidal anti-inflammatory drugs are effective analgesics with a low number needed to treat, and are recommended when not contraindicated. Droperidol, dexamethasone and ondansetron are equally effective in the prevention of postoperative nausea and vomiting during ambulatory surgery. The choice of the anaesthetic technique appears to play a minor role in recovery from anaesthesia or in the occurrence of minor postoperative complications or home discharge, except for the use of total intravenous anaesthesia for the prevention of postoperative nausea and vomiting. SUMMARY: Pain should be prevented adequately and treated vigorously. Postoperative nausea and vomiting is common and should be prevented in the at-risk patient. The choice of inhalation agents during ambulatory surgery is of minor importance in recovery from anaesthesia.