"Constrained Medical Oxygen Supply Chain in India During COVID-19: Red-tapism, the Elephant in the Room?"

BACKGROUND: Recent disruption of medical oxygen during the second wave of coronavirus disease 2019 (COVID-19) has caused nationwide panic. This study attempts to objectively analyze the medical oxygen supply chain in India along the principles of value stream mapping (VSM), identify bottlenecks, and recommend systemic improvements. METHODS: Process mapping of the medical oxygen supply chain in India was done. Different licenses and approvals, their conditions, compliances, renewals, among others were factored in. All relevant circulars (Government Notices), official orders, amendments, and gazette notifications pertaining to medical oxygen from April 2020 to April 2021 were studied and corroborated with information from Petroleum and Explosives Safety Organization (PESO) official website. RESULTS: Steps of medical oxygen supply chain right from oxygen manufacture to filling, storage, and transport up to the end users; have regulatory bottlenecks. Consequently, flow of materials is sluggish and very poor information flow has aggravated the inherent inefficiencies of the system. Government of India has been loosening regulatory norms at every stage to alleviate the crisis. CONCLUSIONS: Regulatory bottlenecks have indirectly fueled the informal sector over the years, which is not under Government's control with difficulty in controlling black-marketing and hoarding. Technology enabled, data-driven regulatory processes with minimum discretionary human interface can make the system more resilient.

COVID-19 infection, and reinfection, and vaccine effectiveness against symptomatic infection among health care workers in the setting of omicron variant transmission in New Delhi, India.

Background: Surge of SARS CoV-2 infections ascribed to omicron variant began in December 2021 in New Delhi. We determined the infection and reinfection density in a cohort of health care workers (HCWs) along with vaccine effectiveness (VE) against symptomatic infection within omicron transmission period (considered from December 01, 2021 to February 25, 2022. Methods: This is an observational study from the All India Institute of Medical Sciences, New Delhi. Data were collected telephonically. Person-time at risk was counted from November 30, 2021 till date of infection/ reinfection, or date of interview. Comparison of clinical features and severity was done with previous pandemic periods. VE was estimated using test-negative case-control design [matched pairs (for age and sex)]. Vaccination status was compared and adjusted odds ratios (OR) were computed by conditional logistic regression. VE was estimated as (1-adjusted OR)X100-. Findings: 11474 HCWs participated in this study. The mean age was 36⋅2 (±10⋅7) years. Complete vaccination with two doses were reported by 9522 (83%) HCWs [8394 (88%) Covaxin and 1072 Covishield (11%)]. The incidence density of all infections and reinfection during the omicron transmission period was 34⋅8 [95% Confidence Interval (CI): 33⋅5-36⋅2] and 45⋅6 [95% CI: 42⋅9-48⋅5] per 10000 person days respectively. The infection was milder as compared to previous periods. VE was 52⋅5% (95% CI: 3⋅9-76⋅5, p = 0⋅036) for those who were tested within 14-60 days of receiving second dose and beyond this period (61-180 days), modest effect was observed. Interpretation: Almost one-fifth of HCWs were infected with SARS CoV-2 during omicron transmission period, with predominant mild spectrum of COVID-19 disease. Waning effects of vaccine protection were noted with increase in time intervals since vaccination. Funding: None.

SARS-CoV-2 Reinfection Rate and Estimated Effectiveness of the Inactivated Whole Virion Vaccine BBV152 Against Reinfection Among Health Care Workers in New Delhi, India.

Importance: A surge of COVID-19 occurred from March to June 2021, in New Delhi, India, linked to the B.1.617.2 (Delta) variant of SARS-CoV-2. COVID-19 vaccines were rolled out for health care workers (HCWs) starting in January 2021. Objective: To assess the incidence density of reinfection among a cohort of HCWs and estimate the effectiveness of the inactivated whole virion vaccine BBV152 against reinfection. Design, Setting, and Participants: This was a retrospective cohort study among HCWs working at a tertiary care center in New Delhi, India. Exposures: Vaccination with 0, 1, or 2 doses of BBV152. Main Outcomes and Measures: The HCWs were categorized as fully vaccinated (with 2 doses and ≥15 days after the second dose), partially vaccinated (with 1 dose or 2 doses with <15 days after the second dose), or unvaccinated. The incidence density of COVID-19 reinfection per 100 person-years was computed, and events from March 3, 2020, to June 18, 2021, were included for analysis. Unadjusted and adjusted hazard ratios (HRs) were estimated using a Cox proportional hazards model. Estimated vaccine effectiveness (1 - adjusted HR) was reported. Results: Among 15 244 HCWs who participated in the study, 4978 (32.7%) were diagnosed with COVID-19. The mean (SD) age was 36.6 (10.3) years, and 55.0% were male. The reinfection incidence density was 7.26 (95% CI: 6.09-8.66) per 100 person-years (124 HCWs [2.5%], total person follow-up period of 1696 person-years as time at risk). Fully vaccinated HCWs had lower risk of reinfection (HR, 0.14 [95% CI, 0.08-0.23]), symptomatic reinfection (HR, 0.13 [95% CI, 0.07-0.24]), and asymptomatic reinfection (HR, 0.16 [95% CI, 0.05-0.53]) compared with unvaccinated HCWs. Accordingly, among the 3 vaccine categories, reinfection was observed in 60 of 472 (12.7%) of unvaccinated (incidence density, 18.05 per 100 person-years; 95% CI, 14.02-23.25), 39 of 356 (11.0%) of partially vaccinated (incidence density 15.62 per 100 person-years; 95% CI, 11.42-21.38), and 17 of 1089 (1.6%) fully vaccinated (incidence density 2.18 per 100 person-years; 95% CI, 1.35-3.51) HCWs. The estimated effectiveness of BBV152 against reinfection was 86% (95% CI, 77%-92%); symptomatic reinfection, 87% (95% CI, 76%-93%); and asymptomatic reinfection, 84% (95% CI, 47%-95%) among fully vaccinated HCWs. Partial vaccination was not associated with reduced risk of reinfection. Conclusions and Relevance: These findings suggest that BBV152 was associated with protection against both symptomatic and asymptomatic reinfection in HCWs after a complete vaccination schedule, when the predominant circulating variant was B.1.617.2.

Assessment of psychological distress pattern & its correlates among people receiving COVID-19 vaccination during the COVID-19 pandemic: A cross-sectional study.

Background & objectives: There is a possibility that vaccinated people may experience lesser psychological distress due to the sense of safety felt by them against getting the COVID-19 infection as compared to those who are not vaccinated. However, there is a paucity of research examining the mental health status of this important sub-group of population. Thus, the present study was aimed to examine the pattern of psychological distress and its correlates among people receiving COVID-19 vaccine. Methods: This cross-sectional study assessed individuals receiving COVID-19 vaccine at a tertiary care hospital. Psychological distress and COVID-19-related anxiety were assessed using the Depression Anxiety Stress Scale (DASS-21) and the COVID-19 Anxiety Scale-7, respectively. Results: The study comprised 728 individuals with a mean age of 44.8 yr. Moderate levels of depression, anxiety and stress were reported by about 50, six and 15 per cent of the participants, respectively, as assessed on DASS-21. Generalized linear model and quantile regression analyses revealed COVID-19-related anxiety, and being a healthcare worker or front-line worker as significant correlates of psychological distress. Interpretation & conclusions: About half of the study participants receiving COVID-19 vaccine reported moderate to severe symptoms of depression. Strategies focusing on alleviation of COVID-19-related fear and anxiety might be effective in improving the symptoms of psychological distress.

One for Everyone: A Study of User Satisfaction Among Health-Care Providers Regarding Extended Use of N95 Masks During the COVID-19 Pandemic.

OBJECTIVE: This study was conducted to assess the feasibility of extended use of N95 masks in our hospital during the coronavirus disease 2019 (COVID-19) pandemic. We also studied the use pattern, user satisfaction, and issues faced during extended use of the mask. METHODS: This cross-sectional study was conducted among health-care providers in a large tertiary care teaching hospital in northern India from April 1 to May 31, 2020. A list was prepared from the institute's register, and participants were chosen by random sampling. The data collected from the physical forms were transferred to excel sheets. RESULTS: A total of 1121 responses were received. The most common problem stated with reuse of N95 masks was loss of fit followed by damage to the slings, highlighted by 44.6% and 44.4% of the participants, respectively. A total of 476 (42.5%) participants responded that they would prefer "cup-shaped N95 mask with respirator". The median scores regarding the satisfaction with the quality of masks and their fit was also 4 each. CONCLUSIONS: It was concluded that the extended use of N95 masks was acceptable, with more than 96% of the participants using these masks.

Effectiveness of an inactivated virus-based SARS-CoV-2 vaccine, BBV152, in India: a test-negative, case-control study.

BACKGROUND: BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine that has been deployed in India. The results of the phase 3 trial have shown clinical efficacy of BBV152. We aimed to evaluate the effectiveness of BBV152 against symptomatic RT-PCR-confirmed SARS-CoV-2 infection. METHODS: We conducted a test-negative, case-control study among employees of the All India Institute of Medical Sciences (a tertiary care hospital in New Delhi, India), who had symptoms suggestive of COVID-19 and had an RT-PCR test for SARS-CoV-2 during the peak of the second wave of the COVID-19 pandemic in India between April 15 and May 15, 2021. Cases (test-positives) and controls (test-negatives) were matched (1:1) on the basis of age and gender. The odds of vaccination with BBV152 were compared between cases and controls and adjusted for level of occupational exposure (to COVID-19), previous SARS-CoV-2 infection, and calendar time, using conditional logistic regression. The primary outcome was effectiveness of two doses of BBV152 (with the second dose received at least 14 days before testing) in reducing the odds of symptomatic RT-PCR-confirmed SARS-CoV-2 infection, expressed as (1 - odds ratio) × 100%. FINDINGS: Between April 15 and May 15, 2021, 3732 individuals had an RT-PCR test. Of these, 2714 symptomatic employees had data on vaccination status, and 1068 matched case-control pairs were available for analysis. The adjusted effectiveness of BBV152 against symptomatic COVID-19 after two doses administered at least 14 days before testing was 50% (95% CI 33-62; p<0·0001). The adjusted effectiveness of two doses administered at least 28 days before testing was 46% (95% CI 22-62) and administered at least 42 days before testing was 57% (21-76). After excluding participants with previous SARS-CoV-2 infections, the adjusted effectiveness of two doses administered at least 14 days before testing was 47% (95% CI 29-61). INTERPRETATION: This study shows the effectiveness of two doses of BBV152 against symptomatic COVID-19 in the context of a huge surge in cases, presumably dominated by the potentially immune-evasive delta (B.1.617.2) variant of SARS-CoV-2. Our findings support the ongoing roll-out of this vaccine to help control the spread of SARS-CoV-2, while continuing the emphasis on adherence to non-pharmacological measures. FUNDING: None. TRANSLATION: For the Hindi translation of the abstract see Supplementary Materials section.

Comparison of microwave and autoclave treatment for biomedical waste disinfection.

As the world is facing a Covid-19 pandemic, this virus teaches a lesson about the importance of on-site disinfection. On-site disinfection/sterilization with real-time monitoring of biomedical waste generated from the medical facilities is mandatory to prevent hospital-acquired infection (HAI). In this study, the life cycle assessment of two technologies, i.e., microwave (radiation-based) and autoclave (steam-based) were performed to summarize the inside-out evaluation of both technologies in terms of efficiency, efficacy, and cost-effectiveness. The results of disinfection efficacy indicated a log 10 reduction (almost 100%) in the vegetative load of microorganisms compared to the control, showing a similar level of disinfection efficacy of both strategies. Additionally, both technologies were compared on several parameters, and it was discovered that the autoclave uses more time and resources than the microwave. The total cost of an autoclave to the government is approximately double that of a microwave, while the operational cost of an autoclave is more than double that of a microwave. The findings from this study indicate that MACS may be used as a dry technique of biomedical disinfection, and its portability, tunability, and compactness make it a suitable alternative for biomedical disinfection and sterilization.

Assessment of Post COVID-19 Health Problems and its Determinants in North India: A descriptive cross section study

With millions of people getting affected with COVID-19 pandemic caused by a novel severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), people living with post COVID-19 Symptoms (PCS) are expected to rise in the future{middle dot} The present study aimed at assessing PCS comprehensively and its associated factors among COVID-19 recovered adult population in north India. MethodsIn a tertiary health centre at Delhi, an online based cross-sectional study was conducted using a semi-structured questionnaire, developed by employing a nominal group technique, in aged 18 years and above who were SARS-CoV-2 positive during the month of January to April 2021. Socio-demographic, various potential risk factors, including pre-existing morbidities, vaccination status, and severity of acute COVID-19 illness, information on acute illness for management and a spectrum of PCS were collected between June 16 to July 28, 2021. Each participant was contacted telephonically before sending the survey link. PCS were presented as relative frequency; chi-square test, odds ratio, including adjusted, were calculated to rule out association between PCS and potential predictors. ResultsA total of 773 of 1801 COVID recovered participants responded to the link reaching a participation rate of 42{middle dot}9%, with a median age of 34 years (IQR 27 to 44). Male respondents were 56{middle dot}4%. Around 33{middle dot}2% of them had PCS at four or more weeks, affecting almost all body organ systems. The most prevalent PCS were fatigue (79{middle dot}3%), pain in the joins (33{middle dot}4%), muscle (29{middle dot}9%), hair loss (28{middle dot}0%), headache (27{middle dot}2%), breathlessness (25{middle dot}3%), sleep disturbance (25{middle dot}3%) and cough (24{middle dot}9%). The prevalence of PCS was reduced to 12{middle dot}8% at 12 weeks after positive test. Factor such as female gender, older age, oxygen supplementation during the acute illness, working in healthcare care facilities, the severity of acute illness, and pre-existing co-morbid were risk factors for PCS. Further, vaccination (second dose) reduced the odds of developing PCS by 45% compared to unvaccinated participants (aOR 0{middle dot}65; 95%CI 0{middle dot}45-0{middle dot}96). Finally, 8{middle dot}3% of participants rated their overall health status was either poor or very poor following COVID-19 illness. ConclusionsThe PCS involves almost all organ systems, regardless of the severity of acute COVID-19 illness. Two doses of vaccine help to reduce development of PCS. Research in ContextO_ST_ABSEvidence before this studyC_ST_ABSAlthough the evidence is mounting in prolonged COVID-19 symptoms among COVID-19 survivors, to date, the full range of such post-COVID-19 symptoms (PCS) is not yet fully understood. There is a lack of studies that assessed PCS comprehensively among persons who have recovered from the COVID-19illness. For example, limited data are available on psychosocial, behavioral, and oral manifestations related to PCS. Further, there is a paucity of studies that included a wide range of determinants of PCS and the association of vaccination with the development of PCS across the world. Our study is the first such study conducted among COVID-19 recovered persons who with a majority of them employed in a tertiary health care institute of north India. Added value of this studyOur study, for the first time, investigated a wide range of post-COVID-19 manifestations among COVID-19 recovered persons in organ-specific and psychosocial behavioral aspects, making this the largest categorization of PCS currently (in total 16). The study included telephonic calls to each eligible candidate which helped in ensuring the COVID-19 status at the time of the study. Since the participants either were employees in the hospital or their dependents that enhance the accuracy of reporting PCS. The most prevalent symptom was unspecific PCS (85.6%), e.g., fatigue, followed by musculoskeletal manifestations (49{middle dot}8%), Ear, Nose and Throat symptoms (47{middle dot}5%), neurological (47{middle dot}0%), cardio-respiratory (42{middle dot}4%, gastrointestinal (36{middle dot}2%), ocular symptoms (31{middle dot}9%), dermatological symptoms (31{middle dot}5%), and cardio-vascular (24{middle dot}5%) symptoms, and mental health symptoms (23{middle dot}7%). The rest of the organ specific symptoms were observed in less than 20% of the respondents. Older age, female gender, pre-existing co-morbid, oxygen supplementation during acute illness, the severity of illness, working in health care institutions were associated with PCS. Vaccination after the second dose was protective against PCS compared to non-vaccinated participants. Further, our study also reported a rating of the overall health status among COVID survivors, whereby around 8.3% of them reported being a poor or very poor health. Implications of all the available evidencePCS affects a multi-organ organ system, irrespective of the severity of acute-phase COVID-19 illness and hospitalization. Such persistent COVID-19 symptoms, compounded by its heterogeneity among COVID survivors can pose a substantial burden to the affected individuals and their families and additional challenges for healthcare delivery and public health service. The current study shows that one in three individuals experience persistent COVID-19 symptoms. Since the COVID pandemic is still ongoing across the world, therefore, the number of people experiencing PCS is likely to be increased substantially further. An integrated PCS care strategy, but not limited to organ-specific healthcare disciplines, others such as psychosocial support, including counseling and education, rehabilitation, community-based rehabilitation programs will be required for management. Prioritization of PCS care to elder and co-morbid patients should be recommended. Expediting the vaccination drive will be helpful to reduce the development of persistent COVID-19 symptoms. Research, collaborative and multidisciplinary, is required to understand the underlying pathophysiology mechanism for PCS.

Knowledge, barriers and facilitators regarding COVID-19 vaccine and vaccination programme among the general population: A cross-sectional survey from one thousand two hundred and forty-nine participants.

BACKGROUND AND AIMS: The success of the COVID-19 vaccination program is dependent on people's knowledge and attitude regarding the vaccination program. Higher vaccine acceptance can be ensured by strengthening the facilitators and limiting the barriers being observed among the general population. MATERIAL AND METHODS: Indexed study is a cross-sectional web-based survey using a pre-validated questionnaire to assess knowledge, barriers and facilitators of COVID-19 vaccine and vaccination programme administered on adults across India using a Google online survey platform. RESULTS: A total of 1294 responses (age: 38.02 ± 13.34 years) were collected. Most of the participants had limited knowledge regarding the eligibility of vaccines in vulnerable population groups such as people with allergies (57.89%) and immune-compromised patients (62.98%), pregnant and lactating women (41.89%) and patients with chronic illness (34.78%). Older participants (>45 years) were more willing to take the COVID-19 vaccine (p < 0.001) as they believed the vaccine is not harmful and considered it as societal responsibility. Younger participants (<45 years) and those residing in urban settings raised concerns on the availability of the vaccine and authenticity of the vaccine (p < 0.001). CONCLUSION: There is a scope for improvement in people's knowledge regarding COVID-19 vaccine and the vaccination programme by addressing the barriers and facilitators which can improve the participants' turnover at vaccination centres.

Workload Indicators of Staffing Need as a tool to determine nurse staffing for a high volume academic Emergency Department: An observational study.

INTRODUCTION: Determination of staffing requirement for an Emergency Department (ED) is often difficult due to random arrivals of a complex mix of cases, fluctuating volumes and lengths of stay. Most staffing strategies are based on patient census, lengths of stay, patient dependency or patient classification systems. However, the actual quantity of workload is seldom employed as a basis to calculate staffing. AIM: The aim of this study was to determine the requirement of nurses for a high volume academic ED and to suggest measures to optimally schedule them. METHODOLOGY: Structured interviews were held with ED nurses to list their health service activities, support and additional activities. Time taken for the activities was calculated based on observations and interviews. Records were perused to obtain annual service statistics. Workload Indicators of Staffing Need (WISN) described by World Health Organization was utilized to analyze and determine staffing need. RESULTS: The study identified 34 health service activities, 21 support activities and 3 additional activities to be performed by 125 nurses with a total available working time of 187,250 h for an annual volume of 105,103 patients. The WISN ratio was 0.90 which indicates that the current staff strength was inadequate. The Emergency Department requires 13 more full time staff nurses for it to function optimally. In case of reallocation of certain relevant duties to phlebotomists or nursing assistants, the requirement of staff nurses is 102. Consequently, a skill mix ratio of 82% nurses to 18% nursing assistants and phlebotomists is suggested. DISCUSSION: The Workload Indicators of Staffing Need is a simple, easy to use method that can prospectively measure direct and indirect nursing activities and translate workload into nursing full time equivalents for the ED. This method is also useful to identify activities that do not require nursing professional skills and prescribe the skill mix of staff.

A comparative cost analysis of polytrauma and neurosurgery Intensive Care Units at an apex trauma care facility in India.

CONTEXT: Although Intensive Care Units (ICUs) only account for 10% of the hospital beds, they consume nearly 22% of the hospital resources. Few definitive costing studies have been conducted in Indian settings that would help determine appropriate resource allocation. AIM: The aim of this study was to evaluate and compare the cost of intensive care delivery between multispecialty and neurosurgery ICUs at an apex trauma care facility in India. MATERIALS AND METHODS: The study was conducted in a polytrauma and neurosurgery ICU at a 203-bedded Level IV trauma care facility in New Delhi, India, from May 1, 2012 to June 30, 2012. The study was cross-sectional, retrospective, and record-based. Traditional costing was used to arrive at the cost for both direct and indirect cost estimates. The cost centers included in the study were building cost, equipment cost, human resources, materials and supplies, clinical and nonclinical support services, engineering maintenance cost, and biomedical waste management. STATISTICAL ANALYSIS: Statistical analysis was performed by Fisher's two tailed t-test. RESULTS: Total cost/bed/day for the multispecialty ICU was Rs. 14,976.9/- and for the neurosurgery ICU, it was Rs. 14,306.7/-, workforce constituting nearly half of the expenditure in both ICUs. The cost center wise and overall difference in the cost among the ICUs were statistically significant. CONCLUSIONS: Quantification of expenditure in running an ICU in a trauma center would assist health-care decision makers in better allocation of resources. Although multispecialty ICUs are more cost-effective, other factors will also play a role in defining the kind of ICU that needs to be designed.

Need for a hands-on approach to hand-offs: A study of nursing handovers in an Indian Neurosciences Center.

CONTEXT: Standardized nursing handovers have been known to improve outcome, reduce error, and enhance communication. Few, if any, studies on nursing handovers have been conducted in the India. AIM: The aim was to study nursing handover practices in a Neurosciences Center in India. SUBJECTS AND METHODS: This study was conducted in a 200 bedded public sector Neurosciences Center in New Delhi, to assess nursing handover practices across five wards, all shifts, weekdays, and weekends using a pretested checklist. Ten elements were observed under the categories of time, duration, process, nurse interaction, and patient communication. STATISTICAL ANALYSIS: Analysis of variance, Z-test, and Spearman's correlation coefficient. RESULTS: Totally, 525 nursing handovers revealed varying compliance levels among (63%) time, place (76%), process (82%), staff interaction (53%), and patient communication (44%) related elements. Poorer compliance was seen in morning shifts and weekends; the difference being statistically significant. Bedside handovers were more frequent during weekends and night shifts and were positively correlated with increased staff interaction and patient communication and negatively related to handover duration. Though nurses showed better adherence to process related elements, background patient information, and assessment was explained less frequently. Differences between wards were insignificant except in categories of nurse interaction and patient communication which was better in the neurosurgery than neurology wards. CONCLUSION: Study revealed a need for a system change and standardization of handovers. Greater administrative commitment, use of technology, training, and leadership development will aid in continuity of care, promote patient safety, and ensure better outcomes.

Does a single specialty intensive care unit make better business sense than a multi-specialty intensive care unit? A costing study in a trauma center in India.

CONTEXT: Though intensive care units (ICUs) only account for 10% of hospital beds, they consume nearly 22% of hospital resources. Few definitive costing studies have been conducted in Indian settings that would help determine appropriate resource allocation. AIM: To evaluate and compare the cost of intensive care delivery between multi-specialty and neurosurgery ICU in an apex trauma care facility in India. MATERIALS AND METHODS: The study was conducted in a polytrauma and neurosurgery ICU at a 203 bedded level IV trauma care facility in New Delhi, India from May, 2012 to June 2012. The study was cross-sectional, retrospective, and record-based. Traditional costing was used to arrive at the cost for both direct and indirect cost estimates. The cost centers included in study were building cost, equipment cost, human resources, materials and supplies, clinical and nonclinical support services, engineering maintenance cost, and biomedical waste management. STATISTICAL ANALYSIS: Fisher's two-tailed t-test. RESULTS: Total cost/bed/day for the multi-specialty ICU was Rs. 14,976.9/- and for the neurosurgery ICU was Rs. 14,306.7/-, manpower constituting nearly half of the expenditure in both ICUs. The cost center wise and overall difference in the cost among the ICUs were statistically significant. CONCLUSIONS: Quantification of expenditure in running an ICU in a trauma center would assist healthcare decision makers in better allocation of resources. Although multi-specialty ICUs are more expensive, other factors will also play a role in defining the kind of ICU that need to be designed.