Simvastatin in Critically Ill Patients with Covid-19.

BACKGROUND: The efficacy of simvastatin in critically ill patients with coronavirus disease 2019 (Covid-19) is unclear. METHODS: In an ongoing international, multifactorial, adaptive platform, randomized, controlled trial, we evaluated simvastatin (80 mg daily) as compared with no statin (control) in critically ill patients with Covid-19 who were not receiving statins at baseline. The primary outcome was respiratory and cardiovascular organ support-free days, assessed on an ordinal scale combining in-hospital death (assigned a value of -1) and days free of organ support through day 21 in survivors; the analyis used a Bayesian hierarchical ordinal model. The adaptive design included prespecified statistical stopping criteria for superiority (>99% posterior probability that the odds ratio was >1) and futility (>95% posterior probability that the odds ratio was <1.2). RESULTS: Enrollment began on October 28, 2020. On January 8, 2023, enrollment was closed on the basis of a low anticipated likelihood that prespecified stopping criteria would be met as Covid-19 cases decreased. The final analysis included 2684 critically ill patients. The median number of organ support-free days was 11 (interquartile range, -1 to 17) in the simvastatin group and 7 (interquartile range, -1 to 16) in the control group; the posterior median adjusted odds ratio was 1.15 (95% credible interval, 0.98 to 1.34) for simvastatin as compared with control, yielding a 95.9% posterior probability of superiority. At 90 days, the hazard ratio for survival was 1.12 (95% credible interval, 0.95 to 1.32), yielding a 91.9% posterior probability of superiority of simvastatin. The results of secondary analyses were consistent with those of the primary analysis. Serious adverse events, such as elevated levels of liver enzymes and creatine kinase, were reported more frequently with simvastatin than with control. CONCLUSIONS: Although recruitment was stopped because cases had decreased, among critically ill patients with Covid-19, simvastatin did not meet the prespecified criteria for superiority to control. (REMAP-CAP ClinicalTrials.gov number, NCT02735707.).

Non-COVID-19 intensive care admissions during the pandemic: a multinational registry-based study.

BACKGROUND: The COVID-19 pandemic resulted in a large number of critical care admissions. While national reports have described the outcomes of patients with COVID-19, there is limited international data of the pandemic impact on non-COVID-19 patients requiring intensive care treatment. METHODS: We conducted an international, retrospective cohort study using 2019 and 2020 data from 11 national clinical quality registries covering 15 countries. Non-COVID-19 admissions in 2020 were compared with all admissions in 2019, prepandemic. The primary outcome was intensive care unit (ICU) mortality. Secondary outcomes included in-hospital mortality and standardised mortality ratio (SMR). Analyses were stratified by the country income level(s) of each registry. FINDINGS: Among 1 642 632 non-COVID-19 admissions, there was an increase in ICU mortality between 2019 (9.3%) and 2020 (10.4%), OR=1.15 (95% CI 1.14 to 1.17, p<0.001). Increased mortality was observed in middle-income countries (OR 1.25 95% CI 1.23 to 1.26), while mortality decreased in high-income countries (OR=0.96 95% CI 0.94 to 0.98). Hospital mortality and SMR trends for each registry were consistent with the observed ICU mortality findings. The burden of COVID-19 was highly variable, with COVID-19 ICU patient-days per bed ranging from 0.4 to 81.6 between registries. This alone did not explain the observed non-COVID-19 mortality changes. INTERPRETATION: Increased ICU mortality occurred among non-COVID-19 patients during the pandemic, driven by increased mortality in middle-income countries, while mortality decreased in high-income countries. The causes for this inequity are likely multi-factorial, but healthcare spending, policy pandemic responses, and ICU strain may play significant roles.

Prognostic evaluation of quick sequential organ failure assessment score in ICU patients with sepsis across different income settings.

BACKGROUND: There is conflicting evidence on association between quick sequential organ failure assessment (qSOFA) and sepsis mortality in ICU patients. The primary aim of this study was to determine the association between qSOFA and 28-day mortality in ICU patients admitted for sepsis. Association of qSOFA with early (3-day), medium (28-day), late (90-day) mortality was assessed in low and lower middle income (LLMIC), upper middle income (UMIC) and high income (HIC) countries/regions. METHODS: This was a secondary analysis of the MOSAICS II study, an international prospective observational study on sepsis epidemiology in Asian ICUs. Associations between qSOFA at ICU admission and mortality were separately assessed in LLMIC, UMIC and HIC countries/regions. Modified Poisson regression was used to determine the adjusted relative risk (RR) of qSOFA score on mortality at 28 days with adjustments for confounders identified in the MOSAICS II study. RESULTS: Among the MOSAICS II study cohort of 4980 patients, 4826 patients from 343 ICUs and 22 countries were included in this secondary analysis. Higher qSOFA was associated with increasing 28-day mortality, but this was only observed in LLMIC (p < 0.001) and UMIC (p < 0.001) and not HIC (p = 0.220) countries/regions. Similarly, higher 90-day mortality was associated with increased qSOFA in LLMIC (p < 0.001) and UMIC (p < 0.001) only. In contrast, higher 3-day mortality with increasing qSOFA score was observed across all income countries/regions (p < 0.001). Multivariate analysis showed that qSOFA remained associated with 28-day mortality (adjusted RR 1.09 (1.00-1.18), p = 0.038) even after adjustments for covariates including APACHE II, SOFA, income country/region and administration of antibiotics within 3 h. CONCLUSIONS: qSOFA was independently associated with 28-day mortality in ICU patients admitted for sepsis. In LLMIC and UMIC countries/regions, qSOFA was associated with early to late mortality but only early mortality in HIC countries/regions.

Epidemiology, Management, and Outcomes of Sepsis in ICUs among Countries of Differing National Wealth across Asia.

Rationale: Directly comparative data on sepsis epidemiology and sepsis bundle implementation in countries of differing national wealth remain sparse. Objectives: To evaluate across countries/regions of differing income status in Asia 1) the prevalence, causes, and outcomes of sepsis as a reason for ICU admission and 2) sepsis bundle (antibiotic administration, blood culture, and lactate measurement) compliance and its association with hospital mortality. Methods: A prospective point prevalence study was conducted among 386 adult ICUs from 22 Asian countries/regions. Adult ICU participants admitted for sepsis on four separate days (representing the seasons of 2019) were recruited. Measurements and Main Results: The overall prevalence of sepsis in ICUs was 22.4% (20.9%, 24.5%, and 21.3% in low-income countries/regions [LICs]/lower middle-income countries/regions [LMICs], upper middle-income countries/regions, and high-income countries/regions [HICs], respectively; P < 0.001). Patients were younger and had lower severity of illness in LICs/LMICs. Hospital mortality was 32.6% and marginally significantly higher in LICs/LMICs than HICs on multivariable generalized mixed model analysis (adjusted odds ratio, 1.84; 95% confidence interval, 1.00-3.37; P = 0.049). Sepsis bundle compliance was 21.5% at 1 hour (26.0%, 22.1%, and 16.2% in LICs/LMICs, upper middle-income countries/regions, and HICs, respectively; P < 0.001) and 36.6% at 3 hours (39.3%, 32.8%, and 38.5%, respectively; P = 0.001). Delaying antibiotic administration beyond 3 hours was the only element independently associated with increased mortality (adjusted odds ratio, 2.53; 95% confidence interval, 2.07-3.08; P < 0.001). Conclusions: Sepsis is a common cause of admission to Asian ICUs. Mortality remains high and is higher in LICs/LMICs after controlling for confounders. Sepsis bundle compliance remains low. Delaying antibiotic administration beyond 3 hours from diagnosis is associated with increased mortality. Clinical trial registered with www.ctri.nic.in (CTRI/2019/01/016898).

Medical Masks Versus N95 Respirators for Preventing COVID-19 Among Health Care Workers : A Randomized Trial.

BACKGROUND: It is uncertain if medical masks offer similar protection against COVID-19 compared with N95 respirators. OBJECTIVE: To determine whether medical masks are noninferior to N95 respirators to prevent COVID-19 in health care workers providing routine care. DESIGN: Multicenter, randomized, noninferiority trial. (ClinicalTrials.gov: NCT04296643). SETTING: 29 health care facilities in Canada, Israel, Pakistan, and Egypt from 4 May 2020 to 29 March 2022. PARTICIPANTS: 1009 health care workers who provided direct care to patients with suspected or confirmed COVID-19. INTERVENTION: Use of medical masks versus fit-tested N95 respirators for 10 weeks, plus universal masking, which was the policy implemented at each site. MEASUREMENTS: The primary outcome was confirmed COVID-19 on reverse transcriptase polymerase chain reaction (RT-PCR) test. RESULTS: In the intention-to-treat analysis, RT-PCR-confirmed COVID-19 occurred in 52 of 497 (10.46%) participants in the medical mask group versus 47 of 507 (9.27%) in the N95 respirator group (hazard ratio [HR], 1.14 [95% CI, 0.77 to 1.69]). An unplanned subgroup analysis by country found that in the medical mask group versus the N95 respirator group RT-PCR-confirmed COVID-19 occurred in 8 of 131 (6.11%) versus 3 of 135 (2.22%) in Canada (HR, 2.83 [CI, 0.75 to 10.72]), 6 of 17 (35.29%) versus 4 of 17 (23.53%) in Israel (HR, 1.54 [CI, 0.43 to 5.49]), 3 of 92 (3.26%) versus 2 of 94 (2.13%) in Pakistan (HR, 1.50 [CI, 0.25 to 8.98]), and 35 of 257 (13.62%) versus 38 of 261 (14.56%) in Egypt (HR, 0.95 [CI, 0.60 to 1.50]). There were 47 (10.8%) adverse events related to the intervention reported in the medical mask group and 59 (13.6%) in the N95 respirator group. LIMITATION: Potential acquisition of SARS-CoV-2 through household and community exposure, heterogeneity between countries, uncertainty in the estimates of effect, differences in self-reported adherence, differences in baseline antibodies, and between-country differences in circulating variants and vaccination. CONCLUSION: Among health care workers who provided routine care to patients with COVID-19, the overall estimates rule out a doubling in hazard of RT-PCR-confirmed COVID-19 for medical masks when compared with HRs of RT-PCR-confirmed COVID-19 for N95 respirators. The subgroup results varied by country, and the overall estimates may not be applicable to individual countries because of treatment effect heterogeneity. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research, World Health Organization, and Juravinski Research Institute.

Determinants of Implementation of a Critical Care Registry in Asia: Lessons From a Qualitative Study.

BACKGROUND: The Collaboration for Research, Implementation, and Training in Critical Care in Asia (CCA) is implementing a critical care registry to capture real-time data to facilitate service evaluation, quality improvement, and clinical studies. OBJECTIVE: The purpose of this study is to examine stakeholder perspectives on the determinants of implementation of the registry by examining the processes of diffusion, dissemination, and sustainability. METHODS: This study is a qualitative phenomenological inquiry using semistructured interviews with stakeholders involved in registry design, implementation, and use in 4 South Asian countries. The conceptual model of diffusion, dissemination, and sustainability of innovations in health service delivery guided interviews and analysis. Interviews were coded using the Rapid Identification of Themes from Audio recordings procedure and were analyzed based on the constant comparison approach. RESULTS: A total of 32 stakeholders were interviewed. Analysis of stakeholder accounts identified 3 key themes: innovation-system fit; influence of champions; and access to resources and expertise. Determinants of implementation included data sharing, research experience, system resilience, communication and networks, and relative advantage and adaptability. CONCLUSIONS: The implementation of the registry has been possible due to efforts to increase the innovation-system fit, influence of motivated champions, and the support offered by access to resources and expertise. The reliance on individuals and the priorities of other health care actors pose a risk to sustainability.

Intravenous Vitamin C for Patients Hospitalized With COVID-19: Two Harmonized Randomized Clinical Trials.

Importance: The efficacy of vitamin C for hospitalized patients with COVID-19 is uncertain. Objective: To determine whether vitamin C improves outcomes for patients with COVID-19. Design, Setting, and Participants: Two prospectively harmonized randomized clinical trials enrolled critically ill patients receiving organ support in intensive care units (90 sites) and patients who were not critically ill (40 sites) between July 23, 2020, and July 15, 2022, on 4 continents. Interventions: Patients were randomized to receive vitamin C administered intravenously or control (placebo or no vitamin C) every 6 hours for 96 hours (maximum of 16 doses). Main Outcomes and Measures: The primary outcome was a composite of organ support-free days defined as days alive and free of respiratory and cardiovascular organ support in the intensive care unit up to day 21 and survival to hospital discharge. Values ranged from -1 organ support-free days for patients experiencing in-hospital death to 22 organ support-free days for those who survived without needing organ support. The primary analysis used a bayesian cumulative logistic model. An odds ratio (OR) greater than 1 represented efficacy (improved survival, more organ support-free days, or both), an OR less than 1 represented harm, and an OR less than 1.2 represented futility. Results: Enrollment was terminated after statistical triggers for harm and futility were met. The trials had primary outcome data for 1568 critically ill patients (1037 in the vitamin C group and 531 in the control group; median age, 60 years [IQR, 50-70 years]; 35.9% were female) and 1022 patients who were not critically ill (456 in the vitamin C group and 566 in the control group; median age, 62 years [IQR, 51-72 years]; 39.6% were female). Among critically ill patients, the median number of organ support-free days was 7 (IQR, -1 to 17 days) for the vitamin C group vs 10 (IQR, -1 to 17 days) for the control group (adjusted proportional OR, 0.88 [95% credible interval {CrI}, 0.73 to 1.06]) and the posterior probabilities were 8.6% (efficacy), 91.4% (harm), and 99.9% (futility). Among patients who were not critically ill, the median number of organ support-free days was 22 (IQR, 18 to 22 days) for the vitamin C group vs 22 (IQR, 21 to 22 days) for the control group (adjusted proportional OR, 0.80 [95% CrI, 0.60 to 1.01]) and the posterior probabilities were 2.9% (efficacy), 97.1% (harm), and greater than 99.9% (futility). Among critically ill patients, survival to hospital discharge was 61.9% (642/1037) for the vitamin C group vs 64.6% (343/531) for the control group (adjusted OR, 0.92 [95% CrI, 0.73 to 1.17]) and the posterior probability was 24.0% for efficacy. Among patients who were not critically ill, survival to hospital discharge was 85.1% (388/456) for the vitamin C group vs 86.6% (490/566) for the control group (adjusted OR, 0.86 [95% CrI, 0.61 to 1.17]) and the posterior probability was 17.8% for efficacy. Conclusions and Relevance: In hospitalized patients with COVID-19, vitamin C had low probability of improving the primary composite outcome of organ support-free days and hospital survival. Trial Registration: ClinicalTrials.gov Identifiers: NCT04401150 (LOVIT-COVID) and NCT02735707 (REMAP-CAP).

Respiratory support in patients with severe COVID-19 in the International Severe Acute Respiratory and Emerging Infection (ISARIC) COVID-19 study: a prospective, multinational, observational study.

BACKGROUND: Up to 30% of hospitalised patients with COVID-19 require advanced respiratory support, including high-flow nasal cannulas (HFNC), non-invasive mechanical ventilation (NIV), or invasive mechanical ventilation (IMV). We aimed to describe the clinical characteristics, outcomes and risk factors for failing non-invasive respiratory support in patients treated with severe COVID-19 during the first two years of the pandemic in high-income countries (HICs) and low middle-income countries (LMICs). METHODS: This is a multinational, multicentre, prospective cohort study embedded in the ISARIC-WHO COVID-19 Clinical Characterisation Protocol. Patients with laboratory-confirmed SARS-CoV-2 infection who required hospital admission were recruited prospectively. Patients treated with HFNC, NIV, or IMV within the first 24 h of hospital admission were included in this study. Descriptive statistics, random forest, and logistic regression analyses were used to describe clinical characteristics and compare clinical outcomes among patients treated with the different types of advanced respiratory support. RESULTS: A total of 66,565 patients were included in this study. Overall, 82.6% of patients were treated in HIC, and 40.6% were admitted to the hospital during the first pandemic wave. During the first 24 h after hospital admission, patients in HICs were more frequently treated with HFNC (48.0%), followed by NIV (38.6%) and IMV (13.4%). In contrast, patients admitted in lower- and middle-income countries (LMICs) were less frequently treated with HFNC (16.1%) and the majority received IMV (59.1%). The failure rate of non-invasive respiratory support (i.e. HFNC or NIV) was 15.5%, of which 71.2% were from HIC and 28.8% from LMIC. The variables most strongly associated with non-invasive ventilation failure, defined as progression to IMV, were high leukocyte counts at hospital admission (OR [95%CI]; 5.86 [4.83-7.10]), treatment in an LMIC (OR [95%CI]; 2.04 [1.97-2.11]), and tachypnoea at hospital admission (OR [95%CI]; 1.16 [1.14-1.18]). Patients who failed HFNC/NIV had a higher 28-day fatality ratio (OR [95%CI]; 1.27 [1.25-1.30]). CONCLUSIONS: In the present international cohort, the most frequently used advanced respiratory support was the HFNC. However, IMV was used more often in LMIC. Higher leucocyte count, tachypnoea, and treatment in LMIC were risk factors for HFNC/NIV failure. HFNC/NIV failure was related to worse clinical outcomes, such as 28-day mortality. Trial registration This is a prospective observational study; therefore, no health care interventions were applied to participants, and trial registration is not applicable.

Adequacy of nutritional support in critically ill patients post implementation of nutritional protocols in surgical intensive care unit of a university hospital.

OBJECTIVE: To evaluate improvement in nutrition support therapy after the implementation of nutritional protocols in critically ill surgical patients. METHODS: The ambidirectional study was conducted at the surgical intensive care unit of Aga Khan University Hospital, Karachi, using an evidenced-based nutritional protocol. The pre-protocol retrospective data group A comprised patient records from July to September 2018, while the post-protocol prospective data group B related to the period between October and December 2018. Both data sets involved patients of either gender aged at least 18 years who needed admission to surgical intensive care unit and were unable to take oral nutrition for >2 days and remained under intensive care for up to seven days. Data was analysed using SPSS 21. RESULTS: Of the 65 patients, 30(46.2%) were in group A; 21(70%) males and 9(30%) females with mean age 40±16.55 years (range: 18-80 years). The remaining 35(53.8%) were in group B; 27(77%) males and 8(23%) females with mean age 48.66±17.7 years (range: 18-86 years). Nutritional screening indicated that 16(53.3%) patients in group A and 35(100%) in group B were at the risk of developing malnutrition. Patients receiving enteral nutrition within 24 hours of admission increased from 7(23.35%) in group A to 17 (48.3%) in group B. Overall, the amount of enterally administered calories increased from mean 321057±2495 kcal (29.6%) in group A to mean 384585±2343 (92.6%) in group B. The amount of protein administered increased from mean 622.2±148.7 kcal (14.7%) in group A to mean 549±125.48 kcal (67.1%) in group B. CONCLUSIONS: Implementation of nutritional protocol resulted in improved delivery of nutritional support in thesurgical intensive care unit.

Visiting and Communication Policy in Intensive Care Units during COVID-19 Pandemic: A Cross-sectional Survey from South Asia and the Middle East.

Purpose: The coronavirus disease-2019 (COVID-19) pandemic had affected the visiting or communicating policies for family members. We surveyed the intensive care units (ICUs) in South Asia and the Middle East to assess the impact of the COVID-19 pandemic on visiting and communication policies. Materials and method: A web-based cross-sectional survey was used to collect data between March 22, 2021, and April 7, 2021, from healthcare professionals (HCP) working in COVID and non-COVID ICUs (one response per ICU). The topics of the questionnaire included current and pre-pandemic policies on visiting, communication, informed consent, and end-of-life care in ICUs. Results: A total of 292 ICUs (73% of COVID ICUs) from 18 countries were included in the final analysis. Most (92%) of ICUs restricted their visiting hours, and nearly one-third (32.3%) followed a "no-visitor" policy. There was a significant change in the daily visiting duration in COVID ICUs compared to the pre-pandemic times (p = 0.011). There was also a significant change (p <0.001) in the process of informed consent and end-of-life discussions during the ongoing pandemic compared to pre-pandemic times. Conclusion: Visiting and communication policies of the ICUs had significantly changed during the COVID-19 pandemic. Future studies are needed to understand the sociopsychological and medicolegal implications of revised policies. How to cite this article: Chanchalani G, Arora N, Nasa P, Sodhi K, Al Bahrani MJ, Al Tayar A, et al. Visiting and Communication Policy in Intensive Care Units during COVID-19 Pandemic: A Cross-sectional Survey from South Asia and the Middle East. Indian J Crit Care Med 2022;26(3):268-275.

Critical Care Bed Capacity in Asian Countries and Regions.

OBJECTIVE: To assess the number of adult critical care beds in Asian countries and regions in relation to population size. DESIGN: Cross-sectional observational study. SETTING: Twenty-three Asian countries and regions, covering 92.1% of the continent's population. PARTICIPANTS: Ten low-income and lower-middle-income economies, five upper-middle-income economies, and eight high-income economies according to the World Bank classification. INTERVENTIONS: Data closest to 2017 on critical care beds, including ICU and intermediate care unit beds, were obtained through multiple means, including government sources, national critical care societies, colleges, or registries, personal contacts, and extrapolation of data. MEASUREMENTS AND MAIN RESULTS: Cumulatively, there were 3.6 critical care beds per 100,000 population. The median number of critical care beds per 100,000 population per country and region was significantly lower in low- and lower-middle-income economies (2.3; interquartile range, 1.4-2.7) than in upper-middle-income economies (4.6; interquartile range, 3.5-15.9) and high-income economies (12.3; interquartile range, 8.1-20.8) (p = 0.001), with a large variation even across countries and regions of the same World Bank income classification. This number was independently predicted by the World Bank income classification on multivariable analysis, and significantly correlated with the number of acute hospital beds per 100,000 population (r = 0.19; p = 0.047), the universal health coverage service coverage index (r = 0.35; p = 0.003), and the Human Development Index (r = 0.40; p = 0.001) on univariable analysis. CONCLUSIONS: Critical care bed capacity varies widely across Asia and is significantly lower in low- and lower-middle-income than in upper-middle-income and high-income countries and regions.

INCIDENCE, OUTCOME AND RISK FACTORS FOR SEPSIS--A TWO YEAR RETROSPECTIVE STUDY AT SURGICAL INTENSIVE CARE UNIT OF A TEACHING HOSPITAL IN PAKISTAN.

BACKGROUND: Sepsis is amongst the leading causes of admission to the intensive care units and is associated with a high mortality. However, data from developing countries is scares. Aim of conducting this study was to determine the incidence, outcome and risk factors for sepsis on admission to surgical intensive care unit (SICU) of a teaching hospital in Pakistan. METHODS: Two year retrospective observational study included all consecutive adult admissions to the surgical intensive care unit (SICU) of a University Hospital, from January 2012 to December 2013. RESULTS: Two hundred and twenty-nine patients met the inclusion criteria. Average age of the patients was 46.35 ± 18.23 years (16-85), mean Acute Physiology and Chronic Health Evaluation II (APACHE II) score was 15.92 ± 8.13 and males were 67.6%. Median length of ICU stay was 4 [IQR 5]. 43% patients fulfilled the criteria of sepsis at the time of admission to the SICU and incidence of severe sepsis/septic shock was 35%. Abdominal sepsis was the most frequent source of infection (57.5%). The overall intensive care unit mortality was 32.31% but the mortality of sepsis-group was 51.15% as compared to 17.7% of the non- sepsis group. Stepwise logistic regression model showed that increasing age, female gender, non-operative admission, admission under general surgery and co-morbidities like ischaemic heart disease and chronic kidney disease were significant predictors of sepsis. CONCLUSION: The incidence of sepsis and severe sepsis/septic shock, on admission to SICU is high and mortality of the sepsis group is nearly three times the mortality of the non-sepsis group.

Anticipated and unanticipated complications of severe dengue in a primigravida.

As the incidence of dengue is rising among adults more cases of dengue fever are being reported during pregnancy. Physiological changes of pregnancy mask the pathognomonic features of severe dengue such as increased hematocrit, thrombocytopenia, and leukopenia and a high index of suspicion are required in endemic areas. Massive hemorrhage may complicate operative deliveries in unsuspected patients. World Health Organization recommends that all patients with severe dengue should be admitted to a hospital with access to intensive care facilities and blood transfusion. We present the successful management of hemorrhage and unanticipated complications of severe dengue in a young primigravida admitted to the Intensive Care Unit after an emergency cesarean section.

Establishment of a patient and public involvement and engagement group to support clinical trials in Pakistan: Initial lessons learned.

BACKGROUND: Patient and public involvement and engagement (PPIE) in clinical trials is increasingly recognized as vital for ensuring research relevance and accessibility. Despite its proven benefits, PPIE remains limited, particularly in low- and middle-income countries, and more examples of effective strategies for involvement are needed. This commentary outlines the establishment of a PPIE group for clinical trials in a lower-middle-income country setting with limited research infrastructure. MAIN BODY: We established Pakistan's first ever PPIE group for clinical trials within a new clinical trials unit at Ziauddin University in Karachi. The objectives of our project were focused on group formation, redesign of informed consent documents for trials, and dissemination of trial results to the public. Recruitment strategies involved referrals from clinicians and existing collaborators as well as engagement at public events, distribution of advertising leaflets and social media posts. Ten potential members were selected based on motivation, commitment and ability to contribute critically, with six members continuing their involvement long-term. An existing tool designed to establish the access needs of public partners was adapted to our project to help us document and account for members' expectations and support requirements. The process of using the tool enabled deep engagement, clarified roles, and fostered trust between coordinators and group members. Patient and public members gained confidence about the legitimacy of the project and felt more comfortable participating in the first group meeting. Lessons learned emphasize the importance of wide-ranging engagement efforts and transparent discussions about expectations to build effective collaborative relationships. CONCLUSION: Our experience demonstrates the feasibility of establishing a PPIE group for clinical trials in Pakistan and highlights strong public interest for research involvement. The use of a formal tool to document needs, prior experiences and expectations encouraged relationship-building and helped coordinators make relevant accommodations for members. This account contributes to the growing body of literature on effective PPIE practices, emphasizing the value of tailored support and transparent communication in facilitating meaningful public involvement in clinical trials.

Working together with patients and members of the public has the potential of making clinical trials better, more person-centered and relevant. Unfortunately, partnerships between trial researchers and the public are still uncommon. It is not known what the best ways are to involve the public in clinical trials, especially when it comes to non-Western populations. We set up the first-ever patient and public involvement and engagement group to support clinical trials in Pakistan. In this commentary, we share our initial experiences of successfully establishing the group and the two main lessons we learned. Ten group members were identified by widely advertising our project to doctors, community organizations, patients and their carers at our hospital. Before the first group meeting, two coordinators met with each potential member to discuss and document their interests, expectations and needs. Both researchers and group members felt that these discussions were a good use of their time and helped make the project a success. The first main lesson learned from our experience was that enough time, funding, staff and resources are needed to identify members and build meaningful collaborative partnerships. The second main lesson learned was that honest discussions are needed at the very beginning of a collaboration about expectations. Our experience shows that involving patients and members of the public in clinical trials in Pakistan is possible and we hope it inspires and helps other researchers in their patient and public engagement efforts.

Factors associated with emergency department disposition among burn injury patients: Analysis of prehospital and emergency care characteristics using South Asia Burn Registry (SABR) data.

INTRODUCTION: Improvement in burn injury data collections and the quality of databanks has allowed meaningful study of the epidemiologic trends in burn care. The study assessed factors associated with disposition of burn injury patients from emergency department accounting for pre-hospital care and emergency care. METHODS: This prospective observational pilot study of the South Asia Burn Registry project was conducted at selected public sector burn centers in Bangladesh and Pakistan (September 2014 - January 2015). All age groups with an initial presentation to the burn centers were enrolled. Descriptive and regression analysis is presented. RESULTS: A total of 2749 patients were enrolled. The mean age was 21.7 ± 18.0 years, 55.3% were males, and about a quarter were children < 5 years. About 46.9% of the females were housewives. Scald burns were common among children (67.6%) while flame burns were common among adults (44.3%). About 75% of patients were brought in via non-ambulance mode of transport. More than 55% of patients were referrals from other facilities or clinics. The most common first aid given pre-hospital was the use of water or oil. About 25% were admitted for further care. The adjusted odds of being admitted compared to being sent home were highest for children < 5 yrs, those with higher total body surface area burnt, having arrived via ambulance, scald and electrical burn, having an associated injury and inhalational injury. CONCLUSION: The study provides insight into emergency burn care and associated factors that influenced outcomes for patients with burn injuries.

Burns in South Asia: Outcomes from South Asian Burn Registry (SABR).

BACKGROUND: South Asian region contributes 59 % to the global mortality due to burns. However, we find a paucity of literature on the outcomes of burns from low- and middle-income countries (LMICs). South Asian Burn Registry (SABR) is a facility-based burns registry that collected data on in-patient burn care. This study assesses factors associated with mortality, length of hospital stay at the burns center, and functional status of burn patients. METHODS: Prospective data was collected from two specialized public sector burn centers between September 2014 - January 2015 from Bangladesh and Pakistan. Multivariable logistic, linear, and ordinal logistic regression was conducted to assess factors associated with inpatient-mortality, length of hospital stay, and functional status at discharge, respectively. RESULTS: Data on 883 patients was analyzed. Increased association with mortality was observed with administration of blood product (OR:3, 95 % CI:1.18-7.58) and nutritional support (OR:4.32, 95 % CI:1.55-12.02). Conversely, antibiotic regimens greater than 8 days was associated with decreased mortality (OR:0.1, 95 % CI:0.03-0.41). Associated increase in length of hospital stay was observed in patients with trauma associated with their burn injury, history of seizures (CE:47.93, 95 % CI 12.05-83.80), blood product (CE:22.09, 95 % CI:0.83-43.35) and oxygen administration (CE:23.7, 95 % CI:7.34-40.06). Patients who developed sepsis (OR:6.89, 95 % CI:1.92-24.73) and received blood products during hospitalization (OR:2.55, 95 % CI:1.38- 4.73) were more likely to have poor functional status at discharge. CONCLUSION: This study identified multiple factors associated with worse clinical outcomes for burn patients in South Asia. Understanding these parameters can guide targeted efforts to improve the process and quality of burn care in LMICs.

Critical care bed capacity in Asian countries and regions before and during the COVID-19 pandemic: an observational study.

Background: The coronavirus disease 2019 (COVID-19) pandemic highlighted the importance of critical care. The aim of the current study was to compare the number of adult critical care beds in relation to population size in Asian countries and regions before (2017) and during (2022) the pandemic. Methods: This observational study collected data closest to 2022 on critical care beds (intensive care units and intermediate care units) in 12 middle-income and 7 high-income economies (using the 2022-2023 World Bank classification), through a mix of methods including government sources, national critical care societies, personal contacts, and data extrapolation. Data were compared with a prior study from 2017 of the same countries and regions. Findings: The cumulative number of critical care beds per 100,000 population increased from 3.0 in 2017 to 9.4 in 2022 (p = 0.003). The median figure for middle-income economies increased from 2.6 (interquartile range [IQR] 1.7-7.8) to 6.6 (IQR 2.2-13.3), and that for high-income economies increased from 11.4 (IQR 7.3-22.8) to 13.9 (IQR 10.7-21.7). Only 3 countries did not see a rise in bed capacity. Where data were available in 2022, 10.9% of critical care beds were in single rooms (median 5.0% in middle-income and 20.3% in high-income economies), and 5.3% had negative pressure (median 0.7% in middle-income and 18.5% in high-income economies). Interpretation: Critical care bed capacity in the studied Asian countries and regions increased close to three-fold from 2017 to 2022. Much of this increase was attributed to middle-income economies, but substantial heterogeneity exists. Funding: None.