Indian Council For Medical Research Research Articles

Effect of scapular and shoulder strengthening exercises on prevention of upper limb lymphedema – a pilot study

Background. The most frequent type of cancer among women is breast cancer. According to the report published by Indian Council for Medical Research (ICMR, 2019), there are 1.5 lakh new instances of breast cancer nationwide and around 70,000 people in India die from breast cancer each year. Secondary lymphedema (SL) following breast cancer surgery can occur due to the removal of lymph nodes during breast cancer surgery. Objective. This pilot study was done with the objectives to improve the strength of scapular and shoulder muscles, increase the shoulder range of motion, prevent the development of upper limb lymphedema, to reduce shoulder pain and disability and to improve the quality of life among women who underwent breast cancer surgery. Methodology. Ten patients with a mean age of 49.9 ± 8.6 and mean Body mass index (BMI) of 28.4 ± 3.9 were included according to the inclusion and exclusion criteria. They were randomized into interventional group (Group A n = 5) and conventional group (Group B n = 5). The interventional group performed the routine exercises prescribed along with the scapular and shoulder muscle strengthening exercises, while the conventional group performed only the routine exercises for 12 weeks. Result. The mean change score values of the outcome variables of both the groups were analyzed using Independent ‘t’ test. Discussion. Arm circumference measurement, shoulder pain, disability and quality of life measures showed significant difference between groups at p < 0.05. Shoulder range of motion, muscle strength and arm volumetry did not show much difference between groups indicating the need for long term continuation of the exercises to produce improvement in those parameters. Conclusion. Long term effect of strengthening exercises will have an effect on improvement of shoulder range of motion, arm volume and muscle strength among the women following breast cancer surgery. Strengthening exercises should be recommended as a part of breast cancer rehabilitation protocol to prevent secondary lymphedema and other postsurgical complications.

Exploring Partial Disclosure in Research: Challenges, Justifications, and Recommendations for Ethical Oversight

AbstractDeception in research is contentious, as ethical codes stress informed consent, yet complete disclosure may jeopardise validity. Indian Council for Medical Research (ICMR) guidelines classify deception into active, incomplete, and authorised forms. This study explores the ethical justification for incomplete (partial disclosure), permissible instances, and the dilemma faced by ethics committees in balancing scientific rigour and participant protection. The qualitative, non-experimental cross-sectional research, using in-depth interviews, identifies themes through thematic analysis. Findings reveal challenges for ethics committees, as incomplete information hampers understanding, amongst others. The paper proposes an ethics committee framework, urging researchers to minimise or avoid partial deception and recommending institutional awareness campaigns and standard operating procedures for minimal-harm studies using partial disclosure. Therefore, it proposes that partial disclosure should be justified by the 3Vs—value, validity, and veracity to preserve research integrity.

Navigating COVID-19 Treatment: CT Scans, Steroids, and Medical Practice Challenges in India

India is facing a severe challenge with the second wave of COVID-19, surpassing two crore cases. Individual treatment varies based on infection severity, with guidelines from the Indian Council for Medical Research (ICMR) advising against unnecessary RT-PCR testing, even for interstate travelers. However, the indiscriminate use of CT scans and steroids poses risks, cautioned by experts like Dr. Randeep Guleria. Overuse of CT scans, equivalent to 300 X-rays, leads to radiation exposure and potential cancer risks. Steroids, beneficial in severe cases, are misused in mild infections, increasing susceptibility to fungal infections. Balancing timely intervention and avoiding undue harm is crucial. Additionally, curbing reliance on costly and unnecessary tests like CT scans and IL-6 tests is essential to prevent patient confusion and long-term health risks.

A REVIEW ON INTEGRATED APPROACH IN CHILDHOOD MALIGNANCIES-PREVENTION AND CONTROL

Introduction: Cancer has become a huge concern since it is the second-leading cause of death in poor nations and the primary cause in economically developed countries. According to the WHO, cancer has become the deadliest killer in the world and is one of the deadliest diseases of the twenty-first century. According to the World Health Organization, India accounts for at least 20% of the world's burden of paediatric cancer, with about 75,000 children diagnosed with the disease annually. According to the Indian Council for medical research, 5.5% of all cancer cases in India include youngsters. Paediatric cancer may primarily be examined under three categories: before conception, throughout pregnancy, and after delivery, according to the adhyatmika vyadhi categorization of illness. According to the current paradigm, DNA alterations that occur early in a child's life cause cancer, which is caused by inherited mutations from parents that raise the chance of cancer in children. Some preventative methods, including dinacharya, ritucharya, rasayana, shodhana, and garbhini paricharya, are explained by Ayurveda. The condition that resembles cancer is described as Granthi and Arbuda in the classical texts of Ayurveda. The purpose of this study to find out the integrated approach in childhood malignancies-prevention and control.

Invasive Fungal Infection of the Duramater as the Presenting Manifestation of Disseminated Sarcoidosis (P10-10.005)

<h3>Objective:</h3> To describe a case of invasive fungal infection of the duramater which was the presenting manifestation of Disseminated sarcoidosis <h3>Background:</h3> Invasive Central nervous system fungal infections are usually encountered in the setting of immunosuppressive conditions, craniospinal trauma or instrumentation. It is rare for a treatment naïve patient with sarcoidosis to develop fungal infection of the duramater. <h3>Design/Methods:</h3> We describe the case of a young male who was found to have nodular thickening of the duramater due to Invasive CNS fungal infection. <h3>Results:</h3> We had a 27 year old man who had no prior comorbidities who presented with a single seizure. On evaluation, he was found to have nodular thickening of the Duramater. Differentials of infective, inflammatory, histiocytic and malignant conditions were considered. He underwent detailed evaluation and PET-CT revealed generalized lymphadenopathy. Biopsy from the dural thickening revealed septate hyphae and fungal culture showed Acremonium species. There were granulomas found on histopathologic examination of the dural as well as subcarinal lymphnode biopsy. He was treated with Voriconazole for 24 weeks followed by treatment of sarcoidosis. <h3>Conclusions:</h3> Sarcoidosis may be associated with immunodeficiency due to its effects on the lymphocytes, bone marrow and other organs such as the thymus. There have been several reports of patients with sarcoidosis being predisposed to infections such as Progressive multifocal leukoencephalopathy, fungal infections, tuberculosis and other bacterial infections. These infections may occur de-novo in the absence of immunosuppressant drugs or corticosteroids which have been traditionally used in the management of sarcoidosis with organ threatening or life threatening symptoms. Infections that occur as the first manifestation of an underlying autoimmune condition are challenging to diagnose. Appropriate diagnosis is essential to ensure optimum treatment of both conditions. <b>Disclosure:</b> Dr. Elavarasi has stock in Pfizer. Dr. Elavarasi has stock in PGHL. The institution of Dr. Elavarasi has received research support from All India Institute of Medical Sciences, New Delhi. The institution of Dr. Elavarasi has received research support from Indian Council for Medical Research. Dr. SINGH has nothing to disclose. Dr. CHHATTERPAL has nothing to disclose. Dr. Wig has nothing to disclose. Dr. Mittal has nothing to disclose. Mehar Chand Sharma has nothing to disclose. Dr. DAS has nothing to disclose. Ajay Garg has nothing to disclose. Dr. Jagdevan has nothing to disclose. Dr. Shamim has nothing to disclose. Dr. Tripathi has nothing to disclose. Dr. Vibha has nothing to disclose. Rajesh Kumar Singh has nothing to disclose.

Association Between Self And Caregiver Reported Sleep Problems And Polysomnographic Findings In Post-stroke Patients: A Cross Sectional Study. (S20.007)

<h3>Objective:</h3> To determine post-stroke sleep disturbances (PSSD) by polysomnography (PSG) and compare them with patient and caregiver reported symptoms and sleep questionnaires <h3>Background:</h3> Post stroke sleep disturbances (PSSD) are common with prevalence of 70–80%. The awareness of patients and caregivers about the various sleep problems and its implications on quality of life &amp; outcome has not studied extensively. Identification can aid in optimum management and rehabilitation of post-stroke patients. <h3>Design/Methods:</h3> In a cross-sectional study, we screened post-stroke patients (between one month to one year after stroke onset) &amp; their caregivers about various sleep problems. This was done by a screening questionnaire, followed by specific sleep questionnaires (Pittsburgh sleep quality index (PSQI) and STOP BANG questionnaire). A subset of consenting patients underwent overnight PSG. The association of sleep questionnaires with PSG findings were done. <h3>Results:</h3> In the study period (January 2021 and June 2022), 103 post-stroke patients were enrolled, of which 41(39.8%) underwent PSG. While only 15.5% (16/103) patients and/or caregivers reported any sleep disorders themselves, when specifically asked about insomnia, snoring, excessive daytime sleepiness &amp; abnormal leg movements in sleep, this number increased to 60.2% (60/103). Further, a PSQI&gt;5, signifying poor sleep quality was present in 71.8% (74/103), and high risk of obstructive sleep apnea (OSA) by STOP BANG questionnaire was present in 33% (34/103). PSG showed Apnea Hypopnea Index (AHI)&gt;5 in 65.9% (27/41) patients, 39% (16/41) had periodic leg movements (PLMS) and 34.2% (14/41) had disrupted sleep. Even when patients &amp; caregivers had denied any sleep disturbances, the PSG in 29 such patients showed OSA in 62 % (18/29) and PLMS in 34.5% (10/29). <h3>Conclusions:</h3> The study provided insight into the knowledge gap between patient &amp; caregiver perceived sleep disturbances &amp; sleep questionnaires and polysomnography. Longitudinal studies are warranted in this population to assess the effect of treatment of sleep disturbances on outcomes like quality of life and stroke recurrence. <b>Disclosure:</b> Dr. Tayade has nothing to disclose. Dr. Vibha has nothing to disclose. Dr. Tripathi has nothing to disclose. Rajesh Kumar Singh has nothing to disclose. Dr. Elavarasi has stock in Pfizer. Dr. Elavarasi has stock in PGHL. The institution of Dr. Elavarasi has received research support from All India Institute of Medical Sciences, New Delhi. The institution of Dr. Elavarasi has received research support from Indian Council for Medical Research.

An observational multi-centric COVID-19 sequelae study among health care workers

India has seen more than 43 million confirmed cases of COVID-19 as of April 2022, with a recovery rate of 98.8%, resulting in a large section of the population including the healthcare workers (HCWs), susceptible to develop post COVID sequelae. This study was carried out to assess the nature and prevalence of medical sequelae following COVID-19 infection, and risk factors, if any. This was an observational, multicenter cross-sectional study conducted at eight tertiary care centers. The consenting participants were HCWs between 12 and 52 weeks post discharge after COVID-19 infection. Data on demographics, medical history, clinical features of COVID-19 and various symptoms of COVID sequelae was collected through specific questionnaire. Mean age of the 679 eligible participants was 31.49±9.54 years. The overall prevalence of COVID sequelae was 30.34%, with fatigue (11.5%) being the most common followed by insomnia (8.5%), difficulty in breathing during activity (6%) and pain in joints (5%). The odds of having any sequelae were significantly higher among participants who had moderate to severe COVID-19 (OR 6.51; 95% CI 3.46-12.23) and lower among males (OR 0.55; 95% CI 0.39-0.76). Besides these, other predictors for having sequelae were age (≥45 years), presence of any comorbidity (especially hypertension and asthma), category of HCW (non-doctors vs doctors) and hospitalisation due to COVID-19. Approximately one-third of the participants experienced COVID sequelae. Severity of COVID illness, female gender, advanced age, co-morbidity were significant risk factors for COVID sequelae. This work is a part of Indian Council for Medical Research (ICMR)- Rational Use of Medicines network. No additional financial support was received from ICMR to carry out the work, for study materials, medical writing, and APC.

Embracing complexity

Pioneering enteric disease researcher Gagandeep Kang discusses her work on rotavirus vaccines, understanding immune responses to oral vaccines, and the importance of mentorship for the next generation of Indian health sciences researchers.Gagandeep Kang is a Professor of Microbiology at the Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences at the Christian Medical College (CMC) in Vellore. She has worked on the development and use of vaccines for rotaviruses, cholera, and typhoid, conducting large studies to define burden, test vaccines, and measure their impact. Working in partnership with non-governmental organizations and the government, she has carried out phase I-III studies of rotaviral vaccines and provided laboratory support for vaccine development in India and for other developing countries. With the Indian Council for Medical Research and the World Health Organization, she has supported the establishment of networks of sentinel hospitals and laboratories that carry out surveillance for rotavirus disease in children and ancillary studies. She is the first woman working in India to be elected a Fellow of the Royal Society.

Comparative analysis of specificity and sensitivity between Cobas 6800 system and SARS-CoV-2 rRT-PCR to detect COVID-19 infection in clinical samples.

Fast and reliable testing for the COVID 19 infection is the need of the hour for the development of effective and reliable tools and assays. However, it is difficult to find the performance relativity among all these tests which are poorly understood. In this study, we aimed to evaluate the two different platforms where we determine the difference of sensitivity and specificity between the fully automated analyzer (Roche Diagnostics Cobas 6800 SARS-CoV-2 test) under FDA Emergency Use Authorization (EUA) and the laboratory designed test (SARS-CoV-2 rRT-PCR) based on the protocol developed by ICMR (Indian Council for Medical Research). The study was conducted for individual samples. We performed our study with two different approaches, first with validation method consisting of 188 samples (2 batches) on cobas 6800 instrument (Roche Molecular Systems, Branchburg, NJ) soon after we received US FDA EUA on 1 June 2021, all these samples were tested earlier with laboratory designed tests on 25th and 26th May 2021. Over all agreement between the two tests is of 88% and the coefficient of agreement between the two testing platform Cohen’sκ coefficient was found to be 0.76 (95% CI, 2.5897–13.4103) suggesting the substantial agreement between the two platforms. However, in some of the cases, both tests have shown a little disagreement. An overall discordance rate between two systems was found 11.1%. The difference may be due to the limit of detection, variation in the sequences of the primer design or may be due to other factors depicting the importance of comparing the two platforms used in the testing for SARS-CoV-2. Second approach includes head to head evaluation which comprises 1631 samples showed overall agreement of 99% and kappa value of 0.98. These results showed that cobas is effective and reliable assay for the detection of SARS-CoV-2 infection.

COVID-19: Situation analysis in the district of Ernakulam.

Context:Corona Virus Disease 2019 (COVID-19) has become a pandemic causing millions of deaths and causing a devastating blow to the global economy. Like all other countries and territories, the Ernakulam district (Kerala, India) is affected by COVID-19. When the number of COVID-19 cases reported in the other states started coming down, the Ernakulam district continued to record a large number of cases.Aims:To analyse the situation of the COVID-19 pandemic in the district of Ernakulam, Kerala.Material and Methods:The authors were part of the COVID-19 surveillance unit of Ernakulam district, and hence, had access to the data collected. The available data were analysed in the following phases of the pandemic: First phase: From the reporting of the first case in Kerala in January to the reporting of the first case in the Ernakulam district. Second phase: Cases reported mostly in those with a travel history and their contacts to the period of community spread. Third phase: From the start of community spread.Results and Discussion:As of July 5, 2021, the Ernakulam district reported 3,60,345 cases of the COVID-19 infection with 1,317 deaths and the recovery rate being 96.45%. Despite factors like high human development index (HDI), access to the Internet and social media, access to affordable healthcare, etc., factors like high population density, airports, seaports, railway stations, container terminals, IT parks, major highways, tourist spots, beaches, large shopping malls, large floating population, a huge number of migrant labourers, a large proportion of the elderly population, high prevalence of non-communicable diseases, etc., are the some of the major challenges. The preparedness of the fight against COVID-19 included the training of all healthcare workers, ward level rapid response teams (RRT), upgradation of health facilities, district-level patient management system, provisions to manage biomedical waste, etc., The containment zone strategy is currently based on the local self-government area-wise weekly test positivity rate (TPR). The cluster containment is focused on the early identification of clusters. Currently, the Ernakulam district reports one of the highest numbers of COVID-19 cases in India. This is mainly because of the high number of tests (five to six times to national average) and targeted testing strategy. This is scientifically proven by the very low case fatality rate (0.35%), low-bed occupancy rate of the COVID treatment facilities and the latest seroprevalence study by Indian Council for Medical Research (ICMR).Conclusions:So far, the Ernakulam district could excel in its efforts to fight against COVID-19. But even now, when we are moving forward with the immunisation of the healthcare workers, front-line workers, elderly population, our main strategies to prevent COVID-19 remain the same—proper social distancing, hand hygiene, use of masks, avoiding unnecessary travels and gathering, early identification of cases and treatment.

Role of accredited social health activists in treatment of persons with severe mental illness in the community.

Role of accredited social health activists in treatment of persons with severe mental illness in the community.

Ethics in Psychiatric Research.

Ethics in Psychiatric Research.

Detection of SARS-CoV-2 in biological samples of pregnant women infected with COVID-19: A prospective cross-sectional study.

SynopsisSARS‐CoV‐2 was detected in the vaginal and cervical fluid, amniotic fluid, cord blood, placental membranes, and breastmilk of pregnant women, therefore suggesting the possibility of vertical transmission.

Safety of Hydroxychloroquine use for COVID-19 prophylaxis: A questionnaire-based pilot study in healthcare professionals

Hydroxychloroquine (HCQ) was recommended for prophylaxis against SARS-COV-2 for the health care professionals by the Indian Council for Medical Research. We conducted this study to explore the safety of Hydroxychloroquine in health care professionals. A validated questionnaire was circulated electronically to the health care professionals, who were on HCQ as per ICMR recommended regimen. Questions on specific adverse drug reactions (ADRs) were asked along with other details. The participants were requested to upload the baseline and additional electrocardiograms (ECGs) taken during HCQ prophylaxis. Incidence, severity, causality (relatedness to the drug), expectedness, and seriousness of the ADRs were determined as per the standard guidelines. The ECGs were evaluated for the appearance of significant changes. The observations were analyzed through descriptive statistics. The ECG changes were compared using the Students t-test and the association of risk factors with the ADRs was evaluated using logistic regression analysis. ADRs were observed in 58 (46 %) of 126 participants. Gastrointestinal symptoms followed by headache and skin rashes were commonly observed. The ADRs were mostly mild to moderate in the category, non-serious, and possibly related to HCQ. Significant ECG changes were rare. Diabetes, hypertension, and the use of concomitant medication/s were the risk factors. Except for blurred vision, all the ADRs were unexpected in terms of frequency. HCQ causes non-specific ADRs of mild to moderate degrees when used as prophylaxis. Though non-serious, almost all were unexpected. ECG changes are probably not frequent in the absence of a pre-existing disease.

Application of pooled testing in estimating the prevalence of COVID-19.

Testing at a mass scale has been widely accepted as an effective way to contain the spread of the SARS-CoV-2 Virus. In the initial stages, the shortage of test kits severely restricted mass-scale testing. Pooled testing was offered as a partial solution to this problem. However, it is a relatively lesser-known fact that pooled testing can also result in significant gains, both in terms of cost savings as well as measurement accuracy, in prevalence estimation surveys. We review here the statistical theory of pooled testing for screening as well as for prevalence estimation. We study the impact of the diagnostic errors, and misspecification of the sensitivity and the specificity on the performances of the pooled as well as individual testing procedures. Our investigation clarifies some of the issues hotly debated in the context of COVID-19 and shows the potential gains for the Indian Council for Medical Research (ICMR) in using a pooled sampling for their upcoming COVID-19 prevalence surveys.

A Neurocognitive Investigation of Low-Level Arsenic Exposure Reveals Impaired Executive Function Mediated by Brain Anomalies

Background: Arsenic, a contaminant of groundwater and irrigated crops, is a global public health hazard. Exposure to low levels of arsenic through food extends well beyond the areas with high arsenic water content. While isolated impairments of cognitive function following chronic exposure to high arsenic levels have been described, a comprehensive assessment of the scope of such impairments and their underlying brain mechanisms does not exist, especially not in the case of the much more common low-level arsenic exposure. Methods: We analyse 1014 participants aged 6 to 23 years of the Indian Consortium-on-Vulnerability-to-Externalizing-Disorders-and-Addictions (cVEDA). Participants were characterised using deep phenotyping measures of behaviour, neuropsychology, psychopathology, brain neuroimaging and exposure to developmental adversities and environmental neurotoxins. Arsenic was measured in urine as an index of exposure. Findings: Using sparse-partial least square analysis (sPLS) we describe a correlation of arsenic exposure with impairments in executive function (r=-0.12, p=5.4x10-4), brain structure (r=-0·2, p=1·8x10-8) and functional connectivity (within-network: r=-0·12, p=7·5x10-4, between-network: r=-0·23, p=1·8x10-10). Impairments in executive function were partially mediated by localised changes in grey-matter volume (b=-0·004, CIs=-0·007 to -0·002) and within-network functional connectivity (b=-0·004, CIs=-0·008 to -0·002). Socio Economic Status (SES) and Body Mass Index (BMI) moderated the link between arsenic and changes in grey-matter volume, with the effect of arsenic being strongest in participants from lower SES and with low BMI. Interpretation: We describe a syndrome of impairments in executive function and their brain correlates associated with low-level arsenic exposure. Our results demonstrate detrimental consequences of arsenic exposure well below currently recommended guidelines that affects people beyond endemic risk areas. Precision medicine approaches to study global-mental-health vulnerabilities, highlight widespread but potentially modifiable risk factors and a mechanistic understanding of the impact of low-level arsenic exposure on brain development. Funding Information: Indian Council for Medical Research and Medical Research Council, United Kingdom. Declaration of Interests: All authors report no competing interests. Ethics Approval Statement: The cVEDA Study was approved by the Health Ministry Screening Committee, Ministry of Health and Family Welfare, Government of India. The study protocol was approved by the Institutional Ethics Review Boards of National Institute of Mental Health and Neurosciences (NIMHANS) Bangalore, India (Item No. VII, SI. No. 7·08, Behavioural Sciences) and all other regional collaborating institutions. Informed consent was obtained from participants over the age of 18 and from parents of participants under 18 years of age (along with assent from minor participants).

COVID-19 Pandemic-Frontline Experiences and Lessons Learned From a Tertiary Care Teaching Hospital at a Suburban Location of Southeastern India.

The key challenges to any health care setup during emergency situations, such as that of the COVID-19 pandemic would be to rapidly address hospital preparedness and response tailored to the local population, societal influences, political factors within the existing infrastructure, and workforce. Second, to adopt and moderate policies, standard operating procedures (SOPs) and guidelines issued by national and international agencies, such as WHO, CDC, and the Indian Council for Medical Research (ICMR) were tailor-made to the local conditions of the hospital and community. In this publication, we have discussed the challenges and experiences in preparation and responses to the ongoing COVID-19 pandemic at a tertiary teaching hospital situated at a suburban locale in a small union territory. Puducherry is located in the South Eastern Coromandel Coast of India. The core processes, such as hospital preparedness, adoption, and amendments to SOPs based on dynamic changes in guidelines released by the central and local government, training given to health care workers, setting up the in-house diagnostic facility, surge capacity, management of supplies during the lockdown, infection prevention, and control and patient care are discussed. We have also reinforced our experiences in translating COVID-related opportunities for research and innovation in the form of awards and research proposals for the faculty and students of our institute. The lessons learned in terms of strength and limitations on the ground level of public health during this process is worth sharing as it would provide guidance in preparing the health care setups for pre- and post-pandemic.

Evaluation of water quality index in some artificial aquatic environments in Port Harcourt, Rivers State, Nigeria

Background and Objective: This study aimed at using application of Water Quality Index (WQI) in evaluating the quality status of some artificial aquatic environments (concrete, earthen and plastic fish tanks/pond) in Roone Fish Farm, Port Harcourt, Rivers State, Nigeria were studied from October 2018 to September 2019. Methodology: Nine water quality parameters were considered and some samples were measured in-situ (Temperature, pH, conductivity (EC), total dissolved solid (TDS), turbidity, dissolved oxygen (DO) while biological oxygen demand (BOD), nitrate (NO3) and phosphate (PO4) were analyzed in the laboratory following standard methods. Results: The results obtained were subjected to Minitab version 16 and Tukey’s comparison test was also employed to separate means. The water quality index (WQI) calculation used the mean values of the nine (9) parameters chosen using the standards recommended by the World Health Organization (WHO), Bureau of Indian Standards (BIS) and Indian Council for Medical Research (ICMR) for drinking water quality. The water quality indices for concrete fish tank, earthen fish pond and plastic fish tank were 60.24, 73.34 and 70.20 respectively. Though, earthen fish ponds had higher WQI value and would have considered very poor water with regard to WQI calculation. The values of the WQI revealed that all the three artificial aquatic environments (concrete, earthen and plastic pond/tanks) were considered to be poor water quality. Conclusion and Recommendations: It was concluded that WQI is used as a tool for communicating information on the status of quality in different water bodies despite their medium and purpose of use. It was also recommended that the three artificial aquatic environments water should be monitored regularly and may be treated before use to avoid related public health issues.

Reviewing the Ethical Concerns of the Convalescent Plasma Therapy in COVID-19.

The understanding of coronavirus disease 2019 (COVID-19) is evolving periodically. There is also a marked increase in COVID-19 patients’ demand for the provision of COVID-19 convalescent plasma (CCP) therapy. With the review of the literature, the stage of speculation is quickly moving towards conformity, with the interim guidelines given by the Food and Drug Administration (FDA) in the United States, United Kingdom’s blood transfusion services, Saudi’s FDA, and the Indian Council for Medical Research, in addition to the European health authorities. It is prudent to address the ethical concerns that merit consideration while harvesting and utilizing CCP as a therapeutic tool in local hospital setting.

Analysis from the NeoOBS Global Neonatal Sepsis Prospective Observational Cohort Study Across 19 Hospitals in 11 Countries; Clinical Presentation, Treatment, Mortality Outcomes and Development of the NeoSEP Sepsis Severity Score

Background: Neonatal sepsis is associated with high mortality, but there is limited clinical data on outcomes in hospital facilities in low and middle income countries (LMIC). The NeoOBS study aimed to determine the clinical features, pathogens and clinical outcomes of infants presenting with neonatal sepsis in hospitals globally. Methods: Infants <60 days of age, fulfilling at least 2 sepsis criteria were enrolled across 19 sites in 11 countries, with prospective data collection to 28 days. A multivariable Cox regression model was built to predict mortality and develop a sepsis severity score in 85% of infants (randomly selected) and validated in 15%. Findings: 3204 infants were enrolled between 2018-2020; median (IQR) postnatal age was 5 (2-15) days, birth weight 2500g (1400-3000g), with 4 (2-5) clinical and 1 (0-2) laboratory sepsis criteria, and 69% hospitalised since birth. Overall mortality was 11.3% (95%CI 10.2-12.5%; n=350), but higher in infants with culture positive blood stream infection at baseline (17.7%, 95%CI 14.7-21.1%, n=564) than culture negative (n=2631, 9.9%, 95%CI 8.8-11.2%). Among 309 infection-related deaths, 59% (n=183) occurred in healthcare-associated infections (HAI). Klebsiella pneumoniae was the most common pathogen identified (n=132, 23.4% of baseline cultures). A wide variety of antibiotic regimens were prescribed, with frequent use of carbapenems. A sepsis severity score was developed using infants’ characteristics, supportive care, and clinical signs. In the validation sample, mortality (95%CI) was 1% (0-5%), 6% (4-10%), and 28% (19-39%) in low (score 0-3), medium (4-6) and high (7-14) risk groups, respectively. Interpretation: High rates of HAI, mortality and carbapenem use were observed in neonatal units globally. Novel strategic treatment and prevention trials are urgently required, where the NeoSEP score may have utility. Funding Information: The study was sponsored by the Global Antibiotic Research and Development Partnership (GARDP) with additional funding from: Bill and Melinda Gates Foundation, German Federal Ministry of Education and Research (BMBF), South African Medical Research Council, UK Department of Health and Social Care, Monaco and in-kind contribution from Indian Council for Medical Research. Declaration of Interests: None to declare. Ethics Approval Statement: Ethical approval was obtained both from St. George’s, University of London Research Ethics Committee and sites’ local, central or national ethics committees and other relevant local bodies, where required.