Institutional Human Ethics Committee Research Articles

The roles and perspectives of an informatics pharmacist practicing in the Australian healthcare setting: a qualitative study

AbstractBackgroundThe implementation of digital healthcare systems in hospitals globally and in Australia has led to the introduction of the informatics pharmacist as a career in the healthcare system. However, informatics pharmacists are not yet part of routine clinical services in Australia, so their perspective and roles are not well understood.AimTo explore pharmacists' and other health professionals' perspectives of the roles of informatics pharmacists within interprofessional teams in Australian health care.MethodThis study used semi‐structured interviews with experts in pharmacy and/or informatics. They were recruited using convenience sampling and snowballing. The interviews were audio‐recorded and transcribed and analysed using inductive thematic techniques to identify major themes. Ethical approval was received from the local institutional Human Research Ethics Committee (Approval No: 2020000069).ResultsThe process of inductive thematic analysis was used to analyse the interview transcriptions of 11 participants. Six themes were identified: (1) a promising future for the informatics pharmacists, (2) education, (3) specific skills, (4) scope of informatics role, (5) impacts, and (6) barriers. Participants described the career of informatics pharmacists as an emerging specialty in today's healthcare systems. The roles of informatics pharmacists in Australian health care are described together with the skills and knowledge required for these roles.ConclusionA key role of informatics pharmacists is to facilitate the appropriate use of digital systems to prevent medication errors and improve patients' safety. While international experience has shown the potential scope for an informatics pharmacist, this research shows the use of informatics pharmacists in Australia is in its infancy.

STUDY OF DEPRESSION, ANXIETY & STRESS AMONG FAMILY MEMBERS OF HOSPITALIZED COVID-19 PATIENTS IN A TERTIARY CARE HOSPITAL OF CENTRAL GUJARAT.

Background: COVID-19 pandemic has caused mental health issues along with physical, social, and economic issues in both patients and their relatives.COVID-19-positive patients were hospitalized in isolation with no or limited access to relatives. These conditions may have contributed to signicant psychological distress in relatives and this study was designed to assess the same. Objectives: To nd the prevalence of Depression, Anxiety, and Stress among Relatives of hospitalized COVID-19 patients. Methods: A cross-sectional quantitative tertiary care hospital-based study was conducted after approval from Institutional Human Ethics Committee. Relatives of hospitalized COVID-19 patients were assessed by purposive sampling method using Semi-Structured Performa including socio-demographic details, illnessrelated details, and DASS-21 (Depression, Anxiety, and Stress scale-21) via a telephonic mode of interview. Results: A total of 200 relatives of COVID-19 positive turned negative patients were interviewed on the rst day of the COVID 19 negative report. Majority of participants were male,mean age 41 years,literate,married & having rst degree relation with the patient. The prevalence of Depression, Anxiety and Stress was 12%. On individual parameters, Depression, Anxiety and Stress was found 25%,21%,and 20% respectively. Female relatives were signicantly associated with depression (χ2= 8.689,P=.003) & anxiety(χ2= 5.790,P=.016) where as longer hospitalization was signicantly associated with anxiety(χ2= 10.216,P=.006) and stress(χ2= 8.936,P=.011). Conclusions: Relatives of COVID-19 patients had a signicant amount of psychological stress. Female gender of relatives and longer duration of hospitalization of patients were important predictors

Aetiologies of Acute Complications in Autoimmune Rheumatologic Diseases: A Hospital-Based Cross-Sectional Study.

Autoimmune rheumaticdiseases (ARD) present unique challenges in clinical practice. Many of them present in medical emergencies in an unstable state and need immediate evaluation for further plans of action. The clinical conundrum is to distinguish between sepsis, disease flare, or Addisonian crisis (AC) (secondary to steroid withdrawal). This may be further complicated by overlapping clinical features like shock/fever and the coexistence of a combination of the above pathophysiologic mechanisms (e.g. AC with sepsis or AC with disease flare). The known biomarkers may not perform optimally to distinguish them and additional supportive investigations like imaging, cultures, autoimmune serological markers, etc. are needed. Ultimately the boundaries between "the art of medicine" and "the science of medicine" may get blurred, as the established literature evidence falls short and the expert opinion is needed in a time-sensitive manner. In this pragmatic study, researchers have attempted to explore the presentation of rheumatologic emergencies on the above three differentials (sepsis, disease flare, and AC). In this hospital-based cross-sectional study, adult patients(age >18 years) with ARDwhohad unplanned hospital admission due to acute worseningwere enrolled. This study was conducted over one year, after getting the Institutional Human Ethics Committee's approval. All relevant hematological, immunological, and hormonal parameters(specifically morning cortisol) were collected and analyzed. The aim was to find the individual and combined prevalence of sepsis, disease flare, or AC in this study group. Forty-onepatients were analyzed, with females in the majority (95%) and the dominant age group being 26-49 years (56.1%). A majority had a diagnosis of rheumatoid arthritis (RA) (56.1%) or systemic lupus erythematosus (SLE) (31.7%); the rest were other connective tissue diseases (12.2%). High-risk Quick Sequential Organ Failure Assessment score (qSOFA) score 2-3 was present in 29.3% while the rest had low-risk scores (qSOFA score 0-1). Thirty-two percenthad severe disease activity, 46% had mild to moderate disease activity, and 22% of patients had no disease activity. While 78% of patients had low procalcitonin (PCT) values <0.5 microgm/L (low risk of sepsis), 15% had <20 microgm/L, and 7% percentage of patients had serum levels >20 microgm/L (high risk of sepsis). A total of 73.2% of patients had no evidence of infection while 26.8% had either microbiological/radiological evidence of infection. Only 7% of all patients had the presence of an AC. qSOFA scores didn't statistically correlate with a diagnosis of infection or AC but positively correlated with PCT and C-reactive protein (CRP) values. Serum PCT didn't correlate with the presence of infection with statistically significance (p-value 0.217). Infections and sepsis are the most important considerations in the emergency presentations of ARDs. Disease flare and AC are also important differentials. Current inflammatory biomarkers like serum CRP and PCT may be less valuable for discriminating between infectious and non-infectious sepsis, especially in chronic inflammatory diseases like ARDs. qSOFA scores may have a prognostic role with less discriminant value. Management of ARD emergencies needs better biomarkers and more research is warranted.

COVID-19 anxiety among undergraduate students of a medical college in Chengalpattu district – A cross-sectional study

Background: COVID-19 is caused by severe acute respiratory syndromes-CoV-2, a virus that affects the physical as well as mental health of people. Aims and Objectives: Our study was conducted to estimate the COVID-19 anxiety prevalence and its associated sociodemographic factors in a medical college. Materials and Methods: Undergraduate medical students of a medical college in Chengalpattu district were the study participants, with inclusion criteria of students above 18 years of age from 2nd, 3rd, and final year and interns being included for the study. Using simple random sampling, students were selected with a sample size of 197. After obtaining approval from the Institutional Human Ethics Committee and informed consent, data were collected using a structured and pre-tested questionnaire, with anxiety being assessed using coronavirus anxiety scale and data analyzed using SPSS version 21. The statistical tests used were proportions, Chi-square test. P&lt;0.05 was considered to be statistically significant. Results: Among the 197 students, males constituted 82 (41.6%) and females 115 (58.4%), of which 60 (73.1%) of males and 88 (76.5%) of females had COVID-19 anxiety. Overall 75.1% had COVID-19 anxiety. Based on the year of study, 43 (22%) 2nd-year students and 38 (19.3%) 3rd-year students, 29 (14.8%) final-year students, and 38 (19.3%) inters had COVID-19 anxiety. Sociodemographic factors such as the type of family, year of study, and staying with parents had a strong association with COVID-19 anxiety. Conclusion: In our study, 75.1% experience Coronavirus related anxiety, and thus, there is need for focus on the mental well-being of undergraduate students requiring attention as well as support from college administration, family, and society to cope up with the pandemic situation.

Neutrophil–lymphocyte ratio as a diagnostic marker for predicting early-stage diabetic nephropathy in patients attending a tertiary health-care center

Background: Diabetes mellitus (DM) is a common metabolic disorder leading to microvascular and macrovascular complications. Chronic inflammation accelerates the development of complications associated with DM. Measurement of inflammatory mediators is not practically feasible. Neutrophil–lymphocyte ratio (NLR) serves as a cheap, reliable, and valid marker for assessing inflammatory activity. Aims and Objectives: (i) To evaluate the correlation of NLR and microalbuminuria in DM patients; (ii) to evaluate the correlation of NLR with HbA1c; and (iii) to evaluate the correlation of platelet count with microalbuminuria. Materials and Methods: One hundred patients of either sex with DM were evaluated for microalbuminuria, NLR, HbA1c, and platelet count after obtaining institutional human ethics committee clearance. NLR was evaluated for correlation with microalbuminuria and HbA1c. Platelet count was also evaluated for correlation with microalbuminuria. Results: Mean NLR of male patient was 2.1 and female was 2.33. The mean microalbuminuria level in male patient was 527.03 mcg/mg of creatinine and female was 215.36 mcg/mg of creatinine. There was a moderate degree of correlation of microalbuminuria with increased NLR. The study showed a strong correlation between NLR, microalbuminuria, HbA1c, and platelet count. Conclusion: NLR has a strong correlation with microalbuminuria and could be used to assess the onset and progression of diabetic nephropathy.

Health System Preparedness in Provision of Noncommunicable Diseases’ Services in Lakhimpur District, Assam State, India

Background: While noncommunicable diseases (NCDs) are one of the leading causes of mortality in the world today, we are unsure of the preparedness of the public health system in terms of provision for and utilization of NCD services in Assam. Methods: Preparedness of public health facility was assessed using WHO-SARA (Service Availability and Readiness Assessment) tool and Indian Public Health Standards tool. Ethics approval was obtained from the Institutional Human Ethics Committee of the Central University of Kerala. Results: The overall readiness of primary health centers (PHCs) ranged from 60% to 76% for NCD services, community health centers (CHCs) ranged from 72% to 87%, subdivisional hospitals from 70% to 87%, and district hospitals from 76% to 100%. Deficiencies were also noted in terms of the availability of equipment and medicines. Conclusion: The deficiencies in the PHCs and CHCs highlighted in the study emphasize the need to strengthen the health system, thereby strengthening the response of the health system to NCDs in India.

Measurement of Neck Circumference, Tongue thickness and Skin to Epiglottis Distance as Predictors of Difficult Intubation: A Prospective Study

Airway Assessment is essential in pre anesthetic assessment. Anticipating and preparing for difficulty in airway management is crucial to avoid airway catastrophes. Routine pre operative airway examination usually includes mouth opening and dentition, Mallampati classification, thyromental distance and neck movements. Neck circumference is a quick bedside test to determine difficult laryngoscopy. Increased tongue thickness and skin to epiglottis distance affects performance of laryngoscopy and tracheal intubation increasing the risk of difficult airway. Presently there is a search for non-invasive and accurate tools to overcome limitations of clinical airway assessment tests. Ultrasonography has been evolving as a useful device for airway assessment especially soft tissue structures in anterior surface of neck. Here we studied the measurement of neck circumference and ultrasound measurement of tonguethickness and skin to epiglottis distance as predictors for difficult intubation. The Aim of the study is to predict difficulty in intubation by measuring neck circumference, thickness of tongue and thickness of skin to epiglottis. Prospective observational study, 120 patients posted for surgery under general anesthesia, Department of anesthesia, Meenakshi medical college, Kanchipuram. After institutional Human ethical committee clearance, 120 Patients were screened during preoperative assessment for undergoing procedures under general anaesthesia. Neck circumference and other airway parameters were measured with measuring tape and distance between Skin to epiglottis and tongue thickness were measured with ultrasound linear probe. Patients were grouped into Group E( Easy Intubation) whose Cormack-lehane grade was 1 and 2 and Group D ( Difficult intubation) whose Cormack-lehane grade was 3 and 4. SPSS version 16 was used for statistical analysis. There was no statistical significance seen between age, sex, height among easy and difficult intubation but significance was seen with weight (p &lt;0.05), Thyromental distance(p&lt;0.05) and Sterno-mental distance(p&lt;0.05). High significance was seen in Distance between skin to epiglottis distance(p&lt;0.001), Tongue thickness(p&lt;0.001) and Neck Circumference(p&lt;0.001) in difficult intubation cases. Neck circumference and ultrasonographic measurement of tongue thickness and skin to epiglottis can avoid unanticipated difficult intubation.

MI RISK ASSESSMENT IN PATIENTS USING THE EZ-CVD RISK ASSESSMENT TOOL

Objective: The objective of this study was to assess the myocardial infarction (MI) risk chances among individuals in the productive age group using easy cardiovascular disease (EZ-CVD) risk assessment tool. Methods: This is a prospective observational and interventional study conducted for 6 months after obtaining the Institutional Human Ethics Committee approval. EZ-CVD risk assessment tool was used in this study which includes six self-reporting questionaries’ such as age, gender, history of diabetes, history of smoking, history of hypertension, and family history of heart attack at the age of 60 or younger. A score of 6 or greater is considered as patients are at high risk of having MI. Results: Sixty subjects were enrolled in to this study using the inclusion criteria. Among them, 36 were male and 24 individuals were female. Out of sixty recruited, 23 found having high risk for MI attack and 37 were at low risk of having chances of further MI. Conclusion: The study conclude that EZ-CVD risk assessment tool was found useful to predict the occurrence of future MI.

Feasibility of a pharmacist-led physical health monitoring for patients on antipsychotic medications: protocol for a longitudinal study

IntroductionPhysical health conditions are the leading causes of death in people living with severe mental illness. In particular, the risk of metabolic syndrome; the constellation of abnormalities in weight, blood...

A study to evaluate and compare the effectiveness of quality of life in patient with COPD by upper limb exercise training program: An experimental study

Background: COPD is one of the world's leading causes of morbidity and mortality. In Early 2020 COPD was the fourth leading cause of death worldwide, it has now become the third leading cause of death after 2020. In fact, COPD already has surpassed cerebro vascular disease to become the third leading cause of death in the United States. In addition, COPD is now recognized as a life-limiting illness that imposes significant symptom burden on those with the disease [1]. India also contributes a significant and growing percentage of COPD mortality which is estimated to be amongst the highest in the world; i.e. more than 64.7 estimated age standardized death rate per 100,000 amongst both sexes as mentioned in the WHO Global InfoBase Updated on 20th January 2011 (India 102.3 and China 131.5). This would translate into approximately 5,56,000 in case of India (>20%) and 1,354,000 cases in China (about 50%) out of a world total of 2,748,000 annually [2]. Aims and Objectives: To measure and compare the association between QoL and upper limb muscle strength and endurance.Material and Methods: The present study was carried out in the department of Pulmonary Medicine, and its allied specialties in Gauhati Medical College and Hospital as well as Rahman Hospital, Pvt Ltd. It was a prospective observational study carried out for a period of about three year from March 2016 to July 2019. After getting the approval from Institutional Human Ethical Committee. All patients diagnosed with COPD above 40 years of age irrespective of gender and giving proper written informed consent were included in this study. Results: In the study, a total of 100 patients diagnosed with COPD were included. Initially at first visit, the average hand grip muscle strength was found to be 33.52±5.57 kg but it significantly increased after 8 weeks of continuous upper limb exercise training with hand held dynamometer and elastic band exercises to 39.23±5.39 kg. On first visit the mean MMRC grading of Dyspnea was 2.28±0.45.On doing regular exercise with the hand held dynamometer and elastic band for duration of eight weeks, the main MMRC grading significantly improved to 1.45±0.5.Conclusion: In the present study it was observed that upper limb exercise training with hand held dynamometer and elastic band for the patients with COPD improves upper limb exercise capacity, decreases dyspnea grading in a significant manner. So upper limb exercise training programme should be included for treatment regimen in COPD patients along with the pharmacotherapy in order to improve quality of life.

A prospective study to evaluate the efficacy and adverse effects of alpha-blockers in the management of benign prostatic hyperplasia

Background: Benign prostatic hyperplasia (BPH) is the most common cause for the lower urinary tract symptoms in men. The conservative management of BPH comprises of alpha blockers, especially selective alpha 1 adrenergic blockers for symptomatic relief. Aims and Objectives: We aimed to evaluate the efficacy and adverse effects of alpha blockers in managing BPH. Materials and Methods: After getting approval from the Institutional Human Ethics Committee and consent from subjects, this prospective, randomized, and controlled trial was conducted. In this study, patients under inclusion criteria were divided into two groups. Group I received silodosin 8 mg once daily for 8 weeks. Group II received tamsulosin 0.4 mg once daily for 8 weeks. Primary outcome measure was reduction in international prostate symptom score (IPSS). Adverse events during study period were recorded. Results: A total of 90 patients were enrolled in this study. Ten patients were excluded and remaining 80 patients were divided as 40 in Group I (Silodosin) and 40 in Group II (Tamsulosin), patients were followed up for 8 weeks. As primary outcome, the IPSS at 8th week was significantly &lt;0 week, that is, baseline in both the groups. The comparison of IPSS within Group I and Group II at 0 week and 8th week was significant (P &lt; 0.05). The quality of life comparison within Group I and Group II at 0 week and 8th week was significant (P &lt; 0.05). Both the drugs were well tolerated. Retrograde ejaculation and diarrhea were noted with silodosin (Group I), dizziness and orthostatic hypotension were noted with Tamsulosin (Group II). Conclusion: The obtained results showed that both silodosin and tamsulosin produced significant improvement in IPSS and quality of Life in BPH patients. In silodosin group, retrograde ejaculation and diarrhea were notable adverse effects and in tamsulosin group, dizziness and orthostatic hypotension were noted.

Salivary Proteome Profile of Women during Fertile Phase of Menstrual Cycle as Characterized by Mass Spectrometry.

Objectives:Ovulation is such a critical physiological process that its noninvasive detection based on salivary constituents has several advantages in humans. Hence, the present study is proposed to identify the ovulatory-specific proteins in saliva in order to detect ovulation phase.Materials and Methods:Samples were collected from women volunteers. The procedure adopted was approved by the Institutional Human Ethical Committee (DM/2014/101/38), Bharathidasan University. The saliva samples were collected from thirty healthy female volunteers, with a prior written consent. One-way analysis of variance was used to calculate protein concentration and band intensity using SPSS 16 software (SPSS Inc., Cary, NC, USA). The salivary protein expression pattern during different phases of menstrual cycle was analyzed using gel-based high resolution-liquid chromatography-mass spectrometry/mass spectrometry and matrix-assisted laser desorption ionization-time of flight/time of flight. Further, bioinformatics tools were adopted to annotate the proteins identified at various phases of menstrual cycle.Results:As many as 530 proteins showed up in the saliva during ovulatory phase, whereas there were only 251 proteins identified during postovulatory phase. The functional annotation of salivary proteins revealed that the proteins got assigned to the class of “extracellular proteins” which are concerned with regulatory functions. The 16 unique and/or differentially expressed protein spots appeared during ovulatory phase, among which Cystatin-S, Prolactin-inducible protein, Cystatin-A, Cystatin-SN, BPI fold-containing family A member 2, Alpha-tubulin N-acetyltransferase 1, Carbonic anhydrase-6, Protein LEG1 homolog, Hemoglobin subunit beta, and Pancreatic alpha-amylase were identified.Conclusion:Total salivary proteome profile has been listed with respect to various phases of menstrual cycle. Among the protein listed, Cystatin-S offers a biomarker protein and/or indicator of ovulatory phase. However, extensive validation is required before arriving to a candidate bio-marker protein.

Variability of ophthalmology residents' perception toward different major training programs in Saudi Arabia.

PURPOSE:The constant demand for ophthalmologists has nationally resulted in creating more programs in different regions of the kingdom. We have previously reported the overall residents’ satisfaction with the current local ophthalmology curriculum and the competency of the ophthalmic training (clinical and surgical) in our local programs in Saudi Arabia compared to international standards. In this study, we aim at comparing the major local training programs and analyze the differences among them aiming at improving our training.METHODS:This is a cross-sectional study using a questionnaire that was completed by residents and graduates of the local ophthalmology programs in Riyadh, Eastern and Western regions. A closed-ended questionnaire was validated and circulated online and a hard copy was distributed to residents and recently graduated ophthalmologists (2009-2015). Data were categorized by demographic variables, and basic statistics were done. The study has been approved by the Institutional Review Board (IRB) and Human Ethics Committee (HEC) of King Saud University.RESULTS:Of the 200 individuals surveyed, 175 (87.5%) completed their responses. The average age was 29.6 years (range: 24-39) with 67.5% males and 32.5% females. The overall satisfaction among senior residents and graduates showed a statistically significant higher result among graduates in Riyadh area (P=<0.001). Satisfaction of senior residents with the program director’s support was higher in the Eastern region (P=<0.001). Clinic-based training was generally satisfactory. Refractive surgery was reported to be significantly insufficient in 70.6% (P=0.003). Most of the graduates in Riyadh area achieved the surgical requirements for training compared to other regions.CONCLUSION:Saudi postgraduate ophthalmology training programs show a variable level of satisfaction among senior residents and graduates. Better surgical exposure has been observed in Riyadh region, however reassessment of the current curriculum and the parameters for training are needed to fulfill the requirements with special attention to the surgical training in all programs.

Spectrum of pulmonary aspergillus diseases in post TB lung diseases

IntroductionPost-Pulmonary TB structural lung disease with cavitation and bronchiectasis favours the growth of Aspergillus. It leads to progressive lung destruction and the persistence of symptoms after successful ATT and can mimic smear-negative PTB. There is lack of prevalence study of this disease from India. Antifungal therapy is very beneficial, as it reduces both morbidity and mortality. The present study is being undertaken to study the occurrence of spectrum of PA in PTBLD. MethodsThis is a prospective observational study, conducted at one of the tertiary chest institute of India over a period of one year, after approval from institutional human ethics committee. A total of 60 patients with history of treatment for PTB were recruited. Active PTB were excluded. Diagnosis of PA in were established on the basis of clinical, radiological, microbiological and serological parameters. Based on this, the spectrum of PA viz. CPA, ABPA and IPA were established. ResultsThe mean age was 47.88 ± 12.89 years with males being 60%. Mean duration of illness was 6.57 ± 5.11 years with mean asymptomatic period of 4.97 ± 7.41 year. Cough and breathlessness (100%) being the most common symptom followed by wheezing (58%). PA was diagnosed in 48% of cases out of which 43% cases were of CPA. The most common subtype of CPA was simple aspergilloma 14 (54%) followed by CCPA 10 (38%), 2CFPA (8%). ABPA was diagnosed in two cases of PA and one case of aspergillus sensitization. None of the case diagnosed as IPA. ConclusionWe found high prevalence of PA among PTBLD, especially CPA. Early recognition and treatment with antifungal has the potential to reduce the morbidity and mortality. There is a need of prospective community-based larger multicentric studies to precisely define the prevalence of these disorders.

A Single Centre, Prospective, Randomized, Open Labelled Clinical Study to Evaluate the Effectiveness of Siddha Poly Herbal Formulation, Viprotm, Towards the Management of Uncomplicated Respiratory Infection

The objective was to evaluate the efficacy of ViproTM, a polyherbal formulation in the management of uncomplicated respiratory infection towards reducing the severity of clinical symptoms, reducing the worsening of clinical symptoms&amp;complications and to determine its safety by detectingadverse events. The study was started after obtaining approval from Institutional Human Ethics Committee. It was a prospective, randomized controlled study done in 60 patients. Patients having uncomplicated respiratory infections, at least for less than 5 days, with clinical symptoms and signs of fever, myalgia, rhinitis, sore throat, throat pain, cough, expectoration and head ache were enrolled and randomly allocated to one of the three groups, A, B and C. Group A received standard treatment, group B ViproTM and group C ViproTM along with the standard treatment. All the patients were followed up for a period of 7 days from starting treatment. Telephonic follow up was done daily for 7 days and physical follow up on day 0, day 4 and day 7. During physical follow up, vitals &amp; body temperature were recorded, general and systemic examination done, adverse events were noted and improvement in constitutional symptoms was assessed. Complete blood count (CBC) and nasal / throat swab for culture were done at the baseline and at the end of study. Vipro TM has demonstrated efficacy in alleviating the clinical symptoms similar to standard treatment. With regard to safety, ViproTM is associated with a few adverse events and all of them are minor in nature and subsided within 24 hours.

Clinical, Virological, Immunological and Genomic Characterization of Asymptomatic and Symptomatic Cases With SARS-CoV-2 Infection, India

Background: The current global pandemic of Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2 led to the investigation with clinical, biochemical, immunological and genomic characterization from the patients to understand the pathophysiology of viral infection.Methods: Samples were collected from six asymptomatic and six symptomatic SARS-CoV-2 confirmed hospitalized patients in Bhubaneswar, Odisha, India. Clinical details, biochemical parameters, treatment regime were collected from hospital, viral load was determined by RT-PCR, levels of cytokines and circulating antibodies in plasma were assessed by Bioplex and isotyping respectively. In addition, the whole genome sequencing of viral strains and mutational analysis were carried out.Findings Analysis of the biochemical parameters highlighted the increased levels of C-Reactive protein (CRP), lactate dehydrogenase (LDH), serum SGPT, serum SGOT and ferritin in symptomatic patients. Symptomatic patients were mostly with one or more comorbidities, especially diabetes (66.6%). The virological estimation revealed that there was no significant difference in viral load of oropharyngeal (OP) samples between the two groups. Whereas, viral load was higher in plasma and serum samples of symptomatic patients and they develop sufficient amounts of antibodies (IgG, IgM and IgA). The levels of 7 cytokines (IL-6, IL-.1α, IP-10, IL-8, IL-10, IFN-α2, IL-15) were found to be highly elevated in symptomatic patients, while three cytokines (soluble CD40L, GRO and MDC) were remarkably higher in asymptomatic patients. The whole genome sequence analysis revealed that the current isolates were clustered with 19B, 20A and 20B clades, however acquired 11 additional changes in Orf1ab, spike, Orf3a, Orf8 and nucleocapsid proteins. The D614G mutation in spike protein is linked with higher virus replication efficiency and severe SARS-CoV-2 infection as three patients had higher viral load and among them two patients with this mutation passed away.Interpretation This is the first comprehensive study of SARS CoV-2 patients from India. This will contribute to a better understanding of the pathophysiology of SARS-CoV-2 infection and advance in the implementation of effective disease control strategies.Funding Information: This study was supported by the core funding of Institute of Life Sciences, Bhubaneswar, Dept of Biotechnology, India.Declaration of Interests: The authors declare no conflict of interest.Ethics Approval Statement: The studies involving human participants were reviewed and approved by the Institutional Human Ethics Committee, Institute of Life Sciences. Written consent informed to participate in this study was provided by the participants’ legal guardian/next of kin.

Epidemiology of Hospital-Based COVID-19 Cluster in Hospital A, Chennai, India

Objectives: To identify risk factors associated with COVID-19 in a hospital-based cluster and to recommend control measures.Methods: We conducted contact-tracing and testing in the hospital and community. We collected information through telephone interviews, abstraction of patient’s clinical records and registers. We described the cluster by time, place and person. We conducted an unmatched case-control study. We computed Odds Ratio (OR) with 95% confidence interval(CI) by comparing attack rates among those exposed and unexposed to the risk factors.Results: The secondary attack rate of COVID-19 was high among in-patients of block A, household contacts and housekeeping staff. The cluster started on 22nd April, had 2 peaks on 26th April and 1st may and lasted till 8th May. Males, older patients (OR-30·7, 95% CI;3·6-264), hypertensives (OR-4·3,95% CI;1·1-16·7) and diabetics (OR-3·8, 95%CI;1·0-14·1) were more likely to be COVID-19 positive. Mask compliance was poor (20%) among hospital workers.Discussion: We suggest screening of all patients for diabetes and hypertension and isolation/testing of anyone with influenza-like illness. Strict adherence to infection control practices will prevent such clusters in hospital settings.Funding Statement: Indian Council of Medical Research.Declaration of Interests: None to declare. Ethics Approval Statement: The study protocol was approved by the institutional human ethics committee of Hospital A. Informed consent was obtained from the participants before commencing the telephone interview.

SARS-CoV-2 Sero-Prevalence Among General Population and Healthcare Workers in India, December 2020 - January 2021

Background: Repeated cross-sectional serosurveys in the same geographic area establish the trend of the evolving pandemic. We present the findings of the third round of a national serosurvey to estimate the seroprevalence of SARS-CoV-2 infection among the general population and health care workers of India. Methods: We conducted the third population-based serosurvey between Dec 18, 2020 and Jan 6, 2021 in the same 700 villages or wards from 70 districts in 21 states across India, which were selected for the first and second serosurveys. We enrolled from each district, at least 400 individuals aged ≥ 10 years from general population and 100 HCWs from sub-district level public health facilities. Serum samples from general population were tested for the presence of IgG antibodies against nucleocapsid (N) and spike protein (S1-RBD) of SARS-CoV-2 using the Abbott and Siemens assays respectively, whereas sera from HCWs were tested for anti-S1-RBD. For general population, sera positive for either of the antibodies were considered positive, while sera positive for anti-S1-RBD were considered as positive for HCW. Weighted seroprevalence estimates were adjusted for sensitivity and specificity of respective assays. Findings: Of the 28,598 sera from general population, 4585 (16%) had IgG antibodies against N, 6647 (23.2%) against S1-RBD and 7436 (26%) against either. The weighted and assay characteristic adjusted seroprevalence against either of the antibodies was 24.1 (95%CI: 23.0% to 25.3%). Seroprevalence was lower in rural areas (21.4%, 95% CI: 20.3% to 22.6%) compared to urban non-slum (29.4%, 95% CI: 26.9% - 32.1%) and slum areas (34.6%, 95% CI: 31.0% to 38.3%). Among 7385 HCWs, the seroprevalence of anti-S1-RBD IgG antibodies was 25.6% (95% CI: 23.5% to 27.8%). Interpretation: Nearly one in four individuals aged 10 years or older from general population as well as HCWs were exposed to SARS-CoV-2 by December 2020 amounting to 271 million infections in India.Funding Statement: Indian Council of Medical ResearchDeclaration of Interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare no competing interestsEthics Approval Statement: The project was approved by Institutional Human Ethics Committee at ICMR-National Institute of Epidemiology.

Prospective Validation of a Host Blood Transcriptomic Biomarker for Pulmonary Tuberculosis in People Living with HIV: A Diagnostic and Prognostic Accuracy Study

Background: We tested diagnostic and prognostic performance of a host blood transcriptomic signature of tuberculosis (RISK11) for screening of people living with HIV (PLHIV) in a prospective, community-based cohort. Methods: Ambulant adult volunteers living with HIV were enrolled at five South African sites. RISK11 status was assessed at baseline by real-time PCR. Participants and study staff were blinded to the result. Participants underwent active surveillance for microbiologically-confirmed tuberculosis from enrolment through 15 months. The primary outcomes were prevalence and cumulative incidence of two-sputum-sample positive tuberculosis in RISK11+ versus RISK11- participants. Findings: Among 820 participants with valid RISK11 results, eight (1%) tuberculosis cases were identified at baseline. Risk of prevalent tuberculosis was 13·1-fold (95%CI 2·1-81·6) greater in RISK11+ than RISK11- participants, with tuberculosis prevalence of 2·5% and 0·2%, respectively. RISK11 had diagnostic area under the receiver-operating-characteristic curve (AUC) 88·2%; sensitivity 87·5% and specificity 65·8% at the pre-defined threshold (60%).Thereafter, eight tuberculosis cases were identified through median 15 months follow-up. Tuberculosis incidence was 2·5 vs 0·2 per 100 person-years in RISK11+ compared to RISK11- participants with cumulative incidence ratio 16·0 (95%CI 2·0-129·5); AUC 80·0%; sensitivity 88·6% and specificity 68·9%. By comparison, QuantiFERON TB Gold-Plus (QFT) had a cumulative incidence ratio of 2·0 (95%CI 0·5-8·4); AUC 70·8%; sensitivity 62·1% and specificity 56·2%. Interpretation: RISK11 identified prevalent tuberculosis and predicted risk of progression to incident tuberculosis within 15 months in ambulant PLHIV. Performance approached the World Health Organization Target Product Profile benchmarks for screening and prognostic tests for tuberculosis. QFT performance fell short of the prognostic benchmark. Funding Statement: The study was funded by the Bill & Melinda Gates Foundation (BMGF) (OPP1151915) and by the Strategic Health Innovation Partnerships Unit of the South African Medical Research Council with funds received from the South African Department of Science and Technology. The BMGF contributed to the study design. The regulatory sponsor was the University of Cape Town. Declaration of Interests: AP-N, GW, GC, TJS, and MH report grants from the Bill & Melinda Gates Foundation, during the conduct of the study; AP-N and GW report grants from the South African Medical Research Council, during the conduct of the study; GW and TJS report grants from the South African National Research Foundation, during the conduct of the study. In addition, AP-N and TJS have patents of the RISK11 and RISK6 signatures pending; GW has a patent “TB diagnostic markers” (PCT/IB2013/054377) issued and a patent “Method for diagnosing TB” (PCT/IB2017/052142) pending. The remaining authors have no competing interests to declare. Ethics Approval Statement: The study protocol (Supplement) was approved by the Institutional Human Ethics Committees of each participating site. All participants provided written informed consent in their language of choice.

Comparison of Expanded New Ballard, Eregie and Parkin Scores in Predicting Gestational Age in Newborns

Background: Postnatal gestational age (GA) estimation is crucial in neonates with absent early trimester ultrasonography (USG) reports to evaluate the risk of morbidity and mortality. Widely used Expanded New Ballard (ENBS) is complex and needs expert medical professional to assess. Eregie (ES) and Parkin (PS) scores are easy to perform with good inter-observer reliability. We aimed to compare these scores for their ability in predicting GA with early trimester USG-GA as gold standard. Methods: This cross-sectional study was conducted among 1114 intramural neonates who qualified the selection criteria. All neonates were evaluated using three scores by residents (blinded to USG-GA) with an acceptable inter-observer difference of <10%. Method applicability was compared in terms of agreement, correlation, accuracy and validity. Results: Gestational age was systematically overestimated by 0.65 weeks, 0.68 weeks, and 0.32 weeks by ENBS, PS and ES respectively. Correlation coefficient was highest for ENBS (ρ value 0.724). For GA sub-groups, ES had best overall accuracy with MD of 0.32 ± 0.88 weeks. Validity was highest for ES (79.6%). Interpretation: We conclude that all three scores were found to be in acceptable agreement, good accuracy and validity. ES had best overall accuracy and validity among the subjects and for subgroups. Hence we recommend that in limited resource settings, ES or PS can substitute for ENBS. Funding: None. Declaration of Interests: None. Ethics Approval Statement: Ethical clearance was obtained from Institutional Human ethics Committee, Mahatma Gandhi Medical College and Research Institute (MGMCRI), Pondicherry, India. All the parents of the participants provided written informed consent before participation.