RESUMEN
OBJECTIVE: Emergency medicine (EM) is a growing specialty in India with the board approving training programme commencing only since 2009. This study aimed to identify the challenges faced by EM department personnel in the country and to obtain valuable insight into the concerns and problems experienced by them. METHODS: This study was a cross-sectional digital survey conducted among EM department personnel in teaching institutions across India. The study involved 170 respondents, who completed an online questionnaire that covered various aspects of their work and identified the challenges they faced. It also captured potential solutions as perceived by the respondents. RESULTS: A total of n=170 participants completed the survey of which N=164 fulfilled the eligibility criteria. The study revealed significant challenges faced by EM personnel in India. Administrative and clerical work consumed a considerable amount of respondents' time. Understaffing (n=144/164; 87.8%), followed by complains about delay due to hospital administrative processes and policies (n=141/164; 85.9%), and delay in interhospital transfers (n=139/164; 84.8%) were the primary concerns spelt out by the respondents. Additionally, respondents experienced interpersonal conflicts, and verbal/physical abuse and inappropriate behaviour from patients and their family members. Potential key solutions suggested were to improve resources including manpower and take steps to prevent violence against EM staff. CONCLUSION: The study's results call for policy-makers and hospital administrators to address the issues faced by EM department staff. Improving EM department operations can improve patient care and staff well-being. Future research should examine challenges in non-teaching institutions and potential solutions.
RESUMEN
OBJECTIVES: Studies show that anxiety and depression are widespread across patients presenting to outpatient services for medical illnesses. We expect similar or even higher prevalence in patients with breast complaints owing to the relevance of breasts in terms of sexuality, identity and confidence. Thus, this study was proposed to estimate the prevalence and identify risk factors for being at risk for anxiety and depression in patients seeking breast services. DESIGN: Descriptive, cross-sectional study. SETTING: Tertiary care teaching hospital in Mumbai, Western India. PARTICIPANTS: Patients seeking breast services for either benign or malignant conditions. OUTCOME MEASURES: Proportion of those at risk for clinical depression (defined as a score of ≥10 on Patient Health Questionnaire-9) and proportion of those at risk for clinical anxiety warranting further clinical evaluation (defined as a score of ≥10 on Generalized Anxiety Disorder-7) and their predictors. RESULTS: A total of 208 patients were screened, and 192 consenting patients were enrolled. The prevalence of those at risk for anxiety requiring further clinical evaluation was 46.4% (95% CI 39.2% to 53.7%) and for those at risk for major depression that warrants further clinical evaluation by a mental health provider was 29.7% (95% CI 23.3% to 36.7%). The predictors of anxiety were age (adjusted odds ratio (aOR) 1.053; 95% CI 1.024 to 1.083; p<0.001) and postmenopausal status (aOR 2.475; 95% CI 1.200 to 5.103; p=0.014). The predictors of depression were age (aOR 0.954; 95% CI 1.927 to 0.981; p=0.001) and rural place of residence (aOR 2.362; 95% CI 1.023 to 5.433; p=0.044). CONCLUSIONS: There is a high prevalence of being at risk for anxiety and depression among patients who seek breast services warranting further clinical evaluation. The predictors of being at risk for anxiety were higher age and postmenopausal status, and for those at risk for depression were young age and residing in rural areas.
Asunto(s)
Ansiedad , Depresión , Humanos , Estudios Transversales , Femenino , Adulto , Persona de Mediana Edad , Factores de Riesgo , India/epidemiología , Prevalencia , Ansiedad/epidemiología , Depresión/epidemiología , Depresión/diagnóstico , Tamizaje Masivo/métodos , Adulto Joven , Neoplasias de la Mama/psicología , Neoplasias de la Mama/epidemiología , Enfermedades de la Mama/epidemiología , Enfermedades de la Mama/psicología , Enfermedades de la Mama/diagnóstico , AncianoRESUMEN
Turmeric is well-known for its analgesic, anti-inflammatory and anti-arthritic properties but 69.4% of the turmeric rhizome contains Turmerosaccharides whose clinical benefit is still unexplored. Turmacin®/NR-INF-02 is an aqueous extract of Turmeric containing Turmerosaccharides (>10%w/w) with negligible curcuminoids. Previous study with low dose Turmacin® confirmed its safety and efficacy in alleviating induced knee pain in healthy volunteers. Hence, this study aimed to assess the safety and explore the efficacy of moderately high dose Turmacin®. It was an open-label, single-arm interventional trial conducted from August 2018 - January 2019 in a tertiary care teaching hospital. Turmacin® was administered for seven days to 15 healthy volunteers as four capsules of 500 mg each in the morning with food. The stair mill at a speed of 60 steps per minute was used to induce knee pain and Visual Analogue Scale (VAS) was used to measure the pain intensity. Assessments were performed at baseline, Days 5 and 7. One participant reported dyspepsia of mild grade that resolved on its own. When compared to baseline, time to initial discomfort significantly increased on Day-5 (Mean Difference [MD] = 30s, p = 0.016) and Day-7 (MD = 32s, p = 0.007). Whereas the maximum VAS score decreased with time and on Day-7 and it was significantly low when compared with baseline (MD = -0.93, p = 0.008). In summary, Turmacin® supplements given at a dose of 2 g/day was safe and tolerable. Similar to the previous study with low dose Turmacin®, there was a significant increase in pain threshold and decrease in the maximum pain score post intervention.
Asunto(s)
Curcuma , Dolor , Extractos Vegetales , Adulto , Humanos , Antiinflamatorios , Curcuma/química , Suplementos Dietéticos , Dolor/tratamiento farmacológico , Dimensión del Dolor , Extractos Vegetales/farmacología , Prueba de Estudio Conceptual , RodillaRESUMEN
INTRODUCTION: Magnesium (Mg) deficiency has been found to be associated with many clinical conditions, such as type 2 diabetes mellitus (T2DM), cardiovascular diseases and likewise. Studies evaluating the association between serum Mg levels and ischaemic stroke in T2DM from India are limited, and this formed the aim of this study. METHODS: We conducted a case-control study among patients with T2DM where cases had a history of acute ischaemic stroke in the preceding 2 years and controls with no such history. Data regarding sociodemographic and clinical details and laboratory parameters, including serum Mg concentration, were collected using a semistructured questionnaire. Furthermore, propensity score matching (PSM) was done to match the controls with the cases. RESULTS: We enrolled a total of 200 participants (cases: 75 and controls: 125), but after PSM, 149 participants (cases: 75 and control:74) were analysed. The serum Mg concentrations were significantly low (p<0.001) among the cases (mean (SD)=1.74 (0.22)) when compared with the controls (mean (SD)=1.95 (0.13)). For every 0.1 mg/dL decrease in serum Mg concentration, the odds of ischaemic stroke increase by approximately 1.918 times (95% CI 1.272 to 2.890; p=0.002). CONCLUSIONS: The mean Mg level in the ischaemic stroke group was significantly low compared with the no stroke group in patients with T2DM. We recommend further controlled studies to evaluate the role of Mg supplementation in the management of acute ischaemic stroke.
Asunto(s)
Isquemia Encefálica , Diabetes Mellitus Tipo 2 , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Diabetes Mellitus Tipo 2/complicaciones , Accidente Cerebrovascular/complicaciones , Isquemia Encefálica/complicaciones , Estudios de Casos y Controles , Magnesio , Puntaje de Propensión , Accidente Cerebrovascular Isquémico/complicacionesRESUMEN
Introduction: The institutional ethics committees (IECs) raise queries following protocol reviews. The quality of these queries would be a useful metric to assess how well the IEC executes its fundamental role of protecting participants. Methods: Queries received after the initial review and replies sent by a single research department were evaluated. A content analysis was done to identify the domains and categories of queries. We categorized these queries as administrative, ethics related, and scientific. The impact of each query in improving the science or safeguarding the rights and safety of research participants (ethics) was evaluated by two authors of this manuscript: one affiliated and the other nonaffiliated to the institute. Kappa statistics were used to evaluate for agreement between the two. Results: A total of 13 studies (investigator-initiated studies [IISs]: 7 and pharmaceutical industry-sponsored studies [PSSs]: 6) formed the final sample size for analysis. The total number of queries was 364 (IIS: 106 and PSS: 258; P < 0.001). With regard to the categories, we found n = 42 (11.54%) to be irrelevant at that stage of the review process; n = 51 (14.01%) were about information already available which the IEC had missed; n = 67 (18.41%) queries where the IEC needed paraphrasing; n = 50 (13.74%) were entirely relevant with the need for further clarification; and n = 154 (42.31%) had been missed by the investigator during the initial submission. The overall agreement between the affiliated and unaffiliated investigators was just 12.9% (P < 0.001). Conclusions: We found that approximately 25% of the queries raised by the IEC were redundant. It is our opinion that this redundancy could have been channeled into greater focus on scientific and ethical aspects of the protocol. Ongoing dialog between investigators and ethics committees may help address this. Perspectives between the affiliated and the unaffiliated investigators with regard to the relevance of queries were grossly different.
RESUMEN
INTRODUCTION: Kalmegh (Andrographis paniculata) is commonly used for treating uncomplicated Upper Respiratory Tract Infection (URTI) in complementary and alternative system of medicine. AP-Bio®(KalmCold®) is a standardized extract derived from the leaves of A. paniculata. This study was proposed to evaluate its efficacy using validated scales and objective measures. METHODS: Participants were randomized in a ratio of 1:1:1 to receive either AP-Bio® 200 mg/day, AP-Bio® 400 mg/day or placebo for 7 days. The primary outcome measure was Wisconsin Upper Respiratory Symptom Survey (WURSS-21) score. The secondary outcome measures were nasal mucous weight, nasal muco-ciliary clearance function and Interleukin-8 in nasal wash, as well as safety and tolerability. RESULTS: A total of n = 331 participants were screened and N = 300 participants were enrolled. The absolute WURSS-21 global score [mean (Standard Deviation - SD)] in the AP-Bio® 400 mg group [5.70 (5.31)] was less than the AP-Bio® 200 mg group [5.81 (4.83)] on Day-3. However, it was much higher in the placebo group [9.55 (14.27)]. AP-Bio® 400 mg group (Mean Difference - MD [Standard Error - SE] = -3.85 [1.52]; 95% CI = -6.85, - 0.85; adjusted p = 0.034) and 200 mg group (MD [SE] = -3.74 [1.51]; 95% CI = -6.73, - 0.76; adjusted p = 0.038) had significantly lower score than placebo. Similarly, on Day-3, the change in global score from baseline was significantly better in the AP-Bio® 400 mg group (MD [SE] = -3.91; [1.82] 95% CI = -7.50, - 0.32; adjusted p = 0.038) and AP-Bio® 200 mg group (MD [SE] = -3.84 [1.97]; 95% CI = -7.72, - 0.04; adjusted p = 0.044) in comparison to the placebo group. Nasal mucous weight, tissue paper counts used, and interleukin-8 showed a trend towards AP-Bio® groups having a favourable outcome when compared with placebo but did not reach statistical significance due to a small sample size. None of the study participants complained of any adverse physical symptoms. However, incident eosinophilia was noted in n = 20 participants on day 3. (n = 6 in AP-Bio® 200 mg group, n = 7 in Ap-Bio® 400 mg group and n = 13 in placebo group; p = 0.181). CONCLUSIONS: Participants in both the AP-Bio® dose groups showed positive tendency towards resolution of URTI symptoms when compared with placebo on Day-3 but not on Day-5 and Day-7.
Asunto(s)
Resfriado Común , Neumonía , Humanos , Resfriado Común/tratamiento farmacológico , Interleucina-8/uso terapéutico , Extractos Vegetales/uso terapéutico , Método Doble Ciego , Neumonía/tratamiento farmacológico , Sistema RespiratorioRESUMEN
OBJECTIVES: In acute coronary syndrome (ACS) patients the focus is on major conventional risk factors - CRF [diabetes, hypertension, elevated low-density cholesterol (LDL-C) and smoking] whereas others - specific metabolic risk factors - MRF [high-density lipoprotein cholesterol (HDL-C), body-mass index (BMI), waist-hip ratio (WHR), and triglycerides, and HbA1c get less attention. METHODS: This is a prospective case-control observational study from 15 tertiary care hospitals in India. CRF and MRF in patients presenting with first incidence of ACS (n = 2153) were compared with matched controls (n = 1210). RESULTS: Propensity score matching (PSM) yielded 1193 cases and matched 1210 controls. Risk factor prevalence in cases vs. controls were CRF: hypertension - 39.4% vs 16.4% (p < 0.0001), diabetes - 42.6% vs 12.7% (p < 0.0001), smoking - 28.3% vs 9.3% (p < 0.0001) and elevated LDL-C - 70.2% vs 57.9% (p < 0.0001). MRF: High BMI - 54.7% vs 55.1% (p = 0.84), increased waist: hip ratio 79.5% vs 63.6% (p < 0.0001), high HbA1c - 37.8% vs 14.9% (p < 0.0001), low HDL-C - 56.2% vs 42.8% (p < 0.0001) and elevated triglycerides - 49.7% vs 44.2% (p = 0.007). Adjusted Odds ratios by multivariate analysis were CRF: hypertension - 2.3 (p < 0.001), diabetes - 4.7 (p < 0.001), high LDL-C - 3.3 (p < 0.001) and smoking- 6.3 (p < 0.001). MRF: High waist: hip ratio - 2.4 (p < 0.001) high HbA1c - 3.2 (p < 0.001), low HDL-C 2.2 (p < 0.001) and elevated triglycerides - 0.878 p = 0.17. CONCLUSION: In India, the risk of ACS conferred by specific metabolic risk factors (High waist: hip ratio, Low HDL-C and High HbA1c) is comparable to that caused by CRF.
Asunto(s)
Síndrome Coronario Agudo , Diabetes Mellitus , Hipertensión , Síndrome Metabólico , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/epidemiología , Síndrome Coronario Agudo/etiología , Índice de Masa Corporal , HDL-Colesterol , LDL-Colesterol , Hemoglobina Glucada , Humanos , Síndrome Metabólico/complicaciones , Síndrome Metabólico/epidemiología , Factores de Riesgo , TriglicéridosRESUMEN
Healthcare workers (HCWs) and frontline workers were recommended hydroxychloroquine (HCQ) 400 mg twice a day on day 1, followed by 400 mg once weekly for the next 7 weeks, as prophylaxis against COVID-19. There was limited information on the population pharmacokinetics (popPK) of HCQ in an Indian setting when administered for prophylaxis against COVID-19, and hence this study was proposed. It was a multicentric prospective study conducted at 3 sites in India wherein HCWs who were already on HCQ prophylaxis, who were about to start prophylaxis or who had stopped the prophylaxis for any reason were enrolled. Each participant gave 2 to 6 blood samples at different time points and whole-blood HCQ concentrations were assayed using liquid chromatography with tandem mass spectrometry (LC MS/MS). popPK analysis was performed using PUMAS 1.1.0. A total of N = 338 blood samples from N = 121 participants were included in the popPK analysis. A 2-compartment structural model with linear elimination was able to explain the observed data. Body weight was found to be a significant covariate influencing drug clearance. The final model was assessed using goodness-of-fit plots, a visual predictive check and a bootstrap, all of which confirmed that the model was appropriate. Simulations based on the current regimen showed that trough values were below the half-maximal effective concentration (EC50) of 0.7 µmol against COVID-19. A new weight-based dosage regimen was proposed to maintain the trough concentration above the EC50 threshold.
Asunto(s)
Tratamiento Farmacológico de COVID-19 , Hidroxicloroquina , Personal de Salud , Humanos , Hidroxicloroquina/uso terapéutico , Estudios Prospectivos , SARS-CoV-2 , Espectrometría de Masas en TándemRESUMEN
INTRODUCTION: Restless leg syndrome (RLS) is a sensorimotor disease characterized by an urge to move the legs, often caused by uncomfortable and unpleasant sensations in the legs. It affects the quality of sleep which in turn affects scholastic performance in children and predisposes them to cardiovascular diseases in the long run. Hence, the primary aim of this study was to assess the prevalence and predictors of RLS, poor sleep quality, and excessive daytime sleepiness (EDS). METHODS: This was a cross-sectional observational study conducted between September 2017 and March 2020 in Bengaluru, India, including all consenting PreUniversity College, Degree College, and Higher Secondary school students. After parental consent and assent (if applicable) was obtained, a semi-structured standardized pilot-tested questionnaire consisting of the RLS diagnostic criteria, Pittsburgh Sleep Quality Index (PSQI), Epworth sleepiness scale, and questions on sleep hygiene was administered. The prevalence was expressed as proportions and 95% confidence intervals (95% CI). Regression analysis was done to determine the predictors. RESULTS: The overall prevalence (95% CI; frequency) of students with RLS, poor sleep quality, and EDS in our study population was 8.36% (7.54, 9.24; n = 1,544/4,211), 36.67% (35.21, 38.14; n = 1,544/4,211), and 39.87% (38.39, 41.37; n = 1,679/4,211), respectively. PSQI and Epworth score were the significant predictors of RLS. Age, Epworth score, knowledge score, and the number of unacceptable sleep habits were the significant predictors of sleep quality. Female gender, PSQI, RLS, knowledge score, and the number of unacceptable sleep habits were the significant predictors of EDS. CONCLUSIONS: The prevalence of RLS, those with poor sleep quality and EDS among adolescents and young adults was higher when compared to the historical data of general population in the same city.
Asunto(s)
Síndrome de las Piernas Inquietas , Adolescente , Niño , Estudios Transversales , Femenino , Humanos , India/epidemiología , Prevalencia , Síndrome de las Piernas Inquietas/complicaciones , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Adulto JovenRESUMEN
BACKGROUND: Undergraduate medical students in India participate in various research activities However, plagiarism is rampant, and we hypothesize that it is the lack of knowledge on how to avoid plagiarism. This study's objective was to measure the extent of knowledge and attitudes towards plagiarism among undergraduate medical students in India. METHODS: It was a multicentre, cross-sectional study conducted over a two-year period (January 2018 - December 2019). Undergraduate medical students were given a pre-tested semi-structured questionnaire which contained: (a) Demographic details; (b) A quiz developed by Indiana University, USA to assess knowledge; and (c) Attitudes towards Plagiarism (ATP) questionnaire. RESULTS: Eleven medical colleges (n = 4 government medical colleges [GMCs] and n = 7 private medical colleges [PMCs]) participated. A total of N = 4183 students consented. The mean (SD) knowledge score was 4.54 (1.78) out of 10. The factors (adjusted odds ratio [aOR]; 95% Confidence interval [CI]; p value) that emerged as significant predictors of poor knowledge score were early years of medical education (0.110; 0.063, 0.156; < 0.001) and being enrolled in a GMC (0.348; 0.233, 0.463; < 0.001).The overall mean (SD) scores of the three attitude components namely permissive, critical and submissive norms were 37.56 (5.25), 20.35 (4.20) and 31.20 (4.28) respectively, corresponding to the moderate category. CONCLUSION: The overall knowledge score was poor. A vast majority of study participants fell in the moderate category of attitude score. These findings warrant the need for incorporating formal training in the medical education curriculum.
Asunto(s)
Plagio , Estudiantes de Medicina , Actitud , Estudios Transversales , Curriculum , Ética en Investigación , Conocimientos, Actitudes y Práctica en Salud , Humanos , India , Encuestas y CuestionariosRESUMEN
BACKGROUND: CYP3A5 enzymes belong to the phase I Group of drug-metabolizing enzymes, which are involved in the metabolism of 50% of the drugs. Participants with CYP3A5 genotype: CYP3A5 *1/*1 are fast metabolizers of drugs and hence will require higher dosing. Whereas those with CYP3A5 * 3/*3 are poor metabolizers of drugs and will require a lower dose to achieve target drug concentration in the blood and those with CYP3A5 * 1/*3 have intermediate drug metabolizing activity. Pharmacogenetic evaluation may improve disease outcomes by maximizing the efficacy and minimizing the toxicity of drugs in patients. MATERIALS AND METHODS: This is a single-center cross-sectional study conducted in the year 2018-2019 to study the population prevalence of genetic polymorphisms of CYP3A5 in healthy participants from western India. Eligible participants willing to give written, informed consent were enrolled in the study. Subsequently, 2 ml venous blood was collected the deoxyribonucleic acid was extracted and then stored at â20°C. Genotyping was done by a polymerase chain reaction and restriction fragment length polymorphism. RESULTS: A total of 400 participants with a median age of 22 years (range: 18-58 years) were included. Among them, the genotype prevalence for CYP3A5 * 1/*1 was 17% (n = 67/400); CYP3A5 * 1/*3 was 37% (n = 149/400) and that of CYP3A5 * 3/*3 was 46% (184/400). Out of the total 400 healthy participants analyzed, the allele frequency for CYP3A5 * 1 was 35% (142/400) and that of CYP3A5*3 was 65% (259/400). CONCLUSION: The genotype prevalence for CYP3A5 * 3*3 (46%) and the allele frequency for CYP3A5 * 3 (65%) respectively were the highest among the western Indian population.
Asunto(s)
Citocromo P-450 CYP3A , Inmunosupresores , Adolescente , Adulto , Estudios Transversales , Citocromo P-450 CYP3A/genética , Genotipo , Voluntarios Sanos , Humanos , India , Persona de Mediana Edad , Polimorfismo Genético , Adulto JovenRESUMEN
Introduction: Proton pump inhibitors (PPIs) are liberally used over the counter medication and is largely considered safe. Off late, there are many reports that suggest increased incidence of chronic kidney disease with long-term PPI use. PPIs are often prescribed in patients with diabetes mellitus (DM) and one of the well-known complications of DM is diabetic nephropathy (DN). Thus, the aim of our study was to evaluate association between PPI use and DN. Methods: It was a case-control study conducted over a 2-year period (April 2017-March 2019). Cases were outpatients with type II DM and associated DN. Controls were age and sex-matched type II DM without DN. Results: A total of 200 participants, 100 each in the case and control group, were recruited. The proportion of participants using PPI was 62% in the cases and 42% in the controls (P = 0.005). The most common PPI used was pantoprazole. Increased duration of PPI use was significantly associated with DN [adjusted odds ratio: 1.171; 95% confidence interval: 1.022, 1.341; P = 0.023]. Conclusion: There is a significant association between the use of PPIs and DN in patients with type II DM. Since PPIs have other beneficial effects in patients with DM such as glycaemic control and relief from gastro-oesophageal symptoms, need for risk benefit assessment for long-term use of PPIs in DM is warranted.
RESUMEN
OBJECTIVES: Posterior urethral valves (PUV) is the commonest obstructive uropathy with varied consequences. Though valve fulguration is the treatment of choice, appropriate bladder management modifies outcome and includes rational use of anticholinergics. Here, we aim to evaluate the effects of oxybutynin on the bladder and urinary tract morphology and function. Concurrently, we document adverse effects encountered, patient compliance, and medication adherence. METHODS: A retrospective study of children below 5 years of age (2012-2017) post fulguration and on oxybutynin for at least 6 months. Patient demographics, clinical features, renal ultrasound, micturating cystourethrogram, dimercaptosuccinic acid scan, adverse effects, and pill count for medication adherence were collated. RESULTS: 48 children below the age of 5 years were included, and 12 were excluded either due to the presence of concomitant problems or were not on oxybutynin. Of the 36, four were lost to follow-up and one had died due to an unrelated condition. Thus, a total of 31 children were analyzed. At follow-up, 28/31 patients were asymptomatic, two had daytime incontinence, and one had recurrent urinary tract infection. All patients except one have preserved renal function tests. On ultrasonography, hydroureteronephrosis worsened in only 1/25 children and two showed significant post void residues. The resolution of vesicoureteral reflux was noted in almost 50%. 4/31 renal units had progressive scars. Only two parents defaulted medication. Urodynamic study done in half of these children showed stable bladder pressures except in two. CONCLUSION: Oxybutynin therapy following adequate valve fulguration aids upper tracts preservation by stabilizing deranged bladder dynamics. The medication is well tolerated with minimal or no side effects.
RESUMEN
AIM: Emergency intensive care of the elderly is often complicated and multifaceted. Understanding the clinical profile of elderly patients admitted in an emergency department-intensive care unit (ED-ICU) is crucial in planning health policies in geriatric emergency medicine. Thus, the aim of the study was to create a local registry of elderly people utilizing the ED-ICU services and to understand the rate and predictors of mortality. METHODS: A retrospective chart analysis was performed including all patients aged ≥60 years who had an ED-ICU admission during a 6-month period (August 2018-January 2019). A structured case record form was used to capture information such as basic demography, clinical profile, and outcomes. RESULTS: Total number of records considered for final analysis were 503. Mortality was seen in 21.07% (n = 106/503). The most common presenting complaint and cause of death was breathing difficulty (n = 48/503; 29.42%) and pneumonia (n = 41/106; 38.67%), repectively. The significant predictors of mortality [adjusted odds ratio; 95% confidence intervals; P value] were hypertension (2.195; 1.255, 3.840; 0.006), chronic liver disease (CLD) (4.324; 1.170, 15.979; 0.028), malignancy (2.854; 1.045, 7.796; 0.041), requiring noninvasive ventilation (NIV) (2.618; 1.449, 4.730; 0.001), requiring intubation (6.638; 3.705, 11.894; <0.001), and requiring vasopressors (3.583; 1.985, 6.465; <0.001). CONLUSION: Approximately one in every five elderly patients getting admitted in ED-ICU died, and respiratory illness was the common diagnosis leading to death. Those with comorbidities such as hypertension, CLD, or malignancy and those requiring NIV, intubation, or vasopressors had higher mortality.
RESUMEN
BACKGROUND: Abnormal laboratory values are a common reason for the exclusion of participants in clinical studies, increasing the recruitment time and cost during conduct. The use of sample-specific reference intervals (RIs) may help to address this issue. Hence, the present study derived site-specific RIs using the department laboratory database and compare the proportion of "out of range" (OOR) values between the new and the old RIs used by the trial site. METHODS: Institutional ethics committee approval was obtained. Data for hematology and biochemistry parameters were analyzed. Normality was assessed and RIs computed using nonparametric method. Data were partitioned for gender and descriptive statistics applied for demographics. The OOR values based on new RIs were compared with old RIs using Chi-squared tests. Between gender OOR proportions compared using Chi-squared test (significance at P< 0.05). Post hoc analysis was performed with Beasley's technique. RESULTS: Data of 601 participants were analyzed. The median (Inter Quartile Range) age was 22 (47) years and 64.72% were male. New RIs for key parameters were: Haemoglobin (9.3-16.5 g/dl), alanine aminotransferase (11.4-47.74 U/I), aspartate aminotransferase (8.8-58 U/I), total bilirubin (0.27-1.4 mg/dl), and creatinine (0.59-1.36 mg/dl). Post partitioning, the RI for hemoglobin (g/dl) was lower (8.72-15.72) in females. The proportion of OOR values were lower with new RIs relative to old laboratory RIs (P < 0.0001). CONCLUSION: A reduction in the proportion of OORs and a change in the upper and lower bound laboratory intervals with new RIs emphasize the need for sample-specific ranges to prevent unnecessary exclusions of volunteers from trials.
RESUMEN
INTRODUCTION: The Investigational New Drug (IND) committee advises the Drug Controller General of India on matters pertaining to clinical trials (CTs) of IND for clinical development. An audit of the minutes of this committee's meetings would shed light on the drug discovery in India. METHODS: Minutes of the IND committee meetings available in the public domain (2-year period) were evaluated. The applications which were postponed were excluded from the study. Outcome measures were therapeutic areas of IND, purpose of the applications, status of registration with the CT Registry of India (CTRI), and the innovator country. RESULTS: The minutes of N = 7 meetings were available in the public domain for the period January 2017-December 2018 with N = 45 agenda items. One agenda item was excluded, and n = 44 agenda items were finally analyzed. The total number of therapeutic agents discussed was N = 29, of which n = 7/29 and n = 6/29 belonged to infectious diseases (ID) and oncology, respectively. The total number of purposes of these applications was N = 46, of which n = 35/46 (76%) were to seek permission to conduct a CT, and n = 31/35 (88.6%) were found registered with CTRI as on April 01, 2019. Of the N = 46 purposes, n = 33/46 (71.7%) were approved. Of the n = 29 INDs discussed, n = 19/29 (65.52%) were of the Indian origin. CONCLUSIONS: Although a majority (65%) of INDs discussed in the meetings were of the Indian origin, the drug discovery was not in line to tackle the top ten causes of years of life lost prematurely (barring ID).
RESUMEN
OBJECTIVES: Though dissertation is mandatory for postgraduates (PG), it is unknown if adequate knowledge on plagiarism exists at that level. Thus, we intended to study the knowledge and attitude towards plagiarism among junior doctors in India. DESIGN: Cross-sectional study SETTING: PG medical residents and Junior faculty from various teaching institutions across south India. PARTICIPANTS: A total of N=786 doctors filled the questionnaires of which approximately 42.7% were from government medical colleges (GMCs) and the rest from private institutions. METHODS: Participants were given a pretested semistructured questionnaire which contained: (1) demographic details; (2) a quiz developed by Indiana University, USA to assess knowledge and (3) Attitudes towards Plagiarism Questionnaire (ATPQ). OUTCOME MEASURES: The Primary outcome measure was knowledge about plagiarism. The secondary outcome measure was ATPQ scores. RESULTS: A total of N=786 resident doctors and junior faculty from across 11 institutions participated in this study. Of this, 42.7% were from GMCs and 60.6% were women. The mean (SD) knowledge score was 4.43 (1.99) out of 10. The factors (adjusted OR; 95% CI; p value) that emerged as significant predictors of knowledge were number of years in profession (-0.181; -0.299 to -0.062; 0.003), no previous publication (0.298; 0.099 to 0.498; 0.003) and working in a GMC (0.400; 0.106 to 0.694; 0.008). The overall mean (SD) scores of the three attitude components were: Permissive attitudes-37.33 (5.33), critical attitudes -20.32 (4.82) and subjective norms-31.05 (4.58), all of which corresponded to the moderate category. CONCLUSION: Participants lacked adequate knowledge on how to avoid plagiarism suggesting a need for a revamp in medical education curriculum in India by incorporating research and publication ethics.
Asunto(s)
Docentes Médicos , Plagio , Estudios Transversales , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , India , Indiana , Masculino , Encuestas y CuestionariosRESUMEN
INTRODUCTION: The post-2005 rise in clinical trials and clinical research conducted in India was accompanied by frequent reports of unethical practices, leading to a series of regulatory changes. We conducted a systematic scoping review to obtain an overview of empirical research pertaining to the ethics of clinical trials/research in India. METHODS: Our search strategy combined terms related to ethics/bioethics, informed consent, clinical trials/research and India, across nine databases, up to November 2019. Peer-reviewed research exploring ethical aspects of clinical trials/research in India with any stakeholder groups was included. We developed an evidence map, undertook a narrative synthesis and identified research gaps. A consultation exercise with stakeholders in India helped contextualise the review and identify additional research priorities. RESULTS: Titles/Abstracts of 9699 articles were screened, full text of 282 obtained and 80 were included. Research on the ethics of clinical trials/research covered a wide range of topics, often conducted with little to no funding. Studies predominantly examined what lay (patients/public) and professional participants (eg, healthcare staff/students/faculty) know about topics such as research ethics or understand from the information given to obtain their consent for research participation. Easily accessible groups, namely ethics committee members and healthcare students were frequently researched. Research gaps included developing a better understanding of the recruitment-informed consent process, including the doctor-patient interaction, in multiple contexts and exploring issues of equity and justice in clinical trials/research. CONCLUSION: The review demonstrates that while a wide range of topics have been studied in India, the focus is largely on assessing knowledge levels across different population groups. This is a useful starting point, but fundamental questions remain unanswered about informed consent processes and broader issues of inequity that pervade the clinical trials/research landscape. A priority-setting exercise and appropriate funding mechanisms to support researchers in India would help improve the clinical trials/research ecosystem.