Indian Setting Research Articles

Team based collaborative care model, facilitated by a mHealth enabled and trained nurse, for management of heart failure in India (TIME-HF): design and rationale of a parallel group, open label, multi-centric cluster randomized controlled trial

Background: Heart failure (HF) is a debilitating condition associated with enormous public health burden. Management of HF is complex as it requires care and coordination with different cadres of health care providers. In resource poor settings, physician driven initiatives to improve HF management is difficult due to multiple barriers. We propose to develop a team based collaborative care model (CCM), facilitated by a trained nurse, for management of HF with the support of mHealth and evaluate their acceptability and effectiveness in Indian setting. Methods: The proposed study will use mixed-methods research for assessment. A formative qualitative research will identify barriers and facilitators for implementing CCM for the management of HF and develop components of the intervention. Subsequently, a cluster randomised controlled trial (RCT) involving 22 centres (tertiary hospitals) with more than 1500 HF patients will be conducted to assess the effectiveness of the CCM in improving the overall survival as well as days alive and out of hospital (DAOH) at two-years (CTRI/2021/11/037797). The DAOH will be calculated by subtracting days in hospital and days from death until end of study follow-up from the total follow-up time. Poisson regression with a robust variance estimate and an offset term to account for clustering will be employed in the analyses of DAOH. A rate ratio and its 95% confidence interval (CI) will be estimated. The scalability of the proposed intervention model will be assessed through economic analyses (cost-effectiveness) and the acceptability of the intervention at both the provider and patient level will be understood through process evaluation. Potential Impact: The TIME-HF trial will provide evidence on whether a nurse-led team based CCM with mHealth support is effective in improving the clinical outcomes of HF in India. The findings may change the practice of management of HF in financially constrained low and middle-income countries.

Perceptions and Experiences of Informal Caregivers of Breast Cancer Patients in South India: A Qualitative Study

This study was conducted to explore the prevailing perceptions and experiences of caregiving burden among informal caregivers of women living with breast cancer in South India. In-depth interviews were conducted among breast cancer care-receivers (n=35) and their informal caregivers (n=39) and a thematic analysis was used to analyze the data. Informal caregiver in the context of this study was defined as one who takes up the responsibility of an informal caregiving role, and were either self-identified or acknowledged by the care-receivers. Four main inductive themes in the domains of: emotional culpability, financial and workplace liability, psychosocial affliction, physical strain and health system demand were identified, that were associated with caregiver burden. Informal caregivers form an integral part of the cancer care continuum in India. It is recommended to factor in the identified themes while developing a caregiver needs assessment model in the context of caring for breast cancer patients in the Indian setting.

ANTENATAL UMBILICAL CORD COILING INDEX AS A PREDICTOR OF PREGNANCY OUTCOME

Introduction: Negative pregnancy outcomes, such as stillbirth, neonatal mortality, premature delivery, low birth weight, and admission to the neonatal intensive care unit (NICU), are linked to anomalies in the umbilical cord, such as the nuchal cord, marginal cord insertion, and aberrant cord coiling. Not many studies throw insight into this topic from South Indian settings. Objective: To investigate the role of the antenatal umbilical cord coiling index (AUCCI) in predicting adverse pregnancy outcomes. Methods: This is a cross-sectional study of 200 pregnant women who underwent antenatal ultrasound scans with ≥ 28 weeks of gestation with singleton live pregnancy who attended the obstetrics department. The AUCCI was measured as the ratio of the total number of coils in the umbilical cord to its length. The primary outcome was to nd the association between AUCCI and adverse pregnancy outcomes, including both maternal and fetal outcomes. Results: The mean AUCCI was 24 ±0.10, we categorised AUCCI <0.42 as hypocoiled, 0.42 – 0.59 as normocoiled and more than equal to 60 as hypercoiled based on distribution. We also observed a signicant association between AUCCI and PPH, PROM, APGAR score, NICU admission, and low birth weight. (p-value <0.05) Conclusion: The antenatal umbilical cord coiling index is a simple and noninvasive tool that can be used to predict adverse pregnancy outcomes. The lower the AUCCI, the higher the risk of adverse pregnancy outcomes

Improvement of Beginning Reading Ability in Class V Dyslexic Students through the Silaba Method at Jombang 05 Public Elementary School

The objective of this research is to look into the inclusion of children with neurological diseases in Indian education. According to the research, a substantial proportion of children in India have neurological disorders, and they frequently face barriers to education. The study examines the current situation of education for children with neurological problems in India, as well as the policies and laws that regulate their education. The review also looks at the difficulties that these children, their families, and educators have had in implementing inclusive education. Lastly, the report explores interventions and techniques that can help children with neurological disorders be included in Indian education settings with a concerted effort from all stakeholders involved in the education process.

Systemic inflammatory response syndrome criteria (SIRS) and sepsis 3 criteria for assessing outcomes in sepsis: A prospective observational study.

Sepsis is a major cause of death in hospitalised patients worldwide. Most studies for assessing outcomes in sepsis are from the western literature. Sparse data from Indian settings are available comparing the systemic inflammatory response syndrome (SIRS), Sequential Organ Failure Assessment (SOFA) and quick SOFA (qSOFA) (sepsis 3 criteria) for assessing outcomes in sepsis. In this study, we aimed to compare the SIRS criteria and sepsis 3 criteria to assess disease outcome at day 28 (recovery/mortality) in a North Indian tertiary care teaching hospital. A prospective observational study was performed in the Department of Medicine from 2019 to early 2020. Patients admitted to the medical emergency with clinical suspicion of sepsis were included. Systemic inflammatory response syndrome, qSOFA and SOFA scores were calculated at the time of presentation to the hospital. Patients were followed through the course of their hospital stay. Out of 149 patients, 139 were included in the analysis. Patients who died had significantly higher mean SOFA, qSOFA scores and mean change in SOFA score than patients who survived (P value <0.01). There was no statistical difference between recovery and deaths at similar SIRS scores. A 40.30% fatality rate was recorded. Systemic inflammatory response syndrome had low Area Under Curve (AUC) (0.47) with low sensitivity (76.8) and specificity (21.7). SOFA had the maximum AUC (0.68) compared to qSOFA (0.63) and SIRS (0.47). SOFA also had the maximum sensitivity (98.1) while the qSOFA score had the maximum specificity (84.3). SOFA and qSOFA scores had superior predictive ability as compared to the SIRS score in assessing mortality in sepsis patients.

Management of B-cell lineage acute lymphoblastic leukemia: expert opinion from an Indian panel via Delphi consensus method.

Currently, there are no guidelines for the management of B-cell lineage acute lymphoblastic leukemia (B-ALL) from an Indian perspective. The diagnostic workup, monitoring, and treatment of B-ALL vary among different physicians and institutes. To develop evidence-based practical consensus recommendations for the management of B-ALL in Indian settings. Modified Delphi consensus methodology was considered to arrive at a consensus. An expert scientific committee of 15 experts from India constituted the panel. Clinically relevant questions belonging to three major domains were drafted for presentation and discussion: (i) diagnosis and risk assignment; (ii) frontline treatment; and (iii) choice of therapy (optimal vs. real-world practice) in relapsed/refractory (R/R) settings. The questionnaire was shared with the panel members through an online survey platform. The level of consensus was categorized into high (≥ 80%), moderate (60%-79%), and no consensus (< 60%). The process involved 2 rounds of discussion and 3 rounds of Delphi survey. The questions that received near or no consensus were discussed during virtual meetings (Delphi rounds 1 and 2). The final draft of the consensus was emailed to the panel for final review. Experts recommended morphologic assessment of peripheral blood or bone marrow, flow cytometric immunophenotyping, and conventional cytogenetic analysis in the initial diagnostic workup. Berlin-Frankfurt-Münster (BFM)-based protocol is the preferred frontline therapy in pediatric and adolescent and young adult patients with B-ALL. BFM/German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia-based regimen is suggested in adult patients with B-ALL. Immunotherapy (blinatumomab or inotuzumab ozogamicin) followed by allogeneic hematopoietic cell transplantation (allo-HCT) is the optimal choice of therapy that would yield the best outcomes if offered in the first salvage in patients with R/R B-ALL. In patients with financial constraints or prior allo-HCT (real-world practice) at first relapse, standard-intensive chemotherapy followed by allo-HCT may be considered. For subsequent relapses, chimeric antigen receptor T-cell therapy or palliative care was suggested as the optimal choice of therapy. This expert consensus will offer guidance to oncologists/clinicians on the management of B-ALL in Indian settings.

Psychopathology and Pattern of Remission of Cannabis-Induced Psychotic Disorder.

Objective: To analyze the psychopathology and pattern of remission in cannabis-induced psychotic disorder with treatment.Methods: This was a prospective cohort study of a group of patients admitted with new-onset psychosis, cannabis use, and no evidence of other drug abuse from January 1 to June 31, 2019, to the psychiatry inpatient department of a multispecialty tertiary care hospital in Kerala, India. Patients were evaluated at admission and after 1 week in the hospital and 1 month after discharge using the Structured Clinical Interview for the Positive and Negative Syndrome Scale and the Clinical Global Impressions-Severity of illness scale.Results: Fifty-six male subjects were recruited for the study. The mean age of the subjects was 22.2 years, and the majority were active smokers of nicotine and cannabis. Total duration of abuse and family history of substance use in first-degree relatives correlated with severity of psychosis. Hostility, excitement, and grandiosity were the predominant positive symptoms, and these symptoms showed a steady reduction toward the end of the study. The most frequent negative symptoms were emotional withdrawal, passive or apathetic social withdrawal, and difficulty in abstract thinking, and these symptoms also showed significant improvement (P < .001 for all). For symptoms such as somatic concern and guilt feelings, significant treatment response was noted only in the initial week (P < .001).Conclusions: Cannabis-induced psychosis in the Indian setting presents with predominant positive symptoms and minimal affective symptoms. The steady improvement noted with complete cessation of cannabis indicates a possible contributory role for cannabis in precipitating psychosis.

Self-rated health among older adults in India: Gender specific findings from National Sample Survey.

The self-rated health (SRH) is a widely adopted indicator of overall health. The sponge hypothesis suggests that predictive power of SRH is stronger among women compared to men. To gain a better understanding of how gender influences SRH, this study examined whether and what determinants of gender disparity exist current self-rated health (SRHcurrent) and change in SRH (SRHchange) among older adults in Indian setting. We used cross-sectional data from the 75th National Sample Survey Organizations (NSSO), collected from July 2017 to June 2018. The analytical sample constitutes 42,759 older individuals aged 60 years or older with 21,902 older men and 20,857 older women (eliminating two non-binary individuals). Outcome measures include two variables of poor/worse SRH status (SRHcurrent and SRHchange). We have calculated absolute gaps in the prevalence of poor SRHcurrent and worse SRHchange by background characteristics. We carried out binary logistic regression models to examine the predictors of poor SRHcurrent and worse SRHchange among older adults. The overall absolute gender gap in poor SRHcurrent was 3.27% and it was 0.58% in worse SRHchange. Older women had significantly higher odds of poor SRHcurrent [AOR = 1.09; CI = 0.99, 1.19] and worse SRHchange [AOR = 1.09; CI = 1.02, 1.16] compared to older men. Older adults belonging to middle-aged, oldest-old, economically dependent, not working, physically immobile, suffering from chronic diseases, belonging to Muslim religion, and Eastern region have found to have higher odds of poor SRHcurrent and worse SRHchange. Educational attainments showed lower odds of have poor SRHcurrent and worse SRHchange compared to those with no education. Respondents belonging to richest income quintile and those who were not covered by any health insurance, belonging to Schedule caste, OBC, Western and Southern regions are found to have lower odds of poor SRHcurrent and worse SRHchange. Compared to those in the urban residence, respondents from rural residence [AOR = 1.09; CI = 1.02, 1.16] had higher odds of worse SRHchange. Supporting the sponge hypothesis, a clear gender gap was observed in poor current SRH and worse change in SRH among older adults in India with a female disadvantage. We further found lower socioeconomic and health conditions and lack of resources as determinants of poor current SRH and its worse change, which is crucial to address the challenge of the older people's health and their perception of well-being.

Therapeutic mammoplasty: a "wise" oncoplastic choice-lessons from the largest single-center cohort from Asia.

The majority of breast cancer patients from India usually present with advanced disease, limiting the scope of breast conservation surgery. Therapeutic mammoplasty (TM), an oncoplastic technique that permits larger excisions, is quite promising in such a scenario and well suited to breast cancer in medium-to-large-sized breasts with ptosis and in some cases of large or multifocal/multicentric tumors. Here, we describe our TM cohort of 205 (194 malignant and 11 benign) patients from 2012 to 2019 treated at a single surgeon center in India, the largest Asian dataset for TM. All patients underwent treatment after careful discussions by a multidisciplinary tumor board and patient counseling. We report the clinicopathological profiles and surgical, oncological, cosmetic, and patient-related outcomes with different TM procedures. The median age of breast cancer patients was 49 years; that of benign disease patients was 41 years. The breast cancer cohort underwent simple (n = 84), complex (n = 71), or extreme (n = 44) TM surgeries. All resection margins were analyzed through intra-operative frozen-section assessment with stringent rad-path analysis protocols. The margin positivity rate was found to be 1.4%. A majority of the cohort was observed to have pT1-pT2 tumors, and the median resection volume was 180 cc. Low post-operative complication rates and good-to-excellent cosmetic scores were observed. The median follow-up was 39 months. We observed 2.07% local and 5.7% distal recurrences, and disease-specific mortality was 3.1%. At median follow-up, the overall survival was observed to be 95.9%, and disease-free survival was found to be 92.2%. The patient-reported outcome measures (PROMs) showed good-to-excellent scores for all types of TMs across BREAST-Q domains. We conclude that in India, a country where women present with large and locally advanced tumors, TM safely expands the indications for breast conservation surgery. Our results show oncological and cosmetic outcomes at acceptable levels. Most importantly, PROM scores suggest improved overall wellbeing and better satisfaction with the quality of life. For patients with macromastia, this technique not only focuses on cancer but also improves self-image and reduces associated physical discomfort often overlooked by women in the Indian setting. The popularization of this procedure will enable Indian patients with breast cancer to receive the benefits of breast conservation.

A Decade of Trend in the Employee Turnover Intention Study in India: A Systematic Review and Recommendation

Employee turnover intentions have emerged as a significant research topic in social sciences as well as a challenge for corporates in Indian settings in past decade. This article presents a systematic literature review of employee turnover intention in India, providing an in-depth analysis of 198 empirical research articles on employee turnover intentions in Indian cultural settings published between 2010 to October 2022 in 126 academic journals listed in Scopus and Web of Sciences and proposes a heuristic model of turnover intention. The study reveals: 53 distinctive correlates of turnover intention which have been grouped into nine broad categories; research being conducted on a few antecedents of turnover intention in isolated pieces without taking a comprehensive approach; lack of attention to testing recent turnover models in Indian settings; too much preference on turnover intention as a proxy for actual turnover. The proposed model was tested on 481 respondents belonging to various industries across service sector in India employing Smart PLS software for validating path analysis provided encouraging results. Taking a note of trends and rifts, this article presents an inclusive approach along with suggestions and recommendations for future employee turnover intention research in India.

Human immunodeficiency virus self-testing in India

The human immunodeficiency virus (HIV) infection has been regarded as a global public health concern. In the global mission to minimize the existing gap on the diagnostic front, a number of strategies to promote HIV testing have been encouraged in heterogeneous settings. Detection of HIV infection using self-testing kits has emerged as an important approach to ascertain the identification of new cases and for connecting the affected people with the health-care delivery system. It is quite an alarming fact that despite HIV is a major public health problem in India, we to date have no policy on the promotion of self-testing. The findings of a recently released report in India revealed that self-testing was found to be acceptable to vulnerable population groups and their partners. To conclude, acknowledging the merits that have been linked with self-testing and considering the encouraging results obtained in Indian settings, it is the need of the hour that policymakers draft the much-awaited policy on the promotion of HIV self-testing in the nation and promote it.

Dyspepsia - The Indian perspective: A cross sectional study on demographics and treatment patterns of Dyspepsia from across India (Power 1.0 study).

Dyspepsia includes a spectrum of symptoms ranging from epigastric pain and early satiety to postprandial fullness. The worldwide prevalence of dyspepsia is 20-30%. It is slightly higher in the Western population and occurs more frequently among women. While the precise prevalence of dyspepsia in India is not available, different studies estimate that it affects 7.6-49% of the Indian population. Through our current study, we wanted to understand the demographics, clinical profile, patient presentation, and management in India. We also wanted to document the pattern of use of proton pump inhibitors (PPI) and patient satisfaction with PPIs in Indian patients with dyspepsia. This pan-India, multi-centric, cross-sectional, questionnaire-based, noninterventional, observational study was conducted between February and October 2021 in patients &gt;18 years of age with a clinical diagnosis of any form of dyspepsia. Descriptive statistics were used for categorical variables, and between-group comparisons were made using Fischer's exact test, with p &lt; 0.05 denoting statistical significance. A total of 3,739 patients from across 29 states of India participated in the study. Most of the patients were male (70.8%) and were from urban areas (56.8%). The highest percentage of patients were aged 31-40 (33.8%), and most patients (60.2%) had dyspepsia for a duration of 6-12 months. Patients with functional dyspepsia (FD) (78.5%) were significantly higher compared to organic dyspepsia (OD) (21.5%) (p &lt; 0.001). The most frequent presenting symptoms were epigastric pain, nausea, vomiting, and heartburn. A quarter (25.6%) of the dyspepsia patients were associated with various comorbid conditions, of which diabetes mellitus, hypertension, and irritable bowel syndrome are the most common ones. A total of 619 patients in the study were on concomitant medications, of which the most common were antidiabetic drugs (271/619, 43.8%). Rabeprazole was the most frequently used PPI (2467/3739, 66.0%) among the study participants. The patient satisfaction analysis showed that, overall, patients were satisfied with PPIs, as most patients (~80%) agreed to almost all questions. The analysis for individual PPIs showed the highest "agree" responses in the rabeprazole group for almost all questions (12 of 13). Around 86.4% of patients on rabeprazole agreed with "immediate relief from acidity," 84.9% for "gives me complete relief," and 85.9% for "relief from nighttime acidity symptoms." Our study involving over 3,700 Indian patients with Dyspepsia adds to the growing knowledge of dyspepsia in India. Dyspepsia is more prevalent in males and in the 31-50 age group. FD is the most common form. Overall, patients were satisfied with PPIs in dyspepsia management in India. Patients on rabeprazole showed higher levels of medication adherence, satisfaction with symptom relief, convenience of therapy, and safety compared to patients on other PPIs. Against the backdrop of a paucity of reliable data about dyspepsia in India, our study results provide valuable insights into Dyspepsia and its management in an Indian setting.

Employing E-learning Tools and Resource Materials in the Successful Implementation of Competency-based Medical Education in India

Competency-based medical education (CBME) has emerged as one of the modes of the curriculum which is built around a framework of competencies and plays an important role in the making of a healthcare professional who is competent enough to meet the health care needs of the society. The purpose of the current review was to explore the role of e-learning in enhancing learning in different domains of learning and identify the various e-learning resources. An extensive search of all materials related to the topic was carried out on the PubMed search engine and a total of 35 articles were selected based upon the suitability with the current review objectives and analyzed. The search was carried out for a period of one month and all articles published between 2003 to 2021 were included. As only one search engine was used, there were no duplications. Keywords used in the search include e-learning and medical education in the title alone only. E-learning has been acknowledged as one of the significant curricular reforms, which has the potential to bring about a paradigm shift in medical education in India. The basic rationale for the utility of e-learning in the medical curriculum originates from the fact that the syllabus is extremely vast and students have to study many subjects in a fully-packed schedule, and that cannot happen only within the classroom hours. E-learning can play an important role in the augmentation of cognitive, psychomotor, and attitudinal/communication skills through the optimal use of e-learning resources. To conclude, e-learning has emerged as an important approach to strengthen the process of implementation of competency-based medical education in Indian settings. The need of the hour is to acknowledge the merits of e-learning and plan strategies for the successful integration so that the overall process of CBME implementation can be strengthened and streamlined.

Management of neonatal pulmonary hypertension-a survey of neonatal intensive care units in India

BackgroundPersistent pulmonary hypertension of the newborn (PPHN) is a common neonatal condition associated with significant morbidity and mortality. First-line diagnostic and treatment options such as echocardiography and inhaled nitric oxide (iNO) are not routinely available in resource limited settings and alternative treatment modalities need to be utilized. This study was conducted to assess current diagnostic and management strategies used for PPHN in Indian neonatal intensive care units (NICUs).MethodsA questionnaire in multiple choice question format was sent to practising neonatologists in India via an online survey tool between July to August 2021. Information pertaining to demographic data, diagnostic criteria and management strategies of PPHN was requested. The responses were collated and information processed.ResultsThere were 118 respondent NICUs (response rate 74%). The majority of neonatal units (65%) admitted an average of 1–3 patients of PPHN per month. Targeted neonatal echocardiography (TnECHO) was practised in 80% of the units. Most common management strategies being followed were pulmonary vasodilators (88.1%), inotropes (85.6%), conventional ventilation (68.6%) and high frequency ventilation (59.3%). The most preferred pulmonary vasodilator was sildenafil (79%) and inotropic agent was milrinone (32%). Only 25% of respondents reported use of iNO. None of the participating units used extracorporeal membrane oxygenation.ConclusionWe found wide variability in management practices of PPHN across Indian NICUs. Non-selective pulmonary vasodilators are more widely used than iNO. There is an urgent need for structured TnECHO training programs and evidence based national guidelines for standardized management of PPHN as per availability of resources in India. Additional research on low cost alternative therapies to iNO in Indian settings might be helpful.

Implications of exclusive breastfeeding and complementary feeding practices on gastrointestinal health and antibiotic exposure: A questionnaire-based assessment

BackgroundInfancy is a very crucial phase of comprehensive development. Optimum nutrition has the potential to boost immunity and decrease disease susceptibility. Our hypothesis is that exclusive breastfeeding and homebased complementary feeding improves gastrointestinal health and reduces antibiotic exposure in infants, in comparison to partial breast feeding and mixed complementary feeding. Very few studies have explored this topic in a rural Indian setting. MethodsA prospective cohort study was conducted with a sample size of 200 mothers of 6–12 months old healthy infants in rural areas of Karnataka, India. Data collection was done by in-depth interview exclusivity of Breast Feeding (Exclusive-EBF, Formula-FF and Partial -PBF), type of Complementary Feeding (Homebased-HCF, Commercial-CCF, Mixed-MCF) followed, episodes of vomiting, diarrhoea and antibiotic exposure. Pearson's chi-square tests were performed using SPSS version 16 for statistical analysis. ResultsEBF was observed in 50.5% (101) of infants, PBF in 49% (98) and FF in 0.5% (1). On EBF for 6 months, 3% (3) of infants had vomiting and 1% (1) had diarrhoea, whereas on PBF, 5.2% (5) and 3% (3) (p > 0.05) of infants had vomiting and diarrhoea, respectively. None of the infants on HCF suffered from diarrhoea or vomiting. While 5.4% (9) and 2.4% (4) of infants on MCF had vomiting and diarrhoea respectively (p > 0.05). Antibiotic exposure was reported in 30.3% (10) of HCF and 54.8% (90) of MCF infants (p > 0.05) respectively. ConclusionA population-level awareness regarding EBF and HCF could lead to decreased incidences of gastrointestinal infections.

Utility of Brief Illness Perception Questionnaire for Assessing the Acute Impact of COVID-19 Infection: A Psychometric Study

Background: The coronavirus disease-19 (COVID-19) pandemic has created mental health repercussions in the lives of many individuals. It is important to understand emergent perceptions of this illness among patients with a recent diagnosis of COVID-19. Due to its good psychometric properties, the brief illness perception questionnaire (BIPQ) has been widely used for various illnesses and in different languages. Its application in recently diagnosed COVID-19 patients is an area worth exploring in an Indian setting. Aim We aim to understand the patient’s perception of COVID-19 illness using the hindi adaptation of BIPQ and validate for its further use in a similar type of acute setting.Method This tool was customized by three subject experts for its application in recently diagnosed COVID-19 patients. A customized tool was circulated to nine subject matter specialists for the computation of the content validity index. The tool link was shared with patients. A total of 112 patients responded. Factor analysis and reliability analysis were also conducted.Result Item content validity index for all items in the BIPQ scale was in the acceptable range (value above 70%). Scale-content validity index/universal agreement was 88.8%. Bartlett’s test was significant (p &lt; 0.001) and the Kaiser-Meier-Olkin measure of sampling adequacy was 0.777. The factor loading threshold was fixed at a value above 0.40. Eight Likert scale items of BIPQ based on factor analysis were regrouped in two. Items one, two, four, five, and eight were in group one, which depicted “concrete perception,” and items three, six, and seven were in group two which depicted “gestalt perception” of recently diagnosed COVID-19 patients. Cronbach’s alpha of the scale was found to be high at 0.808.Conclusion Results depicted a two-factor structure of BIPQ with satisfactory validity and reliability. We suggest regrouping of existing items of BIPQ into two domains, namely “concrete perception” and “gestalt perception” for recently diagnosed patients with COVID-19.

Predictive Performance of Population Pharmacokinetic Models for Amikacin in Term Neonates.

Amikacin is preferred in treating Gram-negative infections in neonates and it has a narrow therapeutic window. The population pharmacokinetic modeling approach can aid in designing optimal dosage regimens for amikacin in neonates. In this study, we attempted to identify the suitable population pharmacokinetic model from the published reports for the study population from an Indian setting. Published population pharmacokinetic studies for amikacin in neonates were identified. Data on structural models and typical pharmacokinetic parameters were extracted from the studies. For the clinical study, neonates who met the inclusion criteria were enrolled in the study from the NICU, Kasturba Medical College, Manipal, during Jan 2020 to March 2022. Drug concentrations were estimated, and demographic and clinical data were collected. Identified population pharmacokinetic models were used to predict the amikacin concentrations in neonates. Predicted concentrations were compared against the observed concentrations. Differences between predicted and observed concentrations were quantified using statistical measures. The population pharmacokinetic model, which was able to predict the data well, is considered a suitable model for the study population. Dosing regimens were suggested for neonates using the pharmacometric simulation approach generated by the selected model. A total of 43 plasma samples were collected from 31 neonates. Twelve population pharmacokinetic models were found for amikacin in neonates. The predictive performance of the 12 studies was performed using clinical data. A two-compartment model reported by Illamola et al. predicted the amikacin concentrations better than other models. Illamola et al. reported creatinine clearance and body weight as the significant covariates impacting the pharmacokinetic parameters of amikacin. This model was able to predict the clinical data with 29.97% and 0.686 of relative median absolute prediction error and relative root mean square error, respectively, which is the best among the published models. The Illamola et al. model was selected as the final model to perform pharmacometric simulations for the subjects with different combinations of creatinine clearance and body weight. Dosage regimens were designed to attain target therapeutic concentrations for the virtual subjects and a nomogram was developed. The population pharmacokinetic model reported by the Illamola et al. model was selected as the final model to explain the clinical data with the lowest relative median absolute prediction error and relative root mean square error when compared with other models. An amikacin nomogram was developed for the neonates whose creatinine clearance and body weight ranged between 10 and 90 mL/min and between 2 and 4 kg, respectively. A developed nomogram can assist clinicians to design an optimal dosage regimen of amikacin for term neonates.

Psychometric Validity of the Anxiety Inventory for Respiratory Disease (AIR) Scale in an Indian Sample of Chronic Obstructive Pulmonary Disease: A Cross-Sectional Study.

Introduction Researchers have found that chronic obstructive pulmonary disease (COPD)patients suffer from anxiety more than the general population.The Anxiety Inventory for Respiratory Disease (AIR) scale has been primarily used to assess non-somatic anxiety in COPD patients. The validity of AIR among COPD patients has not been evaluated in Indian settings. Therefore, this study was undertaken to determine the validity of AIR in these patients. The study aimed to evaluate concurrent criterion and discriminative validity of the AIR screening scale among patients with COPD using Mini International Neuropsychiatric Interview (MINI) 7.0.2 as the gold standard measure for diagnosing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) anxiety disorders. Materials and methods A cross-sectional study was conducted in the Outpatients Department (OPD) of the Department of Pulmonary Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, from August 2018 to July 2019. A total of 100 patients diagnosed with COPD and aged 30 or above were recruited. All participants were further assessed in person by a psychiatry resident doctor using semi-structured proforma, MINI7.0.2, and AIRDisease (Hindi). Mann-Whitney U and receiver operating characteristic (ROC) curves were conducted. The two-sided p-value of less than 0.05 was considered to be statistically significant. Results To assess the concurrent criterion validity of the AIR scale for screening clinical anxiety disorders, the ROCcurve was constructed using MINI diagnoses of anxiety disorder as the gold standard measure. A cut-off score of 5.5 was found to maximize both the specificity and sensitivity of the AIR scale for screening anxiety disorders among COPD patients with COPD. The AIR scale showed a high sensitivity (95%) and specificity (89%) at this cut-point. Conclusion The findings of this studyrecommend a cut-off score of 5.5 on the AIR scale instead of 8 in previous studies, as maintaining the previously recommended cut-offs in Indian settings may lead to an increase in false negatives. This could have negative consequences for patients seeking treatment. Further studies may be planned to explore the psychometric properties of the current tool in a larger population.

A Real-World Perspective of Co-amoxiclav Prescription Pattern With Probiotics for Pediatric Patients With Respiratory Tract Infections: Results of Quantitative and Qualitative Approach in Indian Outpatient Settings.

Probiotics are co-prescribed with co-amoxiclav to prevent antibiotic-associated diarrhea (AAD). The study assesses the co-prescription pattern of probiotics with co-amoxiclav in pediatric patients with respiratory tract infections (RTIs). This was a mixed methods research study with a retrospective study and a prospective survey. The retrospective part included a multicenter, observational, real-world study utilizing patients' electronic medical records for three years (2018-2020) from seven outpatient pediatric clinics and hospitals. The qualitative evaluation was performed with a predefined questionnaire. The patients having RTIs (N=984) were prescribed Clamp® (46.7%), CAA (23.8%), and CAM (29.5%). The mean age of the patients was 4.05 years, with 59.25% males and most patients having upper RTIs. Co-amoxiclav was prescribed twice daily for one to 15 days. A significantly lesser number of probiotic co-prescriptions were observed with Clamp® (19.57%) than with CAA (38.46%) and CAM (29.31%) at baseline (p<0.001). Similar findings were observed for follow-up visits one and two. Saccharomyces boulardii, Bacillus clausii,and lactic acid bacillus were the most commonly co-prescribed probiotics. The qualitative evaluation indicated that most clinicians were aware of the co-amoxiclav-related gastrointestinal side effects and the benefits of probiotics in preventing them. The frequency of co-prescriptions of probiotics with Clamp® among pediatric patients with RTIs was significantly less, potentially indicating better gastrointestinal tolerability.

The Use of Vildagliptin-Dapagliflozin Fixed Dose Combination in Different Patient Profiles in Indian Settings: An Opinion-Based Consensus

The Use of Vildagliptin-Dapagliflozin Fixed Dose Combination in Different Patient Profiles in Indian Settings: An Opinion-Based Consensus