Ferric carboxymaltose in the management of anemia due to non-obstetric conditions in women: a sub-group analysis of a large multi-center real-world study/PROMISE from India

Background: Real-world data on the efficacy and safety of intravenous ferric carboxymaltose (FCM) for treating iron deficiency anemia (IDA) in Indian women is limited. Methods: This was a sub-group analysis of the real-world PROMISE study, which analyzed data of women who received FCM for the management of IDA due to non-obstetric causes. Hematological parameters were retrieved from the charts at baseline and at 4±1 week and analyzed for the whole sub-group and by the severity of anemia. Results: In 442 women with anemia, Hb and serum ferritin improved by 2.77 gm/dl and 62.07 µg/l, respectively (p<0.001 for both) at 4 weeks. There was a significant increase in red blood cell (RBC) count, hematocrit, mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) (p<0.001 for all). In 192 subjects with severe anemia, there was a significant increase in Hb by 3.19 gm/dl, serum ferritin by 61.67 µg/l, RBC count, hematocrit, and MCV (p<0.001 for all); and MCH (p=0.002). In 226 subjects with moderate anemia, there was a significant increase in Hb by 2.41 gm/dl, serum ferritin by 62.75 µg/l, and MCV (p<0.001 for all); and MCH (p=0.003). No subject had mild anemia. No new safety signals or serious adverse events were reported. Physicians rated the efficacy and safety of FCM as very good to good in 94.1 and 94.2% of subjects, respectively. Conclusions: In Indian women, FCM effectively and safely corrects IDA due to non-obstetric causes, in a short span of 4 weeks.

Acute Clopidogrel Use and Outcomes in Patients With Non–ST-Segment Elevation Acute Coronary Syndromes Undergoing Coronary Artery Bypass Surgery

OBJECTIVES We sought to characterize patterns of clopidogrel use before coronary artery bypass grafting (CABG) and examine the drug's impact on risks for postoperative transfusions among patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS). BACKGROUND Adherence in community practice to American College of Cardiology/American Heart Association guidelines for clopidogrel use among NSTE ACS patients has not been previously characterized. METHODS We evaluated 2,858 NSTE ACS patients undergoing CABG at 264 hospitals participating in the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) Initiative. We examined the patterns of acute clopidogrel therapy and its association with bleeding risks among those having early CABG ≤5 days and again among those having late surgery >5 days after catheterization. RESULTS Within 24 h of admission, 852 patients (30%) received clopidogrel. In contrast to national guidelines, 87% of clopidogrel-treated patients underwent CABG ≤5 days after treatment. Among those receiving CABG within ≤5 days of last treatment, the use of clopidogrel was associated with a significant increase in blood transfusions (65.0% vs. 56.9%, adjusted odds ratio [OR] 1.36, 95% confidence interval [CI] 1.10 to 1.68) as well as the need for transfusion of ≥4 U of blood (27.7% vs. 18.4%, OR 1.70, 95% CI 1.32 to 2.19). In contrast, acute clopidogrel therapy was not associated with higher bleeding risks if CABG was delayed >5 days (adjusted OR 1.18, 95% CI 0.54 to 2.58). CONCLUSIONS Despite guideline recommendations, the overwhelming majority of NSTE ACS patients treated with acute clopidogrel needing CABG have their surgery within ≤5 days of treatment. A failure to delay surgery is associated with increased blood transfusion requirements that must be weighed against the potential clinical and economic impacts of such delays

Physics Potential of the ICAL detector at the India-based Neutrino Observatory (INO)

The upcoming 50 kt magnetized iron calorimeter (ICAL) detector at the India-based Neutrino Observatory (INO) is designed to study the atmospheric neutrinos and antineutrinos separately over a wide range of energies and path lengths. The primary focus of this experiment is to explore the Earth matter effects by observing the energy and zenith angle dependence of the atmospheric neutrinos in the multi-GeV range. This study will be crucial to address some of the outstanding issues in neutrino oscillation physics, including the fundamental issue of neutrino mass hierarchy. In this document, we present the physics potential of the detector as obtained from realistic detector simulations. We describe the simulation framework, the neutrino interactions in the detector, and the expected response of the detector to particles traversing it. The ICAL detector can determine the energy and direction of the muons to a high precision, and in addition, its sensitivity to multi-GeV hadrons increases its physics reach substantially. Its charge identification capability, and hence its ability to distinguish neutrinos from antineutrinos, makes it an efficient detector for determining the neutrino mass hierarchy. In this report, we outline the analyses carried out for the determination of neutrino mass hierarchy and precision measurements of atmospheric neutrino mixing parameters at ICAL, and give the expected physics reach of the detector with 10 years of runtime. We also explore the potential of ICAL for probing new physics scenarios like CPT violation and the presence of magnetic monopoles.Comment: 139 pages, Physics White Paper of the ICAL (INO) Collaboration, Contents identical with the version published in Pramana - J. Physic

Impact of Remote Patient Monitoring Platform on Patients With Moderate to Severe Persistent Asthma: Observational Study

BackgroundAsthma is one of the most common respiratory diseases, with an ever-growing health care burden. Remote patient monitoring (RPM) has gained increasing importance in the respiratory care area with the outbreak of the COVID-19 pandemic. In this pilot study, we introduced a novel platform that remotely monitors patients with chronic respiratory illnesses using Centers for Disease Control and Prevention guidelines to reduce hospitalizations and emergency department visits. ObjectiveThis study aimed to understand patient and physician engagement with a new virtual care solution (KevaTalk app and Keva365 platform) and the value, for both patients and providers, of using an RPM tool. We assessed real-world use of the platform from both physician and patient perspectives and the impact of devices on engagement and monitoring. MethodsParticipants with a history of moderate to severe persistent asthma, seen by a pulmonologist at a hospital, were included in this study. The inclusion criteria involved being aged ≥18 years and having access to an Android or iOS mobile device with internet. We provided patient questionnaires to assess the app’s usefulness and evaluate its features. We monitored remote spirometry and oximetry data, app check-ins, alerts, and escalations during this study’s time window. Data were reviewed daily and predetermined criteria were set to escalate for physician review based on the patient’s symptoms and objective data. ResultsOverall, 25 patients were included in this pilot. The mean age was 57 (SD 10.7) years and a majority (n=23, 92%) were female. A baseline questionnaire, which was used to rate the app, indicated that the ease of check-in and ease of modification to the patient’s asthma plan were the 2 highest rated features. In total, 2066 check-ins (1550 green, 506 yellow, and 10 red check-ins) and 1155 spirometry sessions were recorded during this 3-month period. Further, 64% (14/22) and 91% (20/22) of patients were found to have peak flows in their red and yellow zones at least once, respectively. During the course of this study, 484 alerts were recorded and evaluated by the team, of which 37.2% (n=180) required an escalation to the physician; this included a transfer to a medical facility, change in respiratory medication, or further education. ConclusionsIn this pilot study, we demonstrated the feasibility of implementing a novel RPM platform in patients with asthma. Our platform showed high patient engagement and satisfaction and provided physicians with real-time subjective data to evaluate patients remotely that aids in clinical decision-making. The escalations prevented patients from having an exacerbation or flare up, which led to the prevention of an emergency department visit. Continuous monitoring of chronic disease has benefits over episodic monitoring. It allows for improved quality of life, better outcomes, and huge health care savings

Gender identity and gender of rearing in 46 XY disorders of sexual development

Background: Disorders of sexual development (DSD) may pose a challenge to live as a fully-functioning male or female. In this study, we prospectively assessed eleven 46 XY DSD patients who were being treated at our center over the last 8 months for gender dysphoria. Materials and Methods: To determine gender dysphoria, age-appropriate gender identity (GI) questionnaires were used. For patients, 12 years and below, parent report GI questionnaire for children was used and for those above 12 years of age, GI/gender dysphoria questionnaire for adolescents and adults was administered. Results: Of 11 patients with 46 XY DSD, three were diagnosed with 5 alpha reductase deficiency (5aRD), two with partial gonadal dysgenesis, three with partial androgen insensitivity syndrome, one each with ovotesticular, complete gonadal dysgenesis, and complete androgen insensitivity. Gender assigned at birth was female in eight and male in three patients. Among the eight reared as female, gender had been reassigned as male in three patients well before the present study was conducted. None of the eleven patients had gender dysphoria at the time of this study. Conclusion: Early gender of rearing was seen to be a critical indicator of present GI in our patients except in cases of 5aRD

Gender of rearing and psychosocial aspect in 46 XX congenital adrenal hyperplasia

Background: In congenital adrenal hyperplasia (CAH) with ambiguous genitalia, assigning gender of rearing can be complex, especially If genitalia is highly virilized. Apart from karyotype, prenatal androgen exposure, patient's gender orientation, sociocultural, and parental influences play a role. The aim of this study was to assess gender dysphoria and psychosocial issues in patients of CAH raised as males and females. Materials and Methods: This is a cross-sectional study that includes patients (old and new) with CAH who were treated by us in the last 6 months. A semi-structured interview proforma was used to elicit history and psychosocial background of the patients. The clinical and biochemical details were noted. For psychological analysis, patients were screened for gender dysphoria using Parent Report Gender Identity Questionnaire for children <12 years and Gender Identity/Gender Dysphoria Questionnaire for Adolescents and Adults. Results: We analyzed 22 46 XX CAH patients among which, 3 were reared as males and 19 as females. Among the 19 patients reared as females, 17 patients showed no gender dysphoria. Two patients revealed gender dysphoria as indicated by their marginally low scores on the gender dysphoria assessment. However, in view of current literature and the age groups of the patients, behavior of the 6-year-old patient can be best understood as being tomboyish. Gender dysphoria in the 22-year-old can be explained by the dominance of psychosocial factors and not hormones alone. Among the three patients reared as males, two prepubertal were satisfied with their male gender identity. The third patient, aged 32 years, had gender dysphoria when reared as a male that resolved when gender was reassigned as female and feminizing surgery was done. Conclusion: Gender assignment in 46 XX CAH is guided by factors such as degree of virilization of genitalia, gender orientation, patient involvement, sociocultural, and parental influences

Choudhry, “Patients’ perceptions of generic medications

ABSTRACT: Insurers and policymakers encourage the use of generic drugs to reduce costs, but generics remain underused. We conducted a national survey of commercially insured adults to evaluate their perceptions about generic drugs. Patients agreed that generics are less expensive and a better value than brand-name drugs, and are just as safe. However, although 56 percent reported that Americans should use more generics, only 37.6 percent prefer to take generics. We discuss perceptions about communicating with practitioners about generics, generic substitution, and policymakers&apos; role in influencing generic use. These findings underscore the challenge that providers, insurers, and policymakers face in stimulating the cost-effective use of medications. [Health Affairs 28

Study of clinical characteristics, risk factors and outcomes for tuberculosis post allogeneic stem cell transplant: never count it out

Background: Allogeneic stem cell transplant (AlloSCT) recipients remain at a higher risk of developing tuberculosis (TB), especially in endemic populations. We conducted a retrospective study to identify the incidence, clinical presentation, and risk factors for active TB among our alloSCT recipients. Methods: Records of all patients transplanted between 1 January 2012 and 31 July 2020 were reviewed. Patients were followed up for outcome until 30 September 2020. None of the patients received prophylactic anti-tubercular drugs. Proven diagnosis of active TB was considered if Mycobacterium tuberculosis (MTB) was cultured from clinical samples or acid-fast bacilli (AFB) or MTB demonstrated on Ziehl-Neelsen (ZN) staining or histopathology or XPERT MTB, while probable diagnosis of TB was considered if histopathology findings were suggestive of caseation necrosis/epithelioid cell granulomas without any evidence of malignancy or lymphocyte rich exudative effusions (pleural/pericardial) without an alternative cause. Results: Among 381 alloSCT recipients, 15 patients (3.9%) developed TB at median of 246 (74–279) days post AlloSCT, after being symptomatic for a median of 22 (7–60) days, amounting to a cumulative incidence of 4.9%. All patients were started on four-drug anti tubercular therapy, ATT [Rifampicin, Isoniazid, Ethambutol, Pyrazinamide (RHEZ)], of which five patients developed hepatotoxicity at a median of 12 days after start of ATT, leading to drug modification. At last follow up, TB was cured in 13 (86.67%) patients, one succumbed to disease relapse, while others are still on treatment. Age ⩾ 30 years, immunosuppression for graft versus host disease (GvHD) > 6 months, prior use of tyrosine kinase inhibitors (TKI) and chronic GvHD on univariate analysis and immunosuppression for GvHD > 6 months on multivariate analysis were found to be associated with development of TB. Conclusion: A high index of suspicion with timely workup and treatment of TB is the key in AlloSCT recipients, especially in endemic TB populations