Assessment of the Radio-contrast Media-Induced Self-Reported Adverse Drug Reactions in a Tertiary Care Hospital of North India: A Prospective Study.

Background: Radio-contrast media are the agents which are used on daily basis in the radiological practice for either diagnostic or therapeutic purpose. Currently used agents are considered to be safe but not devoid of side effects. Objectives: Objectives of the study were to assess the incidence of adverse drug reactions (ADRs) in the patients who receive radiographic contrast media for computed tomography (CT) and intravenous pyelography (IVP), to stratify the ADRs into different types based on their time of appearance and as per their severity. Materials and Methods: A prospective and observational study of 1-year duration was done on all the patients who received radio-contrast media (Iohexol) intravenously for CT and IVP in the radiodiagnosis department. Patients who experienced ADRs were recorded for the basic demographic characteristics and types of ADRs. Stratification of ADRs as per their severity was done using common terminology criteria for adverse events scale and Modified Hartwig and Siegel ADR Severity Assessment Scale, and casualty assessment was done using Naranjo's Algorithm. Results: Out of the total 3522 patients who were included in the study, eight patients got 12 suspected ADRs with some of the patients having more than one type of ADR. The most frequent ADR was nausea and vomiting (25%), followed by fever, chills, or sweating. Incidence of ADRs was 0.23%. All the ADRs were acute and occurred within 30 min of contrast administration. As per the severity scales used, all the ADRs were mild (75%) to moderate (25%) in nature with none of the reactions to be severe. Causality assessment showed 87.5% of the reactions to be "probable" in nature. Conclusion: Low osmolar nonionic radio contrast media are associated with very low incidence of ADRs in the North Indian population.

Changing Assessment Scenarios: Lessons for Changing Practice.

Assessment is a process that includes ascertainment of improvement in the performance of students over time, motivation of students to study, evaluation of teaching methods, and ranking of student capabilities. It is an important component of the educational process influencing student learning. Although we have embarked on a new curricular model, assessment has remained largely ignored despite being the hallmark of competency-based education. During the earlier stages, the assessment was considered akin to "measurement," believing that competence is "generic, fixed and transferable across content," could be measured quantitatively and can be expressed as a single score. The objective assessment was the norm and subjective tools were considered unreliable and biased. It was soon realized that "competence is specific and nontransferable," mandating the use of multiple assessment tools across multiple content areas using multiple assessors. A paradigm change through "programmatic assessment" only occurred with the understanding that competence is "dynamic, incremental and contextual." Here, information about the students' competence and progress is gathered continually over time, analysed and supplemented with purposefully collected additional information when needed, using carefully selected combination of tools and assessor expertise, leading to an authentic, observation-driven, institutional assessment system. In the conduct of any performance assessment, the assessor remains an important part of the process, therefore making assessor training indispensable. In this paper, we look at the changing paradigms of our understanding of clinical competence, corresponding global changes in assessment and then try to make out a case for adopting the prevailing trends in the assessment of clinical competence.

Trends in the use, complications, and costs of permanent pacemakers in Australia: A nationwide study from 2008 to 2017.

OBJECTIVE: To characterize contemporary pacemaker procedure trends. METHODS: Nationwide analysis of pacemaker procedures and costs between 2008 and 2017 in Australia. The main outcome measures were total, age- and gender-specific implant, replacement, and complication rates, and costs. RESULTS: Pacemaker implants increased from 12,153 to 17,862. Implantation rates rose from 55.3 to 72.6 per 100,000, a 2.8% annual increase (incidence rate ratio [IRR] 1.028; 95% CI, 1.02-1.04; p < .001). Pacemaker implants in the 80+ age group were 17.37-times higher than the < 50 group (95% CI 16.24-18.59; p < .001), and in males were 1.48-times higher than in females (95% CI 1.42-1.55; p < .001). However, there were similar increases according to age (p = .10) and gender (p = .68) over the study period. Left ventricular lead rates were stable (IRR 0.995; 95% CI 0.98-1.01; p = .53). Generator replacements decreased from 20.5 to 18.3 per 100,000 (IRR 0.975; 95% CI 0.97-0.98; p < .001). Although procedures for generator-related complications were stable (IRR 0.995; 95% CI 0.98-1.01; p = .54), those for lead-related complications decreased (IRR 0.985; 95% CI 0.98-0.99; p < .001). Rates for all pacemaker procedures were consistently greater in males (p < .001). Although annual costs of all pacemaker procedures increased from $178 million to $329 million, inflation-adjusted costs were more stable, rising from $294 million to $329 million. CONCLUSIONS: Increasing demand for pacemaker implants is driven by the ageing population and rising rates across all ages, while replacement and complication procedure rates appeared more stable. Males have consistently greater pacemaker procedure rates than females. Our findings have significant clinical and public health implications for healthcare resource planning.

Efficacy, Safety, and Cost Evaluation of the Topical Luliconazole Therapy versus Topical Clotrimazole Therapy in Patients with Localized Dermatophytosis in a Tertiary Care Hospital: An Observational Study.

BACKGROUND: Dermatophytosis is a superficial fungal infection that has high affinity for keratinized tissues of the body. The treatment of localized dermatophytosis is a major concern for the dermatologist especially in tropical countries like India. Various topical antifungals are available for the treatment of localized uncomplicated dermatophytosis. Luliconazole is an azole antifungal available that has potent activity against dermatophytes. OBJECTIVES: The objective of this study was to compare two treatment modalities for the treatment of localized dermatophytosis in terms of efficacy, safety, and cost evaluation. MATERIALS AND METHODS: This was a prospective and observational study carried out for 6 months and included 200 patients (luliconazole group [n = 94] and clotrimazole group [n = 106]). Patients were followed up for 2, 4, and 6 weeks. Outcome parameters such as pruritis, erythema, scaling, vesiculations, and global assessment score were noted at 2, 4, and 6 weeks for the assessment of efficacy. The statistical analysis was done using Chi-square and Student's t-test. RESULTS: Luliconazole and clotrimazole showed 56.38% and 23.58% cure rate at the end of two weeks respectively (P < 0.05). At the end of treatment, the cure rates were 98.93% and 95.28% in luliconazole and clotrimazole, respectively (P > 0.005). Both the drugs were equally safe. On cost-effective analysis, luliconazole was found to be more cost-effective than clotrimazole at the end of 2 weeks. CONCLUSION: Therapeutic efficacy of luliconazole was more as significant proportion of patients achieved complete clearance of lesions at faster rate within 2 weeks with convenient once daily application.

Increasing trends in hospitalisations due to atrial fibrillation in Australia from 1993 to 2013.

OBJECTIVE: The aim of this study is to characterise hospitalisations due to atrial fibrillation (AF) compared with two other common cardiovascular conditions, myocardial infarction (MI) and heart failure (HF), in addition to the associated economic burden of these hospitalisations and contribution of AF-related procedures. METHODS: The primary outcome measure was the rate of increase of AF, MI and HF hospitalisations from 1993 to 2013. The rate of increase of AF-related procedures including cardioversion and ablation were also collected, in addition to direct costs associated with hospitalisations for each of these three conditions. RESULTS: AF hospitalisations increased 295% over the 21-year period to a total of 61 424 in 2013. In comparison, MI and HF hospitalisations increased by only 73% and 39%, respectively, over the same period. Considering population changes, there was an annual increase in AF hospitalisations of 5.2% (incidence rate ratio [IRR] 1.052; 95% CI 1.046 to 1.059; p<0.001). In contrast, there was a 2.2% increase per annum for MI (IRR 1.022; 95% CI 1.017 to 1.027; p<0.001) and negligible annual change for HF hospitalisations (IRR 1.000; 95% CI 0.997 to 1.002; p=0.78). Cardioversion and AF ablation increased by 10% and 26% annually, respectively. AF hospitalisation costs rose by 479% over the 21-year period, an increase that was more than double that of MI and HF. CONCLUSIONS: The burden of AF hospitalisations continues to rise unabated. AF has now surpassed both MI and HF hospitalisations and represents a growing cost burden. New models of healthcare delivery are required to stem this growing healthcare burden.

Contact force and ablation assessment of surgical bipolar radiofrequency clamps in the treatment of atrial fibrillation.

OBJECTIVES: Atrial fibrillation is treated surgically by creating conduction block lesions. Radiofrequency (RF) lesions have reduced efficacy compared to 'cut-and-sew'. Catheter ablation studies demonstrate a relationship between lesion depth and contact force. We hypothesized that contact force and lesion depth are dependent on design of the bipolar surgical RF clamps. METHODS: Hinged and parallel jaw style RF clamps were studied. Muscle samples were clamped with pressure-sensitive film at increasing tissue thicknesses. Films were analysed determining clamp pressure profiles. A sheep model was utilized for ablation testing using each clamp style until the device indicated transmurality. Separate muscle areas had 1, 2 or 3 burns applied. The muscle was excised, sectioned every 1 cm and stained for lesion depth and fat thickness analysis. RESULTS: Pressure profiling comparing the proximal and distal segments of each clamp style demonstrated only one statistically significant difference in the parallel clamp; the hinged clamp had statistically significant differences (P ≤ 0.03) for all tissue thicknesses. There was no evidence for differences in the proximal lesion depth of both clamps (P = 0.13) but deeper distally in the parallel clamp (10.17 mm vs 8.02 mm, P = 0.003). The logistic regression analysis demonstrated increased odds of transmurality with parallel clamps at 1, 2 or 3 burns (P = 0.03, P = 0.003 and P = 0.002). Every 1 mm increase in overlying fat decreased likelihood of transmurality by 11% (P < 0.05). CONCLUSIONS: The parallel and hinged clamps have different pressure profiles with higher likelihood of transmurality using the parallel clamp. Fat reduces the ability of RF to deliver a transmural lesion. These findings have implications for optimal surgical RF ablation technique.

Predicted longevity of contemporary cardiac implantable electronic devices: A call for industry-wide "standardized" reporting.

BACKGROUND: Battery longevity is an important factor that may influence the selection of cardiac implantable electronic devices (CIEDs). However, there remains a lack of industry-wide standardized reporting of predicted CIED longevity to facilitate informed decision-making for implanting physicians and payers. OBJECTIVE: The purpose of this study was to compare the predicted longevity of current generation CIEDs using best-matched CIEDs settings to assess differences between brands and models. METHODS: Data were extracted for current model pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy-defibrillators (CRT-Ds) from product manuals and, where absent, by communication with the manufacturers. Pacemaker longevity estimations were based on standardized pacing outputs (2.5V, 0.40-ms pulse width, 500-Ω impedance) and pacing loads of 50% or 100% at 60 bpm. ICD and CRT-D longevity were estimated at 0% pacing and 15% atrial plus 100% biventricular pacing, with essential capacitor reforms and zero clinical shocks. RESULTS: Mean maximum predicted longevity of single- and dual-chamber pacemakers was 12.0 ± 2.1 and 9.8 ± 1.9 years, respectively. Use of advanced features such as remote monitoring, prearrhythmia electrogram storage, and rate response can result in ∼1.4 years of reduction in longevity. Mean maximum predicted longevity of ICDs and CRT-Ds was 12.4 ± 3.0 and 8.8 ± 2.1 years, respectively. Of note, there were significant variations in predicted CIED longevity according to device manufacturers, with up to 44%, 42%, and 44% difference for pacemakers, ICDs, and CRT-Ds, respectively. CONCLUSION: Contemporary CIEDs demonstrate highly variable predicted longevity according to device manufacturers. This may impact on health care costs and long-term clinical outcomes.

Risk Factor Management and Atrial Fibrillation Clinics: Saving the Best for Last?

Atrial fibrillation (AF) is a leading cause of cardiovascular morbidity and mortality worldwide. Management of AF is a complex process involving: 1) the prevention of thromboembolic complications with anticoagulation; 2) rhythm control; and 3) the detection and treatment of underlying heart disease. However, cardiometabolic risk factors, such as obesity, hypertension, diabetes mellitus, and obstructive sleep apnoea, have been proposed as contributors to the expanding epidemic of atrial fibrillation (AF). Thus, a fourth pillar of AF care would include aggressive targeting of interdependent, modifiable cardiovascular risk factors as part of an integrated care model. Such risk factor management could retard and reverse the pathological processes underlying AF and reduce AF burden.

Practice-based Learning and Improvement (PBLI) in Postgraduate Medical Training: Milestones, Instructional and Assessment strategies.

Patient-safety and quality-improvement are high-priority issues. One of the ways by which this can be implemented is by training residents to gather and appraise scientific evidence, as well as to evaluate their own patient-care practices. This competency is called Practice-based Learning and Improvement (PBLI). Training in PBLI provides residents with skills and knowledge necessary to reflect on their own strengths and deficiencies, identify their own learning needs, and engage in learning for improvement. PBLI also involves teaching residents to access and integrate literature by using scientific evidence and practice experience to make better clinical decisions. Training in PBLI has been found to lead to better health outcomes. We recommend explicitly incorporating elements of PBLI training and assessment in the present residency training curriculum in India. Implementing PBLI training and assessment will also require capacity-building through targeted faculty development programs.

Cost-Effectiveness and Clinical Effectiveness of the Risk Factor Management Clinic in Atrial Fibrillation: The CENT Study.

BACKGROUND: Atrial fibrillation (AF) imposes a substantial cost burden on the healthcare system. Weight and risk factor management (RFM) reduces AF burden and improves the outcomes of AF ablation. OBJECTIVES: This study sought to evaluate the cost and clinical effectiveness of integrating RFM into the overall management of AF. METHODS: Of 1,415 consecutive patients with symptomatic AF, 825 patients had body mass index ≥27 kg/m2. After screening for exclusion criteria, the final cohort comprised 355 patients: 208 patients who opted for RFM and 147 control subjects and were followed by 3 to 6 monthly clinic review, 7-day Holter monitoring, and AF Symptom Score. A decision analytical model calculated the incremental cost-effectiveness ratios of cost per unit of global well-being gained and unit of AF burden reduced. RESULTS: There were no differences in baseline characteristics or follow-up duration (p = NS). Arrhythmia-free survival was better in the RFM compared with control subjects (Kaplan-Meier: 79% vs. 44%; p < 0.001). At follow-up, RFM group had less unplanned specialist visits (0.19 ± 0.40 vs. 1.94 ± 2.00; p < 0.001), hospitalizations (0.74 ± 1.3 vs. 1.05 ± 1.60; p = 0.03), cardioversions (0.89 ± 1.50 vs. 1.51 ± 2.30; p = 0.002), emergency presentations (0.18 ± 0.50 vs. 0.76 ± 1.20; p < 0.001), and ablation procedures (0.60 ± 0.69 vs. 0.72 ± 0.86; p = 0.03). Antihypertensive (0.53 ± 0.70 vs. 0.78 ± 0.60; p = 0.04) and antiarrhythmic (0.26 ± 0.50 vs. 0.91 ± 0.60; p = 0.003) use declined in RFM. The RFM group had an increase of 0.1930 quality-adjusted life years and a cost saving of $12,094 (incremental cost-effectiveness ratios of $62,653 saved per quality-adjusted life years gained). CONCLUSIONS: A structured physician-directed RFM program is clinically effective and cost saving.

Efficacy, safety and cost-effectiveness of insulin sensitizers as add-on therapy in metabolic syndrome in patients with secondary sulfonylurea failure: A comparative study.

OBJECTIVES: Prevalence of metabolic syndrome (MS) is ~25% and it is currently becoming prevalent in children also. India is estimated to have the maximum number of patients of MS in the world. As insulin resistance is an integral part of MS and the rate of secondary sulfonylurea failure (SSUF) is also high, the present study was planned to evaluate the effects of insulin sensitizers as add-on therapy in MS with SSUF. MATERIALS AND METHODS: An open-label, prospective, randomized study was conducted on 200 patients of MS with SSUF, included according to ATP III criteria, after dividing them into two groups. Group I patients were given pioglitazone 30 mg/day while group II patients were given metformin 1,000 mg/day as add-on therapy to the sulfonylurea already prescribed. RESULTS: Fall in fasting blood glucose, glycosylated hemoglobin and serum triglycerides was higher with metformin, but rise in high-density lipoprotein-cholesterol was higher with pioglitazone. Only metformin caused a significant reduction in body mass index. Significant reduction in waist circumference, systolic blood pressure and diastolic blood pressure was not seen with any therapy. Incremental cost-effective ratio was almost six-times higher with pioglitazone. CONCLUSION: Among insulin sensitizers, metformin has more favorable, persistent and multifacet effects in MS with SSUF. Studies of longer duration are required for calculating reduction in the mortality and morbidity.