Cost analysis of critical patient care at a pediatric intensive care unit of a tertiary care public hospital in an urban metropolis of India

Background: The cost of critical care is widely recognized as being high. However, it remains a challenge to accurately assess the cost of intensive care due to a lack of standardized methodology. There is also considerable heterogeneity with regard to allocation of resources and distribution of critical care services.Methods: We conducted a prospective study to analyse diagnosis-based costs of paediatric patient care at a pediatric intensive care unit (PICU) in a public hospital in Mumbai on the basis of identified cost components; direct (fixed and variable) and indirect costs.Results: Out of 167 (102 boys, 61%) patients enrolled, 65 (39%) were aged 1-7 months. They spent an average of 4±1.46 bed days in the PICU. The cost of direct fixed components (salaries, capital equipment, disposables) was Rs. 64,48,200 for six months. The maximum cost of direct variable components spent by the hospital (physiotherapy intervention, expert opinion, investigations, medicines, blood products, piped gases) amounted to Rs. 548.63/patient/day for treatment of non-infectious diseases. Cost of indirect components (building maintenance) was Rs. 12,500/six months. Linear regression analysis showed 83-99.99% dependency of treatment cost to diagnosis and bed days. The average cost of treatment of infectious and non-infectious diagnoses/patient/day spent by the hospital was Rs. 260 and Rs. 548.63 respectively as compared to Rs. 169.96 and Rs. 356.21 spent by the patients.Conclusions: Our study showed that majority of the treatment costs depended on the diagnosis and number of bed days of the patients. Also being a tertiary care public hospital, 60% of the treatment costs were borne by the hospital. Thus, our study attempts to quantify, in financial terms, the expenditure involved in running a paediatric ICU in a tertiary care public hospital so as to assist doctors and healthcare decision makers in the allocation of resources

A double blind, randomized, placebo controlled, phase IV, proof-of-concept, comparative study to evaluate the efficacy and safety of Swasawin asthaloc tablets when given as add-on therapy in patients suffering from mild to moderate persistent bronchial asthma

Background: Asthma, known as “Tamaka Shwasa” in Ayurveda, as a chronic inflammatory disorder of the airways associated with increased airway hyper-responsiveness, recurrent episodes of wheezing, breathlessness, chest tightness and coughing, particularly at night/early morning. The key component to improving control and preventing attacks is the avoidance of triggers. Swasawin Asthaloc tablet, a polyherbal proprietary medication, is claimed to be effective in asthma. The Objective of the study was to evaluate the safety and efficacy of Swasawin Asthaloc tablets when given as add-on therapy to patients suffering from mild to moderate persistent bronchial asthma.Methods: The study was initiated after receiving Institutional Ethics Committee approval. Patients suffering from mild-to-moderate persistent bronchial asthma were randomized to 2 study groups after written informed consent process for 6 months. Group I received the study medication Swasawin Asthaloc tablet (1 tablet twice daily) in addition to regular anti-asthmatic medications (inhaler ± oral medications). Group II received Placebo tablets in a similar dose as add-on therapy. The study efficacy parameters included spirometry, breath holding time (BHT), Asthma symptom score and Ayurvedic Asthma symptom score.Results: 60 patients were enrolled in the study, of which 50 patients completed the study. In case of spirometry, both FEV1 and PEFR values showed statistically significant improvement at the end of 6 months therapy. Significant improvement in the Breath Holding Time (BHT), Ayurvedic Asthma symptom score and Asthma symptom score was observed in the active group as compared to the baseline (p <0.001).Conclusions: Add-on therapy with Swasawin Asthaloc tablets helped in reducing bronchial inflammation and improving asthmatic symptoms by virtue of its anti-inflammatory, bronchodilatory and antihistaminic properties. Hence it can be used as add-on therapy in patients with mild-to-moderate persistent bronchial asthma and may decrease the need for rescue medications especially steroids

A QUESTIONNAIRE BASED SURVEY TO ASSESS THE KNOWLEDGE, ATTITUDE AND PRACTICES OF AYURVEDIC PRACTITIONERS TOWARDS MASANUMASIK KASHAYAS

For a healthy pregnancy and delivery of a normal child, different group of medicines taken for each month of pregnancy is described in Ayurveda as Masanumasik Kashayas (monthly antenatal decoctions). Objectives: To assess the knowledge, attitude and practice of Ayurvedic practitioners regarding Masanumasik Kashayas. Methodology: Following ethical approval, a cross-sectional descriptive survey was conducted among Ayurvedic physicians from Mumbai region. Results: Of 130 questionnaires distributed, 120 physicians responded (92%). Although all the physicians were aware that Masanumasik Kashayasare described in the Samhitas, only 60% knew the number of Kashayas (decoctions). 85% knew the rationale for prescribing these Kashaya s(decoctions) and 93% agreed that these Kashayas (decoctions) improved pregnancy outcome. However, in clinical practice, 45% participants said that they prescribed Kashayas (decoctions) only in patients with bad obstetric history while 52.5% prescribed in regular ante-natal care. 83% preferred Vati (tablet) form rather than Kashaya (decoction) as patient compliance was better. All physicians who prescribed said that there were no adverse complaints and the pregnancy outcome was good. Conclusion: The study thus showed that all Ayurvedic practitioners were still well versed with Masanumasik Kashayas and prescribed these kashayas (decoctions) for a good pregnancy outcome in clinical practice with some modifications like usage of only 9 Kashayas (decoctions) and Vati form (tablet)

Assessment of the degree of awareness among post-graduate medical physicians and Pharmacists about look-alike, sound-alike drug and potential medication errors

Background: With thousands of drugs currently in the market, the potential for medication errors due to confusing drug names amongst practising physicians, pharmacists and patients is significant. The existence of confusing drug names is one of the most common causes of medication error. There are many look-alikes, sound-alike (LASA) combinations that could potentially result in medication errors. There is insufficient data about medication errors due to LASA. Hence, we conducted the present study to determine the degree of awareness regarding LASA drugs among post graduate medical physicians and Pharmacists.Methods: This study was a cross-sectional, questionnaire-based survey, conducted among 137 year post graduate medical residents of a tertiary care teaching hospital and 121 local pharmacists in an urban metropolitan Indian city.Results: There were 34% resident doctors and 17% pharmacists were aware of concept of LASA drugs. Only 46% resident doctors and 22% pharmacists had knowledge about the full form of LASA. Among resident doctors, 39% came across prescription errors due to LASA drugs. Only 69% of the pharmacists agreed that they consulted their doctors when they faced problems due to prescription errors due to similar looking and similar sounding drugs.Conclusions: Look-Alike, Sound-Alike (LASA) drugs are common source of medication errors. Our study suggests that there is lack of awareness about LASA drugs amongst resident doctors and pharmacists, which may contribute to occurrence of medication errors. Therefore, combined efforts by prescribers, pharmacists, organizations, manufacturers and patients is required to overcome medication errors due to LASA drugs

Non-HIV Related Non-Communicable Diseases in HIV Patients

Authors examined the impact of additional factors on fatalities in Chronic HIV patient populations and should have remained on highly active antiretroviral therapy (HAART) for the at least 1 year: Inadequate response to HAART and the existence of AIDS-defining illnesses, depression, and drug and alcohol abuse, and especially in comparison the fatalities to that of the overall demographic. The enhanced rates of mortality in HIV-infected people are primarily impact on risk variables that can be recognized just before to or during the introductory phase of antiretroviral treatment. The fatality rate in patient populations without risk variables who are on effective HAART is virtually identical to something like the non-HIV-infected inhabitants. The significance of a holistic solution for lipid accumulation, cardiovascular, and glomerular comorbidity supervisors in the lengthy effective monitoring of chronic HIV old patients cannot be exaggerated

Ethics reporting practices in clinical research publications: A review of four Indian journals

Background: Manuscript authors of scientific journals are expected to report if their studies were conducted according to international and national ethical guidelines and inform readers regarding ethics approval and informed consent obtained from participants and/or their legally acceptable representative/s. In the present study we assessed the reporting practices of ethics approval and informed consent (assent in case of pediatric studies) in four Indian journals. Materials and Methods: Original research articles published over a period of 4 years (2009-2012) in four major national clinical journals, viz. Journal of Association of Physicians of India (JAPI), Indian Journal of Surgery (IJS), Journal of Obstetrics and Gynecology of India (JOGI), and Indian Journal of Orthopedics (IJO) were reviewed with regard to documentation of ethics approval and written informed consent and assent in case of pediatric participants. Results: We reviewed 673 research articles and found that, overall ethical approval was mentioned in 163 (24.2%) and informed consent or assent was mentioned in 179 (26.5%) articles in all four journals. Individually we found, in JAPI of the 174 manuscripts reviewed, 74 (42.5%) reported having obtained approval from the ethics committee and 68 (39.1%) reported taking written informed consent from participants. In IJS of 123 manuscripts, 18 (14.6%) reported ethics committee approval and 20 (16.2%) reported informed consent from participants. In JOGI of 152 manuscripts, 21 (13.8%) reported ethics committee approval while 49 (32.2%) reported informed consent from participants. In IJO, of 224 manuscripts, 50 (22.3%) reported ethics committee approval and 42 (18.7%) reported obtaining informed consent. Conclusion: Majority of the publications did not provide information regarding compliance to ethical guidelines in spite of the availability of various guidelines. Thus, there is a need for awareness and training on bioethics for authors, reviewers, and editors of biomedical journals

Alterations in lipid metabolism and antioxidant status in lichen planus

Background: Lichen planus (LP), a T-cell-mediated inflammatory disorder, wherein inflammation produces lipid metabolism disturbances, is linked to increase in cardiovascular (CV) risk with dyslipidemia. Increased reactive oxygen species and lipid peroxides have also been implicated in its pathogenesis. Aim and Objective: The aim of the study was to evaluate the status on lipid disturbances, oxidative stress, and inflammation in LP patients. Materials and Methods: The study was initiated after obtaining Institutional Ethics Committee permission and written informed consent from participants. The study included 125 patients (74 LP patients and 51 age and sex-matched controls) visiting the outpatient clinic in the dermatology department of our hospital. Variables analyzed included lipid profile, C-reactive protein (CRP), malondialdehyde (MDA), and catalase (CAT) activity. Results: Analysis of lipid parameters revealed significantly higher levels of total cholesterol (TC), triglycerides, and low-density lipoprotein cholesterol (LDL-C) along with decreased levels of high-density lipoprotein cholesterol (HDL-C) in LP patients as compared to their respective controls. LP patients also presented with a significantly higher atherogenic index that is, (TC/HDL-C) and LDL-C/HDL-C ratios than the controls. A significant increase in CRP levels was observed among the LP patients. There was a statistically significant increase in the serum levels of the lipid peroxidation product, MDA and a statistically significant decrease in CAT activity in LP patients as compared to their respective controls. A statistically significant positive correlation (r = 0.96) was observed between serum MDA levels and duration of LP whereas a significantly negative correlation (r = −0.76) was seen between CAT activity and LP duration. Conclusion: Chronic inflammation in patients with LP may explain the association with dyslipidemia and CV risk. Our findings also suggest that an increase in oxidative stress and imbalance in the antioxidant defense mechanisms in LP may play a role in the pathogenesis of LP

An open-label, prospective clinical study to evaluate the efficacy and safety of TLPL/AY/01/2008 in the management of functional constipation

Functional constipation is one of the most common gastrointestinal symptoms across the globe. Its high prevalence rate, economic burden, and adverse implications on the quality of life make constipation a major public health issue. Though various treatment options are available for the management of constipation, evidence for their efficacy and safety are limited. An open-label, prospective, interventional, and exploratory clinical trial was carried out to evaluate the efficacy and safety of “TLPL/AY/01/2008” in 34 patients suffering from functional constipation. “TLPL/AY/01/2008” is an Ayurvedic proprietary polyherbal formulation in powder form, containing Isabgol husk, Senna extract, and Triphala extract. Administration of “TLPL/AY/01/2008” for 14 days showed a significant increase in mean weekly bowel movements from 10.19 ± 05.64 to 18.29 ± 05.72 (P<0.05). The mean average time spent on toilet for bowel evacuation reduced significantly from 11.02 ± 05.43 minutes (baseline value) to 08.70 ± 04.72 minutes on day 14 (P<0.05). Mean stool form score assessed on Bristol stool form scale was improved from 02.97 ± 00.48 (baseline value) to 04.61 ± 00.84 (P<0.05) on day 14. A significant improvement (P<0.05) was also noted in straining during defecation, sensation of incomplete evacuation, sensation of anorectal blockage, and other associated symptoms of functional constipation. The significant improvement in most of the above symptoms was endured for a post-treatment observatory period of one week. All the study patients showed an excellent tolerability to the study drug. These findings suggest that “TLPL/AY/01/2008” is an effective, safe, and non-habit-forming herbal laxative formulation for the management of constipation. Comparative clinical studies with larger sample size would be able to confirm the above findings

Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India

Background This study assessed safety and immunogenicity of Serum Institute of India Pvt Ltd (SIIPL)’s tetanus toxoid (TT), diphtheria toxoid (DT), and acellular pertussis booster vaccine (Tdap). Research Design and Methods In this Phase II/III, multicenter, randomized, active-controlled, open-label study, 1500 healthy individuals, aged 4–65 years, were randomized to receive a single dose of SIIPL Tdap or comparator Tdap vaccine (Boostrix®; GlaxoSmithKlines, India). Adverse events (AEs) during initial 30 minutes, 7-day, 30-day post-vaccination were assessed. Blood samples were taken before and 30 days post-vaccination for immunogenicity assessment. Results No significant differences in incidence of local and systemic solicited AEs were observed between the two groups; no vaccine-related serious AEs were reported. SIIPL Tdap was non-inferior to comparator Tdap in achieving booster responses to TT and DT in 75.2% and 70.8% of the participants, respectively, and to pertussis toxoid (PT), pertactin (PRN), and filamentous hemagglutinin (FHA) in 94.3%, 92.6%, and 95.0% of the participants, respectively. Anti-PT, anti-PRN, and anti-FHA antibody geometric mean titers in both the groups, were significantly higher post-vaccination compared to pre-vaccination. Conclusions Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to immunogenicity against tetanus, diphtheria, and pertussis and was well tolerated