Good Clinical Practice (GCP) – an alternative, unarticulated narrative

GCP has become the gold-standard for clinical research; initiated as a guideline pertaining to new drug development, it became a law in many countries, extending its scope to include all research. GCP is an excellent document that outlines the responsibilities of stakeholders involved in clinical research. Widely acclaimed, and deservedly so, it is considered as the “go-to” document whenever questions arise during the conduct of a clinical trial. This article presents another narrative, one that has not been articulated so far. Irrespective of whether we consider GCP as a law or a guideline, it is viewed as an “official” document, without the overt realisation that this was actually an initiative of the pharmaceutical industry, the “masters of mankind”. While the stress on documentation and monitoring in GCP was justified, its over-interpretation led to increased costs of clinical trials, with the result that smaller companies find it difficult to conduct the already expensive trials. GCP as an idea is now so entrenched within the scientific community that the real aims which led to its birth and that can be mined from the ICH website, like the need for market expansion, have remained largely unnoticed and undocumented, and are being expressed here.

Evaluation Of Therapeutic Modalities And Outcome In Patients Of Infectious Keratitis: A Prospective Observational Study At A Tertiary Care Eye Hospital

Background:Among corneal diseases, microbial keratitis is a major blinding disease.Objectives: To study the disease pattern and aetiology, to evaluate drug use pattern and the therapeutic outcome in Infectious Keratitis patients.Material And Methods:Prospective observational follow up study was carried out for 16 weeks. IEC permission and Written Informed Consent fr om the patients were taken before hand. Patients above 18 years of age and of either gender presenting to Outpatient department of Ophthalmology and diagnosed with Infectious Keratitis were included in the study. Patient's demographic details, diagnosis and the complete prescription were recorded in a case record form.Result:A total of 150 patients wereenrolled. Infectious Keratitis was prevalent in age group of 61–70 years (39.33%). Bacterial keratitis (52%) was the most common type followed by fungal (42%) and Viral keratitis (5%). A total of 17(11.33%) patients needed surgical intervention. At the last follow up 61(40.66%) patients had improved vision. There was a significant statistical difference found between age groups of <65 years and >65years for keratitis outcome. Improvement in vision (p=0.0264) & slit lamp findings (p=0.0148) were seen in younger age group.Conclusion:Bacterial keratitis was the most common cause of Infectious keratitis. Trauma was the commonest factor found majority of cases. Younger age group had better visual outcome.

Evaluation of corticosteroid use in outpatient department of dermatology of a tertiary care teaching hospital: a prospective observational study

Background: Corticosteroids are widely prescribed drugs in dermatology. Rational prescribing of steroids is important for best therapeutic outcome at lowest possible dose. A study was carried out at a tertiary care teaching hospital in order to evaluate the use of corticosteroids which provided a picture of trends in the usage of corticosteroids in dermatology at that set-up. Materials and Methods: This prospective, observational study was carried out in department of dermatology for 1 year after ethical approval. Data was analysed for parameters related to corticosteroids, their potency, WHO drug prescribing indicators, effectiveness as well as effects of corticosteroids on quality of life of patients. Statistical analysis was done using Microsoft Excel Office 365. Results: In the 223 patients, 44.84% patients belonged to 21-40 years age group. Mostcommon indication was eczema in 29.15% cases. Topical betamethasone (25.11%) and oral prednisolone (20.17%) were most frequently prescribed. 95/140 topical steroids prescribed were super highly potent. Among concomitant drugs, a majority of 38% were antihistaminics. Degree of polypharmacy showed 04 drugs in a majority (43.15%) of prescriptions. Only 6.27% drugs were prescribed by generic name. Conclusion: Corticosteroids were beneficial to a large no. of patients. Initial usage of low potency steroids topically wherever possible can be emphasized. WHO drug prescribing indicators analysis indicated the need to adhere to WHO guidelines as well as prescribing drugs by generic name. To maintain a balance between judicious use and frequent abuse with corticosteroid is important along with physician’s vigilance and patient education.

Anemia at the time of delivery and its association with pregnancy outcomes: A study from a secondary care hospital in Haryana, India

Maternal anemia has been reportedly associated with increased risk of maternal and fetal morbidity and mortality. Adverse pregnancy outcomes such as preterm birth, low birth weight, and stillbirth have been reported to be associated with anemia. However, different studies have shown inconsistent results. In the present study, we report the association between maternal hemoglobin levels at the time of delivery and outcomes among women at a secondary care hospital in northern India. Secondary analysis of routinely collected hospital data from January 2015 to December 2016 was carried out. Sociodemographic details, hemoglobin levels at the time of admission, and birth outcomes were retrieved from the records of women admitted for delivery. The outcomes were compared among anemic and nonanemic women. About 78% of the women were found to have anemia at the time of delivery. A significantly higher proportion of anemic women had preterm labor.

Prevalence and causes of visual impairment among adults aged 15–49 years in a rural area of north India - A population-based study

Purpose: Very few studies have been conducted in India and other parts of the world on visual impairment among individuals aged 15–49 years. This study was conducted to determine the prevalence, causes, and associated factors of visual impairment among adults aged 15–49 years in a rural population of Jhajjar district, Haryana, north India. Methods: A population-based cross-sectional study was conducted in two blocks of Jhajjar district. A total of 34 villages were selected using probability proportionate to size sampling method. Adults aged 15–49 years were selected using compact segment cluster sampling approach. As part of the house-to-house survey, presenting visual acuity using screening chart corresponding to five “E” 6/12 optotypes was measured along with collection of other demographic details. The optometrists performed detailed eye assessment including repeat measurement of visual acuity using retro-illuminated conventional logMAR tumbling “E” charts, torch light examination, and non-cycloplegic refraction at a clinic site within the village to ascertain visual impairment and its cause. Results: Of 5,470 enumerated adults, 5,117 (94%) completed all study procedures. The age- and sex-adjusted prevalence of visual impairment was found to be 1.85% [95% confidence interval (CI): 1.48, 2.23] and blindness was 0.09% (95% CI: 0.01, 0.18). The age- and sex-adjusted prevalence of unilateral visual impairment was 1.11% (95% CI: 0.81, 1.41). Uncorrected refractive errors (84%) contributed maximum to visual impairment in this age group. The visual impairment in study participants was found to be associated with age and educational status. Conclusion: At the community level, uncorrected refractive errors contribute largely to visual impairment in the age group of 15–49 years.

Pharmacokinetics of colistin in patients with multidrug-resistant Gram-negative infections: A pilot study

Background & objectives: There is little information concerning intravenously (i.v.) administered colistin in patients with multidrug-resistant (MDR) Gram-negative infections. Thus, this pilot prospective study was undertaken to characterize efficacy and pharmacokinetics of colistin in patients with MDR Gram-negative infections. Methods: Nine patients with age >12 yr and MDR Gram-negative infections were included, of whom six were given colistin at the doses of 2 MU, while three patients were given 1 MU i.v. dose every 8 h. Blood samples were collected at different time intervals. Determination of colistin concentration was done by a ultra-high-performance liquid chromatography/mass spectrometry/selected reaction monitoring assay. Results: The area under the plasma concentration-versus-time curve over eight hours (AUC0-8) for colistin after the 1st dose ranged from 3.3 to 16.4 mg議/l (median, 4.59). After the 5th dose, AUC0-8for colistin ranged from 4.4 to 15.8 mg議/l (median, 6.0). With minimal inhibitory concentration (MIC) value of 0.125 mg/l, AUC0-8/MIC ranged from 26.7 to 131.4 (median, 36.7) and 35.5 to 126.0 (median, 48.0) after the 1st and the 5th doses of 2 MU every 8 h, respectively. Interpretation & conclusions: As there is a paucity of information on AUC/MIC for colistin, it may not be possible to conclude whether AUC/MIC values in our patients were adequate. There is a microbiological clearance of organism, which goes in favour of the dosing schedule being adequate. Further studies need to be done to understand the pharmacokinetics of colistin in patients with infections.

Fixed‑dose combinations of antimicrobials: A need for special attention.

Objective: To highlight the issue of freely available fixed‑dose combinations (FDCs) of antimicrobials. Methods: A critique of two such antimicrobial FDCs was undertaken wherein the following aspects were assessed ‑ rational and regulatory issues and justification for clinical use. Available in vitro, in vivo (animals and humans) evidence from published literature was analysed. Conclusions: There are several inadequately addressed aspects of the considered FDCs which are available in Indian market. In view of the growing problem of antimicrobial resistance, this issue must get the required attention.

Prevalence of Candiduria in Infants from a Tertiary Care Hospital.

Yeast related urinary tract infections are rare in healthy newborns. Study was conducted in the department of microbiology in a tertiary care hospital, New Delhi from June 2012 to June 2013. Only infants were included in the study. A total of three hundred and thirty three urine samples were received for fungal culture and microscopy. The isolation rate of Candida species amongst the 333 samples was found to be 21.62%. Amongst 333 samples received 37 (11.11%) were positive for Candida albicans while 35 (10.51%) were positive for non albicans Candida species. So, in this study among 72 isolates of Candida, Candida albicans was found in 51.39% while non-albicans Candida species was found to be in 48.61% of the Candida isloates. It is important that the specific species responsible for symptomatic infection is identified, given the differences in antimicrobial susceptibility among Candida species.

Effects of Organisational Stress on Quality of Life of Primary and Secondary School Teachers.

Background: A considerable amount of literature on organizational stress & its health impact has emerged in the context of schools, and in particular teachers. However the effect of organizational stress on quality of life of teachers has largely remained unstudied especially in India. Aims: The aim of the present study was to study the effect of organizational stress on domains of quality of life of teachers. Methodology: Participants were fifty school teachers (twenty five from the primary section and twenty five from the secondary section). Organizational Stress Scale and WHO-QoL Bref were administered to collect data. Correlation and t-test were utilized to analyze the data. Results: Data analysis revealed that there is highly significant difference between Self Role Distance between primary and secondary school teachers. There was significant correlation between physical domain and role overload; so domain with role stagnation, role expectation conflict, role overload, resource inadequacy. There was highly significant correlation between social domain and organizational stress. Conclusion: Study has implications for improving QoL of teachers by managing the dimensions of Organizational Role Stress.

The Potential Role of Infections in Attention- Deficit Hyperactivity Disorder.

Attention deficit hyperactivity disorder ADHD is a behavioral disorder which mostly affects children in the age group of six to eleven years. The disorder affects boys more than girls. Although difficult to assess in infancy and toddlerhood, signs of ADHD may begin to appear as early as age of two or three, but the symptom picture changes as adolescence approaches. Many symptoms, particularly hyperactivity, diminish in early adulthood. However, impulsivity and inattention problems remain with upto 50% of ADHD individuals through their adult life. Recently there have been studies on correlation between ADHD and bacterial and viral infections in brain. This review focuses on possible role of various viruses and certain bacterias in development of ADHD in children.

Bacteremia due to Rhodococcus equi in an immunocompetent infant.

Rhodococcus equi , previously known as Corynebacterium equi, is one of the most important causes of zoonotic infection in grazing animals. Increased cases of human infection with R. equi have been reported especially in immunocompromised patients. Infection in immunocompetent patients is extremely rare. We report a case of R. equi bacteremia in a 26-day-old immunocompetent infant with recurrent swellings on different parts of the body. To the best of our knowledge, this is the first ever report of R. equi bacteremia from an immunocompetent patient from Northern India.

Yoga and Cognitive Behaviour Techniques for Academic Stress and Mental Wellbeing among School Students.

There are many stressors acting upon school children. Today in the era of increasing competitiveness,a child is overloaded with daily living stresses, and he lives a tight rope existence trying to cope up with the tremendous pressures from all institutions, whether it is school, family or society. These are resulting in various stress related ailments and psychological problems, which poses threat and challenges for the physical as well as mental wellbeing of the school going children. The present work was an attempt to measure one of the major source of stress,i.e. academic stress and mental wellbeing of a sample of school children and then to provide an intervention plan for a selected group of students who are having high academic stress and poor mental wellbeing. Certain specific Asanas, Mudras and Pranayams of Yoga were combined with some specific techniques of Cognitive Behaviour therapy (C.B.T.) to reduce the academic stress and to enhance the mental wellbeing of the selected group of school children. The results have shown a significant relief from academic stress and significant improvement in the mental wellbeing of these children. Detailed methodology and results are discussed in this paper. This paper highlights the efficacy of Yoga in combination with certain techniques of C.B.T. in enhancing overall wellbeing of school children.