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   2012| January-March  | Volume 3 | Issue 1  
    Online since January 25, 2012

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Censoring in survival analysis: Potential for bias
Priya Ranganathan, CS Pramesh
January-March 2012, 3(1):40-40
  12,649 1,971 29
Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations
Umesh Chandra Gupta, Saifuddin Kharawala
January-March 2012, 3(1):8-15
Obtaining informed consent in psychiatry clinical research involving subjects with diminished mental abilities and impaired consent capacity has been a challenge for researchers, posing many ethical concerns and procedural hurdles due to participants' cognitive deficits and impaired ability to judge reality. Regulations seem inadequate and provide limited guidance, not sufficient to address all the ethical issues inherent in different situations related to obtaining consent from decisionally impaired persons. Researchers are struggling to find a balance between risk-benefit ratio, research advancement, and autonomy of study subjects. Inspired to improve the consent process in psychiatry clinical research, many studies have been conducted focusing on various informed consent-related ethical concerns, with the aim of developing appropriate strategies and optimizing the informed consent procedure in psychiatry clinical research, overcoming the ethical concerns. This article critically reviews the various ethical issues and consent challenges, their underlying reasons, and investigates the appropriate strategies and practices needed to be adopted while obtaining informed consent from subjects with impaired consent capacity, participating in psychiatry clinical research.
  6,847 1,039 8
Role of community pharmacists in improving knowledge and glycemic control of type 2 diabetes
R Venkatesan, AS Manjula Devi, S Parasuraman, S Sriram
January-March 2012, 3(1):26-31
Objective: To study the role of the community pharmacists in improving knowledge and glycemic control in patients with type 2 diabetes residing in villages of Coimbatore district, Tamil Nadu. Materials and Methods: Fifty patients were interviewed, of whom 39 subjects were included in the study. The literate and chronic diabetic patients were included in the study and illiterate, children below 12 years of age, pregnant women, nursing mothers and subjects with any other chronic disorders were excluded from the study. The subjects were interviewed and divided randomly into two groups. There were 20 subjects in the control group and 19 in the intervention group. The study protocol was explained to all the participants, and written informed consent was obtained from them. Before the initiation of the study, the subjects were interviewedfor 20-40 min to educate them about diabetes. Subjects in the intervention group received continuous counselling and medical advice to improve their awareness about the disease and drugs. During the study period, the Diabetes Care Profile (a questionnaire developed by J.J. Fitzgerald of the Michigan Diabetes Research and Training Center, University of Michigan Medical School, Michigan) was performed to each subject. The interval between visits was 2 months. All the values are expressed in mean ± standard deviation. Results: The intervention group showed better progress in the recovery of diabetics because of the continuous counselling and monitoring. There were significant changes in Diabetes Care Profile subscale scores in both the control and the intervention groups at the end of the study, viz. 1.8 ± 4.52 to 2.75 ± 6.62 and 3.10 ± 3.23 to 1.53 ± 2.66. Similarly, the knowledge test score was found to be increased in the intervention group compared with the baseline values (8.53 ± 1.81 to 12.16 ± 1.34). Conclusions: At the end of the study period, the patients of the intervention group had very good glycemic control. Their health status and understanding of diabetes and its management were better, and they had fewer problems such as episodes of hyperglycemia or hypoglycemia.
  6,070 890 13
Evolving role of pharmaceutical physicians in the industry: Indian perspective
Anant Patil, Viraj Rajadhyaksha
January-March 2012, 3(1):35-39
The Indian pharmaceutical industry, like any other industry, has undergone significant change in the last decade. The role of a Medical advisor has always been of paramount importance in the pharmaceutical companies in India. On account of the evolving medical science and the competitive environment, the medical advisor's role is also increasingly becoming critical. In India, with changes in regulatory rules, safety surveillance, and concept of medical liaisons, the role of the medical advisor is evolving continuously and is further likely to evolve in the coming years in important areas like health economics, public private partnerships, and strategic planning.
  4,335 597 2
A prospective randomized, double-blind, controlled clinical trial comparing epidural butorphanol plus corticosteroid with corticosteroid alone for sciatica due to herniated nucleus pulposus
Abhijan Maity, Bikash Chandra Mondal, Debasish Saha, Debasish Sinha Roy
January-March 2012, 3(1):16-21
Objective: To compare the efficacy of up to 3 epidural butorphanol plus corticosteroid with corticosteroid alone for sciatica due to herniated nucleus pulposus. Materials and Methods: In a randomized, double-blind controlled clinical trial, we administered up to 3 epidural injections of either 80 mg (2 mL) of methylprednisolone acetate and 1 mg (1 mL) of butorphanol diluted with 7 mL of isotonic saline or 80 mg (2 mL) of methylprednisolone acetate diluted with 8 mL of isotonic saline by a lumbar interlaminar approach under fluoroscopic guidance to 120 patients (60 patients in each group) with sciatica due to a herniated nucleus pulposus lasting for 4 weeks to 1 year. All patients had scores higher than 30 mm on visual analog scale (VAS). Information on the use of paracetamol, intensity of pain on a VAS ranging from 0 (no pain) to 100 mm (worst pain possible), Schober's test (cm), Straight Leg Raising test, neurologic examination assessing sensory deficits, motor deficits and reflex changes, and Oswestry Low Back Pain Disability Questionnaire were evaluated at 3 weeks, 6 weeks, and 3 months after the first injection. Results: There were no significant differences between the 2 groups with regard to baseline characteristics, withdrawals, and complication rate. Three weeks, 6 weeks, and 3 months after the first injection, all the outcome measures in the butorphanol plus corticosteroid group were significantly different from that of the corticosteroid group. Conclusions: Epidural butorphanol plus corticosteroid injections, as compared with corticosteroid alone injections, offered marked improvement in pain, reflex, motor and sensory deficits, and functional status and reduced the need for analgesics. Level of Evidence: Therapeutic Level I.
  4,288 604 1
A day in the life of a monitor!
Kunal Shah
January-March 2012, 3(1):32-34
When at a site, the monitor will meet with the Study Coordinator, review the hospital medical records, use the internet database or paper to 'monitor' their data versus their medical records, issue queries, check master files, count tablets or vials, provide the update to the doctor, and so on. When not traveling, the monitor will work in the office, printing letters, filing documents collected from sites, writing reports and follow-up letters, responding to e-mails, calling sites, to follow-up on the pending action items, in addition to calling sites not visited recently, attending study teleconferences, attending study and company training programs, reading standard operating procedures, completing excel spreadsheets or company specific software systems, and so on. The monitor is loaded with all these different types of work requirements and most importantly each and every task is important and time bound. Different skill sets are required for different tasks and the monitor plays different roles, while doing different tasks. This article enlists the tasks that are required to be done by the monitor, the different roles played by the monitor while doing these tasks, analyze which is the most important day for a monitor, what are the tasks performed during this day, and what knowledge and skills are required for performing these tasks.
  4,071 722 1
Compensation conundrum
Shoibal Mukherjee
January-March 2012, 3(1):4-7
Pressured by questions tabled in parliament that point to a lack of adequate enforcement of regulations, the DCG(I) has abruptly initiated action to ensure payment of compensation for trial-related injuries. While it is astounding that non-compliance to the existing regulations could have gone unnoticed by quality assurance staff as well as by the ethics committees and the regulator, for over six years, sudden enforcement of the regulation has thrown up issues and challenges that are difficult to resolve in the absence of an adequately debated and thought-through guidance. In implementing regulations for suomoto compensation, India is seeking to establish a practice not previously tested elsewhere in the world. There is no doubt that industry must support the idea of putting patients first, but procedural considerations in fixing causality and determining the quantum of compensation promise to raise questions of morality, ethics, and jurisprudence that will not be easy to answer.
  4,143 531 3
Indian clinical trials: Paradigm shift from speed to quality?
Arun Bhatt
January-March 2012, 3(1):1-3
  3,716 667 2
Predictors of warfarin-induced bleeding in a South Indian cardiology unit
Haritha Nekkanti, Uday Venkat Mateti, Rajesh Vilakkathala, Thiyagu Rajakannan, Surulivelrajan Mallayasamy, Ramachandran Padmakumar
January-March 2012, 3(1):22-25
Objectives: Warfarin-induced bleedingresults in increased morbidity and mortality and higher cost of healthcare. The objective of the study is to identify the predictors of warfarin-induced bleeding in the Cardiology Unit of a teaching hospital. Materials and Methods: A cross-sectional study was carried out for a period of six months in a tertiary care teaching hospital. A total of 235 patients were enrolled in the study, to identify the predictors of warfarin-induced bleeding. Only prescriptions with warfarin were selected for the study. The chi square test was used to find the association between demography and risk factors. Results: Out of 235 patients, 61 (25.95%) had developed warfarin-induced bleeding and the majority were in the age group of 41 - 61 years (60.65%), and it was also found to be higher in women (62.29%). The length of stay was > 14 days (65.57%) and the number of drugs prescribed was in the range of 6 - 12 (52.45%). Aspirin (40.98%), Heparin (36.06%), Clopidogrel (22.95%), and Streptokinase (14.75%) were the most common drugs involved, and other comorbid conditions like diabetes (37.70%), hypertension (32.78%), smoking (57.37%), and alcohol (32.78%) were found to be major predictors of warfarin-induced bleeding in this study. The severity of warfarin-induced most of the bleeding reactions were moderate (44.26%) and the most common site of bleeding was gastrointestinal system (34.42%). Conclusion: Predictors of warfarin-induced bleeding were found to be female gender, length of stay, number of medications, drugs like aspirin, heparin, and clopidogrel, and other comorbidities like smoking, alcohol, and hypertension.
  3,719 514 3