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   2018| April-June  | Volume 9 | Issue 2  
    Online since April 24, 2018

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An analysis of adverse drug reactions in extremes of age group at tertiary care teaching hospital
Saloni Amin, Samidh Shah, Mira Desai, Asha Shah, KM Maheriya
April-June 2018, 9(2):70-75
DOI:10.4103/picr.PICR_64_17  PMID:29862199
Objectives: To analyze clinical spectrum, seriousness, outcome, causality, severity and preventability of ADRs in geriatrics and pediatric patients. Materials and Methods: All ADRs reported in geriatrics (≥ 65 years) and pediatrics (≤ 12 years) indoor as well outdoor patients from January, 2010 to April, 2016 at ADR monitoring centre, Department of Pharmacology, B. J. Medical College and Civil Hospital were identified. A retrospective analysis was carried out for clinical presentation, causality (as per WHO-UMC scale and Naranjo's algorithm), severity (Hatwig and Seigel scale) and preventability (Schaumock and Thornton criteria). Results: Out of 3690 ADRs, 160 were in geriatric patients (4.33%) while 231 in pediatric patients (6.26%). The most commonly affected body system was gastrointestinal (53, 33.13%) followed by neurological disorders (26, 16.25%) in geriatric patients. While in pediatric patients, the most commonly affected body system was skin and appendages (73, 31.60 %) followed by gastrointestinal disorders (58, 25.11%). The most common causal drugs in geriatric patients was cardiovascular (38, 23.75%) followed by antimicrobials (28, 13.25%). While in pediatric patients, the most common causal drug group was antimicrobials (85, 33.46%) followed by blood products (36, 14.12%). Total 17 ADRs reported following vaccination, 7 (41.17%) were injection site abscess and 11 (64.70%) were due to pentavalent vaccine. Polypharmacy was common in geriatrics (31, 19.37%). Causality assessment for majority of ADRs in geriatrics (83, 52.5%) and pediatrics (171, 67.32%) were probable. Conclusion: ADRs are common in geriatric and pediatric patients usually within four weeks of oral therapy. Active surveillance of drug safety monitoring in these vulnerable population is recommended.
  3,022 297 1
Analysis of serious adverse event: Writing a narrative
Indu Nambiar
April-June 2018, 9(2):103-106
DOI:10.4103/picr.PICR_52_18  PMID:29862205
One of the reasons that a research molecule undergoes through different phases of clinical trials is to establish the safety and efficacy of the drug. To establish the safety profile of any drug, the most important aspect is to evaluate every adverse event (AE) that a clinical trial individual experiences. This detail is provided by any investigator or sponsor through the narratives that is prepared post the analysis of a serious AE. The purpose of this article is to emphasize the importance of these narratives.
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Real world evidence (RWE) - Are we (RWE) ready?
Viraj Ramesh Suvarna
April-June 2018, 9(2):61-63
DOI:10.4103/picr.PICR_36_18  PMID:29862197
Real world evidence is important as it complements data from randomised controlled trials (RCTs). Both have limitations in design, interpretation, and extrapolatability. It is imperative one designs real world studies in the right way, else it can be misleading. An RCT is always considered higher in the evidence ladder and when there is discordance between a real world study and an RCT, it is the latter which is always considered pristine because of the way it is conducted, e.g., randomization, prospective, double-blind, etc. A real world study can also be done prospectively, and propensity score matching can be used to construct comparable cohorts but may not be able to account for certain biases or confounding factors the way an RCT can do. Nevertheless, comparative effectiveness research in the real world is being resorted to, especially for efficiency studies or pharmacoeconomic analyses, and with the advent of machine learning, the electronic healthcare database mining can result in algorithms that help doctors identify clinical characteristics that correlate with optimal response of a patient to a drug/regimen, thus helping him/her select the right patient for the right drug.
  2,169 546 12
Drug prescription behavior: A cross-sectional study in public health facilities in two states of North India
Jaya Prasad Tripathy, Pankaj Bahuguna, Shankar Prinja
April-June 2018, 9(2):76-82
DOI:10.4103/picr.PICR_75_17  PMID:29862200
Background: Poor prescription practices result in increased side effects, adverse drug reactions, and high cost of treatment. The present study was undertaken to describe the drug-prescribing patterns in two North Indian states through prescription auditing. Materials and Methods: The study was carried out in 80 public health facilities across 12 districts in two states of Haryana and Punjab (6 in each) covering all levels of care. The information from prescription slips was abstracted on a structured pro forma for all patients who visited the pharmacy of the health facility. Results: A total of 1609 prescriptions were analyzed. On an average, 2.2 drugs were prescribed per patient. Nearly 84% of the drugs were prescribed from the essential drug list (EDL). Antibiotics were prescribed in 45.3% of prescriptions, followed by vitamins (34.8%) and nonsteroidal anti-inflammatory drugs (33.9%). Drugs were prescribed in their generic names in 70% of cases. Diseases of the ear, nose, and throat (18%) were most common followed by the diseases of the gastrointestinal and renal (17%) and musculoskeletal system (16%). Only 40% of children suffering from diarrhea received oral rehydration salts while 80% of them received antibiotics. Among cases of upper respiratory tract infection, nearly 75% received antibiotics. Conclusion: The results of this study raise concerns about the overuse of antibiotics although most of the drugs (84%) were from the EDL and in generic names (70%). There is lack of data regarding prescription practices which necessitates real-time prescription monitoring through online data entry and transmission.
  2,342 343 1
Payment for participation in clinical research: Review of proposals submitted to the ethics committees
Padmaja A Marathe, Raakhi K Tripathi, Yashashri C Shetty, Sunil S Kuyare, Sandhya K Kamat, Urmila M Thatte
April-June 2018, 9(2):64-69
DOI:10.4103/picr.PICR_159_16  PMID:29862198
Objective: In view of dearth of information in national and international guidelines on payment practices in research, the present study was done to find out payments for participation allowed by 3 Ethics committees (ECs) and reasons for payment. Method: This was a retrospective observational study which analysed research proposals reviewed by 2 institutional and 1 non-institutional ECs over a period of 2 years. The permission of ECs was obtained and confidentiality of data was maintained. Results: Of the 73 studies requiring payment, 89.04% were interventional and 10.96% observational. Reimbursement of travel expenses (60%) was the major reason for payment followed by inconvenience due to participation, loss of wages and time spent. The queries raised by EC in more than 50 % of studies were related to informing patients about the payment in the informed consent document. The investigators complied with the EC requirements regarding payment (15/21) and the remaining provided explanations. The median amount of payment in pharmaceutical sponsored studies was higher compared to investigator initiated studies. Higher payments were approved by ECs on case to case basis in a few studies. The ECs did not have any policy/ standard operating procedure for payment practices. Conclusion: The present study first of its kind in India, demonstrated that quantum of payment was not uniform for pharmaceutical sponsored and investigator initiated studies and payments were not considered for majority of observational studies. Travel reimbursement was the most common reason for payment. There is a need to develop guidelines for determining appropriate payment/incentives to participants for specific types of research related activities.
  2,101 296 2
Understanding the properties of diagnostic tests – Part 2: Likelihood ratios
Priya Ranganathan, Rakesh Aggarwal
April-June 2018, 9(2):99-102
DOI:10.4103/picr.PICR_41_18  PMID:29862204
Diagnostic tests are used to identify subjects with and without disease. In a previous article in this series, we examined some attributes of diagnostic tests – sensitivity, specificity, and predictive values. In this second article, we look at likelihood ratios, which are useful for the interpretation of diagnostic test results in everyday clinical practice.
  1,863 421 -
Research methodology workshops: A small step towards practice of evidence-based medicine
Nithya Jaideep Gogtay
April-June 2018, 9(2):59-60
DOI:10.4103/picr.PICR_28_18  PMID:29862196
  1,439 272 -
Assessment of change in knowledge about research methods among delegates attending research methodology workshop
Manisha Shrivastava, Nehal Shah, Seema Navaid
April-June 2018, 9(2):83-90
DOI:10.4103/picr.PICR_41_17  PMID:29862201
Aim: In an era of evidence based medicine research is an essential part of medical profession whether clinical or academic. A research methodology workshop intends to help participants, those who are newer to research field or those who are already doing empirical research. The present study was conducted to assess the changes in knowledge of the participants of a research methodology workshop through a structured questionnaire. Methods: With administrative and ethical approval, a four day research methodology workshop was planned. The participants were subjected to a structured questionnaire (pre-test) containing 20 multiple choice questions (Q1-Q 20) related to the topics to be covered in research methodology workshop before the commencement of the workshop and then subjected to similar posttest questionnaire after the completion of workshop. The mean values of pre and post-test scores were calculated and the results were analyzed and compared. Results: Out of the total 153 delegates, 45(29 %) were males and 108 were (71 %) females. 92 (60%) participants consented to fill the pre-test questionnaire and 68 (44%) filled the post-test questionnaire. The mean Pre-test and post-test scores at 95% Confidence Interval were 07.62 (SD ±3.220) and 09.66 (SD ±2.477) respectively. The differences were found to be significant using Paired Sample T test (P <0.003). Conclusion: There was increase in knowledge of the delegates after attending research methodology workshops. Participatory research methodology workshops are good methods of imparting knowledge, also the long term effects needs to be evaluated.
  1,338 199 -
Monitoring of approved studies: A difficult tightrope walk by Ethics Committees
Sanish Davis
April-June 2018, 9(2):91-94
DOI:10.4103/picr.PICR_51_18  PMID:29862202
Continuing review of studies approved by the Ethics Committees (ECs) involves review of the progress of the study, annual reports, protocol deviations/violations, serious adverse event monitoring, and on-site monitoring. International and national regulations and guidelines for continuing review state that it is an opportunity for the EC to be assured that risks to subjects are minimized and is are reasonable in relation to anticipated benefits if any to the subjects and the knowledge it will generate. There are several barriers (e.g. lack of workforce, lack of training of members for conducting onsite review, and poor infrastructure) for ECs to do ongoing review of projects approved by them. Industry is an important stakeholder for the research enterprise in India and strongly advocates that ECs should at a minimum have pragmatic standard operating procedures for continuing review/monitoring of studies initially approved. ECs which deal with larger volume of studies with well-functioning secretariat, appropriately trained EC members and funding should definitely conduct onsite review/monitoring in addition to the ongoing review.
  1,267 195 1
Investigator preparedness for monitoring and audits
Renju Ravi, Debdipta Bose, Nithya J Gogtay, Urmila M Thatte
April-June 2018, 9(2):95-98
DOI:10.4103/picr.PICR_42_18  PMID:29862203
Monitoring and audits are two distinct processes that ensure that the rights and safety of the participants are protected, and data integrity is maintained. The present narrative summates authors' experiences with monitoring and audits by sponsor along with challenges faced by the site. It also offers potential solutions for challenges faced during the process of monitoring and audits. It is important to remember that no monitoring or audit can ever substitute for a well-designed and articulated protocol. In addition, a determined approach by the investigator and his/her team to ensure that all aspects of the protocol are adhered to in totality will go a long way in assuring quality.
  1,112 195 -
Antidiabetic medication and quality of life: A comment on Chaturvedi et al. (2018)
Saurav Basu
April-June 2018, 9(2):107-108
DOI:10.4103/picr.PICR_6_18  PMID:29862206
  1,002 148 -
Author's reply
Chetna Desai
April-June 2018, 9(2):108-109
DOI:10.4103/picr.PICR_40_18  PMID:29862207
  862 149 -