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   2015| October-December  | Volume 6 | Issue 4  
    Online since October 12, 2015

 
 
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EDITORIAL
Electronic informed consenting: A boon to modernize consenting process
Premnath Shenoy
October-December 2015, 6(4):173-174
DOI:10.4103/2229-3485.167091  PMID:26623385
  1,676 9,399 3
REVIEW ARTICLES
Clinical operations generation next… The age of technology and outsourcing
Priya Temkar
October-December 2015, 6(4):175-178
DOI:10.4103/2229-3485.167098  PMID:26623386
Huge cost pressures and the need to drive faster approvals has driven a technology transformation in the clinical trial (CT) industry. The CT industry is thus leveraging mobile data, cloud computing, social media, robotic automation, and electronic source to drive efficiencies in a big way. Outsourcing of clinical operations support services to technology companies with a clinical edge is gaining tremendous importance. This paper provides an overview of current technology trends, applicable Food and Drug Administration (FDA) guidelines, basic challenges that the pharma industry is facing in trying to implement such changes and its shift towards outsourcing these services to enable it to focus on site operations.
  2,093 2,762 1
Clinical data acquisition standards harmonization importance and benefits in clinical data management
Jagadeeswara Rao Gaddale
October-December 2015, 6(4):179-183
DOI:10.4103/2229-3485.167101  PMID:26623387
In the clinical trial process, precise and concise data collection at the source is imperative and requires statistical analysis to be performed to derive the primary and secondary endpoints. The quality of raw data collection has a direct impact on the statistical outputs generated as per the statistical analysis plan. Hence, the data collection tools used for data transcription must be clear, understandable, and precise, which helps the investigator to provide the accurate subject data. Clinical Data Acquisition Standards Harmonization (CDASH) provides guidance to develop the case report form (CRF) for domains that are commonly used for the majority of the clinical trials across the therapeutic areas. This white paper describes the importance of CDASH standards, its advantages and its impact on the efforts and the cost in designing the CRF.
  2,694 1,383 3
ORIGINAL ARTICLES
A questionnaire based study to assess knowledge, attitude and practice of pharmacovigilance among undergraduate medical students in a Tertiary Care Teaching Hospital of South India
Bikash Ranjan Meher, N Joshua, B Asha, Deepali Mukherji
October-December 2015, 6(4):217-221
DOI:10.4103/2229-3485.167102  PMID:26623394
Objectives: Spontaneous reporting of adverse drug reaction (ADR) is the backbone of pharmacovigilance program. Under reporting by prescribers is still exist. This study was done to assess the knowledge, attitude, and practice (KAP) of undergraduate students about pharmacovigilance. Materials and Methods: It was a questionnaire-based cross-sectional study. Study tool was a validated questionnaire containing 21 questions to evaluate KAP of pharmacovigilance among undergraduate medical students in a Tertiary Care Teaching Hospital of South India. Results: All data were analyzed by using Microsoft Excel sheet, Chi-square, and ANOVA. The mean score of final, prefinal, and 2nd year students is respectively (4.76, 5.63, and 4.73) for knowledge, (4.26, 4.95, and 4.53) for attitude and (1.66, 1.55, and 1.28) for the practice. There is a significant difference in mean score between three groups for knowledge and attitude, but not for practice. They have a better attitude, but poor in knowledge and practice regarding pharmacovigilance. Conclusion: Students lack adequate knowledge and skill of reporting ADR, but they have a positive attitude toward pharmacovigilance program. The integration of pharmacovigilance with undergraduate curriculum may help in improving ADR monitoring and reporting.
  3,209 629 5
REVIEW ARTICLES
Elderly patients' participation in clinical trials
Premnath Shenoy, Anand Harugeri
October-December 2015, 6(4):184-189
DOI:10.4103/2229-3485.167099  PMID:26623388
The elderly population is a large and the fastest-growing portion of the population worldwide. The elderly make up the lion's share of patients for certain health conditions including cancer, cardiovascular disease, arthritis, and Parkinson's disease, among others in most parts of the world. Furthermore, elderly make up the majority of patients for many medications treating chronic conditions. Typically, clinical trials conducted in adult population include patients between the ages of 18 and 64 years. However, drugs should be studied in all age groups and trial participants should be representative of the patient population receiving the therapy in daily medical practice. Elderly patients are poorly represented in clinical trials. Hence, there is inadequate evidence and knowledge about responses of geriatric patients to medications. Regulatory authorities in developed countries urge to avoid arbitrary upper age limits and advise researchers and industry not to exclude elderly people from clinical trials without a valid reason. Since last few years Indian regulatory authority has been stipulating upper age limit for studies conducted in India. The Central Drugs Standard Control Organization (CDSCO) will be doing a great contribution to the researchers if it changes its view on stipulating upper age restrictions in clinical studies. This article describes the need for including elderly patients in the clinical trials in order to garner data from geriatric patients who form major medication users in most of the chronic diseases.
  3,221 545 60
STATISTICS
Common pitfalls in statistical analysis: Odds versus risk
Priya Ranganathan, Rakesh Aggarwal, CS Pramesh
October-December 2015, 6(4):222-224
DOI:10.4103/2229-3485.167092  PMID:26623395
In biomedical research, we are often interested in quantifying the relationship between an exposure and an outcome. “Odds” and “Risk” are the most common terms which are used as measures of association between variables. In this article, which is the fourth in the series of common pitfalls in statistical analysis, we explain the meaning of risk and odds and the difference between the two.
  2,280 782 7
ORIGINAL ARTICLES
An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting in a tertiary care teaching hospital of Sikkim
Supratim Datta, Shramana Sengupta
October-December 2015, 6(4):200-206
DOI:10.4103/2229-3485.167096  PMID:26623391
Aim: Spontaneous voluntary adverse drug reaction (ADR) reporting is paramount to the success of the Pharmacovigilance Programme of India. There has however been minimal and sporadic voluntary reporting of ADR's at the ADR Monitoring Centre (AMC) Gangtok, Sikkim. Knowledge, perception, attitude, and awareness of health professionals are determinants of reporting practices. This questionnaire study aims at evaluating these indicators in the teaching hospital attached to the Medical Institute and find out methods to improve existing reporting practices. Materials and Methods: This is a cross-sectional questionnaire-based observational study carried out in the Medical, Surgical and Pathology Departments of the Teaching Hospital, Gangtok, Sikkim over a period of 2 months. The questionnaires were filled by the respondents and returned back to us within the next 24 h. Data obtained from filled questionnaires were thereby analyzed. Results: The overall correct response rate to the knowledge-based questions was 56.3%. While 97% of respondents were of the view that ADR reporting was necessary, 35% of the respondents felt that the difficulty in deciding the causality of an ADR discouraged them from reporting. 79% of the respondents were not aware of the presence of an AMC affiliated to the hospital, and 87% of the respondents admitted that they were not sending filled ADR forms to the AMC. Conclusions: The study indicates that the respondents have an average knowledge and positive attitude toward ADR reporting and pharmacovigilance. There is however a lack of awareness and poor ADR reporting practices. Efforts are required to enhance awareness and attitude toward pharmacovigilance and ADR reporting.
  1,889 362 1
Comparative evaluation of oral gabapentin versus clonidine as premedication on preoperative sedation and laryngoscopic stress response attenuation for the patients undergoing general anesthesia
Saikat Majumdar, Anjan Das, Haripada Das, Sambhunath Bandyopadhyay, Bimal Kumar Hajra, Dipankar Mukherjee
October-December 2015, 6(4):211-216
DOI:10.4103/2229-3485.167094  PMID:26623393
Background: Laryngoscopy and endotracheal intubation (L and I) is associated with rise in blood pressure (BP), heart rate (HR), leading to adverse cardiological outcome especially in susceptible individuals. To compare the BP, HR during L and I as well as to evaluate the preoperative sedation status between oral clonidine (Group C) and oral gabapentine (Group G) as premedication for the patients undergoing major surgery under general anesthesia (GA). Materials and Methods: From April 2008 to December 2009; in a prospective, double-blinded, and randomized controlled study; 100 adult patients of either sex, aged 20-45, of American Society of Anesthesiologists status I and II scheduled to undergo major surgery of >1 hour duration, randomly allocated into groups C and G were pre treated with oral clonidine (200 µg) and gabapentin (800 mg) respectively 2 h prior to induction. Preoperative sedation was assessed 2 h after premedication administration. Hemodynamic parameters were noted just before induction, during L and I 1,3,5,7, and10 min after intubation. The results obtained were then analyzed with statistical unpaired “t” test and Chi-square test and compared. Results and Analysis: Preoperative sedation between two groups were similar but group C attenuated HR, systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean blood pressure (MBP) more significantly before induction, during L and I, 1, 3, and 5 min, following L and I, while comparing with group G. Again gabapentin-reduced HR, BP, (SBP, DBP, MBP) significantly more at 7 and 10 min after L and I on comparison clonidine. Conclusion: Oral clonidine is equally effective in producing preoperative sedation in comparison to oral gabapentin, while on the contrary oral clonidine is more efficacious in reducing laryngoscopic stress response than oral gabapentin.
  1,735 315 1
Reasons why patients fail screening in Indian breast cancer trials
P Mahajan, A Kulkarni, S Narayanswamy, J Dalal, V Halbe, S Patkar, A Bhatt
October-December 2015, 6(4):190-193
DOI:10.4103/2229-3485.167100  PMID:26623389
Introduction: An increased number of screen failure patients in a clinical trial increases time and cost required for the recruitment. Assessment of reasons for screen failure can help reduce screen failure rates and improve recruitment. Materials and Methods: We collected retrospective data of human epidermal growth factor receptor (HER2) positive Indian breast cancer patients, who failed screening for phase 3 clinical trials and ascertained their reasons for screen failure from screening logs. Statistical comparison was done to ascertain if there are any differences between private and public sites. Results: Of 727 patients screened at 14 sites, 408 (56.1%) failed screening. The data on the specific reasons for screen failures was not available at one of the public sites (38 screen failures out of 83 screened patients). Hence, after excluding that site, further analysis is based on 644 patients, of which 370 failed screening. Of these, 296 (80%) screen failure patients did not meet selection criteria. The majority -266 were HER2 negative. Among logistical issues, 39 patients had inadequate breast tissue sample. Sixteen patients withdrew their consent at private sites as compared to six at public sites. The difference between private and public sites for the above three reasons was statistically significant. Conclusion: Use of prescreening logs to reduce the number of patients not meeting selection criteria and protocol logistics, and patient counseling to reduce consent withdrawals could be used to reduce screen failure rate.
  1,735 251 1
Pilot studies: Are they appropriately reported?
S Kannan, S Gowri
October-December 2015, 6(4):207-210
DOI:10.4103/2229-3485.167097  PMID:26623392
Introduction: Pilot studies play a pivotal role in deciding whether a main study can be undertaken thereby helping in appropriate framing of time, cost and study methods. However, they cannot be employed for testing a hypothesis and are underpowered in detecting clinically significant differences between the treatment arms. Literature from the west has shown serious lacunae on the part of researchers in reporting pilot studies. The present study assessed the reporting quality of pilot studies published from India. Materials and Methods: All the journal articles with a pilot study design published in Indian Journals between January and December 2013 were identified through PubMed search and were assessed for the following: Reason for undertaking the pilot study; report about intention of further work; mention about sample size calculation; statement on other studies evaluating the same hypothesis published elsewhere; whether any hypothesis was tested in the present study; use of inferential statistics including the total number of statistical analyses performed and whether confidence intervals were reported; post-hoc power calculation; application of randomization and/or blinding; total number of study participants and presence of a control group. Results: A total of 93 articles were considered in the present study. None of these reported reasons for undertaking the present pilot study and intention to carry of carrying out further work depending on their results. Also, none of them discussed the feasibility of conducting such studies in the given set-up. A total of 69/93 (67.7%) studies tested a hypothesis and had employed at least one of the statistical tests to infer whether any significant difference exist between various groups. None of the 93 articles mentioned confidence intervals and calculation of the sample size despite all mentioning the presence of previous studies evaluating a similar hypothesis. Similarly, none of these studies mentioned post-hoc analysis of power and median (range) of times of statistical analyses performed includes 5 (0–57). Conclusion: Pilot studies have been poorly reported in Indian biomedical journals, and more attention is required from all the stakeholders of research; researchers, peer reviewers and journal editors. Key words: Feasibility, preliminary, reporting quality
  1,512 267 5
Exploiting the potential of intranet for managing drug spectrum a web base publication in a Tertiary Care Hospital in Mumbai
Yashashri Chandrakant Shetty, Tejal Chetan Patel, Urwashi Indrakumar Parmar
October-December 2015, 6(4):194-199
DOI:10.4103/2229-3485.167093  PMID:26623390
Objective: The study surveyed the availability of the intranet in campus and also the knowledge related to drug spectrum an intranet publication. Materials and Methods: Institutional ethics committee permission was obtained. Verbal consent was taken from the faculty and resident doctors of departments where all the facilities were available. Universal sampling method was used for recruitment. Pre-validated questionnaires were given to approximately 100 faculty and 500 resident doctors in the year 2012-2013. The questionnaire contained 15 items. Content analysis was done. The study questionnaire focused on a survey to obtain participants feedback on the use of the intranet and to evaluate the use of intranet as a source of knowledge. It also dealt on the relevance of the drug spectrum in the context of their subject. The responses were taken after giving the participants sufficient time. Data was entered into an Excel 2003 spread sheet and analyzed by using descriptive statistics. Results: The total number of respondents who participated in our study was 134 including faculty and residents from various departments. A total of 117 (89.66%) respondents stated that their departments have access to the internet. Departments having access to intranet was 103 (76.29%). 67 (49.62%) respondents have accessed. 67 (49.62%) did not have the time to visit intranet site whereas 67 (49.62%) have not accessed intranet. 89 (65.92%) respondents were not aware of the drug spectrum. 101 (74.81%) respondents felt that drug spectrum is a useful activity on intranet. 45 (33.33%) knew about the intranet periodical drug spectrum, but most of the respondents (33.33%) explained the meaning of the word drug spectrum according to their understanding, but never knew about the online intranet journal drug spectrum. Conclusion: The study found that the intranet is available in the campus, but it is not being utilized. The awareness and knowledge regarding drug spectrum is lacking, but the participants had a lot of suggestions. Thus, intranet has immense utility, and to make drug spectrum more readable suggestions of the respondents needs to be incorporated which in turn can benefit the medical fraternity as a whole.
  1,292 189 -
LETTER TO EDITOR
Relevance of health economics to the Indian healthcare system: A perspective
Sunita R Nair
October-December 2015, 6(4):225-226
DOI:10.4103/2229-3485.167095  PMID:26623396
  1,204 206 2
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