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   2015| April-June  | Volume 6 | Issue 2  
    Online since March 26, 2015

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Ethical issues in electronic health records: A general overview
Fouzia F Ozair, Nayer Jamshed, Amit Sharma, Praveen Aggarwal
April-June 2015, 6(2):73-76
DOI:10.4103/2229-3485.153997  PMID:25878950
Electronic health record (EHR) is increasingly being implemented in many developing countries. It is the need of the hour because it improves the quality of health care and is also cost-effective. Technologies can introduce some hazards hence safety of information in the system is a real challenge. Recent news of security breaches has put a question mark on this system. Despite its increased usefulness, and increasing enthusiasm in its adoption, not much attention is being paid to the ethical issues that might arise. Securing EHR with an encrypted password is a probable option. The purpose of this article is to discuss the various ethical issues arising in the use of the EHRs and their possible solutions.
  20,615 2,332 45
A systematic review of prescription pattern monitoring studies and their effectiveness in promoting rational use of medicines
Shipra Jain, Prerna Upadhyaya, Jaswant Goyal, Kumar Abhijit, Pushpawati Jain, Vikas Seth, Vijay V Moghe
April-June 2015, 6(2):86-90
DOI:10.4103/2229-3485.154005  PMID:25878953
Prescription pattern monitoring studies (PPMS) are a tool for assessing the prescribing, dispensing and distribution of medicines. The main aim of PPMS is to facilitate rational use of medicines (RUM). There is paucity of published data analysing the effectiveness of PPMS. The present review has been done to assess the effectiveness of prescription pattern monitoring studies in promoting RUM. Data search was conducted on internet. A multitude of PPMS done on different classes of drugs were collected and analyzed. PPMS using WHO prescribing indicators were also included. The present article reviews various prescription pattern monitoring studies of drugs conducted all over country and abroad. It was observed in the majority of such studies that physicians do not adhere to the guidelines made by regulatory agencies leading to irrational use of medicines. This in turn leads to increased incidence of treatment failure, antimicrobial resistance and economic burden on the patient and the community as a whole. The treatment of diseases by the use of essential drugs, prescribed by their generic names, has been emphasized by the WHO and the National Health Policy of India. We conclude that the prescription monitoring studies provide a bridge between areas like rational use of drugs, pharmacovigilance, evidence based medicine, pharmacoeconomics, pharmacogenetics and ecopharmacovigilance. In India, this is the need of the hour to utilise the data generated by so many prescription pattern monitoring studies done in every state and on every drug, so that the main aim of promoting rational use of drugs is fulfilled.
  5,326 1,042 17
Common pitfalls in statistical analysis: "P" values, statistical significance and confidence intervals
Priya Ranganathan, CS Pramesh, Marc Buyse
April-June 2015, 6(2):116-117
DOI:10.4103/2229-3485.154016  PMID:25878958
In the second part of a series on pitfalls in statistical analysis, we look at various ways in which a statistically significant study result can be expressed. We debunk some of the myths regarding the 'P' value, explain the importance of 'confidence intervals' and clarify the importance of including both values in a paper
  3,800 1,023 3
Quantity and quality of randomized controlled trials published by Indian physiotherapists
K Hariohm, V Prakash, J Saravankumar
April-June 2015, 6(2):91-97
DOI:10.4103/2229-3485.154007  PMID:25878954
Background and Objectives: Randomized controlled trials (RCTs) are considered as the gold standard evidence for determining efficacy of interventions. Physiotherapeutic interventions are essential in the management of various conditions. However, information on the quantity and quality of RCTs published by Indian physiotherapists is largely unknown. Therefore, the primary objective of this study was to review the RCTs published by Indian physiotherapists for analyzing publication trend and its quality. Materials and Methods: Medline database was searched for eligible RCTs published by Indian physiotherapists between the years 2000 and 2013. We performed quantitative analysis of RCTs including type of participants, area of focus in physiotherapy, clinical condition and geographical location of first author's affiliation and analyzed the methodological quality and reporting of RCTs using Physiotherapy Evidence Database (PEDro) scale and consolidated standards of reporting trials (CONSORTs) key criterion statement, respectively. Results: A total of 45 RCTs have been published by Indian physiotherapists. The common conditions investigated in the trials were low back pain (16.3%), followed by diabetes (6.7%) and chronic obstructive pulmonary disease (6.7%). The mean score of PEDro is 5.5 (standard deviation: 1.2). Trial registration (3 [7%]) and sample size calculation (28.9%) are the most common CONSORT items not reported in the trials. Interpretation and Conclusions: RCTs published by Indian physiotherapists is gradually increasing in numbers and the methodological qualities of studies are fair. However, there is substantial scope for improvement in conducting and reporting trials. In the future, Indian physiotherapists should focus more on conditions such as stroke, asthma, and others, which have a larger burden of illness among Indian population.
  3,739 449 18
Pattern of adverse drug reactions due to cancer chemotherapy in a tertiary care hospital in South India
Ajitha Sharma, K Meena Kumari, Hasitha Diana Manohar, KL Bairy, Joseph Thomas
April-June 2015, 6(2):109-115
DOI:10.4103/2229-3485.154014  PMID:25878957
Purpose: Studies regarding pattern of adverse drug reactions (ADRs) in cancer chemotherapy patients are scarce in India. This study was conducted to evaluate the pattern of occurrence of ADRs due to cancer chemotherapy in hospitalized patients and to assess the causality, severity, predictability, and preventability of these reactions. Materials and Methods: This was a retrospective, descriptive study and the occurrence and nature of ADR, suspected drug, duration of hospital stay and outcome were noted from case records. These ADRs were assessed for causality using both World Health Organization (WHO) causality assessment scale and Naranjo's algorithm. The severity and preventability of the reported reactions were assessed using modified Hartwig and Siegel scale and modified Schumock and Thornton scale respectively. Results: Five hundred ADRs were recorded from 195 patients. Most common ADRs were infections (22.4%), nausea/vomiting (21.6%) and febrile neutropenia (13%). Platinum compounds, nitrogen mustards, taxanes, antibiotics and 5-fluorouracil were the most common drugs causing ADRs. WHO causality assessment scale showed 65% of the reactions to be "probable" and 35% to be "possible," while Naranjo's algorithm indicated that 65.6% of ADRs were "probable" and 34.4% were "possible". Modified Hartwig and Siegel scale showed most reactions (41.4%) to be of "moderate level 4(a)" severity, while 30.6% of reactions were of "mild level 1" severity. About 30.8% of the ADRs were "definitely preventable" according to the modified Schumock and Thornton scale. Conclusion: ADRs are most important causes of morbidity and mortality and increase the economic burden on patient and society. By careful ADR monitoring, their incidence can be decreased.
  2,995 528 8
Post-trial access to treatment for patients participating in clinical trials
Dinesh Chandra Doval, Rashmi Shirali, Rupal Sinha
April-June 2015, 6(2):82-85
DOI:10.4103/2229-3485.154003  PMID:25878952
Clinical trials are the mainstay for bringing out newer and better drugs to serve the mankind. By virtue of participating in a clinical trial, a patient receives access to the newer drugs/therapies, but nothing is generally being offered to them once their participation in the study comes to an end. Though the issue of post-trial access to treatment by patients participating in a clinical trial is debatable, there is no compelling justification either for or against it. We examined a case study in order to evaluate the applicability of post-trial access to treatment for patients participating in clinical trials. The provision of post-trial access to treatment should also keep into consideration the compassionate use of drugs on humanitarian grounds, especially in cases of trial drugs that have offered significant benefit to the trial patients and whose termination would lead to deterioration in patient's overall condition. In the present era of personalized medicine, the incorporation of genetic testing into clinical practice further authenticates the rationale of compassionate use of drugs and post-trial access to treatment.
  2,626 431 5
Indian Regulatory Update: January-March 2015
Kedar Suvarnapathaki
April-June 2015, 6(2):118-119
DOI:10.4103/2229-3485.154018  PMID:25878959
  2,522 533 -
Phase I (first-in-man) prophylactic vaccine's clinical trials: Selecting a clinical trial site
Shantanu Mehta, Vishal Goyal, Kavita Singh
April-June 2015, 6(2):77-81
DOI:10.4103/2229-3485.154001  PMID:25878951
An appropriately equipped and staffed Phase I unit is critical for smooth conduct of a first-in-man clinical trial. The first-in-man prophylactic vaccine trial(s) requires basic infrastructure of clinical trial site, experienced and dedicated site staff and healthy adults as volunteers. The facility should have access to equipment, emergency services, laboratory, pharmacy and archiving.In terms of design, infrastructure, workflow and manpower, a Phase I unit for testing a novel vaccine or drug are quite similar. However, there are some important attributes, which should be taken into consideration, while performing pre-trial site selection for conducting phase I trial with a new or novel vaccine.
  2,585 394 -
GCP compliance and readability of informed consent forms from an emerging hub for clinical trials
Satish Chandrasekhar Nair, Halah Ibrahim
April-June 2015, 6(2):104-108
DOI:10.4103/2229-3485.154012  PMID:25878956
Background: The rapid expansion of trials in emerging regions has raised valid concerns about research subject protection, particularly related to informed consent. The purpose of this study is to assess informed consent form (ICF) compliance with Good Clinical Practice (GCP) guidelines and the readability easeof the ICFs in Abu Dhabi, a potential destination for clinical trials in the UAE. Materials and Methods: A multicenter retrospective cross-sectional analysis of 140 ICFs from industry sponsored and non-sponsored studies was conducted by comparing against a local standard ICF. Flesch-Kincaid Reading Scale was used to assess the readability ease of the forms. Results: Non-sponsored studies had signifi cantly lower overall GCP compliance of 55.8% when compared to 79.5% for industry sponsored studies. Only 33% of sponsored and 16% of non-sponsored studies included basic information on the participants' rights and responsibilities. Flesch-Kincaid Reading ease score for the informed consent forms from industry sponsored studies was signifi cantly higher 48.9 ± 4.8 as compared to 38.5 ± 8.0 for non-sponsored studies, though both were more complex than recommended. Reading Grade Level score was also higher than expected, but scores for the ICFs from the industry sponsored studies were 9.7 ± 0.7, signifi cantly lower as compared to 12.2 ± 1.3 for non-sponsored studies. Conclusion: In spite of the undisputed benefits of conducting research in emerging markets readability, comprehension issues and the lack of basic essential information call for improvements in the ICFs to protect the rights of future research subjects enrolled in clinical trials in the UAE.
  2,472 307 5
Barriers and challenges in researches by Iranian students of medical universities
Zohreh Anbari, Abolfazl Mohammadbeigi, Rahmatollah Jadidi
April-June 2015, 6(2):98-103
DOI:10.4103/2229-3485.154009  PMID:25878955
Background: Health sciences research (HSR) is an essential part of improving health care which plays a critical role in the field of medicine and clinical practice. The aim of the current study was to assess barriers to the research by students of medical sciences as well as to find out effective strategies for management of student researches in Iranian universities. Materials and Methods: This study utilized a hybrid design with quantitative and qualitative analytical approaches conducted on 627 students in six schools of medical sciences in two universities in Central Province in Iran from April to December, 2012. Questionnaires were distributed among researcher and non-researcher students to find barriers to the research. These barriers were approved and validated by similar studies and strategies using the Delphi technique on 36 students. Results: The most important barriers among researcher students were institutional barriers (3.3 ± 1.3), but in non-researcher students they were individual barriers (3.6 ± 1.7). The majority of barriers to involvement in the research among researcher students appeared to be time, lack of access to electronic resources and prolongation of the process of buying equipment. In addition, the greatest barriers among non-researcher students included the lack of time, scientific writing skills, and access to trained assistants. Conclusion: The results showed the issue of attitudes towards compulsory research as a component of critical scholarship in the curriculum of medical courses. Moreover, employment of the research experts can be helpful for research training in schools of medical sciences.
  2,198 303 2
Visual analog scale: Verify appropriate statistics
S Kannan, S Gowri
April-June 2015, 6(2):120-120
DOI:10.4103/2229-3485.154020  PMID:25878960
  1,889 351 3
Sharing individual patient data from clinical trials
Viraj Ramesh Suvarna
April-June 2015, 6(2):71-72
DOI:10.4103/2229-3485.153996  PMID:25878949
  1,867 326 3
Author's reply
Priya Ranganathan
April-June 2015, 6(2):120-121
  1,002 149 -