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   2015| January-March  | Volume 6 | Issue 1  
    Online since January 7, 2015

 
 
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ORIGINAL ARTICLES
A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India
Sandeep Kumar Gupta, Roopa P Nayak, R Shivaranjani, Surendra Kumar Vidyarthi
January-March 2015, 6(1):45-52
DOI:10.4103/2229-3485.148816  PMID:25657902
Objective: The primary objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about pharmacovigilance in Dhanalakshmi Srinivasan Medical College and Hospital (DSMCH), Perambalur (Tamil Nadu), a tertiary care teaching hospital. The second primary objective was to assess the causation of underreporting of adverse drug reactions (ADRs) as it needs to be well-assessed in India. The secondary objective was to compare the findings of this study with the results of the published studies from India on evaluation of the KAP of pharmacovigilance among healthcare professional. Materials and Methods: A cross-sectional study was carried out using a pretested questionnaire. The questionnaire was designed to assess the KAP regarding pharmacovigilance. The healthcare professionals (doctors, nurses, and pharmacists) working in the DSMCH, Perambalur (Tamil Nadu) during the study period were included. Only those who gave their consent to participate were included in the study. The data was analyzed by using the Statistical Package for Social Sciences (SPSS) statistical software, version 16. Results: One hundred and fifty pretested questionnaires were distributed among the healthcare professionals and 101 responded. 62.4% healthcare workers gave correct response regarding the definition of pharmacovigilance. 75.2% of healthcare workers were aware regarding the existence of a National Pharmacovigilance Program of India. 69.3% healthcare professional agreed that ADR reporting is a professional obligation for them. Among the participants, 64.4% have experienced ADRs in patients, but only 22.8% have ever reported ADR to pharmacovigilance center. Unfortunately only 53.5% healthcare workers have been trained for reporting adverse reactions. But, 97% healthcare professionals agreed that reporting of ADR is necessary and 92.1% were of the view that pharmacovigilance should be taught in detail to healthcare professional. Conclusion: This study demonstrated that knowledge and attitude towards pharmacovigilance is gradually improving among healthcare professionals, but unfortunately the actual practice of ADR reporting is still deficient among them.
  4,307 953 20
REVIEW ARTICLES
Practical challenges in conducting respiratory studies
Sanjay D Hake, Mahesh L Patil, Tapankumar M Shah, Partha M Gokhale, Viraj Suvarna
January-March 2015, 6(1):15-19
DOI:10.4103/2229-3485.148798  PMID:25657898
Respiratory studies are complex on account of specific therapeutic knowledge that is needed and various instruments that are used for the management of this condition. Monitoring a respiratory study requires knowledge of the specific disease and associated guidelines. The intent of this article is to help clinical research professionals understand the technicalities, challenges, and the nuances of performing respiratory studies.
  4,185 358 -
ORIGINAL ARTICLES
Comparative evaluation of honey, chlorhexidine gluconate (0.2%) and combination of xylitol and chlorhexidine mouthwash (0.2%) on the clinical level of dental plaque: A 30 days randomized control trial
Ankita Jain, Dara John Bhaskar, Devanand Gupta, Chandan Agali, Vipul Gupta, Rajendra Kumar Gupta, Priyanka Yadav, Akash B Lavate, Mudita Chaturvedi
January-March 2015, 6(1):53-57
DOI:10.4103/2229-3485.148819  PMID:25657903
Aim: To compare the effect of honey, chlorhexidine mouthwash and combination of xylitol chewing gum and chlorhexidine mouthwash on the dental plaque level. Materials and Methods: Ninety healthy dental students, both male and female, aged between 21 to 25 years participated in the study. The subjects were randomly divided into three groups, i.e. the honey group, the chlorhexidine gluconate mouthwash group and the combination of xylitol chewing gum and chlorhexidine (CHX) mouthwash group. The data was collected at the baseline, 15 th day and 30 th day; the plaque was disclosed using disclosing solution and their scores were recorded at six sites per tooth using the Quigley and Hein plaque index modified by Turesky-Gilmore-Glickman. Statistical analysis was carried out later to compare the effect of all the three groups. P ≤ 0.05 was considered as statistically significant. Results: Our result showed that all the three groups were effective in reducing the plaque but post-hoc LSD (Least Significant Difference) showed that honey group and chlorhexidine + xylitol group were more effective than chlorhexidine group alone. The results demonstrated a significant reduction of plaque indices in honey group and chlorhexidine + xylitol group over a period of 15 and 30 days as compared to chlorhexidine.
  3,323 624 4
To evaluate efficacy and safety of Caralluma fimbriata in overweight and obese patients: A randomized, single blinded, placebo control trial
Ekta Arora, Vijay Khajuria, Vishal R Tandon, Atul Sharma, Annil Mahajan, Zahid H Gillani, Naiyma Choudhary
January-March 2015, 6(1):39-44
DOI:10.4103/2229-3485.148812  PMID:25657901
Aim: The aim of the following study is to evaluate the efficacy and safety of Caralluma fimbriata extract (CFE) in overweight and obese individuals in a prospective, randomized, placebo controlled trial. Materials and Methods: Commercially available CFE was assessed in overweight and obese individuals. A total of 89 patients were randomized into a treatment group (n = 47) and placebo group (n = 42) to receive either CFE in the form capsules/oral 500 mg b.d. for 12 weeks or matching placebo in similar way. Patients were evaluated clinically and biochemically at 4, 8 and 12 weeks for anthropometric measurements, appetite, biochemical investigations and other safety parameters. Results: At the end of study period both CFE and placebo for 12 weeks caused only numerical reduction in weight, body mass index, waist circumference, hip circumference and waist hip ratio in overweight and obese individuals. However, these parameters failed to attain significant statistical levels (P ≥ 0.05). CFE and placebo both failed to elucidate any modification of the appetite. There were no significant changes in the biochemical and clinical parameters in both the test and placebo group. However, CFE was well-tolerated and adverse events noted were mild and transient in nature. Conclusion: A commercially available extract of CFE in an oral dose of 1 g/day claimed to have anti-obesity effect failed to yield any positive results on anthropometry and appetite in overweight and obese individuals beyond placebo. There were also no significant differences in the clinical and biochemical parameters. However, CFE was well tolerated. Thereby, underscoring the need to carry more research before CFE is recommended as an anti-obesity drug.
  3,419 438 3
REVIEW ARTICLES
Cartilage oligomeric matrix protein in monitoring and prognostication of osteoarthritis and its utility in drug development
Bibhu R Das, Arnab Roy, Faisal R Khan
January-March 2015, 6(1):4-9
DOI:10.4103/2229-3485.148792  PMID:25657896
Osteoarthritis (OA) is a major public concern as it is one of the leading causes of morbidity and lays a huge medical and economic burden on health resources. Early detection of OA has been a clinical challenge as early signs of joint inflammation are often not evidently identifiable on routine radiographic images. This presents a dire unmet medical need for a biomarker, which could detect early signs of joint inflammation much before irreversible joint damage and radiographic changes set in. Besides, the treatment of OA has remained mainly symptomatic. A disease modifying OA drug (DMOAD), which can act as targeted anti-OA therapy has not been able to receive regulatory approval yet. The clinical development of a DMAOD too warrants the need of a biomarker; which can act as a surrogate clinical endpoint used to monitor therapeutic efficacy and to validate a clinically meaningful change within the restricted time frame of a clinical study. In this regard, the current review focuses on cartilage oligomeric matrix protein (COMP), a potential OA biomarker which has shown significant clinical promise as a tool for early detection, therapeutic monitoring, prognostication and drug development for OA. This brief review is pivoted around the findings of selected relevant publications from PubMed indexed journals.
  2,609 531 10
Conflict of interest in clinical research
Ravindra B Ghooi
January-March 2015, 6(1):10-14
DOI:10.4103/2229-3485.148794  PMID:25657897
Increased focus on ethical review of research demands a number of improvements in the existing system. Although these are being implemented, some factors that have received less attention in the past could be examined. One of these is conflict of interest. Such conflicts could exist for investigators, ethics committee (EC) members, and even the regulators. Guidance for identification and management of conflicts has been issued by many countries and Indian rules also speak about these conflicts. Greater clarity would help investigators and ECs manage conflicts more effectively. It is admitted that conflicts cannot be done away with, but their timely identification, disclosure, and management can reduce their impact and bring more transparency and accountability to trials in this country.
  2,487 590 4
ORIGINAL ARTICLES
Systematic literature review to evaluate and characterize the health economics and outcomes research studies in India
Divya Mishra, Sunita R Nair
January-March 2015, 6(1):20-33
DOI:10.4103/2229-3485.148802  PMID:25657899
Aim: This systematic literature review was conducted to identify, evaluate, and characterize the variety, quality, and intent of the health economics and outcomes research studies being conducted in India. Materials and Methods: Studies published in English language between 1999 and 2012 were retrieved from Embase and PubMed databases using relevant search strategies. Two researchers independently reviewed the studies as per Cochrane methodology; information on the type of research and the outcomes were extracted. Quality of reporting was assessed for model-based health economic studies using a published 100-point Quality of Health Economic Studies (QHES) instrument. Results: Of 546 studies screened, 132 were included in the review. The broad study categories were cost-effectiveness analyses [(CEA) 54 studies], cost analyses (19 studies), and burden of illness [(BOI) 18 studies]. The outcomes evaluated were direct and indirect costs, and incremental cost-effectiveness ratio (ICER), quality-adjusted life years (QALYs), and disability-adjusted life years (DALYs). Direct medical costs assessed cost of medicines, monitoring costs, consultation and hospital charges, along with direct non-medical costs (travel and food for patients and care givers). Loss of productivity and loss of income of patients and care givers were identified as the components of indirect cost. Overall, 33 studies assessed the quality of life (QoL), and the WHO Quality of Life-BREF (WHOQOL-BREF) was the most commonly used instrument. Quality assessment for modeling studies showed that most studies were of high quality [mean (range) QHES score to be 75.5 (34-93)]. Conclusions: This review identified various patterns of pharmacoeconomic studies and good-quality CEA studies. However, there is a need for better assessment of utilization of healthcare resources in India.
  2,596 460 3
Evaluation of adverse drug reactions in HIV positive patients in a tertiary care hospital
Anshu Kumar Jha, Akash Gadgade, Ashok K Shenoy, Mukta N Chowta, John T Ramapuram
January-March 2015, 6(1):34-38
DOI:10.4103/2229-3485.148808  PMID:25657900
Context: The advancement and development of new drugs and treatment strategies increase the risk of unusual Adverse Events (AEs) in HIV patients. Aims: The objective of our study was to assess the incidence, types and nature of AEs in HIV positive subjects. Settings and Design: Patients with WHO stage IV disease irrespective of the CD4 cell count, or WHO stage III disease with a CD4 cell count <350 cell/cu. Mm, or, WHO stage I or II disease with a CD4 cell count of <200 cells/cu. mm, and on prior anti-retroviral therapy for not more than six months preceding the observation date, were included in the study. After initiation of therapy, the patients were examined for the occurrence any adverse events including the type and severity, or any other abnormal laboratory findings. Causality assessment of the adverse events was done using the Naranjo's scale. Results: Out of 327 patients studied prospectively, 43 patients developed AEs. Out of these, 23 (53.5%) were males and 20 (46.5%) were females. A total of 53 (16.21%) AEs were reported. Antitubercular drugs caused the maximum AEs (28.3%) followed by zidovudine (20.7%), nevirapine (15.0%) and efavirenz (5.6%). Stavudine, ethambutol, sulfamethoxazole and trimethoprim, and atazanavir were also responsible for 3.7% of AEs individually. Causality assessment done according to the Naranjo's scale revealed that 66.04% AEs were 'probable' and 33.96% were 'possible'. Conclusions: Anemia, hepatitis and dermatological adverse effects are the most common AEs. Antitubercular drugs contributed significantly for the incidence of AEs in these patients. Frequency of AEs was slightly more in males compared to females.
  2,251 432 1
STATISTICS
Common pitfalls in statistical analysis: "No evidence of effect" versus "evidence of no effect"
Priya Ranganathan, CS Pramesh, Marc Buyse
January-March 2015, 6(1):62-63
DOI:10.4103/2229-3485.148821  PMID:25657905
This article is the first in a series exploring common pitfalls in statistical analysis in biomedical research. The power of a clinical trial is the ability to find a difference between treatments, where such a difference exists. At the end of the study, the lack of difference between treatments does not mean that the treatments can be considered equivalent. The distinction between "no evidence of effect" and "evidence of no effect" needs to be understood.
  1,857 522 2
EDITORIAL
Assessing unmet medical need in India: A regulatory riddle?
Arun Bhatt
January-March 2015, 6(1):1-3
DOI:10.4103/2229-3485.148786  PMID:25657895
  1,578 362 -
ORIGINAL ARTICLES
Assessment of drug-related problems in depressive patients
Uday Venkat Mateti, Tarachand Lalwani, Anantha Naik Nagappa, PV Bhandary, D Verupaksha, Rajesh Balkrishnan
January-March 2015, 6(1):58-61
DOI:10.4103/2229-3485.148820  PMID:25657904
Background: Drug-related problems (DRPs) frequently occur in modern medical practice, increasing the morbidity and mortality as well as increasing cost of care. Objective: The study is to evaluate the incidence of DRPs in patients admitted to a psychiatric department. Materials and Methods: A prospective observational study was conducted for a period of 4 months at Baliga psychiatric hospital. All prescriptions of the study population were screened for DRPs such as adverse drug reactions (ADRs) and potential drug-drug interactions (pDDIs) by using computerized database system. Results: Out of 120 patients, 19 patients had observed 26 DRPs. Out of 33 patients, 19 patients had observed 26 ADRs and 14 patients had observed 24 pDDIs. The overall incidence of DRPs was 15.83%. Female patients outnumbered the male patients, in which 12 women constitute 10% followed by men 7 (5.83%). The common ADRs observed were hyponatremia and headache. Considering the outcomes, 20 (76.9%) cases recovered from ADRs and 20 (76.9%) of the ADRs were definitely preventable. Majority of ADRs were probable and were found to be mild to moderately severe. Conclusions: Age, female gender and polypharmacy were the risk factors for the developing DRPs.
  1,562 364 2
LETTER TO EDITOR
Role of a medical advisor in pharmacovigilance as a business support service
Amit Dang, BN Vallish
January-March 2015, 6(1):64-67
DOI:10.4103/2229-3485.148823  PMID:25657906
  1,194 242 -
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