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   2014| October-December  | Volume 5 | Issue 4  
    Online since September 11, 2014

 
 
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CLINICAL DATA MANAGEMENT
Basics of case report form designing in clinical research
Shantala Bellary, Binny Krishnankutty, MS Latha
October-December 2014, 5(4):159-166
DOI:10.4103/2229-3485.140555  PMID:25276625
Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.
  29,967 3,831 14
EDITORIAL
Comparisons are odious
Viraj Suvarna
October-December 2014, 5(4):143-144
DOI:10.4103/2229-3485.140540  PMID:25276621
  1,758 8,888 -
ETHICS
Insurance in clinical research
Ravindra B Ghooi, Deepa Divekar
October-December 2014, 5(4):145-150
DOI:10.4103/2229-3485.140541  PMID:25276622
Aims and Objectives: Sponsors need to pay for management of all serious adverse events suffered by subjects in a clinical trial and to compensate for injuries or deaths related to the trial. This study examines if insurance policies of trials, cover all contingencies that require reimbursement or compensation. Materials and Methods: Insurance policies of trials submitted to Sahyadri Hospitals between January 2013 and December 2013 were studied, with respect to the policy period, the limit of liability, deductibles, and preconditions if any. Results: All the policies studied had some deficiencies, in one respect or the other and none had a provision to pay full compensation if required. Some insurers have put in preconditions that could jeopardize the payment of compensation to subjects. Conclusions: Insurances are complicated documents, and need to be critically examined by the ethics committee before approval of the study documents.
  2,481 2,623 1
BIOSTATISTICS
Multiple treatment and indirect treatment comparisons: An overview of network meta-analysis
Nidhi Bhatnagar, P.V.M. Lakshmi, Kathiresan Jeyashree
October-December 2014, 5(4):154-158
DOI:10.4103/2229-3485.140550  PMID:25276624
Randomized control trials and its meta-analysis has occupied the pinnacle in levels of evidence available for research. However, there were several limitations of these trials. Network meta-analysis (NMA) is a recent tool for evidence-based medicine that draws strength from direct and indirect evidence generated from randomized control trials. It facilitates comparisons across multiple treatment options, direct comparisons of which have not been attempted till date due to multitude of reasons. These indirect treatment comparisons of randomized controlled trials are based on similarity and consistency assumptions that follow Bayesian or frequentist statistics. Most NMAuntil date use Microsoft Windows WinBUGs Software for analysis which relies on Bayesian statistics. Methodology of NMA is expected to undergo further refinements and become robust with usage. Power and precision of indirect comparisons in NMA is a concern as it is dependent on effective number of trials, sample size and complete statistical information. However, NMA can synthesize results of considerable relevance to experts and policy makers.
  3,289 767 12
ORIGINAL ARTICLE
Drug utilization pattern in South Indian pediatric population: A prospective study
Nimbagiri Swamy Thiruthopu, Uday Venkat Mateti, Raju Bairi, Divya Sivva, Srinivas Martha
October-December 2014, 5(4):178-183
DOI:10.4103/2229-3485.140558  PMID:25276628
Background: Studies on the process of drug utilization focus on factors related to prescribing, dispensing, administering and taking of medication and its associated events. Aims: The aim of this study is to assess the prescribing patterns of medicines, apply the World Health Organization (WHO) core indicators and to assess the appropriateness of prescribed medicines in a pediatric unit. Materials and Methods: A prospective observational drug utilization study was carried out in a pediatric unit of a super specialty hospital in South India for a period of 9 months. Patients who attended the pediatric unit with the age newborn to 18 years were included in the study and patients who were not willing to participate in the study were excluded and the data collected from the pediatric unit were analyzed. Results: Out of 209 patients, the average number of drugs per patient was 4.56. The percentage of drugs prescribed with the generic name was found to be 19.16%. Among 209 prescriptions 49.78% of the drugs were essential drugs. Among the antibiotics 33.33% prescribed, cephalosporin group were the most commonly prescribed followed by amino glycoside and penicillin. Nearly, 21.80% of the medicines were given as intravenous and the prescriptions without drugs were 1.43%. Only 75.6% of patients have knowledge about their dosage schedule and almost all the prescriptions were appropriate. Conclusion: The assessment of WHO core indicators helped to improvise the prescribing pattern, identify significant problems involved in the knowledge gap of patients or caretakers understanding of instructions provided by consultants and even to minimize the cost burden on patient.
  3,151 662 4
RESEARCH METHODOLOGY
Contradicting/negative results in clinical research: Why (do we get these)? Why not (get these published)? Where (to publish)?
S Kannan, S Gowri
October-December 2014, 5(4):151-153
DOI:10.4103/2229-3485.140546  PMID:25276623
Obtaining negative or contradicting results, whereas conducting a study has always been overlooked as inadequacies on the part of the researcher. Many-a-times, negative results are arrived at even after conducting the study with great care and effort. This cannot be considered, a flaw, always. Contradicting results may be arrived at because of various reasons and should be considered and published in order to arrive at a definitive result. Various journals are available which publish these contradicting results exclusively. It is the duty of the researcher to know in detail the cause and effect of these, considering the pros and cons. This article gives a bird's eye view of when, where and how to manage negative or contradicting results of a study.
  2,171 1,101 1
ORIGINAL ARTICLE
Intravenous paracetamol infusion: Superior pain management and earlier discharge from hospital in patients undergoing palliative head-neck cancer surgery
Saikat Majumdar, Anjan Das, Ratul Kundu, Dipankar Mukherjee, Bimal Hazra, Tapobrata Mitra
October-December 2014, 5(4):172-177
DOI:10.4103/2229-3485.140557  PMID:25276627
Background: Paracetamol; a cyclooxygenase inhibitor; acts through the central nervous system as well as serotoninergic system as a nonopioid analgesic. A prospective, double-blinded, and randomized-controlled study was carried out to compare the efficacy of preoperative 1g intravenous (iv) paracetamol with placebo in providing postoperative analgesia in head-neck cancer surgery. Materials and Methods: From 2008 February to 2009 December, 80 patients for palliative head-neck cancer surgery were randomly divided into (F) and (P) Group receiving ivplacebo and iv paracetamol, respectively, 5 min before induction. Everybody received fentanyl before induction and IM diclofenac for pain relief at8 hourly for 24 h after surgery. Visual analogue scale (VAS) and amount of fentanyl were measured for postoperative pain assessment (24 h). Results and Statistical analysis: The mean VAS score in 1 st , 2 nd postoperative hour, and fentanyl requirement was less and the need for rescue analgesic was delayed in ivparacetamol group which were all statistically significant. Paracetamol group had a shorter surgical intensive care unit (SICU) and hospital stay which was also statistically significant. Conclusion: The study demonstrates the effectiveness of ivparacetamol as preemptive analgesic in the postoperative pain control after head-neck cancer surgery and earlier discharge from hospital.
  2,341 388 5
Utilization of potentially inappropriate medications in elderly patients in a tertiary care teaching hospital in India
Binit N Jhaveri, Tejas K Patel, Manish J Barvaliya, Chandrabhanu Tripathi
October-December 2014, 5(4):184-189
DOI:10.4103/2229-3485.140562  PMID:25276629
Aim: To evaluate the use of potentially inappropriate medicines in elderly inpatients in a tertiary care teaching hospital. Materials and Methods: Retrospective analysis was performed for cases of elderly patients admitted between January 2010 and December 2010. Data on age, gender, diagnosis, duration of hospital stay, treatment, and outcome were collected. Prescriptions were assessed for the use of potentially inappropriate medications in geriatric patients by using American Geriatric Society Beer's criteria (2012) and PRISCUS list (2010). Results: A total of 676 geriatric patients (52.12% females) were admitted in the medicine ward. The average age of geriatric patients was 72.69 years. According to Beer's criteria, at least one inappropriate medicine was prescribed in 590 (87.3%) patients. Metoclopramide (54.3%), alprazolam (9%), diazepam (8%), digoxin > 0.125 mg/day (5%), and diclofenac (3.7%) were the commonly used inappropriate medications. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) in heart and renal failure patients was the commonly identified drug-disease interaction. According to PRISCUS list, at least one inappropriate medication was prescribed in 210 (31.06%) patients. Conclusion: Use of inappropriate medicines is highly prevalent in elderly patients.
  2,281 421 9
Effect of vitamin D3 on mild to moderate persistent asthmatic patients: A randomized controlled pilot study
AD Nageswari, MG Rajanandh, R Kamala Priyanka, P Rajasekhar
October-December 2014, 5(4):167-171
DOI:10.4103/2229-3485.140556  PMID:25276626
Background: Asthma is a common chronic inflammatory disease of the bronchial airways. Well defined treatment options for asthma are very few. The role of vitamin D 3 on asthma is still baffling. Aim: We have examined the effect of vitamin D 3 supplementation in mild to moderate persistent asthma patients. Materials and Methods: We conducted an open labeled, randomized comparative trial in 48 asthma patients. The study duration was about 90 days. The study had a run-in-period of 2 weeks. At the end of run-in-period, patients were divided into two groups: Usual care group (n = 31) patients received budesonide and formoterol and intervention care group (n = 32) patients received vitamin D 3 supplementation along with their regular medicine. Results: The primary outcome of the study was to measure the improvement in forced expiratory volume in 1 second (FEV 1 ). Patients in both groups had a significant improvement in FEV 1 at the end of the study. The mean difference in percentage predicted FEV 1 in usual care and intervention care group was 4.95 and 7.07 respectively. Conclusion: The study concluded that adjunctive therapy of vitamin D 3 is effective in asthma patients. The present study will be an evidence based report; however, future studies are warranted in longer duration of time to substantiate the present findings.
  2,147 346 7
Comparative evaluation of aliskiren, ramipril, and losartan on psychomotor performance in healthy volunteers: A preliminary report
Ekta Arora, Vijay Khajuria, Vishal R Tandon, Atul Sharma, Naiyma Choudhary
October-December 2014, 5(4):190-194
DOI:10.4103/2229-3485.140564  PMID:25276630
Aim: To compare the effects of aliskiren, ramipril, and losartan on the psychomotor performance in healthy volunteers. Materials and Methods: In this preliminary, single-dose, open-label, cross-over study conducted in 12 healthy volunteers, psychomotor assessment was carried out by four tests: Simple reaction time (SRT), multiple choice reaction time test (MCRT), critical flicker fusion frequency threshold test (CFFT), and tracking performance test (TPT). Each volunteer received a single dose of each of the three test drugs with a washout period of 10 days between different test sessions and then evaluated for post-drug scores at 2-h intervals up to 12 h and then at 24 h. The changes from the baseline scores by the test drug were statistically analyzed. Results: All the three antihypertensive drugs caused significant improvement in a similar fashion on SRT, MCRT calculated as error index, CFFT, and TPT. Aliskiren caused numerically more improvement than the other two test drugs, suggesting better cognitive profile. However, inter-drug comparisons were nonsignificant. Conclusion: The results of the study highlight improvement of the cognitive functions equally by ramipril, losartan, and aliskiren. The results of the study could be of immense clinical utility in ambulatory hypertensive patients especially engaged in sensory-motor coordination tasks like driving and operating on mechanical tools.
  1,581 235 1
LETTERS TO EDITOR
The (mis)use of statistics: Which test where?
Priya Ranganathan
October-December 2014, 5(4):197-197
DOI:10.4103/2229-3485.140571  PMID:25276632
  946 324 -
REGULATORY UPDATES
Indian Regulatory Update: June-August 2014
Kedar Suvarnapathaki
October-December 2014, 5(4):195-196
DOI:10.4103/2229-3485.140568  PMID:25276631
  987 282 -
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