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   2015| July-September  | Volume 6 | Issue 3  
    Online since July 6, 2015

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Common pitfalls in statistical analysis: Clinical versus statistical significance
Priya Ranganathan, CS Pramesh, Marc Buyse
July-September 2015, 6(3):169-170
DOI:10.4103/2229-3485.159943  PMID:26229754
In clinical research, study results, which are statistically significant are often interpreted as being clinically important. While statistical significance indicates the reliability of the study results, clinical significance reflects its impact on clinical practice. The third article in this series exploring pitfalls in statistical analysis clarifies the importance of differentiating between statistical significance and clinical significance.
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Patient centric approach for clinical trials: Current trend and new opportunities
Neha Shankar Sharma
July-September 2015, 6(3):134-138
DOI:10.4103/2229-3485.159936  PMID:26229748
The clinical research industry today is undergoing a major facelift. Companies are continuously looking to adopt and implement effective and innovative ways to accelerate drug launches in the market. Companies today are more open and do not view patients as mere "subjects" who generate data, - but as informed collaborators whose participation is "core" to the overall success of trials leading to the emergence of the concept of "patient-centric trials." This paper is intended to highlight the current trends and new opportunities that can be seen in industry -indicative of crucial role patients today play in their own health care using technology, social media and self education.
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Cost-effectiveness analysis of three different combinations of inhalers for severe and very severe chronic obstructive pulmonary disease patients at a tertiary care teaching hospital of South India
Mohammed Altaf, Ayesha Mubeen Zubedi, Fareesa Nazneen, Shaik Kareemulla, Syed Amir Ali, NM Aleemuddin, Md. Abdul Hannan Hazari
July-September 2015, 6(3):150-158
DOI:10.4103/2229-3485.159940  PMID:26229751
Background: This study aims at simplifying the practical patient management and offers some general indications for pharmacotherapeutic choice by the implementation of (Global Initiative for Chronic Lung Disease) guidelines. This study was designed to evaluate the clinical and economic consequences of salmeterol/fluticasone (SF), formoterol/budesonide (FB), and formoterol/fluticasone (FF) in severe and very severe chronic obstructive pulmonary disease (COPD) patients. Objectives: The aim was to find out the most cost-effective drug combination between the three combinations (SF/FB/FF) in COPD patients. Materials and Methods: A prospective observational comparative study (cost-effectiveness analysis), in which 90 severe (30 ≤ forced expiratory volume in 1 s [FEV 1 ] <50% predicted) and very severe (FEV 1 <<sub> 30% predicted) COPD patients (outpatients/inpatients) who are prescribed with any one of the following combinations (SF/FB/FF) were selected. In our study, we have divided 90 COPD patients into three groups (Group I, Group II, and Group III) each group consisting of 30 patients. Group I was prescribed with medication SF, Group II with medication FB, and Group III with medication FF. We used five different parameters such as spirometry test (mean FEV 1 initial and final visit), number of symptom-free days (SFDs), number of moderate and severe exacerbations, Number of days of hospitalization and direct, indirect, and total cost to assess the cost-effectiveness of SF/FB/FF. Comparison of cost and effects was done during the period of 6 months of using SF/FB/FF. Results: The average FEV 1 for Group I, Group II, and Group III subjects at initial visit was 33.47%, 33.73%, and 33.20% and was increased to 36.60%, 35.8%, and 33.4%, respectively. A 3% increment in FEV 1 was reported for Group I subjects (SF) and was highly significant statistically (t = −8.833, P = 0.000) at 95% CI. For Group II subjects (FB), a 2% increment in FEV 1 was reported and was highly significant statistically (t = −9.001, P = 0.000) at 95% CI. For Group III (FF) subjects 0.2% increment in FEV 1 . The overall mean total cost for Group I, Group II, and Group III subjects during the 6 months period was found to be Rs. 29,725/-, Rs. 32,602/- and Rs. 37,155/-. Incremental cost-effectiveness of FB versus SF was Rs. 37,781/- per avoided exacerbation and Rs. 661/- per SFD. Conclusion: This study highlights the favorable therapeutic performance of combined inhaled bronchodilators and corticosteroids (SF/FB/FF), thus suggesting that healthcare costs would be also affected positively. Results from our study showed that SF and FB were the most effective strategies in the treatment of COPD, with a slight clinical superiority of SF. The FF strategy was not much effective (i.e. associated with fewer outcomes and higher costs).
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Consent for audio-video recording of informed consent process in rural South India
Ramesh Chand Chauhan, Anil J Purty, Neelima Singh
July-September 2015, 6(3):159-162
DOI:10.4103/2229-3485.159941  PMID:26229752
Introduction and Objectives: In recent times, audio-video (A-V) recording of consent process for all the study subjects entering a clinical trial has been made mandatory. A-V recording of informed consent process is a big challenge due to confidentiality and the sociocultural environment in India. It is important to find out the acceptability for A-V recording of the consent process and reasons for refusal, if any to address this new challenge. Materials and Methods: A descriptive survey was done among 150 residents of a rural community of South India. Acceptability for A-V recording of consent process was assessed among those who had given the informed written consent for participation in the study. An attempt to find the factors determining the refusal was also made. Results: More than one-third (34%) of the study subjects refused to give consent for A-V recording of consent process. Not interested in recording or don't like to be recorded (39%) were the most common reasons to refuse for A-V recording of consent process. The refusal was higher among female and younger age-group adult subjects. Socioeconomic status was not found to be significantly associated with refusal to consent for A-V recording. Conclusion: Refusal for A-V recording of consent process is high in the South Indian rural population. Before any major clinical trial, particularly a field trial, an assessment of consent for A-V recording would be helpful in recruitment of study subjects.
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Regulating off-label drug use in India: The arena for concern
Sukhvinder Singh Oberoi
July-September 2015, 6(3):129-133
DOI:10.4103/2229-3485.159935  PMID:26229747
Off-label use of drugs is relatively common in medical practice, even if it's often not supported by strong scientific evidence. Off-label use of medicine not only involves physicians and pharmaceutical companies, but regulatory agencies and patients as well. Therapeutic options might get restricted without off-label prescribing in some patient population. Off-label uses can be useful to patients with an orphan disease where sometimes it can be the only available treatment. Permitting the promotion of drugs for off-label uses may be appropriate in instances in which a drug can improve the quality (e.g., same or better outcomes at lower cost). Although many controversies exist, experts generally agree that further efforts are needed to increase access to suitable off-label drugs for patients with rare and other diseases. However, they also concur that potential inappropriate promotion, as well as possibly dangerous prescribing practices for these drugs, should be prevented. Proponents argue that the key benefit of allowing manufacturers to distribute off-label information is that it allows more data to be readily available to physicians, enabling them to make better treatment decisions.
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A study of knowledge, attitudes, and practice of dental doctors about adverse drug reaction reporting in a teaching hospital in India
Sarfaraz Alam Khan, Chhaya Goyal, SD Tonpay
July-September 2015, 6(3):144-149
DOI:10.4103/2229-3485.159938  PMID:26229750
Objective: The aim was to investigate the knowledge, attitudes, and practice of dental doctors about adverse drug reaction (ADR) reporting. Materials and Methods: In a cross-sectional study, questionnaire was administered to 95 dental doctors working in a teaching dental hospital attached to a medical college with an ADR monitoring center (AMC). Statistical Analysis Used: Descriptive statistics were used to analyze responses. The association of knowledge and attitude with respect to position of dentists was analyzed with Chi-square test. Results: The response rate and spontaneous reporting rate was found to be 61.0% and 13.7%, respectively. Important factors contributing to under reporting of ADRs include lack of awareness about AMC in the institute (81.0%) and pharmacovigilance program (72.4%), complacency (67.2%), lack of training to identify ADRs (65.5%), fear factor (63.7%), lethargy (58.6%), lack of risk perception of over the counter product related ADR (39.6%), inadequate risk perception of nonallopathic and herbal medicines (31%), indifference (27.5%) and concern that report may be wrong (27.5%). No significant difference in knowledge and attitudes of doctors with respect to position was found except for reporting of ADRs of newly marketed drugs and serious reactions to established product (P < 0.05). Conclusion: The deficiencies in knowledge and attitudes appear to be the underlying factor for under reporting by dental practitioners. It should be addressed urgently in order to increase spontaneous reporting by them.
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Reporting of pre-enrolment screening with randomized clinical trials: A small item that could impact a big difference
Tiffany M Harris-Brown, David L Paterson
July-September 2015, 6(3):139-143
DOI:10.4103/2229-3485.159937  PMID:26229749
Introduction: Randomized controlled trials (RCTs), when conducted using ethical and transparent methods, become the ultimate standard for producing evidence-based knowledge in the field of medical research. We sought to determine the proportion of RCTs in which the number of screened patients is reported, and also to ascertain what predicted efficient screening (i.e., a high number of screened participants being enrolled). Materials and Methods: Thirty-five RCTs from the Journals Clinical Infectious Diseases and The Lancet Infectious Diseases were reviewed from the time period of January 2012 to July 2013 using standardised criteria. Results: From the 35 RCTs, 9 of 35 (26%) did not report the number of patients screened prior to recruitment. From the 26 studies that reported this screening figure, 10,215 (47%; range: 2-98%) of the screened participants (21,862) were subsequently enrolled. About 18.3% of those screened and not enrolled, met inclusion and exclusion criteria yet did not wish to participate in an RCT. Studies performed in developed countries and pediatric populations were more likely to have low rates of enrolment compared with the screened population although there was no statistical significance to these associations (P = 0.2 for both variables). Conclusion: Many reports of RCTs do not report screening figures, even though these add useful information about the feasibility of future trials.
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Accreditation - A solution for problems or a fresh problem?
Ravindra B Ghooi
July-September 2015, 6(3):123-124
DOI:10.4103/2229-3485.159932  PMID:26229745
  - 1,558 338
Good pharmacovigilance practice: Need of the hour from pharmaceutical companies
Neha Bhati, Sridharan Kannan, Prem P Khosla
July-September 2015, 6(3):171-172
DOI:10.4103/2229-3485.159944  PMID:26229755
  - 1,422 228
Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label study
Shallini Gupta, Vijay Khajuria, Vishal R Tandon, Annil Mahajan, Zahid H Gillani
July-September 2015, 6(3):163-168
DOI:10.4103/2229-3485.159942  PMID:26229753
Aim and Objective: The aim was to evaluate and compare the efficacy and safety of combinations of metformin-vidagliptin (MF-VG) and metfromin-glimepiride (MF-GP) in type 2 diabetes mellitus (T2DM) patients. Materials and Methods: A comparative randomized open-label trial was conducted on patients with uncomplicated T2DM, on treatment with MF for 4 months out of which on maximum tolerated dose of MF (1000-2500 mg/day) for 4 weeks, glycosylated Haemoglobin [HbA1c]) ≥6.5%, fasting blood glucose (FBG) ≥126 mg/dl and post prandial glucose (PPG) ≥200 mg/dl were included in the study. Patients were randomized to receive MF (500 mg BD) + VG (50 mg BD) or MF (500 mg BD) + GP (2 mg BD). Results: Both the groups caused significant decline in blood glucose levels both FBG as well as PPG levels (P < 0.01). HbA1c was also reduced significantly in both groups at 12 weeks (P < 0.01). Total serum cholesterol, triglycerides, low-density lipoprotein and very low-density lipoprotein decreased significantly, whereas high-density lipoprotein levels increased significantly from baseline levels in both the groups (P < 0.01). Intergroup comparison failed to demonstrate any statistical difference on all of above parameters. Both weight and body mass index did not alter statistically from baseline in either of the groups as well as demonstrated no difference statistically on comparison (P > 0.05). At the end of the study, both liver functions tests and renal functions tests remained unaltered statistically and within normal clinical range in both the groups (P > 0.05). However, hypoglycemia and other adverse events were numerically more in MF + GP group. Conclusion: Both the regimens on comparison revealed similar efficacy and safety thereby failing to prove superiority over each other.
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Medical writing on an accelerated path in India
Sarika Shirke
July-September 2015, 6(3):125-128
DOI:10.4103/2229-3485.159934  PMID:26229746
The medical writing industry is on an upwards growth path in India. This is probably driven by an increasing urgency to have high-quality documents authored to support timely drug approvals, complemented by the realization that the competencies required are available in emerging geographies such as India. This article reviews the business landscape and the opportunities and challenges associated with outsourcing medical writing work India. It also analyzes the core competencies that a medical writer should possess and enlists various associations supporting learning in this domain.
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