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   Table of Contents - Current issue
January-March 2023
Volume 14 | Issue 1
Page Nos. 1-46

Online since Friday, January 6, 2023

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Declaration of Helsinki: Can it still serve as a North star for ethics in regulatory trials? p. 1
Sanish Davis
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Strategies for participant retention in long term clinical trials: A participant –centric approaches p. 3
Subramani Poongothai, Ranjit Mohan Anjana, Ramasamy Aarthy, Ranjit Unnikrishnan, KM Venkat Narayan, Mohammed K Ali, Kulasegaran Karkuzhali, Viswanathan Mohan
A clinical trial is the most foolproof method to evaluate the efficacy of a new intervention. Successful completion of clinical trials depends on the retention of the participants enrolled. Poor participant retention can lead to significant time and cost burden and have potentially adverse biases on the results. A high retention rate of participants is an important criterion for the validity and credibility of randomized controlled clinical trials. Many long-term trials fail due to low retention of study participants. Efforts at participant retention should start even before the first participant is recruited into the study. Retention is not only the responsibility of the investigators but also all other stakeholders in a clinical trial. In recent years, retention materials, participant camps, and introduction of national study coordinators have helped in improving retention. Quality of the relationship developed between the research staff and the study participant is a key factor for success of any trial. In our experience, in the context of resource-challenged low- and middle-income countries, we have found that it is possible to achieve high retention rates, 95%–100%. The rapport built between the investigating team and the participant plays a vital role in retention. In addition, personalized care, including listening to the participant's problems and enabling to contact investigators or study team at any time of the day, has shown benefits in retention.
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Impact of medical conditions and medications received during pregnancy on adverse birth outcomes: A hospital-based prospective case–control study p. 10
Krishna Undela, Parthasarathi Gurumurthy, MS Sujatha
Purpose: In view of the raising rate of adverse birth outcomes (ABOs) across the globe, this study was conducted to assess the impact of medical conditions and medications received during pregnancy on ABOs. Materials and Methods: A prospective case–control study was conducted at the Department of Obstetrics and Gynecology of a tertiary care hospital over a period of 3 years from July 2015 to June 2018. Liveborn and stillborn neonates included in the study were categorized into cases and controls based on the presence or absence of composite ABOs, respectively. Binary logistic regression analysis was used to identify the risk factors for ABOs among medical conditions and medications received by mothers during their current pregnancy. Results: Among 1214 neonates included in the study, 556 (45.8%) were identified with composite ABOs, the majority were low birth weight (320 [26.4%]) and preterm birth 300 (24.7%). After adjusting for confounding factors, it was identified that hypertension (adjusted odds ratio [aOR] 7.3), oligohydramnios (aOR 3.9), anemia (aOR 3.2), nifedipine (aOR 10.0), nicardipine (aOR 5.3), and magnesium sulfate (aOR 5.3) were the risk factors for overall and specific ABOs like preterm birth and low birth weight. It was also identified that the early detection and management of hypertension with antihypertensives like labetalol and methyldopa can reduce the risk of preterm birth by 93% and 88%, respectively. Conclusion: Medical conditions such as hypertension, oligohydramnios, and anemia and medications such as nifedipine, nicardipine, and magnesium sulfate during pregnancy were identified as the risk factors for overall and specific ABOs like preterm birth and low birth weight.
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Assessment of risk of bias in randomized controlled trials published in Indian journals pertaining to pharmacology p. 16
Saurabh R Patil, Shruti Shripad Bhide
Context: Number of trials in India shows an increasing trend. As these trials will shape clinical practice, their quality is of utmost importance. Among many tools to assess the quality of randomized control trials (RCTs), risk of bias (RoB) is most robust. Aims: To understand the quality of trials being carried out in India in terms of RoB. Settings and Design: We aimed to assess the RoB in a set of RCTs published in Indian pharmacology of randomized trials from journals pertaining to pharmacology. Subjects and Methods: We used published journal articles as source of information for randomized clinical trials and evaluated them using Cochrane RoB tool 2.0. Statistical Analysis Used: Descriptive statistics were used. Results: 158 trials published in seven journals were evaluated in six different domains. Overall evaluation for 97% (153) trials was “high risk,” while 3% (5) were in “some concerns” category, with no trials categorized as “low risk. 74% articles showed a high risk of bias in the domain of 'selection of reported results. Nearly half articles scored “low risk” in domains of “missing data” and “deviations in assignment to intervention.” The study results showed a slowly increasing trend of average RoB over the last 10 years. Conclusions: The study shows concerning rise in RoB in various domains RCTs published in Pharmacology journals in India.
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Evaluation of medical adherence, adverse drug reactions, and quality of life in post tubercular obstructive airway disease Highly accessed article p. 20
Vinita Awasthi, Sarvesh Singh, Narendra Kumar, Manoj Kumar, Amod Kumar Sachan, Rajiv Garg, Rahul Kumar
Background: Increasing incidence of tuberculosis is intensifying the posttubercular obstructive airway disease (PTOAD) in developing countries. Currently, there are no standard treatment guidelines for the management of PTOAD patients. The present study aims to evaluate the prescribing pattern, adherence, adverse drug reactions (ADRs), and quality of life (QoL) in PTOAD patients. Materials and Methods: A prospective observational study was conducted to evaluate the prescriptions of PTOAD patients, estimating the medical adherence using Morisky 8-Item Medication Adherence Questionnaire, assessing ADRs using Hartwig's Severity Assessment Scale and assessing QoL using St. George's respiratory Questionnaire. Chi-square test, analysis of variance, paired t-test were used to compare the data. The significance of change in adherence status was assessed by Wilcoxon signed-rank test. Results: A total of 94 prescriptions of PTOAD were analyzed. Inhaled long-acting muscarinic antagonist was prescribed to 31.9% of patients. The most common inhaled fixed dose combination was long-acting beta-2 agonist with corticosteroid, prescribed to 52.1% of patients. At final follow-up, maximum percentage of patients were found to be highly adherent, i.e. 56.4%. Overall, 34% of patients have complained about mild category of ADRs. A significant improvement in QoL was observed. At baseline, mean forced expiratory volume in 1 (FEV1) was 64.66% ±23.61%, which increased significantly to 73.34% ±21.60% on final follow-up (P < 0.001). Conclusion: Bronchodilators are the mainstay of treatment of PTOAD patients, since both the QoL and FEV1 were improved with treatments. However, to have good treatment outcome, strict adherence along with safety of the medications must be assured.
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Dabigatran: Clinical correlation of drug and its dose with risk of stroke and bleeding p. 26
Anitta Shaji, Doody Thomas, Midhuna Saju, Suja Abraham, Ramdas Nayak
Background: Dabigatran is the first oral direct thrombin inhibitor which is endorsed by Food and Drug Administration in the prevention of embolic events in patients with nonvalvular atrial fibrillation. Suitable dose of the drug for the patient is selected based on CHA2DS2-VASc score and HAS-BLED score. Aim: To determine and compare the risk of occurrence of stroke and bleeding after the initiation of dabigatran therapy in patients prescribed with this drug. Methods: Patients with more than 18 years who were prescribed with dabigatran during 2017-2019 in a tertiary care hospital were selected for the study. Most of the patient's prescriptions contained an antiplatelet, so a comparison was made between the clinical outcomes of patients given with dabigatran alone and dabigatran with an antiplatelet because antiplatelet can have effects on the safety as well as efficacy profile of dabigatran. Results: Out of 75 patients enrolled in the study, 42 patients were in the dabigatran with the antiplatelet group and 33 were in the dabigatran alone group. In both the groups, there was a significant reduction in CHA2DS2-VASc score, i.e., 2.58 ± 1.32–1.94 ± 1.21 in dabigatran-treated patients within 6 months, and the score was lowered from 3.76 ± 1.22 to 2.92 ± 1.22 in other groups. The mean value of the HAS-BLED score of dabigatran was reduced from 1.15 ± 0.83 to 0.84 ± 0.78 and that of dabigatran with antiplatelet group from 2.10 ± 0.94 to 1.74 ± 0.92. Conclusion: It was observed that within 6 months, both the treatment groups showed a reduction in the risk scores. The dabigatran group had lower background risks of stroke and bleeding in comparison to the dabigatran plus antiplatelet group.
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Impact of educational interventions on pharmacovigilance and adverse drug reaction reporting by resident doctors and faculty members: A prospective comparative study p. 32
Mahesh N Belhekar, Shakeeb S Dhorajiwala, B Krishnamurthy
Purpose/Aim: Adverse drug reactions (ADRs) are significantly under-reported worldwide. The aim of this study was to assess the impact of educational interventions (EIs) on knowledge, attitude, and practice (KAP) of hospital resident doctors and faculty members and compare ADR reporting in EI (medical specialties) vs. non-EI (surgical specialties) in these two cadres of doctors. Materials and Methods: This study was a prospective comparative study conducted in two groups (EI and non-EI) in resident doctors and faculty members working at a tertiary care hospital. EI group (medical specialties) were provided with EI to increase awareness about ADR reporting, whereas in non-EI group (surgical specialties), no EI was provided and they served as control. Respondents were asked to fill a pretest questionnaire followed by interactive EI in EI group and posttest questionnaire in both groups. The impact of EI among respondents was evaluated by their response to questionnaire and number of ADRs reported after intervention. Results: Total (n = 202) respondents were enrolled in the study. The number of resident doctors and faculty members in each group were (n = 101 [50%]). Overall, (n = 100 [49.5%]) were from the medical and (n = 102 [50.5%]) from surgical specialty. Post-EI period, there was statistically significant improvement in KAP domains. Conclusion: Our study serves as credible evidence that through EI; statistically significant improvement in KAP of resident doctors and faculty members in both medical and surgical specialties toward ADR reporting and existing pharmacovigilance system can be achieved.
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Introduction to qualitative research methods – Part I p. 39
Shagufta Bhangu, Fabien Provost, Carlo Caduff
Qualitative research methods are widely used in the social sciences and the humanities, but they can also complement quantitative approaches used in clinical research. In this article, we discuss the key features and contributions of qualitative research methods.
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Experience of the selected Ethics Committee of Pune city regarding the review of COVID-19 protocols during the pandemic p. 43
Sonopant G Joshi, Abhijeet Ashok Safai, Samir Sumant Barve
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Profile of clinical trials registered as a medical postgraduate research thesis, 2007 to 2019: Lessons for capacity building p. 45
Janana Priya Gunasekaran, Raginee Dongre, Sri Madhupriya Mahendiran, Mohan Kumar Raju, Manickam Ponnaiah
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