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Perspectives in Clinical Research

Beuy Joob, Viroj Wiwanitkit
No abstract text is available yet for this article.
July 2018: Perspectives in Clinical Research
Amita Bhave
No abstract text is available yet for this article.
July 2018: Perspectives in Clinical Research
Rakesh Aggarwal, Priya Ranganathan
In the previous two articles in this series on biostatistics, we examined the properties of diagnostic tests and various measures of their performance in clinical practice. These performance measures vary according to the cutoff used to distinguish the diseased and the healthy. We conclude the series on diagnostic tests by looking at receiver operating characteristic curves, a technique to assess the performance of a test across several different cutoffs, and discuss how to determine an optimum cutoff.
July 2018: Perspectives in Clinical Research
Rania Indu, Anjan Adhikari, Indira Maisnam, Piyali Basak, Tapas Kumar Sur, Anup Kumar Das
Purpose/Aim: Diabetes mellitus is associated with several comorbid conditions. Thus, often, diabetic patients are prescribed multiple drugs. Although multiple drugs help to combat various diseases, they also increase the propensity of drug interactions and adverse drug reactions. The present study thus tried to evaluate the comorbid conditions and concurrent medications associated with type 2 diabetic patients. It also aimed to address patient compliance for the medications provided to them...
July 2018: Perspectives in Clinical Research
S Shanmugapriya, T Saravanan, S Saranya Rajee, R Venkatrajan, Pinky Mariam Thomas
Purpose: Drug use prescribing indicators advocated by the World Health Organization (WHO) are important tools for assessing the degree of polypharmacy, use of generic medicines, and to evaluate if there is inappropriate use of antibiotics or parenteral medications besides estimating the adherence to the essential drugs list. This study aimed to assess the WHO prescribing indicators in prescriptions given at the medical outpatient department (OPD) in a private medical college hospital in South India...
July 2018: Perspectives in Clinical Research
Natasha Das, Saurendra Das
Aim: The number of scientific papers published from India each year is low. We tried to determine how often Indian surgeons publish in biomedical journals, challenges preventing them from publishing more often, their awareness of the international guidelines that acknowledge professional medical writing as an ethical service, and their willingness to hire medical writers for their publications. Materials and Methods: A convenience sample of 100 of the surgeons attending a national conference were explained about the survey and asked to complete a survey questionnaire...
July 2018: Perspectives in Clinical Research
Manali Mangesh Mahajan, Urmila Mukund Thatte, Nithya Jaideep Gogtay, Siddharth Deshpande
Purpose/Aim: The Adverse Drug Reaction [ADR] form is the source document for the Pharmacovigilance Programme of India [PvPI] and captures information first hand from the patient. The raw data from it then gets converted into an individual case safety report [ICSR] after entry into Vigiflow. The National Coordinating Centre [NCC] uses an instrument to assess quality of these ICSRs. We carried out the present study to assess whether the same instrument with minor modifications could be used to check the quality of ADR forms at our centre...
July 2018: Perspectives in Clinical Research
Viswanathan Mohan
This article describes a 40 year journey in diabetes research of an Indian diabetologist, starting as an undergraduate medical student. The article describes how collaborations with multiple stake-holders is necessary if one is to advance one's research from the simple studies that one starts with and take it to higher and higher levels. It is also essential that the seeds for doing research are planted early in a medico's life even during undergraduate days, as only then will more doctors take up medical research as a career...
July 2018: Perspectives in Clinical Research
Suhasini Sharma
No abstract text is available yet for this article.
July 2018: Perspectives in Clinical Research
Chetna Desai
No abstract text is available yet for this article.
April 2018: Perspectives in Clinical Research
Saurav Basu
No abstract text is available yet for this article.
April 2018: Perspectives in Clinical Research
Indu Nambiar
One of the reasons that a research molecule undergoes through different phases of clinical trials is to establish the safety and efficacy of the drug. To establish the safety profile of any drug, the most important aspect is to evaluate every adverse event (AE) that a clinical trial individual experiences. This detail is provided by any investigator or sponsor through the narratives that is prepared post the analysis of a serious AE. The purpose of this article is to emphasize the importance of these narratives...
April 2018: Perspectives in Clinical Research
Priya Ranganathan, Rakesh Aggarwal
Diagnostic tests are used to identify subjects with and without disease. In a previous article in this series, we examined some attributes of diagnostic tests - sensitivity, specificity, and predictive values. In this second article, we look at likelihood ratios, which are useful for the interpretation of diagnostic test results in everyday clinical practice.
April 2018: Perspectives in Clinical Research
Renju Ravi, Debdipta Bose, Nithya J Gogtay, Urmila M Thatte
Monitoring and audits are two distinct processes that ensure that the rights and safety of the participants are protected, and data integrity is maintained. The present narrative summates authors' experiences with monitoring and audits by sponsor along with challenges faced by the site. It also offers potential solutions for challenges faced during the process of monitoring and audits. It is important to remember that no monitoring or audit can ever substitute for a well-designed and articulated protocol. In addition, a determined approach by the investigator and his/her team to ensure that all aspects of the protocol are adhered to in totality will go a long way in assuring quality...
April 2018: Perspectives in Clinical Research
Sanish Davis
Continuing review of studies approved by the Ethics Committees (ECs) involves review of the progress of the study, annual reports, protocol deviations/violations, serious adverse event monitoring, and on-site monitoring. International and national regulations and guidelines for continuing review state that it is an opportunity for the EC to be assured that risks to subjects are minimized and is are reasonable in relation to anticipated benefits if any to the subjects and the knowledge it will generate. There are several barriers (e...
April 2018: Perspectives in Clinical Research
Manisha Shrivastava, Nehal Shah, Seema Navaid
Aim: In an era of evidence based medicine research is an essential part of medical profession whether clinical or academic. A research methodology workshop intends to help participants, those who are newer to research field or those who are already doing empirical research. The present study was conducted to assess the changes in knowledge of the participants of a research methodology workshop through a structured questionnaire. Methods: With administrative and ethical approval, a four day research methodology workshop was planned...
April 2018: Perspectives in Clinical Research
Jaya Prasad Tripathy, Pankaj Bahuguna, Shankar Prinja
Background: Poor prescription practices result in increased side effects, adverse drug reactions, and high cost of treatment. The present study was undertaken to describe the drug-prescribing patterns in two North Indian states through prescription auditing. Materials and Methods: The study was carried out in 80 public health facilities across 12 districts in two states of Haryana and Punjab (6 in each) covering all levels of care. The information from prescription slips was abstracted on a structured pro forma for all patients who visited the pharmacy of the health facility...
April 2018: Perspectives in Clinical Research
Saloni Amin, Samidh Shah, Mira Desai, Asha Shah, K M Maheriya
Objectives: To analyze clinical spectrum, seriousness, outcome, causality, severity and preventability of ADRs in geriatrics and pediatric patients. Materials and Methods: All ADRs reported in geriatrics (≥ 65 years) and pediatrics (≤ 12 years) indoor as well outdoor patients from January, 2010 to April, 2016 at ADR monitoring centre, Department of Pharmacology, B. J. Medical College and Civil Hospital were identified. A retrospective analysis was carried out for clinical presentation, causality (as per WHO-UMC scale and Naranjo's algorithm), severity (Hatwig and Seigel scale) and preventability (Schaumock and Thornton criteria)...
April 2018: Perspectives in Clinical Research
Padmaja A Marathe, Raakhi K Tripathi, Yashashri C Shetty, Sunil S Kuyare, Sandhya K Kamat, Urmila M Thatte
Objective: In view of dearth of information in national and international guidelines on payment practices in research, the present study was done to find out payments for participation allowed by 3 Ethics committees (ECs) and reasons for payment. Method: This was a retrospective observational study which analysed research proposals reviewed by 2 institutional and 1 non-institutional ECs over a period of 2 years. The permission of ECs was obtained and confidentiality of data was maintained...
April 2018: Perspectives in Clinical Research
Viraj Ramesh Suvarna
Real world evidence is important as it complements data from randomised controlled trials (RCTs). Both have limitations in design, interpretation, and extrapolatability. It is imperative one designs real world studies in the right way, else it can be misleading. An RCT is always considered higher in the evidence ladder and when there is discordance between a real world study and an RCT, it is the latter which is always considered pristine because of the way it is conducted, e.g., randomization, prospective, double-blind, etc...
April 2018: Perspectives in Clinical Research
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