The CONSORT statement and its impact on quality of reporting of trials Priya Ranganathan Perspectives in Clinical Research 2019 10(4):145-147

The National Guidelines for Stem Cell Research (2017): What academicians need to know? Sandeep Lahiry, Shouvik Choudhury, Rajasree Sinha, Suparna Chatterjee Perspectives in Clinical Research 2019 10(4):148-154 India recently updated its guidelines on stem cell research (SCR), the National Guidelines for Stem Cell Research 2017. It was drafted under a collaborative effort from the Indian Council of Medical Research and Department of Biotechnology. The new guidelines are a part of a continuous endeavor to tackle scientific, technical, as well as perceived challenges in the field of SCR. It seeks to facilitate safe, ethical, and regulated translational and clinical SCR by engaging all stakeholders proactively.

Biovigilance: A global perspective Sukhjinder Singh, Shammy Chandel, Phulen Sarma, Dibbanti Harikrishna Reddy, Abhishek Mishra, Subodh Kumar, Prasad Thota, Kotni Murali, Ajay Prakash, Bikash Medhi Perspectives in Clinical Research 2019 10(4):155-162 A biological is a substance which either comprises, contains, or is derived from human cells or human tissues. The use of biological products is associated with the risk of infection transmission, allergic reactions, and other adverse events (AEs). The science and activities relating to the detection, assessment, understanding, and prevention of AEs or any other problems related to biological products (blood, cells, tissues, organs, and vaccine in international perspective) are termed as biovigilance. With more and more biologicals being marketed and the rapid revolutionary changes in transplant-related services, the importance of biovigilance is increasing day by day. Although specific types of vigilance systems (pharmacovigilance and materiovigilance) exist, activities related to “biovigilance” are still in an infancy stage. Many developed countries such as the USA, Europe, and Australia have implemented nationwide biovigilance programs. In India, the National Institute of Biologicals, in collaboration with the Indian Pharmacopoeia Commission, has launched the Biovigilance Programme of India. In this article, the biovigilance systems of different countries across the globe have been reviewed along with highlights of the current biovigilance needs.

A study on usefulness of modified medication adherence scale in assessing adherence among hypertensive patients Sethu Prabhu Shankar, I S. S Suman Babu, Neelakandan Ramya Perspectives in Clinical Research 2019 10(4):163-167 Background: Adherence to medication is important for control of blood pressure (BP) and prevention of its complications. Identifying factors which improve adherence to treatment helps in improving cardiovascular outcome. Aim: The aim is to study the adherence of hypertensive patients to medication using modified medication adherence scale (MMAS). Materials and Methods: This study was done as a cross-sectional study in the Department of General medicine in Aarupadai Veedu Medical College and Hospital, Puducherry, from May 2017 to October 2017. All adult patients of both sexes diagnosed to have hypertension were included in the study after obtaining informed consent. Adherence to hypertension was assessed using MMAS and results were analyzed. SPSS 22 software (International Business Machines Corporation, Released 2013. IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY) was used for statistical purposes. Results: A total of 150 patients were included in the study. There were 83 males and 67 females in the study. Good adherence was observed in 74 (49%) out of the total 150. Forty-nine (59%) males and 25 (37%) females were found adherent to treatment. Patients with monotherapy had a good adherence compared to those with polytherapy. Patients with good adherence had a good control of BP. Conclusion: MMAS is a simple and useful tool for assessing medication adherence among hypertensive patients.

Evaluation of reporting of CONSORT flow diagrams in randomized controlled trials in a national and international pharmacology journal Asif Moeed Shaikh, Manthan M Mehta, Vihang V Chawan Perspectives in Clinical Research 2019 10(4):168-171 Objective: To evaluate and compare the reporting of consolidated standard of reporting trial (CONSORT) flow diagrams in randomized controlled trials (RCTs) published in a national and international pharmacology journal. Methods: RCTs in an international pharmacology journal, European Journal of Clinical Pharmacology (EJCP), and a national journal, Indian Journal of Pharmacology (IJP), published from January 2014 to July 2016 were evaluated for reporting and completeness of CONSORT flow diagrams. A total of 138 articles (EJCP = 90; IJP = 48) were analyzed and compared. Results: Of 138 RCTs analyzed, 90 were from EJCP and 48 were from IJP. 76.6% (69/90) articles from EJCP and 37.5% (18/48) articles from IJP had reported the CONSORT flow diagram. Of these, 95.5% (66/69) had assessed for eligibility in EJCP and 88.8% (16/18) had reported the same in IJP. The number of participants excluded was reported in 86.9% (60/69) flow diagrams in EJCP and 83.3% (15/18) in IJP. 82.6% (57/69) flow diagrams in EJCP and 77.7% (14/18) in IJP had mentioned the details of randomization. Allocation of intervention was reported in 91.3% (63/69) flow diagrams in EJCP and 88.8% (16/18) in IJP. 60.8% (42/69) flow diagrams in EJCP and 44.4% (08/18) in IJP had mentioned the details of follow-up of participants. 95.5% (66/69) flow diagrams in EJCP and 94.4% (17/18) in IJP had mentioned details about analysis. Conclusion: In spite of both the journals, IJP and EJCP endorsing the CONSORT statement, a significant difference in the reporting of CONSORT flow diagrams in RCTs can be noted. The quality of reporting can be improved by stringent publication guidelines by the editors.

Appropriateness and pharmacoeconomics of surgical antimicrobial prophylaxis in open reduction internal fixation surgery practiced in a tertiary hospital compared to recommendations in the national center for disease control guidelines Priyanka Kumari, Jayaram B Siddegowda, Vasundara Krishnaiah Perspectives in Clinical Research 2019 10(4):172-176 Context: Surgical site infections are frequently observed despite the availability of national guideline on surgical antimicrobial prophylaxis (SAP). These infections increase patient morbidity, mortality, and direct and indirect health-care costs. Open reduction internal fixation (ORIF) is a common orthopedic surgery for fracture. There is a paucity of Indian data on SAP in ORIF surgery. Aims: The present study was taken up aiming at the evaluation of appropriateness and pharmacoeconomics of SAP in ORIF based on the national guidelines. Subjects and Methods: One-year observational prospective cohort study was conducted among 412 participants, who underwent ORIF in the Department of Orthopedics in a Tertiary Care Hospital. Name, dose, route, timing, frequency, and duration of administration of prophylactic antimicrobials used were recorded. Statistical Analysis Used: Descriptive statistics were used wherever required. Results: The mean age of participants was 39.24 years, majority (60.92%) were male, and 49.52% had fracture of lower-limb bones. The appropriateness of preoperative SAP in terms of indication in ORIF, timing, and route of administration was 100%. Selection and dose of preoperative and postoperative antimicrobials were appropriate in only 13% of cases. Omission of intraoperative dose was appropriate in all participants. Duration of postoperative Antimicrobial agent administration was inappropriately long in all participants. None of the cases received completely appropriate regimen. Cost analysis showed the mean cost of SAP practiced in our hospital was eleven times higher than that with recommended SAP. Conclusions: Considering the inappropriateness of SAP practiced, monitoring of guideline implementation and awareness among health-care professionals are necessary to prevent SSI and to decrease economic burden on the patients.

Conventional antidiabetic agents and bone health: A pilot case–control study Jeffrey Pradeep Raj, Shreeraam Venkatachalam, Mahesh Shekoba, Joshua Jonathan Norris, Rajkumar S Amaravati Perspectives in Clinical Research 2019 10(4):177-182 Background and Objectives: The burden of noncommunicable diseases such as diabetes (type 2 diabetes mellitus [T2DM]) and osteoporosis is increasing with increasing longevity. Uncontrolled T2DM is an independent risk factor for osteoporosis explained by the insulin osteocalcin pathway. Due to limited information on the effect of various commonly used antidiabetic agents (ADA) on bone health, our study aims to analyze the association between the two. Methodology: This is a case–control study, with 100 cases of clinical osteoporosis and 100 age-, sex-, and dietary status-matched controls in whom osteoporosis was ruled out by dual-energy X-ray absorptiometry scan. Prescription details of T2DM, physical activity levels, and disease status were collected using a pretested questionnaire. Exposure to each ADA was compared using the Chi-squared test. Binary logistic regression was performed to adjust the two main confounders, namely glycemic control and physical activity levels, and adjusted risk estimates were calculated. Results: There were a total of 74 T2DM patients, of whom 45 (60.8%) were cases and 29 (39.2%) were controls. Sulfonylureas (adjusted odds ratio [aOR] = 0.164, P = 0.004) and insulin (aOR = 0.248, P = 0.042) showed a significant protective effect on bone health. Biguanides (OR = 1.994, P = 0.029) and thiazolidinediones (OR: 5.444, P = 0.033), which demonstrated that an increased risk of osteoporosis in univariate analysis became insignificant after multivariate analysis. Conclusion: Sulfonylureas and insulin through the insulin osteocalcin pathway show favorable effect on bone health, but the probability of increased fractures secondary to hypoglycemic falls should be borne in mind. We recommend larger prospective studies to confirm this association.

Study designs: Part 5 – interventional studies (II) Rakesh Aggarwal, Priya Ranganathan Perspectives in Clinical Research 2019 10(4):183-186 In the fifth piece of this series on research study designs, we continue the discussion on interventional studies (clinical trials), in which the investigator decides whether or not a particular participant receives the exposure (or intervention). In this article, we take a closer look at several features which are important to ensure that the findings of such a study represent the real effect of an intervention, such as allocation concealment, blinding, compliance to intervention, the use of co-interventions and participant dropout rate.