scholarly journals A study to assess the completeness of informed consent documents for biomedical research on human participants submitted to the institutional ethics committee of a tertiary care hospital

2019 ◽  
Vol 9 (1) ◽  
pp. 138
Author(s):  
Nishanthi Anandabaskar ◽  
Mourouguessine Vimal ◽  
Amol Rambhau Dongre ◽  
Rajendrakumar Nivaratirao Kagne
Keyword(s):  
Informed Consent ◽  
Biomedical Research ◽  
Tertiary Care ◽  
Ethics Committee ◽  
Essential Elements ◽  
Care Hospital ◽  
Ethical Guidelines ◽  
Cross Sectional ◽  
Institutional Ethics ◽  
Human Participants

Background: Informed consent is an essential pre-requisite for research on human participants. However, many studies have shown that informed consent documents (ICDs) are incomplete and lack many of the essential elements. The objective of the study was to assess the completeness of ICDs submitted to an institutional ethics committee (IEC) against the Indian Council of Medical Research (ICMR) ethical guidelines for biomedical research on human participants.Methods: This is a retrospective cross-sectional study. The ICDs submitted to the IEC during the period from January 2015 to December 2017 were reviewed for completeness, with the help of a checklist which is based ICMR ethical guidelines for biomedical research on human participants 2006.Results: A total of 212 ICDs were reviewed during the study period. More than 50% of the ICDs have clearly explained many of the essential elements like nature and purpose of the study (62.3%), voluntary participation (98.6%), procedures (68.9%), risks (71.2%), benefits (92.9%), alternative treatments (60.7%), maintaining confidentiality (99.1%), no loss of benefits on withdrawal from the study (87.8%) and contact details of principal investigator (99.5%). However, the other essential elements of the ICD are either not mentioned or not clearly explained.Conclusions: This study has shown that although majority of the ICDs submitted for review by the IEC have mentioned many of the essential elements, some of the elements like contact details of Chairman of IEC, future use of sample, compensation for trial related injury and provision of counseling for consent of genetics testing have not been stated.

scholarly journals Drug utilization of antibiotics in post-operative cesarean section inpatients in tertiary care hospital: a prospective observational study

2020 ◽  
Vol 9 (6) ◽  
pp. 859
Author(s):  
Srinivasa B. ◽  
Basavaraj C. Kotinatot
Keyword(s):  
Caesarean Section ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Tertiary Care ◽  
Essential Medicines ◽  
Care Hospital ◽  
Cross Sectional ◽  
Institutional Ethics ◽  
National Model ◽  
Rational Use Of Antibiotics

Background: The aim of this study is to evaluate the pattern and rational use of antibiotics in post-operative caesarean section (CS) inpatients in tertiary care teaching hospital, BIMS Belagavi.Methods: This cross sectional prospective observational study was conducted from December 2019 to February 2020, prior permission from institutional ethics committee was taken. Detailed data of post-operative caesarean section (CS) inpatients including age, diagnosis, line of management, complications and any adverse effects if occurred during the study was collected and entered in a specially designed proforma and MS word excel and analyzed by descriptive statistics like percentage.Results: Total 100 post-operative caesarean section inpatients were involved in the study. Most common indication for C-section was cephalopelvic disproportion. Average no of antibiotics per prescription was 3.32. Most commonly prescribed antibiotic was cefotaxime (27.71%) followed by gentamycin (25.90%) and metronidazole (24.59%). Majority (90%) of patients who admitted for ≤3 days (66%) had received combination antibiotic i.e., cefotaxime, metronidazole and gentamycin. IV fluids (21.21%) and analgesics (13.13%) were most frequently prescribed concomitant drugs. Majority (97.8%) of patients received parenteral preparation. 306 antibiotics (92.17%) used were from national model list of essential medicines (NLEM) and 332 antibiotics (100%). used were by generic name. Polypharmacy was 7.92.Conclusions: Cefotaxime was the most frequently prescribed antibiotic. Most of the antibiotics prescribed was rationally from NLEM and were by generic name.

scholarly journals Knowledge, attitude and practices about hemovigilance among practitioners: a cross-sectional study

2019 ◽  
Vol 8 (11) ◽  
pp. 2553
Author(s):  
Roshi . ◽  
Vishal R. Tandon
Keyword(s):  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Care Hospital ◽  
Blood Products ◽  
Sectional Study ◽  
Cross Sectional ◽  
Medical College ◽  
Institutional Ethics ◽  
Transfusion Reactions

Abstract: Transfusion by blood and blood products forms an important part of treatment. But this is not free from transfusion reactions which may be in the form of fever, rashes, shivering, anaphylaxis or even death. Hemovigilance is a programme of reporting such events.Materials and Methods: The present study was conducted in a tertiary care hospital of Jammu, (J& K). Permission was taken from Institutional Ethics Committee, Govt. Medical College, Jammu. A pretested questionnaire was prepared and circulated among practitioners. They were given time of 15 minutes to fill that questionnaire. After 15 minutes, the filled questionnaire were collected and were analysed. The data was presented in tabulated form.Results: Total 50 practitioners were included in the study. All the practitioners had knowledge about transfusion reactions. Only 10% of the practitioners had knowledge that transfusion reactions can be prevented, 40% of the practitioners had knowledge about hemovigilance programme and had an idea that transfusion reactions can be reported. But only 10% of the practitioners knew where to report and who can report, 6% knew how to report. Only 48% of the practitioners thought that transfusion reactions should be reported, 70% of the practitioners thought that transfusion reactions can be dangerous. 40% of practitioners told that seminars/CMEs should be planned. 80% of practitioners had encountered transfusion reactions, but only 2% had documented the same. 10% of the practitioners had attended seminars, CMEs. Many reasons were quoted for not reporting transfusion reactions.Conclusion:  Overall, most of the practitioners have a positive attitude towards transfusion reaction reporting but knowledge regarding the haemovigilance concept is poor and the majority of them never reported such reaction. Hence, our study demands increased awareness and continued training to strengthen the haemovigilance system.

scholarly journals Cases of Left Against Medical Advice from the Emergency Department of a Tertiary Care Hospital in Kathmandu: A Descriptive Cross-Sectional Study

2020 ◽  
Vol 58 (232) ◽  
Author(s):  
Manish Nath Pant ◽  
Saswat Kumar Jha ◽  
Sauravi Shrestha
Keyword(s):  
Emergency Department ◽  
Informed Consent ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Medical Advice ◽  
Care Hospital ◽  
Sectional Study ◽  
Cross Sectional ◽  
Against Medical Advice

Introduction: Left against medical advice is a worldwide phenomenon. Patients leaving against Left against medical advice do not provide the health professionals with legal impunity. A well-informed consent should be present with surety that they are well understood by the patient before they leave. The study was undertaken to study the prevalence of patients that leave against medical advice. Methods: This is a descriptive cross-sectional study done in the emergency department of a tertiary care hospital from 1st February 2020 to 31 July 2020. Ethical approval was taken from the Institutional Review Committee (ref. no. 130120205). The sample size was calculated and the convenient sampling method was used. Data were analyzed in the Statistical Package of the Social Sciences version 22. Point estimate at 95% Confidence Interval was calculated along with frequency and proportion for binary data. Results: Out of 5834 visits, 332 (5.96%) (4.70-7.22 at 95% Confidence Interval) patients left against medical advice. The mean age was 36.48 years (3 days-91 years) and males 173 (52.3%) were prone to leave than females. Only 50 (15.1%) cases had well-informed consent with complications documented. Hundred (30.5%) patients had wanted to come on follow up the next day in the out-patient department while 41 (12.4%) had to leave because of financial reasons. Only seven (2.9%) of well-oriented patients gave their consent and the remaining 233 (97.1%) were by the kin present. Only 76 (23%) patients were sent home with a well-documented medicine prescription. Conclusions: The proportion of patients who left against medical advice was more than the studies done in a similar setting.

scholarly journals A cross-sectional epidemiological study of prevalence of work stress among resident doctors of a metropolitan tertiary care hospital

2016 ◽  
Vol 4 (1) ◽  
pp. 156
Author(s):  
Swati Deshpande ◽  
Anurag Dhoundiyal ◽  
Dipika Shrestha ◽  
Praveen Davuluri
Keyword(s):  
Work Stress ◽  
Tertiary Care ◽  
Working Hours ◽  
Moderate Degree ◽  
Care Hospital ◽  
Cross Sectional ◽  
Mild Degree ◽  
Institutional Ethics ◽  
One Year ◽  
Severe Degree

Background: To assess the prevalence of work stress , to compare of the prevalance of stress among resident doctors working in clinical and non/para-clinical departments, to determine the factors leading  to stress among resident doctors.Methods: after getting approval from Institutional ethics committee all the resident doctors of the hospital were contacted during a period of data collection of one year. Data was collected using standard questionnaire. Detailed descriptive statistical analysis was done.  Results: The mean age of the participants in the study was 26.8 years with maximum age being 39 years and minimum being 24 yrs. Among 454 study subjects nearly 34.8% were female and 64.2% were male i.e. 158 & 296 respectively. Among 454 resident doctors 188 from 1st , 139 from 2nd & 127 were from 3rd year of residency with percentage contribution of 41.4, 30.6 & 28.0 respectively, 39.4% of resident doctors are suffering from some degree of stress. While 16.1% suffered from mild degree of stress 7.9% suffered from moderate degree of stress, the percent of resident doctors suffering from severe and extremely severe degree of stress was 15.2 & 0.2 respectively. The prevalence of stress among clinical is much more (29.2%) as compared to non/para-clinical (13.9%), stress was more with increasing duration of working hours.Conclusions: It was found that the prevalence of stress among resident doctors was much more as compared to general population. The prevalence was directly correlated to factors like duration of working hours, gender and department.

scholarly journals An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital

PLoS ONE ◽  
2016 ◽  
Vol 11 (1) ◽  
pp. e0146334 ◽  
Author(s):  
Sharmila V. Jalgaonkar ◽  
Shruti S. Bhide ◽  
Raakhi K. Tripathi ◽  
Yashashri C. Shetty ◽  
Padmaja A. Marathe ◽  
...  
Keyword(s):  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Ethics Committee ◽  
Care Hospital ◽  
Institutional Ethics

scholarly journals Critical appraisal of drug promotional literature using World Health Organisation guidelines

2017 ◽  
Vol 6 (8) ◽  
pp. 2014
Author(s):  
Sandhya Rani Gautam ◽  
Preeta Kaur Chugh ◽  
Ravinder Kr. Sah ◽  
C. D. Tripathi
Keyword(s):  
Tertiary Care ◽  
World Health Organisation ◽  
Cross Sectional Study ◽  
Primary Objective ◽  
World Health ◽  
Pharmaceutical Companies ◽  
Care Hospital ◽  
Who Guidelines ◽  
Ethical Guidelines ◽  
Cross Sectional

Background: Pharmaceutical marketing using drug promotional literatures is an important strategy adopted by the companies to promote their drugs. The primary objective of the present study is to compare the drug promotional literature of different pharmaceutical companies on the basis of World Health Organization (WHO) guidelines on ethical drug promotion.Methods: This observational, cross sectional study was conducted at a tertiary care hospital, Delhi. The promotional literature was evaluated in accordance with WHO guidelines, nature of claims, pictorial content presented in it and for the cited references.Results: A total of 208 promotional brochures were analysed. Only few (5.8%) of the promotional literature fulfilled all the criteria as mentioned by the guidelines. Nutritional supplements (27.9%) were the most promoted group of drugs. Pharmaceutical companies were most reluctant to provide information regarding contraindications (9.6%), adjuvants (11.5), side effects (10.6%) and drug interactions (9.6%). Generic name, brand name, dosage form, therapeutic indications were outlined in most of the brochures. Exaggerated emotional claims were made in 47.1% brochures, followed by that of efficacy in 39.4% and safety in 25% of brochures. Pictures of medicinal products outnumbered others with 39.9% followed by pictures of women, children and doctors with 20.7%, 17.3% and 13.5% respectively.Conclusions: Majority of the drug promotional literature did not comply with the ethical guidelines and was inadequate in terms of their adequacy, quality and reliability. Hence, it can be concluded that the majority of the promotional advertisements that are given to the prescribers are not able to spread awareness towards rational prescribing. 

scholarly journals Gynecological profile of patients undergoing laparoscopy/laparotomy in a tertiary care hospital

2017 ◽  
Vol 6 (6) ◽  
pp. 2475
Author(s):  
Sitalakshmi V. ◽  
Alpana Bansal
Keyword(s):  
Clinical Diagnosis ◽  
Ovarian Cyst ◽  
Elective Surgery ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Care Hospital ◽  
Cross Sectional ◽  
Medical College ◽  
Institutional Ethics ◽  
Abdominal Emergencies

Background: Laparoscopy is not only used in the elective surgery but also used in the emergency surgery. It is also found to be useful in the acute abdominal emergencies. It is useful in removing any diagnostic doubts. It is also useful in the treatment of diseases. The objective of the study was to study the gynecologic profile of patients undergoing laparoscopy/laparotomy in gynecology department of a tertiary care hospitalMethods: A hospital based cross sectional study was carried out at department of Obstetrics and Gynecology of S. V. Medical College, Tirupati from September 2014 to February 2015, for a period of six months. A total of 36 patients were evaluated for gynecological problems during the study period based on the inclusion and exclusion criteria. They were evaluated for menstrual complaints, chief presenting complaints, clinical diagnosis, scan diagnosis and laparotomy evaluation. Institutional Ethics Committee permission was taken before the start of the study. Informed consent was taken from all patients after explaining them about the nature of the study.Results: Ovarian cyst was the most common presentation which constituted more than half of the patients (55.6%). All patients i.e. 36 (100%) had menorrhagia as the complaint of menstrual irregularity. Out of 9 cases, clinical diagnosis differed in all cases, thus giving zero percent of accuracy for clinical diagnosis. Scan diagnosis matched with laparotomy confirmation in only 3 (33.3%) of cases. One case which was labeled as normal was found to have bilateral functional ovarian cyst on laparotomy confirmation. One case which was labeled as left ovarian cyst was found to have no cyst on laparotomy confirmation.Conclusions: Thus, laparoscopy is a useful tool for diagnosis and therapeutic accuracy in gynecological disease in routine as well as in emergencies. It is safe, effective, less time consuming, economical and patient friendly.

scholarly journals Knowledge of body mass index and its correlates among the patient at a tertiary care hospital

2020 ◽  
Vol 8 (11) ◽  
pp. 3924
Author(s):  
Mahendra Lodha ◽  
Mayank Badkur ◽  
Ashok Puranik ◽  
Ramkaran Chaudhary ◽  
Mahaveer S. Rodha ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Body Mass ◽  
Tertiary Care ◽  
Care Hospital ◽  
Primary Control ◽  
Cross Sectional ◽  
Prospective Survey ◽  
Institutional Ethics ◽  
Study Population ◽  
And Control

Background: In spite of the numerous chronic diseases that have been linked to obesity, studies focusing on awareness regarding Body mass index (BMI) and its correlates to prevent and control obesity are lacking in the literature, especially in developing countries such as India, where obesity is culturally accepted and nurtured in the society.Methods: A cross-sectional prospective survey was done between November 2018 and November 2019 in a tertiary care research institute after approval from institutional ethics committee. A pre-designed questionnaire was used to collect data in excel sheet (Microsoft Corp, Redmond, WA) and analysed using SPSS.Results: total 264 (80.3% urban and 19.7% rural background) patients with mean age of 42 years with different educational level participated in the study. 1.1% patients were underweight, 2.7% mean BMI of studied population was 34.76. BMI distribution curve was bilaterally symmetrical. No one in the study population was well aware of about the BMI and related comorbidities. 98.5% patients confirmed that their doctor had never discussed their BMI with them.Conclusion: There is a significant gap of knowledge among patients regarding obesity and BMI, and physicians also have to take initiatives to discuss about this for primary control of the disease (obesity) and related comorbidities.

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