Quality of informed consent in cancer clinical trials in India: A cross-sectional survey.

Background: Novel corona virus disease 2019 (COVID-19) pandemic has impacted health care sector adversely and its major impact is seen especially in the field of oncology. One of the areas of cancer care that has been affected is the conduct of clinical trials. Various challenges have emerged in front of the investigators in providing proper treatment and care to the research participants and moreover in safeguarding the rights, safety and well-being of the research participants.Methods: A questionnaire survey was conducted among the oncologists from the major specialties (medical, surgical and radiation) during the lockdown period to assess the challenges faced in conduct of clinical trials during this pandemic.Results: A total of 110 questionnaires were circulated. Of the 110 questionnaires distributed at the Tata Memorial Centre, 50 responded. The overall response rate was 45.45% (50 responses). Majority of investigators (96%) reported that the pandemic affected the initiation of new trials in oncology. 86% investigators reported that COVID-19 situation has resulted in more protocol deviations than usual for ongoing trials also 62% investigators expressed that the quality of the trial data may get affected due to pandemic.Conclusion: Our survey reports that the majority of the researchers are encountering major challenges in conducting clinical trials in an oncology setting during this pandemic. Despite these challenges in trial conduct, efforts are being made by the investigators and their team to adapt to the new methods for effective management of patients in clinical trials.

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Risk Minimization Measures in Off-Label Drug Use: A Survey of Community Pharmacists in Malaysia

Current Drug Safety ◽

10.2174/1573403x16666200615144946 ◽

2020 ◽

Vol 15 (3) ◽

pp. 181-189

Author(s):

Omotayo Fatokun

Keyword(s):

Informed Consent ◽

Drug Use ◽

Perceived Risk ◽

Adverse Drug Events ◽

Community Pharmacists ◽

Risk Minimization ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Off Label ◽

Written Informed Consent

Background: While off-label drug use is common and sometimes necessary, it also presents considerable risks. Therefore, measures intended to prevent or reduce the potential exposure to off-label risks have been recommended. However, little is known about community pharmacists’ beliefs regarding these measures in Malaysia. Objectives: This study examined community pharmacists’ beliefs towards risk minimization measures in off-label drug use in Malaysia and assessed the relationship between perceived risk of off-label drug use and beliefs towards risk minimization measures. Methods: A cross-sectional survey was conducted among 154 pharmacists practicing in randomly selected community pharmacies in Kuala Lumpur and the State of Selangor, Malaysia. Results: The majority agreed or strongly agreed that adverse drug events from the off-label drug should be reported to the regulatory authority (90.9%) and the off-label drug should only be used when the benefit outweighs potential risks (88.3%). Less than half (48.1%) agreed or strongly agreed that written informed consent should be obtained before dispensing off-label drugs and a majority (63.7%) agreed or strongly agreed that the informed consent process will be burdensome to healthcare professionals. Beliefs towards risk minimization measures were significantly associated with perceived risk of off-label drug use regarding efficacy (p = 0. 033), safety (p = 0.001), adverse drug rection (p = 0.001) and medication errors (p = 0.002). Conclusion: The community pharmacists have positive beliefs towards most of the risk minimization measures. However, beliefs towards written informed consent requirements are not encouraging. Enhancing risk perception may help influence positive beliefs towards risk minimization measures.

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Adherence to dietary guidelines is associated with better physical and mental quality of life: results from a cross-sectional survey among 728 Dutch MS patients

Nutritional Neuroscience ◽

10.1080/1028415x.2021.1885240 ◽

2021 ◽

pp. 1-8

Author(s):

I. Evers ◽

M. Heerings ◽

N.M. de Roos ◽

P.J. Jongen ◽

L.H. Visser

Keyword(s):

Quality Of Life ◽

Dietary Guidelines ◽

Cross Sectional Survey ◽

Cross Sectional

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Health-related quality of life in Chinese population with non-alcoholic fatty liver disease: a national multicenter survey

Health and Quality of Life Outcomes ◽

10.1186/s12955-021-01778-w ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Rui Huang ◽

Jian-Gao Fan ◽

Jun-Ping Shi ◽

Yi-Min Mao ◽

Bing-Yuan Wang ◽

...

Keyword(s):

Risk Factors ◽

Liver Disease ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Alcoholic Fatty Liver ◽

Related Quality ◽

Health Related ◽

Independent Risk Factors ◽

Alcoholic Fatty Liver Disease

Abstract Background Health Related Quality of Life (HRQL) is a multi-dimensional construct that can comprehensively evaluate the patient’s health status, including physical, emotional, mental and social well-being. In this study, we aimed to evaluate the impact of non-alcoholic fatty liver disease (NAFLD) on HRQL in a Chinese population. Methods In this national multicenter cross-sectional survey, patients with NAFLD were enrolled. Chronic Liver Disease Questionnaire (CLDQ)-NAFLD was used to qualify HRQL. Univariate and multivariate analysis were used to identify independent risk factors of HRQL. Results A total of 5181 patients with NAFLD from 90 centers were enrolled in this study (mean age, 43.8 ± 13.3 years; male, 65.8%). The overall CLDQ score was 5.66 ± 0.89. Multivariate logistic regression analysis showed that body mass index (BMI: HR, 1.642; 95% CI, 1.330–2.026), alanine transaminase (ALT: HR, 1.006; 95% CI, 1.001–1.011), triglyceride (HR, 1.184; 95% CI, 1.074–1.305), disease severity (HR, 3.203; 95% CI, 1.418–7.232) and cardiovascular disease (HR, 4.305; 95% CI, 2.074–8.939) were independent risk factors for overall CLDQ score. In the logistic analyses of individual domain, BMI and triglyceride were independent risk factors of all domains. ALT, disease severity, diabetes, depression and cardiovascular disease were influencing factors for the CLDQ score of several domains. Conclusions This national multicenter cross-sectional survey in China indicated that the HRQL in patients with NAFLD was impaired. HRQL was found to be significantly associated with sociodemographic and clinical factors. Attention should be paid to the optimally managing care of patients with NAFLD to improve their HRQL.

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Survival after acute episodes of immune-mediated thrombotic thrombocytopenic purpura (iTTP) – cognitive functioning and health-related quality of life impact: a descriptive cross-sectional survey of adults living with iTTP in the United Kingdom

Hematology ◽

10.1080/16078454.2021.1945236 ◽

2021 ◽

Vol 26 (1) ◽

pp. 465-472

Author(s):

Steve Holmes ◽

Lauren Podger ◽

Catherine Bottomley ◽

Ewelina Rzepa ◽

Karen M. A. Bailey ◽

...

Keyword(s):

Health Related Quality ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Thrombocytopenic Purpura ◽

The United Kingdom ◽

Immune Mediated ◽

Life Impact ◽

Related Quality ◽

Health Related

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REXIC project: retrospective cross-sectional study of documentation of informed consent for research biobanking in a public research and teaching hospital

Journal of Public Health Research ◽

10.4081/jphr.2013.e10 ◽

2013 ◽

Vol 2 (1) ◽

pp. 10 ◽

Cited By ~ 1

Author(s):

Marta Nobile ◽

Elena Garavelli ◽

Barbara Gagliardi ◽

Silvia Giovanelli ◽

Paolo Rebulla ◽

...

Keyword(s):

Informed Consent ◽

Standard Model ◽

Cross Sectional Study ◽

Essential Elements ◽

Cross Sectional ◽

Research And Teaching ◽

Single Standard ◽

Set Up ◽

Design And Methods

Background. The Center for Transfusion Medicine, Cell Therapy and Cryobiology, Milan, Northern Italy, is the headquarter of the POLI-MI biobank. It co-ordinates the biobank activities of the Fondazione Ca’ Granda Ospedale Maggiore Policlinico of Milan. Such activities require specific safeguarding of donors’ rights and protection of sensitive and genetic data. The Fondazione Ca’ Granda Ospedale Maggiore Policlinico has set up a project on informed consent with the aim of developing awareness and understanding of this issue. Within this project, it has been decided to evaluate how consent for biobanking material is expressed. Design and methods. The aim of the study was to evaluate the quality and completeness of consent to biobanking in the POLI-MI biobank. This was a retrospective study carried out in 2012 on samples of consent declarations collected by biobank units in 2011. Some units used a single, standard consent model available from a previous POLI-MI biobank workgroup. Other units used models which had been previouly formulated. Evaluation was made using a form that indicated the essential elements of consent. Results. A total of 48 consent declarations were collected using the single, standard model and 84 were collected using other models. The consent declarations that used the single, standard model were found to be the most complete and were filled in better than other models. Conclusions. Progressive adoption of a simple, standard consent model is expected to improve the quality of consent acquisition. Regular audit of the compliance of consent practices with ethical and legal requirements is mandatory to improve the quality of research biobanking.

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