Read by QxMD icon Read

Participant information consent document

Jorie M Colbert-Getz, Katie Lappe, Michael Northrup, Danielle Roussel
Phenomenon: There is an abundance of literature on Entrustable Professional Activities (EPAs) in theory, but there are few studies on the EPAs in practice for undergraduate clinical education. In addition, little is known about the degree to which the EPAs are or are not aligned with physician assessors' performance schemas of the clerkship student. Investigating the degree to which physician assessors' performance schemas are already aligned with the activities described by the EPAs is critical for effective workplace assessment design...
March 15, 2019: Teaching and Learning in Medicine
P E Ekmekci, M D Guner
Medical sciences and medical technologies are developing in an enormous pace. The number of multi-site and multi- cultural clinical trials is increasing in line with this development. Yet, the increase in number brought about a problem, namely that of inconsistencies in institutional review board (IRB) decisions. The efforts to develop a comprehensive and systematic framework for the decision-making procedure of IRB members were ineffective and ended up in form of lists containing general principles of research ethics...
2019: Bratislavské Lekárske Listy
Mutsa Bwakura-Dangarembizi, Beatrice Amadi, Claire D Bourke, Ruairi C Robertson, Benjamin Mwapenya, Kanta Chandwe, Chanda Kapoma, Kapula Chifunda, Florence Majo, Deophine Ngosa, Pamela Chakara, Nivea Chulu, Faithfull Masimba, Idah Mapurisa, Ellen Besa, Kuda Mutasa, Simutanyi Mwakamui, Thompson Runodamoto, Jean H Humphrey, Robert Ntozini, Jonathan C K Wells, Amee R Manges, Jonathan R Swann, A Sarah Walker, Kusum J Nathoo, Paul Kelly, Andrew J Prendergast
INTRODUCTION: Mortality among children hospitalised for complicated severe acute malnutrition (SAM) remains high despite the implementation of WHO guidelines, particularly in settings of high HIV prevalence. Children continue to be at high risk of morbidity, mortality and relapse after discharge from hospital although long-term outcomes are not well documented. Better understanding the pathogenesis of SAM and the factors associated with poor outcomes may inform new therapeutic interventions...
February 1, 2019: BMJ Open
Ciléin Kearns
The author noted surgeons frequently drawing in routine practice. Literature review revealed no prior study of this activity. This research was conducted to examine the prevalence, purpose, and perceived value of this practice. Surgeons' experiences and opinions regarding drawing in surgical practice were canvassed via an online survey. One-hundred surgeons participated. 92% valued drawing routinely in practice. Utility was reported across domains of consent, communication, patient care, medico-legal, education, and planning operations...
February 18, 2019: Journal of Visual Communication in Medicine
Praise O Iyiewuare, Ian D Coulter, Margaret D Whitley, Patricia M Herman
OBJECTIVE: This paper describes a process for ensuring and documenting Health Insurance Portability and Accountability Act (HIPAA) compliance in clinical practice-based research. METHODS: The Center of Excellence for Research in Complementary and Alternative Medicine was funded by National Center for Complementary and Integrative Health to develop the methods for researching the appropriateness of care in complementary and integrative health, which previously was known as complementary and alternative medicine...
February 10, 2019: Journal of Manipulative and Physiological Therapeutics
Sabrina Cerqueira-Santos, Kérilin S S Rocha, Thays C Boaventura, Elisdete M S Jesus, Carina C Silvestre, Bárbara M C Sodré- Alves, Divaldo P de Lyra
WHAT IS KNOWN AND OBJECTIVE: Qualified dispensing is fundamental for the promotion of the rational use of medicines. Documentation is an indicator of quality and one of the essential steps in the care process. However, in Brazil, there are no models of clinical documentation applicable to dispensing practices. Thus, the objective of this study was to develop and validate an instrument to document the dispensing process of prescribed medicines. METHODS: A methodological development study was carried out from February 2017 to October 2017 in two stages, which were (i) the development of the instrument and (ii) content validation of the proposed instrument...
January 30, 2019: Journal of Clinical Pharmacy and Therapeutics
Megan Scott, Jennifer Watermeyer, Samantha Nolle, Claire Penn
Enrollers play a critical yet often overlooked role in clinical research, particularly in informed consent processes. Study retention may depend in part on how complex information is conveyed to potential participants. This qualitative study aimed to assess communicative barriers during consent and enrolment in two South African TB/HIV clinical studies. In particular, we compared our own perceptions of potential challenges to consent with that of thirteen enrollers, gained via reflective journaling and focus group discussions...
January 29, 2019: Developing World Bioethics
Tapasvi Puwar, Sandul Yasobant, Deepak Saxena
Background: Mental health issues becoming the global public health challenge, especially among the youth (12-24 years of age), although they are often detected later in life. In India, the adolescent population constitutes a quarter of the country's population and burden of disease varies from 9.5 to 102/1000 population. Most of the mental health disorders remain unidentified due to negligence and ignorance of multiple factors. Keeping this in mind and lack of population-based studies with good quality for guiding the mental health policies, this study aims to document the prevalence of emotional and behavioral difficulties among adolescents in Sabarkantha district of Gujarat, India...
December 2018: Indian Journal of Community Medicine
Mila Petrova, Stephen Barclay
BACKGROUND: The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change...
January 25, 2019: BMC Medical Ethics
Shih-Han S Huang, Jennifer MacRae, Dana Ross, Rameez Imtiaz, Brittany Hollingsworth, Gihad E Nesrallah, Michael A Copland, Philip A McFarlane, Christopher T Chan, Deborah Zimmerman
BACKGROUND AND OBJECTIVES: Canadian home hemodialysis guidelines highlight the potential differences in complications associated with arteriovenous fistula (AVF) cannulation technique as a research priority. Our primary objective was to determine the feasibility of randomizing patients with ESKD training for home hemodialysis to buttonhole versus stepladder cannulation of the AVF. Secondary objectives included training time, pain with needling, complications, and cost by cannulation technique...
March 7, 2019: Clinical Journal of the American Society of Nephrology: CJASN
Jacques Demotes-Mainard, Catherine Cornu, Aurélie Guérin
Clinical research on human subjects or their data is confronted with conflicting requirements with, on one hand, the principle of open science (transparency and data sharing), the possibilities offered by big data and the reuse of healthcare or research data, and on the other, changes to the regulatory and legislative framework, including the general data protection regulation (GDPR). A roundtable was organized in Giens, France in October 2018 to identify problem areas, the need for clarification and streamlining, and to make recommendations to promote clinical research while ensuring a high level of patient protection...
December 20, 2018: Thérapie
Katie Propst, David M O'Sullivan, Amanda Ulrich, Elena Tunitsky-Bitton
OBJECTIVE: The practice of obstetrics and gynecology poses specific ethical challenges for informed consent (IC). Data regarding resident confidence with the IC process are lacking. Our objective was to evaluate obstetrics and gynecology residents' education, experience, and confidence related to IC. DESIGN: This was a cross-sectional survey of obstetrics and gynecology residents. Descriptive analyses were performed using mean and standard deviation or frequency expressed as a percentage...
January 2, 2019: Journal of Surgical Education
Dmitriy Vazenmiller, Olga Ponamaryova, Larisa Muravlyova, Vilen Molotov-Luchanskiy, Dmitriy Klyuyev, Riszhan Bakirova, Zhanna Amirbekova
AIM: The purpose of the present research was to study the content of erythropoietin and hepcidin in serum in pregnant women with iron deficiency anaemia and anaemia of chronic inflammation. METHODS: The authors examined 98 pregnant women who were observed in LLP (Regional obstetric-gynaecological centre) in Karaganda. The including criteria for pregnant women in the study was the informed consent of the woman to participate in the study. Exclusion criteria were oncological diseases, HIV-infection, tuberculosis, severe somatic pathology, mental illness, drug addiction...
November 25, 2018: Open Access Macedonian Journal of Medical Sciences
Susan Pockett
This paper argues that the prevailing official narrative in New Zealand concerning the relationship between public health and the radio frequency emissions (RF) from cellphone technology, WiFi and electricity smart meters is scientifically and ethically flawed. The main regulatory document in the area, NZS2772.1:1999, is 20 years out of date and ignores existing laboratory evidence disproving its core assumption that the only biological effect of non-ionising radiation is tissue heating. This and further laboratory evidence for harmful effects of RF continues to be ignored, nominally on the contradictory grounds that (a) cellphone manufacturers say their products now emit less RF than early models, so early lab studies exposed tissue to RF levels higher than those now relevant (b) given the lack of actual data on population exposures either then or now, all laboratory evidence is unconvincing anyway...
December 14, 2018: New Zealand Medical Journal
Noor Al Mortadi, Omar F Khabour, Karem H Alzoubi
Background: Research that involves dental pulp stem cells (DPSCs) is growing rapidly. DPSCs can be used for the treatment of craniofacial bone abnormalities and tooth repair. The procedure requires a donation of sound teeth, which might be associated with ethical and moral issues. The purpose of this study was to understand the attitudes and awareness of patients with respect to the donation of their teeth to research. Patients and methods: This study involved 500 patients recruited from Dental Care and Dental Teaching Center in Irbid during May 2017-July 2017...
2018: Clinical, Cosmetic and Investigational Dentistry
Miguel Ángel Celis, José Halabe, Oscar Arrieta, Rubén Burgos, Carlos Campillo, Manuel De la Llata, Judith Domínguez, Sergio Islas, Luis Jasso-Gutiérrez, Alberto Lifshitz, Mucio Moreno, Ricardo Plancarte-Sánchez, Alejandro Reyes-Sánchez, Guillermo Ruiz-Argüelles, Antonio Soda, Emma Verástegui, Julio Sotelo
Informed consent is an indispensable element to obtain adequate patient participation either in research protocols or in therapeutic design. The Committee of Ethics and Transparency in the Physician-Industry Relationship (CETREMI) of the National Academy of Medicine developed several recommendations for informed consent to be documented.
2018: Gaceta Médica de México
Chi-Yin Kao, Sanchia Aranda, Mei Krishnasamy, Bridget Hamilton
PURPOSES: This research set out to contribute to ongoing efforts to improve the quality of informed consent information provided to patients by specifically focusing on establishing consensus with regard to essential information to enhance the informed consent process. DESIGN AND METHODS: A Delphi consensus method was used to conduct three rounds of online surveys. Five groups of experts directly or indirectly involved in the informed consent process were invited to participate: patients, family members/friends, physicians, other health professionals and other key informants, including ethicists, contract research staff and pharmaceutical company staff...
November 2018: European Journal of Cancer Care
Zainab Taha, Malin Garemo, Joy Nanda
Background: Despite the ongoing efforts to improve infant feeding practices, low rates of breastfeeding and early introduction of complementary feeding have been reported in many countries. Systematic documentation of breastfeeding practices in the United Arab Emirates (UAE) is needed in order to directing successful strategies. The aim of this study was to evaluate breastfeeding practices among mothers in Abu Dhabi, UAE, using the World Health Organization (WHO) infant and young child feeding indicators...
2018: International Breastfeeding Journal
Lois Shepherd, Ruth Macklin
This paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental misunderstanding of applicable government regulations and even the research enterprise...
January 2019: Bioethics
Annette Burns, James V Lucey, Judith Strawbridge, Luke Clancy, Frank Doyle
OBJECTIVE: People with mental health difficulties (MHD) are more likely to smoke and to have smoking-related diseases, yet little research has investigated the provision of smoking cessation care in psychiatric inpatient settings. This study aimed to evaluate current levels of cessation care provided, and 3-month quit-rates, in one such setting in Ireland. METHODS: From January to October 2016, inpatients across all 8 adult wards of St Patrick's University Hospital were recruited to participate in a baseline face-to-face survey (N = 246), assessing demographic information, smoking history and quit attempts, motivation to quit, nicotine dependence, attitudes towards cessation advice and actual care received...
December 2018: Journal of Psychosomatic Research
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"