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Participant information consent document

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 The main regulatory document in the area, NZS2772.1:1999, is 20 years out of date and ignores existing laboratory evidence disproving its core assumption that the only biological effect of non-ionising radiation is tissue heating.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...
November 26, 2018: 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
Erika S Squires, Lori A Pakulski, Jennifer Glassman, Emily Diehm
BACKGROUND: Albeit limited, research suggests that students pursuing careers in health care receive limited training on the provision of services for people with hearing loss. As the incidence of hearing loss continues to increase among Americans, it is critical that medical professionals understand how hearing loss among patients may affect the manner in which they can provide services most effectively. PURPOSE: The aim of this project is to assess the amount of experience and confidence that preprofessional health-care students at one university obtain during the course of their training and whether these students would be interested in additional information related to hearing health...
September 24, 2018: Journal of the American Academy of Audiology
Tyler M Bauer, Adam P Johnson, Katerina Dukleska, Johanna Beck, Myles S Dworkin, Kamini Patel, Scott W Cowan, Geno J Merli
Hospital-acquired venous thromboembolism (VTE) affects morbidity and mortality and increases health care costs. Poor adherence to recommended prophylaxis may be a potential cause of ongoing events. This study aims to identify institutional adherence rates and barriers to optimal VTE prophylaxis. The authors performed patient and nurse interviews and a concurrent review of clinical documentation, utilizing a cloud-based, HIPAA-compliant tool, on a convenience sample of hospitalized patients. Adherence and agreement between different assessment modalities were calculated...
October 26, 2018: American Journal of Medical Quality: the Official Journal of the American College of Medical Quality
Michael P Diamond, Esther Eisenberg, Hao Huang, Christos Coutifaris, Richard S Legro, Karl R Hansen, Anne Z Steiner, Marcelle Cedars, Kurt Barnhart, Tracy Ziolek, Tracey R Thomas, Kate Maurer, Stephen A Krawetz, Robert A Wild, J C Trussell, Nanette Santoro, Heping Zhang
BACKGROUND/AIMS: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. METHODS: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites...
October 24, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Mieke Deschodt, Bastiaan Van Grootven, Anthony Jeuris, Els Devriendt, Bernadette Dierckx de Casterlé, Christophe Dubois, Katleen Fagard, Marie-Christine Herregods, Miek Hornikx, Bart Meuris, Steffen Rex, Jos Tournoy, Koen Milisen, Johan Flamaing
INTRODUCTION: Although the majority of older patients admitted to a cardiology unit present with at least one geriatric syndrome, guidelines on managing heart disease often do not consider the complex needs of frail older patients. Geriatric co-management has demonstrated potential to improve functional status, and reduce complications and length of stay, but evidence on the effectiveness in cardiology patients is lacking. This study aims to determine if geriatric co-management is superior to usual care in preventing functional decline, complications, mortality, readmission rates, reducing length of stay and improving quality of life in older patients admitted for acute heart disease or for transcatheter aortic valve implantation, and to identify determinants of success for geriatric co-management in this population...
October 21, 2018: BMJ Open
Jennifer M Shield, Thérèse M Kearns, Joanne Garŋgulkpuy, Lisa Walpulay, Roslyn Gundjirryirr, Leanne Bundhala, Veronica Djarpanbuluwuy, Ross M Andrews, Jenni Judd
BACKGROUND: Education for health literacy of Australian Aboriginal people living remotely is challenging as their languages and worldviews are quite different from English language and Western worldviews. Becoming health literate depends on receiving comprehensible information in a culturally acceptable manner. METHODS: The study objective was to facilitate oral health literacy through community education about scabies and strongyloidiasis, including their transmission and control, preceding an ivermectin mass drug administration (MDA) for these diseases...
January 29, 2018: Tropical Medicine and Infectious Disease
Freddie C Hamdy, Daisy Elliott, Steffi le Conte, Lucy C Davies, Richéal M Burns, Claire Thomson, Richard Gray, Jane Wolstenholme, Jenny L Donovan, Ray Fitzpatrick, Clare Verrill, Fergus Gleeson, Surjeet Singh, Derek Rosario, James Wf Catto, Simon Brewster, Tim Dudderidge, Richard Hindley, Amr Emara, Prasanna Sooriakumaran, Hashim U Ahmed, Tom A Leslie
BACKGROUND: Prostate cancer (PCa) is the most common cancer in men in the UK. Patients with intermediate-risk, clinically localised disease are offered radical treatments such as surgery or radiotherapy, which can result in severe side effects. A number of alternative partial ablation (PA) technologies that may reduce treatment burden are available; however the comparative effectiveness of these techniques has never been evaluated in a randomised controlled trial (RCT). OBJECTIVES: To assess the feasibility of a RCT of PA using high-intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) for intermediate-risk PCa and to test and optimise methods of data capture...
September 2018: Health Technology Assessment: HTA
Sebastian Blecha, Susanne Brandstetter, Frank Dodoo-Schittko, Magdalena Brandl, Bernhard M Graf, Thomas Bein, Christian Apfelbacher
OBJECTIVES: The DACAPO study as a multicentre nationwide observational healthcare research study investigates the influence of quality of care on the quality of life in patients with acute respiratory distress syndrome. The aim of this study was to investigate the acceptability to the participating research personnels by assessing attitudes, experiences and workload associated with the conduct of the DACAPO study. DESIGN, SETTING AND PARTICIPANTS: A prospective anonymous online survey was sent via email account to 169 participants in 65 study centres...
September 24, 2018: BMJ Open
Estela Arcos, Antonia Vollrath, Ximena Sánchez, Christine Bailey
BACKGROUND: The adverse impact of poverty and migration in pregnant women is expressed in diverse results in reproductive, mental and child health, all of which are related to lack of documentation to reside in the country, absence of health insurance and no economic resources to pay private services, or either not understanding the administrative procedures. OBJECTIVE: To understand the experience of immigrant women in the process of motherhood and rearing infants under 6 months, in the context of social vulnerability in an urban area of Santiago de Chile...
August 23, 2018: Midwifery
R G Tairova, E A Berseneva
The sociological survey of physicians and patients was carried out in the state and private sector of medical care services with the purpose of comparison of various defects of paper work and quality of provided medical services. The material of study consisted of the results of survey in state and private medical institutions of Moscow. The quality of medical paper work, satisfaction of patients with received discharge epicrisis, quality of paper work for expertise of medical commission, rate of detection of defects and breaches in medical paper work were evaluated...
March 2018: Problemy Sot︠s︡ialʹnoĭ Gigieny, Zdravookhranenii︠a︡ i Istorii Medit︠s︡iny
Allyson D Gabbard, Leslie K Patatanian
OBJECTIVES: The purpose of this study was to evaluate the efficacy of education modules in preparing staff before the implementation of a pediatric delirium screening protocol. METHODS: After consenting participants began phase 1 of the study, which covered general information on pediatric delirium. It comprised a 21-question assessment administered as a pretest followed by an education module and then the same 21-question assessment administered as a posttest. After completing phase 1, participants proceeded to phase 2, which focused on use of the Cornell Assessment of Pediatric Delirium (CAPD) tool...
July 2018: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
Fleur O'Hare, Zachary Flanagan, Mark Nelson, Andrea Curtis, Stephane Heritier, Simone Spark, Sophia Zoungas
Background Adapting the informed consent process to the needs of older adults may enhance engagement and willingness to participate in a clinical trial. A key aspect of the process is being provided with written clinical trial information and consent documents and having an opportunity to discuss the information with the researcher. However, there are no guidelines on the most appropriate method for delivering this information to older adults and it is not known whether the delivery method is a facilitator or barrier towards clinical trial participation...
August 3, 2018: Clinical Trials: Journal of the Society for Clinical Trials
Allison Bethune, Marisol Davila-Foyo, Mikaeel Valli, Leodante da Costa
BACKGROUND: Patient recall of information about procedures, including risks and benefits and potential outcomes, is often insufficient. We sought to determine whether a multimedia educational tool enhances the informed consent discussion for elective neurosurgical procedures by increasing patient knowledge of the procedure. METHODS: Adult patients from a single neurosurgical site eligible for 4 neurosurgical procedures (lumbar spine or cervical spine decompression for degenerative disease, craniotomy for brain tumour or trigeminal neuralgia treatment) were offered enrolment...
August 1, 2018: Canadian Journal of Surgery. Journal Canadien de Chirurgie
Gibson B Kagaruki, Mary T Mayige, Esther S Ngadaya, Andrew M Kilale, Amos Kahwa, Amani F Shao, Godfather D Kimaro, Chacha M Manga, Doris Mbata, Godlisten S Materu, Ray M Masumo, Sayoki G Mfinanga
BACKGROUND: Type2 Diabetes and Hypertension (T2DM/HTN) have become serious threats to the health and socio-economic development in the developing countries. People living with HIV (PLHIV) infection are more vulnerable of developing T2DM/HTN due to HIV infection itself and antiretroviral treatments. The situation is worse when behavioral and biological risk factors are pervasive to PLHIV. Despite this vicious circle; information on the level of knowledge and perception regarding prevention of T2DM/HTN, risks factors and associated complications among PLHIV is not well documented in Tanzania...
July 28, 2018: BMC Public Health
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