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Participant information consent document

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
Cristina M López, Suparna Qanungo, Carolyn Jenkins, Ron Acierno
We must include rural participants in health-related research if we are to address health-related disparities and inequity, particularly in mental health. However, the first step of the research process, in person, witnessed, signed informed consent is often a limiting factor and insurmountable barrier to precisely the type of research (e.g., telehealth) designed to overcome barriers of geographic distance and travel time. Telehealth, or the provision of medical care or services to patients by means of audio/video and procedure-specific technology, addresses some barriers to health created by rurality by making health care professionals more accessible to patients...
February 2018: Professional Psychology, Research and Practice
Adam Gilbertson, Elizabeth Poole Kelly, Stuart Rennie, Gail E Henderson, JoAnn D Kuruc, Joseph D Tucker
Currently, much of early phase HIV cure research involves unknown and potentially serious risks, with little or no chance of direct health benefits. During informed consent, researchers emphasize this lack of personal medical benefit to minimize misconceptions that undermine genuine consent. We explored participants' and researchers' perspectives on HIV cure clinical research participation and its potential benefits. We conducted semi-structured interviews with 17 HIV cure research participants and nine researchers in North Carolina, USA...
July 16, 2018: AIDS Research and Human Retroviruses
Fleur O'Hare, Simone Spark, Zachary Flanagan, Stephane Heritier, Andrea Curtis, Sophia Zoungas
Aims: To compare recruitment, refusal and randomisation rates of older adults into a general practice-based clinical trial with two versions (varied format, content and language) of the Participant Information and Consent Form (PICF). Methods: This prospective PICF study was conducted within the STAREE (STAtins in Reducing Events in the Elderly) clinical trial. Participants phone screened between October 2015 to February 2016 formed Group 1 and were mailed the extended PICF version and participants phone screened between October 2016 to February 2017 formed Group 2 and were mailed the shortened PICF version...
September 2018: Contemporary Clinical Trials Communications
Madhu Gupta, Jaya Prasad Tripathy, Sanjay Verma
Audiovisual (AV) recording of the informed consent process in a clinical or vaccine trial to document the consent process of participants (especially from vulnerable populations), ensures preservation of their rights and well-being. This paper describes the AV consent process during a phase III rotavirus vaccine trial among healthy infants in Chandigarh and examines its effects. Out of 155 parents/guardians of participating infants who were contacted to be a part of the study, 50 were reluctant to participate in the study trial (not necessarily in the AV consenting process)...
May 28, 2018: Indian Journal of Medical Ethics
Lulu M Muhe, Elizabeth M McClure, Amha Mekasha, Bogale Worku, Alemayehu Worku, Asrat Dimtse, Goitom Gebreyesus, Zemene Tigabu, Mahlet Abayneh, Netsanet Workneh, Beza Eshetu, Abayneh Girma, Mesfin Asefa, Ramon Portales, Mahlet Arayaselassie, Yirgu Gebrehiwot, Tiruzer Bekele, Mesele Bezabih, Gesit Metaferia, Mulatu Gashaw, Bewketu Abebe, Alemu Geleta, Abdulkadir Shehibo, Yohanes Hailu, Hailu Berta, Addisu Alemu, Tigist Desta, Rahel Hailu, Janna Patterson, Assaye K Nigussie, Robert L Goldenberg
BACKGROUND: With nearly 15 million annual preterm births globally, preterm birth is the most common cause of neonatal death. Forty to 60 % of neonatal deaths are directly or indirectly associated with preterm mortality. As countries aim to meet the Sustainable Development Goals to reduce neonatal mortality, significant reductions in preterm mortality are needed. This study aims to identify the common causes of preterm illness and their contribution to preterm mortality in low-resource settings...
June 27, 2018: Reproductive Health
Elizabeth M McClure, Sarah Saleem, Shivaprasad S Goudar, Sangappa Dhaded, G Guruprasad, Yogesh Kumar, Shiyam Sunder Tikmani, Masood Kadir, Jamal Raza, Haleema Yasmin, Janet L Moore, Jean Kim, Carla Bann, Lindsay Parlberg, Anna Aceituno, Waldemar A Carlo, Robert M Silver, Laura Lamberti, Janna Patterson, Robert L Goldenberg
BACKGROUND: In South Asia, where most stillbirths and neonatal deaths occur, much remains unknown about the causes of these deaths. About one-third of neonatal deaths are attributed to prematurity, yet the specific conditions which cause these deaths are often unclear as is the etiology of stillbirths. In low-resource settings, most women are not routinely tested for infections and autopsy is rare. METHODS: This prospective, cohort study will be conducted in hospitals in Davengere, India and Karachi, Pakistan...
June 22, 2018: Reproductive Health
Sheena C Ranade, Christian A Refakis, Aristides I Cruz, Kelly L Leddy, Lawrence Wells, John Todd Lawrence, Theodore J Ganley
BACKGROUND: Greater frequency and intensity level of sports participation may be contributing to an increasing incidence of anterior cruciate ligament (ACL) tears in skeletally immature athletes. Prior studies have assessed the functional outcomes of physeal-respecting ACL reconstruction in this patient population based on adult functional outcomes scoring systems; however, there is only sparse literature evaluating functional outcomes of this specific patient population. This study aimed to retrospectively evaluate a cohort of pediatric patients who had undergone all-epiphyseal ACL reconstruction (AEACLR) with a set of clinically validated, pediatric-specific patient-reported functional outcomes scores (PRFOS)...
June 20, 2018: Journal of Pediatric Orthopedics
S M Iftekhar Uddin, Mohammadhassan Mirbolouk, Zeina Dardari, David I Feldman, Miguel Cainzos-Achirica, Andrew P DeFilippis, Philip Greenland, Ron Blankstein, Kevin L Billups, Martin Miner, Khurram Nasir, Michael J Blaha
Vascular erectile dysfunction (ED) and cardiovascular disease (CVD) share common risk factors including obesity, hypertension, metabolic syndrome, diabetes mellitus, and smoking. ED and CVD also have common underlying pathological mechanisms, including endothelial dysfunction, inflammation, and atherosclerosis.1 Despite these close relationships, the evidence documenting ED as an independent predictor of future CVD events is limited.We therefore leveraged the MESA study (Multi-Ethnic Study of Atherosclerosis), an ethnically diverse, community-based, multisite prospective cohort study, to examine the value of self-reported ED for predicting incident coronary heart disease (CHD) and CVD in those free of these CVD events at baseline...
June 11, 2018: Circulation
Padmaja A Marathe, Raakhi K Tripathi, Yashashri C Shetty, Sunil S Kuyare, Sandhya K Kamat, Urmila M Thatte
Objective: In view of dearth of information in national and international guidelines on payment practices in research, the present study was done to find out payments for participation allowed by 3 Ethics committees (ECs) and reasons for payment. Method: This was a retrospective observational study which analysed research proposals reviewed by 2 institutional and 1 non-institutional ECs over a period of 2 years. The permission of ECs was obtained and confidentiality of data was maintained...
April 2018: Perspectives in Clinical Research
Christian M Simon, Helen A Schartz, Gary E Rosenthal, Eric L Eisenstein, David W Klein
Digital informed consent may better inform individuals about health research and increase participation. In the United States and elsewhere, minorities and rural populations are underrepresented in health research and may benefit from well-designed electronic informed consent (eIC). Seven focus groups were conducted with 50 Caucasian, African American, and rural patients in the United States. Participants were asked their preferences for a paper versus electronic informed consent document. Participants found the e-version easier to use, more interesting, and better for understanding...
May 1, 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
Edwin P Arnold, Giovanni Losco, Sharon English, Frank Frizelle, Angelo Anthony
AIM: To document the symptoms of bowel dysfunction, and how the bowels are managed, in a cohort of patients following a spinal cord injury. To relate these to the level of the spinal injury and to examine the relationship between bowel symptoms and bladder dysfunction. METHOD: Participants were identified from the discharge data from the Burwood Spinal Unit, one of two national Spinal Units in New Zealand, in two two-year sets from 1-3 years post-injury and from 20-21 years post-injury...
May 18, 2018: New Zealand Medical Journal
Jason E Lang, Anusha Vadlamudi
No abstract text is available yet for this article.
May 10, 2018: Journal of Asthma: Official Journal of the Association for the Care of Asthma
Sinyoung Park, Chung Mo Nam, Sejung Park, Yang Hee Noh, Cho Rong Ahn, Wan Sun Yu, Bo Kyung Kim, Seung Min Kim, Jin Seok Kim, Sun Young Rha
BACKGROUND: With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice (GCP) and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise...
April 25, 2018: BMC Medical Ethics
Ezequiel B Ossemane, Troy D Moon, Jahit Sacarlal, Esperança Sevene, Darlene Kenga, Wu Gong, Elizabeth Heitman
Participants' understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study's aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique...
July 2018: Journal of Empirical Research on Human Research Ethics: JERHRE
Alexander C Fanaroff, Shuang Li, Laura E Webb, Vincent Miller, Ann Marie Navar, Eric D Peterson, Tracy Y Wang
BACKGROUND: Patient participation in clinical research is low, in part because of the length and complexity of the informed consent process. Video informed consent may enhance the appeal of research and help break down barriers to participation. METHODS AND RESULTS: The PALM study (Patient and Provider Assessment of Lipid Management) enrolled 7904 patients at cardiology, endocrinology, and primary care clinics across the United States to evaluate cholesterol management practices...
April 2018: Circulation. Cardiovascular Quality and Outcomes
Joanna Nkyekyer, Denny Meyer, Peter J Blamey, Andrew Pipingas, Sunil Bhar
BACKGROUND: Sensorineural hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression, and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. Hearing aids have been proven as successful interventions to alleviate sensorineural hearing loss. In addition to hearing aid use, the positive effects of auditory training-formal listening activities designed to optimize speech perception-are now being documented among adults with hearing loss who use hearing aids, especially new hearing aid users...
March 23, 2018: JMIR Research Protocols
Timothy M Rawson, Luke S P Moore, Enrique Castro-Sanchez, Esmita Charani, Bernard Hernandez, Vivian Alividza, Fran Husson, Christofer Toumazou, Raheelah Ahmad, Pantelis Georgiou, Alison H Holmes
Background: We developed a personalised antimicrobial information module co-designed with patients. This study aimed to evaluate the potential impact of this patient-centred intervention on short-term knowledge and understanding of antimicrobial therapy in secondary care. Methods: Thirty previous patients who had received antibiotics in hospital within 12 months were recruited to co-design an intervention to promote patient engagement with infection management...
2018: Antimicrobial Resistance and Infection Control
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