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Consent forms

Glenda Tettamanti, Alessia Varetta, Marcello Macchi, Cristina Gallotti, Maria Stella Laddomada
The aim of this study was to investigate attitudes and awareness about conventional and electronic cigarettes in a sample of students attending the Faculty of Medicine of Pavia University (Italy). An anonymous and self-reported questionnaire was administered to 226 students attending either the first or third years of medical school during the 2013 to 2014 school year. Participation was voluntary and required signing an informed consent form. The prevalence of smokers was 12%. Sixty-seven percent of smokers reported smoking less than 5 cigarettes/day, and 15% more than 10 cigarettes/day...
July 2016: Igiene e Sanità Pubblica
Elizabeth M Bernthal, H J A Draper, J Henning, J C Kelly
AIMS: To identify and explore features of ethical issues that senior clinicians faced as deployed medical directors (DMDs) to the British Field Hospital in Afghanistan as well as to determine the ethical training requirements for future deployments. METHOD: A qualitative study in two phases conducted from November 2014 to June 2015. Phase 1 analysed 60 vignettes of cases that had generated ethical dilemmas for DMDs. Phase 2 included focus groups and an interview with 13 DMDs...
October 25, 2016: Journal of the Royal Army Medical Corps
Amy M Kilbourne, Michelle M Barbaresso, Zongshan Lai, Kristina M Nord, Margretta Bramlet, David E Goodrich, Edward P Post, Daniel Almirall, Mark S Bauer
OBJECTIVE: Persons with chronic mental disorders are disproportionately burdened with physical health conditions. We determined whether Life Goals Collaborative Care compared to usual care improves physical health in patients with mental disorders within 12 months. METHODS: This single-blind randomized controlled effectiveness study of a collaborative care model was conducted at a midwestern Veterans Affairs urban outpatient mental health clinic. Patients (N = 293 out of 474 eligible approached) with an ICD-9-CM diagnosis of schizophrenia, bipolar disorder, or major depressive disorder and at least 1 cardiovascular disease risk factor provided informed consent and were randomized (February 24, 2010, to April 29, 2015) to Life Goals (n = 146) or usual care (n = 147)...
October 25, 2016: Journal of Clinical Psychiatry
Annie Y Lam, Juliet K Nguyen, Jason J Parks, Donald E Morisky, Donna L Berry, Seth E Wolpin
OBJECTIVES: To test the effect of "Talking Pill Bottles" on medication self-efficacy, knowledge, adherence, and blood pressure readings among hypertensive patients with low health literacy and to assess patients' acceptance of this innovation. DESIGN: Longitudinal nonblinded randomized trial with standard treatment and intervention arms. SETTING AND PARTICIPANTS: Two community pharmacies serving an ethnically diverse population in the Pacific Northwest...
October 21, 2016: Journal of the American Pharmacists Association: JAPhA
Jody Lyneé Madeira, Barbara Andraka-Christou
Though intended to educate patients on the risks, benefits, side effects and alternatives within medical treatment, informed consent documents may have unanticipated consequences for patients. Patients may regard these forms as little more than a ritual to access treatment. Or patients may perceive that these forms exist to protect doctors rather than to contribute to a meaningful, patient-protective educational interaction. To rehabilitate the informed consent project, this essay considers the baggage that informed consent documents have acquired through practical use, explores patients' and providers' lived experience of informed consent, and considers whether a multimedia consent application would be a viable solution to the various difficulties that currently erode perceptions of and confidence in the informed consent process...
April 2016: Journal of Law and the Biosciences
M Alexander, J B Burch, S E Steck, C-F Chen, T G Hurley, P Cavicchia, N Shivappa, J Guess, H Zhang, S D Youngstedt, K E Creek, S Lloyd, K Jones, J R Hébert
PURPOSE: Colorectal cancer (CRC) is one of the most common and preventable forms of cancer but remains the second leading cause of cancer-related death. Colorectal adenomas are precursor lesions that develop in 70-90 % of CRC cases. Identification of peripheral biomarkers for adenomas would help to enhance screening efforts. This exploratory study examined the methylation status of 20 candidate markers in peripheral blood leukocytes and their association with adenoma formation. METHODS: Patients recruited from a local endoscopy clinic provided informed consent and completed an interview to ascertain demographic, lifestyle, and adenoma risk factors...
October 22, 2016: International Journal of Colorectal Disease
Francis Barchi, Madison T Little
BACKGROUND: Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. METHODS: An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country...
October 22, 2016: BMC Medical Ethics
Emily F M Fitzpatrick, Alexandra L C Martiniuk, Heather D'Antoine, June Oscar, Maureen Carter, Elizabeth J Elliott
BACKGROUND: When conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations. METHODS: A systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review...
October 22, 2016: BMC Medical Ethics
Marilyn J Hammer, Patricia Eckardt, Margaret Barton-Burke
The primary goal of the thousands of registered trials in cancer research is to extend survival. With evaluation of efficacy, safety, and tolerability, healthcare providers must ensure that the principles described in the Belmont Report are upheld and that patients are truly informed when signing a consent form. In this article, two cases are highlighted, and reasons for participating in clinical trials are discussed. Challenges, such as healthcare literacy, patients' dedication to their healthcare providers, and choosing between multiple trials, are also explored...
November 1, 2016: Oncology Nursing Forum
Jafra D Thomas, J Mark Vanness, Bradley J Cardinal
The purpose of this study was to perform a construct validity assessment of Kendzierski's exercise self-schema theory questionnaire using objective measures of health-related physical fitness. This study tested the hypothesis that individuals with an exercise self-schema would possess significantly greater physical fitness than those who did not across three domains of health-related physical fitness: Body composition, cardiovascular fitness, and upper-body muscular endurance. Undergraduate student participants from one private university on the west coast of the United States completed informed consent forms and the exercise self-schema questionnaire within a classroom setting or at an on-campus outside tabling session...
2016: International Journal of Exercise Science
Sami Dogan, Ariel J Raigrodski, Hai Zhang, Lloyd A Mancl
STATEMENT OF PROBLEM: Studies evaluating anterior zirconia-based crowns are limited. PURPOSE: The purpose of this prospective cohort clinical study was to assess the efficacy of zirconia-based anterior maxillary crowns with 0.3-mm customized copings at the cervical third and anatomical design elsewhere for up to 5 years of service. MATERIAL AND METHODS: Eighteen participants who required an anterior maxillary crown (n=20) and who had signed a consent form approved by the University of Washington Health Sciences Center Human Subjects Division were enrolled...
October 17, 2016: Journal of Prosthetic Dentistry
Nevzat Dabak, Hasan Göçer, Alper Çıraklı
BACKGROUND: Giant Cell Tumor is considered a benign, local and aggressive tumor. Although considered a benign bone tumor, it is still the subject of discussion and research because of the associated local bone destruction, as well as high rates of recurrence and distant metastases. Options are being developed for both surgical techniques and adjuvant therapies. AIMS: The present study evaluated the administration of cryotherapy via a pressurized-spray technique in giant cell tumors of the bone...
September 2016: Balkan Medical Journal
Marcelo Shigueo Yosikawa Motoki, Fabio Roberto Cabar, Rossana Pulcineli Vieira Francisco
OBJECTIVES: To compare the views of freshman students with senior students of the Faculty of Medicine- University of São Paulo concerning the respect for the mother's freedom of choice, the need to protect the unborn child, the proportionality between the mother's freedom of choice and the protection of the unborn child, and issues related to legal abortion. To determine whether the medical knowledge acquired throughout the academic years can influence the views of medical students on these issues...
October 1, 2016: Clinics
Savino Spadaro, Maurizia Capuzzo, Giorgia Valpiani, Sara Bertacchini, Riccardo Ragazzi, Francesca Dalla Corte, Simona Terranova, Elisabetta Marangoni, Carlo Alberto Volta
BACKGROUND: Fatigue has not been investigated in long-term Intensive Care Unit (ICU) survivors. This study aimed to assess fatigue through a specific instrument, namely the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scale, in ICU survivors one year after hospital discharge. A secondary aim was to compare the findings of FACIT-F with those of the Vitality domain (VT) of the 36-item Short-Form Health Survey (SF-36). METHODS: This prospective cohort study was performed on 56 adult patients with a Length Of Stay (LOS) in ICU longer than 72 h...
October 18, 2016: Health and Quality of Life Outcomes
Vildan Kaya, Aynur Aytekin
AIMS AND OBJECTIVES: To determine the effects of pacifier use on transition to full breastfeeding and sucking skills in preterm infants. BACKGROUND: Feeding problems in preterm infants cause delays in hospital discharge, extend mother-infant reunification, and increase medical cost. Nutritive sucking skills of preterm infants may develop by improving non-nutritive sucking skills and increasing sucking experiences. DESIGN: A prospective, randomised controlled trial conducted in the Eastern Turkey...
October 18, 2016: Journal of Clinical Nursing
Wen Wang, Liyuan Ma, Hui Sui, Lisheng Liu
OBJECTIVE: Chinese Hypertension Intervention Efficacy Study (CHIEF) is a multi-center randomized controlled clinical trial. The objective is to evaluate the collective effects of antihypertensive therapy, lipid lowering treatment and lifestyle modification in patients with hypertension. This paper merely present blood pressure lowering effect of intensive lifestyle intervention compared with standard lifestyle intervention. CLINICAL TRIAL REGISTRATION: Clinical Trials...
September 2016: Journal of Hypertension
Sverre Kjeldsen
Results of outcome trials form the basis for treatment guidelines in hypertension. Further outcome trials are needed wherever there are gaps in knowledge. Thus, rationale for setting up and performing and outcome trial with investment of large resources is based on a strong hypothesis.Second, an outcome trial must be done with sufficient statistical power. Power is calculated from the risk level of the people to be investigated and the event rate, the expected benefit of the agent to be investigated and the number of treatment years (number of participants involved and years in the study)...
September 2016: Journal of Hypertension
Clara Sampaio, Ariane Sampaio Sousa, Luis Gustavo A Fraga, Maria Luiza Veiga, José Murillo Bastos Netto, Ubirajara Barroso
OBJECTIVE: To evaluate the correlation between constipation and lower urinary tract dysfunction (LUTD) and nocturnal enuresis in a population-based study. MATERIAL AND METHODS: This is a cross-sectional study. The criteria for inclusion were children and adolescents of between 5 and 17 years and who agreed to sign the informed consent form. The study excluded students with neurological problems or who had documented abnormalities of the urinary tract. To identify the presence and severity of LUTD, we used the Voiding Dysfunction Symptom Score (DVSS)...
2016: Frontiers in Pediatrics
B Krishnan, G Arun Prasad, B Madhan
AIM: Proper and adequate documentation in operation notes is a basic tool of clinical practice with medical and legal implications. An audit was done to ascertain if oral and maxillofacial surgery operative notes in an Indian public sector hospital adhered to the guidelines published by the Royal College of Surgeons England. METHODS: Fifty randomly selected operative notes were evaluated against the guidelines by RCS England with regards to the essential generic components of an operation note...
September 2016: Journal of Maxillofacial and Oral Surgery
Matthew J Mimiaga, Elizabeth F Closson, Shanice Battle, Jeffrey H Herbst, Damian Denson, Nicole Pitts, Jeremy Holman, Stewart Landers, Gordon Mansergh
Men who have sex with men (MSM) of color are disproportionately affected by HIV in the United States. Pre-exposure prophylaxis (PrEP) using antiretroviral medications is a newer biomedical prevention modality with established efficacy for reducing the risk of acquiring HIV. We conducted formative qualitative research to explore audience reactions and receptivity to message concepts on PrEP as part of the development of prevention messages to promote PrEP awareness among black and Latino MSM in the United States...
October 2016: AIDS Patient Care and STDs
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