keyword
Keywords Participant information consen...

Participant information consent document

https://read.qxmd.com/read/38545607/early-physiologic-numerical-and-waveform-characteristics-of-simulated-hemorrhagic-events-with-healthy-volunteers-donating-blood
#1
JOURNAL ARTICLE
Joo Heung Yoon, Jueun Kim, Theodore Lagattuta, Michael R Pinsky, Marilyn Hravnak, Gilles Clermont
OBJECTIVES: Early signs of bleeding are often masked by the physiologic compensatory responses delaying its identification. We sought to describe early physiologic signatures of bleeding during the blood donation process. SETTING: Waveform-level vital sign data including electrocardiography, photoplethysmography (PPG), continuous noninvasive arterial pressure, and respiratory waveforms were collected before, during, and after bleeding. SUBJECTS: Fifty-five healthy volunteers visited blood donation center to donate whole blood...
April 2024: Critical care explorations
https://read.qxmd.com/read/38532639/automating-sedation-state-assessments-using-natural-language-processing
#2
JOURNAL ARTICLE
Aaron Conway, Jack Li, Mohammad Goudarzi Rad, Sebastian Mafeld, Babak Taati
INTRODUCTION: Common goals for procedural sedation are to control pain and ensure the patient is not moving to an extent that is impeding safe progress or completion of the procedure. Clinicians perform regular assessments of the adequacy of procedural sedation in accordance with these goals to inform their decision-making around sedation titration and also for documentation of the care provided. Natural language processing could be applied to real-time transcriptions of audio recordings made during procedures in order to classify sedation states that involve movement and pain, which could then be integrated into clinical documentation systems...
March 26, 2024: Journal of Nursing Scholarship
https://read.qxmd.com/read/38502996/comparative-study-on-informed-consent-regulation-in-health-care-among-italy-france-united-kingdom-nordic-countries-germany-and-spain
#3
JOURNAL ARTICLE
Vittorio Bolcato, Chiara Franzetti, Giovanni Fassina, Giuseppe Basile, Rosa Maria Martinez, Livio Pietro Tronconi
The information and subsequent expression of will, so-called informed consent, have become the essential element of health right, understood as the right to autonomous choice in health, based on the fiduciary relationship between physician and patient. This gradually leads European Countries to adopt special legislations and to issue frequent judgments on the subject. However, new challenges in daily clinical practice call for further study of legal solutions. The authors analyse and compare the regulations on informed consent in health care of Italy, France, the United Kingdom, the Nordic Countries, Germany, and Spain...
March 14, 2024: Journal of Forensic and Legal Medicine
https://read.qxmd.com/read/38500571/exploring-the-challenges-in-covering-dental-services-through-complementary-insurance-in-iran-a-qualitative-study
#4
JOURNAL ARTICLE
Zahra Pouraskari, Reza Yazdani, Hossein Hessari
BACKGROUND: Financial protection is crucial for attaining universal health coverage. The inclusion of costly dental services in insurance plans poses a significant challenge for all parties involved in the insurance sector. This study aimed to investigate the challenges of covering dental services by complementary insurance in Iran during 2020-2021. MATERIALS AND METHODS: This qualitative research was conducted in Iran during 2020-2021. A triangulation of methods and data sources were employed to achieve a comprehensive perspective...
2024: International Journal of Dentistry
https://read.qxmd.com/read/38486179/experiences-with-telemedicine-based-follow-up-of-chronic-conditions-the-views-of-patients-and-health-personnel-enrolled-in-a-pragmatic-randomized-controlled-trial
#5
RANDOMIZED CONTROLLED TRIAL
Susanna Sten-Gahmberg, Kine Pedersen, Ingrid Gaarder Harsheim, Hanna Isabel Løyland, Birgit Abelsen
BACKGROUND: Telemedicine is often promoted as a possible solution to some of the challenges healthcare systems in many countries face, and an increasing number of studies evaluate the clinical effects. So far, the studies show varying results. Less attention has been paid to systemic factors, such as the context, implementation, and mechanisms of these interventions. METHODS: This study evaluates the experiences of patients and health personnel enrolled in a pragmatic randomized controlled trial comparing telemedicine-based follow-up of chronic conditions with usual care...
March 14, 2024: BMC Health Services Research
https://read.qxmd.com/read/38478133/determining-the-state-of-guidance-on-pediatric-biobanking-for-researchers-hrecs-and-families-regulatory-mapping-of-international-guidance
#6
JOURNAL ARTICLE
Sinead Prince, Shih-Ning Then, Kerry-Ann O'Grady
Biobanking-the storage of human biological samples, including tissue, blood, urine, and genetic data-raises many ethical, legal, and social issues, including confidentiality and privacy. Pediatric biobanking is more complicated, with difficulties arising because children lack capacity to consent and acquire this capacity upon maturity when the research is still ongoing. Yet given the limited availability of pediatric samples, the translational nature of biobanking presents a unique opportunity to share samples and produce clinically necessary information about pediatric development and diseases...
March 13, 2024: European Journal of Pediatrics
https://read.qxmd.com/read/38477437/the-informed-consent-process-an-evaluation-of-the-challenges-and-adherence-of-ghanaian-researchers
#7
JOURNAL ARTICLE
Paa-Kwesi Blankson, Florence Akumiah, Amos Laar, Lisa Kearns, Samuel Asiedu Owusu
This study assessed challenges faced by researchers with the informed consent process (ICP). In-depth interviews were used to explore challenges encountered by Investigators, Research assistants, Institutional Review Board members and other stakeholders. An electronic questionnaire was also distributed, consisting of Likert-scale responses to questions on adherence to the ICP, which were derived from the Helsinki Declaration and an informed consent checklist of the US Department of Health and Human Research (HSS)...
March 13, 2024: Developing World Bioethics
https://read.qxmd.com/read/38476860/united-states-government-supported-family-planning-and-reproductive-health-outreach-in-the-democratic-republic-of-the-congo-lessons-learned-and-recommendations
#8
JOURNAL ARTICLE
Sahra Ibrahimi, Bamba Youssouf, Christine Potts, Alexandre Dumouza, Rani Duff, Landry-Serges Malaba, Bettina Brunner
BACKGROUND: In response to limited contraception availability and a lack of knowledge about family planning (FP) in the Democratic Republic of the Congo (DRC), the United States Agency for International Development (USAID) Integrated Health Program (IHP) in the DRC has been providing FP services, including outreach programs in the DRC. Our study aims to assess the FP outreach program by understanding the participants' perception of the campaign, its impact on their behavior, and their feedback regarding the campaign...
2024: Open Access Journal of Contraception
https://read.qxmd.com/read/38470960/gerontechnologies-ethics-and-care-phases-secondary-analysis-of-qualitative-interviews
#9
JOURNAL ARTICLE
Andrea Martani, Yi Jiao Angelina Tian, Nadine Felber, Tenzin Wangmo
BACKGROUND: Gerontechnologies are increasingly used in the care for older people. Many studies on their acceptability and ethical implications are conducted, but mainly from the perspective of principlism. This narrows our ethical gaze on the implications the use of these technologies have. RESEARCH QUESTION: How do participants speak about the impact that gerontechnologies have on the different phases of care, and care as a process? What are the moral implications from an ethic of care perspective? RESEARCH DESIGN: Secondary analysis of semi-structure interviews, whose segments on specific technologies were analysed through reflexive thematic analysis...
March 12, 2024: Nursing Ethics
https://read.qxmd.com/read/38459552/effects-of-depot-medroxyprogesterone-acetate-the-copper-iud-and-the-levonorgestrel-implant-on-testosterone-sex-hormone-binding-globulin-and-free-testosterone-levels-ancillary-study-of-the-echo-randomized-clinical-trial
#10
JOURNAL ARTICLE
G Justus Hofmeyr, Mandisa Singata-Madliki, Joanne Batting, Yusentha Balakrishna, Chelsea Morroni
BACKGROUND: Robust information on relative effects of hormonal contraceptives on endogenous androgens is important for understanding beneficial and adverse effects, method choice and development of new methods. METHODS: In this ancillary study at the East London, South Africa site of the ECHO multicentre randomized trial, we compared effects of three contraceptive methods on serum androgen levels among contraceptive users aged 18 to 35 years. Participants were allocated by centrally-managed randomization to open label depot medroxyprogesterone acetate (DMPA-IM), copper intrauterine device (IUD) or levonorgestrel implant...
March 8, 2024: BMC Women's Health
https://read.qxmd.com/read/38459131/can-we-screen-for-heart-disease-in-children-at-public-health-centres-a-multicentre-observational-study-of-screening-for-heart-disease-with-a-risk-of-sudden-death-in-children
#11
JOURNAL ARTICLE
Paula Greciano Calero, Silvia Escribá Bori, Juan Antonio Costa Orvay, Nina González Pons, María Del Carmen Martín Pérez, Dolores Cardona Alfonseca, Cristina Nogales Velázquez, Sergi Verd Vallespir, Alicia Esther Tur Salom, Antonella Chiandetti, Marcos Navarro Noguera, Anna Grau Blanch, María Magdalena Rotger Genestar, Marianna Mambié Meléndez, Mercedes Fernández Hidalgo, Juana María Seguí Llinas, Laura Martorell Bon, Patricia Arestuche Aguilar, Beatriz Garrido Conde, María Del Valle Sánchez Grao, Katia Sarraff Trujillo, Antoni Muntaner Alonso, Catalina Grimalt Ferragut, Andrea Soriano Marco, Viviana Gómez Rojas, Juan Pol Serra
Sudden cardiac death in children is a rare event, but of great social significance. Generally, it is related to heart disease with a risk of sudden cardiac death (SCD), which may occur with cardiovascular symptoms and/or electrocardiographic markers; thus, a primary care paediatrician (PCP) could detect them. Therefore, we proposed a study that assesses how to put into practice and conduct a cardiovascular assessment within the routine healthy-child check-ups at six and twelve years of age; that reflects cardiovascular signs and symptoms, as well as the electrocardiographic alterations that children with a risk of SCD in the selected population present; and that assesses the PCP's skill at electrocardiogram (ECG) interpretation...
March 8, 2024: European Journal of Pediatrics
https://read.qxmd.com/read/38452529/fluidity-of-equipoise-in-a-multi-centred-pilot-rct-influences-on-clinician-decision-making-in-offering-trial-entry
#12
JOURNAL ARTICLE
Eleanor Molloy, Nicole Pilarski, Katie Morris, Victoria Hodgetts-Morton, Laura Jones
OBJECTIVES: The embedded Qualitative Process Evaluation (QPE) within the CSTICH- Pilot RCT explored facilitators and barriers to recruitment within the Pilot. This study reports a secondary analysis of the overarching theme of Fluidity of Equipoise and the influences on individual and community clinical equipoise around the use of Emergency Cervical Cerclage (ECC). STUDY DESIGN: RCT recruitment assumes clinical equipoise and is defined as genuine uncertainty about an intervention...
March 3, 2024: European Journal of Obstetrics, Gynecology, and Reproductive Biology
https://read.qxmd.com/read/38446106/returning-clinically-relevant-research-results-to-participants-guidelines-for-investigators-and-the-irb
#13
JOURNAL ARTICLE
Amy Waltz, Bethany Johnson, Peter H Schwartz
In 2019, the revised Common Rule required informed consent documents for research to include a statement about whether clinically relevant research results would be returned to research participants. While there are national discussions regarding the return of results, these do not provide specific guidance about how institutional review boards (IRBs) should address this issue. Through a year-long process involving IRB staff and leadership, science and bioethics faculty members, community IRB members, and others, Indiana University's human research protection program created a framework that offers a clear categorization of types of results for researchers to consider returning, provides language for informed consent documents, and describes an active but intentionally limited role for the IRB...
2024: Ethics & Human Research
https://read.qxmd.com/read/38445335/-not-available
#14
JOURNAL ARTICLE
Helle Svenningsen, Laura Krone Larsen, Marie Oxenbøll Collet, Anne Højager Nielsen, Hanne Pedersen
Delirium in patients has well-documented adverse physical and mental outcomes. Delirium impairs patients' capacity to grasp and retain information, thus affecting their right to informed consent and active participation in treatment and care decisions. In Danish hospitals, delirium afflicts up to 50% of the elderly patients, yet it often goes unreported due to the absence of systematic screening. The selection of a screening tool should be contextually relevant. This review gives an overview of delirium screening instruments available in Danish, each with distinct advantages and disadvantages...
February 19, 2024: Ugeskrift for Laeger
https://read.qxmd.com/read/38444819/grand-plan-safety-and-efficacy-of-glecaprevir-pibrentasvir-for-the-treatment-of-hepatitis-c-virus-infection-among-people-initially-disengaged-from-health-care-who-use-drugs-a-systematic-multidisciplinary-approach
#15
JOURNAL ARTICLE
Brian Conway, Shana Yi, Rossitta Yung, Shawn Sharma
BACKGROUND: GRAND PLAN is a prospective, open-label, phase 4 study. Based at a single center and with a single arm, GRAND PLAN evaluated the safety and efficacy of an 8-week course of glecaprevir/pibrentasvir (G/P) among active drug users with hepatitis C virus (HCV) infection in a population enriched for factors that may reduce treatment uptake and success, such as disengagement from health care and unstable housing. METHODS: Participants were ≥19 years old and actively using drugs and were confirmed viremic, noncirrhotic, and HCV treatment naive...
March 2024: Open Forum Infectious Diseases
https://read.qxmd.com/read/38425705/case-study-on-communicating-with-research-ethics-committees-about-minimizing-risk-through-software-an-application-for-record-linkage-in-secondary-data-analysis
#16
JOURNAL ARTICLE
Cason Schmit, Alva O Ferdinand, Theodoros Giannouchos, Hye-Chung Kum
OBJECTIVE: In retrospective secondary data analysis studies, researchers often seek waiver of consent from institutional Review Boards (IRB) and minimize risk by utilizing complex software. Yet, little is known about the perspectives of IRB experts on these approaches. To facilitate effective communication about risk mitigation strategies using software, we conducted two studies with IRB experts to co-create appropriate language when describing a software to IRBs. MATERIALS AND METHODS: We conducted structured focus groups with IRB experts to solicit ideas on questions regarding benefits, risks, and informational needs...
April 2024: JAMIA Open
https://read.qxmd.com/read/38408853/leveraging-artificial-intelligence-to-detect-ethical-concerns-in-medical-research-a-case-study
#17
JOURNAL ARTICLE
Kannan Sridharan, Gowri Sivaramakrishnan
BACKGROUND: Institutional review boards (IRBs) have been criticised for delays in approvals for research proposals due to inadequate or inexperienced IRB staff. Artificial intelligence (AI), particularly large language models (LLMs), has significant potential to assist IRB members in a prompt and efficient reviewing process. METHODS: Four LLMs were evaluated on whether they could identify potential ethical issues in seven validated case studies. The LLMs were prompted with queries related to the proposed eligibility criteria of the study participants, vulnerability issues, information to be disclosed in the informed consent document (ICD), risk-benefit assessment and justification of the use of a placebo...
February 26, 2024: Journal of Medical Ethics
https://read.qxmd.com/read/38405810/practices-and-attitudes-of-herbalists-regarding-informed-consent-in-uganda-a-qualitative-study
#18
Sumayiya Nalubega, Paul Kutyabami, Adeline Twimukye, David K Mafigiri, Nelson K Sewankambo
Background Informed consent (IC) is a fundamental principle in medical ethics that upholds respect for patient autonomy. Although widely applied in healthcare, its feasibility and implementation in herbal medicine have been underexplored. This study therefore aimed to explore the practices and attitudes of herbalists regarding informed consent. Methods To achieve these objectives, a qualitative cross-sectional study was conducted from June to December 2020. Twenty-one in-depth interviews with herbalists and four key informant interviews with leaders of the different traditional medicine organizations were also conducted...
February 8, 2024: Research Square
https://read.qxmd.com/read/38400905/a-proactive-financial-navigation-intervention-in-patients-with-newly-diagnosed-gastric-and-gastroesophageal-junction-adenocarcinoma
#19
RANDOMIZED CONTROLLED TRIAL
Ari Bell-Brown, Talor Hopkins, Kate Watabayashi, Karen Overstreet, Anthony Leahy, Erin Bradshaw, Kathleen Gallagher, Jennifer Obenchain, Amber Padron, Beth Scott, Brooke Flores, Veena Shankaran
PURPOSE: Many cancer patients and caregivers experience financial hardship, leading to poor outcomes. Gastric and gastroesophageal junction (GEJ) cancer patients are particularly at risk for financial hardship given the intensity of treatment. This pilot randomized study among gastric/GEJ cancer patients and caregivers tested a proactive financial navigation (FN) intervention to obtain a signal of efficacy to inform a larger, more rigorous randomized study. METHODS: We tested a 3-month proactive FN intervention among gastric/GEJ cancer patients and caregivers compared to usual care...
February 24, 2024: Supportive Care in Cancer
https://read.qxmd.com/read/38379369/development-of-a-nomogram-for-predicting-acute-pain-among-patients-after-abdominal-surgery-a-prospective-observational-study
#20
JOURNAL ARTICLE
Ling Wang, Fang Qin, Li Zhen, Ruihua Li, Siqi Tao, Guoxin Li
AIMS: To develop a nomogram to provide a screening tool for recognising patients at risk of post-operative pain undergoing abdominal operations. BACKGROUND: Risk prediction models for acute post-operative pain can allow initiating prevention strategies, which are valuable for post-operative pain management and recovery. Despite the increasing number of studies on risk factors, there were inconsistent findings across different studies. In addition, few studies have comprehensively explored predictors of post-operative acute pain and built prediction models...
February 20, 2024: Journal of Clinical Nursing
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