Informed Consent in a Dangerous Medical Resident Hours Study

In a recent post in this space, I wrote about the iCOMPARE research study that is comparing the effects of increasing medical residents' consecutive duty hours with observing the currently prescribed limits on their shifts. According to the study protocol, the primary hypothesis of the research addresses the safety of patients: that mortality under the increased residents' duty hours will not significantly exceed patient mortality under the current mandated standard for medical residents on duty. I argued that the study design is unethical based on what is known about sleep deprivation. The study's goal -- seeing whether more patients die when residents get less sleep -- is ethically unacceptable because research has definitively shown that residents working very long shifts commit more medical errors than their well-rested counterparts. There is another reason why the study is unethical. Both the residents and the patients are considered research subjects, yet the researchers are not seeking informed consent from either group to participate in the research. The head of the Accreditation Council for Graduate Medical Education, one of the funders of the study, said that research ethics committees or Institutional Review Boards (IRBs) "at all the participating hospitals reviewed the trial protocols and determined that patients did not need to be informed." According to the study protocol, the IRB at the lead institution -- the University of Pennsylvania -- waived the ...
Source: Healthy Living - The Huffington Post - Category: Consumer Health News Source Type: news

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Conclusions: Bioinformatics analysis is a useful tool to explore the mechanism and pathogenesis of PHN. The identified hub genes may participate in the onset and development of PHN and serve as therapeutic targets. PMID: 33029266 [PubMed - in process]
Source: Pain Research and Management - Category: Anesthesiology Authors: Tags: Pain Res Manag Source Type: research
Conclusion: This study will provide theoretical support for the clinical application of auricular point combined with moxibustion in the treatment of insomnia. Ethics and dissemination: The private information from individuals will not publish. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OSF Registration number: DOI 10.17605/OSF.IO/8VZRJ.
Source: Medicine - Category: Internal Medicine Tags: Research Article: Study Protocol Systematic Review Source Type: research
DiscussionIt is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby  reducing the burden of the public healthcare system in Hong Kong.Trial registrationClinicalTrials.govNCT04228146. Retrospectively registered on 14 January 2020.
Source: Trials - Category: Research Source Type: clinical trials
ABSTRACT Objective: To investigate the frequency of Comorbid Fibromyalgia Syndrome and its effects on quality of life and activities of daily living without any known psychiatric problem (schizophrenia or bipolar disorder) or severe disability, other than depression, in patients with multiple sclerosis, which is known to be a chronic disease in young adults. Methods: The study included 103 patients diagnosed with multiple sclerosis, following McDonald criteria, who had relapsing remitting disease. The Fibromyalgia Impact Questionnaire, Beck Anxiety Inventory, Beck Depression Inventory, Pittsburgh Sleep Quality Index, Fatig...
Source: Arquivos de Neuro-Psiquiatria - Category: Neurology Source Type: research
Conclusions: The results provide a basis for the development of psychological interventions that could minimize the prevalence of sleep disorders and depression and could improve patients ’ quality of life during the outbreak.RESUMO Introdu ção: Este estudo relatou uma variedade de reações psicológicas relacionadas a ansiedade, qualidade do sono, depressão, fadiga e qualidade de vida em indivíduos com esclerose múltipla (EM), relacionadas à experiência de quarentena de COVID-19. Objetivo: O objetivo deste estudo foi invest igar os efeitos neuropsiqu...
Source: Arquivos de Neuro-Psiquiatria - Category: Neurology Source Type: research
Authors: Wang WL, Hung HY, Chen YR, Chen KH, Yang SN, Chu CM, Chan YY Abstract Objectives: The aim of this study was to conduct a systematic review, meta-analysis, and metaregression to determine the current best available evidence of the efficacy and safety of foot reflexology for adult depression, anxiety, and sleep quality. Methods: Electronic databases (PubMed, ClinicalKey, ScienceDirect, EMBASE, PsycINFO, and the Cochrane Library) were searched till August, 10, 2020, and the validity of the eligible studies was critically appraised. Randomized controlled trials comparing foot reflexology groups with contro...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
(University of California - San Diego) UC San Diego School of Medicine researchers report that older adults are increasingly using cannabis to treat a variety of common health conditions, including pain, sleep disturbances and psychiatric conditions like anxiety and depression.
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
Increases in depressive and suicide-related symptoms among United States adolescents have been recently linked to increased use of smartphones. Understanding of the brain mechanisms that underlie the potential smartphone dependence may help develop interventions to address this important problem. In this exploratory study, we investigated the neural mechanisms underlying potential smartphone dependence in a sample of 19 adolescent volunteers who completed self-assessments of their smartphone dependence, depressive symptoms, and sleep problems. All 19 adolescents underwent diffusion MRI that allowed for assessment of white ...
Source: Frontiers in Human Neuroscience - Category: Neuroscience Source Type: research
DiscussionThe CITRIP study seeks to evaluate the effectiveness and safety of a randomized withdrawal trial of spinal cord stimulation for patients with intractable trunk or limb pain.Trial registrationClinicalTrials.govNCT03858790. Registered on March 1, 2019, retrospectively registered
Source: Trials - Category: Research Source Type: clinical trials
Are you sad? Just be happy! Does this irritate you? In today’s show, Gabe and Lisa ponder whether happiness really is a choice — especially for people who struggle with mental illness. How do we measure happiness? And what is happiness inflation? Join us for an in-depth conversation on whether or not people can actually choose happiness. (Transcript Available Below) Please Subscribe to Our Show: And We Love Written Reviews!  About The Not Crazy podcast Hosts Gabe Howard is an award-winning writer and speaker who lives with bipolar disorder. He is the author of the popular book, Mental Illness is an A...
Source: World of Psychology - Category: Psychiatry & Psychology Authors: Tags: General Happiness Mental Health and Wellness Not Crazy Podcast Source Type: blogs
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