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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Authors: Horta-Baas G, Peláez-Ballestas I, Queipo G, Montero Hernández U, Romero-Figueroa MDS Abstract OBJECTIVES: Alexithymia is a personality trait related to the quality of life of women with fibromyalgia (FM). It is still unknown whether alexithymia is associated with the clinical manifestations of FM. The present study describes the relationship between alexithymia and the domains included in the core set recommended by the Outcome Measures in Rheumatology (OMERACT) for FM evaluation. METHODS: One hundred two women with FM were enrolled in the cross-sectional study. The domains evaluated were...
Source: Clinical and Experimental Rheumatology - Category: Rheumatology Tags: Clin Exp Rheumatol Source Type: research
Conclusions: The intervention showed no effect on sleep quality, mood or well-being. The circadian lighting environment was safe in our small and diverse patient sample. The trial integrated well with routine clinical care and our sample reflected the heterogeneity of the target population. PMID: 31603013 [PubMed - as supplied by publisher]
Source: Nordic Journal of Psychiatry - Category: Psychiatry Tags: Nord J Psychiatry Source Type: research
This week’s Psychology Around the Net takes an interesting look at how our shadow selves affect relationships, why death anxiety is keeping men awake, strategies to help boost focus and motivation, and more. New Psychology Research Has Linked Death Anxiety to Bedtime Procrastination: A new study published in The Journal of General Psychology suggests “death anxiety” is a predictor of bedtime procrastination in males. After surveying 229 Turkish participants about their attitudes about death, sleeping behaviors, and self-control, researchers found that men who are bothered by their own mortality are more ...
Source: World of Psychology - Category: Psychiatry & Psychology Authors: Tags: Psychology Around the Net Adhd Brain Scans Children death death anxiety Focus Language Skills Mortality Motivation Relationships shadow self Sleep Spiritual Health Suicidal Behavior Suicide Risk Source Type: blogs
Publication date: 2019Source: International Review of Neurobiology, Volume 147Author(s): Jessie S.M. Chan, Siu-Man Ng, Lai-Ping Yuen, Cecilia L.W. ChanAbstractChronic fatigue syndrome (CFS) is often overlooked, has unclear etiology and no effective cure except some symptomatic treatments. Additionally, most people with CFS do not seek medical attention. Qigong exercise, an ancient Eastern body-mind-spirit practice, has been long practiced in Chinese communities and may powerfully trigger the self-healing process. Using full baseline data (n = 1409), the average Hong Kong CFS respondent was found to be female, mar...
Source: International Review of Neurobiology - Category: Neuroscience Source Type: research
Resumo Objetivo Avaliar a qualidade e tempo de sono entre usu ários da rede pública de saúde e fatores associados. Métodos Estudo transversal, realizado com 775 indivíduos de ambos os sexos, em um município da região Centro-Oeste do Brasil. Aplicou-se questionário semiestruturado para avaliar as características sociodemográficas, os hábitos de vid a, as condições de saúde, o binge drinking e qualidade e duração do sono, avaliadas pelo Índice de Qualidade de Sono de Pittsburgh. Aplicou-se a regressão...
Source: Acta Paulista de Enfermagem - Category: Nursing Source Type: research
This study will be conducted as a multicenter, randomized, double-blind, placebo-controlled, parallel, phase 2, proof-of-concept, phenotype-stratified study. The study will enroll 108 patients with peripheral neuropathic pain who will be randomized to a 12-week treatment with lacosamide or placebo up to 400  mg/day in a 2:1 ratio. The primary objective is to compare the change in the mean value of the patients’ daily ratings of average pain intensity from baseline to the last week of treatment in patients with and without the irritable nociceptor phenotype in the per-protocol population. A supporti ve objectiv...
Source: Trials - Category: Research Source Type: clinical trials
Cardiac rehabilitation (CR), or “cardiac rehab,” is a multifaceted, medically supervised program proven to improve heart health and outcomes in people with certain types of cardiovascular disease. CR revolves around three major components: an individualized exercise and training program, education on topics related to heart health, and stress reduction. CR is currently recommended for the following diagnoses: angina (chest pain); heart attack with or without angioplasty or bypass surgery; heart failure with reduced ejection fraction (HFrEF); and heart surgery including heart valve procedures or heart or heart/l...
Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Exercise and Fitness Health Heart Health Source Type: blogs
Sleep problems are major risk factors for the development of internalizing disorders and suicidal thoughts and behaviors in adolescents. Emerging evidence suggests that cognitive-behavioral interventions should be considered as a first-line treatment for a...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
By guest blogger Jack Barton Technology and screens are supposedly the enemy of health. They ruin our sleep, mental health and we’re slaves to their constant need for attention. At least that’s what seems to be the consensus in the news. However, the reality is much more two-sided. In fact, a new study demonstrates that our blue light emitting devices can be a force for good — by providing a novel way to deliver mental health interventions. Problems with sleep, such as insomnia, have been shown to be associated with mental health difficulties such as depression. Although long recognised as a symptom...
Source: BPS RESEARCH DIGEST - Category: Psychiatry & Psychology Authors: Tags: Mental health Sleep and dreaming Technology Source Type: blogs
CONCLUSIONS: SW experience considerably more insomnia and mood disturbances than do DW, and this is significantly related to perfusion changes in multiple brain areas. PMID: 31591830 [PubMed]
Source: Journal of Clinical Neurology - Category: Neurology Tags: J Clin Neurol Source Type: research
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