Remnant Blood Quantification: Informing the Definition of Minimal Risk in Clinical Research.

Guidelines from the Office for Human Research Protections regarding categories of research that institutional review boards (IRBs) may review through expedited procedures limit the volume of blood that can be obtained from research participants for minimal risk research purposes. As defined by the Common Rule, minimal risk research is research in which the probability and magnitude of harm or discomfort anticipated are not greater than the probability and magnitude of harm or discomfort encountered from routine clinical tests. For this study, we considered the volume of remnant blood following routine clinical tests in light of the current definition of minimal risk in research. Conducted at a single institution, this was a prospective cross-sectional study that evaluated blood draws from 122 patients. The median daily remnant blood volume was 11.6 (interquartile range [IQR]: 12.3, 15.2) ml for all patients and 12.9 (IQR: 13.1, 16.9) ml for patients admitted to the intensive care unit. Our findings regarding daily remnant blood volume suggest that the currently allowable blood-volume limits to qualify for expedited review or to qualify as not more than minimal risk research involving blood draws from nonhealthy adults are less than what patients experience in routine medical testing. These findings support permitting an increase in the allowable blood-volume limits to meet the regulatory definition of minimal risk research for obtaining expedited IRB review of studies in which blood samples will be collected.

The Concise Assessment of Leader Management Tool: Evaluation of Healthcare Provider Leadership During Real-Life Pediatric Emergencies.

INTRODUCTION: Resuscitation events in pediatric critical and emergency care are high risk, and strong leadership is an important component of an effective response. The Concise Assessment of Leadership Management (CALM) tool, designed to assess the strength of leadership skills during pediatric crises, has shown promising validity and reliability in simulated settings. The objective of this study was to generate further validity and reliability evidence for the CALM by applying it to real-life emergency events. METHODS: A prospective, video-based study was conducted in an academic pediatric emergency department. Three reviewers independently applied the CALM tool to the assessment of pediatric emergency department physicians as they led both a cardiac arrest and a sepsis event. Time to critical event (epinephrine, fluid, and antibiotic administration) was collected via video review. Based on Kane's framework, we conducted fully crossed, person × event × rater generalizability (G) and decision (D) studies. Interrater reliability was calculated using Gwet AC 2 and intraclass correlation coefficients. Time to critical events was correlated with CALM scores using Spearman coefficient. RESULTS: Nine team leaders were assessed in their leadership of 2 resuscitations each. The G coefficient was 0.68, with 26% subject variance, 20% rater variance, and no case variance. Thirty-three percent of the variance (33%) was attributed to third-order interactions and unknown factors. Gwet AC 2 was 0.3 and intraclass correlation was 0.58. The CALM score and time to epinephrine correlated at -0.79 ( P = 0.01). The CALM score and time to fluid administration correlated at -0.181 ( P = 0.64). CONCLUSIONS: This study provides additional validity evidence for the CALM tool's use in this context if used with multiple raters, aligning with data from the previous simulation-based CALM validity study. Further development may improve reliability. It also serves as an exemplar of the rigors of conducting validity work within medical simulation.

Death of outrage over talking about dying.

OBJECTIVES: We examined public reaction to the proposed Center for Medicare and Medicaid Services rule reimbursing physicians for advanced care planning (ACP) discussions with patients. METHODS: Public comments made on regulations.gov were reviewed for relevance to ACP policy and their perceived position on ACP (ie, positive, negative and neutral). Descriptive statistics were used to quantify the results. RESULTS: A total of 2225 comments were submitted to regulations.gov. On review, 69.0% were categorised as irrelevant; among relevant comments (n=689), 81.1% were positive, 18.6% were negative and 0.002% were neutral. Individuals submitted a greater percentage of the total comments as compared to organisations (63.5% and 36.5%, respectively). CONCLUSIONS: The US Medicare programme is a tax financed social insurance programme that covers all patients 65 years of age and older, including 8 in 10 decedents annually, and it is the part of the US healthcare system most similar to the rest of world. There has been a trend globally towards recognising the importance of aligning patient preferences with care options, including palliative care to deal with advanced life limiting illness. However, ACP is not widely used in the USA, potentially reducing the use of palliative care. Reimbursing ACP discussions between physicians, patients and their family has the potential to have a large impact on the quality of life of persons near death, which can greatly impact public health and the comfort in dealing with our ultimate demise.

Exertional Tolerance Assessments After Mild Traumatic Brain Injury: A Systematic Review.

OBJECTIVE: To review the literature to identify and summarize strategies for evaluating responses to physical exertion after mild traumatic brain injury (mTBI) for clinical and research purposes. DATA SOURCES: PubMed and EBSCOhost through December 31, 2016. STUDY SELECTION: Two independent reviewers selected studies based on the following criteria: (1) inclusion of participants with mTBI/concussion, (2) use of a measurement of physiological or psychosomatic response to exertion, (3) a repeatable description of the exertion protocol was provided, (4) a sample of at least 10 participants with a mean age between 8 and 65 years, and (5) the article was in English. The search process yielded 2685 articles, of which 14 studies met the eligibility requirements. DATA EXTRACTION: A quality assessment using a checklist was conducted for each study by 2 independent study team members and verified by a third team member. Data were extracted by one team member and verified by a second team member. DATA SYNTHESIS: A qualitative synthesis of the studies revealed that most protocols used a treadmill or cycle ergometer as the exercise modality. Protocol methods varied across studies including differences in initial intensity determination, progression parameters, and exertion duration. Common outcome measures were self-reported symptoms, heart rate, and blood pressure. CONCLUSIONS: The strongest evidence indicates that exertional assessments can provide important insight about mTBI recovery and should be administered using symptoms as a guide. Additional studies are needed to verify optimal modes and protocols for post-mTBI exertional assessments.