Defining complexity in terms of the misalignment between patient needs and services offers new insights in how to research and develop solutions to patient care needs.
Improvement has been anecdotally observed in patients with persistent postconcussion symptoms (PCS) after mild traumatic brain injury following treatment with hyperbaric oxygen (HBO). The effectiveness of HBO as an adjunctive treatment for PCS is unknown to date. OBJECTIVES To compare the safety of and to estimate the efficacy for symptomatic outcomes from standard PCS care alone, care supplemented with HBO, or a sham procedure. DESIGN, SETTING, AND PARTICIPANTS Multicenter, double-blind, sham-controlled clinical trial of 72 military service members with ongoing symptoms at least 4 months after mild traumatic brain injury enrolled at military hospitals in Colorado, North Carolina, California, and Georgia between April 26, 2011, and August 24, 2012. Assessments occurred before randomization, at the midpoint, and within 1 month after completing the interventions. INTERVENTIONS Routine PCS care was provided in specialized clinics. In addition, participants were randomized 1:1:1 to 40 HBO sessions administered at 1.5 atmospheres absolute (ATA), 40 sham sessions consisting of room air at 1.2 ATA, or no supplemental chamber procedures. MAIN OUTCOMES AND MEASURES The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) served as the primary outcome measure. A change score of at least 2 points on the RPQ-3 subscale (range, 0-12) was defined as clinically significant. Change scores from baseline were calculated for the RPQ-3 and for the total RPQ. Secondary measures included additional patient-reported outcomes and automated neuropsychometric testing. RESULTS On average, participants had sustained 3 lifetime mild traumatic brain injuries; the most recent occurred 23 months before enrollment. No differences were observed between groups for improvement of at least 2 points on the RPQ-3 subscale (25% in the no intervention group, 52% in the HBO group, and 33% in the sham group; P = .24). Compared with the no intervention group (mean change score, 0.5; 95% CI, −4.8 to 5.8; P = .91), both groups undergoing supplemental chamber procedures showed improvement in symptoms on the RPQ (mean change score, 5.4; 95% CI, −0.5 to 11.3; P = .008 in the HBO group and 7.0; 95% CI, 1.0-12.9; P = .02 in the sham group). No difference between the HBO group and the sham group was observed (P = .70). Chamber sessions were well tolerated. CONCLUSIONS AND RELEVANCE Among service members with persistent PCS, HBO showed no benefits over sham compressions. Both intervention groups demonstrated improved outcomes compared with PCS care alone. This finding suggests that the observed improvements were not oxygen mediated but may reflect nonspecific improvements related to placebo effects. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01306968
The current evidence base is inadequate to inform providers and policymakers about the most effective strategies for managing or allocating scarce resources during mass casualty events. Consensus on methodological standards that encompass a range of study designs is needed to guide future research and strengthen the evidence base. Evidentiary standards should be developed to promote consensus interpretations of the evidence supporting individual strategies.
Learning collaboratives are increasingly used as mechanisms to support and hasten the diffusion and implementation of innovation, clinical evidence, and effective models of care. Factors contributing to the collaboratives' success or failure are poorly understood. The Agency for Healthcare Research and Quality (AHRQ) has sponsored collaboratives for nearly two decades to support improvements in health care quality and value by accelerating the diffusion and implementation of innovation. We examined AHRQ's experience with these collaboratives to characterize their attributes, identify factors that might contribute to their success or failure, and assess the challenges they encountered. Building on the literature and insights from AHRQ's experience, we propose a taxonomy that can offer guidance to decision makers and funders about the factors they should consider in developing collaboratives and planning their evaluation, as well as to researchers who seek to conduct research that will ultimately help decision makers make better investments in diffusing innovation and evidence.
The purpose of this study was to examine physical work performance, energy cost, and physiological fatigue in military personnel during simulated operational conditions. Using a within-subject, repeated-measures design, 34 military personnel volunteered to undergo two experimental conditions: with body armor (BA+) and without BA (BA-). Subjects walked on a treadmill for 30 minutes and completed a physical performance battery during each of two sessions, which were separated by > or = 5 days. Subjects with BA+ as compared with BA- had significantly greater increases in: oxygen uptake (VO2) at slow (16.8 +/- 1.5 vs. 18.8 +/- 1.7 mL x kg(-1) x min(-1)) and moderate paces (34.8 +/- 3.9 vs. 40.8 +/- 5.0 mL x kg(-1) x min(-1)); blood lactate at a moderate pace (4.0 +/- 2.4 vs. 6.7 +/- 2.6 mmol/L); heart rate at slow (107 +/- 14 vs. 118 +/- 16 beats per minute) and moderate paces (164 +/- 16 vs. 180 +/- 13 beats per minute); and ratings of perceived physical exertion at slow (8.4 +/- 1.5 vs. 10.4 +/- 1.8) and moderate paces (14.3 +/- 2.3 vs. 16.7 +/- 2.1). Physical tasks were significantly affected by BA: under BA+, men performed 61% fewer pull-ups and women's hang time was reduced by 63%; stair stepping was reduced by 16% for both men and women. BA significantly impacted the physical work capacity of militarily relevant tasks. Specifically, wearing BA significantly increased VO2 when walking at both slow and moderate paces. The potential for physical exhaustion is high and performance of physical tasks is markedly impaired when wearing BA.
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