Biomedical subjects
R L Wears
Publications and source records attributed to R L Wears.
Organisations and safety in health care.
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Ethical dilemmas in a randomized trial of asthma treatment: can Bayesian statistical analysis explain the results?
OBJECTIVES: The original objective was to determine whether the use of bilevel positive airway pressure (BiPAP) ventilation would reduce the need for endotracheal intubation, the length of hospital stay, and hospital charges in patients with status asthmaticus. The development of physician treatment bias made patient enrollment difficult. The article subsequently describes the use of Bayesian statistics to explain study results when this bias occurs. METHODS: This study was a prospective, randomized controlled clinical trial conducted over a 34.5-month period at an urban university hospital with an emergency department census of 94,000 annual visits. Patients remaining in status asthmaticus after initial standard treatment with inhaled beta-agonists and steroids were randomized to receive BiPAP ventilation plus standard treatment versus standard treatment alone (non-BiPAP), with intubation for either group as needed. Patients with concurrent cardiac or other pulmonary diseases were excluded. The primary outcome measures were endotracheal intubation rate and length of hospital stay. Secondary outcome measures included vital signs (respiratory rate, pulse rate, blood pressure), changes in expiratory peak flow, changes in pulse oximetry values, and hospital charges. Data were analyzed using Fisher's exact test, Mann-Whitney tests, and Bayesian statistics. For patients enrolled in the study more than once, data analysis was performed on the first enrollment only. RESULTS: Nineteen patients were enrolled in the BiPAP group and 16 patients in the non-BiPAP group. Patients were frequently enrolled more than once and the data from the subsequent enrollments were excluded from the analysis. A marked decrease in enrollment, due to physician treatment bias, led to a premature termination of the study. Demographics showed that the groups were similar in age, sex, initial peak flow rate, and arterial blood gas measurements. There was a 7.3% increase (95% CI = -22 to +45) in the intubation rate in the non-BiPAP group (n = 2) compared with that for the BiPAP group (n = 1). No significant difference was seen in length of hospital stay or hospital charges, although there was a favorable trend toward the BiPAP group. Complications encountered in the BiPAP group included one patient with discomfort associated with the nasal BiPAP mask. Bayesian analysis demonstrated that in order for the collected data to be convincing at the 95% confidence level, the prior conviction among treating physicians that BiPAP was a successful treatment modality would have had to be 98.9%. CONCLUSIONS: In this study, BiPAP appeared to have no deleterious effects in patients with status asthmaticus, with a trend toward decreased endotracheal intubation rate, decreased length of hospital stay, and decreased hospital charges. Although further study with more patients is needed to determine the clinical and statistical significance of this intervention, ethical concerns regarding withholding BiPAP treatment from the patients in the control group forced a premature termination of the study in the authors' institution.
Effect of state legislation prohibiting denial of emergency department patient claims.
STUDY OBJECTIVE: On July 1, 1996, two Florida state laws were implemented to prevent denial of legitimate patient claims. Our objective was to determine whether the laws have been effective in reducing inappropriate denials as measured by the proportion of claims and charges denied. METHODS: A comprehensive set of claims for in-state emergency physician services from a physician billing company were analyzed for the period January 1996 through June 1997, covering 6 months before and 12 months after the effective date of state legislation. The number of facilities included in the data varied from 55 to 67 (mean 63). Denials were classified into 6 categories by payer type. Gross denials were those claims that were completely not paid by the payer, net denials represented the amount denied after patient payments. Downcoding was not examined in this study. Main outcome measures were the proportion of claims and charges denied before and after July 1, 1996. RESULTS: The classification of relative proportions of primary payers did not change appreciably over the study period. The proportion of denied claims decreased significantly (Kruskal-Wallis P <.001), starting 2 months after implementation. CONCLUSION: After initiation of state legislation, payers continue to inappropriately deny claims, although the number of claims and total charges denied has decreased. In response to this legislation, payers are denying larger claims and patient copayments have increased.
Human error in medicine: promise and pitfalls, part 1.
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Errors in emergency medicine: a call to action.
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Errors conference: executive summary.
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Setting the educational agenda and curriculum for error prevention in emergency medicine.
Graduate and postgraduate medical education currently teaches safety in patient care by instilling a deep sense of personal responsibility in student practitioners. To increase safety, medical education will have to begin to introduce new concepts from the "safety sciences," without losing the advantages that the values of commitment and responsibility have gained. There are two related educational goals. First, we in emergency medicine (EM) must develop a group of safety-educated practitioners who can understand and implement safe practice innovations in their clinical settings, and will be instrumental in changing our professional culture. Second, EM must develop a group of teachers and researchers who can begin to deeply understand how safety is maintained in emergency care, develop solutions that will work in emergency department settings, and pass on those insights and innovations. The specifics of what should be taught are outlined briefly. Work is currently ongoing to identify more specifically the core content that should be included in educational programs on patient safety in emergency care. Finally, careful attention will have to be paid to the way in which these principles are taught. It seems unlikely that a series of readings and didactic lectures alone will be effective. The analysis of meaningful cases, perhaps supplemented by high-fidelity simulation, seems to hold promise for more successful education in patient safety.
Effect of exogenous melatonin on mood and sleep efficiency in emergency medicine residents working night shifts.
OBJECTIVE: To determine whether melatonin taken prior to attempted daytime sleep sessions will improve daytime sleep quality, nighttime sleepiness, and mood state in emergency medicine (EM) residents, changing from daytime to nighttime work schedules. METHODS: A prospective, randomized, double-blind crossover design was used in an urban emergency department. Emergency medicine residents who worked two strings of nights, of at least three nights' duration each, and separated by at least one week of days were eligible. Subjects were randomized to receive either melatonin 1 mg or placebo, 30 to 60 minutes prior to their daytime sleep session, for three consecutive days after each night shift. Crossover to the other agent occurred during their subsequent night shifts. Objective measures of quality of daytime sleep were obtained using the Actigraph 1000. This device measures sleep motion and correlates with sleep efficiency, total sleep time, time in bed, and sleep latency. The Profile of Mood States (POMS) and the Stanford Sleepiness Scale (SSS) were also used to quantify nighttime mood and sleepiness. RESULTS: Among the 19 volunteers studied, there was no difference in sleep efficiency (91.16% vs 90.98%, NS), sleep duration (379.6 min vs 342.7 min, NS), or sleep latency (7.59 min vs 6.80 min, NS), between melatonin and placebo, respectively. In addition, neither the POMS total mood disturbance (5.769 baseline vs 12.212 melatonin vs 5.585 placebo, NS) nor the SSS (1.8846 baseline vs 2.2571 melatonin vs 2.1282 placebo, NS) demonstrated a statistical difference in nighttime mood and sleepiness between melatonin and placebo. CONCLUSIONS: There are no beneficial effects of a 1-mg melatonin dose on sleep quality, alertness, or mood state during night shift work among EM residents.
The aerial palaces of decision analysis redux.
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Comments on "Clinical decision making: an emergency medicine perspective".
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Estimating the cost of medical care.
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Statistical models and Occam's razor.
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Reliability of editors' subjective quality ratings of peer reviews of manuscripts.
CONTEXT: Quality of reviewers is crucial to journal quality, but there are usually too many for editors to know them all personally. A reliable method of rating them (for education and monitoring) is needed. OBJECTIVE: Whether editors' quality ratings of peer reviewers are reliable and how they compare with other performance measures. DESIGN: A 3.5-year prospective observational study. SETTING: Peer-reviewed journal. PARTICIPANTS: All editors and peer reviewers who reviewed at least 3 manuscripts. MAIN OUTCOME MEASURES: Reviewer quality ratings, individual reviewer rate of recommendation for acceptance, congruence between reviewer recommendation and editorial decision (decision congruence), and accuracy in reporting flaws in a masked test manuscript. INTERVENTIONS: Editors rated the quality of each review on a subjective 1 to 5 scale. RESULTS: A total of 4161 reviews of 973 manuscripts by 395 reviewers were studied. The within-reviewer intraclass correlation was 0.44 (P<.001), indicating that 20% of the variance seen in the review ratings was attributable to the reviewer. Intraclass correlations for editor and manuscript were only 0.24 and 0.12, respectively. Reviewer average quality ratings correlated poorly with the rate of recommendation for acceptance (R=-0.34) and congruence with editorial decision (R=0.26). Among 124 reviewers of the fictitious manuscript, the mean quality rating for each reviewer was modestly correlated with the number of flaws they reported (R=0.53). Highly rated reviewers reported twice as many flaws as poorly rated reviewers. CONCLUSIONS: Subjective editor ratings of individual reviewers were moderately reliable and correlated with reviewer ability to report manuscript flaws. Individual reviewer rate of recommendation for acceptance and decision congruence might be thought to be markers of a discriminating (ie, high-quality) reviewer, but these variables were poorly correlated with editors' ratings of review quality or the reviewer's ability to detect flaws in a fictitious manuscript. Therefore, they cannot be substituted for actual quality ratings by editors.
Positive-outcome bias and other limitations in the outcome of research abstracts submitted to a scientific meeting.
CONTEXT: Studies with positive results are more likely to be published in biomedical journals than are studies with negative results. However, many studies submitted for consideration at scientific meetings are never published in full; bias in this setting is poorly studied. OBJECTIVE: To identify features associated with the fate of research abstracts submitted to a scientific meeting. DESIGN AND SETTING: Prospective observational cohort, with 5-year follow-up of all research submitted for consideration to the major annual 1991 US research meeting in the specialty of emergency medicine. PARTICIPANTS: All research abstracts submitted for consideration at the meeting for possible presentation. MAIN OUTCOME MEASURES: Characteristics associated with acceptance for presentation at the meeting and subsequent publication as a full manuscript. RESULTS: A total of 492 research abstracts were submitted from programs in emergency medicine and other specialties affiliated with 103 US medical schools. A total of 179 (36%) were accepted for presentation and 214 (43%) were published in 44 journals. Of the 179 abstracts accepted for presentation, 111 studies were published. Scientific quality of abstracts or prestige of the journal in which the study was eventually published did not predict either of these outcomes. The best predictors (by logistic regression) of meeting acceptance were a subjective "originality" factor (odds ratio [OR], 2.07; 95% confidence interval [CI], 1.13-3.89) and positive results (OR, 1.99; 95% CI, 1.07-3.84), and, for publication, meeting acceptance (OR, 2.49; 95% CI, 1.49-4.35) and large sample size (OR, 2.26; 95% CI, 1.23-4.31). Forty-nine percent (241) of abstracts did not report on blinding, and 24% (118) did not report on randomization. Acceptance and publication were both more likely for positive outcomes (P=.03). Funnel plots showed the classic distribution of positive-outcome ("publication") bias at each of the submission, acceptance, and publication phases. Meeting acceptance predicted publication with a sensitivity of only 51%, specificity of 71%, positive predictive value of 57%, and negative predictive value of 66%. CONCLUSIONS: Positive-outcome bias was evident when studies were submitted for consideration and was amplified in the selection of abstracts for both presentation and publication, neither of which was strongly related to study design or quality.
Unpublished research from a medical specialty meeting: why investigators fail to publish.
CONTEXT: It is not known whether peer review of research abstracts submitted to scientific meetings influences subsequent attempts at publication. OBJECTIVE: To determine why research submitted to a scientific meeting is not subsequently published. We hypothesized that authors of abstracts rejected by a meeting are less likely to pursue publication than those whose abstracts are accepted, regardless of research quality. DESIGN AND PARTICIPANTS: Blinded review of abstracts submitted to a medical specialty meeting in 1991 and not published as full manuscripts within 5 years. In 1996, authors of 266 unpublished studies were asked to complete questionnaires. MAIN OUTCOME MEASURES: Submission of a full manuscript to a journal between 1991 and 1996; failure to submit a manuscript to a journal because the investigator believed it would not be accepted for publication. RESULTS: A total of 223 (84%) of the unpublished investigators returned the questionnaire. Only 44 (20%) had submitted manuscripts to a journal. Manuscript submission was not associated with abstract quality (odds ratio [OR], 1.16; 95% confidence interval [CI], 0.80-1.64), positive results (OR, 0.75; 95% CI, 0.31-1.57), or other study characteristics. Having an abstract accepted for presentation at the meeting weakly predicted submission of a manuscript to a journal (OR, 1.88; 95% CI, 0.84-4.10). Authors of accepted abstracts were significantly less likely to believe a journal would not publish their manuscript than were authors of rejected abstracts (OR, 0.23; 95% CI, 0.0001-0.61). CONCLUSIONS: Study characteristics do not predict attempts to publish research submitted to a scientific meeting. Investigators whose research is rejected by a meeting are pessimistic about chances for publication and may make less effort to publish.