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"Strait, M"
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Sharing of clinical trial data among trialists: a cross sectional survey
by
Rathi, Vinay
,
Dzara, Kristina
,
Krumholz, Harlan M
in
Authors
,
Clinical decision making
,
Clinical trials
2012
Objective To investigate clinical trialists’ opinions and experiences of sharing of clinical trial data with investigators who are not directly collaborating with the research team.Design and setting Cross sectional, web based survey.Participants Clinical trialists who were corresponding authors of clinical trials published in 2010 or 2011 in one of six general medical journals with the highest impact factor in 2011.Main outcome measures Support for and prevalence of data sharing through data repositories and in response to individual requests, concerns with data sharing through repositories, and reasons for granting or denying requests.Results Of 683 potential respondents, 317 completed the survey (response rate 46%). In principle, 236 (74%) thought that sharing de-identified data through data repositories should be required, and 229 (72%) thought that investigators should be required to share de-identified data in response to individual requests. In practice, only 56 (18%) indicated that they were required by the trial funder to deposit the trial data in a repository; of these 32 (57%) had done so. In all, 149 respondents (47%) had received an individual request to share their clinical trial data; of these, 115 (77%) had granted and 56 (38%) had denied at least one request. Respondents’ most common concerns about data sharing were related to appropriate data use, investigator or funder interests, and protection of research subjects.Conclusions We found strong support for sharing clinical trial data among corresponding authors of recently published trials in high impact general medical journals who responded to our survey, including a willingness to share data, although several practical concerns were identified.
Journal Article
Muon reconstruction in Double Chooz
2015
We describe a muon track reconstruction algorithm for the reactor anti-neutrino experiment Double Chooz. The Double Chooz detector consists of two optically isolated volumes of liquid scintillator viewed by PMTs, and an Outer Veto above these made of crossed scintillator strips. Muons are reconstructed by their Outer Veto hit positions along with timing information from the other two detector volumes. In the ideal case of a through-going muon intersecting the center of the detector, the resolution is ∼40mm in each transverse dimension.
Journal Article
Muon capture on light isotopes in Double Chooz
Using the Double Chooz reactor neutrino detector, we have measured the products of µ − capture on 12C, 13C, 14N and 16O. Over a period of 490 days, we collected 2.3 × 106 stopping cosmic µ −, of which 1.8 × 105 captured on these nuclei in the inner detector. The resulting isotopes were tagged using prompt neutron emission (when applicable), the subsequent beta decays, and, in some cases, β-delayed neutrons. Production of these βn isotopes, primarily 9Li, which are ν ¯ e backgrounds, was found at a significance of 5.5σ. The probability of 9Li production per capture on natC is (2.4 ± 0.9(stat) ± 0.1(syst)) × 10−4. We have made the most precise measurement of the rate of 12C(µ −, ν)12B to date, 6.57 − 0.21 + 0.11 × 10 3 s − 1 , or ( 17.35 − 0.59 + 0.35 ) % of nuclear captures. By tagging excited states emitting gammas, the ground state transition rate to 12B is found to be 5.68 − 0.23 + 0.14 × 10 3 s − 1 .
Journal Article
Hospital variation in admission to intensive care units for patients with acute myocardial infarction
2015
The treatment for patients with acute myocardial infarction (AMI) was transformed by the introduction of intensive care units (ICUs), yet we know little about how contemporary hospitals use this resource-intensive setting and whether higher use is associated with better outcomes.
We identified 114,136 adult hospitalizations for AMI from 307 hospitals in the 2009 to 2010 Premier database using codes from the International Classification of Diseases, Ninth Revision, Clinical Modification. Hospitals were stratified into quartiles by rates of ICU admission for AMI patients. Across quartiles, we examined in-hospital risk-standardized mortality rates and usage rates of critical care therapies for these patients.
Rates of ICU admission for AMI patients varied markedly among hospitals (median 48%, Q1-Q4 20%-71%, range 0%-98%), and there was no association with in-hospital risk-standardized mortality rates (6% all quartiles, P = .7). However, hospitals admitting more AMI patients to the ICU were more likely to use critical care therapies overall (mechanical ventilation [from Q1 with lowest rate of ICU use to Q4 with highest rate 13%-16%], vasopressors/inotropes [17%-21%], intra-aortic balloon pumps [4%-7%], and pulmonary artery catheters [4%-5%]; P for trend < .05 in all comparisons).
Rates of ICU admission for patients with AMI vary substantially across hospitals and were not associated with differences in mortality, but were associated with greater use of critical care therapies. These findings suggest uncertainty about the appropriate use of this resource-intensive setting and a need to optimize ICU triage for patients who will truly benefit.
Journal Article
Acute Decompensated Heart Failure Is Routinely Treated as a Cardiopulmonary Syndrome
2013
Heart failure as recognized and treated in typical practice may represent a complex condition that defies discrete categorizations. To illuminate this complexity, we examined treatment strategies for patients hospitalized and treated for decompensated heart failure. We focused on the receipt of medications appropriate for other acute conditions associated with shortness of breath including acute asthma, pneumonia, and exacerbated chronic obstructive pulmonary disease.
Using Premier Perspective(®), we studied adults hospitalized with a principal discharge diagnosis of heart failure and evidence of acute heart failure treatment from 2009-2010 at 370 US hospitals. We determined treatment with acute respiratory therapies during the initial 2 days of hospitalization and daily during hospital days 3-5. We also calculated adjusted odds of in-hospital death, admission to the intensive care unit, and late intubation (intubation after hospital day 2). Among 164,494 heart failure hospitalizations, 53% received acute respiratory therapies during the first 2 hospital days: 37% received short-acting inhaled bronchodilators, 33% received antibiotics, and 10% received high-dose corticosteroids. Of these 87,319 hospitalizations, over 60% continued receiving respiratory therapies after hospital day 2. Respiratory treatment was more frequent among the 60,690 hospitalizations with chronic lung disease. Treatment with acute respiratory therapy during the first 2 hospital days was associated with higher adjusted odds of all adverse outcomes.
Acute respiratory therapy is administered to more than half of patients hospitalized with and treated for decompensated heart failure. Heart failure is therefore regularly treated as a broader cardiopulmonary syndrome rather than as a singular cardiac condition.
Journal Article
Insurance and Prehospital Delay in Patients ≤55 Years With Acute Myocardial Infarction
2015
This prospective study assessed whether gender differences in health insurance help explain gender differences in delay in seeking care for patients in the US, with acute myocardial infarction (AMI). We also assessed gender differences in such prehospital delay for AMI in Spain, a country with universal insurance. We used data from 2,951 US and 496 Spanish patients aged 18 to 55 years with AMI. US patients were grouped by insurance status: adequately insured, underinsured, or uninsured. For each country, we assessed the association between gender and prehospital delay (symptom onset to hospital arrival). For the US cohort, we modeled the relation between insurance groups and delay of >12 hours. US women were less likely than men to be uninsured but more likely to be underinsured, and a larger proportion of women than men experienced delays of >12 hours (38% vs 29%). We found no association between insurance status and delays of >12 hours in men or women. Only 17.3% of Spanish patients had delays of >12 hours, and there were no significant gender differences. In conclusion, women were more likely than men to delay, although it was not explained by differences in insurance status. The lack of gender differences in prehospital delays in Spain suggests that these differences may vary by health care system and culture.
Journal Article
Variation in the Diagnosis of Aspiration Pneumonia and Association with Hospital Pneumonia Outcomes
2018
National efforts to compare hospital outcomes for patients with pneumonia may be biased by hospital differences in diagnosis and coding of aspiration pneumonia, a condition that has traditionally been excluded from pneumonia outcome measures.
To evaluate the rationale and impact of including patients with aspiration pneumonia in hospital mortality and readmission measures.
Using Medicare fee-for-service claims for patients 65 years and older from July 2012 to June 2015, we characterized the proportion of hospitals' patients with pneumonia diagnosed with aspiration pneumonia, calculated hospital-specific risk-standardized rates of 30-day mortality and readmission for patients with pneumonia, analyzed the association between aspiration pneumonia coding frequency and these rates, and recalculated these rates including patients with aspiration pneumonia.
A total of 1,101,892 patients from 4,263 hospitals were included in the mortality measure analysis, including 192,814 with aspiration pneumonia. The median proportion of hospitals' patients with pneumonia diagnosed with aspiration pneumonia was 13.6% (10th-90th percentile, 4.2-26%). Hospitals with a higher proportion of patients with aspiration pneumonia had lower risk-standardized mortality rates in the traditional pneumonia measure (12.0% in the lowest coding and 11.0% in the highest coding quintiles) and were far more likely to be categorized as performing better than the national mortality rate; expanding the measure to include patients with aspiration pneumonia attenuated the association between aspiration pneumonia coding rate and hospital mortality. These findings were less pronounced for hospital readmission rates.
Expanding the pneumonia cohorts to include patients with a principal diagnosis of aspiration pneumonia can overcome bias related to variation in hospital coding.
Journal Article
Unexpected Opportunities for Manatee (Trichechus manatus latirostris) Education and Citizen Science
2022
The Florida manatee (Trichechus manatus latirostris) mainly resides within the state's coastal waters, but sharing this habitat with thousands of watercrafts, either registered, unregistered, or visiting, has proven challenging for its survival. The future of manatee research among scientists and citizen scientists has strong potential. By taking advantage of venues of opportunity such as boat shows, not only is local population data gathered, but a stronger positive relationship with the public is forged. When people feel they have a stake in the conservation of a species or habitat, they will likely become and remain engaged.
Journal Article
Comparison of Electrocardiographic Characteristics in Men Versus Women ≤ 55 Years With Acute Myocardial Infarction (a Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction Patients Substudy)
by
Dreyer, Rachel P.
,
Geda, Mary
,
Barrabés, José A.
in
Acute coronary syndromes
,
Adolescent
,
Adult
2017
Young women with acute myocardial infarction (AMI) have a worse prognosis than their male counterparts. We searched for differences in the electrocardiographic presentation of men and women in a large, contemporary registry of young adults with AMI that could help explain gender differences in outcomes. The qualifying electrocardiogram was blindly assessed by a central core lab in 3,354 patients (67% women) aged 18 to 55 years included in the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients study. Compared with men, women did not have a different frequency of sinus rhythm, and they had shorter PR and QRS intervals and longer QTc intervals. Intraventricular conduction disturbances were not different among genders. Notably, women were more likely than men to have abnormal Q waves in anterior leads and a lower frequency of Q waves in other territories. ST-segment elevation myocardial infarction (STEMI) diagnosis was less frequent in women than in men (44.6% vs 55.1%, p < 0.001). Among patients with STEMI, women had less magnitude and extent of ST-segment elevation than men. In patients with non-STEMI, the frequency, magnitude, and extent of ST-segment depression were not different among genders, but women had anterior ST-segment depression less frequently and anterior negative T waves more frequently compared with men. These differences remained statistically significant after adjusting for baseline characteristics. In conclusion, there are significant gender differences in the electrocardiographic presentation of AMI among young patients. Further studies are warranted to evaluate their impact on gender-related differences in the management and outcomes of AMI.
Journal Article