Differences in patient characteristics and care practices between two trials of therapeutic hypothermia.
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ABSTRACT:
SUBMITTER: Bonifacio SL
PROVIDER: S-EPMC6857796 | biostudies-literature | 2019 Jun
REPOSITORIES: biostudies-literature
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Differences in patient characteristics and care practices between two trials of therapeutic hypothermia.
Bonifacio Sonia L SL McDonald Scott A SA Chock Valerie Y VY Wusthoff Courtney J CJ Hintz Susan R SR Laptook Abbot R AR Shankara Seetha S Van Meurs Krisa P KP
Pediatric research 20190312 7
<h4>Background</h4>The Induced Hypothermia (IH) and Optimizing Cooling (OC) trials for hypoxic-ischemic encephalopathy (HIE) had similar inclusion criteria. The rate of death/moderate-severe disability differed for the subgroups treated with therapeutic hypothermia (TH) at 33.5 °C for 72 h (44% vs. 29%, unadjusted p = 0.03). We aimed to evaluate differences in patient characteristics and care practices between the trials.<h4>Methods</h4>We compared pre/post-randomization characteristics and care ...[more]
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Project description:BackgroundSeparate trials to evaluate therapeutic hypothermia after paediatric cardiac arrest for out-of-hospital and in-hospital settings reported no statistically significant differences in survival with favourable neurobehavioral outcome or safety compared to therapeutic normothermia. However, larger sample sizes might detect smaller clinical effects. Our aim was to pool data from identically conducted trials to approximately double the sample size of the individual trials yielding greater statistical power to compare outcomes.MethodsCombine individual patient data from two clinical trials set in forty-one paediatric intensive care units in USA, Canada and UK. Children aged at least 48 h up to 18 years old, who remained comatose after resuscitation, were randomized within 6 h of return of circulation to hypothermia or normothermia (target 33.0 °C or 36.8 °C). The primary outcome, survival 12 months post-arrest with Vineland Adaptive Behaviour Scales, Second Edition (VABS-II) score at least 70 (scored from 20 to 160, higher scores reflecting better function, population mean = 100, SD = 15), was evaluated among patients with pre-arrest scores ≥70.Results624 patients were randomized. Among 517 with pre-arrest VABS-II scores ≥70, the primary outcome did not significantly differ between hypothermia and normothermia groups (28% [75/271] and 26% [63/246], respectively; relative risk, 1.08; 95% confidence interval [CI], 0.81 to 1.42; p = 0.61). Among 602 evaluable patients, the change in VABS-II score from baseline to 12 months did not differ significantly between groups (p = 0.20), nor did, proportion of cases with declines no more than 15 points or improvement from baseline [22% (hypothermia) and 21% (normothermia)]. One-year survival did not differ significantly between hypothermia and normothermia groups (44% [138/317] and 38% [113/ 297], respectively; relative risk, 1.15; 95% CI, 0.95 to 1.38; p = 0.15). Incidences of blood-product use, infection, and serious cardiac arrhythmia adverse events, and 28-day mortality, did not differ between groups.ConclusionsAnalysis of combined data from two paediatric cardiac arrest targeted temperature management trials including both in-hospital and out-of-hospital cases revealed that hypothermia, as compared with normothermia, did not confer a significant benefit in survival with favourable functional outcome at one year.
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Project description:ImportanceMedical practices increasingly allow patients to schedule their own visits through online patient portals, yet little is known about who adopts direct scheduling or how this service is used.ObjectiveTo determine patient and visit characteristics associated with direct scheduling, visit patterns, and potential implications for access and continuity in the primary care setting.Design, setting, and participantsThis cross-sectional study used electronic health record (EHR) data from 17 adult primary care practices in a large academic medical center in the Boston, Massachusetts, area. Participants included patients 18 years or older who were attributed in the EHR to an active primary care physician at 1 of the included primary care practices, were enrolled in the patient portal, and had at least 1 visit to 1 of these practices between March 1, 2018, and March 1, 2019, the period of analysis. Data were analyzed from October 25, 2019, to April 14, 2020.Main outcomes and measuresAdoption of direct scheduling, defined as at least 1 use during the study period. Usual scheduling was defined as scheduling with clinic staff by telephone or in person.ResultsWe examined 134 225 completed visits by 62 080 patients (mean [SD] age, 51.1 [16.4] years, 37 793 [60.9%] women) attributed to 140 primary care physicians at 17 primary care practices. A total of 5020 patients (8.1% [95% CI, 7.9%-8.3%]) adopted direct scheduling, with an age range of 18 to 95 years. Compared with nonadopters in the same practices, adopters were younger (adjusted odds ratio [AOR] per additional year, 0.98 [95% CI, 0.98-0.99]) and were more likely to be White (AOR, 1.09 [95% CI, 1.01-1.17]) and commercially insured (AOR vs uninsured, 1.40 [95% CI, 1.11-1.76]) and to have more comorbidities (AOR per additional comorbidity, 1.07 [95% CI, 1.04-1.11]). Compared with usually scheduled visits, directly scheduled visits were more likely to be for general medical examinations (1979 visits [36.7%] vs 26 519 visits [21.9%]; P < .001) and with one's own primary care physician (5267 visits [95.2%] vs 94 634 visits [73.5%]; P < .001).Conclusions and relevanceThese findings suggest that direct scheduling was associated with greater primary care continuity. Early adopters were more likely to be young, White, and commercially insured, and to the extent these differences persist as direct scheduling is used more widely, this service may widen socioeconomic disparities in primary care access.
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Project description:BackgroundThis study evaluated the difference in brain metabolite profiles between normothermia and hypothermia reaching 25°C in humans in vivo.MethodsThirteen patients who underwent thoracic aorta surgery under moderate hypothermia were prospectively enrolled. Plasma samples were collected simultaneously from the arteries and veins to estimate metabolite uptake or release. Targeted metabolomics based on liquid chromatographic mass spectrometry and direct flow injection were performed, and changes in the profiles of respective metabolites from normothermia to hypothermia were compared. The ratios of metabolite concentrations in venous blood samples to those in arterial blood samples (V/A ratios) were calculated, and log2 transformation of the ratios [log2(V/A)] was performed for comparison between the temperature groups.ResultsTargeted metabolomics were performed for 140 metabolites, including 20 amino acids, 13 biogenic amines, 10 acylcarnitines, 82 glycerophospholipids, 14 sphingomyelins, and 1 hexose. Of the 140 metabolites analyzed, 137 metabolites were released from the brain in normothermia, and the release of 132 of these 137 metabolites was decreased in hypothermia. Two metabolites (dopamine and hexose) showed constant release from the brain in hypothermia, and 3 metabolites (2 glycophospholipids and 1 sphingomyelin) showed conversion from release to uptake in hypothermia. Glutamic acid demonstrated a distinct brain metabolism in that it was taken up by the brain in normothermia, and the uptake was increased in hypothermia.ConclusionTargeted metabolomics demonstrated various degrees of changes in the release of metabolites by the hypothermic brain. The release of most metabolites was decreased in hypothermia, whereas glutamic acid showed a distinct brain metabolism.
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Project description:The Therapeutic Hypothermia After Pediatric Cardiac Arrest trials will determine whether therapeutic hypothermia improves survival with good neurobehavioral outcome, as assessed by the Vineland Adaptive Behavior Scales Second Edition, in children resuscitated after cardiac arrest in the in-hospital and out-of-hospital settings. We describe the innovative efficacy outcome selection process during Therapeutic Hypothermia After Pediatric Cardiac Arrest protocol development.Consensus assessment of potential outcomes and evaluation timepoints.None.We evaluated practical and technical advantages of several follow-up timepoints and continuous/categorical outcome variants. Simulations estimated power assuming varying hypothermia benefit on mortality and on neurobehavioral function among survivors. Twelve months after arrest was selected as the optimal assessment timepoint for pragmatic and clinical reasons. Change in Vineland Adaptive Behavior Scales Second Edition from prearrest level, measured as quasicontinuous with death and vegetative status being worst-possible levels, yielded optimal statistical power. However, clinicians preferred simpler multicategorical or binary outcomes because of easier interpretability and favored outcomes based solely on postarrest status because of concerns about accurate parental assessment of prearrest status and differing clinical impact of a given Vineland Adaptive Behavior Scales Second Edition change depending on prearrest status. Simulations found only modest power loss from categorizing or dichotomizing quasicontinuous outcomes because of high expected mortality. The primary outcome selected was survival with 12-month Vineland Adaptive Behavior Scales Second Edition no less than two SD below a reference population mean (70 points), necessarily evaluated only among children with prearrest Vineland Adaptive Behavior Scales Second Edition greater than or equal to 70. Two secondary efficacy outcomes, 12-month survival and quasicontinuous Vineland Adaptive Behavior Scales Second Edition change from prearrest level, will be evaluated among all randomized children, including those with compromised function prearrest.Extensive discussion of optimal efficacy assessment timing, and of the advantages versus drawbacks of incorporating prearrest status and using quasicontinuous versus simpler outcomes, was highly beneficial to the final Therapeutic Hypothermia After Pediatric Cardiac Arrest design. A relatively simple, binary primary outcome evaluated at 12 months was selected, with two secondary outcomes that address the potential disadvantages of primary outcome.
| S-EPMC4396179 | biostudies-literature
Project description:Therapeutic hypothermia (TH) is a potent neuroprotectant for experimental ischemic stroke, but studies of TH for intracerebral hemorrhage (ICH) are emerging. We systematically reviewed the experimental literature to assess TH efficacy for ICH. We found 18 suitable papers; quality scores were moderately good. Compared with normothermia, TH reduced measures of edema (mean effect size (95% CI) -1.6873 (-2.3640, -1.0106), p?<?0.0001) or blood-brain barrier leakage (p?<?0.0001) and improved behavioral outcomes (p?<?0.0001). There was no evidence of publication bias. In this meta-analysis of available preclinical studies of ICH, TH is potently effective for reducing perihematomal edema and for improving behavioral outcomes.
| S-EPMC5612495 | biostudies-literature
Project description:ObjectiveTo determine whether an 18-month vanguard phase, in the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials, confirmed study feasibility and patient safety, a prerequisite to continued funding by the sponsor.DesignRandomized controlled trial.SettingPediatric intensive care and pediatric cardiac care units in 15 clinical sites in the United States and Canada.PatientsChildren aged 48 hrs to 18 yrs of age, with return of circulation after cardiac arrest.InterventionsTherapeutic hypothermia vs. therapeutic normothermia.Measurements and main resultsThe first 15 of 20 potential sites to obtain Institutional Review Board and subcontract approvals were selected as vanguard sites. Institutional Review Board approvals were obtained 92 days (median, interquartile range 65-114) and subcontracts signed 34 days (interquartile range 20-48) after distribution. Sites screened subjects at 13 days (interquartile range 9-21) and enrolled the first subjects 64 days (interquartile range 13-154) after study launch. The recruitment milestone was reached 4 months ahead of schedule, with no safety concerns identified. Overall recruitment in this ongoing trial remains on target.ConclusionsThe Therapeutic Hypothermia after Pediatric Cardiac Arrest vanguard phase proved beneficial for the investigators and funding agency. Because complex multicenter trials are rarely ready to launch when grant funds are received, the vanguard allowed time to refine the protocol and recruitment approaches. Competition for vanguard positions led to expedient Institutional Review Board and subcontract completion. Early success and sustained momentum contributed to recruitment at or above goals. Financial risks to the sponsor were minimized by tying funding for the full trial to achieving prespecified milestones. A vanguard phase may be a desirable strategy for the successful conduct of other complex clinical trials.
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| S-EPMC3235622 | biostudies-literature
Project description:ImportanceTherapeutic hypothermia is used for patients following both out-of-hospital and in-hospital cardiac arrest. However, randomized trials on its efficacy for the in-hospital setting do not exist, and comparative effectiveness data are limited.ObjectiveTo evaluate the association between therapeutic hypothermia and survival after in-hospital cardiac arrest.Design, setting, and patientsIn this cohort study, within the national Get With the Guidelines-Resuscitation registry, 26 183 patients successfully resuscitated from an in-hospital cardiac arrest between March 1, 2002, and December 31, 2014, and either treated or not treated with hypothermia at 355 US hospitals were identified. Follow-up ended February 4, 2015.ExposureInduction of therapeutic hypothermia.Main outcomes and measuresThe primary outcome was survival to hospital discharge. The secondary outcome was favorable neurological survival, defined as a Cerebral Performance Category score of 1 or 2 (ie, without severe neurological disability). Comparisons were performed using a matched propensity score analysis and examined for all cardiac arrests and separately for nonshockable (asystole and pulseless electrical activity) and shockable (ventricular fibrillation and pulseless ventricular tachycardia) cardiac arrests.ResultsOverall, 1568 of 26 183 patients with in-hospital cardiac arrest (6.0%) were treated with therapeutic hypothermia; 1524 of these patients (mean [SD] age, 61.6 [16.2] years; 58.5% male) were matched by propensity score to 3714 non-hypothermia-treated patients (mean [SD] age, 62.2 [17.5] years; 57.1% male). After adjustment, therapeutic hypothermia was associated with lower in-hospital survival (27.4% vs 29.2%; relative risk [RR], 0.88 [95% CI, 0.80 to 0.97]; risk difference, -3.6% [95% CI, -6.3% to -0.9%]; P = .01), and this association was similar (interaction P = .74) for nonshockable cardiac arrest rhythms (22.2% vs 24.5%; RR, 0.87 [95% CI, 0.76 to 0.99]; risk difference, -3.2% [95% CI, -6.2% to -0.3%]) and shockable cardiac arrest rhythms (41.3% vs 44.1%; RR, 0.90 [95% CI, 0.77 to 1.05]; risk difference, -4.6% [95% CI, -10.9% to 1.7%]). Therapeutic hypothermia was also associated with lower rates of favorable neurological survival for the overall cohort (hypothermia-treated group, 17.0% [246 of 1443 patients]; non-hypothermia-treated group, 20.5% [725 of 3529 patients]; RR, 0.79 [95% CI, 0.69 to 0.90]; risk difference, -4.4% [95% CI, -6.8% to -2.0%]; P < .001) and for both rhythm types (interaction P = .88).Conclusions and relevanceAmong patients with in-hospital cardiac arrest, use of therapeutic hypothermia compared with usual care was associated with a lower likelihood of survival to hospital discharge and a lower likelihood of favorable neurological survival. These observational findings warrant a randomized clinical trial to assess efficacy of therapeutic hypothermia for in-hospital cardiac arrest.
| S-EPMC5486217 | biostudies-literature
Project description:BackgroundNo primary practice care model has been shown to be superior in achieving high-quality primary care. We aimed to identify the organizational characteristics of primary care practices that provide high-quality primary care.MethodsWe performed a cross-sectional observational study involving a stratified random sample of 37 primary care practices from 3 regions of Quebec. We recruited 1457 patients who had 1 of 2 chronic care conditions or 1 of 6 episodic care conditions. The main outcome was the overall technical quality score. We measured organizational characteristics by use of a validated questionnaire and the Team Climate Inventory. Statistical analyses were based on multilevel regression modelling.ResultsThe following characteristics were strongly associated with overall technical quality of care score: physician remuneration method (27.0; 95% confidence interval [CI] 19.0-35.0), extent of sharing of administrative resources (7.6; 95% CI 0.8-14.4), presence of allied health professionals (15.3; 95% CI 5.4-25.2) and/or specialist physicians (19.6; 95% CI 8.3-30.9), the presence of mechanisms for maintaining or evaluating competence (7.7; 95% CI 3.0-12.4) and average organizational access to the practice (4.9; 95% CI 2.6-7.2). The number of physicians (1.2; 95% CI 0.6-1.8) and the average Team Climate Inventory score (1.3; 95% CI 0.1-2.5) were modestly associated with high-quality care.InterpretationWe identified a common set of organizational characteristics associated with high-quality primary care. Many of these characteristics are amenable to change through practice-level organizational changes.
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Project description:OBJECTIVE:We examined relationships between organizational policies and practices (OPPs) (safety practices, ergonomic practices, and people-oriented culture) and work limitations in a sample of hospital workers. METHODS:We used the 6-item Work Limitations Questionnaire (WLQ) to assess workers' perceptions of health-related work limitations. Self-reported OPPs and the WLQ were collected from workers in Boston, Massachusetts (n?=?1277). We conducted random-intercept multi-level logistic regression models for each OPP using stepwise selection of covariates. RESULTS:As the unit-average ergonomic practice score increased by one, the odds of a worker reporting work limitations decreased by approximately 39% (P-value?=?0.018), adjusted for job title, age, and body mass index. A similar relationship existed for people-oriented culture (P-value?=?0.038). The association between safety practices and work limitations was similar, but not statistically significant. CONCLUSIONS:This study demonstrated the importance of workplace OPPs. OPPs that promote positive and supportive environments and that foster improvements in ergonomics may help reduce work limitations.
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