Home aed trial

Patients in the AED group were more likely to report being extremely or quite a bit reassured by their treatment assignment. Automated external defibrillators AEDs can be used to identify and promptly terminate ventricular fibrillation and ventricular tachycardia in patients with sudden cardiac arrest SCA.

They may thereby allow bystanders to administer potentially life-saving therapy critical minutes earlier than can be accomplished by emergency medical personnel. As a consequence, AEDs are increasingly being deployed in public places, such as airports and shopping malls, and available evidence suggests that they do increase survival to hospital discharge following a SCA.

We conducted the Home Automatic External Defibrillator Trial HAT , an international, multicenter, randomized clinical trial, to compare the effect of placing an AED in the home versus no home AED in stable patients with a prior anterior myocardial infarction. As previously reported, home access to an AED had no significant effect on all-cause mortality.

In a randomized trial of patients with a recent acute ischemic event, home AED access was associated with trends toward worse quality of life on most subscales of the Short Form, particularly for social functioning. Between January 23, and October 20, , clinically stable patients with a history of anterior wall Q-wave or non-Q-wave myocardial infarction and who had a spouse or companion who was willing and able to call EMS, perform CPR, and use an AED were enrolled.

No overall survival advantage was observed for the home AED arm over a mean follow-up of Quality of life was a prespecified secondary endpoint of the HAT trial. Additional funding came from Philips Medical Systems and Laerdal Medical as a subsidiary distributor. The corporate sponsors were not involved in trial design, data collection or analysis, or manuscript preparation.

The authors had complete independence in the conduct of the analyses, interpretation of the data, and preparation of this paper and are solely responsible for its content.

Data were transferred to the DCRI for analyses. Both sub-scales were scored from 0—, with higher scores representing better psychological well-being and more energy. A change of 5 points or greater is considered clinically significant. The MHI-5 has shown excellent validity against more comprehensive measures of anxiety and depression.

In addition, we calculated the two summary scores for the SF covering physical and mental health. The SF Mental Health summary scale is a composite of the SF vitality, social functioning, role-emotional, and mental health subscales. For the two summary scales, we report results using the more recently devised scoring method in which the standard 0— scores are transformed to a norm-based score where the reference score has a mean of 50 and a standard deviation of There are no official standards for what constitutes a clinically significant difference in the SF scores.

To facilitate interpretation, we have used a one-quarter standard deviation difference between groups as the benchmark for the minimum clinically significant difference corresponding to approximately 2. The Influential Relationships Questionnaire IRQ : This is a item measure that assesses perceptions of three aspects of interpersonal relationships: care, overprotection, and criticism.

Defining a clinically significant difference as one quarter of a SD translates to 1. We used a modification of a questionnaire developed by Dracup and colleagues to examine how reassured patients felt knowing that CPR or an AED would be used if needed. The EuroQoL-5D EQ-5D consists of two parts: a a visual analog scale self-rated measure of generic health status where 0 represents the worst imaginable and the best imaginable health state and b the EQ-5D index, which summarizes and expresses the assessment of health status in five dimensions.

Continuous or ordinal variable comparisons between groups used the Wilcoxon rank-sum test, and group comparisons of categorical variables used a chi-square test. Summary statistics for continuous variables are reported as medians with interquartile ranges or means with standard deviations.

Discrete variables are summarized using frequencies and percentages. In addition, baseline characteristics of patients in the two treatment arms were well balanced Table 1. Median time from the qualifying anterior MI to enrollment was 2 years. Seventy-five percent had a history of previous coronary revascularization.

These differences in response rates were part of a pattern seen in the clinical follow-up of the entire trial. No clinically and statistically significant differences were found between groups for the SF Physical Health and Mental Health summary scales or the SF subscales for general health perceptions, physical functioning, role functioning-physical, role-functioning-emotional, and social functioning Appendix Table A2.

Continuous variables shown as median 25 th to 75 th percentiles. No differences by treatment group were found in the EQ-5D visual analog scale or single summary index. Continuous variable p-values are based on Wilcoxon Signed-rank test. Our study has 3 important findings. The Home Automatic External Defibrillator Trial was the first large-scale randomized test of the hypothesis that providing home AED access to patients at increased risk for SCA could lower all-cause mortality.

Previous studies have focused solely on cardiac arrest mortality. As reported previously, the trial did not demonstrate a survival benefit with home AED access, probably for several reasons. Second, although almost three-quarters of tachyarrhythmic SCAs occurred in the home, as expected, less than half were witnessed.

While the home AED does save lives when used appropriately in a timely fashion and although there was no documented instance of an inappropriate shock, HAT shows that it is an inefficient means of addressing the important public health problem of SCA in the population and in the manner of implementation we selected.

Assessing the effects of a home AED on patient QOL differs from most clinical trial assessments of QOL, since placing an AED in the home of an at risk patient does not require anything specific to be done to the patient beyond some explanation and training of household members. A reasonable presumption, therefore, is that effects of the AED on QOL most likely would be mediated primarily through the explanations given by study personnel when the patients were randomized or the sense of dependency or responsibility inculcated in the participants.

Prior to randomization, patients may not have been aware of their potential for SCA and finding out that their doctors felt that the risk was significant enough to consider participation in HAT could have induced a number of different psychological reactions.

Similarly, the unblinded treatment assignment might have augmented or mitigated those reactions in different ways, depending on knowledge about cardiac arrests and their treatment, prior experience with CPR and AEDs, and individual personality factors. However, most of the differences were not large enough to be considered clinically significant, and significant imbalances in some baseline scores combined with a small sample size made the results of the study inconclusive.

Several caveats should be kept in mind when evaluating our results. This may have led to undetected biases, although it seems unlikely that a clinically important difference in QOL was obscured by this follow-up difference.

Finally, two countries Germany and the Netherlands entered HAT late 16 patients total enrollment and were not included in the QOL portion of the study, in part due to the added expense of obtaining valid translations of the study instruments for those countries. Daniels for editing this manuscript. New to Flash? US prosecutors argued the daughter of former British newspaper baron Robert Maxwell was a knowing participant in the conduct of Epstein, who killed himself in a US jail in while awaiting his own sex crimes trial.

Maxwell did not testify but in a defiant statement to the court earlier this month said that prosecutors had failed to prove her guilt. The jury must reach a unanimous decision on each of the six counts facing Maxwell. Edward Rashad Lee Fulks , 26, of Lexwin Avenue, pleaded guilty to two counts of assault with a deadly weapon on a government official, fleeing or eluding arrest with a motor vehicle, possession of a firearm by a convicted felon, carrying a concealed weapon, being a habitual felon and several other minor charges.

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