Key result
Screening ECGs in healthy psychiatric research volunteers yielded abnormal or borderline reports in 22.4% of subjects, though none were clinically significant or led to study exclusion.
Why the study?
Does screening ECG detect significant cardiac pathology or affect study eligibility in healthy volunteers for psychiatric research?
Cross-Sectional (n=500)
Does screening ECG detect significant cardiac pathology or affect study eligibility in healthy volunteers for psychiatric research?
Screening ECGs in healthy volunteers for psychiatric research frequently yield false-positive abnormalities without detecting significant cardiac pathology or altering study eligibility.
Frequent false-positive ECGs in healthy psychiatric volunteers caution against routine screening; leaves open its value for research eligibility criteria.
AIMS: While there is controversy regarding utility of screening electrocardiograms (ECGs) in competitive athletes and children exposed to psychostimulants, there is no data on the use of screening ECGs in psychiatric research. We aimed to examine the prevalence and clinical significance of ECG abnormalities and their impact on eligibility for studies. METHODS: We analysed 500 consecutive ECG reports from physically healthy volunteers who had a negative cardiac history, normal cardiovascular examination and no other significant medical illnesses. For the purpose of this report, all ECGs were over-read by one cardiologist. RESULTS: The mean age of our cohort was 28.3 ± 8.0 years. A total of 112 (22.4%) ECGs were reported as abnormal (14.2%) or borderline (8.2%). These abnormalities were considered clinically insignificant in all but eight subjects (1.6%) who underwent evaluation with an echocardiogram. All echocardiograms were normal. No subject was excluded from studies. After the over-reading, no abnormalities or isolated bradycardia were present in 37 of 112 (33%) ECGs that were initially reported as abnormal or borderline, while minor abnormalities were found in 7 of 204 (3.4%) ECGs that were reported as normal. CONCLUSIONS: Although screening ECGs did not detect significant cardiac pathology or affect eligibility for our studies, over 20% of subjects were labelled as having an abnormal or borderline ECG which was incorrect in one-third of cases. Strategies to minimise unintended consequences of screening are discussed.
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Pavletic et al. (2013) conducted a cross-sectional in Healthy volunteers in psychiatric research (n=500). Screening electrocardiograms was evaluated on Prevalence of abnormal or borderline ECGs. Screening ECGs in healthy psychiatric research volunteers yielded abnormal or borderline reports in 22.4% of subjects, though none were clinically significant or led to study exclusion.
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