Key result
Computer-assisted digoxin dosage calculation yielded similar efficacy and no toxicity compared to unaided physician judgment, though prediction errors were unacceptably large.
Why the study?
Does a computer program for computing digoxin dosage improve the achievement of desired serum concentrations and clinical efficacy compared to unaided physician judgment in patients requiring digitalis?
RCT (n=42)
randomly divided
Does a computer program for computing digoxin dosage improve the achievement of desired serum concentrations and clinical efficacy compared to unaided physician judgment in patients requiring digitalis?
Computer-assisted digoxin dosing based on patient size and renal function did not sufficiently reduce prediction errors compared to physician judgment, highlighting the necessity of therapeutic drug monitoring (measuring serum concentrations for feedback adjustment).
Computer assistance adds no benefit over physician judgment for digoxin; reinforces therapeutic drug monitoring over unvalidated pharmacokinetic predictions.
In 42 patients requiring digitalis, and randomly divided into two groups, the performance of a computer program using patient size and renal function to compute digoxin dosage was compared to that of unaided physician judgment. Serum digoxin concentrations were measured repeatedly. Efficacy was measured by changes in the manifestations of heart failure, and toxicity by electrocardiographic criteria. For each patient, physicians specified a desired serum digoxin concentration and predicted this concentration at each visit. For one group, the computer program suggested the dosage needed to achieve the desired digoxin concentration. Efficacy was the same in both groups, and there was no toxicity. Although the computer slightly outperformed the physicians, prediction and achievement errors were unacceptably large. Hence, much between-patient variability in serum digoxin concentrations remains unexplained after adjustments for dose, body size and renal function. This argues for measurement of digoxin concentrations and their use for feedback dosage adjustment. (N Engl J Med 289:441–446, 1973)
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Peck et al. (1973) conducted an RCT in Heart failure requiring digitalis (n=42). Computer-assisted digoxin dosage calculation vs. Unaided physician judgment was evaluated on Efficacy (changes in manifestations of heart failure) and toxicity (electrocardiographic criteria). Computer-assisted digoxin dosage calculation yielded similar efficacy and no toxicity compared to unaided physician judgment, though prediction errors were unacceptably large.
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