The value of computer-administered self-report data in central nervous system clinical trials.
Over the past decade, significant research has been conducted into the development of computer-delivered interviews and scoring methods to assess disease severity in a number of central nervous system indications. In particular, equivalence has been demonstrated between gold standard assessments (such as the Hamilton depression and Hamilton anxiety rating scales) delivered either by computer or by clinicians, in a number of clinical studies. Such computer-based approaches have a number of advantages including the elimination of inter-rater variance and prevention of inclusion bias when inclusion criteria are based upon baseline ratings. In addition, some studies have demonstrated that computer-administered ratings can be more sensitive to the detection of treatment-related changes than clinician ratings. Much of this evidence has led to recent US Food and Drug Administration acceptance of certain computer-administered assessments as primary endpoints in depression clinical trials.
Byrom
Bill
B
ClinPhone Group Ltd, Lady Bay House, Meadow Grove, Nottingham NG23HF, UK. bbyrom@clinphone.com
Mundt
James C
JC
D002493:Central Nervous System Diseases / Q000175:diagnosis*; D002986:Clinical Trials as Topic / Q000379:methods*; D003936:Diagnosis, Computer-Assisted; D001330:Electronic Data Processing; D006801:Humans; D017063:Outcome Assessment, Health Care; D015203:Reproducibility of Results; D012720:Severity of Illness Index