Current clinical computing systems have evolved over the past three decades and can now be implemented from any touch-tone telephone using interactive voice response (IVR) technology, permitting accessibility 24 hours a day, 7 days a week. Ten years of research and development investigating computer automation of the Hamilton Depression Rating Scale (HDRS), involving 10 separate studies and 1761 subjects, shows strong correspondence with clinician administered assessments. The psychometric properties concerning assessment reliability and validity of clinician- and computer-administered versions of the HDRS are compared and points of divergence between methods drawn from a recently completed clinical trial are discussed. Future challenges facing expanded use of such clinical computing systems in clinical trials of investigational drugs are also discussed.
SearlesJSPerrineMWMundtJCHeizerJESelf-report of drinking using touch-tone telephone: Extending the limits of reliable daily contact. J Studies Alcohol.1995;56(4):375–382.
6.
HileMGAdkinsREDo substance abuse and mental health clients prefer automated assessments?Behavior Res Methods, Instruments, Computers.1997;29(2):146–150.
7.
TurnerCFKuLRogersSMLindbergLDPleckJHSonensteinFLAdolescent sexual behavior, drug use, and violence: Increased reporting with computer survey technology. Science.1998;280(May 8):867–873.
8.
AppelMVNichollsWLNew CASIC technologies at the U.S. Census Bureau. Report to the CASIC committee of technology testing. Washington, DC: U. S. Census Bureau; 1994.
9.
SchumacherRMHardzinskiMLSchwartzALIncreasing the usability of interactive voice response systems: Research and guidelines for phone-based interfaces. Human Factors.1995;37(2):251–264.
10.
MundtJCInteractive voice response systems in clinical research and treatment. Psychiatric Serv.1997;48(5):611–612.
11.
MaruishKAMundtJCKatzelnickDJFuture directions in psychological assessment in primary care settings. In KobakM. E. (Ed.) Handbook of Psychological Assessment in Primary Care Settings.Mahwah, NJ: Erlbaum Associates; In press.
12.
GreistJHThe computer as clinician assistant: assessment made simple. Psychiatric Serv.1998;49(4): 467–472.
13.
CortinaJMWhat is coefficient alpha? An examination of theory and applications. J App Psychology.1993;78(1):98–104.
14.
HamiltonM.A rating scale for depression. J Neurology, Neurosurgery, Psychiatry.1960;23:56–62.
15.
AltaianEGilmoreCPetersonJAndriukatisS.Psychiatric rating scales in diagnostic assessment and clinical treatment. Psychiatric Med.1991;9: 189–211.
16.
HedlundJLViewegBWThe Hamilton Rating Scale for Depression: A comprehensive review. J Operation Psychiatry.1979;10:149–161.
17.
MontgomerySAAsbergM.A new depression scale designed to be sensitive to change. Br J Psychiatry.1979;134:382–389.
18.
HamiltonM.Development of a rating scale for primary depressive illness. Br J Social Clin Psychol.1967;6:278–296.
19.
WilliamsJBWA structured interview guide for the Hamilton Depression Rating Scale. Arch General Psychiatry.1988;45:742–747.
20.
BechPAllerupPGramLFReisbyNRosenbergRJacobsenONagyA.The Hamilton Depression Scale: Evaluation of objectivity using logistic models. Acta Psychiatrica Scandinavica.1981;63:290–299.
21.
MillerIWBishopSNormanWHMaddeverH.The modified Hamilton Depression Rating Scale for Depression: reliability and validity. Psychiatry Res.1985;14:131–142.
22.
HooijerCZitmanEGGriezEvan TrilburgWWillemseADinkgreveMAHMThe Hamilton Depression Rating Scale (HDRS): Changes in scores as a function of training and version used. J Affective Disorders.1991;22:21–29.
23.
DemitrackMAFariesDHerreraJMDeBrotaDJPotterWZThe problem of measurement error in multisite clinical trials. Psychopharmacology Bull.1998;34(1): 19–24.
24.
AbramowitzJ.Effectiveness of psychological and pharmacological treatments for obsessive-compulsive disorder: A quantitative review. J Consulting Clin Psychol.1997;65:44–52.
25.
FisherSGreenbergRPHow sound is the double-blind design for evaluating psychotropic drugs?J Nervous Mental Disease.1993;181:345–350.
26.
KobakKAReynoldsWMRosenfeldRGreistJHDevelopment and validation of a computer-administered version of the Hamilton Depression Rating Scale. Psycholog Assess: A J Consulting Clin Psychol.1990;2(1):56–63.
27.
MundtJCKobakKATaylorLVHAdministration of the Hamilton Depression Rating Scale using interactive voice response technology. M.D. Computing.1998;15(1):31–39.
28.
KirschISapirsteinG.Listening to Prozac but hearing placebo: A meta-analysis of antidepressant medication. Prevention Treatment.1998;1:1–16.
29.
GibbonsRDClarkDCKupferDJExactly What Does the Hamilton Depression Rating Scale Measure. J Psychiatr Res.1993;27(3):259–273.
30.
DeBrotaDJDemitrackMALandinRA Comparison Between Interactive Voice Response System-Administered HAM-D and Clinician-Administered HAM-D. Presented at the 39th Annual Meeting of the New Clinical Drug Evaluation Unit Program, Boca Raton, FL, June 1–4, 1999.
31.
DottlSLTaylorLvKobakKAComputerassisted, telephone-administered version of the Brief Social Phobia Scale. Presented at the 38th Annual Meeting of the New Clinical Drug Evaluation Unit Program, Boca Raton, FL, June 10–13, 1998.
32.
KobakKAGreistJHJeffersonJWKatzelnickDJBurroughsD.The Utility of the IVR Hamilton Depression Rating Scale in Multi-site Depression Trial: A Feasibility Study. Presented at the 38th Annual Meeting of the New Clinical Drug Evaluation Unit Program, Boca Raton, FL, June 10–13, 1998.
33.
EwingHReesalRKobakKAGreistJHPatient satisfaction with computerized assessment in a multicenter clinical trial. Presented at the 38th Annual Meeting of the New Clinical Drug Evaluation Unit Program, Boca Raton, FL, June 10–13, 1998.
34.
KobakKAGreistJHJeffersonJWMundtJCKatzelnickDJComputerized assessment of depression and anxiety over the telephone using interactive voice response. MD Computing.1999;16:64–68.
35.
PetrieKAbellW.Responses of parasuicides to a computerized interview. Computers Human Behavior.1994;10(4):415–418.
36.
KatzelnickDJKobakKAHelstadCPGreistJHThe indirect costs of social phobia in managed care patients. Presented at the 37th Annual Meeting of the American College of Neuropsychopharmacology, Las Croabas, Puerto Rico, December 14–18, 1998.
37.
PerrineMWMundtJCSearlesJSLesterLSValidation of Daily Self-Reported Alcohol Consumption Using Interactive Voice Response (IVR) Technology. J Studies Alcohol.1995;56(5):487–490.
38.
FDA: 21 CRF Part 11 Electronic Records; Electronic Signatures. Washington, DC: Dept. of Health and Human Services; 1997.
39.
MillerLLCocchettoDMThe regulatory affairs professional in the “Hot Seat” in the drug development process. Drug Inf J.1997;31:805–823.
40.
LampeAJWeilerJMData capture for the sponsors’ and investigators’ perspective: Balancing quality, speed, and cost. Drug Inf J.1998;32:871–886.
41.
KubickWRThe elegant machine: Applying technology to optimize clinical trials. Drug Inf J.1998;32:861–869.
42.
SchoichetSCreaseyGKasayS.A systems infrastructure for sponsor/CRO collaboration on international clinical trials. Drug Inf J.1998;32:155–161.
