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Titolo:
RANDOMIZED CLINICAL-TRIALS IN SINGLE PATIENTS DURING A 2-YEAR PERIOD
Autore:
LARSON EB; ELLSWORTH AJ; OAS J;
Indirizzi:
UNIV WASHINGTON,MED CTR,RD-30 SEATTLE WA 98195 UNIV WASHINGTON,SCH MED,DEPT MED SEATTLE WA 98195 UNIV WASHINGTON,SCH MED,DEPT PHARM SEATTLE WA 98195 UNIV WASHINGTON,SCH MED,DEPT FAMILY MED SEATTLE WA 98195 UNIV WASHINGTON,SCH PHARM SEATTLE WA 98195
Titolo Testata:
JAMA, the journal of the American Medical Association
fascicolo: 22, volume: 270, anno: 1993,
pagine: 2708 - 2712
SICI:
0098-7484(1993)270:22<2708:RCISPD>2.0.ZU;2-1
Fonte:
ISI
Lingua:
ENG
Soggetto:
INDIVIDUAL PATIENTS; N-OF-1;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
16
Recensione:
Indirizzi per estratti:
Citazione:
E.B. Larson et al., "RANDOMIZED CLINICAL-TRIALS IN SINGLE PATIENTS DURING A 2-YEAR PERIOD", JAMA, the journal of the American Medical Association, 270(22), 1993, pp. 2708-2712

Abstract

Objective.-To describe the feasibility of a single patient trial (SPT) service and study the influence of formal SPTs on therapeutic precision. Design.-Descriptive and evaluative study of SPTs. All planned trials were double-blind, randomized, multiple crossover trials. Other key features of individual trials were random assignment of order and assessment of predetermined explicit outcomes. Patients and physicians rated level of confidence in treatment before and after the SPT on visual analog scales. Setting.-Two-year experience (September 1988 to September 1990) of an SPT trial referral service available to physicians in an academic medical center. Outcome Measures.-The number of planned and completed SPTs; proportion of completed trials yielding definitiveanswers; patient- and physician-rated levels of confidence in treatment pre- and post-SPT; time-motion studies to estimate resource consumption (costs) for selected SPTs. Results.-Of 34 completed trials, 17 were judged to give definitive results whereas 17 showed trends only. Results favored active treatment in 16 trials that led to treatment being continued (nine patients) or started (seven patients). Treatment wasdiscontinued (seven patients) or not started (11 patients) based on 18 trial results that demonstrated active treatment was ineffective (seven), harmful (two), or apparently equivalent (nine). Most patients (65%) reported no change in their already high level of confidence in therapy as a result of trials, whereas physicians' confidence levels in therapy either increased or decreased post-SPT depending on the direction of trial results. Patients consistently rated the SPT service as extremely useful. Time-motion estimates indicate that 16.75 staff hourswere spent per trial leading to a direct cost estimate of approximately $450 to $500 per trial. Conclusion.-We conclude that an SPT serviceis feasible, trial costs compare favorably with other conventional services, and clinicians appear to gain confidence and precision from SPTs. When patients or clinicians are uncertain about the value (including the possibility of side effects) of treatment for symptomatic chronic diseases, we believe an SPT can be offered to a patient and will likely yield results that will effect subsequent treatment.

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Documento generato il 01/12/20 alle ore 19:10:54