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Sequential allocation to balance prognostic factors in a psychiatric clinical trial.

ABSTRACT: OBJECTIVE:This paper aims to describe and discuss a minimization procedure specifically designed for a clinical trial that evaluates treatment efficacy for OCD patients. METHOD:Aitchison's compositional distance was used to calculate vectors for each possibility of allocation in a covariate adaptive method. Two different procedures were designed to allocate patients in small blocks or sequentially one-by-one. RESULTS:We present partial results of this allocation procedure as well as simulated data. In the clinical trial for which this procedure was developed, successful balancing between treatment arms was achieved. Separately, in an exploratory analysis, we found that if the arrival order of patients was altered, most patients were allocated to a different treatment arm than their original assignment. CONCLUSION:Our results show that the random arrival order of patients determine different assignments and therefore maintains the unpredictability of the allocation method. We conclude that our proposed procedure allows for the use of a large number of prognostic factors in a given allocation decision. Our method seems adequate for the design of the psychiatric trials used as models. Trial registrations are available at clinicaltrials.gov NCT00466609 and NCT00680602.

SUBMITTER: Fossaluza V

PROVIDER: S-EPMC2705482 | biostudies-literature | 2009

REPOSITORIES: biostudies-literature

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Sequential allocation to balance prognostic factors in a psychiatric clinical trial.

Fossaluza Victor V Diniz Juliana Belo JB Pereira Basilio de Bragança Bde B Miguel Eurípedes Constantino EC Pereira Carlos Alberto de Bragança CA

Clinics (Sao Paulo, Brazil) 20090101 6

<h4>Objective</h4>This paper aims to describe and discuss a minimization procedure specifically designed for a clinical trial that evaluates treatment efficacy for OCD patients.<h4>Method</h4>Aitchison's compositional distance was used to calculate vectors for each possibility of allocation in a covariate adaptive method. Two different procedures were designed to allocate patients in small blocks or sequentially one-by-one.<h4>Results</h4>We present partial results of this allocation procedure a ...[more]

PMID: 19578654

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Project description:IntroductionStratified medicine might allow improvement of patient outcomes while keeping costs stable or even diminishing them. Our objective was to measure if a prediction model, developed to predict non-return to work (nRTW) after orthopaedic trauma, improves the allocation to various vocational pathways for use in clinical practice.Material and methodsRandomised-controlled trial on vocational inpatients after orthopaedic trauma (n = 280). In the intervention group, nRTW risk (estimated using the WORRK tool) was given to the clinician team before allocation of vocational pathways, while in the control group it was not. Three pathways were available: simple, coaching and evaluation (EP). Accompanying indications for interpretation of the nRTW risk were given. The primary outcome was the proportion of patients allocated to the EP. The secondary outcome was patients' and clinicians' satisfaction.Results450 patients were assessed for eligibility, 280 included, 139 randomized to the control group (mean age 42.3years) and 141 to the intervention group (43.2years). The two groups had a similar risk profile. The patients in the intervention group were more often referred to the EP compared to the control group, but not statistically significantly more (risk ratio 1.31 [95% CI 0.70-2.46]). The number needed to treat was 30. When considering patients transferred to different pathways during rehabilitation, more patients from the intervention group were transferred to the EP over the course of the rehabilitation, increasing the risk ratio to 1.57 [95% CI 0.89 to 2.74].DiscussionThe knowledge of the risk of nRTW has an influence, that is not however statistically significant and is without clinical importance as previously defined by our own power calculations (based on a 15% increase in referral to EP in the intervention group compared to the control group), on clinical decision making with regards to the allocation of patients to different physical and vocational rehabilitation programs after orthopaedic trauma. This influence is less than what was expected, possibly due to insufficient directive guidelines accompanying the WORRK model, or because clinicians associate less hours of therapy (as with certain rehabilitation programs) to disadvantaging the patient. These findings do, however, support the multi-factorial aspect of clinician decision-making.

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Sequential allocation to balance prognostic factors in a psychiatric clinical trial.

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Sequential allocation to balance prognostic factors in a psychiatric clinical trial.

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