Publications

OBJECTIVE

To compare the cost-effectiveness of 3 common alternate treatments for depression.

METHODS

The cost-effectiveness analysis was conducted as part of a randomized clinical trial, the Veterans Affairs Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D) trial, in which patients were randomized from December 2012 to May 2015 and followed for 12 weeks in 35 Veterans Affairs medical centers. Depression diagnosis was based on ICD-9 codes. Patients were randomized to standard antidepressant therapy augmented with aripiprazole, standard antidepressant therapy augmented with bupropion, or switch to bupropion. Remission was measured using the 16-item Quick Inventory of Depressive Symptomatology-Clinican Rated. Outcomes included the incremental cost-effectiveness ratio (ICER) comparing costs per remission and costs per quality-adjusted life-year (QALY) with 12 weeks as the time horizon using the health care sector perspective.

RESULTS

The mean age of participants enrolled in the trial (N = 1,522) was 54 years, and participants were predominantly male. The rate of remission at 12 weeks was highest for the aripiprazole augmentation arm (29%), followed by bupropion augmentation (27%), and lowest for switching to bupropion (22%). Switching to bupropion was strongly dominated by bupropion augmentation at an ICER of -$640/remission (95% CI, -$5,770 to $3,008). The ICER for the aripiprazole augmentation versus switching to bupropion was $1,074/remission (95% CI, $47 to $5,022), and the ICER for aripiprazole augmentation versus bupropion augmentation was $5,094/remission (95% CI, -$34,027 to $32,774). There were no significant differences in QALYs, mental health care costs, employment, or other work and social adjustment outcomes between treatment groups.

CONCLUSIONS

In treatment of depression with less than optimal response, augmentation with either aripiprazole or bupropion was cost-effective relative to switching to bupropion.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT01421342.

BACKGROUND

Characterization of colonic lesions in inflammatory bowel disease (IBD) remains challenging. We developed an endoscopic classification of visual characteristics to identify colitis-associated neoplasia using multimodal advanced endoscopic imaging (Frankfurt Advanced Chromoendoscopic IBD LEsions [FACILE] classification).

METHODS

The study was conducted in three phases: 1) development - an expert panel defined endoscopic signs and predictors of dysplasia in IBD and, using multivariable logistic regression created the FACILE classification; 2) validation - using 60 IBD lesions from an image library, two assessments of diagnostic accuracy for neoplasia were performed and interobserver agreement between experts using FACILE was determined; 3) reproducibility - the reproducibility of the FACILE classification was tested in gastroenterologists, trainees, and junior doctors after completion of a training module.

RESULTS

The experts initially selected criteria such as morphology, color, surface, vessel architecture, signs of inflammation, and lesion border. Multivariable logistic regression confirmed that nonpolypoid lesion, irregular vessel architecture, irregular surface pattern, and signs of inflammation within the lesion were predictors of dysplasia. Area under the curve of this logistic model using a bootstrapped estimate was 0.76 (0.73 - 0.78). The training module resulted in improved accuracy and kappa agreement in all nonexperts, though in trainees and junior doctors the kappa agreement was still moderate and poor, respectively.

CONCLUSION

We developed, validated, and demonstrated reproducibility of a new endoscopic classification (FACILE) for the diagnosis of dysplasia in IBD using all imaging modalities. Flat shape, irregular surface and vascular patterns, and signs of inflammation predicted dysplasia. The diagnostic performance of all nonexpert participants improved after a training module.