A scoping review on two-stage randomized preference trial in the field of mental health and addiction

Abstract Background Randomized Controlled Trial is the most rigorous study design to test the efficacy and effectiveness of an intervention. Patient preference may negatively affect patient performance and decrease the generalizability of a trial to clinical population. Patient preference trial have...

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Main Authors: Sheng Chen, Wei Wang
Format: Article
Language:English
Published: BMC 2023-03-01
Series:BMC Psychiatry
Subjects:
Online Access:https://doi.org/10.1186/s12888-023-04676-1
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author Sheng Chen
Wei Wang
author_facet Sheng Chen
Wei Wang
author_sort Sheng Chen
collection DOAJ
description Abstract Background Randomized Controlled Trial is the most rigorous study design to test the efficacy and effectiveness of an intervention. Patient preference may negatively affect patient performance and decrease the generalizability of a trial to clinical population. Patient preference trial have particular implications in the field of mental health and addiction since mental health interventions are generally complex, blinding of intervention is often difficult or impossible, patients may have strong preference, and outcome measures are often subjective patient self-report which may be greatly influenced if patient’s preference did not match with the intervention received. Methods In this review, we have surveyed the application of two-stage randomized preference trial with focus on studies in the field of mental health and addiction. The study selection followed the guideline provided by Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Results Six two-stage randomized preference trials (ten publications) have been identified in the field of mental health field and addiction. In these trials, the pooled dropout rates were 18.3% for the preference arm, and 28.7% for the random arm, with a pooled RR of 0.70 (95% CI, 0.56–0.88; P = 0.010) indicating lower risk of dropout in the preference arm. The standardized preference effects varied widely from 0.07 to 0.57, and could be as large as the treatment effect in some of the trials. Conclusion This scoping review has shown that two-stage randomized preference trials are not as popular as expected in mental health research. The results indicated that two-stage randomized preference trials in mental health would be beneficial in retaining patients to expand the generalizability of the trial.
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spelling doaj.art-abbe6851426e450dad5d3cdbff100e662023-03-26T11:15:30ZengBMCBMC Psychiatry1471-244X2023-03-012311910.1186/s12888-023-04676-1A scoping review on two-stage randomized preference trial in the field of mental health and addictionSheng Chen0Wei Wang1Biostatistics Core, Centre for Addiction and Mental HealthBiostatistics Core, Centre for Addiction and Mental HealthAbstract Background Randomized Controlled Trial is the most rigorous study design to test the efficacy and effectiveness of an intervention. Patient preference may negatively affect patient performance and decrease the generalizability of a trial to clinical population. Patient preference trial have particular implications in the field of mental health and addiction since mental health interventions are generally complex, blinding of intervention is often difficult or impossible, patients may have strong preference, and outcome measures are often subjective patient self-report which may be greatly influenced if patient’s preference did not match with the intervention received. Methods In this review, we have surveyed the application of two-stage randomized preference trial with focus on studies in the field of mental health and addiction. The study selection followed the guideline provided by Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Results Six two-stage randomized preference trials (ten publications) have been identified in the field of mental health field and addiction. In these trials, the pooled dropout rates were 18.3% for the preference arm, and 28.7% for the random arm, with a pooled RR of 0.70 (95% CI, 0.56–0.88; P = 0.010) indicating lower risk of dropout in the preference arm. The standardized preference effects varied widely from 0.07 to 0.57, and could be as large as the treatment effect in some of the trials. Conclusion This scoping review has shown that two-stage randomized preference trials are not as popular as expected in mental health research. The results indicated that two-stage randomized preference trials in mental health would be beneficial in retaining patients to expand the generalizability of the trial.https://doi.org/10.1186/s12888-023-04676-1Clinical trialPatient preferenceTwo-stage randomized preference trialMental healthPreference effect
spellingShingle Sheng Chen
Wei Wang
A scoping review on two-stage randomized preference trial in the field of mental health and addiction
BMC Psychiatry
Clinical trial
Patient preference
Two-stage randomized preference trial
Mental health
Preference effect
title A scoping review on two-stage randomized preference trial in the field of mental health and addiction
title_full A scoping review on two-stage randomized preference trial in the field of mental health and addiction
title_fullStr A scoping review on two-stage randomized preference trial in the field of mental health and addiction
title_full_unstemmed A scoping review on two-stage randomized preference trial in the field of mental health and addiction
title_short A scoping review on two-stage randomized preference trial in the field of mental health and addiction
title_sort scoping review on two stage randomized preference trial in the field of mental health and addiction
topic Clinical trial
Patient preference
Two-stage randomized preference trial
Mental health
Preference effect
url https://doi.org/10.1186/s12888-023-04676-1
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