Evaluating the Reporting of Clinical Significance and Efficacy in Psychology Clinical Trials: A Systematic Review.

Disciplines

Psychology

Abstract (300 words maximum)

To develop and refine mental health interventions, it’s critical that we assess their significance in clinical trials and allow comparisons between various studies and methods. Consistency in reporting clinical significance and efficacy ensures that we can determine if the intervention makes a meaningful impact on participants’ lives and facilitates progress in the field. This study aimed to determine how many clinical trials for psychology evaluate and apply both of these in a quantifiable way, specifically focusing on standardized mean difference (SMD) for standardized units and reliable change index (RCI) for clinical significance. Our systematic review included 4 prominent journals that published clinical trials in 2020-2023 and recorded whether they reported these measures. We found that studies were inconsistent in reporting clinical significance and, when reported, methods varied greatly. Results from 225 published clinical trials in psychology revealed that 55.6% of the studies included an SMD method and just 12.9% included RCI. There were 7 distinct methods used to determine SMD and 10 methods used for RCI. Our goal was to evaluate current practices and provide recommendations to guide future mental health research. This study highlights the need for more consistency in clinical trials to measure and report standardized effect size and clinical significance. Standardizing these practices would provide a more accurate and detailed look at how well interventions work in studies and improve comparability between clinical trials.

Academic department under which the project should be listed

RCHSS - Psychological Science

Primary Investigator (PI) Name

Alexander Crenshaw

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Evaluating the Reporting of Clinical Significance and Efficacy in Psychology Clinical Trials: A Systematic Review.

To develop and refine mental health interventions, it’s critical that we assess their significance in clinical trials and allow comparisons between various studies and methods. Consistency in reporting clinical significance and efficacy ensures that we can determine if the intervention makes a meaningful impact on participants’ lives and facilitates progress in the field. This study aimed to determine how many clinical trials for psychology evaluate and apply both of these in a quantifiable way, specifically focusing on standardized mean difference (SMD) for standardized units and reliable change index (RCI) for clinical significance. Our systematic review included 4 prominent journals that published clinical trials in 2020-2023 and recorded whether they reported these measures. We found that studies were inconsistent in reporting clinical significance and, when reported, methods varied greatly. Results from 225 published clinical trials in psychology revealed that 55.6% of the studies included an SMD method and just 12.9% included RCI. There were 7 distinct methods used to determine SMD and 10 methods used for RCI. Our goal was to evaluate current practices and provide recommendations to guide future mental health research. This study highlights the need for more consistency in clinical trials to measure and report standardized effect size and clinical significance. Standardizing these practices would provide a more accurate and detailed look at how well interventions work in studies and improve comparability between clinical trials.