Eighteen Years of Measuring Treatment Satisfaction in Clinical Research: A Scoping Review of Instruments and Contexts...

Despite the widespread use of Patient Reported Outcomes (PRO) instruments to assess treatment satisfaction in clinical trials and academic research, a comprehensive review mapping these tools across therapeutic areas has been lacking. This scoping review addresses this gap by examining the application of PRO instruments over the past 18 years.

Following Arksey and O'Malley's framework and mixed-method principles, we searched Ovid MEDLINE and Ovid EMBASE from 2004 to June 2022. Data extraction was structured according to review objectives and key domains.

Of 3,497 articles retrieved, 1,398 studies reported using PRO instruments for treatment satisfaction. The most common therapeutic areas were endocrine, nutrition, and metabolic disorders, followed by mental and behavioral conditions. Most studies were conducted in academic settings (53.1%) or Phase III clinical trials (27.5%). The Treatment Satisfaction Questionnaire for Medication (TSQM) was the most frequently used generic instrument, while the Diabetes Treatment Satisfaction Questionnaire (DTSQ) was the leading disease-specific tool. Many instruments lacked psychometric validation, limiting comparability.

PRO instruments for treatment satisfaction are primarily used in chronic disease contexts. Their widespread adoption underscores the need for validated tools to ensure robust, comparable data and support better patient outcomes.