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

Carolina Navas, Inigo Valiente-Alandi, Laura Luque-Aguilera, Ana Maria Rodriguez-Leboeuf Patient-Centered Solutions, IQVIA, Madrid, SpainCorrespondence: Ana Maria Rodriguez-Leboeuf, Patient-Centered Solutions, IQVIA, Juan Esplandiu 11-13. 6 Floor, Madrid, 28007, Spain, Email [email protected]: 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.Methods: 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.Results: 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.Conclusion: 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.Plain Language Summary: The objectives of this scoping review were to summarize, understand, and disseminate findings from a broad body of literature where treatment satisfaction was used as an outcome in clinical research and academic settings.Most studies used treatment satisfaction instruments without proper psychometric validation.The TSQM was identified as being a validated generic instrument most frequently utilized in all studies reviewed (both in industry and academia).The second most frequently utilized treatment satisfaction instrument is a disease-specific instrument, the DTSQ, which evaluates treatment satisfaction in diabetes.Keywords: treatment satisfaction, PRO, clinical trials, academic research, TSQM, DTSQ