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Assessment of Reporting of Patient-Reported Outcomes in Randomized Controlled Trials for Interventions of Post-Traumatic Stress Disorder

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Abstract

Background: Post-traumatic stress disorder (PTSD) has debilitating effects on quality of life. Patient-reported outcomes (PROs) assess changes in quality of life and serve as subjective measurements of patient experience. The aim of this study is to assess the completeness of PRO reporting within randomized controlled trials with interventions pertaining to PTSD. Methods: This cross-sectional, meta-epidemiological study assessed the completeness of PRO reporting in RCTs investigating PTSD interventions. We searched multiple databases for published RCTs of PTSD interventions that used PROs as a primary or secondary outcome. We assessed PRO completeness using the PRO adaptation of the Consolidated Standards of Reporting Trial (CONSORT). We used a bivariate regression model to determine the association between trial characteristics and the completeness of reporting. Results: After an initial screening of 5906 articles, our final sample of RCTs for inclusion was 43. The mean completeness of reporting of PROs was 58.4% (SD = 14.50). We found no significant associations between trial characteristics and completeness of the CONSORT-PRO adaptation. Conclusion: Reporting of PROs was often incomplete among RCTs focused on PTSD. We believe that adherence to CONSORT-PRO will improve both PRO reporting and implementation into clinical practice to improve assessment of quality of life.

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Acknowledgements

We are grateful to April Schweikhard who assisted in the development of our search strategy and to the OSU medical library for their procurement of relevant literature. Development of this study was funded by the Oklahoma State University Center for Health Sciences Presidential Mentor-Mentee Research Fellowship Grant.

Funding

This study was not funded.

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Authors and Affiliations

  1. Office of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17th St, 74107, Tulsa, OK, USA

    Griffin Hughes, Bethany Sutterfield, Reece Anderson, Sam Streck, Cody Hillman, Samuel Shepard, Audrey Wise, Micah Hartwell & Matt Vassar

  2. Department of Dermatology, Trinity Health, Ann Arbor, MI, USA

    Ryan Ottwell

  3. Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA

    Micah Hartwell & Matt Vassar

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  1. Griffin Hughes
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  2. Bethany Sutterfield
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Correspondence to Griffin Hughes.

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Competing Interests

No financial or other sources of support were provided during the development of this manuscript. Dr. Hartwell reports receiving funding from the National Institute of Justice for work unrelated to the current subject. Dr. Vassar reports receipt of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the US Office of Research Integrity, Oklahoma Center for Advancement of Science and Technology, and internal grants from Oklahoma State University Center for Health Sciences—all outside of the present work. All other authors have nothing to report.

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Hughes, G., Sutterfield, B., Anderson, R. et al. Assessment of Reporting of Patient-Reported Outcomes in Randomized Controlled Trials for Interventions of Post-Traumatic Stress Disorder. Psychiatr Q 94, 127–139 (2023). https://doi.org/10.1007/s11126-023-10017-y

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