TY - JOUR
T1 - The evaluation of reporting of patient-reported outcomes in MDD
T2 - A meta-epidemiological study of clinical trials
AU - Minley, Kirstien
AU - Smith, Caleb A.
AU - Batioja, Kelsi
AU - Peña, Andriana
AU - Shepard, Samuel
AU - Heigle, Benjamin
AU - Kee, Micah
AU - Wise, Audrey
AU - Hillman, Cody
AU - Ottwell, Ryan
AU - Hartwell, Micah
AU - Vassar, Matt
N1 - Funding Information:
Development of this study was funded by the Oklahoma State University Center for Health Sciences Presidential Mentor-Mentee Research Fellowship Grant.
Funding Information:
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.
Publisher Copyright:
© 2022 Elsevier Ltd
PY - 2022/6
Y1 - 2022/6
N2 - Major depressive disorder (MDD) is a multifaceted disease that profoundly affects quality of life. Patient reported outcomes (PROs) are used in randomized controlled trials (RCTs) to better understand patient perspectives on interventions. Therefore, we sought to assess the completeness of reporting PROs in RCTs addressing MDD. We identified RCTs evaluating MDD containing a PRO measure published between 2016 and 2020 from MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. Inclusion of studies was performed in duplicate. The completion of reporting of RCTs was assessed using the Consolidated Standards of Reporting Trials (CONSORT-PRO) adaptation. Bivariate regression analyses were used to evaluate reporting completeness and trial characteristics. A total of 49 RCTs were included in our analysis, with a mean CONSORT-PRO completion score of 56.7% (SD = 17.3).Our findings show a significant association with completeness of reporting and the following: secondary PRO trials were less completely reported as compared to primary PRO trials (t = −3.19, p = .003); studies with a follow-up period between six months and year were more completely reported as compared to three months or less (6 months to a year, t = 2.34, p = .024); and increased trial sample size was associated with more completeness of reporting (t = 3.17, p = .003). As compared to brain stimulation, the intervention types classified as combination, other, and psychotherapy had greater completeness of reporting (combination, t = 2.35, p = .024; other, t = 3.13, p = .003; psychotherapy, t = 3.41, p = .001). There were no other significant findings. Our study found the completeness of PRO reporting to be inconsistent in RCTs regarding MDD. Moreover, we advocate for the need to establish a core outcome set relevant to the management of adults diagnosed with MDD and facilitate training on the application of PRO data.
AB - Major depressive disorder (MDD) is a multifaceted disease that profoundly affects quality of life. Patient reported outcomes (PROs) are used in randomized controlled trials (RCTs) to better understand patient perspectives on interventions. Therefore, we sought to assess the completeness of reporting PROs in RCTs addressing MDD. We identified RCTs evaluating MDD containing a PRO measure published between 2016 and 2020 from MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. Inclusion of studies was performed in duplicate. The completion of reporting of RCTs was assessed using the Consolidated Standards of Reporting Trials (CONSORT-PRO) adaptation. Bivariate regression analyses were used to evaluate reporting completeness and trial characteristics. A total of 49 RCTs were included in our analysis, with a mean CONSORT-PRO completion score of 56.7% (SD = 17.3).Our findings show a significant association with completeness of reporting and the following: secondary PRO trials were less completely reported as compared to primary PRO trials (t = −3.19, p = .003); studies with a follow-up period between six months and year were more completely reported as compared to three months or less (6 months to a year, t = 2.34, p = .024); and increased trial sample size was associated with more completeness of reporting (t = 3.17, p = .003). As compared to brain stimulation, the intervention types classified as combination, other, and psychotherapy had greater completeness of reporting (combination, t = 2.35, p = .024; other, t = 3.13, p = .003; psychotherapy, t = 3.41, p = .001). There were no other significant findings. Our study found the completeness of PRO reporting to be inconsistent in RCTs regarding MDD. Moreover, we advocate for the need to establish a core outcome set relevant to the management of adults diagnosed with MDD and facilitate training on the application of PRO data.
KW - Completeness of reporting
KW - CONSORT-PRO
KW - Major depressive disorder
KW - Patient-reported outcomes
KW - Randomized controlled trials
KW - Risk of bias
UR - http://www.scopus.com/inward/record.url?scp=85127055177&partnerID=8YFLogxK
U2 - 10.1016/j.jpsychires.2022.03.028
DO - 10.1016/j.jpsychires.2022.03.028
M3 - Article
C2 - 35358835
AN - SCOPUS:85127055177
SN - 0022-3956
VL - 150
SP - 79
EP - 86
JO - Journal of Psychiatric Research
JF - Journal of Psychiatric Research
ER -