TY - JOUR
T1 - Missing outcome data in randomised clinical trials of psychological interventions
T2 - a review of published trial reports in major psychiatry journals
AU - Juul, Sophie
AU - Faltermeier, Pascal
AU - Petersen, Johanne Juul
AU - Olsen, Markus Harboe
AU - Andersen, Rebecca Kjaer
AU - Kamp, Caroline Barkholt
AU - Siddiqui, Faiza
AU - Simonsen, Sebastian
AU - Mbuagbaw, Lawrence
AU - Thabane, Lehana
AU - Jakobsen, Janus Christian
N1 - © 2024. The Author(s).
PY - 2024/11/14
Y1 - 2024/11/14
N2 - BACKGROUND: Missing outcome data can pose a serious threat to the validity of randomised clinical trial results. We aimed to study the extent of missing outcome data in randomised clinical trials of psychological interventions.METHODS: We performed a retrospective study of randomised clinical trial reports of psychological interventions published in World Psychiatry, JAMA Psychiatry, Lancet Psychiatry, American Journal of Psychiatry, British Journal of Psychiatry, or Psychotherapy and Psychosomatics from 2017 to 2022. We assessed the proportion of missing outcome data, whether missing data patterns differed between types of outcomes, participants, intervention lengths, and psychological intervention types, how missing outcome data were handled in the statistical analyses, and whether trialists discussed missing outcome data in the discussion section of the manuscript.RESULTS: We identified 182 randomised clinical trials (233 primary outcomes), of which 206 outcomes (88.4%) were assessed at high risk of bias due to missing data. The overall mean percentage of missing outcome data was 18.3% (95% confidence interval (CI): 16.7-20%) for all outcomes. The percentages of missing data were 18.9% (95% CI: 17.1-20.6%; 180 outcomes) for symptom severity scales and 1.8% (95% CI: 2.3-3.3%; 6 outcomes) for 'hard' binary outcomes. Trials including participants with borderline personality disorder had the highest percentage of missing outcome data (33.1%; 95% CI: 22.3-43.9%) compared with other psychiatric disorders. Fisher's exact test showed that intervention lengths and psychological intervention types were associated with the proportion of missing outcome data (p < 0.001), but there were no clear patterns.CONCLUSION: Missing outcome data is a considerable problem in randomised clinical trials of psychological interventions, and trialists should consider the corresponding methodological limitations in the design and analysis to reduce the risk of bias due to missing outcome data.CLINICAL TRIAL REGISTRATION NUMBER: Not applicable.
AB - BACKGROUND: Missing outcome data can pose a serious threat to the validity of randomised clinical trial results. We aimed to study the extent of missing outcome data in randomised clinical trials of psychological interventions.METHODS: We performed a retrospective study of randomised clinical trial reports of psychological interventions published in World Psychiatry, JAMA Psychiatry, Lancet Psychiatry, American Journal of Psychiatry, British Journal of Psychiatry, or Psychotherapy and Psychosomatics from 2017 to 2022. We assessed the proportion of missing outcome data, whether missing data patterns differed between types of outcomes, participants, intervention lengths, and psychological intervention types, how missing outcome data were handled in the statistical analyses, and whether trialists discussed missing outcome data in the discussion section of the manuscript.RESULTS: We identified 182 randomised clinical trials (233 primary outcomes), of which 206 outcomes (88.4%) were assessed at high risk of bias due to missing data. The overall mean percentage of missing outcome data was 18.3% (95% confidence interval (CI): 16.7-20%) for all outcomes. The percentages of missing data were 18.9% (95% CI: 17.1-20.6%; 180 outcomes) for symptom severity scales and 1.8% (95% CI: 2.3-3.3%; 6 outcomes) for 'hard' binary outcomes. Trials including participants with borderline personality disorder had the highest percentage of missing outcome data (33.1%; 95% CI: 22.3-43.9%) compared with other psychiatric disorders. Fisher's exact test showed that intervention lengths and psychological intervention types were associated with the proportion of missing outcome data (p < 0.001), but there were no clear patterns.CONCLUSION: Missing outcome data is a considerable problem in randomised clinical trials of psychological interventions, and trialists should consider the corresponding methodological limitations in the design and analysis to reduce the risk of bias due to missing outcome data.CLINICAL TRIAL REGISTRATION NUMBER: Not applicable.
KW - Humans
KW - Mental Disorders/therapy
KW - Outcome Assessment, Health Care/statistics & numerical data
KW - Periodicals as Topic
KW - Psychiatry
KW - Psychosocial Intervention/methods
KW - Psychotherapy/methods
KW - Randomized Controlled Trials as Topic
KW - Retrospective Studies
KW - Randomised clinical trials
KW - Missing outcome data
KW - Psychological interventions
UR - http://www.scopus.com/inward/record.url?scp=85209083600&partnerID=8YFLogxK
U2 - 10.1186/s12888-024-06263-4
DO - 10.1186/s12888-024-06263-4
M3 - Review
C2 - 39543512
SN - 1471-244X
VL - 24
SP - 798
JO - BMC Psychiatry
JF - BMC Psychiatry
IS - 1
M1 - 798
ER -