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Addressing the challenges of obtaining functional outcomes in traumatic brain injury research: missing data patterns, timing of follow-up, and three prognostic models.
J Neurotrauma. 2014 Jun 01; 31(11):1029-38.JN

Abstract

Traumatic brain injury (TBI) is common and debilitating. Randomized trials of interventions for TBI ideally assess effectiveness by using long-term functional neurological outcomes, but such outcomes are difficult to obtain and costly. If there is little change between functional status at hospital discharge versus 6 months, then shorter-term outcomes may be adequate for use in future clinical trials. Using data from a previously published multi-center, randomized, placebo-controlled TBI clinical trial, we evaluated patterns of missing outcome data, changes in functional status between hospital discharge and 6 months, and three prognostic models to predict long-term functional outcome from covariates available at hospital discharge (functional measures, demographics, and injury characteristics). The Resuscitation Outcomes Consortium Hypertonic Saline trial enrolled 1282 TBI patients, obtaining the primary outcome of 6-month Glasgow Outcome Score Extended (GOSE) for 85% of patients, but missing the primary outcome for the remaining 15%. Patients with missing outcomes had less-severe injuries, higher neurological function at discharge (GOSE), and shorter hospital stays than patients whose GOSE was obtained. Of 1066 (83%) patients whose GOSE was obtained both at hospital discharge and at 6-months, 71% of patients had the same dichotomized functional status (severe disability/death vs. moderate/no disability) after 6 months as at discharge, 28% had an improved functional status, and 1% had worsened. Performance was excellent (C-statistic between 0.88 and 0.91) for all three prognostic models and calibration adequate for two models (p values, 0.22 and 0.85). Our results suggest that multiple imputation of the standard 6-month GOSE may be reasonable in TBI research when the primary outcome cannot be obtained through other means.

Authors+Show Affiliations

1 Department of Biostatistics, University of Washington ROC Clinical Trial Center , Seattle, Washington.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

24552494

Citation

Zelnick, Leila R., et al. "Addressing the Challenges of Obtaining Functional Outcomes in Traumatic Brain Injury Research: Missing Data Patterns, Timing of Follow-up, and Three Prognostic Models." Journal of Neurotrauma, vol. 31, no. 11, 2014, pp. 1029-38.
Zelnick LR, Morrison LJ, Devlin SM, et al. Addressing the challenges of obtaining functional outcomes in traumatic brain injury research: missing data patterns, timing of follow-up, and three prognostic models. J Neurotrauma. 2014;31(11):1029-38.
Zelnick, L. R., Morrison, L. J., Devlin, S. M., Bulger, E. M., Brasel, K. J., Sheehan, K., Minei, J. P., Kerby, J. D., Tisherman, S. A., Rizoli, S., Karmy-Jones, R., van Heest, R., & Newgard, C. D. (2014). Addressing the challenges of obtaining functional outcomes in traumatic brain injury research: missing data patterns, timing of follow-up, and three prognostic models. Journal of Neurotrauma, 31(11), 1029-38. https://doi.org/10.1089/neu.2013.3122
Zelnick LR, et al. Addressing the Challenges of Obtaining Functional Outcomes in Traumatic Brain Injury Research: Missing Data Patterns, Timing of Follow-up, and Three Prognostic Models. J Neurotrauma. 2014 Jun 1;31(11):1029-38. PubMed PMID: 24552494.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Addressing the challenges of obtaining functional outcomes in traumatic brain injury research: missing data patterns, timing of follow-up, and three prognostic models. AU - Zelnick,Leila R, AU - Morrison,Laurie J, AU - Devlin,Sean M, AU - Bulger,Eileen M, AU - Brasel,Karen J, AU - Sheehan,Kellie, AU - Minei,Joseph P, AU - Kerby,Jeffrey D, AU - Tisherman,Samuel A, AU - Rizoli,Sandro, AU - Karmy-Jones,Riyad, AU - van Heest,Rardi, AU - Newgard,Craig D, AU - ,, Y1 - 2014/05/08/ PY - 2014/2/21/entrez PY - 2014/2/21/pubmed PY - 2015/1/16/medline KW - clinical trial design KW - functional outcomes KW - prognostic models KW - traumatic brain injury SP - 1029 EP - 38 JF - Journal of neurotrauma JO - J. Neurotrauma VL - 31 IS - 11 N2 - Traumatic brain injury (TBI) is common and debilitating. Randomized trials of interventions for TBI ideally assess effectiveness by using long-term functional neurological outcomes, but such outcomes are difficult to obtain and costly. If there is little change between functional status at hospital discharge versus 6 months, then shorter-term outcomes may be adequate for use in future clinical trials. Using data from a previously published multi-center, randomized, placebo-controlled TBI clinical trial, we evaluated patterns of missing outcome data, changes in functional status between hospital discharge and 6 months, and three prognostic models to predict long-term functional outcome from covariates available at hospital discharge (functional measures, demographics, and injury characteristics). The Resuscitation Outcomes Consortium Hypertonic Saline trial enrolled 1282 TBI patients, obtaining the primary outcome of 6-month Glasgow Outcome Score Extended (GOSE) for 85% of patients, but missing the primary outcome for the remaining 15%. Patients with missing outcomes had less-severe injuries, higher neurological function at discharge (GOSE), and shorter hospital stays than patients whose GOSE was obtained. Of 1066 (83%) patients whose GOSE was obtained both at hospital discharge and at 6-months, 71% of patients had the same dichotomized functional status (severe disability/death vs. moderate/no disability) after 6 months as at discharge, 28% had an improved functional status, and 1% had worsened. Performance was excellent (C-statistic between 0.88 and 0.91) for all three prognostic models and calibration adequate for two models (p values, 0.22 and 0.85). Our results suggest that multiple imputation of the standard 6-month GOSE may be reasonable in TBI research when the primary outcome cannot be obtained through other means. SN - 1557-9042 UR - https://www.unboundmedicine.com/medline/citation/24552494/Addressing_the_challenges_of_obtaining_functional_outcomes_in_traumatic_brain_injury_research:_missing_data_patterns_timing_of_follow_up_and_three_prognostic_models_ L2 - https://www.liebertpub.com/doi/full/10.1089/neu.2013.3122?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -