Rehab Centers: Attrition Rates, Reasons, and Predictive Factors in Supportive Care and Palliative Oncology Clinical Trials.

Attrition rates, reasons, and predictive factors in supportive care and palliative oncology clinical trials.

Filed under: Rehab Centers

Cancer. 2012 Nov 6;
Hui D, Glitza I, Chisholm G, Yennu S, Bruera E

BACKGROUND: Attrition is common among supportive care/palliative oncology clinical trials. However, to the authors’ knowledge, few studies to date have documented the reasons and predictors for dropout. In the current study, the authors’ objective was to determine the rate, reasons, and factors associated with attrition both before reaching the primary endpoint and at the end of the study. METHODS: A review of all prospective interventional supportive care/palliative oncology trials conducted in the Department of Palliative Care and Rehabilitation Medicine at The University of Texas MD Anderson Cancer Center in Houston between 1999 and 2011 was performed. Patient and study characteristics and attrition data were extracted. RESULTS: A total of 1214 patients were included in 18 clinical trials. The median age of the patients was 60 years. Approximately 41% had an Eastern Cooperative Oncology Group performance status of ? 3, a median Edmonton Symptom Assessment Scale (ESAS) for fatigue of 7 of 10, and a median ESAS for dyspnea of 2 of 10. The attrition rate was 26% (95% confidence interval [95% CI], 23%-28%) for the primary endpoint and 44% (95% CI, 41%-47%) for the end of the study. Common reasons for primary endpoint dropout were symptom burden (21%), patient preference (15%), hospitalization (10%), and death (6%). Primary endpoint attrition was associated with a higher baseline intensity of fatigue (odds ratio [OR], 1.10 per point; P = .01) and a longer study duration (P = .04). End-of-study attrition was associated with higher baseline levels of dyspnea (OR, 1.06; P = .01), fatigue (OR, 1.08; P = .01), Hispanic race (OR, 1.87; P = .002), higher level of education (P = .02), longer study duration (P = .01), and outpatient studies (P = 0.05). CONCLUSIONS: The attrition rate was high in supportive care/palliative oncology clinical trials, and was associated with various patient characteristics and a high baseline symptom burden. These findings have implications for future clinical trial design including eligibility criteria and sample size calculation. Cancer 2012. © 2012 American Cancer Society.
HubMed – rehab


Neurocognitive predictors of financial capacity in traumatic brain injury.

Filed under: Rehab Centers

J Head Trauma Rehabil. 2012 Nov; 27(6): E81-90
Martin RC, Triebel K, Dreer LE, Novack TA, Turner C, Marson DC

: To develop cognitive models of financial capacity (FC) in patients with traumatic brain injury (TBI).: Longitudinal design.: Inpatient brain injury rehabilitation unit.: Twenty healthy controls, and 24 adults with moderate-to-severe TBI were assessed at baseline (30 days postinjury) and 6 months postinjury.: The FC instrument (FCI) and a neuropsychological test battery. Univariate correlation and multiple regression procedures were employed to develop cognitive models of FCI performance in the TBI group, at baseline and 6-month time follow-up.: Three cognitive predictor models of FC were developed. At baseline, measures of mental arithmetic/working memory and immediate verbal memory predicted baseline FCI performance (R = 0.72). At 6-month follow-up, measures of executive function and mental arithmetic/working memory predicted 6-month FCI performance (R = 0.79), and a third model found that these 2 measures at baseline predicted 6-month FCI performance (R = 0.71).: Multiple cognitive functions are associated with initial impairment and partial recovery of FC in moderate-to-severe TBI patients. In particular, arithmetic, working memory, and executive function skills appear critical to recovery of FC in TBI. The study results represent an initial step toward developing a neurocognitive model of FC in patients with TBI.
HubMed – rehab


Life Expectancy Following Rehabilitation: A NIDRR Traumatic Brain Injury Model Systems Study.

Filed under: Rehab Centers

J Head Trauma Rehabil. 2012 Nov; 27(6): E69-E80
Harrison-Felix C, Kreider SE, Arango-Lasprilla JC, Brown AW, Dijkers MP, Hammond FM, Kolakowsky-Hayner SA, Hirshson C, Whiteneck G, Zasler ND

OBJECTIVE:: To characterize overall and cause-specific mortality and life expectancy among persons who have completed inpatient traumatic brain injury rehabilitation and to assess risk factors for mortality. DESIGN:: Prospective cohort study. SETTING:: The Traumatic Brain Injury Model Systems. PARTICIPANTS:: A total of 8573 individuals injured between 1988 and 2009, with survival status per December 31, 2009, determined. INTERVENTIONS:: Not applicable. MAIN OUTCOME MEASURES:: Standardized mortality ratio (SMR), life expectancy, cause of death. RESULTS:: SMR was 2.25 overall and was significantly elevated for all age groups, both sexes, all race/ethnic groups (except Native Americans), and all injury severity groups. SMR decreased as survival time increased but remained elevated even after 10 years postinjury. SMR was elevated for all cause-of-death categories but especially so for seizures, aspiration pneumonia, sepsis, accidental poisonings, and falls. Life expectancy was shortened an average of 6.7 years. Multivariate Cox regression showed age at injury, sex, race/ethnic group, marital status and employment status at the time of injury year of injury, preinjury drug use, days unconscious, functional independence and disability on rehabilitation discharge, and comorbid spinal cord injury to be independent risk factors for death. CONCLUSION:: There is an increased risk of death after moderate or severe traumatic brain injury. Risk factors and causes of death have been identified that may be amenable to intervention.
HubMed – rehab



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