IU Indianapolis ScholarWorks :: Browsing by Author "Malec, James F."

Browsing by Author "Malec, James F."

Now showing 1 - 10 of 23

Amantadine Did Not Positively Impact Cognition in Chronic Traumatic Brain Injury: A Multi-Site, Randomized, Controlled Trial
(Mary Ann Liebert, 2018-10-01) Hammond, Flora M.; Sherer, Mark; Malec, James F.; Zafonte, Ross D.; Dikmen, Sureyya; Bogner, Jennifer; Bell, Kathleen R.; Barber, Jason; Temkin, Nancy; Physical Medicine and Rehabilitation, School of Medicine
Despite limited evidence to support the use of amantadine to enhance cognitive function after traumatic brain injury (TBI), the clinical use for this purpose is highly prevalent and is often based on inferred belief systems. The aim of this study was to assess effect of amantadine on cognition among individuals with a history of TBI and behavioral disturbance using a parallel-group, randomized, double-blind, placebo-controlled trial of amantadine 100 mg twice-daily versus placebo for 60 days. Included in the study were 119 individuals with two or more neuropsychological measures greater than 1 standard deviation below normative means from a larger study of 168 individuals with chronic TBI (>6 months post-injury) and irritability. Cognitive function was measured at treatment days 0, 28, and 60 with a battery of neuropsychological tests. Composite indices were generated: General Cognitive Index (included all measures), a Learning Memory Index (learning/memory measures), and Attention/Processing Speed Index (attention and executive function measures). Repeated-measures analysis of variance revealed statistically significant between-group differences favoring the placebo group at day 28 for General Cognitive Index (p = 0.002) and Learning Memory Index (p = 0.001), but not Attention/Processing Speed Index (p = 0.25), whereas no statistically significant between-group differences were found at day 60. There were no statistically significant between-group differences on adverse events. Cognitive function in individuals with chronic TBI is not improved by amantadine 100 mg twice-daily. In the first 28 days of use, amantadine may impede cognitive processing. However, the effect size was small and mean scores for both groups were generally within expectations for persons with history of complicated mild-to-severe TBI, suggesting that changes observed across assessments may not have functional significance. The use of amantadine to enhance cognitive function is not supported by these findings.
Amantadine effect on perceptions of irritability after traumatic brain injury: results of the amantadine irritability multisite study
(Mary Ann Liebert, Inc., 2015-08-15) Hammond, Flora M.; Sherer, Mark; Malec, James F.; Zafonte, Ross D.; Whitney, Marybeth; Bell, Kathleen; Dikmen, Sureyya; Bogner, Jennifer; Mysiw, Jerry; Pershad, Rashmi; Physical Medicine and Rehabilitation, School of Medicine
This study examines the effect of amantadine on irritability in persons in the post-acute period after traumatic brain injury (TBI). There were 168 persons ≥6 months post-TBI with irritability who were enrolled in a parallel-group, randomized, double-blind, placebo-controlled trial receiving either amantadine 100 mg twice daily or equivalent placebo for 60 days. Subjects were assessed at baseline and days 28 (primary end-point) and 60 of treatment using observer-rated and participant-rated Neuropsychiatric Inventory (NPI-I) Most Problematic item (primary outcome), NPI Most Aberrant item, and NPI-I Distress Scores, as well as physician-rated Clinical Global Impressions (CGI) scale. Observer ratings between the two groups were not statistically significantly different at day 28 or 60; however, observers rated the majority in both groups as having improved at both intervals. Participant ratings for day 60 demonstrated improvements in both groups with greater improvement in the amantadine group on NPI-I Most Problematic (p<0.04) and NPI-I Distress (p<0.04). These results were not significant with correction for multiple comparisons. CGI demonstrated greater improvement for amantadine than the placebo group (p<0.04). Adverse event occurrence did not differ between the two groups. While observers in both groups reported large improvements, significant group differences were not found for the primary outcome (observer ratings) at either day 28 or 60. This large placebo or nonspecific effect may have masked detection of a treatment effect. The result of this study of amantadine 100 mg every morning and noon to reduce irritability was not positive from the observer perspective, although there are indications of improvement at day 60 from the perspective of persons with TBI and clinicians that may warrant further investigation.
Evidence-Based Cognitive Rehabilitation: Systematic Review of the Literature From 2009 Through 2014
(Elsevier, 2019) Cicerone, Keith D.; Goldin, Yelena; Ganci, Keith; Rosenbaum, Amy; Wethe, Jennifer V.; Langenbahn, Donna M.; Malec, James F.; Bergquist, Thomas F.; Kingsley, Kristine; Nagele, Drew; Trexler, Lance; Fraas, Michael; Bogdanova, Yelena; Harley, J. Preston; Physical Medicine and Rehabilitation, School of Medicine
Objective To conduct an updated, systematic review of the clinical literature, classify studies based on the strength of research design, and derive consensual, evidence-based clinical recommendations for cognitive rehabilitation of people with TBI or stroke. Data Sources Online Pubmed and print journal searches identified citations for 250 articles published from 2009 through 2014. Study Selection 186 articles were selected for inclusion after initial screening. 50 articles were initially excluded (24 healthy, pediatric or other neurologic diagnoses, 10 non-cognitive interventions, 13 descriptive protocols or studies, 3 non-treatment studies). 15 articles were excluded after complete review (1 other neurologic diagnosis, 2 non-treatment studies, 1 qualitative study, 4 descriptive papers, 7 secondary analyses). 121 studies were fully reviewed. Data Extraction Articles were reviewed by CRTF members according to specific criteria for study design and quality, and classified as providing Class I, Class II, or Class III evidence. Articles were assigned to 1 of 6 possible categories (based on interventions for attention, vision and neglect, language and communication skills, memory, executive function, or comprehensive-integrated interventions). Data Synthesis Of 121 studies, 41 were rated as Class I, 3 as Class Ia, 14 as Class II, and 63 as Class III. Recommendations were derived by CRTF consensus from the relative strengths of the evidence, based on the decision rules applied in prior reviews. Conclusions CRTF has now evaluated 491 papers (109 Class I or Ia, 68 Class II, and 314 Class III) and makes 29 recommendations for evidence-based practice of cognitive rehabilitation (9 Practice Standards, 9 Practice Guidelines and 11 Practice Options). Evidence supports Practice Standards for attention deficits after TBI or stroke; visual scanning for neglect after right hemisphere stroke; compensatory strategies for mild memory deficits; language deficits after left hemisphere stroke; social communication deficits after TBI; metacognitive strategy training for deficits in executive functioning; and comprehensive-holistic neuropsychological rehabilitation to reduce cognitive and functional disability after TBI or stroke.
Impact of TBI on caregivers of veterans with TBI: Burden and interventions
(Taylor and Francis, 2017-07-29) Malec, James F.; Houtven, Courtney Harold Van; Tanielian, Terri; Atizado, Adrian; Dorn, Michael C.; Physical Medicine and Rehabilitation, School of Medicine
Objectives: Describe State-of-the-Art in practice and research in caregiving with individuals, specifically, Veterans with traumatic brain injury (TBI) and the implications for current practice and future research. Sources: Professional literature and personal experience of review panel.Main Outcomes: Unpaid caregiving for individuals with TBI is most often provided by a spouse, parent or other blood relative; the majority of caregivers are women. Although caregiving can be rewarding, it also may create financial burden and psychological stress. Depression among family caregivers occurs four times more frequently than in the general population. Positive coping can help reduce the impact of stress, and Department of Veterans Affairs (VA) programmes are available to ease financial burden. Group interventions show promise in reinforcing and improving positive coping for both family caregivers and Veterans with TBI.Conclusions: Identifying the specific needs of caregivers and families of Veterans with TBI and other traumatic injuries, including post-traumatic stress syndrome (PTSD), will require further longitudinal research. Currently available group interventions and programmes appear to benefit injured Veterans and their family caregivers financially and psychologically. Increased understanding of characteristics of quality family caregiving and its long term costs and benefits is likely to lead to additional improvements in these interventions and programmes.
Long-term survival after traumatic brain injury: a population-based analysis controlled for nonhead trauma
(Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2014-01) Brown, Allen W.; Leibson, Cynthia L.; Mandrekar, Jay; Ransom, Jeanine E.; Malec, James F.; Department of Physical Medicine and Rehabilitation, IU School of Medicine
OBJECTIVE: To examine the contribution of co-occurring nonhead injuries to hazard of death after traumatic brain injury (TBI). PARTICIPANTS: A random sample of Olmsted County, Minnesota, residents with confirmed TBI from 1987 through 1999 was identified. DESIGN: Each case was assigned an age- and sex-matched, non-TBI "regular control" from the population. For "special cases" with accompanying nonhead injuries, 2 matched "special controls" with nonhead injuries of similar severity were assigned. MEASURES: Vital status was followed from baseline (ie, injury date for cases, comparable dates for controls) through 2008. Cases were compared first with regular controls and second with regular or special controls, depending on case type. RESULTS: In total, 1257 cases were identified (including 221 special cases). For both cases versus regular controls and cases versus regular or special controls, the hazard ratio was increased from baseline to 6 months (10.82 [2.86-40.89] and 7.13 [3.10-16.39], respectively) and from baseline through study end (2.92 [1.74-4.91] and 1.48 [1.09-2.02], respectively). Among 6-month survivors, the hazard ratio was increased for cases versus regular controls (1.43 [1.06-2.15]) but not for cases versus regular or special controls (1.05 [0.80-1.38]). CONCLUSIONS: Among 6-month survivors, accounting for nonhead injuries resulted in a nonsignificant effect of TBI on long-term mortality.
Longitudinal Effects of Medical Comorbidities on Functional Outcome and Life Satisfaction After Traumatic Brain Injury: An Individual Growth Curve Analysis of NIDILRR Traumatic Brain Injury Model System Data
(Wolters Kluwer, 2019-09-01) Malec, James F.; Ketchum, Jessica M.; Hammond, Flora M.; Corrigan, John D.; Dams-O'Connor, Kristen; Hart, Tessa; Novack, Thomas; Dahdah, Marie; Whiteneck, Gale G.; Bogner, Jennifer; Physical Medicine and Rehabilitation, School of Medicine
Objective: To explore associations of specific physical and neuropsychiatric medical conditions to motor and cognitive functioning and life satisfaction over the first 10 years following traumatic brain injury (TBI). Setting: Telephone follow-up through six TBI Model System centers. Participants: 404 individuals or proxies with TBI enrolled in the TBI Model System longitudinal study participating in 10 year follow-up. Design: Individual growth curve analysis. Main Measures: FIM™ Motor and Cognitive subscales, Life Satisfaction Scales, Medical and Mental Health Co-Morbidities Interview. Results: Hypertension, diabetes, cancers, rheumatoid arthritis, and anxiety negatively affected the trajectory of motor functioning over time. Diabetes, cancers, chronic bronchitis, anxiety, and depression negatively impacted cognitive functioning. Numerous neuropsychiatric conditions (sleep disorder, alcoholism, drug addiction, anxiety, panic attacks, PTSD, depression, bipolar disorder), as well as hypertension, liver disease, and cancers diminished life satisfaction. Other medical conditions had a negative effect on functioning and satisfaction at specific follow-up periods. Conclusion: Natural recovery after TBI may include delayed onset of functional decline or early recovery followed by progressive deterioration and is negatively affected by medical comorbidities. Results contribute to the growing evidence that TBI is most appropriately treated as a chronic medical condition complicated by a variety of comorbid conditions.
The Minimal Clinically Important Difference for the Mayo-Portland Adaptability Inventory
(Wolters Kluwer, 2017-07) Malec, James F.; Kean, Jacob; Monahan, Patrick O.; Physical Medicine and Rehabilitation, School of Medicine
OBJECTIVES: To determine the Minimal Clinically Important Difference (MCID) and Robust Clinically Important Difference (RCID) of the Mayo-Portland Adaptability Inventory-4 (MPAI-4) as measures of response to intervention. METHODS: Retrospective analysis of existing data. Both distribution- and anchor-based methods were used to triangulate on the MCID and to identify a moderate, that is, more robust, level of change (RCID) for the MPAI-4. These were further evaluated with respect to clinical provider ratings. PARTICIPANTS: Data for individuals with acquired brain injury in rehabilitation programs throughout the United States in the OutcomeInfo Database (n = 3087) with 2 MPAI-4 ratings. MAIN MEASURES: MPAI-4, Supervision Rating Scale, Clinician Rating of Global Clinical Improvement. RESULTS: Initial analyses suggested 5 T-score points (5T) as the MCID and 9T as the RCID. Eighty-one percent to 87% of clinical raters considered a 5T change and 99% considered a 9T change to indicate meaningful improvement. CONCLUSIONS: 5T represents the MCID for the MPAI-4 and 9T, the RCID. Both values are notably less than the Reliable Change Index (RCI). While the RCI indicates change with a high level of statistical confidence, it may be insensitive to change that is considered meaningful by providers and participants as indicated by the MCID.
Minimal Clinically Important Difference for the Rasch Neuropsychiatric Inventory Irritability and Aggression Scale for Traumatic Brain Injury
(Elsevier, 2017) Malec, James F.; Hammond, Flora M.; Physical Medicine and Rehabilitation, School of Medicine
Objective To determine the minimal clinically important difference (MCID) for a Rasch measure derived from the Irritability/Lability and Agitation/Aggression subscales of the Neuropsychiatric Inventory (NPI)—the Rasch NPI Irritability and Aggression Scale for Traumatic Brain Injury (NPI-TBI-IA). Design Distribution-based statistical methods were applied to retrospective data to determine candidates for the MCID. These candidates were evaluated by anchoring the NPI-TBI-IA to Global Impression of Change (GIC) ratings by participants, significant others, and a supervising physician. Setting Postacute rehabilitation outpatient clinic. Participants 274 cases with observer ratings; 232 cases with self-ratings by participants with moderate-severe TBI at least 6 months postinjury. Interventions Not applicable. Main Outcome Measure NPI-TBI-IA. Results For observer ratings on the NPI-TBI-IA, anchored comparisons found an improvement of 0.5 SD was associated with at least minimal general improvement on GIC by a significant majority (69%–80%); 0.5 SD improvement on participant NPI-TBI-IA self-ratings was also associated with at least minimal improvement on the GIC by a substantial majority (77%–83%). The percentage indicating significant global improvement did not increase markedly on most ratings at higher levels of improvement on the NPI-TBI-IA. Conclusions A 0.5 SD improvement on the NPI-TBI-IA indicates the MCID for both observer and participant ratings on this measure.
Negative Attribution Bias and Anger After Traumatic Brain Injury
(Wolters Kluwer, 2017-05) Neumann, Dawn; Malec, James F.; Hammond, Flora M.; Physical Medicine and Rehabilitation, School of Medicine
Objectives: Negative attributions pertain to judgments of intent, hostility, and blame regarding others' behaviors. This study compared negative attributions made by people with and without traumatic brain injury (TBI) and examined the degree to which these negative attributions predicted angry ratings in response to situations. Setting: Outpatient rehabilitation hospital. Participants: Forty-six adults with moderate to severe TBI and 49 healthy controls. Design: Cross-sectional study using a quasi-experimental research design. Main Measures: In response to hypothetical scenarios, participants rated how irritated and angry they would be, and how intentional, hostile, and blameworthy they perceived characters' behaviors. There were 3 scenario types differentiated by the portrayal of characters' actions: benign, ambiguous, or hostile. All scenarios theoretically resulted in unpleasant outcomes for participants. Results: Participants with TBI had significantly higher ratings for feeling “irritated” and “angry” and attributions of “intent,” “hostility,” and “blame” compared with healthy controls for all scenario types. Negative attribution ratings accounted for 72.4% and 65.3% of the anger rating variance for participants with and without TBI, respectively. Conclusion: People with TBI may have negative attribution bias, in which they disproportionately judge the intent, hostility, and blameworthiness of others' behaviors. These attributions contributed to their ratings of feeling angry. This suggests that participants with TBI who have anger problems should be evaluated for this bias, and anger treatments should possibly aim to alter negative attributions. However, before implementing clinical practice changes, there is a need for replication with larger samples, and further investigation of the characteristics associated with negative attribution bias.
Patterns of Functional Change Five to Ten Years after Moderate-Severe Traumatic Brain Injury
(Mary Ann Liebert, Inc., 2021) Hammond, Flora M.; Malec, James F.; Corrigan, John D.; Whiteneck, Gale G.; Hart, Tessa; Dams-O’Connor, Kristen; Novack, Thomas A.; Bogner, Jennifer; Dahdah, Marie N.; Eagye, C.B.; Sevigny, Mitch; Ketchum, Jessica M.; Physical Medicine and Rehabilitation, School of Medicine
This study aims to characterize the patterns of functional change experienced between 5 and 10 years after moderate-severe traumatic brain injury (TBI). The study included TBI Model Systems national database participants (N = 372) at six sites who experienced TBI, received inpatient rehabilitation, and were followed at 5 and 10 years post-TBI. Outcome measures included self- or proxy-reported Functional Independence Measure (FIMTM) structured interview at 5 and 10 years post-TBI and domain change indices (DCIs) at 10 years to assess subjective change over the previous 5 years. When all seven FIM and subjective DCI subscales were considered together, 69% reported improvement in at least one subscale and 41% reported decline in at least one subscale; 51% reported more domains improved than declined, and 20% reported more domains declined than improved. Age at injury, post-traumatic amnesia duration, FIM, and depression and anxiety at year 5 were associated with FIM change and DCI measures. Although most persons with moderate-severe TBI do not experience widespread change from year 5 to 10 on individual FIM subscales or perceived domain-specific subscales, the vast majority do report change in one or more domains, with more improvement than decline and more change in subjective DCI than in FIM. Clinicians and researchers should be alert to the possibility of both positive and deleterious changes many years after TBI.

Browsing by Author "Malec, James F."

Results Per Page

Sort Options