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Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

ABSTRACT: OBJECTIVE:To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury. DESIGN:Multicentre, pragmatic, observer-blinded, randomized controlled trial in England. SETTING:Community. PARTICIPANTS:People with memory problems following traumatic brain injury, aged 18-69?years, able to travel to group sessions, communicate in English, and give consent. INTERVENTIONS:A total of 10 weekly group sessions of manualized memory rehabilitation plus usual care (intervention) vs. usual care alone (control). MAIN MEASURES:The primary outcome was the patient-reported Everyday Memory Questionnaire (EMQ-p) at six months post randomization. Secondary outcomes were assessed at 6 and 12?months post randomization. RESULTS:We randomized 328 participants. There were no clinically important differences in the primary outcome between arms at six-month follow-up (mean EMQ-p score: 38.8 (SD 26.1) in intervention and 44.1 (SD 24.6) in control arms, adjusted difference in means: -2.1, 95% confidence interval (CI): -6.7 to 2.5, p?=?0.37) or 12-month follow-up. Objectively assessed memory ability favoured the memory rehabilitation arm at the 6-month, but not at the 12-month outcome. There were no between-arm differences in mood, experience of brain injury, or relative/friend assessment of patient's everyday memory outcomes, but goal attainment scores favoured the memory rehabilitation arm at both outcome time points. Health economic analyses suggested that the intervention was unlikely to be cost effective. No safety concerns were raised. CONCLUSION:This memory rehabilitation programme did not lead to reduced forgetting in daily life for a heterogeneous sample of people with traumatic brain injury. Further research will need to examine who benefits most from such interventions.

SUBMITTER: das Nair R

PROVIDER: S-EPMC6585159 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

das Nair Roshan R Bradshaw Lucy E LE Day Florence Ec FE Drummond Avril A Harris Shaun Rs SR Fitzsimmons Deborah D Montgomery Alan A AA Newby Gavin G Sackley Catherine C Lincoln Nadina B NB

Clinical rehabilitation 20190412 7

<h4>Objective</h4>To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury.<h4>Design</h4>Multicentre, pragmatic, observer-blinded, randomized controlled trial in England.<h4>Setting</h4>Community.<h4>Participants</h4>People with memory problems following traumatic brain injury, aged 18-69 years, able to travel to group sessions, communicate in English, and give consent.<h4>Interventions</h4>A total of 10 weekly group ...[more]

PMID: 30977398

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Project description:BackgroundTraumatic brain injury (TBI) is a leading cause of disability worldwide. TBI is a highly heterogeneous disease, which makes it complex for effective therapeutic interventions. Cluster analysis has been extensively applied in previous research studies to identify homogeneous subgroups based on performance in neuropsychological baseline tests. Nevertheless, most analyzed samples are rarely larger than a size of 100, and different cluster analysis approaches and cluster validity indices have been scarcely compared or applied in web-based rehabilitation treatments.ObjectiveThe aims of our study were as follows: (1) to apply state-of-the-art cluster validity indices to different cluster strategies: hierarchical, partitional, and model-based, (2) to apply combined strategies of dimensionality reduction by using principal component analysis and random forests and perform stability assessment of the final profiles, (3) to characterize the identified profiles by using demographic and clinically relevant variables, and (4) to study the external validity of the obtained clusters by considering 3 relevant aspects of TBI rehabilitation: Glasgow Coma Scale, functional independence measure, and execution of web-based cognitive tasks.MethodsThis study was performed from August 2008 to July 2019. Different cluster strategies were executed with Mclust, factoextra, and cluster R packages. For combined strategies, we used the FactoMineR and random forest R packages. Stability analysis was performed with the fpc R package. Between-group comparisons for external validation were performed using 2-tailed t test, chi-square test, or Mann-Whitney U test, as appropriate.ResultsWe analyzed 574 adult patients with TBI (mostly severe) who were undergoing web-based rehabilitation. We identified and characterized 3 clusters with strong internal validation: (1) moderate attentional impairment and moderate dysexecutive syndrome with mild memory impairment and normal spatiotemporal perception, with almost 66% (111/170) of the patients being highly educated (P<.05); (2) severe dysexecutive syndrome with severe attentional and memory impairments and normal spatiotemporal perception, with 49.2% (153/311) of the patients being highly educated (P<.05); (3) very severe cognitive impairment, with 45.2% (42/93) of the patients being highly educated (P<.05). We externally validated them with severity of injury (P=.006) and functional independence assessments: cognitive (P<.001), motor (P<.001), and total (P<.001). We mapped 151,763 web-based cognitive rehabilitation tasks during the whole period to the 3 obtained clusters (P<.001) and confirmed the identified patterns. Stability analysis indicated that clusters 1 and 2 were respectively rated as 0.60 and 0.75; therefore, they were measuring a pattern and cluster 3 was rated as highly stable.ConclusionsCluster analysis in web-based cognitive rehabilitation treatments enables the identification and characterization of strong response patterns to neuropsychological tests, external validation of the obtained clusters, tailoring of cognitive web-based tasks executed in the web platform to the identified profiles, thereby providing clinicians a tool for treatment personalization, and the extension of a similar approach to other medical conditions.

Project description:ObjectiveTo assess the effects of an additional programme of physiotherapy in adults with a first-time traumatic shoulder dislocation compared with single session of advice, supporting materials, and option to self-refer to physiotherapy.DesignPragmatic, multicentre, randomised controlled trial (ARTISAN).Setting and participantsTrauma research teams at 41 UK NHS Trust sites screened adults with a first time traumatic anterior shoulder dislocation confirmed radiologically, being managed non-operatively. People were excluded if they presented with both shoulders dislocated, had a neurovascular complication, or were considered for surgical management.InterventionsOne session of advice, supporting materials, and option to self-refer to physiotherapy (n=240) was assessed against the same advice and supporting materials and an additional programme of physiotherapy (n=242). Analyses were on an intention-to-treat basis with secondary per protocol analyses.Main outcome measuresThe primary outcome was the Oxford shoulder instability score (a single composite measure of shoulder function), measured six months after treatment allocation. Secondary outcomes included the QuickDASH, EQ-5D-5L, and complications.Results482 participants were recruited from 40 sites in the UK. 354 (73%) participants completed the primary outcome score (n=180 allocated to advice only, n=174 allocated to advice and physiotherapy). Participants were mostly male (66%), with a mean age of 45 years. No significant difference was noted between advice compared with advice and a programme of physiotherapy at six months for the primary intention-to-treat adjusted analysis (between group difference favouring physiotherapy 1.5 (95% confidence interval -0.3 to 3.5)) or at earlier three month and six week timepoints. Complication profiles were similar across the two groups (P>0.05).ConclusionsAn additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy.Trial registrationCurrent Controlled Trials ISRCTN63184243.

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Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

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Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

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