A Biopsychosocial Approach to Persistent Post-COVID-19 Fatigue and Cognitive Complaints: Results of the Prospective Multicenter NeNeSCo Study.

OBJECTIVE: To evaluate whether psychological and social factors complement biomedical factors in understanding post-COVID-19 fatigue and cognitive complaints. Additionally, to incorporate objective (neuro-cognitive) and subjective (patient-reported) variables in identifying factors related to post-COVID-19 fatigue and cognitive complaints. DESIGN: Prospective, multicenter cohort study. SETTING: Six Dutch hospitals. PARTICIPANTS: 205 initially hospitalized (March-June 2020), confirmed patients with SARS-CoV-2, aged ≥18 years, physically able to visit the hospital, without prior cognitive deficit, magnetic resonance imaging (MRI) contraindication, or severe neurologic damage post-hospital discharge (N=205). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Nine months post-hospital discharge, a 3T MRI scan and cognitive testing were performed and patients completed questionnaires. Medical data were retrieved from medical dossiers. Hierarchical regression analyses were performed on fatigue severity (Fatigue Severity Scale; FSS) and cognitive complaints (Cognitive Consequences after Intensive Care Admission; CLC-IC; dichotomized into CLC-high/low). Variable blocks: (1) Demographic and premorbid factors (sex, age, education, comorbidities), (2) Illness severity (ICU/general ward, PROMIS physical functioning [PROMIS-PF]), (3) Neuro-cognitive factors (self-reported neurological symptoms, MRI abnormalities, cognitive performance), (4) Psychological and social factors (Hospital Anxiety and Depression Scale [HADS], Utrecht Coping List, Social Support List), and (5) Fatigue or cognitive complaints. RESULTS: The final models explained 60% (FSS) and 48% (CLC-IC) variance, with most blocks (except neuro-cognitive factors for FSS) significantly contributing. Psychological and social factors accounted for 5% (FSS) and 11% (CLC-IC) unique variance. Higher FSS scores were associated with younger age (P=.01), lower PROMIS-PF (P<.001), higher HADS-Depression (P=.03), and CLC-high (P=.04). Greater odds of CLC-high were observed in individuals perceiving more social support (OR=1.07, P<.05). CONCLUSIONS: Results show that psychological and social factors add to biomedical factors in explaining persistent post-COVID-19 fatigue and cognitive complaints. Objective neuro-cognitive factors were not associated with symptoms. Findings highlight the importance of multidomain treatment, including psychosocial care, which may not target biologically-rooted symptoms directly but may reduce associated distress.

The Effects of a Blended Care Intervention in Partners of Patients With Acquired Brain Injury - Results of the CARE4Carer Randomized Controlled Trial.

OBJECTIVE: To assess effects of the CARE4Carer blended care intervention on caregiver mastery and psychosocial functioning compared with usual care in partners of patients with acquired brain injury (ABI). DESIGN: Multicenter randomized controlled trial. SETTING: Nine sites for rehabilitation medicine. PARTICIPANTS: 120 partners of outpatients with ABI were randomly allocated to blended care (N=59) or usual care (N=61). INTERVENTION: The blended care intervention (20 weeks) was aimed at improving caregiving skills and consisted of 9 online sessions, combined with 2 face-to-face consultations with a social worker. MAIN OUTCOME MEASURES: Mastery was assessed with the Caregiver Mastery Scale, secondary outcome measures were caregiver strain (Caregiver Strain Index), family functioning (Family Assessment Device), anxiety and depression (Hospital Anxiety and Depression Scale), burden (self-rated), and quality of life (CarerQol). Assessments were performed at baseline, 24, and 40 weeks. RESULTS: The adjusted mean difference in caregiver mastery between intervention and control group at week 24 was 1.31 (SD3.48, 95% confidence interval (CI) -0.12 to 2.74, P=.072) and at week 40 was 1.31 (SD3.69, 95% CI -0.26 to 2.88, P=.100). In the per protocol analysis, the adjusted mean difference in caregiver mastery at week 24 was 1.53 (SD3.38, 95% CI 0.10 to 2.96, P=.036) and at week 40 was 1.57 (SD3.63, 95% CI 0.01 to 3.14, P=.049). Regarding secondary outcomes, caregiver strain was lower in the intervention group in the per protocol analysis at week 40. Family functioning was higher in the intervention group in week 24, whereas anxiety was lower at both timepoints. CONCLUSIONS: In the subset of participants who were able to complete the intervention, caregiver mastery and psychosocial functioning improved. Future work should focus on improving adherence as this will optimize beneficial effects of blended care.

Efficacy of an Intensive Exposure Intervention for Individuals With Persistent Concussion Symptoms Following Concussion: A Concurrent Multiple Baseline Single-Case Experimental Design (SCED) Study.

OBJECTIVE: After a concussion, 1 in 3 patients report persistent symptoms and experience long-term consequences interfering with daily functioning, known as persistent concussion symptoms (PCS). Evidence suggests PCS is (partly) maintained by anxious thoughts about brain functioning, recovery, and experienced symptoms, leading to avoidance behaviors, which may prevent patients from meeting life demands. We aimed to investigate the efficacy of a newly developed intensive exposure intervention for individuals with PCS after concussion aimed to tackle avoidance behavior. SETTING: Participants took part in the intervention at the Maastricht University faculty. PARTICIPANTS: Four participants who experienced PCS after concussion partook in the exploratory study. Participants' age ranged between 20 and 32 (mean = 26.5, SD = 5.9) years, with an average length of time after the concussion of 9.8 months. DESIGN: A concurrent multiple-baseline single-case design was conducted. The baseline period (A phase) length was randomly determined across participants (3, 4, 5, or 6 weeks). The exposure intervention (B phase) was conducted by psychologists over a 4-week period and consisted of 3 stages: exploration (2 sessions), active exposure (12 sessions conducted over 1 week), and 2 booster sessions. MAIN MEASURES: Participants answered daily questions on a visual analog scale related to symptom experience, satisfaction with daily functioning, and degree of avoidance of feared activities. Additional outcomes included symptom severity, catastrophizing, fear of mental activity, anxiety, depression, and societal participation. RESULTS: Tau-U yielded significant effects (P < .05) for all participants on all measures when comparing baseline and intervention phases. The pooled standardized mean difference was high for all measures (symptom experience = 0.93, satisfaction of daily functioning = 1.86, and activity avoidance = -2.05). CONCLUSIONS: The results show efficacy of the newly developed intensive exposure treatment for PCS after concussion, which is based on the fear avoidance model. Replication in a larger heterogeneous sample is warranted and needed.

Acceptance and Commitment Therapy is feasible for people with acquired brain injury: A process evaluation of the BrainACT treatment.

OBJECTIVE: To evaluate the feasibility of Acceptance and Commitment Therapy for people with acquired brain injury. DESIGN: A process evaluation of the BrainACT treatment was conducted alongside a randomised controlled trial. SETTING: Psychology departments of hospitals and rehabilitation centres. SUBJECTS: Tweny-seven participants with acquired brain injury and 11 therapists. INTERVENTION: BrainACT is an Acceptance and Commitment Therapy adapted for the needs and possible cognitive deficits of people with acquired brain injury, provided in eight one-hour face-to-face or video-conference sessions. MEASUREMENTS: The attendance and compliance rates, engagement, satisfaction, and perceived barriers and facilitators for delivery in clinical practice were investigated using semi-structured interviews with participants and therapists and therapy logs. RESULTS: 212 of the 216 sessions in total were attended and 534 of the 715 protocol elements across participants and sessions were delivered. Participants were motivated and engaged. Participants and therapists were satisfied with the intervention and participants reported to have implemented skills in their daily routines acquired during therapy. Key strengths are the structure provided with the bus of life metaphor, the experiential nature of the intervention, and the materials and homework. Participants and therapists often preferred face-to-face sessions, however, when needed video-conferencing is a good alternative. CONCLUSION: BrainACT is a feasible intervention for people with anxiety and depressive symptoms following acquired brain injury. However, when the content of the intervention is too extensive, we recommend adding two extra sessions.

Does cognitive learning potential measured with the dynamic Wisconsin Card Sorting Test predict rehabilitation outcome in elderly patients post-stroke?

OBJECTIVE: To determine whether cognitive learning potential measured with the dynamic Wisconsin Card Sorting Test has added value in predicting rehabilitation outcome in elderly patients post-stroke after controlling for age, ADL independence at admission, global cognitive functioning and depressive symptoms. METHODS: Participants were patients with stroke admitted to a geriatric rehabilitation unit. ADL independence (Barthel Index) at discharge was used as measure for rehabilitation outcome. Predictor variables included age, ADL independence at admission, global cognitive functioning (Montreal Cognitive Assessment), depressive symptoms (Geriatric Depression Scale) and cognitive learning potential measured with the dWCST. RESULTS: Thirty participants were included. Bivariate analyses showed that rehabilitation outcome was significantly correlated with ADL independence at admission (r = 0.443, p = 0.014) and global cognitive functioning (r = 0.491, p = 0.006). Regression analyses showed that the dWCST was not an independent predictor of rehabilitation outcome. ADL independence at admission was the only significant predictor of rehabilitation outcome (beta = 0.480, p = 0.007). CONCLUSIONS: Cognitive learning potential, measured with the dWCST has no added value in predicting rehabilitation outcome in elderly patients post-stroke. ADL independence at admission was the only significant predictor of rehabilitation outcome. REGISTRATION NUMBER NETHERLANDS TRIAL REGISTER: Trial NL7947.

The Montreal Cognitive Assessment detects cognitive deficits that go unnoticed during clinical observation in the acute phase after stroke.

BACKGROUND: Detecting cognitive impairments early after stroke is essential for appropriate referrals. Although recommended in stroke guidelines, early cognitive screening is not always implemented. We assessed whether the Montreal Cognitive Assessment (MoCA) adds diagnostic value compared to clinical observation alone. In addition, discharge destinations for stroke patients with and without cognitive deficits detected with the screening tool or the treatment team were explored. METHODS: Forty-four stroke patients were screened with the MoCA during stroke unit admission. Their charts were studied for cognitive impairments reported by the stroke care team, who were blinded to screening scores. Proportions of detected cognitive deficits were compared between screening (score <26) and patient charts. Discharge destination distribution (home vs. rehabilitation) was explored. RESULTS: The proportion of cognitively impaired patients indicated by the MoCA (84%) and reported in patients' charts (25%) differed significantly (p < 0.001). The distribution of discharge destination did not suggest an association with the detection of cognitive deficits by the treatment team or the cognitive screening. CONCLUSIONS: The MoCA detects more cognitive deficits than clinical impression alone, emphasizing the importance of standard screening for cognitive impairments in acute stroke patients. Ultimately, systematic screening may enhance discharge planning and improve long-term outcomes.

Neurological and (neuro)psychological sequelae in intensive care and general ward COVID-19 survivors.

BACKGROUND AND PURPOSE: Coronavirus disease 2019 (COVID-19) affects the brain, leading to long-term complaints. Studies combining brain abnormalities with objective and subjective consequences are lacking. Long-term structural brain abnormalities, neurological and (neuro)psychological consequences in COVID-19 patients admitted to the intensive care unit (ICU) or general ward were investigated. The aim was to create a multidisciplinary view on the impact of severe COVID-19 on functioning and to compare long-term consequences between ICU and general ward patients. METHODS: This multicentre prospective cohort study assessed brain abnormalities (3 T magnetic resonance imaging), cognitive dysfunction (neuropsychological test battery), neurological symptoms, cognitive complaints, emotional distress and wellbeing (self-report questionnaires) in ICU and general ward (non-ICU) survivors. RESULTS: In al, 101 ICU and 104 non-ICU patients participated 8-10 months post-hospital discharge. Significantly more ICU patients exhibited cerebral microbleeds (61% vs. 32%, p < 0.001) and had higher numbers of microbleeds (p < 0.001). No group differences were found in cognitive dysfunction, neurological symptoms, cognitive complaints, emotional distress or wellbeing. The number of microbleeds did not predict cognitive dysfunction. In the complete sample, cognitive screening suggested cognitive dysfunction in 41%, and standard neuropsychological testing showed cognitive dysfunction in 12%; 62% reported ≥3 cognitive complaints. Clinically relevant scores of depression, anxiety and post-traumatic stress were found in 15%, 19% and 12%, respectively; 28% experienced insomnia and 51% severe fatigue. CONCLUSION: Coronavirus disease 2019 ICU survivors had a higher prevalence for microbleeds but not for cognitive dysfunction compared to general ward survivors. Self-reported symptoms exceeded cognitive dysfunction. Cognitive complaints, neurological symptoms and severe fatigue were frequently reported in both groups, fitting the post-COVID-19 syndrome.

Acceptance and commitment therapy for people with acquired brain injury: Rationale and description of the BrainACT treatment.

BACKGROUND: The treatment of anxiety and depressive symptoms following acquired brain injury is complex and more evidence-based treatment options are needed. We are currently evaluating the BrainACT intervention; acceptance and commitment therapy for people with acquired brain injury. RATIONALE: This paper describes the theoretical underpinning, the development and content of BrainACT. Acceptance and commitment therapy focuses on the acceptance of feelings, thoughts and bodily sensations and on living a valued life, without fighting against what is lost. Since the thoughts that people with acquired brain injury can experience are often realistic or appropriate given their situation, this may be a suitable approach. THEORY INTO PRACTICE: Existing evidence-based protocols were adapted for the needs and potential cognitive deficits after brain injury. General alterations are the use of visual materials, summaries and repetition. Acceptance and commitment therapy-specific adaptions include the Bus of Life metaphor as a recurrent exercise, shorter mindfulness exercises, simplified explanations, a focus on experiential exercises and the monitoring of committed actions. The intervention consists of eight one-hour sessions with a psychologist, experienced in acceptance and commitment therapy and in working with people with acquired brain injury. The order of the sessions, metaphors and exercises can be tailored to the needs of the patients. DISCUSSION: Currently, the effectiveness and feasibility of the intervention is evaluated in a randomised controlled trial. The BrainACT intervention is expected to be a feasible and effective intervention for people with anxiety or depressive symptoms following acquired brain injury.

Acceptance and commitment therapy for individuals with depressive and anxiety symptoms following acquired brain injury: A non-concurrent multiple baseline design across four cases.

Patients with acquired brain injury (ABI) often experience symptoms of anxiety and depression. Until now, evidence-based treatment is scarce. This study aimed to investigate the effectiveness of Acceptance and Commitment Therapy (ACT) for patients with ABI. To evaluate the effect of ACT for people with ABI, a non-concurrent multiple baseline design across four cases was used. Participants were randomly assigned to a baseline period, followed by treatment and then follow-up phases. Anxiety and depressive symptoms were repeatedly measured. During six measurement moments over a year, participants filled in questionnaires measuring anxiety, depression, stress, participation, quality of life, and ACT-related processes. Randomization tests and NAP scores were used to calculate the level of change across phases. Clinically significant change was defined with the Reliable Change Index. Three out of four participants showed medium to large decreases in anxiety and depressive symptoms (NAP = 0.85 till 0.99). Furthermore, participants showed improvements regarding stress, cognitive fusion, and quality of life. There were no improvements regarding psychological flexibility, value-driven behaviour, or social participation. This study shows that ACT is possibly an effective treatment option for people experiencing ABI-related anxiety and depression symptoms. Replication with single case or large scale group studies is needed to confirm these findings.

A cross-sectional comparison of patient characteristics across healthcare settings using the minimal dataset for adults with acquired brain injury (MDS-ABI).

Acquired Brain Injury (ABI) can have lifelong consequences and accordingly, persons with ABI often receive various types of healthcare. Facilities have their own preferences towards measurement instruments used to evaluate patients, impeding data comparison across healthcare settings. In this cross-sectional study, we used the previously developed minimal dataset for persons with ABI (MDS-ABI) to uniformly document and compare characteristics and outcomes of ABI patients in three healthcare settings: (1) residential care (n = 21), (2) non-residential care (n = 80), and (3) no ABI-related care (n = 22). Overall, patients of residential care settings had the lowest functional outcome compared with patients in the remaining groups. Nonetheless, all groups showed substantial disabilities within numerous life domains, indicating that the consequences of ABI are widespread among patients within and outside of healthcare facilities. These results demonstrate the need for a broad measurement of the potential consequences of ABI. The MDS-ABI covers twelve life domains most frequently affected by ABI and therefore helps to better recognize the consequences of ABI. In research contexts, implementation of the MDS-ABI allows for direct comparison of research findings. Future directions should be aimed at further implementation of the MDS-ABI to guide clinical decision-making and assist in identifying treatment goals specific to each healthcare setting.

The bidirectional relationship between sleep and physical activity following traumatic brain injury.

Sleep and physical activity are both modifiable behavioural factors that are associated with better health and are potentially related. Following traumatic brain injury, damage to the brain caused by an external force, sleep disturbances are common. Exploring bidirectional relationships between sleep and physical activity might provide insight into whether increasing physical activity could decrease these sleep disturbances. The current study, therefore, examined inter- and intra-individual temporal associations between sleep and daytime physical activity in 64 people with traumatic brain injury reporting sleep problems or fatigue (47 males; mean age, 40 years). Sleep and physical activity were measured using actigraphy with corroborating sleep diaries over 14 consecutive days. Multilevel models were used to examine inter- and intra-individual associations between physical activity and sleep. Inter-individual variations showed that earlier bedtimes, earlier wake-up times and lower sleep efficiency were associated with more physical activity. Intra-individual temporal variations showed no significant association of daytime physical activity with sleep duration or continuity. However, shorter sleep time and less wake after sleep onset than usual were associated with more time spent in light-intensity activity the next day. Therefore, sleep may have more of an influence on physical activity than physical activity has on sleep in people with traumatic brain injury. In conclusion, the results do not confirm a potential beneficial effect of physical activity on sleep but suggest that improving sleep quality might be relevant to support of a physically active lifestyle in people with traumatic brain injury. Further research is necessary to confirm these results.

Effectiveness of an integrated multidisciplinary geriatric rehabilitation programme for older persons with stroke: a multicentre randomised controlled trial.

BACKGROUND: Almost half of the stroke patients admitted to geriatric rehabilitation has persisting problems after discharge. Currently, there is no evidence based geriatric rehabilitation programme available for older stroke patients, combining inpatient rehabilitation with adequate ambulatory aftercare in the community. Therefore, we developed an integrated multidisciplinary rehabilitation programme that includes aftercare for older persons with stroke. We evaluated the effectiveness of this newly developed rehabilitation programme in comparison to usual care. METHODS: A multicentre randomised controlled trial was conducted in eight geriatric rehabilitation stroke units and their collaborating partners in primary care. The study population involved stroke patients and their informal caregivers who were aged 65 or over, living in the community before admission to geriatric rehabilitation, and expected to be able to return home after discharge. The programme consisted of three modules: inpatient neurorehabilitation, home-based self-management training, and stroke education. For patients, daily activity (FAI) was assessed as primary outcome and functional dependence (Katz-15), perceived quality of life (SSQoL) and social participation (IPA) as secondary outcomes. Additionally, among informal caregivers perceived care burden (self-rated burden VAS), objective care burden (Erasmus iBMG), and quality of life (CarerQol), were assessed as secondary outcomes. RESULTS: In total 190 patients and 172 informal caregivers were included. Mean age of the patients in the intervention group was 78.9 years (SD = 7.0) and in the usual care group 79.0 years (SD = 6.5). Significant favourable effects for the programme were observed for the subscale autonomy outdoors of the IPA (- 2.15, P = .047, and for the informal caregivers perceived care burden (1.23, P = .048. For the primary outcome daily activity and the other secondary outcomes, no significant effects were observed. CONCLUSION: The integrated multidisciplinary programme had no effect on daily activity of older stroke patients. However, patients participating in the programme had a higher level of perceived autonomy of outdoor activities and their informal caregivers perceived a lower care burden. The programme might be promising in providing adequate (after) care, although adaptation of the programme is recommended to increase its feasibility and improve its effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN62286281 . Registered 19-3-2010.

ZMILE, a multicomponent self-management intervention for adults with epilepsy: Rationale and description of the intervention.

OBJECTIVE: In this paper, we aim to provide a comprehensive description of the multicomponent self-management intervention for adults with epilepsy, ZMILE. RATIONALE OR THEORY: Acquiring self-management skills has been shown to play a vital role in enabling patients with epilepsy overcoming (health-related) struggles in daily life and coping with limitations their condition poses on them. ZMILE is a course consisting of education (to increase concordance to treatment), goal-setting (proactive coping), and self-monitoring. RESOURCES NEEDED: The course is guided by two nurse practitioners and each patient is allowed to bring one family member or friend. Self-monitoring plays an important role and can be done through e-Health tools or written diaries. PROCESSES INVOLVED: During and after the course, patients are required to work toward a personally defined goal using a five-step approach by means of pro-active coping. Moreover, patients are expected to use self-monitoring tools to reflect on their own behavior and identify ways to optimize medication intake when required. QUANTIFICATION: ZMILE is provided in an outpatient setting over five weekly group sessions and one booster session. From the start, patients are encouraged to set individual goals. Each group session will have a different theme but part of every session is reflecting on personal goals and to learn from eachother. CONCLUSIONS: The ZMILE-intervention has been evaluated and may be a promising intervention in terms of effectiveness and feasibility for adults with epilepsy, relatives, and professionals. We present the adapted version which can be implemented in clinical practice.

The relationship between social cognition and participation in the long term after stroke.

Social cognitive impairments may play a role in participation restrictions after stroke. Understanding their relationship could inform treatment approaches to improve participation. We investigated the relationship between social cognition and participation in the long term after stroke. Of 395 patients participating in a large prospective cohort study, cross-sectional data were available at 3-4 years post-stroke of 118 patients on tests for emotion recognition, theory of mind, empathy, and behaviour regulation. Participation was assessed with the Utrecht Scale for Evaluation of Rehabilitation - Participation (USER-P). Bivariate and multivariate regression analysis were used to examine the relationship between social cognitive domains and participation. The majority suffered from minor stroke (83.1% scored NIHSS 0-4). Only behaviour regulation was related to participation restrictions in bivariate analysis, but social cognitive impairments did not predict participation restrictions in multivariate regression in this group. To conclude, in a sample of minor stroke patients with mild impairments in theory of mind, emotion recognition and behavioural control, there were no associations with restrictions in participation. Research should examine whether a relationship is present in patients with more severe stroke. In addition, measuring social aspects of participation is necessary to further unravel this relationship, to determine treatment targets for improving participation.

Feasibility of an integrated multidisciplinary geriatric rehabilitation programme for older stroke patients: a process evaluation.

BACKGROUND: Almost half of the stroke patients admitted to geriatric rehabilitation has persisting problems after discharge. Currently, there is no evidence based geriatric rehabilitation programme available for older stroke patients, combining inpatient rehabilitation with adequate aftercare aimed at reducing the impact of persisting problems after discharge from a geriatric rehabilitation unit. Therefore, we developed an integrated multidisciplinary rehabilitation programme consisting of inpatient neurorehabilitation treatment using goal attainment scaling, home based self-management training, and group based stroke education for patients and informal caregivers. We performed a process evaluation to assess to what extent this programme was performed according to protocol. Furthermore, we assessed the participation of the patients in the programme, and the opinion of patients, informal caregivers and care professionals on the programme. METHODS: In this multimethod study, process data were collected by means of interviews, questionnaires, and registration forms among 97 older stroke patients, 89 informal caregivers, and 103 care professionals involved in the programme. RESULTS: A part of patients and informal caregivers did not receive all key elements of the programme. Almost all patients formulated rehabilitation goals, but among two thirds of the patients the goal attainment scaling method was used. Furthermore, the self-management training was considered rather complex and difficult to apply for frail elderly persons with stroke, and the percentage of therapy sessions performed in the patients' home environment was lower than planned. In addition, about a quarter of the patients and informal caregivers attended the education sessions. However, a majority of patients, informal caregivers and care professionals indicated the beneficial aspects of the programme. CONCLUSION: This study revealed that although the programme in general is perceived to be beneficial by patients, and informal and formal caregivers, the feasibility of the programme needs further attention. Because of persisting cognitive deficits and specific care needs in our frail and multimorbid target population, some widely used methods such as goal attainment scaling, and self-management training seemed not feasible in their current form. To optimize feasibility of the programme, it is recommended to tailor these elements more optimally to the population of frail older patients.

Defining the content of a minimal dataset for acquired brain injury using a Delphi procedure.

BACKGROUND: The lack of consistency in outcome measurement within the field of acquired brain injury (ABI) leads to incomparability of collected data and, consequently, reduced generalisation of findings. We aim to develop a set of standardised measures which can be used to obtain the minimum amount of data necessary to characterise ABI-patients across all healthcare sectors and disciplines and in every stage of recovery; i.e., an ABI-specific minimal dataset (MDS-ABI). The current study was conducted to identify the core outcome domains for adults with ABI (what to measure?) and to select the most suitable measurements within these domains (how to measure it?). METHODS: An initial comprehensive set of outcome domains and measurement instruments relevant for measuring the consequences of ABI was identified by a literature study. The selection of relevant domains was based on the International Classification of Functioning, Disability and Health framework. Measurement instruments were included in the Delphi procedure when they met pre-set requirements. A three-round Delphi study was conducted among Dutch experts (n = 48) using iterative web-based surveys to prioritise the proposed domains and instruments for the MDS-ABI. Throughout all rounds, participants could recommend additional or alternative domains and measurement instruments, and were fed back the collated group responses of the previous round. RESULTS: Response rates ranged from 89 to 100%. After three rounds, the expert panel reached consensus (≥51%) on the inclusion of 12 outcome domains (demographics, injury characteristics, comorbidity, cognitive functioning, emotional functioning, energy, mobility, self-care, communication, participation, social support and quality of life), measured with six measurement instruments, two screening questions and a registry of demographic- and injury information. No consensus was reached on how to measure quality of life. CONCLUSIONS: The current study achieved consensus on the content of a minimal dataset for patients with ABI. The current version of the MDS-ABI will be evaluated and optimised if necessary in the near future.

Effectiveness of the Brains Ahead! Intervention: 6 Months Results of a Randomized Controlled Trial in School-Aged Children With Mild Traumatic Brain Injury.

OBJECTIVE: To examine the effectiveness of Brains Ahead!, a psychoeducational intervention aimed to prevent long-term problems with activities and participation in children after mild traumatic brain injury (mTBI). PARTICIPANTS: In total, 124 children, aged 6 to 18 years, diagnosed with mTBI and their caregivers. METHOD: After randomization, participants in the intervention group received a face-to-face psychoeducational session with written take-home information and follow-up telephone call(s). Participants in the control group received usual care, consisting of a concise information brochure. PRIMARY OUTCOME MEASURES: Activities and participation (Child and Adolescent Scale of Participation [CASP]). SECONDARY OUTCOMES: fatigue, postconcussive symptoms (PCSs), posttraumatic stress symptoms (PTSSs), and quality of life (QOL). RESULTS: Generalized Estimated Equation analyses showed that both groups improved over the first 6 months post-mTBI, but the intervention group did not differ significantly on the CASP. Mann-Whitney U tests showed that the intervention group reported significantly less fatigue, PCSs, and PTSSs and better QOL compared with the control group at 6 months post-MTBI. CONCLUSIONS: The Brains Ahead! intervention resulted in significant improvements compared with usual care in reducing fatigue, PCSs, and PTSSs and improving QOL. Lack of an effect on activities and participation may be due to the ceiling effect of the CASP.

Activities and Participation in the First 6 Months After Mild Traumatic Brain Injury in Children and Adolescents.

OBJECTIVE: To investigate the natural course of activities and participation of children up to 6 months after a mild traumatic brain injury (mTBI). METHODS: A prospective longitudinal cohort study with complete data sets of 231 children diagnosed with mTBI and their caregivers. MAIN MEASURES: Activities and participation assessed with the Child and Adolescent Scale of Participation (CASP) and the Children's Assessment of Participation and Enjoyment (CAPE) measured at 2 weeks, 3 months, and 6 months post-mTBI. Because of a ceiling effect, the primary outcome measure (CASP) was divided into deviant (not maximum score) or full functioning. RESULTS: Friedman's, Cochran's Q, and McNemar's tests (CASP) and repeated-measures analyses of variance (CAPE) showed significant increases in activities and participation between 2 weeks and 3 and 6 months after mTBI. Based on the parents' perspective, 67% of the children returned to full functioning at 6 months postinjury, with only 38% of the children describing themselves as functioning at their premorbid level. DISCUSSION: Findings indicate that most children return to maximum level of activities and participation over time after mTBI. In a substantial number of children, however, the level of activities and participation at 6 months postinjury is evaluated as lower than that of peers. The importance of investigating predictors for child and caregiver perspectives is emphasized.

Process evaluation of 'Brains Ahead!': an intervention for children and adolescents with mild traumatic brain injury within a randomized controlled trial.

OBJECTIVE: To investigate whether the 'Brains Ahead! Intervention for children and adolescents with mild traumatic brain injury' was implemented as intended. In addition, involvement in and satisfaction with the intervention among patients, caregivers and professionals delivering the intervention were studied. DESIGN: Mixed methods, prospective study. PARTICIPANTS: Children with mild traumatic brain injury and their caregivers, allocated to the intervention group of the randomized controlled trial in the 'Brains Ahead!' study, and the two professionals providing the intervention. INTERVENTION: The intervention consists of a standardized and individualized psychoeducational session with written take-home information, and follow-up telephone call(s). MAIN MEASURES: Registration forms, evaluation questionnaires for patients and caregivers and semi-structured interviews for professionals. DATA ANALYSIS: Qualitative data were categorized based on content. Quantitative data were reported as descriptive statistics. RESULTS: Fifty-five patients and caregivers out of 60 study-participants attended both sessions. All elements of the intervention were delivered to 53 study-participants. Evaluation questionnaires were completed by 21 of the 31 patients aged 12 years and older, and by 41 caregivers. Overall, the sessions were considered useful by 19 patients, 40 caregivers and both professionals. Reassurance, creating a better understanding and recognition of symptoms were rated as important aspects. On a scale from 1 to 10, the intervention was rated by children, caregivers and professionals with 7.6 (SD 1.2), 8.1 (SD .9) and 8.0 (SD .0), respectively. CONCLUSION: The 'Brains Ahead!' intervention was largely implemented as intended and the process evaluation revealed that it is considered feasible according to patients, caregivers and professionals.

A trial-based economic evaluation of the Restore4Stroke self-management intervention compared to an education-based intervention for stroke patients and their partners.

BACKGROUND: Since stroke survivors are increasingly responsible for managing stroke-related changes in their own health and lifestyle, self-management skills are required. In a recent randomised controlled trial a self-management intervention based on proactive coping action planning (SMI) in comparison with an education-based intervention (EDU) in stroke patients was investigated. However, no relevant treatment effects on the Utrecht Proactive Coping Competence scale (UPCC) and the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-Participation) were found. The current study is a trial-based economic evaluation from a societal perspective comparing the same interventions (SMI versus EDU). METHODS: UPCC, USER-Participation and EuroQol (EQ-5D-3 L) and costs were measured at baseline, three, six and twelve months after treatment. For the cost-effectiveness analyses, incremental cost effectiveness ratios (ICERs) were calculated for UPCC and USER-Participation. For the cost-utility analyses the incremental cost utility ratio (ICUR) was expressed in cost per Quality Adjusted Life Years (QALYs). Outcomes were tested by means of AN(C)OVA analyses and costs differences by means of bootstrapping. Bootstrapping, sensitivity analyses and a subgroup analysis were performed to test the robustness of the findings. RESULTS: One hundred thirteen stroke patients were included in this study. The mean differences in USER-Participation scores (95%CI:-13.08,-1.61, p-value = .013) were significant different between the two groups, this does not account for UPCC scores (95%CI:-.267, .113, p-value = not significant) and QALYs (p-value = not significant) at 12 months. The average total societal costs were not significantly different (95%CI:€-3380,€7099) for SMI (€17,333) in comparison with EDU (€15,520). Cost-effectiveness analyses showed a mean ICER of 26,514 for the UPCC and 346 for the USER-Participation. Cost-utility analysis resulted in an ICUR of €44,688 per QALY. Assuming a willingness to pay (WTP) threshold of €50,000 per QALY, the probability that SMI will be cost-effective is 52%. Sensitivity analyses and subgroup analysis showed the robustness of the results. CONCLUSIONS: SMI is probably not a cost-effective alternative in comparison with EDU. Based on the current results, the value of implementing SMI for a stroke population is debatable. We recommend further exploration of the potential cost-effectiveness of stroke-specific self-management interventions focusing on different underlying mechanisms and using different control treatments.