Communication and Psychosocial Outcomes 2-Years After Severe Traumatic Brain Injury: Development of a Prognostic Model.

OBJECTIVE: To examine predictive factors underlying communication and psychosocial outcomes at 2 years post-injury. Prognosis of communication and psychosocial outcomes after severe traumatic brain injury (TBI) is largely unknown yet is relevant for clinical service provision, resource allocation, and managing patient and family expectations for recovery. DESIGN: A prospective longitudinal inception design was employed with assessments at 3 months, 6 months, and 2 years. PARTICIPANTS: The cohort included 57 participants with severe TBI (N=57). SETTING: Subacute and post-acute rehabilitation. MAIN OUTCOME MEASURES: Preinjury/injury measures included age, sex, education years, Glasgow Coma Scale, and PTA. The 3-month and 6-month data points included speech, language, and communication measures across the ICF domains and measures of cognition. The 2-year outcome measures included conversation, perceived communication skills, and psychosocial functioning. Predictors were examined using multiple regression. INTERVENTIONS: Not applicable. RESULTS: The cognitive and communication measures at 6 months significantly predicted conversation measures at 2 years and psychosocial functioning as reported by others at 2 years. At 6 months, 69% of participants presented with a cognitive-communication disorder (Functional Assessment of Verbal Reasoning and Executive Strategies [FAVRES]). The unique variance accounted for by the FAVRES measure was 7% for conversation measures and 9% for psychosocial functioning. Psychosocial functioning at 2 years was also predicted by pre-injury/injury factors and 3-month communication measures. Pre-injury education level was a unique predictor, accounting for 17% of the variance, and processing speed/memory at 3 months uniquely accounted for 14% of the variance. CONCLUSION: Cognitive-communication skills at 6 months are a potent predictor of persisting communication challenges and poor psychosocial outcomes up to 2 years after a severe TBI. Findings emphasize the importance of addressing modifiable cognitive and communication outcomes variables during the first 2 years after severe TBI to maximize functional patient outcomes.

The psychological benefits of neuropsychological assessment feedback as a psycho-educational therapeutic intervention: A randomized-controlled trial with cross-over in multiple sclerosis.

ABSTRACTEvidence supporting the direct therapeutic benefits of neuropsychological assessment (NPA) feedback relies mostly upon post-feedback consumer surveys. This randomized-controlled trial with cross-over investigated the benefits of NPA feedback in multiple sclerosis (MS). Seventy-one participants were randomly allocated to NPA with feedback or a "delayed-treatment" control group. The primary hypotheses were that NPA feedback would lead to improved knowledge of cognitive functioning and improved coping. Outcome instruments were administered by a research assistant blinded to group allocation. At 1-week post-NPA feedback there were no significant group-by-time interaction effects, indicating no improvement. But nor was there any significant deterioration in psychological wellbeing, despite most participants receiving "bad news" confirming cognitive impairment. At 1-month follow-up, within-subjects' analyses not only found no evidence of any delayed deterioration, but showed clinically significant improvement (small-medium effects) in perceived everyday cognitive functioning, MS self-efficacy, stress and depression. Despite lack of improvement in the RCT component at 1-week post-NPA feedback, the absence of deterioration at this time, in addition to significant improvements in perceived cognitive functioning, self-efficacy and mood at follow-up, together with high satisfaction ratings, all support NPA feedback as a safe psycho-educational intervention that is followed by improved psychological wellbeing over time.Trial registration: Uniform Trial Number identifier: U1111-1127-1585.Trial registration: Australian New Zealand Clinical Trials Registry identifier: ACTRN12612000161820.

Neuropsychological recovery during the first 12 months after severe traumatic brain injury: A longitudinal study with monthly assessments.

Neuropsychologists are commonly asked practical questions about cognitive recovery in the first year following moderate-to-severe traumatic brain injury (TBI), however guiding evidence to provide answers is limited. The design of this longitudinal study rectifies methodological problems in the literature by taking serial assessments on a monthly basis from 3- to 12-months post-trauma in a severe TBI sample (n = 23), and using four alternate forms of a brief yet sensitive cognitive assessment battery. Fifteen variables sampling seven cognitive domains were used: orientation, attention, processing speed, executive function, memory, language and visuospatial function. A matched control group (n = 23) was used to establish equivalence of the four alternate forms (no statistically significant differences), document practice effects (no statistically significant differences), and provide a comparison standard of cognitive functioning against which to interpret the TBI recovery curves. Twenty-one of 23 consenting TBI participants continued with the serial assessments. Hierarchical growth model analyses typically revealed linear recovery trajectories over the first 12 months. However, by 12-months post-trauma, a significant proportion (up to 36%) had residual mild to severe impairments in various cognitive domains. These results provide detailed information about patterns of cognitive recovery that also have direct clinical application.

A randomized controlled trial of cognitive behavioural therapy for managing anxiety in adolescents with acquired brain injury.

The aim of this randomized controlled trial was to evaluate an adapted cognitive behavioural therapy (CBT) programme for treating anxiety in adolescents with acquired brain injury (ABI). Participants with ABI (12-19 years, N = 36) recruited from two sites were randomly allocated into either the intervention receiving 11 sessions of CBT (n = 19) or a wait-list control group (n = 17). The primary outcome was participants' anxiety and secondary outcomes were participants' depression, self-perception, and participation in daily activities, and parental stress, measured at (i) pre-intervention, (ii) immediately post-intervention, (iii) 2 months post-intervention and (iv) 6 months post-intervention. Repeated measures ANOVAs revealed significant treatment effects with the intervention group demonstrating greater improvements in self-reported anxiety, as well as self- and parent-reported depression from pre- to immediately post-treatment, compared to wait-list controls. Little evidence of treatment effects was found for the remaining outcomes (parent-reported anxiety, self-perception, daily participation, and parental stress). Significant improvement in self-reported anxiety found immediately post-treatment was maintained at two- and six-month follow-up. Findings provide support for adapted CBT as an effective means of reducing anxious and depressive symptomatology in adolescents with ABI compared to waitlist controls, and offer support for the use of these techniques to manage anxiety in this population..

Behavioural activation therapy to improve participation in adults with depression following brain injury: A single-case experimental design study.

Following brain injury, the risk of depression increases. There are few studies of non-pharmacological interventions for this problem. Behavioural Activation (BA) could help because it has been demonstrated to be as effective as cognitive-behaviour therapy but is less cognitively demanding and more suitable for people with brain impairment. The current study evaluated BA using a multiple-baseline design across behaviours with replication. Three male participants with clinically significant depressive symptoms (two with traumatic brain injury aged 26 and 46, one who experienced strokes in infancy, aged 26) engaged in a 10-14-week trial of BA focusing on three activity domains: physical, social and functional activities. Participants completed an online form three times a day which recorded activity participation and responses to a single-item mood scale. There was little evidence in support of BA for increasing participation. There was also a lack of change in average mood, but some positive effects were found on measures of depression symptoms and quality of life in these participants. Various factors affected participation which might have been mitigated by extended treatment contact, greater use of prompts or electronic aids or the addition of other therapy modes.

Are single item mood scales (SIMS) valid for people with traumatic brain injury?

Objectives: Single-item mood scales (SIMS) are used in clinical practice and research as simple and convenient measures to track mood and response to interventions but have rarely been formally evaluated in neurological samples. The current study sought to evaluate the psychometric properties of SIMS in verbal and visual formats.Participants: Sixty-one people living in community settings in metropolitan and regional Australia, with a history of traumatic brain injury.Methods: SIMS were compared with measures of related constructs (depressed mood and satisfaction with life) on two occasions between one and three weeks apart.Results: The study met COSMIN method quality criteria for evaluation of validity. The SIMS showed evidence of construct validity, having moderate magnitude correlation coefficients with measures of similar constructs, and conversely low and non-significant correlation with dissimilar constructs. There was also evidence of discriminant validity, with significant differences based on diagnostic status (participants with depression rated SIMS lower). Correlation coefficients on the SIMS between Times 1 and 2 were of moderate magnitude, with a small but statistically significant increase in mean ratings.Conclusions: the data support the SIMS as a valid measure that can be administered to track changes in mood in clinical practice and research.

A longitudinal study of support needs after severe traumatic brain injury.

OBJECTIVES: The need for support following traumatic brain injury (TBI) is well documented. Yet the evidence is limited about the types of support required, how support needs change over time, and the effect of level of disability. This study addresses this limitation in the evidence. METHOD: Longitudinal design with a state-wide inception cohort of 131 people with severe TBI. Support needs were assessed using the Care and Needs Scale at 3- and 5-years post-trauma. RESULTS: By 3 years post-trauma, the level of disability on the Disability Rating Scale stabilized (49.6% low disability, 39.7% moderate disability, 10.7% severe disability). By contrast, support needs were high at 3 years (95%) and 5 years (94%). The most common type of support need was psychosocial (95%), then instrumental activities of daily living (IADL; 63%). The most frequently occurring intensity level of support need was every few days (24%). A significant increase in the total number of support needs occurred between 3 and 5 years, particularly for IADL supports. At the individual participant level, intensity of support changed for 53% (increase in 35% and decrease in 18%). Disability subgroups showed different patterns of support needs. CONCLUSIONS: Support needs after severe TBI are prevalent, varied, and change over time, which have implications for care-giving and service delivery.

Evaluating an intervention to increase meaningful activity after severe traumatic brain injury: A single-case experimental design with direct inter-subject and systematic replications.

Severe traumatic brain injury (sTBI) often results in significant morbidity, with fewer than 50% returning to work and only a minority resuming leisure and social activity. Yet few effective interventions are available for non-vocational activity. The aim of the study was to develop a new goal-directed intervention, the Programme for Engagement, Participation and Activities (PEPA), and evaluate its effect. The research design was a multiple-baseline design across behaviours, with direct inter-subject and systematic replications. Seven participants with sTBI, neurobehavioural impairment including apathy, inability to work, and limited leisure/social activities were categorised into two groups. Group 1 (n = 4) had cognitive impairments but were functionally independent. Systematic replication was conducted in a further three participants (group 2) with major neurobehavioural impairments and functional disability. Generalisation measures evaluated other life domains in group 1 participants (e.g., mood, community participation). Results of the weighted average Tau-U across the tiers was significant for six out of seven participants, with large effect sizes (≥.64) for five participants. Generalisation effects extended to other domains of life. The PEPA thus shows promise as an effective intervention to increase non-vocational activity and improve mental health outcomes in people with neurobehavioural disability after sTBI. These results add to the evidence for the effectiveness of goal-directed interventions.

Psychosocial functioning following moderate-to-severe pediatric traumatic brain injury: recommended outcome instruments for research and remediation studies.

Psychosocial functioning is compromised following pediatric traumatic brain injury (TBI), with the past few decades witnessing a proliferation of research examining the effect of childhood brain insult on a range of psychosocial outcomes. This paper describes the systematic recommendation of outcome instruments to address psychosocial functioning following pediatric TBI.A total of 65 instruments across 11 psychosocial areas (i.e., Global Outcome, Communication, Social Cognition, Behavioural and Executive Function, Other Neuropsychological Functioning, Psychological Status, TBI-related Symptoms, Activities and Participation, Support and Relationships, Sense of Self, and Health-Related Quality of Life) were reviewed using various assessment methods, including working groups, literature searches, comparisons with selection guidelines, and international expert opinion. Each measure was reviewed for its usefulness across early recovery, intervention, and outcome related studies.34 instruments were recommended and classified according to the World Health Organization's International Classification of Functioning, Disability and Health taxonomy and categorised by psychosocial area.This compilation provides a common framework to guide the activities of clinicians and researchers in psychosocial rehabilitation. It is anticipated that these will foster a multidisciplinary approach to psychosocial dysfunction to enhance the evaluation, prediction, and improvement of functional outcomes for those with pediatric TBI.

Discourse recovery after severe traumatic brain injury: exploring the first year.

OBJECTIVES: Although much is known about discourse impairment, little is known about discourse recovery after severe traumatic brain injury (TBI). This paper explores discourse recovery across the critical first year, controlling for pre-injury, injury and post-injury variables. DESIGN AND METHODS: An inception cohort comprising 57 participants with severe TBI was examined at 3, 6, 9 and 12 months post-injury and compared to a cross-section of matched healthy control participants. A narrative discourse task was analyzed with main concept analysis (MCA). A mixed linear model approach was used to track recovery controlling for pre-injury, injury and post-injury variables. RESULTS: An upward trajectory of recovery was observed, with peak periods of improvement between 3-6 and 9-12 months and all time points were significantly below controls. Years of education and PTA duration were significant covariates in the recovery model. Presence of aphasia also influenced the recovery model. CONCLUSIONS: Individuals with TBI typically improve over the first year, however many will continue to have discourse deficits at 12 months. Years of education, PTA duration and aphasia should be considered when planning services. The 3-6- and 9-12-month periods may offer optimal periods for discourse recovery and increased supports may be beneficial between 6-9 months.

Patterns of early conversational recovery for people with traumatic brain injury and their communication partners.

PRIMARY OBJECTIVE: To investigate whether the degree of participation by people with severe Traumatic Brain Injury (TBI), and the degree of support by their communication partners (CPs) changes in conversation during subacute recovery. METHODS AND PROCEDURES: Seventeen pairs of participants with TBI and their CPs were video-recorded during a 10 min casual conversation at 3 and 6 months post-injury. Communication behaviors were rated using the adapted Measure of Participation in Conversation (MPC) and the adapted Measure of Support in Conversation (MSC) at both time points and compared. RESULTS: Inferential analyses showed that there was no significant change in the degree of participation in conversation by participants with TBI and the degree of conversation support by their CPs from 3 to 6 months post. Comparison of qualitative field notes revealed that specific conversational behaviors changed over time, including better turn-taking and topic maintenance. CONCLUSION: Documenting early communication recovery is a complex and challenging endeavor. The lack of change in conversational effectiveness during the sub-acute period using global rating scales highlights the need for social communication tools that are sensitive to communication recovery following severe TBI.

Outcome instruments in moderate-to-severe adult traumatic brain injury: recommendations for use in psychosocial research.

BACKGROUND: Traumatic brain injury (TBI) can reduce psychosocial functioning, causing relationship, family, and employment difficulties. The present study by Moving Ahead: Centre for Research Excellence (CRE) in Brain Recovery aimed to identify a set of adult outcome instruments for moderate-to-severe TBI psychosocial research. PROCEDURE: A review of 115 instruments (identified through nomination, literature search, and international expert opinion) was conducted over a 15-month period. Eleven psychosocial areas were examined: Global Outcome, Communication, Social Cognition, Behavioural and Executive Function, Other Neuropsychological Functioning, Psychological Status, TBI-related Symptoms, Activities and Participation, Support and Relationships, Sense of Self, and Health-related Quality of Life. Individual instruments were considered against selection guidelines, and specific measures that best met the guidelines were identified as core (common across all studies), supplemental (dependent on study type) or emerging. RESULTS: The final recommendations, organised in accordance with the World Health Organisation's International Classification of Functioning taxonomy, comprised 56 instruments for use in early recovery, outcome, and intervention studies. CONCLUSION: These recommendations provide a coherent framework along with identified outcome instruments to guide psychosocial research in moderate-to-severe TBI. Adherence to the recommendations will enable data-pooling and comparison across studies and research settings facilitating consistent measurement across the lifespan.

Individual- and Population-Level Impacts of Traumatic Brain Injury and Maternal Characteristics on Subsequent Offending Behavior.

OBJECTIVE: To evaluate the individual- and population-level impact of a combination of factors, including traumatic brain injury (TBI) and certain maternal characteristics, on subsequent criminal conviction. DESIGN AND PARTICIPANTS: A retrospective record linkage study involving a cohort of 30 599 individuals born between 1980 and 1985, with ratio of 1 (with TBI): 3 (no TBI), matched by sex and the year of birth. METHODS AND PROCEDURES: Cox proportional hazard regression models and population attributable risk percentages (PAR%) were used to assess the contribution of TBI and other risk factors on subsequent criminal convictions. MAIN OUTCOMES AND RESULTS: Overall, individuals born to the teenaged mothers (<20 years) have significantly higher proportion of TBI than those born to older mothers (35% vs 22%; P < .001). In the gender-specific analyses, a history of TBI was associated with increased risk for criminal convictions (adjusted hazard ratio [aHR]: 1.48, 95% confidence interval [CI]: 1.36-1.60, and aHR: 1.45, 95% CI: 1.22-1.73, for men and women, respectively). Maternal characteristics (maternal age, single parent, multiparity) were identified as the greater contributor to the criminal convictions (PAR%: 57% and 67% for men and women, respectively). The combined impact of mental illness, maternal factors, and TBI was estimated to be 67% and 74% (for men and women, respectively); with nonoverlapping 95% CIs for PAR%, these factors were estimated to have had a higher impact among females than among males. CONCLUSION: More than half of the criminal convictions were associated with a relatively small number of risk factors, including poor mental health, low socioeconomic status, and TBI as well as certain maternal characteristics.

Cognitive-communication and psychosocial functioning 12 months after severe traumatic brain injury.

OBJECTIVE: Cognitive-communication deficits after severe Traumatic Brain Injury (TBI) may contribute to poor psychosocial functioning, however, the possible nature of this relationship remains unclear and warrants investigation. The current study explored the variance and correlations of a measure of cognitive-communication with a measure of psychosocial outcome in adults 12 months following TBI. METHOD: 36 adults with severe TBI evaluated at 12 months post-injury. Cognitive-communication skills were evaluated with the Functional Assessment of Verbal Reasoning and Executive Strategies (FAVRES), Sydney Psychosocial Reintegration Scale-2 (SPRS-2) Form A - Informant version assessed psychosocial functioning. Multiple regression analyses were used to investigate association between cognitive-communication and psychosocial outcomes. RESULTS: Two measures of cognitive-communication assessment (Accuracy and Rationale of the FAVRES) contributed significantly to total psychosocial outcome (SPRS-2). Multiple regression analyses revealed these variables accounted for 29.1% of the variance. Cognitive-communication variables accounted for 24.0% and 28.6% of the Work/Leisure and Relationship domains of the SPRS-2. CONCLUSION: Cognitive-communication ability was significantly related to psychosocial functioning at 12 months post-TBI. Findings suggested continued speech pathology involvement in the post-acute stages of recovery may improve social, vocational and overall psychosocial functioning. The FAVRES is a promising cognitive-communication assessment for identification of treatable factors impacting psychosocial outcomes.

Procedural discourse performance in adults with severe traumatic brain injury at 3 and 6 months post injury.

BACKGROUND: There is limited research on communicative recovery during the early stages after a severe traumatic brain injury (TBI) in adults. METHODS AND PROCEDURES: In the current study 43 people with severe TBI described a simple procedure at 3 and 6 months post injury and this was compared to the description provided by 37 healthy speakers. Linguistic productivity and the presence of macrostructural discourse elements were analysed. MAIN OUTCOMES AND RESULTS: No change occurred in productivity in the TBI group between the two time points. There was increased use of relevant information (macrostructure) over time for the TBI group, reflecting improvement. People with TBI differed from controls in speech rate and in two out of three macrostructural categories at both time points, indicating difficulties even after 12 weeks of recovery. CONCLUSIONS: Overall, the quality, rather than the quantity of discourse was disordered for participants with TBI. Findings indicate that procedural discourse is sensitive to discourse deficits of people with TBI and can be used to map recovery during the sub-acute phase.

Exploring the relationship between cognition and functional verbal reasoning in adults with severe traumatic brain injury at six months post injury.

OBJECTIVE(S): This study aims to determine the association between cognitive impairment and functional verbal reasoning in adults with severe traumatic brain injury (TBI), at six months post-injury. METHOD(S): 38 participants with severe TBI were assessed using the four tasks on the Functional Assessment of Verbal Reasoning and Executive Strategies (FAVRES) [1] and a battery of neuropsychological tests at 6 months post injury in a cross-sectional observational study. RESULTS: Overall performance on the FAVRES [1] was strongly associated with overall performance on the neuropsychological battery (rho = 0.60). FAVRES Task 2 and FAVRES Task 4 had the most significant positive associations with the cognitive indices of Attention and speed of processing, Memory and Executive functions. There was one weak significant association between the Task 1 Accuracy score and the Total Cognitive index (rho = 0.46). CONCLUSIONS: Performance on the FAVRES [1] is positively associated with cognitive processes. Participants with stronger verbal reasoning skills which may be required for activities in work, home and social contexts also had higher scores on tests of cognitive functioning. These findings may inform clinical practices for speech pathologists and other health professionals, in the assessment and treatment of cognitive communication disorders during early stages of recovery in people with severe TBI.

The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement.

We developed a reporting guideline to provide authors with guidance about what should be reported when writing a paper for publication in a scientific journal using a particular type of research design: the single-case experimental design. This report describes the methods used to develop the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016. As a result of 2 online surveys and a 2-day meeting of experts, the SCRIBE 2016 checklist was developed, which is a set of 26 items that authors need to address when writing about single-case research. This article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016 ) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated. We recommend that the SCRIBE 2016 is used by authors preparing manuscripts describing single-case research for publication, as well as journal reviewers and editors who are evaluating such manuscripts. SCIENTIFIC ABSTRACT Reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) Statement, improve the reporting of research in the medical literature (Turner et al., 2012 ). Many such guidelines exist and the CONSORT Extension to Nonpharmacological Trials (Boutron et al., 2008 ) provides suitable guidance for reporting between-groups intervention studies in the behavioural sciences. The CONSORT Extension for N-of-1 Trials (CENT 2015) was developed for multiple crossover trials with single individuals in the medical sciences (Shamseer et al., 2015 ; Vohra et al., 2015 ), but there is no reporting guideline in the CONSORT tradition for single-case research used in the behavioural sciences. We developed the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016 to meet this need. This Statement article describes the methodology of the development of the SCRIBE 2016, along with the outcome of 2 Delphi surveys and a consensus meeting of experts. We present the resulting 26-item SCRIBE 2016 checklist. The article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016 ) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated.

Conversational topics discussed by individuals with severe traumatic brain injury and their communication partners during sub-acute recovery.

PRIMARY OBJECTIVE: To investigate the nature and patterns of conversational topics discussed by individuals with severe TBI and familiar communication partners at 3 and 6 months post-injury, and to examine changes occurring in conversational topics during sub-acute recovery. RESEARCH DESIGN: Qualitative content analysis was used to explore the nature of topics and generate conversational themes. Topic analysis provided an understanding of conversational topic management by identifying patterns of topic initiation and maintenance. METHODS: Twenty-two people with severe TBI and a familiar communication partner engaged in a 10-minute casual conversation on self-selected topics at 3 and 6 months post-injury. MAIN OUTCOMES AND RESULTS: Three main conversational themes were identified: connecting; re-engaging; and impacts of injury. The nature of topics related to these themes changed over time to reflect participants' sub-acute rehabilitation experiences. Most conversational dyads maintained similar conversational and topic patterns during sub-acute recovery. CONCLUSIONS: Qualitative analysis provides a new insight into the conversational topics of individuals with severe TBI. Many participants engaged in appropriate conversations and discussed mutually important topics with familiar communication partners. Findings may inform speech-language pathology intervention in sub-acute recovery to improve conversational discourse abilities of individuals with severe TBI and support their communication partners.

Computerised cognitive training in acquired brain injury: A systematic review of outcomes using the International Classification of Functioning (ICF).

Computerised cognitive training (CCT) is an increasingly popular intervention for people experiencing cognitive symptoms. This systematic review evaluated the evidence for CCT in adults with acquired brain injury (ABI), focusing on how outcome measures used reflect efficacy across components of the International Classification of Functioning, Disability and Health. Database searches were conducted of studies investigating CCT to treat cognitive symptoms in adult ABI. Scientific quality was rated using the PEDro-P and RoBiNT Scales. Ninety-six studies met the criteria. Most studies examined outcomes using measures of mental functions (93/96, 97%); fewer studies included measures of activities/participation (41/96, 43%) or body structures (8/96, 8%). Only 14 studies (15%) provided Level 1 evidence (randomised controlled trials with a PEDro-P score ≥ 6/10), with these studies suggesting strong evidence for CCT improving processing speed in multiple sclerosis (MS) and moderate evidence for improving memory in MS and brain tumour populations. There is a large body of research examining the efficacy of CCT, but relatively few Level 1 studies and evidence is largely limited to body function outcomes. The routine use of outcome measures of activities/participation would provide more meaningful evidence for the efficacy of CCT. The use of body structure outcome measures (e.g., neuroimaging) is a newly emerging area, with potential to increase understanding of mechanisms of action for CCT.

The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement.

Reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) Statement, improve the reporting of research in the medical literature (Turner et al., 2012). Many such guidelines exist, and the CONSORT Extension to Nonpharmacological Trials (Boutron et al., 2008) provides suitable guidance for reporting between-groups intervention studies in the behavioral sciences. The CONSORT Extension for N-of-1 Trials (CENT 2015) was developed for multiple crossover trials with single individuals in the medical sciences (Shamseer et al., 2015; Vohra et al., 2015), but there is no reporting guideline in the CONSORT tradition for single-case research used in the behavioral sciences. We developed the Single-Case Reporting guideline In Behavioral interventions (SCRIBE) 2016 to meet this need. This Statement article describes the methodology of the development of the SCRIBE 2016, along with the outcome of 2 Delphi surveys and a consensus meeting of experts. We present the resulting 26-item SCRIBE 2016 checklist. The article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated.