Recent literature suggests a revival of interest in single-case methodology (e.g., the randomised n-of-1 trial is now considered Level 1 evidence for treatment decision purposes by the Oxford Centre for Evidence-Based Medicine). Consequently, the availability of tools to critically appraise single-case reports is of great importance. We report on a major revision of our method quality instrument, the Single-Case Experimental Design Scale. Three changes resulted in a radically revised instrument, now entitled the Risk of Bias in N-of-1 Trials (RoBiNT) Scale: (i) item content was revised and increased to 15 items, (ii) two subscales were developed for internal validity (IV; 7 items) and external validity and interpretation (EVI; 8 items), and (iii) the scoring system was changed from a 2-point to 3-point scale to accommodate currently accepted standards. Psychometric evaluation indicated that the RoBiNT Scale showed evidence of construct (discriminative) validity. Inter-rater reliability was excellent, for pairs of both experienced and trained novice raters. Intraclass correlation coefficients of summary scores for individual (experienced) raters: ICC(TotalScore) = .90, ICC(IVSubscale) = .88, ICC(EVISubscale) = .87; individual (novice) raters: ICC(TotalScore)= .88, ICC(IVSubscale) = .87, ICC(EVISubscale) = .93; consensus ratings between experienced and novice raters (ICC(TotalScore) = .95, ICC(IVSubscale) = .93, ICC(EVISubscale) = .93. The RoBiNT Scale thus shows sound psychometric properties and provides a comprehensive yet efficient examination of important features of single-case methodology.

IntroductionUser engagement in mental health service design is heralded as integral to health systems quality and performance, but does engagement improve health outcomes? This article describes the CORE study protocol, a novel stepped wedge cluster randomised controlled trial (SWCRCT) to improve psychosocial recovery outcomes for people with severe mental illness.MethodsAn SWCRCT with a nested process evaluation will be conducted over nearly 4 years in Victoria, Australia. 11 teams from four mental health service providers will be randomly allocated to one of three dates 9 months apart to start the intervention. The intervention, a modified version of Mental Health Experience Co-Design (MH ECO), will be delivered to 30 service users, 30 carers and 10 staff in each cluster. Outcome data will be collected at baseline (6 months) and at completion of each intervention wave. The primary outcome is improvement in recovery score using the 24-item Revised Recovery Assessment Scale for service users. Secondary outcomes are improvements to user and carer mental health and well-being using the shortened 8-item version of the WHOQOL Quality of Life scale (EUROHIS), changes to staff attitudes using the 19-item Staff Attitudes to Recovery Scale and recovery orientation of services using the 36-item Recovery Self Assessment Scale (provider version). Intervention and usual care periods will be compared using a linear mixed effects model for continuous outcomes and a generalised linear mixed effects model for binary outcomes. Participants will be analysed in the group that the cluster was assigned to at each time point.Ethics and disseminationThe University of Melbourne, Human Research Ethics Committee (1340299.3) and the Federal and State Departments of Health Committees (Project 20/2014) granted ethics approval. Baseline data results will be reported in 2015 and outcomes data in 2017.Trial registration numberAustralian and New Zealand Clinical Trials Registry ACTRN12614000457640.

BACKGROUND AND AIMS: Good assessment is an essential component of effective patient management. Yet the sheer volume of available assessment instruments presents a barrier for the clinician or researcher to (a) be knowledgeable about suitable measures and (b) keep up-to-date with new measures that are published. In order to create a resource of currently-used measures, we conducted a systematic review of assessment tools used in the research literature on traumatic brain injury (TBI). METHODS: We used two electronic databases (Medline and PsycINFO) to identify full-length, English-language articles published between 2000 and 2012 in which outcome in adults with TBI was assessed with behavioural tests or questionnaires. RESULTS: The searches yielded 5,735 articles and after deletion of duplicates (n = 1,383) and articles not meeting selection criteria (n = 1,759), 2,593 articles were further examined. The articles contained 910 behavioural instruments, with a final set of 728 unique instruments. Each instrument was classified against the International Classification of Functioning, Disability and Health (ICF). Half of the instruments (n = 370, 50.8%) evaluated the mental functions domain of the ICF body functions component, with a substantially smaller proportion (n = 64, 8.8%) examining specific motor-sensory and other body functions. Instruments also covered domains of activities/participation (n = 109, 15.0%), environmental factors (n = 22, 3.0%) and personal factors (n = 36, 4.9%). A substantial number of scales (n = 93, 12.8%) were multidimensional across the body function domains (n = 32), as well as the functioning and disability part of the ICF (n = 60). The remaining 5% of instruments addressed concepts not covered by the ICF, including quality of life (n = 19, 2.6%) and rehabilitation process tools (such as therapeutic alliance). The 728 instruments were listed and more than 70 of the most common, spread across 20 domains, were highlighted. CONCLUSION: These data provide a comprehensive and up-to-date resource that gives the researcher or clinician a very large selection of assessment instruments covering the major areas of function pertinent to TBI.