Search

Clinical practice offers the opportunity for the clinician to be a scientist-practitioner in the workplace. This, in turn, facilitates building practice-based evidence. But this can only occur if the effects of the interventions are objectively and systematically evaluated. To this end, single-case methodology is a valuable tool to implement an intervention in a scientifically rigorous manner and gather data on treatment effectiveness. It is possible to incorporate single-case methods into routine clinical practice by using a few simple strategies. This paper examines the ways in which single-case methodology departs from (a) routine clinical practice and (b) the familiar between-groups research design, such as the randomised controlled trial. It presents five practical strategies that will bridge the gap between routine clinical practice and single-case methodology. The Model for Assessing Treatment Effect is described as providing context for and a framework to self-evaluate the scientific rigour in clinical practice and benchmark service delivery.

There is substantial evidence that research studies reported in the scientific literature do not provide adequate information so that readers know exactly what was done and what was found. This problem has been addressed by the development of reporting guidelines which tell authors what should be reported and how it should be described. Many reporting guidelines are now available for different types of research designs. There is no such guideline for one type of research design commonly used in the behavioral sciences, the single-case experimental design (SCED). The present study addressed this gap. This report describes the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016, which is a set of 26 items that authors need to address when writing about SCED research for publication in a scientific journal. Each item is described, a rationale for its inclusion is provided, and examples of adequate reporting taken from the literature are quoted. It is recommended that the SCRIBE 2016 is used by authors preparing manuscripts describing SCED research for publication, as well as journal reviewers and editors who are evaluating such manuscripts.

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 non-pharmacological trials (Boutron et al., 2008)provides suitable guidance for reporting betweengroups 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 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.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.Nous avons elabore des normes de presentation (sorte de lignes directrices)servant de guide pratique pour la redaction d'un article a publier dans une revue scientifique, utilisantun design de recherche particulier: le protocole experimental a cas unique. Le present article decrit la procedure utilisee afin d’elaborer ces normes: « single-case reporting guideline in behavioural interventions » (SCRIBE-2016). A l'issue de deux enquetes en ligne et d'une conference de consensus reunissant des experts durant deux jours, une liste de conformite (check-list)SCRIBE-2016 comprenant 26 items que les auteurs devraient considerer lorsqu'ils redigent des travaux utilisant les protocoles a cas unique a ete etablie. Cet article complete ainsi l'article intitule « SCRIBE-2016 explication and elaboration » (Tate et al., 2016)qui detaille et explique chaque item de la liste tout en fournissant, en guise de modele, des illustrations pratiques tires de travaux exemplaires de la litterature. Ces deux ressources aideront les auteurs a rediger avec clarte, exhaustivite, exactitude et transparence des articles de recherche portant sur des cas uniques. Elles fourniront egalement aux experts des revues ainsi qu’a leurs redacteurs en chef une liste de verification pratique qui leur servira de grille de lecture critique de ces articles. Nous recommandons de fait que le SCRIBE-2016 soit utilise aussi bien par les auteurs qui envisagent de publier des manuscrits rendant compte d'une recherche a cas unique, que par les experts et editeurs de revues qui les evaluent.Les normes en matiere de redaction d'articles, a l'instar de celles dediees a l’ecriture de travaux d'essais randomises controles (CONSORT), ameliorent la qualite des comptes rendus de la recherche dans la litterature medicale (Turner et al., 2012). Il existe de nombreuses normes de ce genre parmi lesquelles l'extension du CONSORT pour les essais non-pharmacologiques (Boutron et al., 2008)qui fournit deja un cadre approprie pour rendre compte d’etudes experimentales intergroupes en science du comportement. Une extension du CONSORT pour les essais « N = 1 » (CENT 2015)a egalement bien ete developpee en sciences medicales pour les essais transversaux multiples realises aupres de cas uniques (Shamseer et al., 2015; Vohra et al., 2015). Toutefois il n'existait pas, jusqu’a lors, de normes de presentation comparables au CONSORTet applicables aux protocoles a cas uniques en sciences du comportement. Pour repondre a ce besoin, nous avons mis au point ces « normes de presentation d'une recherche interventionnelle utilisant un protocole a cas unique » (SCRIBE-2016). Cet article decrit la procedure d’elaboration du SCRIBE-2016, ainsi que les resultats des deux enquetes Delphi et de la conference de consensus d'experts realises dans ce contexte. Nous y presentonsles normes SCRIBE-2016 en 26 items qui en resultent. La presente declaration est un preambule a l'article plus detaille intitule « SCRIBE-2016 explanation and elaboration » (Tate et al., 2016), qui detaille et apporte un eclaircissement pour chacun des items des normes de presentation et les illustre par des exemples de travaux adequats tires de la litterature. Ces deux ressources aideront les auteurs a rediger avec clarte, exhaustivite, exactitude et transparence des travaux de recherche portant sur des cas uniques. Elles fourniront egalement aux experts des revues ainsi qu'aux redacteurs en chef une liste de verification pratique qui leur servira de grille de lecture critique de ces travaux.

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 (

There has been controversy over Null Hypothesis Significance Testing (NHST) since the first quarter of the 20th century and misconceptions about it still abound. The first section of this paper briefly discusses some of the problems and limitations of NHST. Overwhelmingly, the ‘holy grail’ of researchers has been to obtain significantp-values. In 1999 the American Psychological Association (APA) recommended that if NHST was used in data analysis, then researchers should report effect sizes (ESs) and their confident intervals (CIs) as well asp-values. The APA recommendations are summarised in the next section of the paper. But as neuropsychological rehabilitation clinicians, the primary interest is (or should be) to determine whether or not the effect of an intervention is clinically important, not just statistically significant. In this context, ESs and their CIs provide information relevant to clinicians. The next section of the paper reviews common ESs and worked out examples are provided for the calculation of three commonly used ES (Cohen'sd, Hedge'sgand Glass’delta). Web-based resources for calculating other ESs and their CIs are also reviewed.

We are pleased to bring you this special issue ofBrain Impairmenton quantitative data analysis, an area of increasing complexity and sophistication. In planning the special issue, our intention was to bring together a set of articles covering diverse and topical areas in the field, with the idea of having the volume serve as a ‘go-to’ resource. The special issue is aimed at researchers, clinicians engaged in research, and advanced students all of whom may have passing familiarity with a particular data analytic technique, but wish to know more about it and how to apply it. Accordingly, our aim is to equip the reader with concrete, hands-on information that can be applied in the day-to-day world of research. The authors of the articles comprising the special issue, each of whom is an expert in his/her field, were charged with the task of writing a practical guide and providing worked examples to illustrate the application of their selected technique/s. The papers in the special issue cover three domains: the single-case method, between-groups design, and psychometric aspects of instrument development.

The Alice in Wonderland Syndrome (AWS) was first described more than 60 years ago by Lippman. It refers to episodes during which an individual may variously experience (as did Alice during her time in Wonderland) somatic, visuo-perceptual and/or visuo-spatial hallucinations, as well as feelings of depersonalisation, derealisation and distorted sense of time. Although the prevalence of AWS is unknown, indirect evidence from both retrospective and prospective studies suggests that it is a rare disorder. This paper describes the case of Zoe, a right-handed, native English speaker who was age 45 years when she experienced an episode of AWS. On neuropsychological assessment, Zoe demonstrated notable impairment of attention, learning and recall (particularly for visuo-spatial information) as well as executive dysfunction (viz., impairment of planning, cognitive flexibility and abstraction), consistent with fronto-temporal dysfunction. Detailed profiles of neuropsychological impairment in the context of AWS have not previously been reported, and it is unclear if such impairment is, indeed, a central and characteristic feature of AWS.

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. 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 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.

Single-case experimental design (SCED) studies in the behavioral sciences literature are not only common, but their proportion has also increased over past decades. Moreover, methodological complexity of SCEDs and sophistication in the techniques used to analyze SCED data has increased apace. Yet recent reviews of the behavioral sciences literature have shown that reporting of SCED research is highly variable and often incomplete. Explicit, precise and transparent reporting is crucial not only for critical evaluation of the study methodology and conclusions, but also to facilitate exact replication of investigations, and ascertain applicability and possible generality of results. Accordingly, we developed the SCRIBE 2016 (Single-Case Reporting guideline In BEhavioural interventions) by a consensus process by experts in SCED methodology and research in the behavioral sciences, as well as experts in reporting guideline development. The SCRIBE 2016 Explanation and Elaboration article describes a set of 26 items to guide and structure the reporting of SCED research. A rationale and minimum reporting standards that stipulate what needs to be reported are provided for each item. In addition, examples of adequate and clear reporting drawn from the literature are included for each item. It is recommended that the SCRIBE 2016 Explanation and Elaboration article is used in conjunction with the complementary SCRIBE 2016 Statement (Tate et al., 2016) by authors preparing manuscripts for publication and journal reviewers and editors considering manuscripts for publication.

Background: Whiplash associated disorder (WAD), a common and disabling condition, incurs huge burden and costs to Australia. Yet, current treatments for whiplash are not very effective; improved outcomes are urgently needed. Clinical guidelines recommend simple analgesia (paracetamol and non-steroidal anti-inflammatory drugs) but there have been no trials of guideline-recommended drugs. This study will investigate the effectiveness of evidence-based advice (EBA), paracetamol, naproxen, and both paracetamol and naproxen, in reducing daily neck pain and preventing chronic neck pain after whiplash injury. Methods: This study is a pilot series of multi-cycle, double-blinded, randomised N-of-1 trials, nested in a multiple baseline design. The design will comprise three baselines of 5, 8 or 11 days duration. Post enrolment, participants will be randomly assigned to one of the baselines. Fifteen participants with acute (

The reliable change index (RCI) was introduced approximately 30 decades ago in order to provide an empirical, statistically grounded technique for determining whether improvement after a therapeutic intervention was real or due to measurement error. Since the definitions of the properties and limitations of scales of measurement described by Stevens in 1947, there has been vigorous controversy about whether it is permissible to analyse ordinal data with parametric statistics. Specifically, are parameters and statistics such as means and standard deviations meaningful in the context of ordinal data? These are important concerns because many of the scales used to measure outcomes in behavioural research and clinical settings yield ordinal-scale measures. Given that the standard deviation is used in the computation of the RCI, the question as to whether or not the RCI is reliable when used with ordinal-scale data is explored. Data from the SPRS-2 was used to calculate minimum reliable difference criteria in terms of both (ordinal) Total Raw Scores (MRDRS) and logit scores (MRDLS) derived from Rasch analysis. Test–retest differences across the Total Raw Score range were evaluated using each criterion. At both extremes of the range, small changes in Total Raw Score not deemed to be reliable according to the MRDRScriterion were classified as reliable according to the MRDLScriterion. Conversely, test–retest changes in the centre of the range deemed to be reliable according to the MRDRScriterion were classified as unreliable according to the MRDLScriterion. It is suggested that while MRDRScan determinenumericallyreliable differences, MRDLScan determine reliable differences that are meaningful in terms of the underlying construct being measured.

Published reports describing interventions featuring a single participant are common in neurorehabilitation. Yet, not all such reports use rigorous single-case methodology and there is mounting evidence to suggest that the design, conduct and report of single-case research in the behavioural sciences (including neurorehabilitation) needs improvement. The first part of this article describes resources that will guide the improved design, conduct and critical appraisal of single-case research, including recently published standards in the field of special education and the Risk of Bias in N-of-1 Trials (RoBiNT) Scale for evaluating internal and external validity of designs using a single participant. The second part of the article reports on work currently in progress in developing a reporting guideline in the CONSORT tradition specifically for single-case experimental designs in the behavioural sciences, entitled the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE). It is anticipated that adoption and use of these resources by authors, reviewers and journal editors will improve the reporting and, potentially, the quality of the single-case literature.

Reversible cerebral vasoconstriction syndrome (RCVS) is a relatively rare, non-progressive angiopathy frequently heralded by severe thunderclap headache. It is characterised by vasoconstriction of cerebral arteries which usually resolves within three months of onset. Transient focal neurological signs may occur, and persistent deficits associated with haemorrhagic comorbidities have been reported in a small percentage of individuals. In this paper we report the case of RH, a 36-year-old woman who presented at a university teaching hospital in Sydney with a clinical history and radiological evidence consistent with RCVS. There were no haemorrhagic events during the course of her illness, and vasoconstriction resolved within a few days, following treatment with verapamil. Neuropsychological evaluation 16 months later revealed significant deficits in autobiographical memory, verbal and non-verbal new learning and active delayed recall, cognitive flexibility, abstraction and (to a lesser extent) immediate attention span and information processing speed. RH's case was unusual because the "trigger" for RCVS (Ear, Nose and Throat surgery) has not been previously reported, and because despite there being no haemorrhagic complications during the course of RCVS and no subsequent radiological abnormalities, she had significant cognitive impairment. To date, persistent neuropsychological deficits have not been recognised as a feature of RCVS.

Critical appraisal scales play an important role in evaluating methodological rigor (MR) of between-groups and single-case designs (SCDs). For intervention research this forms an essential basis for ascertaining the strength of evidence. Yet, few such scales provide classifications that take into account the differential weighting of items contributing to internal validity. This study aimed to develop an algorithm derived from the Risk of Bias in N-of-1 Trials (RoBiNT) Scale to classify MR and risk of bias magnitude in SCDs. The algorithm was applied to 46 SCD experiments. Two experiments (4%) were classified as Very High MR, 14 (30%) as High, 5 (11%) as Moderate, 2 (4%) as Fair, 2 (4%) as Low, and 21 (46%) as Very Low. These proportions were comparable to the What Works Clearinghouse classifications: 13 (28%) met standards, 8 (17%) met standards with reservations, and 25 (54%) did not meet standards. There was strong association between the two classification systems.

Recent studies have found that cannabinoids may improve neuropsychological performance, ameliorate negative symptoms, and have antipsychotic properties for a subgroup of the schizophrenia population. These findings are in contrast to the longstanding history of adverse consequences of cannabis use, predominantly on the positive symptoms, and a balanced neurochemical basis for these opposing views is lacking. This paper details a review of the neurobiological substrates of schizophrenia and the neurochemical effects of cannabis use in the normal population, in both cortical (in particular prefrontal) and subcortical brain regions. The aim of this paper is to provide a holistic neurochemical framework in which to understand how cannabinoids may impair, or indeed, serve to ameliorate the positive and negative symptoms as well as cognitive impairment. Directions in which future research can proceed to resolve the discrepancies are briefly discussed.

One could be forgiven for thinking that the only road to evidence-based clinical practice is the application of results from randomised controlled trials (or systematic reviews of such). By contrast, single-subject designs in the context of evidence-based clinical practice are believed by many to be strange bedfellows. In this paper, we argue that single-subject designs play an important role in evidence-based clinical practice. We survey the contents of Neuropsychological Rehabilitation in relation to single-subject designs and tackle the main criticisms that have been levelled against them. We offer practical guidance for rating the methodological quality of single-subject designs and applying statistical techniques to measure treatment efficacy. These guides are equally applicable to research studies and everyday clinical practice with individual patients.

Background: This paper examines the methodological quality of aphasia therapy research using the Psychological database for Brain Impairment Treatment Efficacy (www.psycbite.com). PsycBITETM includes five designs: Systematic Reviews (SR), Randomised Controlled Trials (RCT), non‐RCTs (NRCT), Case Series (CS), and Single Subject Designs (SSD). Aim: To provide an overview of the types of research designs and levels of compliance used in aphasia treatment research studies, and assess the methodological quality of aphasia research. Methods & Procedures: A search was completed on 27 September 2007 of all papers in the target area Communication/Language/Speech on the PsycBITETM database. Papers were listed according to the methodology used and a mean methodological quality rating (MQR) score was determined for RCTs, and NRCTs based on the PEDro scale. Finally, the rate of compliance of RCTs and NRCTs for each of the criteria on the PEDro scale was analysed. Outcomes & Results: Of 339 studies indexed for aphasia:...

The International Classification of Functioning, Disability and Health (ICF) is a taxonomy that classifies health states and health conditions. It is a complex and detailed taxonomy, with 1,424 categories, covering body structures and functions, activities and participation, and environmental factors. The complexity and detail, however, can serve as a barrier in its everyday application. A number of strategies have been developed to facilitate use of the ICF in clinical and research practice, including the development of ‘core sets’. In this article, we present another method which will assist both the newcomer and those more familiar with the ICF. Along with a description of the ICF structure and contents, the article presents a graphical representation of ‘ICF trees’ as a vehicle to more readily grasp the detail of the ICF structure and contents and facilitate its use in the area of acquired brain impairment.

Rating scales that assess methodological quality of clinical trials provide a means to critically appraise the literature. Scales are currently available to rate randomised and non-randomised controlled trials, but there are none that assess single-subject designs. The Single-Case Experimental Design (SCED) Scale was developed for this purpose and evaluated for reliability. Six clinical researchers who were trained and experienced in rating methodological quality of clinical trials developed the scale and participated in reliability studies. The SCED Scale is an 11-item rating scale for single-subject designs, of which 10 items are used to assess methodological quality and use of statistical analysis. The scale was developed and refined over a 3-year period. Content validity was addressed by identifying items to reduce the main sources of bias in single-case methodology as stipulated by authorities in the field, which were empirically tested against 85 published reports. Inter-rater reliability was assessed using a random sample of 20/312 single-subject reports archived in the Psychological Database of Brain Impairment Treatment Efficacy (PsycBITE). Inter-rater reliability for the total score was excellent, both for individual raters (overall ICC = 0.84; 95% confidence interval 0.73-0.92) and for consensus ratings between pairs of raters (overall ICC = 0.88; 95% confidence interval 0.78-0.95). Item reliability was fair to excellent for consensus ratings between pairs of raters (range k = 0.48 to 1.00). The results were replicated with two independent novice raters who were trained in the use of the scale (ICC = 0.88, 95% confidence interval 0.73-0.95). The SCED Scale thus provides a brief and valid evaluation of methodological quality of single-subject designs, with the total score demonstrating excellent inter-rater reliability using both individual and consensus ratings. Items from the scale can also be used as a checklist in the design, reporting and critical appraisal of single-subject designs, thereby assisting to improve standards of single-case methodology.

This study examined the relationship between neuropsychological performance and three different indices of cannabis use in schizophrenia. These indices were DSM-IV lifetime abuse/dependence, frequency of use, and recency of use. Sixty males with schizophrenia/schizoaffective disorder and 17 healthy males were recruited. The two groups were matched for age, years of education, and premorbid IQ. Medical history, substance use, and psychiatric symptoms were assessed. A neuropsychological battery was also administered to assess attention/processing speed, executive functions, memory, and perceptual organisation. Substance use within 24 hours of cognitive assessment was screened by urine analysis, and a range of confounds were controlled. In the schizophrenia group, 44 participants met DSM-IV criteria for lifetime cannabis abuse/dependence. In addition, there were three mutually exclusive frequency-of-cannabis-use subgroups comprising “high” frequency users ( n = 11), “medium” frequency users ( n = 7), and “low” frequency users ( n = 34) over the preceding year. There were also four mutually exclusive recency-of-cannabis-use categories comprising “cannabis abuse/dependence in the past week” ( n = 11 users), “non-dependent cannabis use in the past week” ( n = 7 users), “non-dependent cannabis use in the past month, but prior to the past week” ( n = 7 users), and “non-dependent cannabis use prior to the past month” ( n = 9 users). The control group performed better than the schizophrenia group in all cognitive domains. Within the schizophrenia group, a larger proportion of participants with lifetime cannabis abuse/dependence demonstrated better performance than those without lifetime abuse/dependence on a component of psychomotor speed. Frequency and recency of cannabis use were also associated with better neuropsychological performance, predominantly in the domains of attention/processing speed and executive functions. In conclusion, cannabis use is associated with enhanced cognitive functioning in schizophrenia. Implications of the results, limitations of the study, and directions for future research are discussed.

This chapter describes the application of N-of-1 trials in the behavioural sciences, where they are commonly referred to as single-case experimental designs (SCEDs). Four essential features demarcate single-case methodology from between-group designs: (i) the individual serves as his or her own control, (ii) use of a specific and operationally-defined behaviour that is targeted by the intervention, (iii) frequent and repeated measurement of the target behaviour throughout all phases of the experiment, and (iv) issues surrounding external validity. Features that strengthen internal and external validity of SCEDs are discussed in the context of a standardised scale to evaluate the scientific quality of SCEDs and N-of-1 trials, the Risk of Bias in N-of-1 Trials (RoBiNT) Scale. New work in developing a reporting guide in the CONSORT tradition (the Single-Case Reporting guideline In BEhavioural interventions, SCRIBE) is referenced. Subsequent sections in the chapter highlight differences among the prototypical single-case designs reported in the literature, both experimental (withdrawal/reversal, multiple-baseline, alternating-treatments, and changing-criterion designs) and non-experimental (biphasic A-B design, B-phase training study, pre-intervention/post-intervention design, and case description/report), along with illustrative examples reported in the literature. The final section of the chapter describes available methods to analyse data produced by SCEDs, including structured visual analysis, randomization tests and other statistical procedures.

In the context of evidence-based clinical practice (EBCP), the reliability of empirical data is largely determined by the methodological quality of research design. PsycBITE™ (Psychological Database of Brain Impairment Treatment Efficacy) is a web-based database listing all published, empirical reports on the effectiveness of nonpharmacological interventions for the psychological consequences of acquired brain impairment (ABI). The aim of this study was to survey the listings of PsycBITE™ and examine the methodological quality of the reports it contains. Reports listed in PsycBITE™ include systematic reviews (SRs), randomised controlled trials (RCTs), non-RCTs, case series (CSs) and single-subject designs (SSDs). They are indexed according to research design, neurological group, patient age group, target area and intervention type. The PEDro Scale is used to rate the methodological quality of RCTs, nonRCTs and CSs, with maximum obtainable methodological quality rating (MQR) of 10/10, 8/10 and 2/10 respectively. A search identified 1298 reports indexed in PsycBITE™. The largest proportion was SSDs (39%), followed by CSs (22%), RCTs (21%), non-RCTs (11%) and SRs (7%). The majority of reports was concerned with stroke (41%), traumatic brain injury (29%) and Alzheimer's and related dementias (22%). The most frequently investigated deficits were communication/language/speech disorders (24%); independent/self-care activities (19%); behaviour problems (17%); memory impairments (17%); anxiety, depression, stress, adjustment (15%). Approximately half of the RCTs, non-RCTs and CSs were rated for methodological quality. Mean MQR scores for RCTs, non-RCTs and CSs were 4.49, 2.85 and 1.15 respectively. While some PEDro criteria were met by a high proportion of RCTs and non-RCTs (≥ 70%), other criteria were only met by a small proportion of reports (as low as 1.6%). There was no significant difference in MQR scores between RCTs focusing on different neurological groups or target areas. Furthermore, there was no discernible improvement in MQR score for RCTs published over the last three decades. The methodological quality of studies investigating the efficacy of rehabilitation interventions in ABI has been consistently modest over several decades. This is largely attributable to poor adherence to fundamental tenets of research design, and requires urgent remediation. RCTs (and to a lesser extent, non-RCTs) are research methodologies which can potentially yield a high level of evidence, but only if they are adequately designed. PsycBITE™ has the facility to raise awareness of these issues and be instrumental in promoting EBCP in the field of ABI.

Background: Clinicians face significant obstacles in their access to evidence for the efficacy of different communicative and cognitive treatments after brain impairment. These include the need to search across diverse journals and different clinical conditions to find potential treatments and the lack of easily accessible standards by which to evaluate the methodological rigour of treatment studies once found. Funding for the development of PsycBITETM was provided by the Motor Accidents Authority of New South Wales with additional funds provided by the NSW Psychologists Registration Board, the Australian Society for the Study of Brain Impairment, and the Rehabilitation Studies Unit, University of Sydney. The resources of the library at the Royal Rehabilitation Centre Sydney have been indispensable.Additional funds are desperately needed for the ongoing maintenance of PsycBITETM as a freely available resource. For details regarding sponsorship, please contact the authors. Aims: We aimed to address these i...

It is important to know when improvement or deterioration in cognitive function occurs. Until fairly recently neuropsychologists have made these judgments clinically, with little resort to empirical methods. In addition to the issue of whether a change in performance is reliable, there is also the consideration of whether it is clinically significant. This article briefly discusses these concepts, reviews the most common methods for determining reliability in change in test scores, considers their use in the broader clinical context, and illustrates their application with reference to an actual database.

This paper describes developmental work underpinning a database resource containing published reports of therapies targeting the psychological consequences of acquired brain impairment (ABI). The resource, entitled the Psychological Database for Brain Impairment Treatment Efficacy (PsycBITETM), was primarily developed to aid clinicians to identify and implement evidence-based interventions for individuals with ABI. PsycBITETM is modelled on the Physiotherapy Evidence Database (PEDro) and is available, free of charge, on the internet (http://www.psycbite.com). Reports meeting five selection criteria are eligible for inclusion on PsycBITETM : (1) the report is a full-length publication in a peer-reviewed scientific journal, (2) regarding populations with brain impairment of acquired aetiology, (3) who are older than 5 years of age, (4) receiving an intervention that targets a psychological consequence of ABI, and (5) the report contains empirical data regarding treatment efficacy. Like PEDro, a distinctive ...

This paper introduces the Special Issue of Neuropsychological Rehabilitation on Single Case Experimental Design (SCED) methodology. SCED studies have a long history of use in evaluating behavioural and psychological interventions, but in recent years there has been a resurgence of interest in SCED methodology, driven in part by the development of standards for conducting and reporting SCED studies. Although there is consensus on some aspects of SCED methodology, the question of how SCED data should be analysed remains unresolved. This Special Issues includes two papers discussing aspects of conducting SCED studies, five papers illustrating use of SCED methodology in clinical practice, and nine papers that present different methods of SCED data analysis. A final Discussion paper summarises points of agreement, highlights areas where further clarity is needed, and ends with a set of resources that will assist researchers conduct and analyse SCED studies.

Objectives To determine a set of variables that would reliably predict duration of posttraumatic amnesia (PTA) in patients with traumatic brain injury and to test the efficacy of the model. Design Simultaneous standard multiple regression analyses. Participants Two independent samples of patients with traumatic brain injury who were in the early stages of PTA: a test sample (n = 61) and a cross-validation sample (n = 25). Main outcome measure The Modified Oxford PTA Scale (MOPTAS) is a 12-item test measuring orientation (8 items) and anterograde memory (4 items). The Galveston Orientation and Amnesia Test (GOAT) was also used on a subset of the test sample. Procedure Patients were examined daily until they emerged from PTA. Results A statistically significant model, using three predictor variables, was derived that reliably predicted duration of PTA, accounting for 89% of the variance. A second model, using two predictor variables readily available to the clinician (day posttrauma on which PTA testing began and aggregate PTA scores over the first 5 days of testing) had comparable predictive accuracy. A third model, using GOAT data, was also statistically significant and successfully accounted for 72% of the variance. The MOPTAS model showed excellent application to an independent (validation) sample, with an intraclass correlation coefficient between observed and predicted durations of PTA of 0.95. Regression equations for all three models are provided to enable calculation of the predicted duration of PTA. Conclusions These models can be readily applied in clinical practice and will provide clinically useful estimates of the duration of PTA within the first week of testing after admission to rehabilitation. This information will be important in terms of family counseling and planning of rehabilitation programs.

Aims: A modified version of the Mental Adjustment to Cancer Scale (The Mental Adjustment to HIV Scale-MAHIVS) was used to evaluate patterns of psychological adjustment in response to HIV infection. Methods: A sample of 164 HIV positive homosexual/bisexual men were recruited across three Australian centers (79 asymptomatic (CDC II/III) and 85 symptomatic HIV infection (CDC IV)). Factor analysis of the MAHIVS was conducted and the predictive validity of the MAHIVS was investigated using the General Health Questionnaire, while The Diagnostic Interview Schedule was used to assess current and lifetime psychiatric disorder. Other measures of adjustment/coping were used to investigate the construct validity of the MAHIVS (neuroticism, locus of control, defense style). Results: Factor analysis of the MAHIVS detected four factors: Hopelessness, Fighting Spirit/Self Efficacy, Personal Control, and Minimization. Hopelessness and Fighting Spirit factors exhibited acceptable levels of internal consistency and validity, with significant correlations detected with psychological symptoms and significant association with other measures of psychological adjustment and personality. Fighting Spirit emerged as a potential indicator of psychological resilience, whereas Hopelessness was significantly associated with psychological symptoms and current major depression (but not past depression). Conclusions: The findings indicate the validity of the MAHIVS and support the presence of common themes in the psychological adaptation to life-threatening illness that can be detected across disease categories and groups.

A cross-sectional study was performed to investigate the prevalence and predictors of suicidal ideation and past suicide attempt in an Australian sample of human immunodeficiency virus (HIV)-positive and HIV-negative homosexual and bisexual men. Sixty-five HIV-negative and 164 HIV-positive men participated. A suicidal ideation score was derived from using five items selected from the Beck Depression Inventory and the General Health Questionnaire (28-item version). Lifetime and current prevalence rates of psychiatric disorder were evaluated with the Diagnostic Interview Schedule Version-III-R. The HIV-positive (Centers for Disease Control and Prevention [CDC] Stage IV) men (n = 85) had significantly higher total suicidal ideation scores than the asymptomatic HIV-positive men (CDC Stage II/III) (n = 79) and the HIV-negative men. High rates of past suicide attempt were detected in the HIV-negative (29%) and HIV-positive men (21%). Factors associated with suicidal ideation included being HIV-positive, the presence of current psychiatric disorder, higher neuroticism scores, external locus of control, and current unemployment. In the HIV-positive group analyzed separately, higher suicidal ideation was discriminated by the adjustment to HIV diagnosis (greater hopelessness and lower fighting spirit), disease factors (greater number of current acquired immunodeficiency syndrome [AIDS]-related conditions), and background variables (neuroticism). Significant predictors of a past attempted suicide were a positive lifetime history of psychiatric disorder (particularly depression diagnoses), a lifetime history of infection drug use, and a family history of suicide attempts. The findings indicate increased levels of suicidal ideation in symptomatic HIV-positive men and highlight the role that multiple psychosocial factors associated with suicidal ideation and attempted suicide play in this population.

It has been argued that the Wisconsin Card Sorting Test (WCST) is not suitable for repeated administrations because people benefit from prior exposure to the test. This study examined the stability of nine variables from the WCST in two groups, examined on two occasions approximately nine months apart. In a non-brain-injured group, correlations on eight WCST variables were stable, with coefficients at rI = 0.67 and above, yet the magnitude of change between test occasions was small (maximum 0.33 standard deviations). These results suggest that the WCST is suitable for repeated administrations. The data also provided the basis for clinical decision-making in individuals, in terms of determining the reliability of change in scores from one test administration to another. Application of this procedure to individuals from a traumatically brain-injured group was demonstrated.

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.

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 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 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.