Robyn Tate

Rating the methodological quality of single-subject designs and n-of-1 trials: Introducing the Single-Case Experimental Design (SCED) Scale

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 (PsycBITETM). 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.

The Behavioural Assessment of the Dysexecutive Syndrome (BADS): Ecological, Concurrent and Construct Validity

Issues of validity, and in particular ecological validity, are a current concern for tests examining disorders of executive abilities related to frontal systems dysfunction. The Behavioural Assessment of the Dysexecutive Syndrome (BADS, Wilson et al., 1996) was developed in response to the need for better neuropsychological tests in this area. The present study examines the validity of the BADS, along with six other commonly used tests of executive ability in two groups of participants with either neurological disorder (n = 36) or without brain damage (n = 37). The BADS and most of its subtests correlate significantly with the standard executive tests indicating that it possesses adequate concurrent validity. In terms of construct validity, it is comparable to standard executive tests in discriminating between neurological and non-brain-damaged participants. The ecological validity of the BADS is superior to standard executive tests in terms of predicting competency in role functioning.

Adjustment to chronic obstructive pulmonary disease: the importance of psychological factors

Research has indicated a weak relationship between the degree of physical problems and quality of life in patients with chronic obstructive pulmonary disease (COPD). The importance of adaptive psychological functioning to maintain optimum quality of life has long been recognized, but there is a lack of empirical evidence concerning the nature of psychological factors involved in adjustment to COPD. Ninety-two males completed questionnaires to determine their coping strategies, levels of self-efficacy of symptom management and social support. Adjustment was measured in terms of depression, anxiety and quality of life. Symptom severity, socioeconomic status, duration of disease and age, which have been demonstrated to be of consequence in COPD, were used as control variables in hierarchical multiple regression analyses. Higher levels of catastrophic withdrawal coping strategies and lower levels of self-efficacy of symptom management were associated with higher levels of depression, anxiety and a reduced quality of life. Higher levels of positive social support were linked to lower levels of depression and anxiety, while higher levels of negative social support were linked to higher levels of depression and anxiety. To maximize quality of life in patients with chronic obstructive pulmonary disease, psychological factors need to be carefully assessed and addressed.

Incidence of hospital-treated traumatic brain injury in an Australian community

This paper reports findings from an incidence study of head trauma in a defined population. In the North Coast Health Region of NSW, 1,259 subjects with head trauma were admitted to hospitals in a 12‐month period in 1988. Direct examination of the medical records confirmed brain injury in only 413 of these cases, corresponding to an annual incidence of approximately 100/100,000 resident population. Although most injuries (62.2%) were mild, 38% were serious (either moderate, 20.3%, or severe, 13.6%; and 3.9% died after admission to hospital). Severe brain injury represented an annual incidence of 12/100,000 resident population. Road traffic accidents accounted for a higher proportion of injuries in the severe group in comparison with the other injury groups. Methodological issues involved in case ascertainment of brain injury are discussed.

Evaluation of an Anger Management Therapy Programme Following Acquired Brain Injury: A Preliminary Study

Problems with anger management after traumatic brain injury are one of the most frequent changes in the long term reported by relatives of injured people. In spite of their impact there have been few reports either describing therapy procedures for this disorder or examining their efficacy. The present study evaluated a cognitive-behavioural intervention for anger management difficulties following acquired brain injury. Participants were screened and randomly allocated to either a Treatment Group (TREAT) or Waiting List Group (WAIT). Each participant in TREAT received approximately six, hourly individual sessions of anger-management therapy while those in WAIT monitored their anger daily. Sixteen participants proceeded through to the final stages of the study. A significant decrease in anger on the State-Trait Anger Expression Inventory (STAXI) was found for TREAT in comparison with WAIT at post-treatment. Repeated-measures analyses for TREAT showed significant improvements between pre-treatment and post-treatment measures (immediate and 2-month follow-up) on the STAXI. No significant generalisation of treatment effects to self-esteem, anxiety, depression, or degree of self-awareness were found.

Suicidality in people surviving a traumatic brain injury: Prevalence, risk factors and implications for clinical management

Background: A systematic search was conducted of the literature addressing suicidality after traumatic brain injury (TBI). Results from population-based studies found that people with TBI have an increased risk of death by suicide (3–4 times greater than for the general population), as well as significantly higher levels of suicide attempts and suicide ideation. Clinical studies have also reported high levels of suicide attempts (18%) and clinically significant suicide ideation (21–22%) in TBI samples. Methods and Results: In reviewing risk factors, two prognostic studies using multivariate analysis were identified. Adjusted risk statistics from these studies found an elevated risk of suicide for people with severe TBI in comparison to concussion (hazard ratio 1.4, 95% CI 1.15–1.75) and an elevated risk of suicide attempts among people displaying post-injury suicide ideation (adjusted odds ratio 4.9, 95% CI 1.79–13.17) and psychiatric/emotional distress (adjusted odds ratio 7.8, 95% CI 2.11–29.04). Conclusions: To date, little evidence exists for the role of pre-morbid psychopathology, neuropathology, neuropsychological impairments or post-injury psychosocial factors as major risk factors for post-injury suicidality. Finally, there has been little empirical examination of approaches to suicide prevention. Therefore, current best practice is based on clinical judgement and the untested extrapolation of prevention approaches from other clinical populations.

Social Skills Treatment for People With Severe, Chronic Acquired Brain Injuries: A Multicenter Trial

OBJECTIVE To determine whether social skills deficits including unskilled, inappropriate behavior, problems reading social cues (social perception), and mood disturbances (such as depression and anxiety) could be remediated after severe traumatic brain injuries. DESIGN Randomized controlled trial comparing a social skills program with social activity alone or with waitlist control. Several participants were reassigned after randomization. SETTING Hospital outpatient and community facilities. PARTICIPANTS Fifty-one outpatients from 3 brain injury units in Sydney, Australia, with severe, chronic acquired brain injuries were recruited. A total of 39 people (13 in skills training, 13 in social activity, 13 in waitlist) completed all phases of the study. INTERVENTION Twelve-week social skills treatment program encompassing weekly 3-hour group sessions focused on shaping social behavior and remediating social perception and 1-hour individual sessions to address psychologic issues with mood, self-esteem, etc. MAIN OUTCOME MEASURES Primary outcomes were: (1) social behavior during encounters with a confederate as rated on the Behaviorally Referenced Rating System of Intermediary Social Skills-Revised (BRISS-R), (2) social perception as measured by The Awareness of Social Inference Test, and (3) depression and anxiety as measured by the Depression, Anxiety and Stress Scale. Secondary outcomes were: relative report on social behavior and participation using: the Katz Adjustment Scale-R1; the Social Performance Survey Schedule; the La Trobe Communication Questionnaire; and the Sydney Psychosocial Reintegration Scale (both relative and self-report). RESULTS Repeated-measures analysis of variance indicated that social activity alone did not lead to improved performance relative to waitlist (placebo effect) on any outcome variable. On the other hand, the skills training group improved differentially on the Partner Directed Behavior Scale of the BRISS-R, specifically the self-centered behavior and partner involvement behavior subscales. No treatment effects were found for the remaining primary outcomes (social perception, emotional adjustment) or for secondary outcome variables (relative and self-report measures of social function). CONCLUSIONS This study suggested that treatment effects after social skills training in people with severe, chronic brain injuries are modest and are limited to direct measures of social behavior.

Suicidality after traumatic brain injury: demographic, injury and clinical correlates

BACKGROUND In spite of the high frequency of emotional distress after traumatic brain injury (TBI), few investigations have examined the extreme of such distress, namely, suicidality, and no large scale surveys have been conducted. The current study examined both the prevalence and demographic, injury, and clinical correlates of hopelessness, suicidal ideation and suicide attempts after TBI. METHODS Out-patients (N = 172) with TBI were screened for suicidal ideation and hopelessness using the Beck Scale for Suicide Ideation and the Beck Hopelessness Scale. Data were also collected on demographic, injury, pre-morbid and post-injury psychosocial variables and included known risk factors for suicide. RESULTS A substantial proportion of participants had clinically significant levels of hopelessness (35%) and suicide ideation (23%), and 18% had made a suicide attempt post-injury. There was a high degree of co-morbidity between suicide attempts and emotional/psychiatric disturbance. Results from regression analyses indicated that a high level of hopelessness was the most significant association of suicide ideation and a high level of suicide ideation, along with occurrence of post-injury emotional/psychiatric disturbance, were the most significant associations of post-injury suicide attempts. Neither injury severity nor the presence of pre-morbid suicide risk factors contributed to elevated levels of suicidality post-injury. CONCLUSIONS Suicidality is a common psychological reaction to TBI among out-patient populations. Management should involve careful history taking of previous post-injury suicidal behaviour, assessment of post-injury adjustment to TBI with particular focus on the degree of emotional/psychiatric disturbance, and close monitoring of those individuals with high levels of hopelessness and suicide ideation.

Revision of a method quality rating scale for single-case experimental designs and n-of-1 trials: The 15-item Risk of Bias in N-of-1 Trials (RoBiNT) Scale

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: ICCTotalScore = .90, ICCIVSubscale = .88, ICCEVISubscale = .87; individual (novice) raters: ICCTotalScore = .88, ICCIVSubscale = .87, ICCEVISubscale = .93; consensus ratings between experienced and novice raters (ICCTotalScore = .95, ICCIVSubscale = .93, ICCEVISubscale = .93. The RoBiNT Scale thus shows sound psychometric properties and provides a comprehensive yet efficient examination of important features of single-case methodology.

Executive Dysfunction and Characterological Changes After Traumatic Brain Injury: Two Sides of the Same Coin?

This study examined the capacity of neuropsychological variables indicative of dysfunction in the regulation of executive abilities (e.g. noncompliance with rules) to reflect changes in character associated with disturbances in regulatory abilities (e.g. impulsivity). A close relative of 30 participants with traumatic brain injury (TBI) was administered the Current Behaviour Scale (CBS) at admission (rating premorbid character) and six months posttrauma (rating current character). The TBI group was examined neuropsychologically at six months posttrauma, along with 30 nonbrain-damaged (NBD) participants. Significant increases in CBS factors, Loss of Emotional Control and Loss of Motivation, occurred in the TBI group posttrauma. Differences between TBI and NBD groups were found for most executive variables. Those TBI participants with impairments on the neuropsychological Rule Breaking variable showed significant posttrauma increases in Loss of Emotional Control. There was also a trend for individuals with frontal lesions to make rule-breaking and perseverative errors.