Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial.

BACKGROUND: Treatment fidelity is inconsistently reported in aphasia research, contributing to uncertainty about the effectiveness of types of aphasia therapy following stroke. We outline the processes and outcomes of treatment fidelity monitoring in a pre-specified secondary analysis of the VERSE trial. METHODS: VERSE was a 3-arm, single-blinded RCT with a 12-week primary endpoint comparing Usual Care (UC) to two higher intensity treatments: Usual Care-Plus (UC-Plus) and VERSE, a prescribed intervention. Primary outcome results were previously reported. This secondary analysis focused on treatment fidelity. Video-recorded treatment sessions in the higher intensity study arms were evaluated for treatment adherence and treatment differentiation. Treatment components were evaluated using a pre-determined fidelity checklist. PRIMARY OUTCOME: prescribed amount of therapy time (minutes); secondary outcomes: (i) adherence to therapy protocol (%) and (ii) treatment differentiation between control and high intensity groups. RESULTS: Two hundred forty-six participants were randomised to Usual Care (n=81), Usual Care-Plus (n=82), and VERSE (n=83). One hundred thirty-five (82%) participants in higher intensity intervention arms received the minimum prescribed therapy minutes. From 10,805 (UC 7787; UC-Plus 1450; VERSE 1568) service events, 431 treatment protocol deviations were noted in 114 participants. Four hundred thirty-seven videos were evaluated. The VERSE therapists achieved over 84% adherence to key protocol elements. Higher stroke and aphasia severity, older age, and being in the UC-Plus group predicted more treatment deviations. CONCLUSIONS: We found high levels of treatment adherence and differentiation between the intervention arms, providing greater confidence interpreting our results. The comprehensive systems for intervention fidelity monitoring and reporting in this trial make an important contribution to aphasia research and, we argue, should set a new standard for future aphasia studies. TRIAL REGISTRATION: ACTRN 12613000776707.

A randomized control trial of intensive aphasia therapy after acute stroke: The Very Early Rehabilitation for SpEech (VERSE) study.

BACKGROUND: Effectiveness of early intensive aphasia rehabilitation after stroke is unknown. The Very Early Rehabilitation for SpEech trial (VERSE) aimed to determine whether intensive aphasia therapy, beginning within 14 days after stroke, improved communication recovery compared to usual care. METHODS: Prospective, randomized, single-blinded trial conducted at 17 acute-care hospitals across Australia/New Zealand from 2014 to 2018. Participants with aphasia following acute stroke were randomized to receive usual care (direct usual care aphasia therapy), or one of two higher intensity regimens (20 sessions of either non-prescribed (usual care-plus or prescribed (VERSE) direct aphasia therapy). The primary outcome was improvement of communication on the Western Aphasia Battery-Revised Aphasia Quotient (AQ) at 12 weeks after stroke. Our pre-planned intention to treat analysis combined high intensity groups for the primary outcome. FINDINGS: Among 13,654 acute stroke patients screened, 25% (3477) had aphasia, of whom 25% (866) were eligible and 246 randomized to usual care (n = 81; 33%), usual care-plus (n = 82; 33%) or VERSE (n = 83; 34%). At 12 weeks after stroke, the primary outcome was assessed in 217 participants (88%); 14 had died, 9 had withdrawn, and 6 were too unwell for assessment. Communication recovery was 50.3% (95% CI 45.7-54.8) in the high intensity group (n = 147) and 52.1% (95% CI 46.1-58.1) in the usual care group (n = 70; difference -1.8, 95% CI -8.7-5.0). There was no difference between groups in non-fatal or fatal adverse events (p = 0.72). INTERPRETATION: Early, intensive aphasia therapy did not improve communication recovery within 12 weeks post stroke compared to usual care.

A Survey of Counseling Curricula Among Accredited Communication Sciences and Disorders Graduate Student Programs.

Purpose The purpose of this article is to examine the current state of counseling curriculum within the discipline. The last systematic survey of counseling curriculum within the disciplines of communication sciences and disorders was completed with data from 1983 (McCarthy et al., 1986). The Council on Academic Accreditation in Audiology and Speech-Language Pathology (2017) states that counseling should be included in accredited programs but does not specify to what extent. Currently, there are no standards to specify number of credits, need for a stand-alone course, or guidance regarding content delivered. Method The present investigation collected data on the status of counseling curricula in accredited communication sciences and disorders graduate programs. A Qualtrics survey was distributed to identify counseling curriculum practices across accredited programs. Quantitative data such as percentages and frequency counts were compiled to summarize program offerings. Qualitative analyses were used to characterize written responses. Survey responses were also cross-validated with a review of offerings listed on program websites. Results Of programs currently accredited by the Council on Academic Accreditation in Audiology and Speech-Language Pathology, 42.4% responded to the current survey. Fifty-nine percent of programs offer a stand-alone course. Review of curricula from program websites indicated that only 40% of accredited programs offer a stand-alone counseling course. Quantitative details about requirements, number of credits, and embedding counseling within other courses were compared to data from the 1983 survey. Qualitative analyses identified common learner outcomes and the nature of course or curricular content. Conclusions Investigators found a lack of consistency in incorporating counseling across programs and discussed implications of this in speech-language pathology practice. A decrease in the number of programs that offer a stand-alone counseling course was identified as compared to offerings in 1983, as well as a disparity regarding how programs provide training in counseling. Furthermore, survey responses differed from curriculum listings on program websites. Information derived from this study may serve as a starting point for the development of flexible standards that provide direction for achieving consistent preparation of counseling skills. Supplemental Material https://doi.org/10.23641/asha.12149703.

Using AphasiaBank for Discourse Assessment.

AphasiaBank is a shared, multimedia database for the study of communication in aphasia. This article describes a variety of discourse measurement tools and teaching resources available at the AphasiaBank website. The discourse measurement tools include main concept analysis, core lexicon checklists, correct information unit computation techniques, and other automated analyses using the CLAN program. These tools can be used to measure a variety of aspects of language production for assessment as well as treatment evaluation and clinical research purposes. Importantly, they are intended to help make the discourse analysis process more efficient and reliable. Teaching resources include an online tutorial on aphasia, videos of typical behaviors seen in aphasia, group treatment videos, classroom activities, tutorial screencasts, and conference posters. These resources can be used for a variety of clinical and educational purposes. The AphasiaBank website is part of the larger TalkBank project which provides many other shared databases and resources that are relevant to professionals interested in communication and communication disorders.

Communicative Strengths in Severe Aphasia: The Famous People Protocol and Its Value in Planning Treatment.

Purpose This clinical focus article describes the development and use of the Famous People Protocol (FPP), a clinical tool for observing the strategies people with severe aphasia (PWSA) can use to communicate when speech is limited. Its goal is to provide a systematic approach to identifying individually appropriate communication strategies for PWSA. Method Though not a test, the FPP's development and pilot testing were consonant with qualitative approaches to test development. Eighty-one people with aphasia and 37 nonaphasic participants were given the current version of FPP and the Western Aphasia Battery-Revised (WAB-R; Kertesz, 2006). This clinical focus article reports on the 36 PWA who scored near or below the mean WAB score of the larger group. Results The FPP has a maximum score of 100 based on (a) identification of famous people in different categories, entertainers, athletes, U.S. presidents, sports figures, and internationally famous people, and (b) responses to additional questions about the famous people. Identification is scored quantitatively on a 3-point scale, and question responses are scored correct (1) or incorrect (0). Mean scores for the PWSA and control groups were 54.6 and 95.2, respectively. FPP and WAB-R scores were moderately correlated (r = .67). Qualitative results describe the variety of strategies that PWSA used on the FPP. Conclusions The FPP is a way for clinicians to engage PWSA in an activity that can reveal personally relevant strategies to help PWSA communicate more effectively. The strategies can then become the basis for subsequent training on using them conversationally. Appendixes provide examples of clinical approaches.

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.

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.

Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy.

Background Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Objective To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statistician. This plan was developed using outcome measures and trial data collection forms. Results The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusions Publication of a statistical analysis plan serves to reduce potential trial reporting bias and outlines transparent pre-specified analyses. Australian New Zealand Clinical Trials Registry (ANZCTR) Registration number: ACTRN12613000776707; Universal Trial Number (UTN) is U1111-1145-4130.

The Relationship Between Confrontation Naming and Story Gist Production in Aphasia.

Purpose: The purpose of this study was to examine the relationship between picture naming performance and the ability to communicate the gist, or essential elements, of a story. We also sought to determine if this relationship varied according to Western Aphasia Battery-Revised (WAB-R; Kertesz, 2007) aphasia subtype. Method: Demographic information, test scores, and transcripts of 258 individuals with aphasia completing 3 narrative tasks were retrieved from the AphasiaBank database. Narratives were subjected to a main concept analysis to determine gist production. A correlation analysis was used to investigate the relationship between naming scores and main concept production for the whole group of persons with aphasia and for WAB-R subtypes separately. Results: We found strong correlations between naming test scores and narrative gist production for the large sample of persons with aphasia. However, the strength of the correlations varied by WAB-R subtype. Conclusions: Picture naming may accurately predict gist production for individuals with Broca's and Wernicke's aphasia, but not for other WAB-R subtypes. Given the current reprioritization of outcome measurement, picture naming may not be an appropriate surrogate measure for functional communication for all persons with aphasia. Supplemental Materials: https://doi.org/10.23641/asha.5851848.

Long-term Recovery in Stroke Accompanied by Aphasia: A Reconsideration.

BACKGROUND: This work focuses on the twenty-six individuals who provided data to AphasiaBank on at least two occasions, with initial testing between 6 months and 5.8 years post-onset of aphasia. The data are archival in nature and were collected from the extensive database of aphasic discourse in AphasiaBank. AIMS: The aim is to furnish data on the nature of long-term changes in both the impairment of aphasia as measured by the Western Aphasia Battery-Revised (WAB-R) and its expression in spoken discourse. METHODS AND PROCEDURES: AphasiaBank's demographic database was searched to discover all individuals who were tested twice at an interval of at least a year with either: 1) the AphasiaBank protocol; or 2) the AphasiaBank protocol at first testing, and the Famous People Protocol (FPP) at second testing. The Famous People Protocol is a measure developed to assess the communication strategies of individuals whose spoken language limitations preclude full participation in the AphasiaBank protocol. The 26 people with aphasia (PWA) who were identified had completed formal speech therapy before being seen for AphasiaBank. However, all were participants in aphasia centers where at least three hours of planned activities were available, in most cases, twice weekly. WAB-R Aphasia Quotient scores (AQ) were examined, and in those cases where AQ scores improved, changes were assessed on a number of measures from the AphasiaBank discourse protocol. OUTCOMES AND RESULTS: Sixteen individuals demonstrated improved WAB-R AQ scores, defined as positive AQ change scores greater than the WAB-R AQ standard error of the mean (WAB-SEM); seven maintained their original WAB quotients, defined as AQ change scores that were not greater than the WAB-SEM; and the final three showed negative WAB-R change scores, defined as a negative WAB-R AQ change score greater than the WAB-SEM. Concurrent changes on several AphasiaBank tasks were also found, suggesting that the WAB-R improvements were noted in more natural discourse as well. CONCLUSIONS: These data are surprising, since conventional wisdom suggests that spontaneous improvement in language is unlikely to occur beyond one year. Long-term improvement or maintenance of early test scores, such as that shown here, has seldom been demonstrated in the absence of formal treatment. Speculations about why these PWA improved, maintained or declined in their scores are considered.

Discourse Characteristics in Aphasia Beyond the Western Aphasia Battery Cutoff.

PURPOSE: This study examined discourse characteristics of individuals with aphasia who scored at or above the 93.8 cutoff on the Aphasia Quotient subtests of the Western Aphasia Battery-Revised (WAB-R; Kertesz, 2007). They were compared with participants without aphasia and those with anomic aphasia. METHOD: Participants were from the AphasiaBank database and included 28 participants who were not aphasic by WAB-R score (NABW), 92 participants with anomic aphasia, and 177 controls. Cinderella narratives were analyzed using the Computerized Language Analysis programs (MacWhinney, 2000). Outcome measures were words per minute, percent word errors, lexical diversity using the moving average type-token ratio (Covington, 2007b), main concept production, number of utterances, mean length of utterance, and proposition density. RESULTS: Results showed that the NABW group was significantly different from the controls on all measures except MLU and proposition density. These individuals were compared to participants without aphasia and those with anomic aphasia. CONCLUSION: Individuals with aphasia who score above the WAB-R Aphasia Quotient cutoff demonstrate discourse impairments that warrant both treatment and special attention in the research literature.

Automated Proposition Density Analysis for Discourse in Aphasia.

Purpose: This study evaluates how proposition density can differentiate between persons with aphasia (PWA) and individuals in a control group, as well as among subtypes of aphasia, on the basis of procedural discourse and personal narratives collected from large samples of participants. Method: Participants were 195 PWA and 168 individuals in a control group from the AphasiaBank database. PWA represented 6 aphasia types on the basis of the Western Aphasia Battery-Revised (Kertesz, 2006). Narrative samples were stroke stories for PWA and illness or injury stories for individuals in the control group. Procedural samples were from the peanut-butter-and-jelly-sandwich task. Language samples were transcribed using Codes for the Human Analysis of Transcripts (MacWhinney, 2000) and analyzed using Computerized Language Analysis (MacWhinney, 2000), which automatically computes proposition density (PD) using rules developed for automatic PD measurement by the Computerized Propositional Idea Density Rater program (Brown, Snodgrass, & Covington, 2007; Covington, 2007). Results: Participants in the control group scored significantly higher than PWA on both tasks. PD scores were significantly different among the aphasia types for both tasks. Pairwise comparisons for both discourse tasks revealed that PD scores for the Broca's group were significantly lower than those for all groups except Transcortical Motor. No significant quadratic or linear association between PD and severity was found. Conclusion: Proposition density is differentially sensitive to aphasia type and most clearly differentiates individuals with Broca's aphasia from the other groups.

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.

A randomized controlled trial of very early rehabilitation in speech after stroke.

RATIONALE: The efficacy of rehabilitation therapy for aphasia caused by stroke is uncertain. AIMS AND HYPOTHESIS: The Very Early Rehabilitation of Speech (VERSE) trial aims to determine if intensive prescribed aphasia therapy (VERSE) is more effective and cost saving than non-prescribed, intensive (usual care-plus) and non-intensive usual care (UC) therapy when started within 15 days of stroke onset and continued daily over four weeks. We hypothesize that aphasia therapy when started very early after stroke and delivered daily could enhance recovery of communication compared with UC. SAMPLE SIZE ESTIMATES: A total of 246 participants (82 per arm) will provide 80% power to detect a 4.4% improvement on aphasia quotient between VERSE and UC plus at a significance level of α = 0.05. SETTING: Acute-care hospitals and accompanying rehabilitation services throughout Australia, 2014-2017. DESIGN: Three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment (PROBE) trial. PARTICIPANTS: Acute stroke in previous 14 days and aphasia diagnosed by aphasia quotient (AQ) of the Western Aphasia Battery (WAB). RANDOMIZATION: Computer-generated blocked randomization procedure stratified by aphasia severity according to Western Aphasia Battery, to one of three arms. INTERVENTION: All participants receive UC-usual ward-based aphasia therapy. Arm 1: UC-no additional therapy; Arm 2: UC-plus usual ward-based therapy; Arm 3: VERSE therapy-a prescribed and structured aphasia therapy program. Arms 2 and 3 receive a total of 20 additional sessions (45-60 min, provided daily) of aphasia therapy. The additional intervention must be provided before day 50 post stroke. STUDY OUTCOME MEASURES: The aphasia quotient of Western Aphasia Battery at 12 weeks post stroke. Secondary outcomes include discourse measures, the Stroke and Aphasia Quality of Life Scale-39 and the Aphasia Depression Rating Scale at 12 and 26 weeks. ECONOMIC EVALUATION: Incremental cost-effectiveness ratios at 26 weeks will be reported. DISCUSSION: This trial is designed to test whether the intensive and prescribed VERSE intervention is effective in promoting maximum recovery and preventing costly health complications in a vulnerable population of survivors of stroke. It will also provide novel, prospective, aphasia specific cost-effectiveness data to guide future policy development for this population.

Optimizing the quality of breast cancer biomarker use at Duke Cancer Institute.

Advances in identifying biomarker profiles in patients with early-stage breast cancer have improved 5-year curative rates. Identification of the HER2 receptor provides valuable information that has been shown to extend survival in adjuvant and metastatic settings. Current clinical guidelines discuss when confirmatory testing may be inappropriate. Using a quality improvement approach, the team at Duke Cancer Institute determined HER2 ordering practices in a large academic cancer center. HER2 ordering using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) was abstracted from the charts of 314 patients with early-stage breast cancer. Qualitative responses to current clinical practices were obtained from clinicians. Of the patients included, duplicate IHC was performed for 36% and in triplicate for 6%; repeat testing resulted in clinically significant change in HER2 status for approximately 20%. Repeat biomarker testing on metastatic biopsy sites "all of the time" was favored by the surveyed physicians. FISH was ordered for each grade of IHC: 0+ (>20% of cases), 1+ (>20%), 2+ (99%), 3+ (54%). Most physicians "strongly" or "somewhat" favored solutions that integrate order sets and care pathways into the electronic medical record. This quality improvement project identified root causes and solutions to practice variance in breast cancer biomarker ordering and interpretation. Further investigations are planned to standardize best practices while appreciating the clinical challenges posed by discordant test results.

Damage to the anterior arcuate fasciculus predicts non-fluent speech production in aphasia.

Non-fluent aphasia implies a relatively straightforward neurological condition characterized by limited speech output. However, it is an umbrella term for different underlying impairments affecting speech production. Several studies have sought the critical lesion location that gives rise to non-fluent aphasia. The results have been mixed but typically implicate anterior cortical regions such as Broca's area, the left anterior insula, and deep white matter regions. To provide a clearer picture of cortical damage in non-fluent aphasia, the current study examined brain damage that negatively influences speech fluency in patients with aphasia. It controlled for some basic speech and language comprehension factors in order to better isolate the contribution of different mechanisms to fluency, or its lack. Cortical damage was related to overall speech fluency, as estimated by clinical judgements using the Western Aphasia Battery speech fluency scale, diadochokinetic rate, rudimentary auditory language comprehension, and executive functioning (scores on a matrix reasoning test) in 64 patients with chronic left hemisphere stroke. A region of interest analysis that included brain regions typically implicated in speech and language processing revealed that non-fluency in aphasia is primarily predicted by damage to the anterior segment of the left arcuate fasciculus. An improved prediction model also included the left uncinate fasciculus, a white matter tract connecting the middle and anterior temporal lobe with frontal lobe regions, including the pars triangularis. Models that controlled for diadochokinetic rate, picture-word recognition, or executive functioning also revealed a strong relationship between anterior segment involvement and speech fluency. Whole brain analyses corroborated the findings from the region of interest analyses. An additional exploratory analysis revealed that involvement of the uncinate fasciculus adjudicated between Broca's and global aphasia, the two most common kinds of non-fluent aphasia. In summary, the current results suggest that the anterior segment of the left arcuate fasciculus, a white matter tract that lies deep to posterior portions of Broca's area and the sensory-motor cortex, is a robust predictor of impaired speech fluency in aphasic patients, even when motor speech, lexical processing, and executive functioning are included as co-factors. Simply put, damage to those regions results in non-fluent aphasic speech; when they are undamaged, fluent aphasias result.

Systematic review of communication partner training in aphasia: methodological quality.

Twenty-three studies identified from a previous systematic review examining the effects of communication partner training on persons with aphasia and their communication partners were evaluated for methodological quality. Two reviewers rated the studies on defined methodological quality criteria relevant to each study design. There were 11 group studies, seven single-subject participant design studies, and five qualitative studies. Quality scores were derived for each study. The mean inter-rater reliability of scores for each study design ranged from 85-93%, with Cohen's Kappa indicating substantial agreement between raters. Methodological quality of research on communication partner training in aphasia was highly varied. Overall, group studies employed the least rigorous methodology as compared to single subject and qualitative research. Only two of 11 group studies complied with more than half of the quality criteria. No group studies reported therapist blinding and only one group study reported participant blinding. Across all types of studies, the criterion of treatment fidelity was most commonly omitted. Failure to explicitly report certain methodological quality criteria may account for low ratings. Using methodological rating scales specific to the type of study design may help improve the methodological quality of aphasia treatment studies, including those on communication partner training.