Assessing the outcomes of a clinical trial: Primary outcome measures only tell part of the story

Identifying outcome measures that are sensitive to change and meaningful to participants is a challenge when designing clinical trials of complex communication interventions. Outcome measures encompassing participants’ perceptions of clinically meaningful change and their experience of the treatment process are frequently neglected. This paper presents an overview of the outcome measures used in a 3 arm clinical trial which aimed to investigate (i) social skills training for the person with TBI alone (which we have termed the TBI SOLO condition) and (ii) training communication partners to deal with difficult communication behaviors (the JOINT condition) compared to a delayed waitlist CONTROL condition. The paper asks two research questions: 1. What information did the self-report of perceived communication ability using the La Trobe Communication Questionnaire, and qualitative measures provide in addition to blinded ratings on the Adapted Kagan Scales, the primary outcome measure? 2.How did participants perceive the training experience as measured through post treatment interviews

Communication skills of people with severe traumatic brain injury can be improved by training everyday communication partners: Findings from a single-blind multi-centre clinical trial

This controlled group comparison study examined the effectiveness of everyday communication partner (ECP) training for people with TBI. 44 participants with severe TBI and their ECPs were allocated to a) TBI SOLO group where the person with TBI was trained; b) JOINT group where the communication partner was also trained; or c) a delayed CONTROL. Conversations were videotaped pre and post training and rated by two blind assessors on conversational skills. Training ECPs was more efficacious than training the person with TBI alone. Involving communication partners in treatment appears crucial for improved communication interactions for people with severe TBI

Interpersonal functioning in hoarding : an investigation of the link between hoarding symptoms and social support, social anhedonia, and social rewards

Background: One of the key areas of functional impairment in hoarding is interpersonal difficulties, with burgeoning evidence suggesting that these social difficulties are a component of the psychopathology observed in hoarding. The specific nature of these interpersonal difficulties, however, has yet to be fully elucidated. The aim of the current study was to investigate the contribution of social support and motivation to socialise, specifically social anhedonia and rewards from social stimuli, to hoarding symptom severity. Method: A total of 278 participants recruited via the crowd-sourcing website MTurk completed questionnaires assessing hoarding symptoms, social support, social anhedonia, and response to social rewards. Results: Results for social reward processing indicated that hoarding symptoms were associated with finding both negative and positive behaviours towards others more rewarding. Social anhedonia also positively predicted hoarding symptoms. Furthermore, social integration, a component of social support, was inversely associated with hoarding symptoms. These associations remained significant when controlling for depressive symptoms. These results suggest that hoarding may be linked to decreased social support and reduced social motivation, particularly, dysregulated reward processing of social stimuli, and greater social anhedonia. Limitations: Limitations of the current study include utilising an unselected sample, use of self-report measures, and analyses being correlational in nature. Future research utilising longitudinal or experimental research methods in a clinical population may further delineate the clinical conceptualisation of social difficulties in hoarding disorder. Conclusions: Current findings may inform interpersonal conceptualisations for hoarding disorder and suggest additional treatment avenues

Quality Evaluation Tool for Clinician Online Continuing Medical Education

The purpose of this study was to develop and assess an instrument evaluating the quality of online continuing medical education interventions for clinicians. A review of seminal literature for evaluating health-related websites was conducted to incorporate best practices from health education, health communication, and web-based design principles. After reviewing the literature, 12 preliminary quality indicators were developed. Two independent coders used the preliminary quality indicators to code continuing medical education interventions. Internal reliability of the preliminary indicators was calculated using the Krippendorff’s alpha coefficient. After completing the reliability testing and revising the tool, the quality evaluation framework consisted of six quality indicators: accessibility, content, design, evaluation, interactivity, and theory/models. The indicators are not specifically tied to one content area; therefore, this tool can be utilized to assess the quality of continuing medical education interventions of various content areas. Future research should be conducted to further develop a comprehensive metric to assess indicators’ effect on behavior change and clinician communication with patients. These quality indicators are important as they are a foundation for intervention developers to effectively communicate current medical information and new guidelines from medical organizations and, in turn, impact patient communication and care

Reprint of “The Single-Case Reporting Guideline In BEhavioural interventions (SCRIBE) 2016: explanation and elaboration”

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.Published versio

The methodological quality of aphasia research: an investigation using the PsycBITE™ database

This paper examines methodological quality of aphasia research using the Psychological database for Brain Injury Treatment Efficacy™(www.psycbite.com). PsycBITE™ includes five designs: Systematic Reviews (SR), Randomised Controlled Trials (RCT), non-RCT (NRCT); Case Series (CS) and Single Subject Designs (SSD). Of 310 studies indexed for aphasia: SR=8 (3%); RCT=22 (7%); NRCT=17 (5%); CS=48 (15%); SSD=215 (69%). Methodological quality ratings (MQR) using the PEDro scale (scored out of 10) were available for 9 RCTs (mean MQR=4.6 SD = 1.5), 5 NRCTs (mean MQR=2.3, SD =1.1), and 12 CSs (mean MQR=0.9, SD =0.7). Methodological quality is discussed with suggestions for future treatment studies

Inter-rater reliability of the Measure of Support in Conversation and Measure of Participation in Conversation (Kagan et al., 2004) adapted for people with Traumatic Brain Injury (TBI) and their communication partners

Aim: This study reports inter-rater reliability of the Adapted Measure of Support in Conversation (MSC) and Measure of Participation in Conversation (MPC) for TBI interactions. Method: The MSC and MPC were adapted to reflect theoretical models of cognitive-communication support for people with TBI. 10 casual and 10 purposeful TBI interactions were independently rated. Results: Strong inter-rater agreement was established on the MSC (ICC = 0.85-0.97) and the MPC (ICC = 0.85-0.97). All ratings scored within 0.5 on a 9 point scale. Conclusion: This is the first scale to measure the communication partner during TBI interactions. It shows promise in evaluating communication partner training programs

Comparing static and dynamic emotion recognition tests:Performance of healthy participants

Facial expressions have a communicatory function and the ability to read them is a prerequisite for understanding feelings and thoughts of other individuals. Impairments in recognition of facial emotional expressions are frequently found in patients with neurological conditions (e.g. stroke, traumatic brain injury, frontotemporal dementia). Hence, a standard neuropsychological assessment should include measurement of emotion recognition. However, there is debate regarding which tests are most suitable. The current study evaluates and compares three different emotion recognition tests. 84 healthy participants were included and assessed with three tests, in varying order: a. Ekman 60 Faces Test (FEEST) b. Emotion Recognition Task (ERT) c. Emotion Evaluation Test (EET). The tests differ in type of stimuli from static photographs (FEEST) to more dynamic stimuli in the form of morphed photographs (ERT) to videos (EET). Comparing performances on the three tests, the lowest total scores (67.3% correct answers) were found for the ERT. Significant, but moderate correlations were found between the total scores of the three tests, but nearly all correlations between the same emotions across different tests were not significant. Furthermore, we found cross-over effects of the FEEST and EET to the ERT; participants attained higher total scores on the ERT when another emotion recognition test had been administered beforehand. Moreover, the ERT proved to be sensitive to the effects of age and education. The present findings indicate that despite some overlap, each emotion recognition test measures a unique part of the construct. The ERT seemed to be the most difficult test: performances were lowest and influenced by differences in age and education and it was the only test that showed a learning effect after practice with other tests. This highlights the importance of appropriate norms

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

We developed a reporting guideline to provide authors with guidance about what should be reported when writing a paper for publication in a scientific journal using a particular type of research design: the single-case experimental design. This report describes the methods used to develop the Single-Case Reporting guideline In BEhavioural interventions (SCRIBE) 2016. As a result of 2 online surveys and a 2-day meeting of experts, the SCRIBE 2016 checklist was developed, which is a set of 26 items that authors need to address when writing about single-case research. This article complements the more detailed SCRIBE 2016 Explanation and Elaboration article (Tate et al., 2016) that provides a rationale for each of the items and examples of adequate reporting from the literature. Both these resources will assist authors to prepare reports of single-case research with clarity, completeness, accuracy, and transparency. They will also provide journal reviewers and editors with a practical checklist against which such reports may be critically evaluated. We recommend that the SCRIBE 2016 is used by authors preparing manuscripts describing single-case research for publication, as well as journal reviewers and editors who are evaluating such manuscripts.Funding for the SCRIBE project was provided by the Lifetime Care and Support Authority of New South Wales, Australia. The funding body was not involved in the conduct, interpretation or writing of this work. We acknowledge the contribution of the responders to the Delphi surveys, as well as administrative assistance provided by Kali Godbee and Donna Wakim at the SCRIBE consensus meeting. Lyndsey Nickels was funded by an Australian Research Council Future Fellowship (FT120100102) and Australian Research Council Centre of Excellence in Cognition and Its Disorders (CE110001021). For further discussion on this topic, please visit the Archives of Scientific Psychology online public forum at http://arcblog.apa.org. (Lifetime Care and Support Authority of New South Wales, Australia; FT120100102 - Australian Research Council Future Fellowship; CE110001021 - Australian Research Council Centre of Excellence in Cognition and Its Disorders)Published versio

Red hot frogs:Identifying the Australian frogs most at risk of extinction

More than a third of the world’s amphibian species are listed as Threatened or Extinct, with a recent assessment identifying 45 Australian frogs (18.4% of the currently recognised species) as ‘Threatened’ based on IUCN criteria. We applied structured expert elicitation to 26 frogs assessed as Critically Endangered and Endangered to estimate their probability of extinction by 2040. We also investigated whether participant experience (measured as a self-assigned categorical score, i.e. ‘expert’ or ‘non-expert’) influenced the estimates. Collation and analysis of participant opinion indicated that eight species are at high risk (>50% chance) of becoming extinct by 2040, with the disease chytridiomycosis identified as the primary threat. A further five species are at moderate–high risk (30–50% chance), primarily due to climate change. Fourteen of the 26 frog species are endemic to Queensland, with many species restricted to small geographic ranges that are susceptible to stochastic events (e.g. a severe heatwave or a large bushfire). Experts were more likely to rate extinction probability higher for poorly known species (those with <10 experts), while non-experts were more likely to rate extinction probability higher for better-known species. However, scores converged following discussion, indicating that there was greater consensus in the estimates of extinction probability. Increased resourcing and management intervention are urgently needed to avert future extinctions of Australia’s frogs. Key priorities include developing and supporting captive management and establishing or extending in-situ population refuges to alleviate the impacts of disease and climate change