A powerful partnership: researchers and patients working together to develop a patient-facing summary of clinical trial outcome data.

OBJECTIVE: Availability of easy-to-understand patient-reported outcome (PRO) trial data may help individuals make more informed healthcare decisions. Easily interpretable, patient-centric PRO data summaries and visualizations are therefore needed. This three-stage study explored graphical format preferences, understanding, and interpretability of clinical trial PRO data presented to people with prostate cancer (PC). MATERIALS AND METHODS: A 7-day online survey exploring people with PC's preferences for different PRO data presentations (stage 1; n = 30) informed development of a draft plain-language resource sheet containing PRO data. After refining for clarity during cognitive debriefing interviews (stage 2; n = 18), the final resource sheet was circulated to people with PC for broader feedback (stage 3; n = 45). RESULTS: Although participants expressed preferences for certain graphical formats (pie charts and bar charts), preference did not always associate with interpretability and overall message clarity. Iterative development (stages 1 and 2) led to a final resource sheet, which 91.1% of participants in stage 3 considered useful and informative, and 88.9% expressed interest in receiving similar resources in the future. DISCUSSION: Findings demonstrate PRO data are relevant to people with PC and highlights that targeted resource sheets can support patient-clinician discussions. Appropriate graphical formatting and use of plain-language text is essential for conveying interpretable PRO data. Data visualization preferences are context dependent. CONCLUSION: Resource sheets summarizing clinical trial PRO data can be helpful for decision-making in PC. Researchers and patients can work together to develop clear, relevant, sensitive, and understandable resource sheets, which equally consider patient priorities as well as those of scientists.

Prolonged NoGo P3 latency as a possible neurobehavioral correlate of aggressive and antisocial behaviors: A Go/NoGo ERP study.

Aggressive and antisocial behaviors are detrimental to society and constitute major challenges in forensic mental health settings, yet the associated neural circuitry remains poorly understood. Here, we investigated differences in aggressive and antisocial behaviors between healthy controls (n = 20) and violent mentally disordered offenders (MDOs; n = 26), and examined associations between aggressive and antisocial behaviors, behavioral inhibitory control, and neurophysiological activity across the whole sample (n = 46). Event-related potentials were obtained using EEG while participants completed a Go/NoGo response inhibition task, and aggressive and antisocial behaviors were assessed with the Life History of Aggression (LHA) instrument. Using a robust Bayesian linear regression approach, we found that MDOs scored substantially higher than healthy controls on LHA Aggression and Antisocial subscales. Using the whole sample and after adjusting for age, we found that scores on the LHA Aggression and Antisocial subscales were robustly associated with longer NoGo P3 latency, and less robustly with longer NoGo N2 latency. Post-hoc analyzes suggested that healthy controls and MDOs exhibited similar associations. With several limitations in mind, we suggest that prolonged NoGo P3 latency, reflecting decreased neural efficiency during the later stages of conflict monitoring or outcome evaluation, is a potential neurobehavioral correlate of aggressive and antisocial behaviors.

Trait Disinhibition and NoGo Event-Related Potentials in Violent Mentally Disordered Offenders and Healthy Controls.

Trait disinhibition may function as a dispositional liability toward maladaptive behaviors relevant in the treatment of mentally disordered offenders (MDOs). Reduced amplitude and prolonged latency of the NoGo N2 and P3 event-related potentials have emerged as promising candidates for transdiagnostic, biobehavioral markers of trait disinhibition, yet no study has specifically investigated these two components in violent, inpatient MDOs. Here, we examined self-reported trait disinhibition, experimentally assessed response inhibition, and NoGo N2 and P3 amplitude and latency in male, violent MDOs (N = 27) and healthy controls (N = 20). MDOs had a higher degree of trait disinhibition, reduced NoGo P3 amplitude, and delayed NoGo P3 latency compared to controls. The reduced NoGo P3 amplitude and delayed NoGo P3 latency in MDOs may stem from deficits during monitoring or evaluation of behavior. NoGo P3 latency was associated with increased trait disinhibition in the whole sample, suggesting that trait disinhibition may be associated with reduced neural efficiency during later stages of outcome monitoring or evaluation. Findings for NoGo N2 amplitude and latency were small and non-robust. With several limitations in mind, this is the first study to demonstrate attenuated NoGo P3 amplitude and delayed NoGo P3 latency in violent, inpatient MDOs compared to healthy controls.

Characterizing hippocampal dynamics with MEG: A systematic review and evidence-based guidelines.

The hippocampus, a hub of activity for a variety of important cognitive processes, is a target of increasing interest for researchers and clinicians. Magnetoencephalography (MEG) is an attractive technique for imaging spectro-temporal aspects of function, for example, neural oscillations and network timing, especially in shallow cortical structures. However, the decrease in MEG signal-to-noise ratio as a function of source depth implies that the utility of MEG for investigations of deeper brain structures, including the hippocampus, is less clear. To determine whether MEG can be used to detect and localize activity from the hippocampus, we executed a systematic review of the existing literature and found successful detection of oscillatory neural activity originating in the hippocampus with MEG. Prerequisites are the use of established experimental paradigms, adequate coregistration, forward modeling, analysis methods, optimization of signal-to-noise ratios, and protocol trial designs that maximize contrast for hippocampal activity while minimizing those from other brain regions. While localizing activity to specific sub-structures within the hippocampus has not been achieved, we provide recommendations for improving the reliability of such endeavors.

The Autism-Spectrum Quotient in Siblings of People With Autism.

This study measures the distribution of autistic traits, using the autism-spectrum quotient (AQ), in siblings of individuals with autism spectrum conditions (ASC). Total AQ scores, along with AQ subscales, were collected from child, adolescent and adult controls, siblings, and volunteers with ASC using one of the three age-appropriate versions of the instrument: the AQ (adult self-report), the AQ-adolescent and AQ-child (both parent-reports). We examined the effect of Group (case, sibling and control) and AQ version (adult, adolescent and adult) on total and subscale scores. In addition, we tested for sex differences in all groups and on all versions. We found that in male and female adults, AQ scores in siblings fell between cases and controls (cases > siblings > controls). In children and adolescents, female siblings also scored higher than control females (female cases > female siblings > female controls), but there was no difference between male siblings and controls (male cases > male siblings = male controls). An investigation of subscale scores revealed that male siblings only differed from controls on the "Communication" subscale (male cases > male siblings > male controls), while female siblings differed from controls on all subscales except "Imagination" (female cases > female siblings > female controls). This study confirms the broader autism phenotype in siblings, and reveals this is modulated by sex and AQ version. Autism Res 2017, 10: 289-297. © 2016 The Authors Autism Research published by Wiley Periodicals, Inc. on behalf of International Society for Autism Research.

Subgrouping siblings of people with autism: Identifying the broader autism phenotype.

We investigate the broader autism phenotype (BAP) in siblings of individuals with autism spectrum conditions (ASC). Autistic traits were measured in typical controls (n = 2,000), siblings (n = 496), and volunteers with ASC (n = 2,322) using the Autism-Spectrum Quotient (AQ), both self-report and parent-report versions. Using cluster analysis of AQ subscale scores, two sibling subgroups were identified for both males and females: a cluster of low-scorers and a cluster of high-scorers. Results show that while siblings as a group have intermediate levels of autistic traits compared to control individuals and participants with ASC, when examined on a cluster level, the low-scoring sibling group is more similar to typical controls while the high-scoring group is more similar to the ASC clinical group. Further investigation into the underlying genetic and epigenetic characteristics of these two subgroups will be informative in understanding autistic traits, both within the general population and in relation to those with a clinical diagnosis. Autism Res 2016, 9: 658-665. © 2015 The Authors Autism Research published by Wiley Periodicals, Inc. on behalf of International Society for Autism Research.

Sex and STEM Occupation Predict Autism-Spectrum Quotient (AQ) Scores in Half a Million People.

This study assesses Autism-Spectrum Quotient (AQ) scores in a 'big data' sample collected through the UK Channel 4 television website, following the broadcasting of a medical education program. We examine correlations between the AQ and age, sex, occupation, and UK geographic region in 450,394 individuals. We predicted that age and geography would not be correlated with AQ, whilst sex and occupation would have a correlation. Mean AQ for the total sample score was m = 19.83 (SD = 8.71), slightly higher than a previous systematic review of 6,900 individuals in a non-clinical sample (mean of means = 16.94) This likely reflects that this big-data sample includes individuals with autism who in the systematic review score much higher (mean of means = 35.19). As predicted, sex and occupation differences were observed: on average, males (m = 21.55, SD = 8.82) scored higher than females (m = 18.95; SD = 8.52), and individuals working in a STEM career (m = 21.92, SD = 8.92) scored higher than individuals non-STEM careers (m = 18.92, SD = 8.48). Also as predicted, age and geographic region were not meaningfully correlated with AQ. These results support previous findings relating to sex and STEM careers in the largest set of individuals for which AQ scores have been reported and suggest the AQ is a useful self-report measure of autistic traits.

Erratum: Measuring autistic traits in the general population: a systematic review of the Autism-Spectrum Quotient (AQ) in a nonclinical population sample of 6,900 typical adult males and females.

[This corrects the article DOI: 10.1186/2040-2392-6-2.].

Measuring autistic traits in the general population: a systematic review of the Autism-Spectrum Quotient (AQ) in a nonclinical population sample of 6,900 typical adult males and females.

The Autism-Spectrum Quotient (AQ) is a self-report measure of autistic traits. It is frequently cited in diverse fields and has been administered to adults of at least average intelligence with autism and to nonclinical controls, as well as to clinical control groups such as those with schizophrenia, prosopagnosia, anorexia, and depression. However, there has been no empirical systematic review of the AQ since its inception in 2001. The present study reports a comprehensive systematic review of the literature to estimate a reliable mean AQ score in individuals without a diagnosis of an autism spectrum condition (ASC), in order to establish a reference norm for future studies. A systematic search of computerized databases was performed to identify studies that administered the AQ to nonclinical participant samples representing the adult male and female general population. Inclusion was based on a set of formalized criteria that evaluated the quality of the study, the usage of the AQ, and the population being assessed. After selection, 73 articles, detailing 6,934 nonclinical participants, as well as 1,963 matched clinical cases of ASC (from available cohorts within each individual study), were analyzed. Mean AQ score for the nonclinical population was 16.94 (95% CI 11.6, 20.0), while mean AQ score for the clinical population with ASC was found to be 35.19 (95% CI 27.6, 41.1). In addition, in the nonclinical population, a sex difference in autistic traits was found, although no sex difference in AQ score was seen in the clinical ASC population. These findings have implications for the study of autistic traits in the general population. Here, we confirm previous norms with more rigorous data and for the first time establish average AQ scores based on a systematic review, for populations of adult males and females with and without ASC. Finally, we advise future researchers to avoid risk of bias by carefully considering the recruitment strategy for both clinical and nonclinical groups and to demonstrate transparency by reporting recruitment methods for all participants.

Spatio-temporal mapping cortical neuroplasticity in carpal tunnel syndrome.

Neuroimaging data demonstrate that carpal tunnel syndrome, a peripheral neuropathy, is accompanied by maladaptive central neuroplasticity. To further investigate this phenomenon, we collected magnetoencephalography data from 12 patients with carpal tunnel syndrome and 12 healthy control subjects undergoing somatosensory stimulation of the median nerve-innervated Digits 2 and 3, as well as Digit 5, which is innervated by the ulnar nerve. Nerve conduction velocity and psychophysical data were acquired to determine whether standard clinical measures correlated with brain response. In subjects with carpal tunnel syndrome, but not healthy controls, sensory nerve conduction velocity for Digits 2 and 3 was slower than Digit 5. However, somatosensory M20 latencies for Digits 2 and 3 were significantly longer than those of Digit 5. The extent of the M20 delay for median nerve-innervated Digit 2 was positively correlated with decreasing nerve conduction velocity and increasing pain severity. Thus, slower peripheral nerve conduction in carpal tunnel syndrome corresponds to greater delays in the first somatosensory cortical response. Furthermore, spectral analysis demonstrated weaker post-stimulus beta event-related desynchronization and earlier and shorter event-related synchronization in subjects with carpal tunnel syndrome. The extent of the decreased event-related desynchronization for median nerve-innervated digits was positively correlated with paraesthesia severity. We propose that ongoing paraesthesias in median nerve-innervated digits render their corresponding sensorimotor cortical areas 'busy', thus reducing their capacity to process external stimulation. Finally, subjects with carpal tunnel syndrome demonstrated a smaller cortical source separation for Digits 2 and 3 compared with healthy controls. This supports our hypothesis that ongoing paraesthesias promote blurring of median nerve-innervated digit representations through Hebbian plasticity mechanisms. In summary, this study reveals significant correlation between the clinical severity of carpal tunnel syndrome and the latency of the early M20, as well as the strength of long latency beta oscillations. These temporal magnetoencephalography measures are novel markers of neuroplasticity in carpal tunnel syndrome and could be used to study central changes that may occur following clinical intervention.