Clinical Rating Research Articles

The Role of Lifestyle on Adherence to Treatment in a Sample of Patients with Unipolar and Bipolar Depression.

Introduction: Poor adherence to treatment is currently stated to be one of the causes of depression relapse and recurrence. The aim of the present study is to assess potential differences in terms of clinical and lifestyle features related to adherence to treatment in a sample of patients with unipolar and bipolar depression. Methods: One hundred and eight patients with a diagnosis of unipolar or bipolar depressive episode were recruited from January 2021 to October 2022. Adherence to psychopharmacological treatment was assessed using the clinician rating scale. Descriptive and association analyses were performed to compare subgroups based on adherence to treatment. Results: Lower levels of adherence to treatment were associated with fewer years of education, work impairment, manic prevalent polarity lifetime, and greater comorbidity with alcohol and drug abuse. The majority of patients with positive adherence did not report any hospitalization and involuntary commitment lifetime. Conclusions: Patients with a positive treatment adherence showed significant differences in terms of lifestyle and clinical features compared to non-adherent patients. Our results may help to identify patients more likely to have poor medication adherence, which seem to lead to a worse disease course and quality of life.

Communicating the Gynecologic Brachytherapy Experience (CoGBE): Clinician perceived benefits of a graphic narrative discussion guide

Many current radiotherapy patient education materials are not patient-centered. An interprofessional team developed Communicating the Gynecologic Brachytherapy Experience (CoGBE), a graphic narrative discussion guide for cylinder, intracavitary, and interstitial high-dose-rate (HDR) gynecologic brachytherapy. This study assesses perceived clinical benefits, usability, and anxiety-reduction of CoGBE. An electronic survey was sent to members of the American Brachytherapy Society. Participants were assigned to assess one of the three modality-specific CoGBE versions using a modified Systems Usability Scale (SUS), modified state-trait anxiety index (mSTAI), and Likert-type questions. Free response data was analyzed using modified grounded theory. Median modified SUS score was 76.3 (interquartile range [IQR], 71.3-82.5) and there were no significant differences between guide types. Median mSTAI was 40 (IQR, 40-43.3) for all guides collectively. The cylinder guide had a significantly higher median mSTAI than the intracavitary and interstitial guides (41.6 vs. 40.0 and 40.0; p = 0.04) suggesting the cylinder guide may have less impact on reducing anxiety. Most respondents reported that CoGBE was helpful (72%), would improve patient understanding (77%) and consultation memorability (82%), and was at least moderately likely to be incorporated into their practice (80%). Qualitative analysis themes included personalization and relatability (positive); generalizability (negative); illustrations (both). Clinicians rate CoGBE as usable with potential to reduce patient anxiety, especially with more invasive treatment modalities including intracavitary or interstitial high-dose-rate. CoGBE has the potential to improve patient-clinician communication for a wider range of patients due to its accessible, adaptable, and patient-centered design.

Clinical trials of novel psychotropic agents: some caveats.

Clinical trials of novel psychotropic agents: some caveats.

Using Movement Disorder Society Unified Parkinson's Disease Rating Scale Parts 2 and 3 Simultaneously: Combining the Patient Voice with Clinician Ratings.

Regulatory recommendations favor outcomes combining objective and patient input. The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the most commonly used scale in Parkinson's disease (PD), includes patient and investigator ratings in distinct parts, but original clinimetric analyses failed to confirm the validity of combining parts by simple summing. The aim was to develop clinimetrically valid constructs for combining patient-reported Part 2 and investigator-rated Part 3 MDS-UPDRS scores. Using 7888 MDS-UPDRS scores, we assessed construct validity of combined Part 2 and Part 3 items using exploratory factor analysis (EFA) and graded item response theory (IRT) with threshold criteria: comparative fit index≥0.9 (EFA) and discrimination parameters≥0.65 (IRT). The direct sum of Parts 2+3 failed to meet the threshold for a valid outcome of PD severity (comparative fit index, CFI=0.855). However, a two-domain construct combining item scores for tremor and non-tremor domains from Parts 2 and 3 confirmed validity, meeting both EFA and IRT criteria as distinct but correlated indices of disease severity (CFI=0.923; discrimination mean 2.197 ± 0.480 [tremor] and 1.737 ± 0.344 [non-tremor] domains). The sum of Parts 2+3 is not clinimetrically sound. However, considering tremor and non-tremor items of both Parts 2 and 3 as two outcomes results in a valid summary of PD motor severity that leverages simultaneous patient- and investigator-derived measures. This analytic application addresses regulatory prioritizations and retains the well-validated MDS-UPDRS items. In future interventional trials, we suggest that tremor and non-tremor components of PD motor severity from Parts 2+3 be monitored and analyzed to accurately detect objective changes that integrate the patient's voice. © 2023 International Parkinson and Movement Disorder Society.

A simulation-based OSCE with case presentation and remote rating - development of a prototype.

Simulation-based examination formats improve the possibility to assess medical students' competences during their performance. Additionally, videotaping of simulations allows for remote rating, providing advantages for raters, students, and exam organizers. We describe a simulation-based OSCE prototype with remote rating of students' competences, developed to replace a conventional OSCE at Hamburg Medical Faculty. The assessment consists of two phases: a consultation phase with four simulated patient encounters and a case presentation phase where four students present two cases each. All encounters from the consultation and the presentation phase are to be videotaped and remotely rated by clinical raters. Advanced medical students (year 4) are to be assessed regarding their clinical knowledge as well as physician-patient-communication, clinical reasoning competence, and patient management competence. We provide detailed schedules for the simulation-based OSCE procedure and a roster for organization. When piloting the assessment, we encountered two major obstacles with respect to legal obligations regarding examination time and videotaping which allowed us to provide tips on how to successfully implement this assessment prototype. Remote rating will, when successfully implemented, help students to concentrate on their consultation or presentation tasks, reduce raters' time constraints and also allow for randomized rating. Using established instruments for competence-rating rather than OSCE checklists provides an additional feature for this simulation-based OSCE prototype. Legal issues can be avoided by using the prototype for formative assessment but should be addressed in advance when it is planned to be used as summative assessment.

A Soft Label Method for Medical Image Segmentation with Multirater Annotations.

In medical image analysis, collecting multiple annotations from different clinical raters is a typical practice to mitigate possible diagnostic errors. For such multirater labels' learning problems, in addition to majority voting, it is a common practice to use soft labels in the form of full-probability distributions obtained by averaging raters as ground truth to train the model, which benefits from uncertainty contained in soft labels. However, the potential information contained in soft labels is rarely studied, which may be the key to improving the performance of medical image segmentation with multirater annotations. In this work, we aim to improve soft label methods by leveraging interpretable information from multiraters. Considering that mis-segmentation occurs in areas with weak supervision of annotations and high difficulty of images, we propose to reduce the reliance on local uncertain soft labels and increase the focus on image features. Therefore, we introduce local self-ensembling learning with consistency regularization, forcing the model to concentrate more on features rather than annotations, especially in regions with high uncertainty measured by the pixelwise interclass variance. Furthermore, we utilize a label smoothing technique to flatten each rater's annotation, alleviating overconfidence of structural edges in annotations. Without introducing additional parameters, our method improves the accuracy of the soft label baseline by 4.2% and 2.7% on a synthetic dataset and a fundus dataset, respectively. In addition, quantitative comparisons show that our method consistently outperforms existing multirater strategies as well as state-of-the-art methods. This work provides a simple yet effective solution for the widespread multirater label segmentation problems in clinical diagnosis.

Psychometric performance of the Primary Mitochondrial Myopathy Symptom Assessment (PMMSA) in a randomized, double-blind, placebo-controlled crossover study in subjects with mitochondrial disease

BackgroundThe Primary Mitochondrial Myopathy Symptom Assessment (PMMSA) is a 10-item patient-reported outcome (PRO) measure designed to assess the severity of mitochondrial disease symptoms. Analyses of data from a clinical trial with PMM patients were conducted to evaluate the psychometric properties of the PMMSA and to provide score interpretation guidelines for the measure.MethodsThe PMMSA was completed as a daily diary for approximately 14 weeks by individuals in a Phase 2 randomized, placebo-controlled crossover trial evaluating the safety, tolerability, and efficacy of subcutaneous injections of elamipretide in patents with mitochondrial disease. In addition to the PMMSA, performance-based assessments, clinician ratings, and other PRO measures were also completed. Descriptive statistics, psychometric analyses, and score interpretation guidelines were evaluated for the PMMSA.ResultsParticipants (N = 30) had a mean age of 45.3 years, with the majority of the sample being female (n = 25, 83.3%) and non-Hispanic white (n = 29, 96.6%). The 10 PMMSA items assessing a diverse symptomology were not found to form a single underlying construct. However, four items assessing tiredness and muscle weakness were grouped into a “general fatigue” domain score. The PMMSA Fatigue 4 summary score (4FS) demonstrated stable test–retest scores, internal consistency, correlations with the scores produced by reference measures, and the ability to differentiate between different global health levels. Changes on the PMMSA 4FS were also related to change scores produced by the reference measures. PMMSA severity scores were higher for the symptom rated as “most bothersome” by each subject relative to the remaining nine PMMSA items (most bothersome symptom mean = 2.88 vs. 2.18 for other items). Distribution- and anchor-based evaluations suggested that reduction in weekly scores between 0.79 and 2.14 (scale range: 4–16) may represent a meaningful change on the PMMSA 4FS and reduction in weekly scores between 0.03 and 0.61 may represent a responder for each of the remaining six non-fatigue items, scored independently.ConclusionsUpon evaluation of its psychometric properties, the PMMSA, specifically the 4FS domain, demonstrated strong reliability and construct-related validity. The PMMSA can be used to evaluate treatment benefit in clinical trials with individuals with PMM.Trial registration ClinicalTrials.gov identifier, NCT02805790; registered June 20, 2016; https://clinicaltrials.gov/ct2/show/NCT02805790.

Tele-assessment of young children referred for autism spectrum disorder evaluation during COVID-19: Associations among clinical characteristics and diagnostic outcome.

The diagnosis of autism spectrum disorder (ASD) has traditionally been made through in-person evaluation. While the COVID-19 pandemic disrupted access to ASD services, there has been remarkable growth in research focused on novel ASD diagnostic practices, including the use of telemedicine. We implemented a standard ASD tele-assessment evaluation procedure, including use of a novel remote clinician-coached, caregiver-delivered ASD assessment tool (TELE-ASD-PEDS; TAP), with the goal of continuing to provide diagnostic services to young children and their families during the pandemic. We examined the relationship between child characteristics and diagnostic outcome for 335 children, ages 14-78 months, who received ASD tele-assessment conducted by psychologists and pediatricians in an outpatient clinic of a Midwestern academic medical center. We found that clinicians could make a determination about ASD diagnosis for most children (85%) evaluated using tele-assessment. Child clinical characteristics, including TAP scores and clinician ratings of ASD symptoms, were related to diagnostic outcome (i.e. diagnosis of ASD, no ASD, and Unsure about ASD). When all clinical characteristics were examined together, the presence of specific repetitive behaviors predicted ASD diagnosis. We also found that the TAP is effective for making an ASD diagnosis when used as part of comprehensive tele-assessment evaluation in children ⩾ 36 months of age with delayed language. Our study adds to an increasing body of research supporting use of tele-assessment for diagnosis of ASD. Although further research is needed, telemedicine may help families from different backgrounds and geographic locations to access high-quality diagnostic services.

Macrophage Migration Inhibitory Factor in Major Depressive Disorder: A Multilevel Pilot Study.

Macrophage migration inhibitory factor (MIF) is a controversially discussed inflammatory marker in major depressive disorder (MDD). While some studies show an association of high MIF protein levels with depression, animal models have yielded conflicting results. Thus, it remains elusive as to whether MIF plays an anti- or pro-depressive role. Therefore, we aimed to examine the potential of MIF at the genetic, expression and protein levels as a risk factor and biomarker to diagnose, monitor, or predict the course of MDD. Patients with a current major depressive episode (n = 66 with, and n = 63 without, prior medication) and remitted patients (n = 39) were compared with healthy controls (n = 61). Currently depressed patients provided a second blood sample after three weeks of therapy. Depression severity was assessed by self-evaluation and clinician rating scales. We genotyped for three MIF polymorphisms and analyzed peripheral MIF expression and serum levels. The absence of minor allele homozygous individuals in the large group of 96 female patients compared with 10-16% in female controls suggests a protective effect for MDD, which was not observed in the male group. There were no significant group differences of protein and expression levels, however, both showed predictive potential for the course of depression severity in some subgroups. While MIF protein levels, but not MIF expression, decreased during treatment, they were not associated with changes in depression severity. This project is the first to investigate three biological levels of MIF in depression. The data hint toward a genetic effect in women, but do not provide robust evidence for the utility of MIF as a biomarker for the diagnosis or monitoring of MDD. The observed predictive potential requires further analysis, emphasizing future attention to confounding factors such as sex and premedication.

Relationship between clinician rated amyloid status and traditional AD biomarkers in cognitively healthy older adults

AbstractBackgroundAccumulating evidence suggests that Alzheimer’s Disease (AD) plasma biomarkers aid in screening for at‐risk individuals, tracking disease progression, and monitoring response to interventions. Plasma amyloid‐β (Aβ) and phosphorylated tau (pTau) have shown promise in predicting cerebral deposition of Aβ, while neurofilament light chain (NfL) serves as a more global marker of neurodegeneration. However, blood collection protocols often differ, and it is important to confirm the relationship between blood biomarker values and established neuroimaging markers for AD neuropathology.MethodHere, we examined which blood biomarkers could predict clinician rating of cerebral amyloid status. We leveraged available clinical, cognitive, and neuroimaging data for 140 cognitively healthy older adults (65+, mean 72 ± 6.4) who participated in the Alzheimer’s Prevention Program (APP) study and had blood specimens available. Participants were assessed by a trained clinician and neuropsychometric test battery to exclude the presence of MCI or dementia syndromes. Cerebral amyloid burden was measured by Florbetapir (18F) positron emission tomography and images were rated by three trained clinicians as “elevated” or “non‐elevated”. Biomarkers were measured in plasma collected in acid citrate dextrose (ACD) tubes using a Quanterix Simoa® HD‐X platform, and included NfL, Aβ42, Aβ40, and p‐tau181.ResultPlasma Aβ42/40 ratio was significantly lower in the “elevated” group than in the “non‐elevated” group (p < 0.001), while NfL (p =0.008) and p‐tau 181 (p = 0.001) were both significantly higher. Aβ42/40 ratio was able to discriminate the rating groups in a ROC analysis with an AUC of 0.835, significantly outperforming p‐tau 181 (AUC = 0.640) and NfL (AUC = 0.572).ConclusionDespite collecting samples with ACD rather than the traditional EDTA as an anti‐coagulant, expected group differences were observed. Our results suggest that Aβ42/40 ratio is useful in discriminating clinician‐rated elevated cerebral amyloid status, which has important implications regarding disclosure of blood biomarker results from different collection protocols in the context of AD risk.

Construct Validity and Concordance of Clinician- and Patient-Rated DUNDRUM Programme Completion and Recovery Scales

The DUNDRUM Programme Completion (D3) and Recovery (D4) scales present a promising approach to a recovery-oriented and collaborative method of assessing risk, need, and rehabilitative tasks in forensic settings. We collected clinician- (n = 185) and patient- (n = 118) rated D3 and D4 scores across three security levels (medium, minimum, and outpatient) in a large Canadian forensic service over a 12-month period. Results supported the construct validity of the D3 and D4, showing that clinician (D3 and D4) and patient (D4 only) ratings differed across inpatient and outpatient settings, with lower outpatient scores signaling greater progress in treatment and recovery goals. Only clinician-rated scores differed across patients with moves from higher to lower levels of therapeutic security to those with no movement over the study period. Concordance analyses revealed poor to modest agreement between clinician- and patient-rated item scores, with patient self-ratings observed to be more optimistic than their clinician counterparts. However, concordance strengthened as patients progressed from higher to lower levels of security and restriction. Current findings add to the literature on the feasibility of shared approaches to care planning, and provide validation data for the DUNDRUM scales as part of available tools in collaborative, recovery-oriented forensic care.

Development of a Web-Based Training Platform for School Clinicians in Evidence-Based Practices for ADHD

Lack of training for school clinicians in evidence-based practices (EBPs) contributes to underutilization of such services for youth with attention-deficit/hyperactivity disorder (ADHD). Advances in web-based technology and videoconferencing have allowed for expanded access to and optimization of training. We describe the development and outcomes of a novel web-based platform for training school clinicians to gain skills in EBPs for school-age youth with ADHD. The training platform is adapted from an empirically supported, in-person training for a school–home behavioral intervention (Collaborative Life Skills program) and includes skill modules for working with teachers, parents, and students. Training methods include web-accessed manuals/handouts, skill example video clips, automated progress monitoring tools, and consultation/in-session coaching via videoconferencing. We gathered stakeholder qualitative and quantitative feedback during discovery and design phases of the iterative development. We then evaluated the usability, acceptability, fidelity and clinician and student outcomes of the remote training program. Focus group themes and qualitative feedback identified clinician preferences for remote training features (e.g., interactive, brief, role-plays/coaching methods), video tools (recorded samples of skills and therapy sessions), and progress monitoring tools (e.g., clear, easy to use). Clinician usability ratings of the platform were high with most components rated as moderately to very useful/easy to use. Clinician ratings of usability, fidelity implementing the treatment, and their EBP knowledge and confidence following training were favorable. Student’s outcomes were similar to those achieved in prior studies of clinician in-person training. Results support the promise of remote, web-based clinician training for the dissemination of evidence-based practices.

The Effect of a Climate Event on Voice-Related Processes in Seniors

Purpose: This project considered the relationship of harmful algal blooms, specifically red tide, to patient reports of respiratory diseases, use of respiratory medications, reflux symptoms, excessive coughing/throat clearing, water consumption, voice handicap scores, clinician judgments of voice quality, and voice therapy outcomes in senior voice patients in coastal Southwest Florida. Method: A retrospective chart review of 131 seniors receiving voice therapy during 2013–2019 was conducted. Patients formed two groups—those evaluated during periods of high versus low red tide. Patient reports, clinician ratings, and therapy outcomes were analyzed with nonparametric statistics to determine differences between patient groups. Results: No relationship was found between the presence of high red tide and reports of airway disorders, use of airway medications, coughing/throat clearing, Reflux Symptom Index scores, or voice therapy success. A significant relationship was found between high red tide months and ratings of voice severity and Voice Handicap Index scores. Conclusions: Harmful algal blooms may have negatively impacted the voices of seniors in this study, as shown by higher clinician voice severity ratings and higher patient perceptions of voice handicap during periods of high red tide. While voice success was still achieved by many of these seniors, speech-language pathologists should be aware of environmental issues and their possible negative impacts on voice.

Quality of the therapeutic working alliance as a factor in intensive residential treatment of obsessive-compulsive disorder

Objective: Intensive residential treatment (IRT) for obsessive-compulsive disorder (OCD) includes frequent meetings with a cognitive–behavioral therapist. We examined whether this therapeutic working alliance relates to IRT outcomes. Method: Data came from a naturalistic sample of patients with OCD (n = 124) who received IRT at a specialty OCD clinic. Patients completed measures of OCD severity and well-being at admission and discharge. Both the patient and treating psychologist completed the Working Alliance Inventory-Short Form (WAI-SF). Alliance ratings were tested as predictors in models predicting outcomes (discharge scores adjusting for baseline and treatment duration) as well as logistic regression predicting treatment response (≥35% symptom reduction in OCD symptoms). Results: Patient and clinician ratings of the quality of the alliance were weakly yet significantly correlated. Patient ratings of the alliance predicted outcomes, while therapist ratings did not. Moreover, greater discrepancy between patient and client ratings predicted worse outcomes. Patient ratings of the task dimension of the alliance uniquely related to responder status. Conclusions: Patient perceptions of the working alliance, particularly as pertaining to agreement on therapeutic tasks, related to success with IRT for OCD. Further study is needed test interventions to improve task alliance as a strategy to enhance treatment.

Acoustic and Kinematic Assessment of Motor Speech Impairment in Patients With Suspected Four-Repeat Tauopathies.

The aim of this study was to use acoustic and kinematic speech measures to characterize type of motor speech impairment-apraxia of speech (AOS) versus dysarthria-in individuals with four-repeat tauopathy (4RT)-associated syndromes, including nonfluent variant primary progressive aphasia (nfvPPA), primary progressive AOS (PPAOS), corticobasal syndrome (CBS), and progressive supranuclear palsy syndrome (PSPs). Twenty patient participants were recruited and stratified into two groups: (a) a motor-speech-impaired group of individuals with nfvPPA, PPAOS, CBS, or PSPs and suspected 4RT pathology ("MSI+") and (b) a non-motor-speech-impaired group of individuals with logopenic variant primary progressive aphasia ("MSI-"). Ten healthy, age-matched controls also participated in the study. Participants completed a battery of speech tasks, and 15 acoustic and kinematic speech measures were derived. Quantitative speech measures were grouped into feature categories ("AOS features," "dysarthria features," "shared features"). In addition to quantitative speech measures, two certified speech-language pathologists made independent, blinded auditory-perceptual ratings of motor speech impairment. A principal component analysis (PCA) was conducted to investigate the relative contributions of quantitative features. Quantitative speech measures were generally concordant with independent clinician ratings of motor speech impairment severity. Hypothesis-driven groupings of quantitative measures differentiated predominantly apraxic from predominantly dysarthric presentations within the MSI+ group. PCA results provided additional evidence for differential profiles of motor speech impairment in the MSI+ group; heterogeneity across individuals is explained in large part by varying levels of overall severity-captured by the shared feature variable group-and degree of apraxia severity, as measured by the AOS feature variable group. Quantitative features reveal heterogeneity of MSI in the 4RT group in terms of both overall severity and subtype of MSI. Results suggest the potential for acoustic and kinematic speech assessment methods to inform characterization of motor speech impairment in 4RT-associated syndromes. https://doi.org/10.23641/asha.21401778.

Protocol for a randomised placebo-controlled trial investigating the efficacy and safety of a vitamin-mineral formula targeting dysregulated emotions in teenagers: The balancing emotions of adolescents with micronutrients (BEAM) study

BackgroundEmotional dysregulation (ED) is a significant contributing factor to psychological distress in young people. ED is a transdiagnostic dimension characterized by an excessive reactivity to negative emotional stimuli with affective (anger) and behavioral (aggression) components, and is present across anxiety, mood and behavioral disorders. Due to early onset, high prevalence and persistence, ED in childhood is one of the most psychosocially impairing and cost-intensive mental health conditions, with not enough children improving with conventional treatments. Clinical trials have established preliminary efficacy of micronutrients (vitamins and minerals) in the treatment of ED. This project expands the research to examine micronutrient efficacy for teenagers with ED. MethodsThis study is the first double-blind (participant and investigators) 8 week randomized controlled trial (with 8 week open-label extension and one year follow-up) designed to explore the efficacy and safety of micronutrients compared with placebo in 150 medication-free emotionally dysregulated youth (12–17 years), referred via self-referral, delivered remotely throughout New Zealand, using a website for monitoring symptoms, with a psychologist available online via text, email and video for assessment and monitoring. The primary outcome measures will be the Clinical Global Impression (CGI-I), the reactivity subscale of the Emotion Dysregulation Inventory (EDI) and the Clinician Rated Temper and Irritability Scale (CL-ARI). DiscussionMicronutrient intervention delivered alongside online assessment and monitoring has the potential to transform delivery of mental health care to young people who may not be willing or able to access traditional therapies. We also hope that this intervention shows acceptability across different ethnicities.

Differentiating Oncocytic Renal Tumors from Chromophobe Renal Cell Carcinoma: Comparison of Peak Early-phase Enhancement Ratio to Clinical Risk Factors and Rater Predictions

BackgroundMost surgically resected benign renal tumors are found to be oncocytomas or indolent hybrid oncocytic tumors, which are difficult to differentiate from chromophobe renal cell carcinoma (chRCC) on renal mass biopsy. Both often exhibit CD117+ staining. ObjectiveTo evaluate the ability of the peak early-phase enhancement ratio (PEER) to distinguish oncocytomas from chRCC and compare its discrimination to traditional clinical risk factors and blinded clinical raters. Design, setting, and participantsThis was a diagnostic case-control study of patients (2006–2020) with oncocytoma or chRCC according to surgical pathology. InterventionPartial or radical nephrectomy. Outcome measurements and statistical analysisThree clinical raters blinded to histology measured the PEER and the presence of stellate scar and predicted the final histology for each tumor. Averaged and individual PEER values were compared to surgical pathology and assessed for interobserver variability. Subanalyses were conducted for patients with confirmed CD117+ status. Results and limitationsFor the 76 patients identified, PEER was higher among the 32 (42.1%) oncocytomas than among the 44 (57.9%) chRCCs (median 0.81 vs 0.43; p < 0.001), with high correlation across raters (correlation coefficients ≥0.85). A PEER cutoff of <0.60 was strongly associated with identification of chRCC (OR 95.7 (95% CI 19.9–460.8), p < 0.001). In the overall and CD117+ cohorts, sensitivity was 93.2% and 97.0%, the negative predictive value was 90.3% and 95.5%, and the area under the receiver operating characteristic curve (AUC) on multivariable modeling was 95.0% and 98.1%, respectively. PEER outperformed models with clinical risk factors alone (AUC 70.4%) and histology predictions by three raters (AUC 51.6%, 62.5%, and 63.1%). Limitations include reliance on surgical pathology and inclusion of a mix of early contrast-enhanced phases. ConclusionsPEER reliably differentiated benign renal oncocytomas and indolent hybrid tumors from malignant chRCC with excellent diagnostic performance. A diagnostic pathway with biopsy, CD117 staining, and PEER deserves further study to potentially avoid unnecessary surgery for oncocytic renal tumors. Patient summaryWe assessed a measurement called PEER on computed tomography (CT) scans and found higher values for benign and lower values for malignant kidney masses, so we were able to tell these apart. PEER was reliable for identifying tumors with positive staining for the CD117 protein biomarker as well as in the overall patient group. Our results show that PEER could be considered for use with biopsy and CD117 staining to potentially avoid unnecessary surgery for benign kidney masses.

An Evaluation of KELVIN, an Artificial Intelligence Platform, as an Objective Assessment of the MDS UPDRS Part III.

Parkinson's disease severity is typically measured using the Movement Disorder Society Unified Parkinson's disease rating scale (MDS-UPDRS). While training for this scale exists, users may vary in how they score a patient with the consequence of intra-rater and inter-rater variability. In this study we explored the consistency of an artificial intelligence platform compared with traditional clinical scoring in the assessment of motor severity in PD. Twenty-two PD patients underwent simultaneous MDS-UPDRS scoring by two experienced MDS-UPDRS raters and the two sets of accompanying video footage were also scored by an artificial intelligence video analysis platform known as KELVIN. KELVIN was able to produce a summary score for 7 MDS-UPDRS part 3 items with good inter-rater reliability (Intraclass Correlation Coefficient (ICC) 0.80 in the OFF-medication state, ICC 0.73 in the ON-medication state). Clinician scores had exceptionally high levels of inter-rater reliability in both the OFF (0.99) and ON (0.94) medication conditions (possibly reflecting the highly experienced team). There was an ICC of 0.84 in the OFF-medication state and 0.31 in the ON-medication state between the mean Clinician and mean Kelvin scores for the equivalent 7 motor items, possibly due to dyskinesia impacting on the KELVIN scores. We conclude that KELVIN may prove useful in the capture and scoring of multiple items of MDS-UPDRS part 3 with levels of consistency not far short of that achieved by experienced MDS-UPDRS clinical raters, and is worthy of further investigation.

Development of the Tracheostomy Well-Being Score in critically ill patients

PurposeLittle attention has been given to understanding the experiences and perceptions of tracheostomized patients. This study aimed to measure the impact of tracheostomy on well-being in critically ill patients with the development of the Tracheostomy Well-Being Score (TWBS).MethodsThis is a prospective, monocentric, observational study including critically ill patients with a tracheostomy without delirium. A 25-item questionnaire with items from six categories (respiration, coughing, pain, speaking, swallowing, and comfort) was used to select the 12 best items (two per category) to form the TWBS score after testing on two consecutive days. Item selection secured (1) that there were no skewed response distributions, (2) high stability from day 1 to day 2, and (3) high prototypicality for the category in terms of item-total correlation.ResultsA total of 63 patients with a mean age of 56 years were included. The 12 items of the TWBS were characterized by a high retest reliability (τ = 0.67–0.93) and acceptable internal consistency. The overlap with the clinician rating was low, suggesting that acquiring self-report data is strongly warranted.ConclusionWith the TWBS, an instrument is available for the assessment of the subjective effects a tracheostomy has on in critically ill patients. The score potentially offers a chance to increase well-being of these patients. Additionally, this score could also increase their quality of life by improving tracheostomy and weaning management.Clinical Trial RegistrationGerman Clinical Trials Register Identifier DRKS00022073 (2020/06/02).

Patient Satisfaction and Clinical Effects of Platelet-Rich Plasma on Pattern Hair Loss in Male and Female Patients.

IntroductionHair loss is a widespread condition in both genders. Over the past decade, platelet-rich plasma (PRP) has become a common treatment for hair loss. Our goal was to analyze patient satisfaction and the clinical effects of PRP on male and female pattern hair loss.MethodsOver a period of 12 months, we treated a total of 56 patients for androgenetic alopecia with PRP. All of these patients were included in this study; 15 cc of whole blood was spun in an ACP double syringe (Arthrex Inc., Naples, Forida) for five minutes. The yielded 5 to 6 cc of PRP were then injected into the scalp. Forty-nine patients were treated with a series of three injections at monthly intervals, three patients with a series of four injections, two patients with a series of five injections, one patient was treated with a series of seven injections, and one patient with a series of eight injections. Follow-ups were conducted one month after the last treatment. A self-drawn questionnaire was used to assess the satisfaction and clinical results from the patient's and the clinician's perspectives.ResultsThe average age was 41 years (20-68 years). Fifty-seven percent of all patients were male and 43% female. In total, the patients were satisfied with the treatment results. The average score was 7.29 on a scale from 0 to 10. The clinician's rating was similar (6.46). Moreover, with an average score of 8 on a scale from 0 to 10, it is very likely that the patients will recommend PRP treatments to friends. The probability of occurrence of clinical effects among the entire study population was reported as follows: improvement in hair density (patient‘s rating: 64%; clinician's rating: 46%), thickness (38%; 45%), quality (46%; 54%), sheen/lustre (27%; 21%), new hair growth (57%; 68%), less hair loss (48%; 20%), other positive effects (5%, 2%), no effects (4%; 4%), negative effects (0%; 0%).ConclusionOur study revealed encouraging results for the treatment of male and female pattern hair loss with PRP. The autologous treatment was rated with high satisfaction scores and can be considered a safe and effective treatment modality.