Clinical Utility Ratings Research Articles

Advancements in Dexterity Measurements: the digital Nine Hole Peg Test

Abstract Digitalization in the healthcare sector is progressing rapidly. In the field of measuring instruments for manual dexterity, digitization has resulted in major limitations in terms of ease of use and usability. This study describes the development of a digital nine-hole peg test (dNHPT) for assessing hand dexterity that can be used just as easily and quickly as the original nine-hole peg test. The extensive validation of the dNHPT includes the investigation of validity, reliability, clinical utility and user-friendliness This paper presents the validation of clinical utility and usability of the dNHPT. The comparison of the original ninehole peg test (NHPT) und the dNHPT show similar clinical utility of the dNHPT and the NHPT (74% of all ratings of dNHPT are equal to or better than the NHPT) and good to excellent System Usability Scale Scores of 78 (CI95: 75;81) and 85 (CI95: 80;89). Several recommendations for further development of the dNHPT were identified. The newly developed dNHPT presented here supports the quality of data collection through automated time measurement and result presentation and shows good usability and clinical utility ratings.

Utility of an amplicon-based ctDNA platform for advanced cholangiocarcinomas (CCA) in Asia.

e16206 Background: Cholangiocarcinoma represents a major cause of cancer mortality in Asia. While clinical outcomes have improved with the addition of anti-PD1/PDL1 agents to standard-of-care chemotherapy for advanced disease, recent data suggests that novel agents against IDH1 mutations, FGFR2 and NTRK rearrangements, BRAF V600E mutations, and microsatellite instability (MSI) are effective. Tumor-based next generation sequencing (NGS) is routinely recommended by guidelines but is limited by tissue availability and quality in patients with unresectable disease. A comprehensive circulating tumor DNA-based (ctDNA) NGS platform offers an acceptable alternative, but its clinical utility and pickup rate for oncogenic drivers remain unknown. Methods: In our multi-national cohort of advanced CCA across 5 countries, we explored the utility of Lucence LiquidHALLMARK (LHM), a Medicare-reimbursed, amplicon-based NGS ctDNA platform targeting 80 cancer related genes, 10 fusions, and MSI. Performance of LHM has been previously reported. Data was retrieved in-house by a de-identified centralized database and pooled for analysis. Here, we report the demographic and genomic findings of our cohort and highlight the impact of testing on actionable molecular alteration discovery. Results: Between Jan 2020 and Dec 2023, 60 samples from 56 patients (62.5% male) with advanced CCA in Hong Kong SAR (50.0%), Singapore (41.1%), Thailand (3.6%), Philippines (3.6%), and Malaysia (1.8%) underwent LHM testing. Metastatic disease accounted for 83.9% and 8.9% had locally advanced disease. Median age was 67 years (range 33-88), with 34% and 30% of tests obtained during first-line therapy and at diagnosis respectively. Only 6 cases had available tissue NGS results. Analysis on 56 baseline samples showed an 80.4% discovery rate (45/56 patients) for ≥1 molecular alterations. A median of 2 variants (mean 3.27) was detected per sample, with variant allele fraction ranging from 0.05% to 66.5%. Importantly, 8.9% (5/56) of patients harbored ≥1 actionable variants, including 3 with FGFR2 rearrangements ( FGFR2- WAC, FGFR2- ACTR1A, FGFR2- CAMK2D) and 2 with BRAF V600E drivers. A further 3 patients had potentially druggable variants in IDH2 and FGFR3 and 12 harbored BRCA1/2 variants, of which 4 were deleterious. None of the samples had MSI. Top 10 mutated genes were TP53 (48%), KRAS (21%), BRCA2 (18%), PIK3CA (11%), TERT (9%), CDKN2A (9%), SMAD4 (9%), FGFR2 (7%), BRAF (7%), and CDK6 (5%). Limited histopathological and treatment outcomes are available in the current dataset. Conclusions: Our advanced cholangiocarcinoma cohort of 56 patients from 5 Asian countries showed that an amplicon based ctDNA liquid biopsy platform overcomes the tissue-related challenges of genomic profiling specific to unresectable biliary tumors. We showed an 80.4% discovery rate for any molecular alterations and a 8.9% pickup rate for variants with strong actionability.

Case-controlled field study of the ICD-11 clinical descriptions and diagnostic requirements for Bodily Distress Disorders

AimsMental disorders characterized by preoccupation with distressing bodily symptoms and associated functional impairment have been a target of major reconceptualization in the ICD-11, in which a single category of Bodily Distress Disorder (BDD) with different levels of severity replaces most of the Somatoform Disorders in ICD-10. This study compared the accuracy of clinicians' diagnosis of disorders of somatic symptoms using either the ICD-11 or ICD-10 diagnostic guidelines in an online study. MethodsClinically active members of the World Health Organization's Global Clinical Practice Network (N = 1065) participating in English, Spanish, or Japanese were randomly assigned to apply ICD-11 or ICD-10 diagnostic guidelines to one of nine pairs of standardized case vignettes. The accuracy of the clinicians' diagnoses as well as their ratings of the guidelines' clinical utility were assessed. ResultsOverall, clinicians were more accurate using ICD-11 compared to ICD-10 for every presentation of a vignette characterized primarily by bodily symptoms associated with distress and impairment. Clinicians who made a diagnosis of BDD using ICD-11 were generally correct in applying the severity specifiers for the condition. LimitationsThis sample may represent some self-selection bias and thus may not generalize to all clinicians. Additionally, diagnostic decisions with live patients may lead to different results. ConclusionsThe ICD-11 diagnostic guidelines for BDD represent an improvement over those for Somatoform Disorders in ICD-10 in regard to clinicians' diagnostic accuracy and perceived clinical utility.

The Clinical Utility of the Adolescent and Young Adult Psycho-Oncology Screening Tool (AYA-POST): Perspectives of AYA Cancer Patients and Healthcare Professionals.

ObjectiveRoutine psychosocial screening and assessment of people diagnosed with cancer are crucial to the timely detection of distress and provision of tailored supportive care; however, appropriate screening tools have been lacking for adolescents and young adults (AYAs), who have unique needs and experiences. One exception is the recently validated AYA Psycho-Oncology Screening Tool (AYA-POST) for use with young people aged 15–29 years, which comprises a distress thermometer and age-specific needs assessment. This study investigates the clinical utility of this measure, as well as the subsequent service responsiveness within the Australian Youth Cancer Services.MethodIn total, 118 AYAs and 29 healthcare professionals: (HCPs) completed surveys about the clinical utility of the AYA-POST; a subset of 30 AYAs completed a 3-month follow-up survey assessing service responsiveness. Descriptive statistics (frequencies/means) were computed for all items, with chi-square analyses used to explore whether perceived clinical utility varied with AYA age, AYA sex, HCP discipline or HCP length of time using the AYA-POST.ResultsParticipants’ responses demonstrate high levels of satisfaction with the tool, evidencing its appropriateness, practicability and acceptability. Moreover, the AYA-POST was reported to facilitate communication about psychosocial needs and prompt referrals, indicating good service responsiveness. Ratings of clinical utility did not differ significantly between AYA and HCP groups.ConclusionThis study demonstrates that the AYA-POST is an appropriate tool in the psychosocial screening of AYAs with cancer, facilitating the identification of distress and unique concerns in this population and valuable in triaging and tailoring care for young cancer patients.

Delivering Remote Measurement-Based Care in Community Addiction Treatment: Engagement and Usability Over a 6-Month Clinical Pilot.

ObjectiveMeasurement-based care (MBC) is an evidence-based practice in which patients routinely complete standardized measures throughout treatment to help monitor clinical progress and inform clinical decision-making. Despite its potential benefits, MBC is rarely used in community-based substance use disorder (SUD) treatment. In this pilot study, we evaluated the feasibility of incorporating a digital and remotely delivered MBC system into SUD treatment within a community setting by characterizing patients’ and clinicians’ engagement with and usability ratings toward the MBC system that was piloted.MethodsA pilot study was conducted with 30 patients receiving SUD treatment and eight clinicians providing SUD treatment in a large, publicly funded addiction and mental health treatment clinic. Services as usual within the clinic included individual psychotherapy, case management, group therapy, peer support, and medication management for mental health and SUD, including buprenorphine. Patients who enrolled in the pilot continued to receive services as usual and were automatically sent links to complete a 22-item questionnaire, called the weekly check-in, via text message or email weekly for 24 weeks. Results of the weekly check-in were summarized on a clinician-facing web-based dashboard. Engagement was characterized by calculating the mean number of weekly check-ins completed by patients and the mean number times clinicians logged into the MBC system. Ratings of the MBC system’s usability and clinical utility were provided by patients and clinicians.ResultsPatient participants (53.3% male, 56.7% white, 90% Medicaid enrolled) completed a mean of 20.60 weekly check-ins (i.e., 85.8% of the 24 expected per patient). All but one participating clinician with a patient enrolled in the study logged into the clinician-facing dashboard at least once, with an average of 12.20 logins per clinician. Patient and clinician ratings of usability and clinical utility were favorable: most patients agreed with statements that the weekly check-in was easy to navigate and aided self-reflection. All clinicians who completed usability questionnaires agreed with statements indicating that the dashboard was easy to navigate and that it provided meaningful information for SUD treatment.ConclusionsA digital and remotely delivered MBC system can yield high rates of patient and clinician engagement and high ratings of usability and clinical utility when added into SUD treatment as usual. The success of this clinical pilot may be attributable, in part, to the user-centered design processes that were used to develop and refine the MBC system that was piloted. Future efforts may focus on strategies to test whether MBC can be sustainably implemented and offers clinical benefits to patients in community SUD treatment settings.

An international field study of the ICD-11 behavioural indicators for disorders of intellectual development.

The World Health Organization (WHO) has approved the 11th Revision of the International Classification of Diseases (ICD-11). A version of the ICD-11 for Mental, Behavioural and Neurodevelopmental Disorders for use in clinical settings, called the Clinical Descriptions and Diagnostic Requirements (CDDR), has also been developed. The CDDR includes behavioural indicators (BIs) for assessing the severity of disorders of intellectual development (DID) as part of the section on neurodevelopmental disorders. Reliable and valid diagnostic assessment measures are needed to improve identification and treatment of individuals with DID. Although appropriately normed, standardised intellectual and adaptive behaviour assessments are considered the optimal assessment approach in this area, they are unavailable in many parts of the world. This field study tested the BIs internationally to assess the inter-rater reliability, concurrent validity, and clinical utility of the BIs for the assessment of DID. This international study recruited a total of 206 children and adolescents (5-18years old) with a suspected or established diagnosis of DID from four sites across three countries [Sri-Lanka (n=57), Italy (n=60) and two sites in India (n=89)]. Two clinicians assessed each participant using the BIs with one conducting the clinical interview and the other observing. Diagnostic formulations using the BIs and clinical utility ratings were collected and entered independently after each assessment. At a follow-up appointment, standardised measures (Leiter-3, Vineland Adaptive Behaviour Scales-II) were used to assess intellectual and adaptive abilities. The BIs had excellent inter-rater reliability (intra-class correlations ranging from 0.91 to 0.97) and good to excellent concurrent validity (intra-class correlations ranging from 0.66 to 0.82) across sites. Compared to standardised measures, the BIs had more diagnostic overlap between intellectual and adaptive functioning. The BIs were rated as quick and easy to use and applicable across severities; clear and understandable with adequate to too much level of detail and specificity to describe DID; and useful for treatment selection, prognosis assessments, communication with other health care professionals, and education efforts. The inclusion of newly developed BIs within the CDDR for ICD-11 Neurodevelopmental Disorders must be supported by information on their reliability, validity, and clinical utility prior to their widespread adoption for international use. BIs were found to have excellent inter-rater reliability, good to excellent concurrent validity, and good clinical utility. This supports use of the BIs within the ICD-11 CDDR to assist with the accurate identification of individuals with DID, particularly in settings where specialised services are unavailable.

Clinical outcomes of temocillin use for invasive Enterobacterales infections: a single-centre retrospective analysis.

BackgroundWith increasing frequency of resistant Gram-negative bacteria, temocillin has potential utility in reducing carbapenem use. The 2020 EUCAST guideline changes temocillin breakpoints and reclassifies isolates with an MIC of 0.001–16 mg/L as ‘susceptible, increased exposure’ necessitating 6 g/day rather than the previous 4 g/day, associated with significant cost implications.ObjectivesWe explore the clinical utility and treatment failure rate of temocillin at 4 g/day dosing.MethodsAll adult inpatient electronic prescriptions of temocillin (3 days or greater) from March 2016 to October 2019 were retrieved using a clinical decision support system (ICNET®). Treatment success was defined as survival, no switch to broad-spectrum agent for the same indication and no subsequent recrudescence of infection, occurring within 30 days.ResultsTemocillin was used in 205 eligible patient-episodes, median age 79 years (IQR : 71–87 years), 42.4% female. Median temocillin course length was 5.9 days (IQR : 4.6–7.8 days). Indications for use: urinary tract infection (UTI) (n = 141), pneumonia (n = 53), other (n = 11). In total, 144 (70.2%) patients had targeted treatment; 74 (36.1%) against Escherichia coli, 70 (34.4%) other Enterobacterales. A total of 130 (63%) patients received 4 g/day; the remaining patients had reduced renal function with dosing in accordance with guidance. Overall temocillin treatment success was 79.5%; highest when used to treat UTI 85.8% (versus 67.9% in respiratory infections, P = 0.008). Empirical treatment demonstrated 82.0% (50/61) success [versus 78.5% (113/144) among targeted treatment, P = 0. 71].ConclusionsTemocillin at 4 g/day is an effective and safe alternative in treating patients with Gram-negative infections, but should be considered in the context of patient age and comorbidities. Increased dosing or alternate strategies may be indicated when the infection is not of a urinary source.

Evaluation of the International Classification of Diseases-11 chronic pain classification: study protocol for an ecological implementation field study in low-, middle-, and high-income countries.

The purpose of the present ecological implementation field study is to evaluate the new classification of chronic pain as implemented in the 11th revision of the International Classification of Diseases (ICD-11) with regard to clinical utility and interrater reliability. To evaluate the classification in a variety of settings, the study will be implemented in different low-, middle-, and high-income countries. The study will be conducted in 2 phases. Participating pain clinics of the first phase are located in India, Cuba, and New Zealand. Two or more clinicians per study center will use the ICD-11 classification of chronic pain to diagnose 75 to 100 consecutive new chronic pain patients per center. A structured classification algorithm will guide the diagnostic process. Interrater reliability will be analyzed for the first 20 consecutive new patients per center. Before the coding, a training workshop will introduce the clinicians to the new classification. The main outcome parameter of the ecological implementation field study is clinical utility. More specifically, this entails clinical utility ratings, interrater reliability, as well as the exhaustiveness of the classification and the mutual exclusiveness of the new chronic pain categories. Differences between countries with different cultural backgrounds and income levels will be analyzed. The ecological implementation field study presented here will be implemented in several countries with different income levels. This increases the generalizability of the results and allows initial insight into the global applicability of the new chronic pain classification. A positive evaluation can facilitate the implementation of the classification.

A brief psychometric and clinimetric evaluation of self-report burden and mental health measures completed by care partners of people with Parkinson's-related dementia.

This report describes the evaluation of the psychometric and clinimetric properties of nine self-report measures completed by informal care partners of individuals with mild cognitive impairment or dementia in Parkinson's disease and dementia with Lewy bodies. One hundred thirty-six care partners completed measures on relationship satisfaction, burden, stress, mood, resilience, health, quality of life, and feelings related to care provision. Psychometric properties, such as internal consistency, convergent validity, floor and ceiling effects, completion rate and data missingness, as well as clinimetric properties, such as time to administer, ease of scoring, readability and availability of the scales, were examined. Additionally, the design of the measure development studies was assessed with the 2018 COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) Risk of Bias checklist. Participants were mostly married women (>85%) with a mean age of 69.4 years. The methodological quality of the design of all measure development studies was "inadequate." Five widely applied measures (Zarit Burden Interview, Hospital Anxiety and Depression Scale, Short Form 12 Health Survey, Relatives' Stress Scale, and EuroQoL-5D) and two less researched instruments (Brief Resilience Scale and Relationship Satisfaction Scale) had high internal consistency and completion rates, moderate to strong convergent validity, low missingness and floor effects, and excellent clinical utility ratings. Two scales (Dyadic Relationship Scale and Family Caregiving Role) received poor psychometric ratings, and their usage among informal care partners is not recommended. In conclusion, well-validated and widely used measures received strong psychometric and clinimetric ratings. Future studies are required to determine the most reliable, valid and robust caregiver-reported measures.

Anxiety and Fear-Related Disorders in the ICD-11: Results from a Global Case-controlled Field Study

This article reports the results of one of a series of global field studies implemented by the World Health Organization (WHO) to evaluate the accuracy, clinical utility, and global applicability of the new diagnostic guidelines for Mental, Behavioural and Neurological Disorders included in the next version of WHO's International Classification of Diseases (ICD-11). The purpose of this study was to compare the diagnostic accuracy and clinical utility ratings of global clinicians implementing the ICD-11 diagnostic guidelines for Anxiety and Fear-Related Disorders, relative to those applying ICD-10 guidelines. The study also aimed to identify elements of the guidelines that required further refinement or clarification. 1840 global mental health professionals registered with WHO's Global Clinical Practice Network completed the study in one of six study languages. Participants were randomly assigned to apply either the ICD-11 or ICD-10 guidelines to diagnose standardized case vignettes, and to rate the clinical utility of their assigned guidelines. ICD-11's diagnostic accuracy and clinical utility were equivalent or superior to that of ICD-10. Global clinicians were significantly more accurate in diagnosing Generalized Anxiety Disorder, Specific Phobia and adult cases of Separation Anxiety Disorder when using ICD-11 and provided high clinical utility ratings for these disorders. Clinicians also found the ICD-11 guidelines easy to use, clear, and a good fit to patients they see in their clinical practice. However, clinicians had difficulty with distinguishing the boundary between disorder and normality for subthreshold cases of anxiety, and also with applying the new ICD-11 guidelines on panic attacks. The new diagnostic guidelines for Anxiety Disorders in ICD-11 can be applied in an acceptably consistent manner by global clinicians and perform as well or better than the previous guidelines for ICD-10. Study findings also helped identify aspects of the ICD-11 guidelines that required refinement prior to their publication and areas that should be emphasized in training programs.

Clinical utility of categorical and dimensional perspectives on personality pathology: A meta-analytic review.

Increasing dissatisfaction with categorical personality disorder (PD) diagnoses has led to the development of dimensional PD frameworks, which have gained influence in recent years. Although most studies contrasting the dimensional and categorical frameworks focus on issues related to construct validity, there is a burgeoning literature evaluating the clinical utility of these two approaches, with studies typically contrasting clinicians' ratings of various dimensions of clinical utility in the 2 frameworks using case vignettes or actual patients. This study used meta-analytic techniques to synthesize extant findings in this area, integrating data from 11 studies (103 total effect sizes, N of raters = 2,033) wherein clinical utility ratings of categorical and dimensional PD frameworks were compared. Dimensional models in general, and the five-factor model in particular, received more positive clinical utility ratings than categorical PD models in the majority of clinical utility domains. Stronger results were obtained for ratings of actual patients than ratings derived from case vignettes. Implications of these findings for the conceptualization and diagnosis of personality pathology are discussed, and suggestions for future research in this area are offered. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

The classification of feeding and eating disorders in the ICD-11: results of a field study comparing proposed ICD-11 guidelines with existing ICD-10 guidelines

BackgroundThe World Health Organization (WHO) International Classification of Diseases and Related Health Problems (ICD) is used globally by 194 WHO member nations. It is used for assigning clinical diagnoses, providing the framework for reporting public health data, and to inform the organization and reimbursement of health services. Guided by overarching principles of increasing clinical utility and global applicability, the 11th revision of the ICD proposes major changes that incorporate empirical advances since the previous revision in 1992. To test recommended changes in the Mental, Behavioral, and Neurodevelopmental Disorders chapter, multiple vignette-based case-controlled field studies have been conducted which examine clinicians’ ability to accurately and consistently use the new guidelines and assess their overall clinical utility. This manuscript reports on the results from the study of the proposed ICD-11 guidelines for feeding and eating disorders (FEDs).MethodParticipants were 2288 mental health professionals registered with WHO’s Global Clinical Practice Network. The study was conducted in Chinese, English, French, Japanese, and Spanish. Clinicians were randomly assigned to apply either the ICD-11 or ICD-10 diagnostic guidelines for FEDs to a pair of case vignettes designed to test specific clinical questions. Clinicians selected the diagnosis they thought was correct for each vignette, evaluated the presence of each essential feature of the selected diagnosis, and the clinical utility of the diagnostic guidelines.ResultsThe proposed ICD-11 diagnostic guidelines significantly improved accuracy for all FEDs tested relative to ICD-10 and attained higher clinical utility ratings; similar results were obtained across all five languages. The inclusion of binge eating disorder and avoidant-restrictive food intake disorder reduced the use of residual diagnoses. Areas needing further refinement were identified.ConclusionsThe proposed ICD-11 diagnostic guidelines consistently outperformed ICD-10 in distinguishing cases of eating disorders and showed global applicability and appropriate clinical utility. These results suggest that the proposed ICD-11 guidelines for FEDs will help increase accuracy of public health data, improve clinical diagnosis, and enhance health service organization and provision. This is the first time in the revision of the ICD that data from large-scale, empirical research examining proposed guidelines is completed in time to inform the final diagnostic guidelines.

It's not that Difficult: An Interrater Reliability Study of the DSM–5 Section III Alternative Model for Personality Disorders

ABSTRACTThe Diagnostic and Statistical Manual of Mental Disorders (5th ed. [DSM–5]; American Psychiatric Association, 2013) Section III Alternative Model for Personality Disorders (AMPD) represents a novel approach to the diagnosis of personality disorder (PD). In this model, PD diagnosis requires evaluation of level of impairment in personality functioning (Criterion A) and characterization by pathological traits (Criterion B). Questions about clinical utility, complexity, and difficulty in learning and using the AMPD have been expressed in recent scholarly literature. We examined the learnability, interrater reliability, and clinical utility of the AMPD using a vignette methodology and graduate student raters. Results showed that student clinicians can learn Criterion A of the AMPD to a high level of interrater reliability and agreement with expert ratings. Interrater reliability of the 25 trait facets of the AMPD varied but showed overall acceptable levels of agreement. Examination of severity indexes of PD impairment showed the level of personality functioning (LPF) added information beyond that of global assessment of functioning (GAF). Clinical utility ratings were generally strong. The satisfactory interrater reliability of components of the AMPD indicates the model, including the LPF, is very learnable.

Contrast-enhanced intra-operative ultrasound as a clinical decision making tool during surgery for colorectal liver metastases: The ULIIS study.

422 Background: In the era of parenchymal sparing surgery, detecting more colorectal liver metastases (CRLM) is essential to optimize the treatment. We evaluated the added-value of contrast enhanced intraoperative ultrasound (CE-IOUS) with a prospective design. Methods: We used an optimal 2-stage Simon’s design for this two-center study open for patients with operable CRLMs. Primary objective was the justified clinical utility of contrast-enhanced IOUS. Secondary objectives included detection rate of CRLMs, characterization rate of focal liver lesions, specific toxicity and detection of missing CRLMs. Results: Among the 58 eligible patients, 54 were eligible and assessable. Of these 54 patients, 36 were men (66.7%), median age was 63.6 years (range, 37-81), and 43 patients underwent pre-operative chemotherapy. The median number of CRLMs was 2 (range, 1-11). Pre-operative staging was performed using MRI in all 58 eligible patients, CT scan in 41 (70%) and PET-scan in 21 (36%). Compared to pre-operative staging, IOUS allowed identification of 40 new CRLMs in 11 (20.4%) patients. Furthermore, compared to IOUS, CE-IOUS allowed identification of 9 additional CRLMs in 8 (14.8%) patients. The correct detection rate based on pathological exams was 0.94. No additional missing CRLM was diagnosed. The surgical procedure was altered in 5 (9.26%) patients but was justified only in 4 patients (one lesion was ablated without previous biopsy), leading to a clinical utility rate of 7.70% (95 CI, [3.2, 18.6]). There was no specific toxicity reported. Conclusions: Despite the primary endpoint not met for one protocol violation,the Uliis study demonstrates an added-value for CE-IOUS for surgeons treating CRLMs, especially for advanced cases pre-treated by chemotherapy. Clinical trial information: NCT01880554.

Clinicians' Judgments of the Clinical Utility of Personality Disorder Trait Descriptions.

Proposed for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) was a five-domain, 25-dimensional trait model that would have constituted a significant part of the diagnostic criteria for each personality disorder. A primary concern with respect to the proposal was that clinicians might find such an approach to be unacceptable. This study provides results from three independent data collections that compared clinicians' clinical utility ratings for each iteration of the DSM-5 dimensional trait assignments, along with an alternative list of traits derived from the Five Factor Form (FFF). The clinicians considered the final trait assignments that were posted for the avoidant, narcissistic, obsessive-compulsive, and schizoid personality disorders to be significantly less acceptable than the original assignments. They also considered the FFF trait assignments to be preferable to the DSM-5 final postings with respect to the avoidant, narcissistic, obsessive-compulsive, dependent, and histrionic personality disorders. The implications of these results for future editions of the diagnostic manual are discussed.

The Validity and Clinical Utility of the COVERS Scale and Pain Assessment Tool for Assessing Pain in Neonates Admitted to an Intensive Care Unit.

Infants admitted to a neonatal intensive care unit (NICU) are routinely subject to a range of painful procedures. However, pain assessments in NICUs are under-utilized due to a lack of a gold standard pain measure. In this study we assessed the psychometric properties and clinical utility of the COVERS and Pain Assessment Tool (PAT), in a neonatal unit. We had 72 nurses use the scales to assess pain at baseline and during a heel-lance procedure in 80 NICU infants. An independent research observer and the infant's mother also completed pain ratings. After the study, we assessed nurse preference and clinical utility ratings for both scales. The COVERS had satisfactory internal consistency at baseline (Cronbach α=0.74) and heel lance (α=0.78), as did the PAT (baseline α=0.79, heel lance α=0.85). Intraclass correlation coefficients demonstrated good inter-rater reliability at baseline and heel lance, respectively, for both the COVERS (0.82 and 0.80) and the PAT (0.83 and 0.86). There were strong associations between total scores on the 2 scales at baseline (r=0.81, P<0.001) and heel lance (r=0.91, P<0.001), between researcher's ratings and total COVERS (ρ=0.75, P<0.001) and PAT scores (ρ=0.69, P<0.001), and between maternal ratings and total COVERS (r=0.74, P<0.05) and PAT scores (r=0.65, P<0.05). Both scales were sensitive to pain and nonpain events. Reliability and validity was mostly upheld across gestational age. Most nurses preferred the COVERS (52%) to the PAT (16%), and 32% had no preference. This study builds on evidence for the COVERS scale and the PAT; both scales were reliable and valid measures of acute pain in neonates as premature as 24-week gestational age.

S.01.03 Neurobiology of adult separation anxiety disorder

This article reports the results of one of a series of global field studies implemented by the World Health Organization (WHO) to evaluate the accuracy, clinical utility, and global applicability of the new diagnostic guidelines for Mental, Behavioural and Neurological Disorders included in the next version of WHO's International Classification of Diseases (ICD-11).The purpose of this study was to compare the diagnostic accuracy and clinical utility ratings of global clinicians implementing the ICD-11 diagnostic guidelines for Anxiety and Fear-Related Disorders, relative to those applying ICD-10 guidelines. The study also aimed to identify elements of the guidelines that required further refinement or clarification.1840 global mental health professionals registered with WHO's Global Clinical Practice Network completed the study in one of six study languages. Participants were randomly assigned to apply either the ICD-11 or ICD-10 guidelines to diagnose standardized case vignettes, and to rate the clinical utility of their assigned guidelines.ICD-11's diagnostic accuracy and clinical utility were equivalent or superior to that of ICD-10. Global clinicians were significantly more accurate in diagnosing Generalized Anxiety Disorder, Specific Phobia and adult cases of Separation Anxiety Disorder when using ICD-11 and provided high clinical utility ratings for these disorders. Clinicians also found the ICD-11 guidelines easy to use, clear, and a good fit to patients they see in their clinical practice. However, clinicians had difficulty with distinguishing the boundary between disorder and normality for subthreshold cases of anxiety, and also with applying the new ICD-11 guidelines on panic attacks.The new diagnostic guidelines for Anxiety Disorders in ICD-11 can be applied in an acceptably consistent manner by global clinicians and perform as well or better than the previous guidelines for ICD-10. Study findings also helped identify aspects of the ICD-11 guidelines that required refinement prior to their publication and areas that should be emphasized in training programs.

A Prototype Approach to Personality Disorder Diagnosis

Objective Virtually no research has tested alternatives to the diagnostic method used since DSM-III, which requires decisions about the presence/absence of individual diagnostic criteria, followed by counting symptoms and applying cutoffs (the count/cutoff method). This study tested an alternative, prototype matching procedure designed to simplify diagnosis. The procedure was applied to personality disorders. Method A random national sample of psychiatrists and clinical psychologists (N=291) described a randomly selected patient in their care. Clinician-provided diagnostic data were used to generate categorical and dimensional DSM-IV diagnoses (number of symptoms present per disorder). Clinicians also used one of two prototype matching systems to provide a diagnosis for the selected patient. Results Prototype diagnosis led to reduced comorbidity relative to DSM-IV diagnosis, yielded similar estimates of validity in predicting criterion variables (adaptive functioning, treatment response, and etiology), and outperformed DSM-IV diagnosis in ratings of clinical utility and ease of use. Adding a personality health prototype further increased prediction. Conclusions A simple prototype matching procedure provides a viable alternative for improving diagnosis of personality disorders in clinical practice. Prototype diagnosis has multiple advantages, including ease of use, minimization of artifactual comorbidity, compatibility with naturally occurring cognitive processes, and ready translation into both categorical and dimensional diagnosis. (Reprinted with permission from The American Journal of Psychiatry 2006; 163:846–856)

Can Personality Disorder Experts RecognizeDSM-IVPersonality Disorders From Five-Factor Model Descriptions of Patient Cases?

Dimensional models of personality are under consideration for integration into the next Diagnostic and Statistical Manual of Mental Disorders (DSM-5), but the clinical utility of such models is unclear. To test the ability of clinical researchers who specialize in personality disorders to diagnose personality disorders using dimensional assessments and to compare those researchers' ratings of clinical utility for a dimensional system versus for the DSM-IV. A sample of 73 researchers who had each published at least 3 (median = 15) articles on personality disorders participated between December 2008 and January 2009. The Five-Factor Model (FFM), one of the most-studied dimensional models to date, was compared to the DSM-IV. Participants provided diagnoses for case profiles in DSM-IV and FFM formats and then rated the DSM-IV and FFM on 6 aspects of clinical utility. Overall, participants had difficulty identifying correct diagnoses from FFM profiles (t₇₂ = 12.36, P < .01), and the same held true for a subset reporting equal familiarity with the DSM-IV and FFM (t₂₃ = 6.96, P < .01). Participants rated the FFM as less clinically useful than the DSM for making prognoses, devising treatment plans, and communicating with professionals (all t₆₉ > 2.19, all P < .05), but more useful for communicating with patients (t₆₉ = 3.03, P < .01). The results suggest that personality disorder expertise and familiarity with the FFM are insufficient to correctly diagnose personality disorders using FFM profiles. Because of ambiguity inherent in FFM profile descriptors, this insufficiency may prove unlikely to be attenuated with increased clinical familiarity with the FFM.

Dimensions of Personality: Clinicians' Perspectives

To obtain the opinions and preferences of practising clinicians about the clinical utility of personality scales included within 8 alternative dimensional models of personality disorder for inclusion within an official diagnostic nomenclature. Psychiatrists (n = 226) and psychologists (n = 164) from 2 continents provided clinical utility ratings on personality scales organized from 8 alternative dimensional models of personality disorder. The psychiatrists and the psychologists supported the inclusion of most of the scales from all 8 of the models that were compared. Normal personality traits were endorsed, although abnormal personality traits generally received higher levels of endorsement. The list of endorsed traits was reduced further by organizing the scales into groups based on redundancy within each of 5 broad domains and then selecting within each group the scale that received the highest rating. This list appears to represent each domain in a manner that is comprehensive both in its coverage of the respective domain, as well as in representing particular strengths of each of the alternative dimensional models, at least for the stated preferences of psychiatrists and psychologists.