The European Organisation for Research and Treatment of Cancer Quality of Life Utility-Core 10 Dimensions: Development and Investigation of General Population Utility Norms for Canada, France, Germany, Italy, Poland, and the United Kingdom.

OBJECTIVES: The European Organisation for Research and Treatment of Cancer Quality of Life Utility-Core 10 Dimensions (EORTC QLU-C10D) is a cancer-specific preference-based measure, providing health utilities for use in economic evaluations derived from the widely used health-related quality of life measure, EORTC QLQ-C30. Several EORTC QLU-C10D country-specific value sets are available. This article aimed to provide EORTC QLU-C10D general population utility norms for Canada, France, Germany, Italy, Poland, and the United Kingdom, to aid interpretability of obtained utilities in these countries. METHODS: Data were collected in aforementioned countries via a quota-sampled, cross-sectional online survey (n = 100/age-sex group; N = approximately 1000/country). Participants were asked to complete the EORTC QLQ-C30 and provide sociodemographic data. Country-specific utility norms were calculated using the respective country tariff on the country's EORTC QLQ-C30 data after weighting to achieve population representativeness for age and sex. Norm values are provided as means (SDs) by country, age, and sex groups. Tukey's multiple comparison test investigated mean differences among countries. The impact of country, age, and sex on utility values was investigated with a multiple linear regression model. RESULTS: Country-specific mean utilities range from 0.724 (United Kingdom) to 0.843 (Italy). Country-, sex-, and age-specific mean utilities range from 0.664 for 30- to 39-year-old male Canadians to 0.899 for > 70-year-old male Italians. Utilities were lower in females in 4 of 6 countries, and the impact of age differed among countries. Independent of the impact of age and sex, between-country differences were found (P ≤ .05). CONCLUSION: Results showed a varying impact of age and sex on EORTC QLU-C10D utilities and significant between-country differences. Using national utility norms and utility decrements is recommended.

Construct validity of the Mini-TQ-15 for a rapid and differentiated assessment of tinnitus-related distress.

OBJECTIVE: Different domains of tinnitus-related distress can be assessed by self-report questionnaires, such as the original 52-item version of the Tinnitus Questionnaire (TQ). Short forms of the TQ allow a more rapid assessment. For this purpose, a new 15-item short form (Mini-TQ-15) has been previously developed. In the present retrospective cohort study, we aimed to compare construct validity of the Mini-TQ-15 and the original TQ. METHODS: Data of 7112 patients with chronic tinnitus that filled out the German 52-item version of the TQ at the Tinnitus Center at Charité University Hospital Berlin, Germany were retrospectively analyzed. 1409 of the 7112 patients completed additional psychological tests (ADS-L, BSF, PHQ, ACSA, SWOP) before starting therapy. Data of these 1409 patients with higher tinnitus distress on average were included in the present study. We compared convergent and discriminant validity of the TQ and the Mini-TQ-15 by calculating Spearman's rank correlation between their different factors and the results of further self-report questionnaires. RESULTS: The factor emotional and cognitive distress of the original TQ and of the Mini-TQ-15 showed specific high correlations with depression scales (correlation coefficients between 0.50 and 0.60) and considerably lower correlations with the other scales. CONCLUSION: Results of the present study indicate good convergent and discriminant validity of the Mini-TQ-15 and of the original TQ. The three factorial Mini-TQ-15 represents a promising short version with good construct validity for a rapid and differentiated assessment of tinnitus-related distress.

[Assessment of Patient-reported Outcomes in Routine Medical Care: Patient-reported Outcome Measures (PROMs) and Patient-reported Experience Measures (PREMs)]. / Empirische Erfassung patient*innenberichteter Merkmale: PROMs und PREMs.

Information from patients about their own quality of life, experiences in care, and individual assessments of treatment processes and outcomes are becoming increasingly important. Patient-reported characteristics can refer to subjective information about their own health (Patient-Reported Outcome Measures [PROMs]) or to objective information about their experience during the treatment process (Patient-Reported Experience Measures [PREMs]). This article provides an overview of the similarities and differences between PROMs and PREMs. Subsequently, ways to collect PROMs and PREMs are presented and in doing so, an insight into probabilistic testing theory (item response theory) and computer adaptive testing is given. Using national and international initiatives as examples, the implementation of PROMs and PREMs in health care systems is presented and future implementation strategies are discussed within an outlook.

Towards a unification of treatments and interventions for tinnitus patients: The EU research and innovation action UNITI.

Tinnitus is the perception of a phantom sound and the patient's reaction to it. Although much progress has been made, tinnitus remains a scientific and clinical enigma of high prevalence and high economic burden, with an estimated prevalence of 10%-20% among the adult population. The EU is funding a new collaborative project entitled "Unification of Treatments and Interventions for Tinnitus Patients" (UNITI, grant no. 848261) under its Horizon 2020 framework. The main goal of the UNITI project is to set the ground for a predictive computational model based on existing and longitudinal data attempting to address the question of which treatment or combination of treatments is optimal for a specific patient group based on certain parameters. Clinical, epidemiological, genetic and audiological data, including signals reflecting ear-brain communication, as well as patients' medical history, will be analyzed making use of existing databases. Predictive factors for different patient groups will be extracted and their prognostic relevance validated through a Randomized Clinical Trial (RCT) in which different patient groups will undergo a combination of tinnitus therapies targeting both auditory and central nervous systems. From a scientific point of view, the UNITI project can be summarized into the following research goals: (1) Analysis of existing data: Results of existing clinical studies will be analyzed to identify subgroups of patients with specific treatment responses and to identify systematic differences between the patient groups at the participating clinical centers. (2) Genetic and blood biomarker analysis: High throughput Whole Exome Sequencing (WES) will be performed in well-characterized chronic tinnitus cases, together with Proximity Extension Assays (PEA) for the identification of blood biomarkers for tinnitus. (3) RCT: A total of 500 patients will be recruited at five clinical centers across Europe comparing single treatments against combinational treatments. The four main treatments are Cognitive Behavioral Therapy (CBT), hearing aids, sound stimulation, and structured counseling. The consortium will also make use of e/m-health applications for the treatment and assessment of tinnitus. (4) Decision Support System: An innovative Decision Support System will be implemented, integrating all available parameters (epidemiological, clinical, audiometry, genetics, socioeconomic and medical history) to suggest specific examinations and the optimal intervention strategy based on the collected data. (5) Financial estimation analysis: A cost-effectiveness analysis for the respective interventions will be calculated to investigate the economic effects of the interventions based on quality-adjusted life years. In this paper, we will present the UNITI project, the scientific questions that it aims to address, the research consortium, and the organizational structure.

Accuracy of diagnostic classification and clinical utility assessment of ICD-11 compared to ICD-10 in 10 mental disorders: findings from a web-based field study.

In this web-based field study, we compared the diagnostic accuracy and clinical utility of 10 selected mental disorders between the ICD-11 Clinical Descriptions and Diagnostic Guidelines (CDDG) and the ICD-10 CDDG using vignettes in a sample of 928 health professionals from all WHO regions. On average, the ICD-11 CDDG displayed significantly higher diagnostic accuracy (71.9% for ICD-11, 53.2% for ICD-10), higher ease of use, better goodness of fit, higher clarity, and lower time required for diagnosis compared to the ICD-10 CDDG. The advantages of the ICD-11 CDDG were largely limited to new diagnoses in ICD-11. After limiting analyses to diagnoses existing in ICD-11 and ICD-10, the ICD-11 CDDG were only superior in ease of use. The ICD-11 CDDG were not inferior in diagnostic accuracy or clinical utility compared to the ICD-10 CDDG for any of the vignettes. Diagnostic accuracy was consistent across WHO regions and independent of participants' clinical experience. There were no differences between medical doctors and psychologists in diagnostic accuracy, but members of other health professions had greater difficulties in determining correct diagnoses based on the ICD-11 CDDG. In sum, there were no differences in diagnostic accuracy for diagnoses existing in ICD-10 and ICD-11, but the introduction of new diagnoses in ICD-11 has improved the diagnostic classification of some clinical presentations. The favourable clinical utility ratings of the ICD-11 CDDG give reason to expect a positive evaluation by health professionals in the implementation phase of ICD-11. Yet, training in ICD-11 is needed to further enhance the diagnostic accuracy.

Health economic evaluation of a web-based intervention for depression: the EVIDENT-trial, a randomized controlled study.

BACKGROUND: Depression often remains undiagnosed or treated inadequately. Web-based interventions for depression may improve accessibility of treatment and reduce disease-related costs. This study aimed to examine the potential of the web-based cognitive behavioral intervention "deprexis" in reducing disease-related costs. METHODS: Participants with mild to moderate depressive symptoms were recruited and randomized to either a 12-week web-based intervention (deprexis) in addition to care as usual (intervention group) or care as usual (control group). Outcome measures were health-related resource use, use of medication and incapacity to work as well as relating direct health care costs. Outcomes were assessed on patients' self-report at baseline, three months and six months. RESULTS: A total of 1013 participants were randomized. In both groups total direct health care costs decreased during the study period, but changes from baseline did not significantly differ between study groups. Numeric differences between study groups existed in outpatient treatment costs. They could be attributed to differences in changes of costs for psychotherapeutic treatment from baseline. Whereas costs for psychotherapeutic treatment decreased in the intervention group, costs increased in the control group (- 16.8% (€80) vs. + 14.7% (€60)) (tdf = 685 = 2.57; p = 0.008). CONCLUSION: The study indicates the health economic potential of innovative e-mental-health programs. There is evidence to suggest that the use of deprexis over a period of 12 weeks leads to a decrease in outpatient treatment cost, especially in those related to different types of psychotherapeutic treatment.

[Empirical Assessment of Patient-Reported Outcomes and Exemplary Introduction to Health-Related Quality of Life]. / Empirische Erfassung subjektiver Gesundheitsmerkmale am Beispiel der gesundheitsbezogenen Lebensqualität.

Health-related quality of life (HRQoL) acquires increased importance as a target parameter for different stakeholders in healthcare, e. g. to assess treatment outcome in chronically ill patients. In this educational article, we explain the levels of the health-related quality of life construct and associated main dimensions including physical, mental and social health. State-of-the-art approaches for assessment of patient-reported outcomes (PROs) are introduced on the basis of the HRQoL model. Furthermore, modern test-theoretical approaches and their applications are presented, which are aimed at standardizing and improving the assessment of PROs (e. g., computer-adaptive testing). Finally, we present 2 major international PRO initiatives (PROMIS® and EORTC Quality of Life Group) that have been influential in advancing the assessment of patient outcomes over the last few years.

Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group.

PURPOSE: National initiatives, such as the UK Improving Access to Psychological Therapies program (IAPT), demonstrate the feasibility of conducting empirical mental health assessments on a large scale, and similar initiatives exist in other countries. However, there is a lack of international consensus on which outcome domains are most salient to monitor treatment progress and how they should be measured. The aim of this project was to propose (1) an essential set of outcome domains relevant across countries and cultures, (2) a set of easily accessible patient-reported instruments, and (3) a psychometric approach to make scores from different instruments comparable. METHODS: Twenty-four experts, including ten health outcomes researchers, ten clinical experts from all continents, two patient advocates, and two ICHOM coordinators worked for seven months in a consensus building exercise to develop recommendations based on existing evidence using a structured consensus-driven modified Delphi technique. RESULTS: The group proposes to combine an assessment of potential outcome predictors at baseline (47 items: demographics, functional, clinical status, etc.), with repeated assessments of disease-specific symptoms during the treatment process (19 items: symptoms, side effects, etc.), and a comprehensive annual assessment of broader treatment outcomes (45 items: remission, absenteeism, etc.). Further, it is suggested reporting disease-specific symptoms for depression and anxiety on a standardized metric to increase comparability with other legacy instruments. All recommended instruments are provided online ( www.ichom.org ). CONCLUSION: An international standard of health outcomes assessment has the potential to improve clinical decision making, enhance health care for the benefit of patients, and facilitate scientific knowledge.

German translation, cultural adaptation, and validation of the Health Literacy Questionnaire (HLQ).

The Health Literacy Questionnaire (HLQ), developed in Australia in 2012 using a 'validity-driven' approach, has been rapidly adopted and is being applied in many countries and languages. It is a multidimensional measure comprising nine distinct domains that may be used for surveys, needs assessment, evaluation and outcomes assessment as well as for informing service improvement and the development of interventions. The aim of this paper is to describe the German translation of the HLQ and to present the results of the validation of the culturally adapted version. The HLQ comprises 44 items, which were translated and culturally adapted to the German context. This study uses data collected from a sample of 1,058 persons with chronic conditions. Statistical analyses include descriptive and confirmatory factor analyses. In one-factor congeneric models, all scales demonstrated good fit after few model adjustments. In a single, highly restrictive nine-factor model (no cross-loadings, no correlated errors) replication of the original English-language version was achieved with fit indices and psychometric properties similar to the original HLQ. Reliability for all scales was excellent, with a Cronbach's Alpha of at least 0.77. High to very high correlations between some HLQ factors were observed, suggesting that higher order factors may be present. Our rigorous development and validation protocol, as well as strict adaptation processes, have generated a remarkable reproduction of the HLQ in German. The results of this validation provide evidence that the HLQ is robust and can be recommended for use in German-speaking populations. TRIAL REGISTRATION: German Clinical Trial Registration (DRKS): DRKS00000584. Registered 23 March 2011.

Impact of Multiple Factors on the Degree of Tinnitus Distress.

OBJECTIVE: The primary cause of subjective tinnitus is a dysfunction of the auditory system; however, the degree of distress tinnitus causes depends largely on the psychological status of the patient. Our goal was to attempt to associate the grade of tinnitus-related distress with the psychological distress, physical, or psychological discomfort patients experienced, as well as potentially relevant social parameters, through a simultaneous analysis of these factors. METHODS: We determined the level of tinnitus-related distress in 531 tinnitus patients using the German version of the tinnitus questionnaire (TQ). In addition, we used the Perceived Stress Questionnaire (PSQ); General Depression Scale Allgemeine Depression Skala (ADS), Berlin Mood Questionnaire (BSF); somatic symptoms inventory (BI), and SF-8 health survey as well as general information collected through a medical history. RESULTS: The TQ score significantly correlated with a score obtained using PSQ, ADS, BSF, BI, and SF-8 alongside psychosocial factors such as age, gender, and marital status. The level of hearing loss and the auditory properties of the specific tinnitus combined with perceived stress and the degree of depressive mood and somatic discomfort of a patient were identified as medium-strong predictors of chronic tinnitus. Social factors such as gender, age, or marital status also had an impact on the degree of tinnitus distress. The results that were obtained were implemented in a specific cortical distress network model. CONCLUSIONS: Using a large representative sample of patients with chronic tinnitus permitted a simultaneous statistical measurement of psychometric and audiological parameters in predicting tinnitus distress. We demonstrate that single factors can be distinguished in a manner that explains their causative association and influence on the induction of tinnitus-related distress.

[Review Model for the Assessment of Psychometric Instruments--Recommendations of the German College of Psychosomatic Medicine (DKPM)]. / Kriterienkatalog zur Beurteilung psychodiagnostischer Selbstbeurteilungsinstrumente--Empfehlung des Deutschen Kollegiums für Psychosomatische Medizin (DKPM).

OBJECTIVES: Psychometric instruments are commonly applied in psychotherapeutic research and care for the baseline assessment of symptoms, the planning of therapeutic interventions, the assessment of the longitudinal course of symptoms and outcomes of therapeutic interventions as well as quality management of care. Psychometric properties as well as economic aspects should be considered in the selection of specific instruments. It is assumed that users of psychometric instruments face a great variety of instruments and related information. For that reason, it seems challenging to absorb the current knowledge and to integrate it into clinical practice and research. Thus, it is likely that well-known, established and easily accessible instruments are commonly used, while new developed instruments might not be disseminated in research and healthcare. METHODS: Based on available international review models, the working group "Psychometrics and Psychodiagnostics" of the German College of Psychosomatic Medicine (DKPM) has developed and tested a review model specifically tailored for psychotherapeutic research and care. RESULTS: The different steps of development, as well as the final review model based on the consensus of the working group are presented. The review model contains 6 generic terms (reliability, validity, objectivity, reference groups and aspects of application) with 21 different criteria to be assessed with 0-3 asterisks (*). The criteria are clearly operationalized and the practical use of the review model is explained and discussed. CONCLUSIONS: With the review model for the assessment of psychometric instruments a well-defined evaluation system is made available for research and clinical practice which has been developed by an expert group. The review model facilitates systematic, transparent and comparative evaluation of psychometric instruments along clearly defined criteria. It also supports the selection of psychometric instruments in research and care. Next, the working group aims at disseminating and implementing the review model as well as the application and publication of reviews for different psychometric instruments based on the review model.

Assessment of patient-reported symptoms of anxiety.

Patient self-reported symptoms are of crucial importance to identify anxiety disorders, as well as to monitor their treatment in clinical practice and research. Thus, for evidence-based medicine, a precise, reliable, and valid (ie, "objective") assessment of the patient's reported "subjective" symptoms is warranted. There is a plethora of instruments available, which can provide psychometrically sound assessments of anxiety, but there are several limitations of current tools that need to be carefully considered for their successful use. Nevertheless, the empirical assessment of mental health status is not as accepted in medicine as is the assessment of biomarkers. One reason for this may be that different instruments assessing the same psychological construct use different scales. In this paper we present some new developments that promise to provide one common metric for the assessment of anxiety, to facilitate the general acceptance of mental health assessments in the future.

Los síntomas auto-informados por el paciente son de crucial importancía para identificar los trastornos de ansiedad, como también para monitorizar su tratamiento en la práctica clínica y en investigación. Por lo tanto, para la medícina basada en la evidencía está justificada la evaluación precisa, confiable y válida (es decir, "objetiva") de los síntomas "subjetivos" percibidos por el paciente. Existe una gran cantidad de instrumentos disponibles que pueden proporcionar evaluaciones psícométricas fidedignas de la ansiedad, pero hay algunas limitaciones de las herramientas actuales que necesitan ser consideradas con cuidado para un empleo exitoso. Sin embargo, en medicina, la evaluación empírica del estado de salud mental no es tan aceptada como ocurre con los biomarcadores. Una razón para esto puede ser que los diferentes instrumentos que evalúan el mismo constructo psicológico utilizan distintas escalas. En este artículo se presentan algunos nuevos desarrollos que prometen proporcionar una métrica común para la evaluación de la ansiedad, y así facilitar a futuro la aceptación general de las evaluaciones en salud mental.

Les symptômes rapportés par les patients sont très importants pour identifier les troubles anxieux et surveiller leur traitement en recherche et en pratique cliniques. Une évaluation précise, fiable et valable (c'est-à-dire « objective ¼) des symptômes « subjectifs ¼ rapportés par le patient est donc justifiée pour la médecine basée sur les preuves. Les instruments disponibles sont très nombreux, capables d'évaluer l'anxiété de façon psychométrique mais certaines limites d'outils actuels méritent d'être soigneusement analysées pour une utilisation fructueuse. L'évaluation empirique de l'état de santé mentale n'est néanmoins pas aussi bien acceptée en médecine que l'évaluation des biomarqueurs, ce qui peut s'expliquer par l'utilisation d'instruments différents pour évaluer la même construction psychologique à l'aide d'échelles différentes. Nous présentons dans cet article de nouvelles avancées promettant la conception d'une mesure commune d'évaluation de l'anxiété afin de faciliter à l'avenir l'acceptation générale de l'évaluation de la santé mentale.

Item response theory, computerized adaptive testing, and PROMIS: assessment of physical function.

OBJECTIVE: Patient-reported outcome (PRO) questionnaires record health information directly from research participants because observers may not accurately represent the patient perspective. Patient-reported Outcomes Measurement Information System (PROMIS) is a US National Institutes of Health cooperative group charged with bringing PRO to a new level of precision and standardization across diseases by item development and use of item response theory (IRT). METHODS: With IRT methods, improved items are calibrated on an underlying concept to form an item bank for a "domain" such as physical function (PF). The most informative items can be combined to construct efficient "instruments" such as 10-item or 20-item PF static forms. Each item is calibrated on the basis of the probability that a given person will respond at a given level, and the ability of the item to discriminate people from one another. Tailored forms may cover any desired level of the domain being measured. Computerized adaptive testing (CAT) selects the best items to sharpen the estimate of a person's functional ability, based on prior responses to earlier questions. PROMIS item banks have been improved with experience from several thousand items, and are calibrated on over 21,000 respondents. RESULTS: In areas tested to date, PROMIS PF instruments are superior or equal to Health Assessment Questionnaire and Medical Outcome Study Short Form-36 Survey legacy instruments in clarity, translatability, patient importance, reliability, and sensitivity to change. CONCLUSION: Precise measures, such as PROMIS, efficiently incorporate patient self-report of health into research, potentially reducing research cost by lowering sample size requirements. The advent of routine IRT applications has the potential to transform PRO measurement.

Development and evaluation of a crosswalk between the SF-36 physical functioning scale and Health Assessment Questionnaire disability index in rheumatoid arthritis.

BACKGROUND: The SF-36 physical functioning scale (PF-10) and the Health Assessment Questionnaire disability index (HAQ-DI) are the most frequently used instruments for measuring self-reported physical function in rheumatoid arthritis (RA). The objective of this study was to develop a crosswalk between scores on the PF-10 and HAQ-DI in RA. METHODS: Item response theory (IRT) methods were used to co-calibrate both scales using data from 1791 RA patients. The appropriateness of a Rasch-based crosswalk was evaluated by comparing it with crosswalks based on a two-parameter and a multi-dimensional IRT model. The accuracy of the final crosswalk was cross-validated using baseline (n = 532) and 6-month follow-up (n = 276) data from an independent cohort of early RA patients. RESULTS: The PF-10 and HAQ-DI adequately fit a unidimensional Rasch model. Both scales measured a wide range of functioning, although the HAQ-DI tended to better target lower levels of functioning. The Rasch-based crosswalk performed similarly to crosswalks based on the two-parameter and multidimensional IRT models. Agreement between predicted and observed scale scores in the cross-validation sample was acceptable for group-level comparisons. The longitudinal validity in discriminating between disease response states was similar between observed and predicted scores. CONCLUSION: The crosswalk developed in this study allows for converting scores from one scale to the other and can be used for group-level analyses in patients with RA.

Short and precise patient self-assessment of heart failure symptoms using a computerized adaptive test.

BACKGROUND: Assessment of dyspnea, fatigue, and physical disability is fundamental to the monitoring of patients with heart failure (HF). A plethora of patient-reported measures exist, but most are too burdensome or imprecise to be useful in clinical practice. New techniques used for computer adaptive tests (CATs) may be able to address these problems. The purpose of this study was to build a CAT for patients with HF. METHODS AND RESULTS: Item banks of 74 queries ("items") were developed to assess self-reported physical disability, fatigue, and dyspnea. All queries were administered to 658 adults with HF to build 3 item banks. The resulting HF-CAT was administered to 100 patients with ancillary HF (New York Heart Association I, 11%; II, 53%; III and IV, 36%). In addition, the physical function and vitality domains of the SF-36 Health Survey questionnaire, an established shortness-of-breath scale, and the Minnesota Living with Heart Failure Questionnaire were applied. The HF-CAT assessment took 3:09±1:52 minutes to complete and score. All HF-CAT scales demonstrated good construct validity through high correlations with the corresponding SF-36 Health Survey physical function (r=-0.87), vitality (r=-0.85), and shortness-of-breath (r=0.84) scales. Simulation studies showed a more precise measurement of all HF-CAT scales over a larger range than comparable static tools. The HF-CAT scales identified significant differences between patients classified by the New York Heart Association symptom criteria, similar to the Minnesota Living with Heart Failure Questionnaire. CONCLUSIONS: A new CAT for patients with HF was built using modern psychometric methods. Initial results demonstrate its potential to increase the feasibility and precision of patient self-assessments of symptoms of HF with minimized respondent burden. CLINICAL TRIAL REGISTRATION- URL: http://www.projectreporter.nih.gov. Unique identifier: 1R43HL083622-01.

The PROMIS of better outcome assessment: responsiveness, floor and ceiling effects, and Internet administration.

OBJECTIVE: Use of item response theory (IRT) and, subsequently, computerized adaptive testing (CAT), under the umbrella of the NIH-PROMIS initiative (National Institutes of Health-Patient-Reported Outcomes Measurement Information System), to bring strong new assets to the development of more sensitive, more widely applicable, and more efficiently administered patient-reported outcome (PRO) instruments. We present data on current progress in 3 crucial areas: floor and ceiling effects, responsiveness to change, and interactive computer-based administration over the Internet. METHODS: We examined nearly 1000 patients with rheumatoid arthritis and related diseases in a series of studies including a one-year longitudinal examination of detection of change; compared responsiveness of the Legacy SF-36 and HAQ-DI instruments with IRT-based instruments; performed a randomized head-to-head trial of 4 modes of item administration; and simulated the effect of lack of floor and ceiling items upon statistical power and sample sizes. RESULTS: IRT-based PROMIS instruments are more sensitive to change, resulting in the potential to reduce sample size requirements substantially by up to a factor of 4. The modes of administration tested did not differ from each other in any instance by more than one-tenth of a standard deviation. Floor and ceiling effects greatly reduce the number of available subjects, particularly at the ceiling. CONCLUSION: Failure to adequately address floor and ceiling effects, which determine the range of an instrument, can result in suboptimal assessment of many patients. Improved items, improved instruments, and computer-based administration improve PRO assessment and represent a fundamental advance in clinical outcomes research.

Trauma exposure and posttraumatic stress disorder in primary care patients: cross-sectional criterion standard study.

OBJECTIVE: Posttraumatic stress disorder (PTSD) is one of the most common but least recognized anxiety disorders in primary care. This study aimed to describe the association of PTSD and trauma exposure with somatic symptoms, psychiatric comorbidity, functional impairment, and the actual treatment of PTSD in primary care. METHOD: This cross-sectional criterion standard study included 965 consecutive primary care patients from 15 civilian primary care clinics in the United States. The Structured Clinical Interview for DSM-IV (SCID) was used to establish diagnosis of PTSD and other anxiety disorders. Somatic symptoms, depression, and anxiety were measured with the Patient Health Questionnaire (PHQ), and functional impairment was measured with the Medical Outcomes Study Short-Form General Health Survey (SF-20). The study was conducted from November 2004 to June 2005. RESULTS: PTSD was diagnosed in 83 patients (8.6%; 95% CI, 7.0%-10.5%), and trauma exposure without fulfilling DSM-IV criteria for PTSD was reported by 169 patients (17.5%; 15.2%-20.0%). With odds ratios ranging between 2.1 (95% CI, 1.2-3.6) for headache and 9.7 (3.8-24.8) for chest pain, PTSD patients had markedly elevated somatic symptom rates compared to the reference group of patients with no PTSD or trauma exposure. PTSD was significantly associated with elevated rates of psychiatric comorbidity, pain, and impaired functioning. Patients reporting trauma but no PTSD had rates of somatic symptoms, psychiatric comorbidity, and functional impairment that were intermediate between PTSD and reference group patients. Adjusting for depression substantially attenuated the association of PTSD and trauma with somatic symptoms, suggesting that depression may be an important mediator of the PTSD-somatic symptoms relationship. CONCLUSIONS: The high frequency of PTSD in primary care and its association with psychiatric comorbidity and functional impairment underscore the need to better detect and treat PTSD in primary care. Recognizing the frequent somatic presentation of PTSD and appreciating the salience of comorbid depression may be especially important in optimizing PTSD care.

Better assessment of physical function: item improvement is neglected but essential.

INTRODUCTION: Physical function is a key component of patient-reported outcome (PRO) assessment in rheumatology. Modern psychometric methods, such as Item Response Theory (IRT) and Computerized Adaptive Testing, can materially improve measurement precision at the item level. We present the qualitative and quantitative item-evaluation process for developing the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function item bank. METHODS: The process was stepwise: we searched extensively to identify extant Physical Function items and then classified and selectively reduced the item pool. We evaluated retained items for content, clarity, relevance and comprehension, reading level, and translation ease by experts and patient surveys, focus groups, and cognitive interviews. We then assessed items by using classic test theory and IRT, used confirmatory factor analyses to estimate item parameters, and graded response modeling for parameter estimation. We retained the 20 Legacy (original) Health Assessment Questionnaire Disability Index (HAQ-DI) and the 10 SF-36's PF-10 items for comparison. Subjects were from rheumatoid arthritis, osteoarthritis, and healthy aging cohorts (n = 1,100) and a national Internet sample of 21,133 subjects. RESULTS: We identified 1,860 items. After qualitative and quantitative evaluation, 124 newly developed PROMIS items composed the PROMIS item bank, which included revised Legacy items with good fit that met IRT model assumptions. Results showed that the clearest and best-understood items were simple, in the present tense, and straightforward. Basic tasks (like dressing) were more relevant and important versus complex ones (like dancing). Revised HAQ-DI and PF-10 items with five response options had higher item-information content than did comparable original Legacy items with fewer response options. IRT analyses showed that the Physical Function domain satisfied general criteria for unidimensionality with one-, two-, three-, and four-factor models having comparable model fits. Correlations between factors in the test data sets were > 0.90. CONCLUSIONS: Item improvement must underlie attempts to improve outcome assessment. The clear, personally important and relevant, ability-framed items in the PROMIS Physical Function item bank perform well in PRO assessment. They will benefit from further study and application in a wider variety of rheumatic diseases in diverse clinical groups, including those at the extremes of physical functioning, and in different administration modes.

Evaluation of a computer-adaptive test for the assessment of depression (D-CAT) in clinical application.

In the past, a German Computerized Adaptive Test, based on Item Response Theory (IRT), was developed for purposes of assessing the construct depression [Computer-adaptive test for depression (D-CAT)]. This study aims at testing the feasibility and validity of the real computer-adaptive application.The D-CAT, supplied by a bank of 64 items, was administered on personal digital assistants (PDAs) to 423 consecutive patients suffering from psychosomatic and other medical conditions (78 with depression). Items were adaptively administered until a predetermined reliability (r > or = 0.90) was attained. For validation purposes, the Hospital Anxiety and Depression Scale (HADS), the Centre for Epidemiological Studies Depression (CES-D) scale, and the Beck Depression Inventory (BDI) were administered. Another sample of 114 patients was evaluated using standardized diagnostic interviews [Composite International Diagnostic Interview (CIDI)].The D-CAT was quickly completed (mean 74 seconds), well accepted by the patients and reliable after an average administration of only six items. In 95% of the cases, 10 items or less were needed for a reliable score estimate. Correlations between the D-CAT and the HADS, CES-D, and BDI ranged between r = 0.68 and r = 0.77. The D-CAT distinguished between diagnostic groups as well as established questionnaires do.The D-CAT proved an efficient, well accepted and reliable tool. Discriminative power was comparable to other depression measures, whereby the CAT is shorter and more precise. Item usage raises questions of balancing the item selection for content in the future.