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A survey of validated automated home blood pressure monitors available for the Internet shopper.

OBJECTIVE: Self-measurement of blood pressure using an automated home blood pressure monitoring (AHBPM) is increasingly used in hypertension management. Internet commerce increases dramatically each year. This study looked to identify the availability of validity of AHBPM and the correct cuff size to go with the AHBPM. METHODS AND RESULTS: Using the search engine 'Google.com', the author identified 124 consecutive unique sites offering at least one AHBPM. Validated AHBPM were those devices that had published studies showing that they had passed a recognized validation protocol. Each site was evaluated for all forms of sphygmomanometer, number of AHBPM, manual blood pressure devices, all cuff sizes available, additional cost of large adult cuff, number of validated AHBPM offered, and whether the site mentioned device validation. Of the 124 sites, 109 (81%) offered arm AHBPM and 66 (53%) offered one or more (range, 1-11) validated AHBPM. Only six of the 66 (9%) offering a validated AHBPM mentioned that fact; 58 of the 109 (53%) sites offering arm AHBPM offered more than one size of cuff; and 46 of the 58 (80%) charged extra for a large adult cuff (average US dollars 23.75, range, US dollars 4.80-98). CONCLUSIONS: Validated AHBPMs are readily available on the Internet. Currently, these sites do little to aid the consumer in purchasing a validated AHBPM. Large adult cuffs, commonly needed by hypertensive patients, are not always available for purchase. Charging extra for large adult cuffs is a potential hindrance to consumers purchasing the correct cuff size for accurate blood pressure measurement and should be eliminated.

Blood Pressure Determination↗

Survey of wound, ostomy and continence (WOC) nurse clinicians on stomal and peristomal complications: a content validation study.

PURPOSE: Validated and reliable stomal and peristomal complication definitions and associated interventions are lacking. Available literature is either narrowly medically focused or only of case study level. The objectives of this study were to establish content validation data for the proposed stomal and peristomal complication definitions and their associated interventions, to obtain the data related to contact with stomal and peristomal complication patients, and to gain insight into the ostomy care process. METHODS: A researcher-designed survey was sent to 2900 expert Wound, Ostomy and Continence nurse clinicians via a national mailing to a representative nonrandomized sample of participants who identified that they included ostomy care in their professional practice. In total, 686 nurses returned the survey, a response rate of 24%. The purposive sample was asked to quantify the degree of validity of the survey's stated stomal and peristomal definitions and interventions. Hand-written qualitative comments of the participants were transcribed, analyzed, and themes were derived. RESULTS: On a scale of 1 to 4, the mean score for all definitions and interventions was 3.64 (SD=0.30). The overall survey's content validity index was .91. Ratings demonstrated high consensus validation on the stomal and peristomal definitions and interventions, with definitions scoring higher. The mean scores and the content validity index results on selected items were slightly lower for interventions, especially stomal interventions. Qualitative analysis of participants' comments about the whole instrument generated 10 themes and associated subthemes related to omitted complications and interventions and general observations about the ostomy care process and the validation research process. CONCLUSION: The proposed stomal and peristomal definitions and interventions were rated as generally valid. Further research documenting validation of participants' comments is necessary. Given the findings, additional complications and interventions not identified in the literature were noted and need to be further scrutinized and researched.

Adult↗

The Maine-Seattle back questionnaire: a 12-item disability questionnaire for evaluating patients with lumbar sciatica or stenosis: results of a derivation and validation cohort analysis.

STUDY DESIGN: Analysis of health-related quality of life data obtained from a prospective cohort study of patients with sciatica due to an intervertebral disc herniation or lumbar spinal stenosis. OBJECTIVE: To derive and validate a shortened version of a previously validated 23-item modification of the Roland-Morris Disability Questionnaire. SUMMARY OF BACKGROUND DATA: For patients with low back pain, improving health-related quality of life is often the main goal of therapy. The Roland-Morris Disability Questionnaire is one of the best validated and most frequently used back-specific functional status measures. A shortened version may permit more widespread use in clinical and research settings. METHODS: Data from 507 patients with sciatica enrolled in the Maine Lumbar Spine Study were used to derive a shortened version of a 23-item modification of the original Roland-Morris Disability Questionnaire using qualitative and cluster analysis techniques. The internal consistency, construct validity, reproducibility, and responsiveness in detecting change over a 3-month period for a new 12-item scale was compared to the original 23-item scale. The 12-item scale was then validated in an independent cohort of 148 patients with lumbar spinal stenosis. RESULTS: Internal consistency was very good but modestly lower for the 12-item instrument compared to the 23-item original scale. Reproducibility over a 3-month interval was good and did not differ between the 12-item and original scale. Findings from the validation cohort were similar or better than the derivation cohort. A high degree of construct validity with patient-reported symptoms was demonstrated for the 12-item and original scales. The responsiveness and interpretability of the 12-item scale over 3 months was excellent and comparable to the original scale. Responsiveness assessed in patients with lumbar spinal stenosis in the independent validation cohort showed consistent findings compared to patients with a disc herniation in the derivation cohort. CONCLUSIONS: This short, simple, self-administered 12-item back-specific functional status questionnaire performed extremely well in comparison with the original 23-item scale. If validated in additional study populations, this new questionnaire may be useful in the clinical setting as a way for providers to prospectively compare their outcomes of care to other patient populations, and to study treatment effectiveness.

Adult↗

Reliability and validity of adapted Turkish Version of Scoliosis Research Society-22 (SRS-22) questionnaire.

STUDY DESIGN: Outcome study to determine the internal consistency, and validity of adapted Turkish version of Scoliosis Research Society-22 (SRS-22) Instrument. OBJECTIVES: To evaluate the validity and reliability of adapted Turkish Version of SRS-22 questionnaire. SUMMARY OF BACKGROUND DATA: The SRS-22 questionnaire is a widely accepted questionnaire to assess the health-related quality of life for scoliotic patients in the United States. However, its adaptation in languages other than the source language is necessary for its multinational use. METHODS: Translation/retranslation of the English version of the SRS-22 was done, and all steps for cross-cultural adaptation process were performed properly by an expert committee. Later, SRS-22 questionnaires and previously validated Short Form-36 (SF-36) outcome instruments were mailed to 82 patients who had been surgically treated for idiopathic scoliosis. All patients had a minimum of 2 years follow-up. Fifty-four patients (66%) responded to the first set of questionnaires. Forty-seven of the first time respondents returned their second survey. The average age of the 47 patients (12 male, 35 female) was 19.8 years (range, 14-31 years). The two measures of reliability as internal consistency and reproducibility were determined by Cronbach alpha statistics and intraclass correlation coefficient, respectively. Concurrent validity was measured by comparing with an already validated questionnaire (SF-36). Measurement was made using the Pearson correlation coefficient (r). RESULTS: The study demonstrated satisfactory internal consistency with high Cronbach alpha values for the four of the corresponding domains (pain, 0.72; self-image, 0.80; mental health, 0.72; and satisfaction, 0.83). However, the Cronbach alpha value for function/activity domain (0.48) was considerably lower than the original questionnaire. The intraclass correlation coefficient for the same domains was 0.80, 0.82, 0.78, 0.81, and 0.76, respectively, demonstrating a satisfactory test/retest reproducibility. Considering concurrent validity, two domains had excellent correlation (r = 0.75-1), while 9 had good correlation (r = 0.50 to 0.75), and 6 had moderate correlation (r =0.25-0.50). Based on these results, question 18 in the function/activity domain with lower Cronbach alpha value was revised while question 15 was excluded. The revised SRS-22 was given to 30 adolescent idiopathic scoliosis patients not included in the index study. The revision could improve the Cronbach alpha value for function/activity domain from 0.48 to 0.81. CONCLUSION: This study demonstrated that, if measures are to be used across cultures, the items must not only be translated well linguistically but also must be culturally adapted to maintain the content validity of the instrument at a conceptual level across different cultures. This may necessitate several validation studies to ensure and improve consistency in the content and face validity between source and target versions of a questionnaire due to difficulty in detecting subtle differences in the living habits of different cultures.

Adolescent↗

Validity of single variables and composite indices for measuring disease activity in rheumatoid arthritis.

There is no agreement as to which variable best mirrors disease activity in rheumatoid arthritis (RA) and no studies have been performed on the validity of disease activity variables. In this study the validity of 10 commonly used single variables and three composite indices was tested. All patients participated in a large follow up study in two clinics. The patients (n = 233) had classical or definite RA and a disease duration of less than one year at entry. The mean follow up time was 30 months; the follow up frequency was once every four weeks; 6011 records were used in the analysis. The validation criteria included correlations with the other variables (correlational validity), with the physical disability (criterion validity I), and with the radiographically determined damage of hands and feet (construct validity). The judgment of a group of rheumatologists in clinical practice was also used as a model of criterion validity (II). In this comparison the disease activity score and Mallya index showed the best validity. The best single variable was the number of swollen joints. The validity of most single variables was poor and these variables were not suitable as single endpoint measures in clinical trials.

Arthritis, Rheumatoid↗

Development and validation of a patient based measure of outcome in ocular melanoma.

BACKGROUND: Patients with uveal melanoma can be treated by a number of modalities. As none of the different treatments offer a survival advantage, a key factor in choosing among treatments is their differential impact on patients' quality of life. A short, patient based questionnaire was developed and validated for evaluating outcomes following treatment for uveal melanoma. METHODS: The 21 item measure of outcome in ocular disease (MOOD) assesses the patient's view of outcome in terms of visual function and the impact of treatment. The reliability and validity of the three MOOD scores (total, vision, impact) were evaluated in 176 patients who had been treated for uveal melanoma (75 brachytherapy, 78 proton beam radiotherapy, 23 enucleation). Of these, 165 patients also completed the SF-36. RESULTS: All three MOOD scales met standard criteria for acceptability, reliability, and validity. The proportion of missing data was low, and responses to all items were well distributed across response categories. Internal consistency, assessed by Cronbach's alpha coefficients, exceeded the standard criterion of 0. 70 for all three summary scores. Item total correlations ranged from 0.22 to 0.77 (mean item total correlation 0.58), indicating good homogeneity. Test-retest correlations for all three summary scores exceeded 0.85. Scaling assumptions, assessed by item convergent and discriminant validity correlations, were met for the vision and impact scores. The MOOD showed good content validity, as assessed by review by ophthalmologists and patients. Construct validity was demonstrated by high intercorrelations between the vision and impact scores and the total scale; higher scores for patients who reported being very satisfied compared with those who were not very satisfied and for those who reported persistent red eye compared with those who did not have this complication (known group differences/hypothesis testing); moderate correlations between the MOOD and the SF-36 and visual acuity (convergent validity); and low correlations between the MOOD and age and sex (discriminant validity). CONCLUSIONS: The MOOD is a practical and scientifically sound patient based measure which can be used in research and audit to evaluate outcomes following treatment for uveal melanoma. It takes 5 minutes to complete and meets standard psychometric criteria for reliability and validity.

Activities of Daily Living↗

Biostatistical methods for the validation of alternative methods for in vitro toxicity testing.

Statistical methods for the validation of toxicological in vitro test assays are developed and applied. Validation is performed either in comparison with in vivo assays or in comparison with other in vitro assays of established validity. Biostatistical methods are presented which are of potential use and benefit for the validation of alternative methods for the risk assessment of chemicals, providing at least an equivalent level of protection through in vitro toxicity testing to that obtained through the use of current in vivo methods. Characteristic indices are developed and determined. Qualitative outcomes are characterised by the rates of false-positive and false-negative predictions, sensitivity and specificity, and predictive values. Quantitative outcomes are characterised by regression coefficients derived from predictive models. The receiver operating characteristics (ROC) technique, applicable when a continuum of cut-off values is considered, is discussed in detail, in relation to its use for statistical modelling and statistical inference. The methods presented are examined for their use for the proof of safety and for toxicity detection and testing. We emphasise that the final validation of toxicity testing is human toxicity, and that the in vivo test itself is only a predictor with an inherent uncertainty. Therefore, the validation of the in vitro test has to account for the vagueness and uncertainty of the "gold standard" in vivo test. We address model selection and model validation, and a four-step scheme is proposed for the conduct of validation studies. Gaps and research needs are formulated to improve the validation of alternative methods for in vitro toxicity testing.

Animal Testing Alternatives↗

The predictive validity of a diagnosis of schizophrenia. A report from the International Study of Schizophrenia (ISoS) coordinated by the World Health Organization and the Department of Psychiatry, University of Nottingham.

BACKGROUND: Outcome is important in the validation of psychiatric diagnosis, as most disorders lack clinicopathological correlates. We describe the predictive validity of four definitions of schizophrenia (DSM-III-R, ICD-10, ICD-9 and CATEGO S+), in a representative cohort of patients selected during their first episode of psychosis. METHOD: Each definition of schizophrenia was applied to 99 patients. Their respective ability to predict 13-year outcome (Global Assessment of Functioning scales) was assessed. RESULTS: DSM-III-R and ICD-10 diagnoses of schizophrenia have high predictive validity for long-term outcome, and both provide relatively stable diagnoses. ICD-9 is reasonably good at predicting disability, but not symptoms, and CATEGO S+ showed no predictive validity. Adding six-month duration criteria to ICD-10, ICD-9 and CATEGO S+ improved their predictive validity, and removing the six-month duration criterion from DSM-III-R commensurately reduced predictive validity. CONCLUSIONS: Modern diagnostic systems (DSM-III-R and ICD-10) have high predictive validity, and are superior to ICD-9. The six-month duration criterion of DSM-III-R schizophrenia accounts for its predictive validity and stability over 13 years, but restricts its use in first-episode studies. The one-month duration criterion of ICD-10 is less restrictive, without major compromises in predictive validity or stability.

Adolescent↗

Development and validation of the self-administration of medication tool.

BACKGROUND: Consumer participation in planning and implementing health care is actively encouraged as a means of improving patient outcomes. In assessing the ability of patients to self-medicate, health professionals can identify areas in which patients need assistance, education, and intervention to optimize their health outcomes after discharge. OBJECTIVE: To develop and validate a tool to quantify the ability of patients to administer their regularly scheduled medications while they are hospitalized. METHODS: Past research enabled us to develop the Self-Administration of Medication (SAM) tool. Using a Delphi technique of 3 rounds, a panel of expert health professionals established the content validity of the tool. For determining level of agreement in using the SAM tool, 56 patients were selected; for each patient, 2 randomly selected nurses completed an assessment. Construct validity and internal consistency were examined by testing the tool in 50 patients and comparing with other validated scales. RESULTS: The 29-item SAM tool had high content validity scores for clarity, representation, and comprehensiveness, with content validity index values ranging from 0.95-1.0. In testing the level of agreement between 2 nurses, out of 43 valid cases, 95.3% of nurses overwhelmingly agreed about the patients' competence to self-administer their drugs. The intraclass correlation coefficient was 0.819 (95% CI 0.666 to 0.902). Internal consistency for the SAM tool was high, with a Cronbach's alpha of 0.899. A moderate to strong correlation was obtained when comparing the SAM tool with other validated measures. CONCLUSIONS: The SAM tool is valid and reliable for quantifying patients' ability to manage their regularly scheduled medications in the hospital setting.

Adult↗

Validation of serological assays for diagnosis of infectious diseases.

Assay validation is a series of the following interrelated processes: an experimental process: reagents and protocols are optimised by experimentation to detect the analyte with accuracy and precision, and to ensure repeatability and reproducibility in the assay. a relative process: its diagnostic sensitivity and diagnostic specificity are calculated relative to test results obtained from reference animal populations of known infection/exposure status. a conditional process: classification of animals in the target population as infected or uninfected is conditional upon how well the reference animal population used to validate the assay represents the population to which the assay will be applied (accurate predictions of the infection status of animals from test results and predictive values of positive and negative test results are conditional upon the estimated prevalence of disease/infection in the target population) an incremental process: confidence in the validity of an assay increases over time when use confirms that it is robust as demonstrated by accurate and precise results (the assay may also achieve increasing levels of validity as it is upgraded and extended by adding reference populations of known infection status) a continuous process: the assay remains valid only insofar as the assay continues to provide accurate and precise results as proved through statistical verification. Therefore, validation of diagnostic assays for infectious diseases does not end with a time-limited series of experiments based on a few reference samples. Rather, it is a process that also requires constant vigilance and maintenance, along with reassessment of its performance characteristics for each population of animals to which it is applied. It is certain that the current movement to develop and implement accreditation criteria for veterinary diagnostic laboratories may be of little worth unless there is some assurance that the assays conducted in such laboratories are properly validated. Fully accredited laboratories may generate highly reproducible test results, but the results may still misclassify animals as to their infection status due to an improper assay validation process. Therefore, assay validation is foundational to the core product of veterinary diagnostic laboratories--test results and their interpretation.

Animals↗

[Evaluation of worry: validation of a French translation of the Penn State Worry Questionnaire].

UNLABELLED: Excessive worry, which is the central feature of Generalized Anxiety Disorder (GAD), is recognized as an important clinical phenomenon with many negative consequences on people's health. For example, studies report that excessive worry is associated with higher frequencies of work absenteeism and medical consultations, increased risk of other anxiety disorders, depression, heart disease, diabetes and cancer. It is thus imperative to develop effective measures to assess worry among adult. Until now, no measures were available in French for the practitioners and researchers to evaluate the tendency to engage in excessive and uncontrollable worry. One of the most frequently used questionnaires to assess worry in English is The Penn State Worry Questionnaire (PSWQ). This self-report measure has been widely studied and has shown excellent psychometric properties among the non-clinical and clinical populations. This manuscript presents the results of three studies evaluating the psychometric properties of a French Translation of the PSWQ, the Questionnaire sur les Inquiétudes de Penn State (QIPS). The first study includes the translation procedures used to create the French version of the questionnaire, the factorial structure, the internal consistency, the quality of the items, and the convergent validity among non-clinical participants. The second study examines the temporal stability, and the convergent and divergent validity of the questionnaire. Finally, the third study investigates the internal consistency, the quality of the items, and the convergent and divergent validity of the questionnaire among GAD patients. Study 1. This study describes the translation procedures used to create the QIPS, the factorial structure, the internal consistency, the quality of the items, and the convergent validity among non-clinical participants. The French version was translated by a group of clinical psychologists with the assistance of a professional translator and a linguist. A back translation procedure was also conducted. Finally, a pilot study confirmed the intelligibility of the questionnaire. French-speaking university students (N = 352) completed a battery of questionnaires during a lecture. The questionnaires were: The Questionnaires sur les Inquiétudes de Penn State, the Intolerance of Uncertainty Questionnaire, the Cognitive Avoidance Questionnaire, the Why Worry Questionnaire-Revised, and the Social Problem-Solving Inventory-Revised. The statistical analyses reveal that the QIPS shows an appropriate factorial structure, an excellent internal consistency and a very good convergent validity. This French Questionnaire thus seems to be suitable to assess the tendency to worry among the nonclinical population. Study 2. This second study examines the temporal stability, and the convergent and divergent validity of the QIPS. The sample includes 95 French-speaking University students who volunteered to complete the QIPS and the Beck anxiety Inventory. Two self-rating questions were also asked to evaluate the percentage of time spent worrying and to what extent does worrying causes a problem. Eighty-six students participated at the second administration of the questionnaires, four weeks later. The results indicate that the QIPS is very stable over time, thus supporting its temporal stability. Different correlations confirm its convergent and divergent validity. It is concluded that the QIPS is a suitable measure of worry in a non-clinical population. Study 3. This study investigates the internal consistency, the quality of the items, and the convergent and divergent validity of the questionnaire among GAD patients. Seventy-seven GAD patients, as defined by the Diagnostic and Statistical Manual of Mental disorders, fourth edition (DSM IV), participated in this study. They completed the QIPS, the Worry Domains Questionnaire, The Worry and Anxiety Questionnaire, the Intolerance of Uncertainty Questionnaire, the Beck Anxiety Inventory, the Beck Depression Inventory, and a daily diary of differents aspects of worry. The results reveal that the QIPS has an excellent internal consistency, a very good convergent and divergent validity. The QIPS thus seems to be suitable to assess the tendency to worry among GAD patients. CONCLUSION: The overall results presented in these studies confirm the excellent psychometric properties of the QIPS. This French questionnaire is a useful tool for clinicians and researchers to assess the tendency to worry among non-clinical and clinical populations.

Adult↗

Reliability and validity of measures from the Behavioral Risk Factor Surveillance System (BRFSS).

OBJECTIVES: To assess the reliability and validity of measures on the BRFSS, to assist users in evaluating the quality of BRFSS data, and to identify areas for further research. METHODS: Review and summary of reliability and validity studies of measures on the BRFSS and studies of measures that were the same or similar to those on the BRFSS from other surveys. RESULTS: Measures determined to be of high reliability and high validity were current smoker, blood pressure screening, height, weight, and BMI, and several demographic characteristics. Measures of both moderate reliability and validity included when last mammography was received, clinical breast exam, sedentary lifestyle, intense leisure-time physical activity, and fruit and vegetable consumption. Few measures were of low validity and only one measure was determined to be of low reliability. Several other measures were of high or moderate reliability or validity, but not both. The reliability or validity could not be determined for some measures, primarily due to lack of research. CONCLUSIONS: Most questions on the core BRFSS instrument were at least moderately reliable and valid, and many were highly reliable and valid. Additional research is needed for some measures.

Adult↗

Methods for defining equity-stratifying variables: a systematic review of validation studies.

BACKGROUND AND OBJECTIVE: Disease burden is often disproportionally higher among those who are socially disadvantaged by factors defined in the PROGRESS-Plus framework (ie, Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, and Social capital, with "Plus" covering features like age and disability). The accuracy and applicability of case definitions to identify these variables from administrative and clinical health data are unknown. We conducted a systematic review to explore how equity-stratifying variables, as categorized by the PROGRESS-Plus framework, have been defined and validated in epidemiologic studies using administrative health, population-level, or electronic health record (EHR) data. METHODS: Medline, EMBASE, CINAHL, Web of Science, and Google Scholar were searched from the inception of the databases to 2024 for validation studies of equity-stratifying variables in adults using administrative health datasets, health registries, or EHR data. Titles and abstracts, followed by relevant full-text articles, were screened in duplicate by two reviewers for eligibility. The data sources utilized, algorithms employed, and their associated performance measures were extracted and synthesized from included studies. Given substantial heterogeneity in study design, equity-stratifying variable definition, and performance metrics, meta-analysis was not possible. RESULTS: Of the 9099 unique citations screened, 188 full texts were reviewed and 116 were included in this review. Most studies were published between 2019 and 2024 (n = 64, 55%) and were validation studies of race/ethnicity definitions that used race/ethnicity codes or surname list algorithms (n = 66, 57%). No studies examined religion. Regarding the reported performance measure estimates, the race/ethnicity/culture/language equity-stratifying variables category had the largest variability across sensitivity, positive predictive value (PPV), and Cohen's Kappa. Occupation validation studies had the lowest variation in sensitivity and PPV. CONCLUSION: Despite an increasing number of publications reporting on the validation of equity-stratifying variables relevant to the PROGRESS-Plus framework, performance measures varied widely across studies. The significant heterogeneity in equity-stratifying variable definitions and methods used to validate them support the need for further rigorous validation of equity-stratifying variables in administrative and clinical health data. PLAIN LANGUAGE SUMMARY: Disease burden is often higher in people who experience financial hardships, lower level of education, discrimination due to race/ethnicity, and unstable housing. These social factors can be considered health equity factors and are important for understanding health inequalities. Health researchers often use large datasets, such as hospital or electronic health records (EHRs), to study these health equity factors. However, it is not clear how accurately these data sources capture information about people's social circumstances and how these factors are defined. In this study, we reviewed existing research to understand how health equity factors have been defined across health data sources and how accurate they are at measuring aspects of health equity and social disadvantage. Of the more than 9000 studies we identified, we included 116 that met our criteria for this systematic review. Most included studies focused on identifying race and ethnicity, often using codes or surname-based methods. We found that the accuracy of these methods varied widely across studies, meaning results may not always be reliable or comparable. Overall, our findings show that there are inconsistencies in how social factors are defined and measured in health data. This makes it difficult to fully understand and address health inequalities using routinely collected health data. More work is needed to develop and validate better quality and more consistent methods for capturing these important social factors.

Humans↗

Development and validation of the ITG Health-Related Quality-of-Life Short-Form measure for use in patients with coronary artery disease. Integrated Therapeutics Group.

BACKGROUND: Available coronary artery disease (CAD)-specific health-related quality-of-life (HRQL) measures are not ideally suited for routine clinical practice. We report development of a valid and reliable CAD-specific short-form measure. HYPOTHESIS: The Integrated Therapeutics Group (ITG) CAD-specific short-form HRQL measure is reliable and valid for assessing the health status of patients with CAD. METHODS: In all, 409 patients (mean age 62.4 years) completed the 24-item CAD-specific HRQL questionnaire. Factor analysis was used to identify the scaling of the 24 CAD-specific items. Analysis of variance was used to reduce the number of items within each scale, and reliability (Cronbach's alpha), discriminant validity, and ceiling and floor effects of short-form scales were evaluated. Short-form scales were compared with the longer scales using relative validity coefficients. The CAD severity was assessed using New York Heart Association criteria, physician assessment, electrocardiogram results, the number of myocardial infarctions, and the number of CAD-specific medications. Clinical validity of short-form scales was then assessed based on their ability to discriminate across severity levels of these clinical criteria. RESULTS: Four scales were identified: Extent of Chest Pain, Functioning and Well-Being, Activities Level-Physical, and Activities Level-Social. The 24-item questionnaire was reduced to a 13-item short form, with reliability exceeding 0.70 for all four scales. Relative validity estimates comparing short-form to original scales ranged from 0.68 to 2.58. Mean scores varied significantly (p < 0.05) by clinical severity, supporting the discriminant validity of the ITG CAD short-form scales. CONCLUSIONS: The ITG CAD short form (used alone or with a general HRQL measure) is valid and practical for assessing patients with CAD.

Aged↗

Analysis of location specific observer performance data: validated extensions of the jackknife free-response (JAFROC) method.

RATIONALE AND OBJECTIVES: The free-response paradigm is being increasingly used in the assessment of medical imaging systems. The currently implemented method of analyzing the data, namely jackknife free-response (JAFROC) analysis, has some validation and applicability limitations. The purpose of this work is to address these limitations. MATERIALS AND METHODS: The general principles of modality evaluation and methodology validation are reviewed. A model for simulating free-response data was used to test the statistical validity of several methods of analyzing the data. The methods differed only in the choice of the figure of merit used to quantify performance. Statistical validity was judged by investigating the behaviors of the methods under null hypothesis conditions of no difference between modalities. RESULTS: The validity of the different methods of analyzing the data was found to be dependent on the choice of figure of merit. A figure of merit is identified that accommodates abnormal images with multiple (one or more) lesions, detections of which could have different clinical significances (weights). This figure of merit is shown to be statistically valid. An extension of the analysis to single reader interpretations of images from different modalities is also shown to be statistically valid. CONCLUSION: With the validated enhancements, JAFROC is expected to be of greater utility to users of the free-response method. The extension to single-reader interpretations should be of particular value to developers of image processing algorithms, including developers of computer-aided diagnosis algorithms.

Algorithms↗

Validation of a beta-agonist long-term asthma control scale derived from computerized pharmacy data.

BACKGROUND: Asthma control has been defined clinically by using validated tools, but an asthma control scale using administrative data has not been reported. OBJECTIVE: We sought to validate a beta-agonist asthma control scale derived from administrative data. METHODS: Surveys that included validated asthma symptom and control tools were completed by a random sample of 2250 health maintenance organization members aged 18 to 56 years with persistent asthma. Linked computerized pharmacy data provided beta-agonist canister and oral corticosteroid dispensings. The proposed 4-level asthma control scale was based on the number of short-acting beta-agonist canisters dispensed in 12 months. Construct validity and predictive validity were assessed. RESULTS: For construct validity, factor analysis showed significant loading of the beta-agonist scale on the symptom control factor, and the beta-agonist scale was significantly related to the validated asthma control and symptom scales (r = 0.31, P < .0001). For predictive validity, each progressive level of the proposed beta-agonist control scale was associated with an increased risk of subsequent asthma hospitalizations or emergency department visits and oral corticosteroid use, independent of prior use. CONCLUSION: A scale based on the number of beta-agonists dispensed in a 1-year period and derived from administrative data reflects asthma symptom control over that period of time. This scale can help identify patients who are at risk for future acute asthma health care use. CLINICAL IMPLICATIONS: This information can be used in population management and by clinicians to assess long-term asthma control and identify patients who need intervention to prevent future morbidity.

Adolescent↗

Reliability and validity of the VSP-A, a health-related quality of life instrument for ill and healthy adolescents.

PURPOSE: To report the preliminary validation results of a generic self-administered measure for adolescents the VSP-A (Vecu et Sante Percue de l'Adolescent). METHODS: The validation survey of the 37-item VSP-A involved 1938 adolescents: 1758 adolescents attending school (90.7%) and 180 inpatient youths (9.3%) with medical, surgical, or psychiatric conditions; mean age was 14.8 years (SD = 2.1; range = 10-17) and 1018 (52.5%) were girls. Ten dimensions scores were computed: psychological well-being, body image, physical well-being, vitality, friends, parents, teachers, school performance, medical staff, and a global HRQL index. Construct validity was tested using inter-item correlations, item-dimension correlations, and principal component analysis. The unidimensionality of the scales was studied using Rasch rating scale model and the internal consistency of the scales using Cronbach alpha. Known group comparisons were performed and effect sizes computed to assess the clinical validity and sensitivity of the instrument. RESULTS: VSP-A, completed in less than 15 minutes, is consistent (Cronbach alpha = 0.74-0.91). Content and construct validity are good. Factorial validity, item-internal consistency, item-discriminant validity, and inter-dimension correlations support the item grouping in 10 dimensions. The results of the comparison of the VSP-A scores according to external criteria (sociodemographics, health status) show they are in accordance with the literature and previous works. CONCLUSIONS: These preliminary results support the reliability and validity of the VSP-A as a multidimensional adolescent report of HRQL in healthy and patient populations. The next phase of the research consists of testing the sensitivity to changes of the VSP-A.

Adolescent↗

Social anxiety and fear of negative evaluation: construct validity of the BFNE-II.

The Brief Fear of Negative Evaluation Scale [BFNE; Leary, M. R. (1983). A brief version of the Fear of Negative Evaluation Scale. Personality and Social Psychology Bulletin, 9, 371-375] is a self-report measure designed to assess fear of negative evaluation, a characteristic feature of social anxiety disorders [Rapee, R. M., & Heimberg, R. G. (1997). A cognitive-behavioral model of anxiety in social phobia. Behaviour Research and Therapy, 35, 741-756]. Recent psychometric assessments have suggested that a 2-factor model is most appropriate, with the first factor comprising the straightforwardly worded items and the second factor comprising the reverse-worded items [Carleton, R. N., McCreary, D., Norton, P. J., & Asmundson, G. J. G. (in press-a). The Brief Fear of Negative Evaluation Scale, Revised. Depression & Anxiety; Rodebaugh, T. L., Woods, C. M., Thissen, D. M., Heimberg, R. G., Chambless, D. L., & Rapee, R. M. (2004). More information from fewer questions: the factor structure and item properties of the original and brief fear of negative evaluation scale. Psychological Assessment, 2, 169-181; Weeks, J. W., Heimberg, R. G., Fresco, D. M., Hart, T. A., Turk, C. L., Schneier, F. R., et al. (2005). Empirical validation and psychometric evaluation of the Brief Fear of Negative Evaluation Scale in patients with social anxiety disorder. Psychological Assessment, 17, 179-190]. Some researchers recommend the reverse-worded items be removed from scoring [e.g., Rodebaugh, T. L., Woods, C. M., Thissen, D. M., Heimberg, R. G., Chambless, D. L., & Rapee, R. M. (2004). More information from fewer questions: the factor structure and item properties of the original and brief fear of negative evaluation scale. Psychological Assessment, 2, 169-181; Weeks, J. W., Heimberg, R. G., Fresco, D. M., Hart, T. A., Turk, C. L., Schneier, F. R., et al. (2005). Empirical validation and psychometric evaluation of the Brief Fear of Negative Evaluation Scale in patients with social anxiety disorder. Psychological Assessment, 17, 179-190]; however [Carleton, R. N., McCreary, D., Norton, P. J., & Asmundson, G. J. G. (in press-a). The Brief Fear of Negative Evaluation Scale, Revised. Depression & Anxiety; Collins, K. A., Westra, H. A., Dozois, D. J. A., & Stewart, S. H. (2005). The validity of the brief version of the fear of negative evaluation scale. Journal of Anxiety Disorders, 19, 345-359] recommend that these items be reworded to maintain scale sensitivity. The present study examined the reliability and validity of the BFNE-II, a version of the BFNE evaluating revisions of the reverse-worded items in a community sample. A unitary model of the BFNE-II resulted in excellent confirmatory factor analysis fit indices. Moderate convergent and discriminant validity were found when BFNE-II items were correlated with additional independent measures of social anxiety [i.e., Social Interaction Anxiety & Social Phobia Scales; Mattick, R. P., & Clarke, J. C. (1998). Development and validation of measures of social phobia scrutiny fear and social interaction anxiety. Behaviour Research and Therapy, 36, 455-470], and fear [i.e., Anxiety Sensitivity Index; Reiss, S., & McNally, R. J. (1985). The expectancy model of fear. In S. Reiss, R. R. Bootzin (Eds.), Theoretical issues in behaviour therapy (pp. 107--121). New York: Academic Press. and the Illness/Injury Sensitivity Index; Carleton, R. N., Park, I., & Asmundson, G. J. G. (in press-b). The Illness/Injury Sensitivity Index: an examination of construct validity. Depression & Anxiety). These findings support the utility of the revised items and the validity of the BFNE-II as a measure of the fear of negative evaluation. Implications and future research directions are discussed.

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