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Rigorous statistical reliability, validity, and responsiveness testing of the Cincinnati knee rating system in 350 subjects with uninjured, injured, or anterior cruciate ligament-reconstructed knees.

Although many instruments are used to assess outcome after knee ligament reconstruction, their reliability, validity, and responsiveness have not been adequately proven. Our purpose was to assess these statistical measures in a commonly used instrument, the Cincinnati Knee Rating System. Reliability was determined from the responses of 100 subjects who completed the instrument twice, a mean of 7 days apart. Validity and responsiveness were assessed from 250 patients observed for at least 2 years after autogenous ACL reconstruction. Questionnaire items included symptoms, functional limitations with sports and daily activities, patient perception of the knee condition, and sports- and occupational-activity levels. The items demonstrated high test-retest reliability, supporting their use in evaluating groups of patients between two different treatment periods (all intraclass correlation coefficients > 0.70). In addition, the questionnaire demonstrated good content validity, construct validity, and item-discriminant validity. For the overall rating score, no "floor effects" (worst score possible) were found before or after surgery. No "ceiling effects" (best score possible) were found before surgery, and, at follow-up, these effects were calculated in only 22 patients (9%). The questions were found to be highly responsive to detecting changes between evaluations. The data demonstrated that this rating system has acceptable reliability, validity, and responsiveness for use in outcome studies after knee ligament reconstruction.

Adolescent↗

Validation plots in antenatal screening for Down's syndrome.

OBJECTIVE: To validate empirically the accuracy of antenatal Down's syndrome screening using the Integrated test, to compare this with other screening tests (including the Integrated test with the addition of cross trimester [CT] marker ratios) and to suggest how such validation analyses should be presented and interpreted. METHODS: Using data from 7809 unaffected and 27 Down's syndrome pregnancies that had had an Integrated test, risk estimates for various screening tests (maternal age, Double, Triple, Quadruple, Combined, Integrated and serum Integrated tests) that use Integrated test markers were categorized according to quintile categories of risk estimates of the 27 affected pregnancies. For each screening test, the median risk estimate for each category was plotted against the observed prevalence within each category. Such validation plots were also produced for the Integrated test with CT marker ratios by measuring the level of the serum markers in the trimester of pregnancy not already measured in stored samples of all affected and a one-in-five sample of unaffected pregnancies. The robustness of the method was assessed by repeating the analysis for the Integrated test after re-classifying affected pregnancies with low risk estimates as unaffected, simulating the underascertainment of cases. RESULTS: The validation plots (i) confirmed the accuracy of risk estimation for the different tests (by how close the points lay to the line of identity between predicted risk and observed prevalence), (ii) demonstrated the differences in screening performance of the different tests (by the range of risk spanned by the points and, in particular, the separation between the points representing the lowest risk and the next point), and (iii) are robust to underascertainment of affected pregnancies (by having little influence on the closeness of the points to the line of identity). CONCLUSION: The validation plot is a useful, simple and robust way to assess the validity of new screening methods, to assess the accuracy of risk estimation and to audit the performance of screening programmes.

Biomarkers↗

The Four-Dimensional Symptom Questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization.

BACKGROUND: The Four-Dimensional Symptom Questionnaire (4DSQ) is a self-report questionnaire that has been developed in primary care to distinguish non-specific general distress from depression, anxiety and somatization. The purpose of this paper is to evaluate its criterion and construct validity. METHODS: Data from 10 different primary care studies have been used. Criterion validity was assessed by comparing the 4DSQ scores with clinical diagnoses, the GPs' diagnosis of any psychosocial problem for Distress, standardised psychiatric diagnoses for Depression and Anxiety, and GPs' suspicion of somatization for Somatization. ROC analyses and logistic regression analyses were used to examine the associations. Construct validity was evaluated by investigating the inter-correlations between the scales, the factorial structure, the associations with other symptom questionnaires, and the associations with stress, personality and social functioning. The factorial structure of the 4DSQ was assessed through confirmatory factor analysis (CFA). The associations with other questionnaires were assessed with Pearson correlations and regression analyses. RESULTS: Regarding criterion validity, the Distress scale was associated with any psychosocial diagnosis (area under the ROC curve [AUC] 0.79), the Depression scale was associated with major depression (AUC = 0.83), the Anxiety scale was associated with anxiety disorder (AUC = 0.66), and the Somatization scale was associated with the GPs' suspicion of somatization (AUC = 0.65). Regarding the construct validity, the 4DSQ scales appeared to have considerable inter-correlations (r = 0.35-0.71). However, 30-40% of the variance of each scale was unique for that scale. CFA confirmed the 4-factor structure with a comparative fit index (CFI) of 0.92. The 4DSQ scales correlated with most other questionnaires measuring corresponding constructs. However, the 4DSQ Distress scale appeared to correlate with some other depression scales more than the 4DSQ Depression scale. Measures of stress (i.e. life events, psychosocial problems, and work stress) were mainly associated with Distress, while Distress, in turn, was mainly associated with psychosocial dysfunctioning, including sick leave. CONCLUSION: The 4DSQ seems to be a valid self-report questionnaire to measure distress, depression, anxiety and somatization in primary care patients. The 4DSQ Distress scale appears to measure the most general, most common, expression of psychological problems.

Anxiety↗

Validating a Work Group Climate Assessment Tool for improving the performance of public health organizations.

BACKGROUND: This article describes the validation of an instrument to measure work group climate in public health organizations in developing countries. The instrument, the Work Group Climate Assessment Tool (WCA), was applied in Brazil, Mozambique, and Guinea to assess the intermediate outcomes of a program to develop leadership for performance improvement. Data were collected from 305 individuals in 42 work groups, who completed a self-administered questionnaire. METHODS: The WCA was initially validated using Cronbach's alpha reliability coefficient and exploratory factor analysis. This article presents the results of a second validation study to refine the initial analyses to account for nested data, to provide item-level psychometrics, and to establish construct validity. Analyses included eigenvalue decomposition analysis, confirmatory factor analysis, and validity and reliability analyses. RESULTS: This study confirmed the validity and reliability of the WCA across work groups with different demographic characteristics (gender, education, management level, and geographical location). The study showed that there is agreement between the theoretical construct of work climate and the items in the WCA tool across different populations. The WCA captures a single perception of climate rather than individual sub-scales of clarity, support, and challenge. CONCLUSION: The WCA is useful for comparing the climates of different work groups, tracking the changes in climate in a single work group over time, or examining differences among individuals' perceptions of their work group climate. Application of the WCA before and after a leadership development process can help work groups hold a discussion about current climate and select a target for improvement. The WCA provides work groups with a tool to take ownership of their own group climate through a process that is simple and objective and that protects individual confidentiality.

Journal Article↗

Construct validity of the Rosenzweig Picture-Frustration Study.

Projective and semiprojective techniques are both tools and tests. A schema for assessing the validity of projective devices is proposed: (1) Primary, consisting of (a) construct validity i.e., the soundness of the techniques vis-a-vis its underlying concepts; and (b) criterion-related validity, i.e., the concordance between tool results and specified external criteria. (2) Secondary, viz., pragmatic validity, i.e., the usefulness of the instrument in applied fields. Discussion then focuses on the construct validity of the conceptually-based, semiprojective Rosenzweig P-F Study. specifically the evidence on (a) the self-consistency of its conceptual dimensions; (b) the sequential. social development of the Types and Directions of Aggression; (c) levels of behavior elicited; (d) sensitivity to scorable changes after induced frustration: and (e) physiological correlates oft he aggression categories. In each of these areas evidence exists in support of the validity of the P-F Study.

Journal Article↗

An examination of the construct validity of the Social Anhedonia Scale.

Two studies bearing on the construct validity of the Social Anhedonia Scale (SA) are reported. Study 1 reported convergent validity coefficients between the SA scale and numerous measures of traits reflecting a generalized attitude toward others (e.g., social interest and empathy) as well as several traits reflecting maladjustment without a social component as a test of discriminant validity (e.g., pessimism and rigidity). Study 1 found impressive convergent validity for the SA scale and mixed discriminant validity. Study 2 found that the SA scale was related to two dimensions of striving for security, one of which is strongly influenced by negative interpersonal tendencies, suggesting support for the validity of the SA scale. Implications for the measurement and concept of social anhedonia are presented.

Journal Article↗

The incremental validity of passive-aggressive personality symptoms rivals or exceeds that of other personality symptoms in suicidal outpatients.

We examined the incremental validity of passive-aggressive and other personality symptoms, by determining personality syndromes' ability to account for unique variance in distress and impairment as indexed by several Axis I-related symptoms. Two hundred fifty young adults, referred for suicidal behavior or ideation, completed the Millon Clinical Multiaxial Inventory (Millon, 1983) as well as several other symptom measures. The personality syndromes varied considerably in their ability to account for unique variance in Axis I-related symptoms. Several syndromes, including schizoid, schizotypal, and compulsive symptoms, showed relatively low incremental validity, whereas the incremental validity of passive-aggressive symptoms exceeded all others. The criterion of incremental validity represents an inclusive and persuasive means to evaluate personality disorder validity. On this criterion, passive-aggressive symptoms display high validity, and passive-aggressive personality disorder, in some form, may deserve inclusion on Axis II of future editions of Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association).

Adult↗

Development and validation of the Malingering Discriminant Function Index for the MMPI-2.

The predictive capacity of the MMPI-2 (Butcher et al., 2001) "fake-bad" validity scales (F, FB, and FP) is diminished when respondents have knowledge (i.e., coached) about the operating characteristics of these scales. In this investigation, we endeavored to develop a MMPI-2 fake bad validity index that would be less vulnerable to validity-scale knowledge. Applying discriminant function procedures, we derived a set of weighted Clinical and Content scales that reliably distinguished large samples of validity-scale coached undergraduate research participants instructed to feign mental illness (n = 534) from psychiatric patient samples (n = 590). We subsequently validated this Malingering Discriminant Function Index (M-DFI) in independent samples of research participants (n = 230) and patients (n = 300) and showed relatively less attenuation in predictive capacity compared with F, FB, and FP across uncoached and validity scale coached feigning conditions.

Adolescent↗

Development and validation of the Dartmouth Operative Conditions Scale.

Studies of pediatric sedation practice have suffered from the lack of an objective scale that would allow for a comparison of the effectiveness and safety of sedation provided by various providers and techniques. We present the Dartmouth Operative Conditions Scale (DOCS), which is designed as a research tool to codify the appropriateness of the procedural conditions provided by various sedation interventions. To begin, human factors methodology was used to develop a model of the pediatric sedation process and to define the criteria for measuring a patient's condition during a procedure (DOCS). To accomplish validation, 70 video clips (30-s duration) were then selected from more than 300 h of procedural video tape for testing/grading purposes. Inter-rater reliability was tested by comparing the score for each video clip among 10 different raters. Intra-rater reliability was evaluated by retesting all of the raters 1 yr after their initial rating. Construct validity was confirmed by analyzing the change in DOCS score relative to the time that sedation intervention was undertaken. Criterion validity was tested by comparing the DOCS to a modified COMFORT score. The DOCS was completed with excellent inter-rater (kappa = 0.84) and intra-rater (kappa = 0.91) agreement by 10 health care providers with various backgrounds during the 1-yr study period. Criterion validity was supported by the close correlation between the DOCS and the modified COMFORT scores for 20 distinct video clips (Spearman correlation coefficient = 0.98; P <0.001). The distribution of DOCS scores 20 min after the anesthetic induction was significantly lower than the scores before initiation of sedation, and scores after emergence were consistently higher than those 20 min after sedation (P <0.001), thus confirming construct validity of the scale. The DOCS is a validated research tool when used with video data for comparing the effectiveness and safety of pediatric sedation service, regardless of technique used for decreasing anxiety or pain during a procedure.

Child↗

Evaluation (not validation) of quantitative models.

The present regulatory climate has led to increasing demands for scientists to attest to the predictive reliability of numerical simulation models used to help set public policy, a process frequently referred to as model validation. But while model validation may reveal useful information, this paper argues that it is not possible to demonstrate the predictive reliability of any model of a complex natural system in advance of its actual use. All models embed uncertainties, and these uncertainties can and frequently do undermine predictive reliability. In the case of lead in the environment, we may categorize model uncertainties as theoretical, empirical, parametrical, and temporal. Theoretical uncertainties are aspects of the system that are not fully understood, such as the biokinetic pathways of lead metabolism. Empirical uncertainties are aspects of the system that are difficult (or impossible) to measure, such as actual lead ingestion by an individual child. Parametrical uncertainties arise when complexities in the system are simplified to provide manageable model input, such as representing longitudinal lead exposure by cross-sectional measurements. Temporal uncertainties arise from the assumption that systems are stable in time. A model may also be conceptually flawed. The Ptolemaic system of astronomy is a historical example of a model that was empirically adequate but based on a wrong conceptualization. Yet had it been computerized--and had the word then existed--its users would have had every right to call it validated. Thus, rather than talking about strategies for validation, we should be talking about means of evaluation. That is not to say that language alone will solve our problems or that the problems of model evaluation are primarily linguistic. The uncertainties inherent in large, complex models will not go away simply because we change the way we talk about them. But this is precisely the point: calling a model validated does not make it valid. Modelers and policymakers must continue to work toward finding effective ways to evaluate and judge the quality of their models, and to develop appropriate terminology to communicate these judgments to the public whose health and safety may be at stake.

Models, Biological↗

Development and validation of an instrument to determine patient knowledge: the oral anticoagulation knowledge test.

BACKGROUND: Studies examining the relationship between patient knowledge regarding warfarin therapy and its safe and effective use are limited by the lack of validated knowledge assessment tools. OBJECTIVE: To develop and validate an instrument to assess patient knowledge regarding oral anticoagulation therapy. METHODS: Four nationally recognized anticoagulation experts participated in the instrument development process to ensure content validity. The Oral Anticoagulation Knowledge (OAK) test was administered to subjects on warfarin and a group of age-matched subjects not on warfarin to assess construct validity. A subgroup of warfarin subjects were retested approximately 2-3 months after initial testing to assess test-retest reliability. Internal consistency reliability was assessed by calculating a Kuder-Richardson 20 value. Item analysis was used to assess performance of individual questions. RESULTS: An initial 23 item instrument was pilot tested for readability and comprehension. The OAK test was administered to 74 subjects taking warfarin and 27 age-matched subjects not on warfarin. Thirty-two subjects on warfarin repeated the OAK test an average of 75 days following initial administration. Subjects taking warfarin scored significantly higher than those not on warfarin (72% vs 52%, respectively; p < 0.001), supporting the construct validity of the instrument. Test-retest reliability was acceptable, with a Pearson's correlation coefficient of 0.81. Internal consistency reliability was confirmed by a calculated Kuder-Richardson 20 value of 0.76. CONCLUSIONS: The OAK test is a brief, valid, and reliable knowledge assessment instrument that may be a useful tool for research and clinical practice to augment patient education programs.

Adult↗

Conflict between guideline methodologic quality and recommendation validity: a potential problem for practitioners.

BACKGROUND: It is not clear if good methodologic quality in current practice guidelines necessarily leads to more valid recommendations, i.e., those that are supported with consistent research evidence or, when evidence is conflicting or lacking, with sufficient consensus among the guideline development team. To help clarify this issue, we assessed whether there is a link between methodologic quality and recommendation validity in practice guidelines for the use of laboratory tests in the management of patients with non-small cell lung cancer (NSCLC). METHODS: We conducted a systematic review of data on laboratory tests in NSCLC published in English or in French within the last 10 years and retrieved 11 practice guidelines for the use of these tests. The guidelines were critically appraised and scored for methodologic quality and recommendation validity based on the Appraisal of Guidelines Research and Evaluation (AGREE) criteria and on the systematic review. RESULTS: Overall, these 11 guidelines had considerable shortcomings in methodologic quality and, to a lesser extent, in recommendation validity. Practice guidelines with the best methodologic quality were not necessarily the most valid in their recommendations, and conversely. CONCLUSIONS: Poor methodologic quality and lack of recommendation validity in laboratory medicine call for methodologic standards of guideline development and for international collaboration of guideline development agencies. We advise readers of guidelines to critically evaluate the methods used as well as the content of the recommendations before adopting them for use in practice.

Carcinoma, Non-Small-Cell Lung↗

Self-reported drinking and alcohol-related problems among early adolescents: dimensionality and validity over 24 months.

OBJECTIVE: Researchers rely on adolescents' self-reports of alcohol consumption and alcohol-related problems, despite little evidence concerning their validity. We assessed the reliability and validity of adolescents' self-reports, employing collateral validation and focusing on the understudied transitional years of early adolescence. METHOD: Subjects were 214 boys and 247 girls who participated in school-wide surveys that assessed drinking, drunkenness and alcohol-related problems each year for 3 years. These measures were validated by collateral (peer) reports and by separate, 7-day drinking calenders. Internal consistency and test-retest reliability were also assessed. RESULTS: Results replicated findings with older adolescents that drinking/drunkenness and alcohol-related problems fall on two partially overlapping dimensions. Scales assessing each dimension had moderate to high internal consistency and high test-retest stability. Correlations with collateral reports were relatively strong for the drinking/drunkenness scale, moderate for a dichotomous variable reflecting the presence or absence of alcohol-related problems, and more modest for the alcohol-related problems scale. Correlations with diary reports of drinking behavior were strong for drinking/drunkenness. Results generally replicated across gender and over time. CONCLUSIONS: Researchers can have some confidence in the reliability and validity of early adolescents' survey self-reports, particularly of alcohol consumption (alcohol-related problems occurred with low base rates, perhaps limiting validity coefficients). Because drinking/drunkenness and alcohol-related problems shared 30% of their variance, factors other than consumption (e.g., personality factors) apparently influenced the experience of alcohol-related problems.

Adolescent↗

Validation of the Addiction Severity Index in French-speaking alcoholic patients.

OBJECTIVE: Evaluation of a French translation of the Addiction Severity Index (ASI) in 100 (78 male) alcoholic patients. METHOD: Validity of the instrument was assessed by measuring test-retest and interrater reliability, internal consistency and convergence and discrimination between items and scales. Concurrent validity was assessed by comparing the scores from the ASI with those obtained from three other clinimetric instruments. RESULTS: Test-retest reliability of ASI scores (after a 10-day interval) was good (r = 0.63 to r = 0.95). Interrater reliability was evaluated using six video recordings of patient interviews. Severity ratings assigned by six rates were significantly different (p < .05), but 72% of the ratings assigned by those who viewed the videos were within two points of the interviewer's severity ratings. Cronbach alpha coefficient of internal consistency varied from 0.58 to 0.81 across scales. The average item-to-scale convergent validity (r value) was 0.49 (range 0.0 to 0.84) for composite scores and 0.35 (range 0.00 to 0.68) for severity ratings, whereas discriminant validity was 0.11 on average (range-0.19 to 0.46) for composite scores and 0.12 (range-0.20 to 0.52) for severity ratings. Finally, concurrent validity with the following instruments was assessed: Severity of Alcoholism Dependence Questionnaire (40% shared variance with ASI alcohol scale), Michigan Alcoholism Screening Test (2% shared variance with ASI alcohol scale) and Hamilton Depression Rating Scale (31% shared variance with ASI psychiatric scale). CONCLUSIONS: The Addiction Severity Index covers a large scope of problems encountered among alcoholics and quantifies need for treatment. This French version presents acceptable criteria of reliability and validity.

Adult↗

Social validity assessments: is current practice state of the art?

The use of evaluative feedback from consumers to guide program planning and evaluation is often referred to as the assessment of social validity. Differing views of its role and value in applied behavior analysis have emerged, and increasingly stereotyped assessments of social validity are becoming commonplace. This paper argues that current applications of social validity assessments are straying from the point originally proposed for them. Thus, several suggestions for improving current social validity assessment are proposed, including (a) expanding the definition of consumers to acknowledge the variety of community members able and likely to affect a program's survival, (b) increasing the psychometric rigor of social validity assessments, (c) extending assessment to heretofore underrepresented populations, (d) implementing widespread application of well-designed social validity assessments, (e) increasing meaningful consumer involvement in the planning and evaluation of behavioral programs, and (f) educating consumers to make better informed programming decisions.

Community Participation↗

Is social validity what we are interested in? Argument for a functional approach.

It is argued that neither the term social nor the term validity is best to identify the processes used or the results obtained in questioning consumers about the goals set, procedures employed, or outcomes achieved in habilitative programming. The term consumer satisfaction acknowledges the fact that it is essentially a collection of consumer opinions. The underlying intent of the process might be called habilitative validation, a name that seems to better guide our validation efforts. More important, in carefully considering consumer satisfaction assessment, it becomes clear that not only does consumer satisfaction itself need to be validated, but also that more objective methods can be used for assessing habilitative validity. However, legitimate uses still remain for consumer satisfaction measurement, as long as we do not mistake it for strong evidence of the habilitative validity of our goals, procedures, or outcomes.

Adult↗

Extending the concept of social validity: behavior analysis for disease prevention and health promotion.

A broader definition of social validity is proposed wherein a socially valid behavior-change intervention is directed to a problem of verifiable importance, the intervention is valued and used appropriately by designated target groups, and the intervention as used has sufficient behavioral impact to substantially reduce the probability of the problem's occurrence in target populations. The verifiable importance of a problem is based on epidemiological data, and the value and appropriate use of an intervention are enhanced through the use of conceptual frameworks for social marketing and behavior change and considerable formative and pilot research. Behavioral impact is assessed through efficacy and effectiveness studies. Thus, the social validity of a behavior-change intervention is established through a number of interactive, a priori steps. This approach to defining social validity is related to critical analysis and intervention issues including individual and population perspectives and "top-down" and "bottom-up" approaches to intervention design. This broader definition of social validity is illustrated by a project to reduce the risk of HIV infection among adolescents. Although the various steps involved in creating socially valid interventions can be complicated, time-consuming, and expensive, following all the steps can result in interventions capable of improving a nation's health.

Adolescent↗

Short musculoskeletal function assessment questionnaire: validity, reliability, and responsiveness.

BACKGROUND: A short questionnaire on functional status was designed for use in community-based outcome studies and in the management of individual patients who have musculoskeletal disease. As most musculoskeletal care is delivered in community practices, short, validated instruments are necessary to perform clinical studies on the effectiveness of treatment in this setting. METHODS: A forty-six-item questionnaire was created as an extension of the work to develop the longer, 101-item Musculoskeletal Function Assessment (MFA) questionnaire. The Short Musculoskeletal Function Assessment (SMFA) questionnaire consists of the dysfunction index, which has thirty-four items for the assessment of patient function, and the bother index, which has twelve items for the assessment of how much patients are bothered by functional problems. The SMFA questionnaire was evaluated for reliability, validity, and responsiveness in a population of 420 patients who had a musculoskeletal disease or injury. RESULTS: The SMFA questionnaire demonstrated excellent internal consistency and stability, with most values greater than 0.90. Content validity for the dysfunction and bother indexes was supported with very little skew (less than 1.00), few ceiling effects (less than 5 percent), and no floor effects. Convergent validity was supported with significant correlations between the SMFA dysfunction and bother indexes and the physicians' ratings of patient function (for example, activities of daily living, recreational and leisure activities, and emotional function [rho > or = 0.40]) and standard clinical measures (for example, grip strength and walking speed [r > or = 0.401). Convergent and discriminant construct validity of the SMFA indexes were demonstrated (p < 0.01) in comparisons with clinical, demographic, Short Form-36 (SF-36), and life-change data. The responsiveness of the SMFA questionnaire to change over time was demonstrated with standardized response means ranging from moderate (0.76) to large (-1.14) for patients who had changes in health status. CONCLUSIONS: The SMFA questionnaire may be used for clinical assessments of the impact of treatment in groups of patients who have musculoskeletal disease or injury. It also may be used in clinical settings to provide reliable and valid assessments of the health status of an individual patient.

Adolescent↗