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PubMed2003

Development of a reliable and valid questionnaire to test the prostate cancer knowledge of men with the disease.

Several prostate cancer knowledge questionnaires exist but none have demonstrated both reliability and validity when used by men with the disease. This study aims to develop a reliable and valid knowledge questionnaire for men with prostate cancer. After developing a 40-item Prostate Cancer Knowledge Questionnaire (PCKQ-40) in phase I, it was piloted in phase II with 391 medical students. This resulted in the reduction of the tool by removing items of poor discriminatory value. A balance between true and false items and content domains was also maintained in the reduced scale. The PCKQ-12 had a moderate internal consistency. Phase III of the study assessed the reliability and construct validity of the tool by measuring the prostate cancer knowledge levels of men with prostate cancer (n=28), men with other cancers (n=10) and men without cancer (n=84). Men with prostate cancer achieved significantly higher PCKQ-12 scores compared with men without cancer, supporting the construct validity of the tool. The tool's reliability was also confirmed with a moderate internal consistency. This study provides some evidence for the reliability and validity of the PCKQ-12 and supports its use with men with prostate cancer in further research.

Adolescent↗

PubMed2002

A measure of the quality of dying and death. Initial validation using after-death interviews with family members.

A reliable and valid measure of the quality of the dying experience would help clinicians and researchers improve care for dying patients. To describe the validity of an instrument assessing the quality of dying and death using the perspective of family members after death and to identify clinical correlates of a high quality death, a retrospective cohort study evaluated the 31-item Quality of Dying and Death (QODD) questionnaire. The questionnaire was administered to family members of patients who died in Missoula county Montana in 1996 and 1997. The interview included questions assessing symptoms, patient preferences, and satisfaction with care. Measurement validity was examined for item and total scores and reliability analyses for the QODD total score were assessed. Construct validity was assessed using measures of concepts hypothesized to be associated with the quality of dying and death. There were 935 deaths, of which 252 (27.0%) family interviews were represented. Non-enrolled decedents were not significantly different from enrolled decedents on age, sex, cause of death, or location of death. We excluded sudden deaths (n = 45) and decedents under age 18 (n = 2), leaving 205 after-death interviews. A total QODD score, on a scale from 0 to 100 with higher scores indicating better quality, ranged from 26.0 to 99.6, with a mean of 67.4 and Cronbach's alpha of 0.89. The total QODD score was not associated with patient age, sex, education, marital status, or income. As hypothesized, higher QODD scores were significantly associated with death at home (P < 0.01), death in the location the patient desired (P < 0.01), lower symptom burden (P < 0.001), and better ratings of symptom treatment (P< 0.01). Although the total score was not associated with the presence of an advance directive, higher scores were associated with communication about treatment preferences (P < 0.01), compliance with treatment preferences (P < 0.001), and family satisfaction regarding communication with the health care team (P < 0.01). Availability of a health care team member at night or on weekends was also associated with a higher QODD score (P < 0.001). The QODD total score demonstrated good cross-sectional validity. Clinicians caring for dying patients should focus on improving communication with the patient and family and improving symptom assessment and treatment. Health care teams should focus on continuity of care, including having a team member familiar with the patient available for calls at nights and on weekends. Future work will assess the potential role of the QODD in improving the quality of the dying experience.

Aged↗

PubMed2001

The validity of different definitions of radiographic worsening for longitudinal studies of knee osteoarthritis.

Several definitions have been used to characterize radiographic worsening of knee osteoarthritis in longitudinal studies, yet a valid definition with maximal power to detect differences between groups is not known. We used serial radiographs from the Framingham Osteoarthritis Study to compare five dichotomous definitions according to construct validity (strength of association) and discriminant power (power to reject null hypotheses of no difference) for 1) known risk factors for knee osteoarthritis, and 2) development of new knee pain. For risk factors: definitions that included scores for osteophytes (bone spurs) showed good construct validity and discriminant power; a definition using the Kellgren and Lawrence grade of overall knee osteoarthritis was conservative with good construct validity but low discriminant power; a definition based solely on ordinal assessment of joint space narrowing had weak construct validity and low discriminant power. All definitions had comparably strong associations with the development of new knee pain. Similar associations with new knee pain were found when the analysis was confined to either knees with no osteoarthritis at baseline or knees with prevalent osteoarthritis, with increased standard errors for prevalent osteoarthritis. Use of any of these definitions, other than joint space narrowing alone, would permit detection of associations with most known risk factors. Definitions incorporating both osteophytes and joint space narrowing offer the most precise estimation of the association of risk factors with disease worsening.

Aged↗

PubMed2002

Development of a new seizure severity questionnaire: initial reliability and validity testing.

PURPOSE: This report describes the initial steps for development of a new scale to assess seizure severity as a treatment response. METHODS: Standard methodology was used to develop the test instrument. Item generation was performed by selecting items from other questionnaires, and asking patients and epileptologists about seizure components. Face and content validity were assessed in a pilot study with patients and observers. The questionnaire was formatted as a structured interview for a reliability study. Construct validity was assessed with three existing questionnaires. Inter-rater reliability and test-retest reliability were performed as two independent ratings on one day, and one re-interview. RESULTS: Based on item generation and pilot testing (33 patients, 28 observers), the Seizure Severity Questionnaire (SSQ) was organized into warning, activity-movement, and recovery (cognitive, emotional, and physical aspects) stages of seizures. Questions reviewed duration, severity, bothersomeness and overall ratings, and the most bothersome aspect of seizures. The mean SSQ Summary Score was 5.78+/-3.24, inter-rater reliability was 0.76 (N=91), and test-retest reliability was 0.74 (N=63). Construct validity showed statistically significant correlations with other scales. CONCLUSION: This study has explored the psychometric properties of the SSQ for face and content validity, inter-rater and test-retest reliability, and construct validity. The Summary Score reliably represents the major components of seizures.

Adult↗

PubMed2005

Validation of the Spanish and English versions of the asthma portion of the Brief Pediatric Asthma Screen Plus among Hispanics.

BACKGROUND: The health and health care needs of non-English-speaking Hispanic families with children are poorly understood, in part because they are often excluded from research owing to language barriers. Instruments that are valid in English and Spanish are necessary to accurately evaluate the magnitude of asthma prevalence and morbidity among Hispanics. OBJECTIVE: To establish the sensitivity and specificity of the English and Spanish versions of the asthma portion of the Brief Pediatric Asthma Screen Plus (BPAS+) in a low-income Hispanic population. METHODS: The validation sample consisted of 145 children whose parents completed the BPAS+ in Spanish and 78 whose parents completed it in English. Bilingual clinicians conducted the examinations on which the clinical assessments were based. We compared the BPAS+ results with the clinical assessment findings to determine the sensitivity and specificity of the BPAS + among Hispanics in terms of identifying children who warrant further medical evaluation for asthma. RESULTS: The sensitivity and specificity of the asthma portion of the Spanish BPAS+ were 74% and 86%, respectively. The sensitivity and specificity of the asthma portion of the English BPAS+ were 61% and 83%, respectively. CONCLUSIONS: The asthma portion of the BPAS+, a valid screen for identifying children who are in need of further evaluation for potentially undiagnosed asthma, is valid for low-income Hispanics in Spanish and English. As the Hispanic population continues to grow, it is imperative that researchers have English and Spanish instruments that are valid for this population.

Asthma↗

PubMed1999

Inventory of validation approaches in selected health telematics projects.

This paper presents the results from an inventory of validation approaches and methodologies which have been used in selected health telematics projects. The inventory was performed in the VATAM Validation of Telematic Applications in Medicine project, HC1115HC. The purpose of the inventory was to analyse the methodologies and their application assumptions in order to identify possibilities for harmonization and consolidation. The inventory was performed using five validation dimensions: IT-development; quality; user; technology assessment and marketing. The inventory results show that possibilities exist to synthesise methodologies and to provide practical guidance and support for projects that are developing health telematics applications. All stakeholders in health telematics projects, i.e. users, health care decision-makers, developers, suppliers and IT-industries, can benefit from practical validation guidelines and support for validation when guidelines are represented in a usable, easy to access and informative way.

Humans↗

PubMed2003

Guidelines for analytical method development and validation of biotechnological synthesis of drugs. Production of a hydroxyprogesterone as model.

In connection with biotechnological synthesis of pharmaceutical drugs, validated methods for quantification of both product and substrate at different time intervals are essential for proper calculation of rate coefficients. In this field, there still exist no guidelines for analytical validation, unlike the situation in the bioanalytical field. Therefore, in this study the detailed guidelines by FDA for bioanalytical method validation were applied to a typical biotechnological process; the enzymatic synthesis of 9alpha-hydroxyprogesterone in E. coli using progesterone as substrate. The process liquid was extracted and analyzed using an HPLC-DAD system. The quality control (QC) samples of the product demonstrated excellent precision (C.V.<1.5%) and accuracy between 99.3 and 107%. The study showed that the recommendations and the validation terms for bioanalytical methods can be used also for biotechnological production, but with some important exceptions. The tolerances (C.V. values) of the validation terms should be much narrower; the internal standard (I.S.) must be present in the process liquid before the start of the process and must be much different in structure from the substrate (so as not to participate in the biotechnological process). In addition, the selectivity must be checked very frequently during the process due to the changes in the blank process liquid with time.

Biotechnology↗

PubMed2005

[Validation of an asthma knowledge questionnaire for use in parents or guardians of children with asthma].

OBJECTIVE: Interventions to increase asthma knowledge enable children and/or their parents to acquire skills needed for the prevention and/or appropriate management of crises. Periods of illness caused by the disease can thereby be reduced. However, no validated instrument for quantifying knowledge of asthma is available in Spanish. The aim of the present study was to develop and validate an asthma knowledge questionnaire that could be self-administered by parents and/or persons charged with caring for asthmatic children. MATERIAL AND METHODS: The 17 items that make up the questionnaire were obtained on the basis of a review of the literature, focus group discussions, the professional experience of the researchers, and pilot studies. We evaluated the instrument's face, content, and concurrent validity and analyzed its factorial structure. The test-retest reliability of the questionnaire and its sensitivity to change were also assessed. RESULTS: A total of 120 pediatric patients with a mean (SD) age of 4.5 (3.7) years participated. Factor analysis demonstrated a probable structure of 3 factors that together explained 85% of the total variance in results. The opinion of an interdisciplinary group of experts on asthma confirmed the face validity of the instrument. The questionnaire's ability to distinguish between parents with high and low asthma knowledge demonstrated its concurrent validity. Test-retest reliability was demonstrated, as was sensitivity to change between 2 different testing moments. CONCLUSIONS: The asthma knowledge questionnaire developed is useful and reliable for quantifying the baseline level of asthma knowledge of parents of asthmatic children as well as to assess the efficacy of an educational intervention aiming to increase knowledge and understanding of the disease.

Adult↗

PubMed2003

The internal and external validity of the Major Depression Inventory in measuring severity of depressive states.

BACKGROUND: We have developed the Major Depression Inventory (MDI), consisting of 10 items, covering the DSM-IV as well as the ICD-10 symptoms of depressive illness. We aimed to evaluate this as a scale measuring severity of depressive states with reference to both internal and external validity. METHOD: Patients representing the score range from no depression to marked depression on the Hamilton Depression Scale (HAM-D) completed the MDI. Both classical and modern psychometric methods were applied for the evaluation of validity, including the Rasch analysis. RESULTS: In total, 91 patients were included. The results showed that the MDI had an adequate internal validity in being a unidimensional scale (the total score an appropriate or sufficient statistic). The external validity of the MDI was also confirmed as the total score of the MDI correlated significantly with the HAM-D (Pearson's coefficient 0.86, P < or = 0.01, Spearman 0.80, P < or = 0.01). CONCLUSION: When used in a sample of patients with different states of depression the MDI has an adequate internal and external validity.

Adult↗

PubMed2003

The social phobia diagnostic questionnaire: preliminary validation of a new self-report diagnostic measure of social phobia.

BACKGROUND: The development and validation of the Social Phobia Diagnostic Questionnaire (SPDQ), a new self-report diagnostic instrument for social phobia is described in three separate studies. STUDY 1: The participants were 125 undergraduates seeking help for an anxiety disorder of whom 60 had social phobia. Receiver operating characteristics (ROC) analysis was conducted comparing SPDQ diagnoses and clinician-based Anxiety Disorder Interview Schedule-IV (ADIS-IV) diagnoses of social phobia. Diagnoses made by the SPDQ showed an 85% specificity, an 82% sensitivity and kappa agreement with the ADIS-IV of 0.66. STUDY 2: The participants were 462 undergraduates who completed the SPDQ and a battery of additional questionnaires. The SPDQ had good internal consistency (alpha=0.95), good split-half reliability (r=0.90) and strong convergent and discriminant validity. STUDY 3: The participants were 145 undergraduates who completed the SPDQ at two time points separated by 2 weeks as well as several additional questionnaires. Scores on the SAD, FNE and SISST of SPDQ categorized undergraduates were also compared to scores on these measures from 35 clinical community participants to determine the clinical validity of the SPDQ. The SPDQ had strong 2-week test-retest reliability and good convergent and discriminant validity. Undergraduates diagnosed with social phobia by the SPDQ were not significantly different on the SAD, FNE and SISST from the socially phobic community sample, but both groups had significantly higher scores than undergraduates identified by the SPDQ as not meeting criteria for social phobia, demonstrating clinical validity of the SPDQ. CONCLUSIONS: These three studies provide preliminary evidence of the strong psychometric properties of the SPDQ as a measure to identify socially phobic participants.

Adolescent↗

PubMed2004

Standardized finger-nose test validity for coordination assessment in an ataxic disorder.

OBJECTIVES: Evaluation of coordination with the Finger-Nose Test is an essential part of the neurological examination. This study explored the convergent and discriminant construct validity of the Standardized Finger-Nose Test (SFNT) in a neuromuscular disorder with ataxic features. METHOD: A cross-sectional study was carried out with 24 participants with recessive spastic ataxia of Charlevoix-Saguenay. Convergent construct validity was tested by correlating the SFNT with other upper extremity function tests, a functional independence measure and social participation. Upper extremity function tests included gross and fine dexterity (Box and Block Test and Purdue Pegboard), upper extremity strength (dynamometry) and global upper extremity performance (TEMPA). The Functional Independence Measure (FIM) and the Assessment of Life Habits scale (LIFE-H) measured functional independence and social participation respectively. Discriminant construct validity was explored by comparing performance on the SFNT between two age groups (< 40 years and > or = 40 years). RESULTS: Convergent validity of the SFNT was demonstrated by moderate to strong correlations with gross and fine finger dexterity (r = 0.82-0.84), global upper extremity performance (0.74-0.79), functional independence (r = 0.74) and social participation (r = 0.78). Upper extremity coordination of the older group was significantly lower than in the younger group, suggesting the ability of the SFNT to discriminate between different levels of function. CONCLUSION: This study demonstrated the convergent and discriminant construct validity of the SFNT in a neuromuscular disorder with ataxic features.

Activities of Daily Living↗

PubMed2005

A study of the reliability and validity of the Chinese version of the Dementia Rating Scale.

BACKGROUND: The present study aims to develop and validate a Chinese version of the Dementia Rating Scale (DRS) for use with Chinese populations in psychogeriatric settings. METHODS: The DRS was translated into Chinese and its content validity was evaluated by an 11-member expert panel. To assess reliability and concurrent validity, 52 subjects with dementia were recruited from medical and psychogeriatric settings using purposive sampling. RESULTS: With percentage of agreement as an indicator, 28 out of 36 items (78%) had satisfactory content validity. Items with a percentage of agreement below 70% were reviewed and modified, based on the comments of the experts. The CDRS had excellent test-retest and inter-rater reliability, with intraclass correlation coefficient (ICC) at 0.94 and 0.93 respectively. Intraclass correlation coefficients ranged between 0.75 and 0.89 for the subscales. The internal consistency of the CDRS subscale, as measured by Cronbach's a, ranged from 0.57 to 0.82. The CDRS had high correlations with the Chinese Mini-mental State Examination (r = 0.80 for total score, r = 0.58 to 0.84 for subscales. CONCLUSIONS: The CDRS is a valid instrument for the assessment of dementia in Chinese-speaking subjects.

Aged↗

PubMed2005

Florida Cognitive Activities Scale: initial development and validation.

We used a rational-empirical approach in the construction and validation of a cognitive activity scale for use with elderly populations. The scale development effort produced a 25-item scale with a reasonably high level of internal consistency in a sample of 200 elderly individuals. Scale scores were positively correlated with years of education and measures of various domains of cognitive ability. In a separate cross-validation sample, a similar pattern of reliability and validity coefficients was obtained. The full scale score was found to contribute significantly to the prediction of cognitive ability after controlling for the effects of age, education, and gender. Two subscales (Higher Cognitive Abilities and Frequent Cognitive Abilities) and a measure of self-reported maintenance of cognitive activity were also developed. In a separate study, the maintenance score was found to differ significantly between the validation sample and a sample of individuals with a history of neurological disorder, with a moderate effect size (d approximately = .7). Further cross-validation studies in minority groups and groups of varying socioeconomic status will be critical in establishing the research and clinical value of the scale and subscales.

Aged↗

PubMed2004

Reliability and validity of the Japanese version of the Support Team Assessment Schedule (STAS-J).

OBJECTIVE: The aim of this project was to develop an appropriate and valid instrument for assessment by medical professionals in Japanese palliative care settings. METHODS: We developed a Japanese version of the Support Team Assessment Schedule (STAS-J), using a back translation method, and tested its reliability and validity. In the reliability study, 16 nurses and a physician who work in a palliative care unit evaluated 10 hypothetical cases twice at 3-month intervals. For the validity study, external researchers interviewed 50 patients with matignancy and their families and compared the results with ratings by the nurses in the palliative care unit. RESULTS: Our results with hypothetical cases were: interrater reliability weighted kappa = 0.53-0.77 and intrarater reliability weighted kappa = 0.64-0.85. In the validity study comparing nurse evaluations and the results of interviews with patients and families, complete agreement was 36-70%, and close agreement (+/-1) was 74-100%. As a whole, weighted kappa were low: between -0.07 and 0.51. Our results were similar to those in the United Kingdom and Canada. SIGNIFICANCE OF RESULTS: Although this research was conducted under methodologically limited conditions, we concluded that the STAS-J is a reliable tool and its validity is acceptable. The STAS-J should become a valuable tool, not only for daily clinical use, but also for research.

Adult↗

PubMed2004

A QSAR for baseline toxicity: validation, domain of application, and prediction.

The interest in modeling and application of structure-activity relationships has steadily increased in recent decades. It is generally acknowledged that these empirical relationships are valid only within the same domain for which they were developed. However, model validation is sometimes neglected, and the application domain is not always well-defined. The purpose of this paper is to outline how validation and domain definition can facilitate the modeling and prediction of baseline toxicity for a large database. A large number of theoretical descriptors (867) were generated from two-dimensional molecular structures for compounds present in the U.S. EPA's Fathead Minnow Database (611) and the Syracuse Research Corporation's PhysProp Database (25,000+). A quantitative structure-activity relationship model was developed for baseline toxicity (narcosis) toward the fathead minnow (Pimephales promelas) using a projection-based regression technique, PLSR (partial least squares regression). The PLSR model was subsequently validated with an external test set. The main factors of variation were related to size/shape and polar interactions. The prediction error was comparable to, or slightly better than, the ECOSAR procedures. A set of 16,805 compounds, drawn from the PhysProp Database, was projected onto the PLSR model. More than 90% (15,597) of the compounds fall within the valid model domain, defined by the residual standard deviation and the leverage. The predicted baseline toxicity indicates an acute hazard for two-thirds of these compounds, classes I-III in the OECD Globally Harmonized Classification System (LC50 < or = 100 mg L(-1)). Finally, the mode of action assigned in the U.S. EPA Fathead Minnow Database was investigated. Reclassification to narcosis as the mode of action is suggested for 92 compounds, mostly from the groups "unsure" and "mixed". The present classification into specific modes of action seems to be further strengthened by the findings in this investigation.

Animals↗

PubMed2001

Testing the validity of a critical sulfur and nitrogen load model in southern Ontario, Canada, using soil chemistry data from MARYP.

The validity of a steady-state mass balance model (Arp et al., 1996; referred to as ARP) was tested using physicochemical soil data from the Monitoring Acid Rain Youth Program (MARYP). Four ARP sites were matched with ten MARYP sites according to proximity, bedrock type and subsoil pH to test the validity of the ARP model for critical load exceedances. Soil solution pH, base concentration and A1 concentration from MARYP sites, which were well matched to ARP sites, validated the modelled critical load exceedances. Higher exceedance areas were associated with more acidic pH and lower base and higher A1 concentrations from matched MARYP sites and vice versa. One ARP site was inappropriately matched with MARYP sites and could not be validated using base and A1 concentrations. This study also confirmed the southern limit of the zero critical load exceedance isopleth from the model. However, variability of the other exceedance isopleths was noted due to the limited number of sites used in the model. The validation of these sites in the ARP model and the zero critical load exceedance isopleth nonetheless allows greater confidence in using this model as a management tool for acidic deposition.

Aluminum↗

PubMed2001

Reliability and validity of a modified Colorado Symptom Index in a national homeless sample.

This study examined the reliability and construct validity of a modified version of the Colorado Symptom Index (MCSI), a brief, self-report measure of psychological symptomatology, in a study of interventions to prevent homelessness. Eight projects in a national, cooperative study collected new data at baseline, 6, and 12 months using a set of common measures as well as site-specific instruments. The pooled sample consisted of 1,381 persons in treatment for mental illness or substance abuse (or both), of which 84% had a history of homelessness. The analyses employed classical and Rasch methods to examine the MCSI's content validity, internal consistency and item quality, test/retest reliability, dimensionality, appropriateness for the sample, construct validity, and responsiveness to change. This 14-item scale was found to be a reliable and valid measure of psychological symptoms in this sample. Its content was consistent with other symptom measures, its high internal consistency and test-retest coefficients supported its reliability, its relationships to other measures indicated that it had good construct validity, and it was responsive to change. We conclude that the MC

Adolescent↗

PubMed2001

A community-based study of scaling assumptions and construct validity of the English (UK) and Chinese (HK) SF-36 in Singapore.

Scaling assumptions and validity of the English (UK) and Chinese (HK) short form 36 health survey (SF-36) were assessed in a community-based survey of 5,503 Chinese, Malays and Indians in Singapore using the international quality of life assessment project approach of item and scale level validation. Missing data for SF-36 items and scales occurred in less than 1.0% of subjects. Item level validation of both versions generally supported assumptions underlying Likert scoring and hypothesised item-order clustering. Item level factor analysis supported the eight-scale structure of the SF-36. In scale level validation, SF-36 scale scores showed wide variability and acceptable internal-consistency reliability (Cronbach's alpha > 0.70 for six English and seven Chinese scales), conformed to hypothesised patterns and generally varied according to hypotheses in subjects known to differ in quality of life. Scale level factor analysis of both versions yielded very similar patterns of factor correlation, comparable to that found in Japan, but differing from that seen in Western populations. Taken together, these results support the validity of the English (UK) and Chinese (HK) SF-36 versions in the multi-ethnic Asian socio-cultural context of Singapore.

Adult↗