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PubMed1991

Coronary heart disease knowledge test: developing a valid and reliable tool.

This study tested the validity and reliability of a written test designed to assess knowledge of coronary heart disease (CHD) and its risk factors. The subjects were 93 males diagnosed with CHD. Subjects were classified into a treatment group (n = 48) or a control group (n = 45) based on whether or not they participated in a cardiac rehabilitation program (CRP). An additional 38 subjects were used to pilot test the original form of the knowledge test, which consisted of 80 multiple-choice questions. Content validity was established by a five-member jury of cardiac rehabilitation experts. Each question was rated using a Likert-type scale. Questions that did not receive an average rating of at least four were eliminated. The revised form was pilot tested for validity and internal consistency with the discrimination index (point biserial correlation coefficient) and the Kuder-Richardson formula 20 (KR-20). Questions with a discrimination index of less than 0.14 were eliminated; thus, the final form of the test consisted of 40 questions. Validation of this test yielded difficulty ratings (DRs) between 0 percent and 98 percent, with an average DR of 63 percent. Construct validation indicated that the average test score of subjects participating in a CRP was significantly higher than that of non-participants (t = 3.51, df = 91, p less than or equal to 0.01). The internal-consistency reliability of the test was 0.84. The results indicate that this test is a valid and reliable tool for assessing patients' knowledge of CHD and its risk factors.

Adult↗

PubMed1985

Borderline disorders--the validity of the diagnostic concept.

Reliable concepts of borderline disorders are a prerequisite for studies of validity. Gunderson's and DSM-III's definition of Borderline personality disorder (BPD) and DSM-III's definition of Schizotypal personality disorder (SPD) fulfill these demands. The empirical evidence for descriptive, construct and predictive validity of these disorders is presented and discussed. The review concludes that BPD has descriptive validity but lacks the 2 other stronger types of validity. SPD has both descriptive and construct validity but lacks predictive validity. Various strengths and weaknesses of the empirical studies of these borderline concepts are discussed.

Adolescent↗

PubMedDate not supplied

The significance of sieve-retention to the filter validation process.

Current efforts at filter validation involve the need to test under "worst case conditions" the bacterial retentive action of filters utilizing the very drug being processed. These concerns recognize that the adsorptive retentions of organisms vary in their efficiencies, depending upon the filtration conditions and the presence or absence of surfactant. The sieve retention of organisms is independent of such conditions, deriving solely from considerations of organism-size, pore-size relationships. Flow-decay studies, can serve to differentiate between filter actions based on sieve-retentions and adsorptive-retentions. A filter's dependence solely upon sieving effects is demonstrable. What is involved is a plotting of flow rates as a function of time in accordance with established mathematical equations. Appropriate plots would indicate the exclusive sieve retention of organisms, a condition of absolute filter reliability deriving from organism-pore size relationships. The clear demonstration by a filter company that its sterilizing filter retains organisms solely by the sieve retention mechanism would suffice to validate that filter for all pharmaceutical filtrations, eliminating the need for individual user validations. The advantage of this mode of filter validation, one based on structurally-inherent filter pore architecture, is that pharmaceutical manufacturers would be free from the need to validate a given filter for each and every pharmaceutical preparation. This would also simplify the FDA's confirmation of filter validation, since a single inspection of the filter manufacturer's records would suffice for all the filter's users.

Adsorption↗

PubMed1996

Validity, reliability, and sensitivity to change of a French version of the arthritis impact measurement scales 2 (AIMS2) in patients with rheumatoid arthritis treated with methotrexate.

OBJECTIVE: To develop and validate a cross cultural version of the Arthritis Impact Measurement Scales 2 (AIMS2) to be used by French speaking populations. METHODS: A French version of the AIMS2 was obtained using back translation, committee review, and pretesting. The French AIMS2 was studied in 127 patients with rheumatoid arthritis (RA) about to receive therapy with methotrexate (MTX). Construct validity of the questionnaire was assessed by factor analysis. Convergent validity was evaluated by correlation coefficients with joint counts, pain assessment, and sedimentation rate. Reliability was assessed by test-retest procedure at a 10-day interval, Cronbach's coefficients of internal consistency, and within scale factor analyses. Sensitivity to change after 12 and 24 weeks of therapy with MTX was assessed with computation of standardized response means (SRM) and paired t test comparisons. RESULTS: Factor analyses of the French version clearly identified the same scales of the AIMS2, except for the walking and bending scale which loaded on several factors. Convergent validity of the physical and symptom components of the instrument was demonstrated by significant correlations with clinical and laboratory features. All the scales were reliable (intraclass correlation coefficients: 0.65 to 0.90; percentage of explained variance larger than 50% in all but one scale; Cronbach's alpha: 0.70 to 0.90). Sensitivity to change was demonstrated in 11 of the 12 scales (SRM: 0.30 to 0.77). Most of the improvement was noted by Week 12. CONCLUSIONS: This cross cultural adaptation of AIMS2 in French is valid, reliable, and responsive in patients with RA in whom MTX therapy is instituted. It would permit international comparison studies. This study provides evidence for construct validity and responsiveness of the original version of the AIMS2, not demonstrated previously.

Activities of Daily Living↗

PubMed1997

[Reliability and validity of a self-administered questionnaire of patient health care behavior and satisfaction].

The reliability of a self-administered questionnaire of health care behavior and patient satisfaction, and also the validity of measuring patient satisfaction by a single question, were investigated on 754 outpatients and 204 inpatients. In order to assess the reliability and the validity, the questionnaire was administrated twice. Subjects for reliability tests were 194 outpatients and 91 inpatients and validity tests were performed with 280 outpatients and 84 inpatients. To assess the validity of patient satisfaction, supplementary questions about satisfaction (outpatients 22 items, inpatients 14 items) were included in the questionnaire. Reliability was assessed using kappa coefficient and proportion of agreement. To assess validity, principal component analysis was performed, and the correlation between principal-components and the score of patient satisfaction was analyzed. With the exception of patient understanding of the doctor's explanation and patient satisfaction, kappa coefficient and proportion of agreement were high (kappa: 0.4 approximately 0.82), indicating that question contents were objective and easily understood. By making the question categories simple, a higher kappa coefficient and proportion of agreement in patient understanding about doctor's explanation and patient satisfaction were achieved. This suggests that in questionnaire, similar question category must be made simple or similar categories should be put together in analysis. Spearman's correlation coefficient between the question about patient satisfaction and the first principal component (which summarizes all of the questions about patient satisfaction) was high (outpatients: 0.63, inpatients: 0.67). Therefore the validity of measuring general information about patient satisfaction by using a single question is suggested.

Female↗

PubMed1976

Validity of certification measures for occupational therapists.

Major factors that can affect the results of validation studies are identified and include reliability, homogeneity of sample, and criterion contamination. An overview and a description of content, predictive, concurrent, and construct validities are presented as well as a review of the recent studies of the validity of the Field Work Performance Report and the Certification Examination for Occupational Therapists. Adequate evidence of content and concurrent validity has been established for the Field Work Performance Report, although evidence for long-range predictive validity is lacking. Content validity alone has been established for the Certification Examination for Occupational Therapists. The evidence indicates that the instruments should not be abandoned, that they are better than no measures at all. The directions research might take in the future are given and the implications of continued use of the instruments are evaluated.

Certification↗

PubMedDate not supplied

[Validation of French translation of the "Tinnitus Reaction Questionnaire", Wilson et al. 1991].

The present study proposes a validation of a french translation of the TRQ initially published by Wilson et al., for evaluating the psychological distress of tinnitus sufferers. The 26 items translated into french were used on a sample of 173 tinnitus sufferers, who also filled out the Mini-Mult, a short version of the MMPI proposed by Kincannon. Internal validity was demonstrated by strong correlations (i) between each item (except items 5 and 20) and total TRQ score (0.33 < or = r < or = 0.87, p < or = 0.0001), (ii) between each internal TRQ factor (0.58 < r < 0.81, p < 0.0001) and the others. Cronbach's alpha test also showed the questionnaire to have a good internal validity (alpha = 0.94). The external factors used for testing concurrent validity were the scores on depression, psychaesthenia and anxiety Mini-Mult scales. The strong correlations (one factor ANOVA and simple linear regression tests) between scores on depression and psychaesthenia scales and (1) each TRQ item, (2) each TRQ factor, (3) total TRQ scores, confirmed concurrent validity. Scores obtained on anxiety index showed high correlations only with TRQ score, factor 3 score and some TRQ items (most of them included in factor 3). The internal and concurrent validities of the French version of the TRQ justify the use of this questionnaire, with the reserve that items 5 and 20 appeared irrelevant for the measuring of tinnitus distress in French-speaking countries. Such a questionnaire should improve our knowledge of tinnitus' life-impact and enable detection of patients whose psychological distress necessitates rapid intervention.

Adaptation, Psychological↗

PubMed1998

[Validation of an instrument for identifying styles of the professional practice of the primary care doctor].

OBJECTIVE: To elaborate and validate a questionnaire for identifying common styles of Primary Care doctors' practice. SETTING: Primary Health Care. Public sector in Spain. DESIGN: This was a study to validate a questionnaire administered in two phases with different samples. In the first phase, the items (item-total correlation, using Alpha on eliminating item), validity of construction, empirical validity and internal consistency, were analysed. In the second, discriminatory validity and reliability of the questionnaire (test-retest) were calculated. MEASUREMENTS AND MAIN RESULTS: 81.5% of the doctors replied in the first phase; and 100% in the second. Two factors were isolated with the Principal Components procedure, which confirmed the validity of the questionnaire's construction (52% variance explained). Internal consistency (Alphas ranged between 0.55 and 0.75) and reliability (ranging between 0.50 and 0.95 in function of the time elapsed) were also demonstrated. CONCLUSIONS: This instrument could be used to differentiate two styles in practice, characterised by focusing on the physical illness vs the psycho-social aspects of the disease process. The instrument is also useful because it gives the feeling of control over the task.

Family Practice↗

PubMed1998

The Schwartz Cancer Fatigue Scale: testing reliability and validity.

PURPOSE/OBJECTIVES: To describe the psychometric development of the Schwartz Cancer Fatigue Scale (SCFS). DESIGN: A multiphase instrumentation study describing construct and operational definitions, informal and formal content validity, reliability, and validity analysis. SAMPLE: Content validity established with 20 subjects. Reliability and validity evaluated with 166 subjects residing in diverse parts of the United States. FINDINGS: Eleven items that failed to show variance, had high interitem correlations, or failed to discriminate were eliminated. Factor analysis resulted in a four-factor solution that accounted for 70% of the variance. Cronbach's alpha for the total scale was estimated to be 0.96 and to be between 0.82 and 0.93 for the subscales. CONCLUSIONS: The 28-item SCFS has demonstrated reliability and content and construct validity. Factor analysis supports the four subscales (physical, emotional, cognitive, and temporal). Preliminary construct validity has been demonstrated by differences in fatigue between those people who are currently receiving treatment and those who have completed treatment and by scores on a visual analogue scale of fatigue. IMPLICATIONS FOR NURSING PRACTICE: The SCFS may prove to be clinically relevant in assessing the effect of interventions to treat and manage cancer-related fatigue.

Adult↗

PubMed1998

[Construction and initial validation of a research attitude questionnaire in primary care].

OBJECTIVE: To construct and validate a research attitude questionnaire in primary care physicians. DESIGN: Validation study of a attitude questionnaire. SETTING: Teaching health centres of family medicine in Valencia (Spain). SUBJECTS: All the physicians (253) of 18 centres: family and general physicians, pediatricians and third-year family residents. MEASUREMENTS AND RESULTS: It was constructed a five Likert scale of 31 items and two dichotomic items. Pretest phase to 25 physicians. Validation Phase: 1. Reliability: a) Spearman-Brown correlation coefficient item-global and Cronbach coefficient; b) test-retest through comparing item punctuation and global. 2. Content validation; construction validation through exploratory factorial analysis and method of extreme groups (research or no) [corrected]. One hundred and fifty physicians (59.3%) answered the first contact, and 107 (71.3%) of them, the second contact. The questionnaire evidenced good internal consistency (alpha = 0.82) and time stability. Five factors were extracted that explained 58.7% of variability: research integration in primary care, self-capacity in study development, subjectives barriers, perception of education's need in research methodology, and structural barriers. Three factors showed significant differencies between extreme groups [corrected]. Definitive questionnaire of 20 items. CONCLUSIONS: The questionnaire is a valid and reliable instrument to know the research attitude of primary care physicians.

Attitude↗

PubMed1998

Validation of the Edinburgh Postnatal Depression Scale on a cohort of South African women.

UNLABELLED: Postnatal depression occurs in 10-15% of women. The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report scale designed specifically as a screening instrument for the postnatal period. It was initially validated for use in the UK, but has subsequently been validated for other communities. It has not been validated for an African community. OBJECTIVE: To determine whether the EPDS is a valid screening scale for depression in a Johannesburg community cohort. PARTICIPANTS AND SETTING: 103 women attending the postnatal clinic at Coronation Hospital, Johannesburg, South Africa. METHOD: The EPDS was validated against the Diagnostic and Statistical Manual (DSM-IV) criteria for depression. It was administered verbally to participants and translated into one of six South African languages where necessary. RESULTS: A threshold of 11/12 on the EPDS identified 100% of women with major depression and 70.6% of women with minor depression. For major and minor depression combined, sensitivity was 80%, specificity 76.6%, positive predictive value 52.6% and negative predictive value 92.2%. CONCLUSION: The EPDS, administered verbally, is a valid screening instrument in this urban South African community.

Cohort Studies↗

PubMedDate not supplied

Validation of a high voltage leak detector for use with pharmaceutical blow-fill-seal containers--a practical approach.

Proposed requirements for pharmaceutical package integrity testing outlined in the EU Guide for Sterile Medicinal Products may make it necessary to evaluate and validate alternate ways to perform 100% leak inspection. One such method is high voltage leak detection (HVLD). Even though HVLD has been used for glass ampoules and vials for years, qualification and validation strategies are not well established. In this article, we describe and discuss our practical approach to validation and the protocols used to qualify and validate a high voltage leak detector for use with blow-fill-seal containers. For this work, we used laser drilled pinholes as a model for pinholes produced during manufacturing and defined a "window diagram." This diagram allowed us to plot the parameters of influence and the settings of the HVLD in an easy to visualize pictorial display. In the validation step, we initially determined the most sensitive standard integrity test for our product and container design from the available choices, the vacuum chamber, dye bath and microbial challenge visual inspection tests. In the next phase of our work, the HVLD was crossed-validated against the most sensitive of these tests, the dye bath visual inspection test. This was accomplished with a large number of containers mixed with deliberately defective ampoules. Our conclusion from this work is that the HVLD is an appropriate and feasible integrity test for 100% inspection of blow-fill-seal containers.

Drug Packaging↗

PubMed1998

Contraceptive knowledge: development of a valid measure and survey of pill users and general practioners.

AIMS: To design, pilot, and validate a questionnaire to test contraceptive knowledge in combined oral contraceptive pill users. METHOD: To ensure face and content validity the questionnaire was developed using existing unvalidated instruments and in consultation with GPs, local and national family planning experts, and with pill users. The questionnaire was then piloted with 15 current oral contraceptive pill users and 10 local GPs, modified, and a contraceptive knowledge 'score' developed. Construct validity-that the degree of family planning training should predict contraceptive knowledge-was tested in four groups: family planning trainers (n=28), GPs (n=40), current pill users (n=53), and male medical students (n=59). Thirty current pill users were sent the questionnaire after two weeks to determine test-retest reliability. RESULTS: The questionnaire showed construct validity: there was a gradient of scores across the four knowledge groups. Family planning trainers had the highest scores, followed by GPs, and current pill users, with male medical students having the lowest scores (Kruskal-Wallis test p<0.001). Women had good knowledge of situations when pill efficacy is reduced but poorer knowledge of what action to take subsequently. Predictors of knowledge in pill users were educational level, age, and the importance attached to not falling pregnant-thus providing further evidence for the construct validity of the questionnaire. Test-retest reliability was good (rank correlation 0. 73). CONCLUSION: A contraceptive knowledge questionnaire suitable for use in audit or research has been developed which is reliable and has face, content and construct validity. Pill users have poor knowledge of what to do in situations of pill failure and about the details of emergency contraception. Trials are needed to assess the effectiveness of different strategies to improve contraceptive knowledge in women.

Adult↗

PubMedDate not supplied

Validation of a quality-of-life instrument for patients with nonmelanoma skin cancer.

OBJECTIVE: To validate a disease-specific quality-of-life instrument--the Skin Cancer Index--intended to measure quality-of-life issues relevant to patients with nonmelanoma skin cancer. METHODS: Internal reliability, convergent and divergent validity with existing scales, and factor analyses were performed in a cross-sectional study of 211 patients presenting with cervicofacial nonmelanoma skin cancer to a dermatologic surgery clinic. RESULTS: Factor analyses of the Skin Cancer Index confirmed a multidimensional scale with 3 distinct subscales-emotional, social, and appearance. Excellent internal validity of the 3 subscales was demonstrated. Substantial evidence was observed for convergent validity with the Dermatology Life Quality Index, Rosenberg Self-Esteem Scale, Lerman's Cancer Worry Scale, and Medical Outcomes Survey Short-Form 12 domains for vitality, emotion, social function, and mental health. CONCLUSIONS: These findings validate a new disease-specific quality-of-life instrument for patients with cervicofacial nonmelanoma skin cancer. Studies on the responsiveness of the Skin Cancer Index to clinical intervention are currently under way.

Adult↗

PubMed2002

Development and validation of the neck dissection impairment index: a quality of life measure.

OBJECTIVES: To validate a health-related quality-of-life (QOL) instrument for patients following neck dissection and to identify the factors that affect QOL following neck dissection. DESIGN: Cross-sectional validation study. SETTING: The outpatient clinic of a tertiary care cancer center. PATIENTS: Convenience sample of 54 patients previously treated for head and neck cancer who underwent a selective neck dissection or modified radical neck dissection (64 total neck dissections). Patients had a minimum postoperative convalescence of 11 months. Thirty-two underwent accessory nerve-sparing modified radical neck dissection, and 32 underwent selective neck dissection. MAIN OUTCOME MEASURE: A 10-item, self-report instrument, the Neck Dissection Impairment Index (NDII), was developed and validated. Reliability was evaluated with test-retest correlation and internal consistency using the Cronbach alpha coefficient. Convergent validity was assessed using the 36-Item Short-Form Health Survey (SF-36) and the Constant Shoulder Scale, a shoulder function test. Multiple variable regression was used to determine variables that most affected QOL following neck dissection RESULTS: The 10-item NDII test-retest correlation was 0.91 (P<.001) with an internal consistency Cronbach alpha coefficient of.95. The NDII correlated with the Constant Shoulder Scale (r = 0.85, P<.001) and with the SF-36 physical functioning (r = 0.50, P<.001) and role-physical functioning (r = 0.60, P<.001) domains. Using multiple variable regression, the variables that contributed most to QOL score were patient's age and weight, radiation treatment, and neck dissection type. CONCLUSIONS: The NDII is a valid, reliable instrument for assessing neck dissection impairment. Patient's age, weight, radiation treatment, and neck dissection type were important factors that affect QOL following neck dissection.

Aged↗

PubMed2001

Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated?

CONTEXT: Practice guidelines need to be up-to-date to be useful to clinicians. No published methods are available for assessing whether existing practice guidelines are still valid, nor does any empirical information exist regarding how often such assessments need to be made. OBJECTIVES: To assess the current validity of 17 clinical practice guidelines published by the US Agency for Healthcare Research and Quality (AHRQ) that are still in circulation, and to use this information to estimate how quickly guidelines become obsolete. DESIGN, SETTING, AND PARTICIPANTS: We developed criteria for defining when a guideline needs updating, mailed surveys to members of the original AHRQ guideline panels (n = 170; response rate, 71%), and searched the literature for evidence through March 2000 (n = 6994 titles yielding 173 articles plus 159 new guidelines on the same topics). MAIN OUTCOME MEASURES: Identification of new evidence calling for a major, minor, or no update of the 17 guidelines; survival analysis of the rate at which guidelines became outdated. RESULTS: For 7 guidelines, new evidence and expert judgment indicated that a major update is required; 6 were found to be in need of a minor update; 3 were judged as still valid; and for 1 guideline, we could reach no conclusion. Survival analysis indicated that about half the guidelines were outdated in 5.8 years (95% confidence interval [CI], 5.0-6.6 years). The point at which no more than 90% of the guidelines were still valid was 3.6 years (95% CI, 2.6-4.6 years). CONCLUSIONS: More than three quarters of the AHRQ guidelines need updating. As a general rule, guidelines should be reassessed for validity every 3 years.

Practice Guidelines as Topic↗

PubMed2006

Development and validation of a prognostic index for 4-year mortality in older adults.

CONTEXT: Both comorbid conditions and functional measures predict mortality in older adults, but few prognostic indexes combine both classes of predictors. Combining easily obtained measures into an accurate predictive model could be useful to clinicians advising patients, as well as policy makers and epidemiologists interested in risk adjustment. OBJECTIVE: To develop and validate a prognostic index for 4-year mortality using information that can be obtained from patient report. DESIGN, SETTING, AND PARTICIPANTS: Using the 1998 wave of the Health and Retirement Study (HRS), a population-based study of community-dwelling US adults older than 50 years, we developed the prognostic index from 11,701 individuals and validated the index with 8009. Individuals were asked about their demographic characteristics, whether they had specific diseases, and whether they had difficulty with a series of functional measures. We identified variables independently associated with mortality and weighted the variables to create a risk index. MAIN OUTCOME MEASURE: Death by December 31, 2002. RESULTS: The overall response rate was 81%. During the 4-year follow-up, there were 1361 deaths (12%) in the development cohort and 1072 deaths (13%) in the validation cohort. Twelve independent predictors of mortality were identified: 2 demographic variables (age: 60-64 years, 1 point; 65-69 years, 2 points; 70-74 years, 3 points; 75-79 years, 4 points; 80-84 years, 5 points, >85 years, 7 points and male sex, 2 points), 6 comorbid conditions (diabetes, 1 point; cancer, 2 points; lung disease, 2 points; heart failure, 2 points; current tobacco use, 2 points; and body mass index <25, 1 point), and difficulty with 4 functional variables (bathing, 2 points; walking several blocks, 2 points; managing money, 2 points, and pushing large objects, 1 point. Scores on the risk index were strongly associated with 4-year mortality in the validation cohort, with 0 to 5 points predicting a less than 4% risk, 6 to 9 points predicting a 15% risk, 10 to 13 points predicting a 42% risk, and 14 or more points predicting a 64% risk. The risk index showed excellent discrimination with a cstatistic of 0.84 in the development cohort and 0.82 in the validation cohort. CONCLUSION: This prognostic index, incorporating age, sex, self-reported comorbid conditions, and functional measures, accurately stratifies community-dwelling older adults into groups at varying risk of mortality.

Aged↗

PubMed2003

Validation of a rheumatoid arthritis health-related quality of life instrument, the CSHQ-RA.

OBJECTIVE: To test the validity and reliability of a newly developed disease-specific multidimensional quality of life instrument: the Cedars-Sinai Health-Related Quality of Life Instrument (CSHQ-RA). METHODS: A total of 350 rheumatoid arthritis (RA) patients were asked to complete the CSHQ-RA at 2 time points (4 weeks apart). Patients also completed the Medical Outcomes Study Short Form 36 (SF-36) and the Stanford Health Assessment Questionnaire (HAQ) Disability Index (DI) at the second time point. Construct validity was tested, using Pearson's correlations, by comparing subscale scores on the CSHQ-RA to those obtained from the mental component summary (MCS) and physical component summary (PCS) of the SF-36. HAQ DI scores were used to assess the discriminant validity of the CSHQ-RA. Intraclass correlation coefficients (ICCs) were used to assess test-retest reliability. RESULTS: Response rates for the first and second survey were 83% (291) and 93% (276), respectively; 84% of respondents were women, and mean age was 57 years. Mean scores +/- SDs on instruments were: HAQ 0.73 +/- 0.69; MCS 49 +/- 12; and PCS 33 +/- 11. Pearson's correlations between the CSHQ-RA subscale scores and the SF-36 scores ranged from 0.55 to 0.76 (P < 0.001). Analysis of variance indicate that scores on the CSHQ-RA discriminated between levels of physical disability as measured by the HAQ (P < 0.001). Test-retest reliability was demonstrated in the instrument's subscale scores (ICC 0.70-0.90). CONCLUSION: These results support the construct validity, discriminant validity, and reliability of the CSHQ-RA as a measure that captures the impact of RA on patients' health-related quality of life.

Arthritis, Rheumatoid↗