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PubMed1995

[French version and validation of a scale evaluating compliance in diabetic children].

In order to evaluate the educational needs of diabetic children, a study was performed to validate a scale for adherence to treatment (compliance) by diabetic children. The lack of such scales in France, led us to validate an existing American scale. After a classic linguistic translation, back-translation, and a pilot study, 165 diabetic children aged 7 to 13 years filled out a 25 item questionnaire that assessed four areas: glucose testing, diet, hypoglycemia, insulin adjustment. Face validity as measured by response rates was excellent and the reliability as measured by Cronbach's alpha was good (alpha = 0.65) as in the American scale. Concordant validity was studied: the insulin adjustment score was inversely correlated with hypoglycemia (r = -0.23, p < 0.01); age (r = 0.28, p < 0.001), age at diagnosis (r = 0.18, p < 0.05), and diabete knowledge (r = 0.47, p < 0.001) were all correlated with adherence. The French version of the adherence to treatment scale is valid and reliable for the study of adherence to treatment in diabetic children. This scale provides an evaluative tool that will facilitate the performance of an educational diagnosis.

Adolescent↗

PubMed1994

The validity of the Michigan Alcoholism Screening Test (MAST).

This review examines the validity of the Michigan Alcoholism Screening Test (MAST) as a screening instrument for alcohol problems. Studies that compare the MAST-questionnaire with other defined diagnostic criteria of alcohol problems were retrieved through MEDLINE and a cross-bibliographic check. A total of 20 validity studies were included. The studies varied considerably regarding the prevalence of alcohol problems, the diagnostic criteria, and the examined patient categories. The MAST compared with other diagnostic criteria of alcohol problems gave validity measures with the following span: predictive positive value (PVpos) 0.24-0.96, predictive negative value (PVneg) 0.78- approximately 1, sensitivity 0.36- approximately 1, and specificity 0.36-0.96. It appears that the PVneg are high. Except from one study, the sensitivities (0.57- approximately 1) are also high. The PVpos and the specificities show substantial variations. The variables that seem to have the largest influence on the PVpos seem to be the prevalence of alcohol problems, the diagnostic method against which the MAST-questionnaire is validated, and the populations on which the MAST is applied. The MAST should in the future be validated against internationally accepted diagnostic methods on populations with representative prevalences of alcohol problems.

Alcoholism↗

PubMed1994

[Computer-assisted validation system applied to hematology: Valab-hemato].

Validation of laboratory reports is the ultimate step before transmission of results to the clinician. The biologist checks the intrinsic consistency of the data as well as their possible medical value that is liable to lead to other investigations. Such a policy, when performed on all the data, is time-consuming, boring and uncertain. This step may be simplified by the use of a computerized expert system. The computer assisted validation system presented here concerns routine haematology data (Valab-haemato). Like its predecessor devoted to clinical chemistry (Valab-Biochem) it is based on the performance of a powerful inference engine which generates a decision-making tree for each report according to the data. This adaptability gives the system a capacity very close to human reasoning. In its haematology version the system deals with many variables including sex, age, origin of the patient (hospital ward), and the haematological data (blood cell count, differential, reticulocyte count, various information drawn from microscope examination of the blood smear as well as any report concerning the blood sample, erythrocyte sedimentation rate). Previous data are also taken into account, as well as the normal ranges, the values beyond which no result can be automatically validated and the delta-check. Some information definitely prevents validation of the results, others can be validated if they have been previously approved. Whereas the method of reasoning is fixed, all items are changeable in order to adapt the system to the type of activity of the laboratory.(ABSTRACT TRUNCATED AT 250 WORDS)

Artificial Intelligence↗

PubMedDate not supplied

Role of quality control in validation of biopharmaceutical processes: case example of clean-in-place (CIP) procedure for a bioreactor.

If ever clear instruction and close teamwork is needed, it is in the validation of manufacturing processes. All members of the Validation Team need to understand how the Quality Control testing fits into the overall validation work plan. This affords the team members the opportunity to understand how data will be used and avoids a situation where the test results either invalidate or inadequately support the validation plan. A case example is presented for an approach used to validate Clean-in-Place (CIP) procedures for 1600 L bioreactors which are operated on a campaign basis for multi-biopharmaceutical synthesis.

Chromatography, High Pressure Liquid↗

PubMedDate not supplied

Validation--how much can the world afford? Are we getting value for money?

The author raises questions not usually considered in discussions of validation: "How much validation can the world afford?," "Are we getting value for money?," and "What's in it for the patient?." The paper develops the theme that, while validation is undoubtedly important, the pharmaceutical industry has not given adequate thought as to whether the benefits of validation outweigh the costs in implementation of validation.

Cost-Benefit Analysis↗

PubMed1993

Exploring the validity of data-gathering instruments.

The validity of an instrument is another important issue for the clinician to consider when selecting a tool for use in data collection. Broadly defined, validity refers to the extent to which an instrument measures what it is supposed to be measuring. Although validity is a unitary concept, this article explores three common categories of validity: content, criterion-related, and construct validity.

Data Collection↗

PubMed1996

Assessing functional disability and health status of women with fibromyalgia: validation of a Hebrew version of the Fibromyalgia Impact Questionnaire.

OBJECTIVE: To validate a translated version of the Fibromyalgia Impact Questionnaire (FIQ) to be used by Hebrew speaking populations. METHODS: We administered the FIQ to 100 women with fibromyalgia (FM). The FIQ measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. All patients were asked about the presence and severity (assessed by visual analog scale) of relevant FM symptoms (pain, fatigue, anxiety, etc.); a count of 18 tender points was conducted by thumb palpation, and tenderness thresholds were assessed by dolorimetry. Test-retest reliability was assessed using Spearman correlations. Internal consistency was evaluated with Cronbach's alpha coefficient of reliability. To assess content validity a cutoff criterion of > or = 25% impairment responses was set to indicate a valid item. Construct validity of the FIQ was evaluated by correlating the physical functioning score as well as the separate items with measures of symptom severity, count of tender points, and tenderness thresholds. RESULTS: Test-retest reliability was r = 0.96 for physical functioning, and 0.80-0.96 for other items of FIQ. Internal consistency was alpha = 0.93 at Time 1 and 0.86 at Time 2. Seventeen of 19 items of the FIQ met the > or = 25% criterion. Significant moderate to high correlations were obtained between the FIQ items and severity symptoms, point count, and tenderness threshold. CONCLUSION: The FIQ is a reliable and valid instrument for measuring functional disability and health status in Israeli women with FM.

Disability Evaluation↗

PubMed1995

[Effectiveness of validation. A literature study].

This review-article reports on literature on the effectiveness of validation; and approach used for disoriented elderly. Literature has been searched for by means of several (computerized) indexes and references. By contacting Feil, who developed validation, unpublished articles and reports became available. This search resulted in 13 effect-studies, of which 7 are unpublished, 2 descriptive reports, and 1 research-proposal. The effect-studies have varying designs with different methodological restrictions causing bias. The analysis showed that the quality and therefore the evidential value of the effect-studies is limited. The better the study, the less validation appeared to be effective. It is concluded that the hypothesis, that validation has positive effects on disoriented elderly and their caregivers, has no or minimal scientific basis. Before validation is implemented more and more in Dutch health care, scientific research addressing its effects is indicated.

Aged↗

PubMed1996

[Validity of the protocol for evaluating the inappropriate use of hospitalization].

BACKGROUND: The study was carried out in order to assess the inter-observer reliability and validity in respect of clinical appraisal given by the Appropriateness Evaluation Protocol (AEP), in the context of the Spanish Public Hospital System. MATERIAL AND METHOD: In order to assess the reliability a total of 614 hospital stays chosen at random from 56 hospital admissions were independently analysed by three reviewers (two doctors and one nurse). In order to assess the validity, the findings obtained by the nurse were compared with the majority opinion given by the 7 hospital specialists in respect of each of hospital stays under evaluation. As part of the analytical procedure, indices for observed agreement, and specific agreement were calculated, as well as the Kappa statistic, all forming of various random samples of 614 hospital stays. In order to assess the predictive validity of the AEP, its sensitivity, specificity and predictive values were all measured against the majority clinical judgement. RESULTS: The study exhibited a high degree of inter-observer reliability (specific agreement > 64%, kappa > 0.75) and a reasonable validity in comparison with the consensus of opinions formed by a least 4 or 5 of its 7 clinical reviewers (specific agreement > 61%, kappa > 0.64), these values decreasing notably when the consensus of 6 or 7 of the reviewers was required. The AEP revealed a high degree of sensitivity and a low degree of specificity in comparison with the majority clinical assessment, thus minimising the occurrence of false results when the stay was regarded as appropriate, and producing false negatives (appropriate hospital stays regarded as inappropriate) varying in degree from moderate to very high. CONCLUSIONS: The results showing high reliability and moderate validity regarding clinical assessment shows the AEP to be a useful instrument in the sifting-out of inappropriate use of hospitalisation, although they do not allow a definitive judgement to be made concerning the efficiency of hospital services nor judgements regarding individual cases.

Evaluation Studies as Topic↗

PubMed1996

Replacement, reduction or refinement of animal use in the quality control of veterinary vaccines: development, validation and implementation.

Various different methods have been developed to replace, reduce or refine the use of animals in batch quality control tests of veterinary vaccines. The development, validation and implementation of those alternatives which lead to a significant reduction in the numbers or the suffering of the animals used must receive priority. Validation is one of the hurdles to the implementation of alternative methods into relevant legislation, so it deserves special attention. For proper validation studies, co-operation between various organisations of both government and industry is necessary. International and national organisations such as ECVAM, FRAME, SIATT, ZEBET and the recently established Netherlands Centre Alternatives to Animal Use (NCA) could contribute significantly to the development, validation and implementation of alternative methods by simulating and co-ordinating research projects, by providing information through databases, and by co-ordinating validation studies.

Animal Testing Alternatives↗

PubMed1996

Development and validation of a critical care patient classification system.

OBJECTIVE: To describe the research methodology used in development and validation of a scientific patient classification instrument for South African critical care patients. METHOD: This is a contextual, exploratory, and descriptive study. A two-phase validating model was used as a research method. In the development phase a literature review was carried out (domain identification), a provisional instrument developed (item generation), and a peer group discussion conducted (item formation). In the quantification phase 16 experts determined if both the items of the instrument and the entire instrument were content valid. The study was conducted within the framework of South African critical care nursing. RESULTS: In the peer group discussion the instrument was debated until consensus was reached. In the quantification phase, both the items of the instrument and the entire instrument were rated as content valid. CONCLUSIONS: Established patient classification systems can be successfully adapted and validated for local use.

Critical Illness↗

PubMed1996

Development and validation of a rheumatoid hand functional disability scale that assesses functional handicap.

OBJECTIVE: To construct a functional disability scale for the rheumatoid hand and to determine if this scale also assesses functional handicap. METHODS: Outpatients and inpatients with rheumatoid arthritis (RA) according to the ACR criteria answered a set of questions on their daily hand activities. Intrarater and interrater reliability were examined. Criterion referenced validity, and convergent and divergent validities were investigated. Factor analysis followed by varimax rotation was performed. Spearman's (rs) correlation coefficients between 2 quantitative variables were examined. The level of significance was p < 0.05. RESULTS: 96 patients with RA were recruited. The provisional scale had 41 questions. The elimination process left 18 hand activity questions with 6 levels of answers. The intrarater and interrater reliabilities of the scale were 0.97 and 0.96, respectively. Correlation of the scale's total score with visual analog scale (VAS) measure of functional handicap (rs = 0.78) showed good criterion referenced validity. The scale had good convergence with Revel's Functional Index (rs = 0.91) and a moderate relation to the Hand Functional Index (HFI) (rs = 0.58). The scale had a moderate, fair, or no relation to age, morning stiffness, pain measures, and hand swelling. The scale had 3 main factors by factor analysis. An English translation of the scale was validated. CONCLUSION: We have developed a practical functional disability scale for rheumatoid hands that also assesses functional handicap. It has 18 hand activity questions and has been validated in a French population.

Adolescent↗

PubMed1995

Validity and reliability of the family inventory of needs (FIN): measuring the care needs of families of advanced cancer patients.

Two studies balanced qualitative and quantitative data to provide evidence of satisfactory validity and reliability of the Family Inventory of Needs (FIN). The FIN is designed to measure the importance of care needs of families of advanced cancer patients (FIN-Importance of Care Needs subscale) and the extent to which families perceive that their care needs have been met (FIN-Fulfillment of Care Needs subscale). The first study involved development of the instrument and testing for clarity, apparent internal consistency (non-quantitative assessment of homogeneity of content), and content validity using a panel of six experts (family members of advanced cancer patients). The FIN met or exceeded the preset criteria specified used in this phase of testing. The second study of the project used 109 family members of advanced cancer patients from three hospice programs to test the FIN for internal consistency and construct validity. Internal consistency of the FIN-Importance of Care Needs subscale as measured by Cronbach's alpha coefficient was .83 without redundancy. Construct analysis was assessed using factor analysis techniques. An inability to extract a substantively meaningful minimum number of factors, together with the fact that a theta reliability coefficient of .85 was obtained (only .02 higher than the alpha coefficient), suggested that the items were parallel supporting the conclusion that the subscale is unidimensional. Support for the construct validity of the FIN-Importance of Care Needs subscale was also obtained using predictive modeling. The internal structure of the FIN-Fulfillment of Care Needs subscale was assessed using cluster analysis. Results suggested that the subscale is a unidimensional one. Overall, the FIN met the preset reliability and validity criteria providing promising evidence for the instrument's sound psychometric properties for use in research and clinical settings.

Adult↗

PubMed1996

[Construction and validation of an attitude scale to primary health care].

OBJECTIVES: To elaborate and validate a scale which can be used as an instrument to find the attitudes towards primary health care of doctors at the first care level. DESIGN: Validation study and questionnaire on attitudes. SETTING: The first care level in the Murcia region. Subjects were 155 doctors (27 family and 128 general doctors) in fixed and provisional posts working in the out-clinics and health centres. MEASUREMENTS AND RESULTS: A Likert-type attitudes scale was designed with five reply options. After the pilot-study on the initial scale and the full item-item correlation, the definitive 46-item survey was elaborated. Selection of subjects was through two-stage stratified randomised sampling, by specialty (general/family medicine) and health district. Reliability was high. Contents validity was reached through various consensus methods. To test validity of construction, a factorial analysis of the main components was performed, with 7 factors isolated: overall patient care, team-work, guidance on health problems, doctor's interest in in-work training, professional role, concern for the psychosocial aspects of the illness and inclusion of second level professionals. CONCLUSIONS: The scale designed is a valid instrument, both a reliable way of identifying PHC doctors' attitudes and the attitudes, which could be improved.

Attitude of Health Personnel↗

PubMed1996

The cardiac health profile: content, reliability and validity of a new disease-specific quality of life questionnaire.

BACKGROUND: The Cardiac Health Profile (CHP) is a new questionnaire for assessing health-related quality of life of patients with cardiovascular diseases. It consists of three parts assessed as follows: the degree of angina pectoris (the CCS scale), the quality of life and subjective scoring of psychosocial 'cost-benefit'. Parts II and III of the questionnaire are based on visual analogous scales and consist of 16 and two questions, respectively, covering nine areas. This quality of life questionnaire has been tested for reliability, validity and sensitivity. METHODS: Eighty consecutive patients with angina pectoris, who were waiting for coronary angiography, were enrolled in the study. Four sets of data were deleted since the respondents were not able to fill in the forms correctly. Fifty-one healthy volunteers constituted a control group. RESULTS: Reliability was assessed by a 'test and retest' method. The resulting correlation coefficient was 0.927 (P = 0.0009). Internal consistency was studied by applying Cronbach's alpha. The internal alpha-coefficient was 0.89. Concurrent validity was studied by comparing the outcome in the Nottingham Profile with the CHP. The intercorrelation indicated good concurrent validity (r = 0.753, P = 0.0001). The construct validity was assessed by performing a factor analysis. The sensitivity was assessed in three ways: analysis of kurtosis, comparison of the group of angina pectoris patients with a healthy control group and by comparing CHP results before a standard intervention (coronary artery bypass grafting) and after. The CHP showed in all of these ways a good sensitivity with statistically significant differences between angina patients and the control group (P < 0.0001). A significant improvement in health-related quality of life was also found after coronary artery bypass grafting compared with before (P = 0.02). CONCLUSIONS: The CHP has been found to be reliable, valid and sensitive and the present findings encourage use of the questionnaire in clinical trials for its further development.

Angina Pectoris↗

PubMed1997

The validity of self-reported drug use in survey research: an overview and critique of research methods.

Since illicit drug use is by definition illegal, the tasks of measuring incidence and prevalence and charting the course of the epidemic have fallen to survey researchers over the past 30 years. Although survey methods have obvious advantages over indirect measures such as arrests, seizures, and treatment admissions, they are frequently criticized because the rely on valid self-reporting of sensitive and highly stigmatized behavior. Validation studies conducted before the mid-1980s involving known samples of drug users or urinalysis techniques suggested that drug use was fairly accurately reported in self-report surveys. However, more recent validation studies conducted with criminal justice and former treatment clients using improved urinalysis techniques and hair analyses demonstrate that self-report methods miss a lot of recent drug use. A review of the research literature suggests that neither self-reports nor bioassays are wholly accurate, and both have inherent problems. However, because self-report measures are necessary to understand the complexity of causal and correlational attributes of drug abuse, it is necessary to determine what can be done to improve valid self-reporting. This chapter examines the research literature on validation studies to provide an overview of what is known about the accuracy of self-reported drug use.

Health Surveys↗

PubMed1997

Reliability and validity of stationary cystometry, stationary cysto-urethrometry and ambulatory cysto-urethro-vaginometry.

OBJECTIVE: The purpose of this article is to evaluate the reliability and validity of stationary cystometry, stationary cysto-urethrometry and ambulatory cysto-urethro-vaginometry for the diagnosis of urinary incontinence. MATERIAL AND METHODS: Literature search on reproducibility of cystometry is based on articles written in the English language found in Medline from 1987 to 1993. Five articles were found. These articles had references for another 6 older articles about the same topic. One recently published article is evaluated as well. Data about reproducibility of cystometry performed in these studies are given. Knowledge of reproducibility of cystometry combined with urethrometry, urethro-vagino or rectometry with leak detection during stationary or ambulatory recording is given. An evaluation of validity of the different methods is presented. RESULTS AND CONCLUSION: Conflicting data has been found for sensory parameters of stationary cystometry such as volume or pressure at first desire to void, strong desire to void and maximum cystometric capacity. No data were found concerning the reliability of cystometry for the recording of urinary incontinence. The main problem of urge-incontinent patients is leakage with a strong feeling of urgency. The recording of sensory parameters by cystometry is not valid when the main problem is urge incontinence. Cystometry will be valid for the diagnosis of urge incontinence when a leak detector is used or a mark is made at the tracings when leakage is observed. The reliability of cystometry concerning urge incontinence should be documented. The reliability of a urethral pressure recording when the urethral catheter is extracorporally fixed is low. The reliability and validity of ambulatory cysto-urethro-vaginometry in diagnosing urge incontinence, unstable urethra and genuine stress incontinence seems to be good, but needs better documentation.

Female↗

PubMed1996

[Development of a questionnaire to measure the effect of urinary incontinence on female sexuality: a reliability and validity study].

OBJECTIVES: This study developed a measure of the degree of the effect of urinary incontinence on female sexuality and tested the reliability and validity of the developed measure. Effect of Urinary Incontinence on Sexuality Questionnaire (EISQ). METHODS: The EISQ was developed from a thorough literature review and interviews of 20 individuals with urinary incontinence who said their incontinence had affected their dyadic relationship. These items were submitted to an analysis of content validity. This work resulted in a 28 items questionnaire that used a 4-point Likert-type response scale. The reliability and validity of the EISQ was tested with 144 women with incontinence who visited out-patient clinic in six hospitals. RESULTS: Cronbach's alpha as the index of internal consistency was high. The EISQ total was 0.90 and alpha ranged from 0.70 to 0.93 for the six subscales. Six factors each with an eigenvalue greater-than-or-equal-to-one were extracted from a principal components factors analysis with varimax rotation. The cumulative percentage of variance explained by this solution was 69.0%. Concurrent validity analyses confirmed our predictions that the EISQ scores were related to Patient Incontinence Stress (ISQ-P) scores. CONCLUSION: The EISQ proved to be reliable and valid as a self-administered measure for assessing the effect of urinary incontinence on female sexuality. The EISQ has demonstrated sufficient psychometric properties to warrant continued study of other samples and to explore the relationship between EISQ and other outcome variables.

Adult↗