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The development and validation of a knowledge, attitude and behaviour questionnaire to assess undergraduate evidence-based practice teaching and learning.

OBJECTIVES: Most evidence-based practice (EBP) educational assessment tools evaluated to date have focused on specific knowledge components or technical skills. Other important potential barriers to the adoption of EBP, such as attitudinal, perceptual and behavioural factors, have yet to be studied, especially in the undergraduate setting. Therefore, we developed and validated a knowledge, attitude and behaviour questionnaire designed to evaluate EBP teaching and learning in an undergraduate medical curriculum. METHODS: We derived the questionnaire from a comprehensive literature review, informed by international and local experts and a Year 5 student focus group. We determined its factor structure and refined and validated the questionnaire according to the responses of a cohort of Year 5 and a combined group of Years 2 and 3 students using principal components factor analysis with varimax rotation. Factor reliability was computed using Cronbach's alpha coefficient. We assessed construct validity by correlating the factors with other measures of EBP activity and examined responsiveness through paired t-test of the pre/post factor mean scores. RESULTS: A 43-item questionnaire was developed. Four factors were identified from both student groups. The overall questionnaire as well as each factor had high construct validity (Cronbach's alpha > 0.7 for each scale). No significant correlations were found between the 4 factors, confirming their orthogonality. Positive correlations, however, resulted between factor mean scores and other EBP activities. The responsiveness of the questionnaire was satisfactory. CONCLUSION: A reliable knowledge, attitude and behaviour measure of EBP teaching and learning appropriate for undergraduate medical education has been developed and validated.

Adult↗

Evaluation of different methods for assessing intracellular fluid in healthy older people: a cross-validation study.

OBJECTIVES: To cross-validate existing anthropometric and bioimpedance equations to establish their validity and accuracy for estimating intracellular water (ICW) in healthy older Germans and to develop a new equation with improved accuracy and precision for predicting ICW from multifrequency bioimpedance analysis (MFBIA). DESIGN: Cross-validation study. SETTING: University of Mainz. PARTICIPANTS: One hundred fifty-five healthy volunteers aged 60 to 80 years (77 men, 78 women; mean ages +/- standard deviation 67.7 +/- 4.8 and 68.6 +/- 5.5 years, respectively). MEASUREMENTS: ICW was measured by whole-body counting of (40)potassium ((40)K) ((40)K method) as the reference method and compared by cross-validation techniques against five existing bioimpedance and three anthropometric prediction equations. A new equation for estimating ICW from MFBIA was developed using the (40)K method as criterion method. RESULTS: Compared with the (40)K method, the existing bioimpedance and anthropometric equations showed large prediction errors in ICW estimates for older men (-32.3% to +37.7%) and women (-34.2% to +26.6%), depending significantly and positively on ICW volume and inversely on weight. A new equation for estimating ICW from MFBIA was developed (R(2)=0.933, standard error of the estimate (SEE)=0.92 L) involving phase angle at 5 kHz, impedance, height, and gender, with data from 100 subjects chosen at random. Cross-validation on an independent group (n=55, R(2)=0.958, SEE=0.68 L) showed no significant bias (0.013 +/- 1.52 L). CONCLUSIONS: Published bioimpedance and anthropometric prediction equations are not applicable to older Germans because they might be population-specific. The bioimpedance equation of the manufacturer of the bioimpedance analyzer used in this study provides accurate estimates of ICW for normal weight, but not overweight, older men. The newly developed equation improves accuracy and precision of ICW estimates by MFBIA.

Aged↗

The yield, reliability, and validity of a postal survey for screening community-dwelling older people.

OBJECTIVES: To assess the yield, reliability, and validity of a postal survey developed to identify older persons in need of outpatient geriatric assessment and follow-up services. DESIGN: A longitudinal cohort study. SETTING: Outpatient primary care clinic at a Department of Veterans Affairs teaching ambulatory care center. PARTICIPANTS: Patients (N = 2,382) aged 65 and older who returned a Geriatric Postal Screening Survey (GPSS) that screened for common geriatric conditions (depression, cognitive impairment, urinary incontinence, falls, and functional status impairment). Validity and reliability testing was performed with subsamples of patients classified as high or lower risk based on responses to the GPSS. MEASUREMENTS: Test-retest reliability was measured by percentage agreement and kappa statistic. The diagnostic validity of the 10-item GPSS was tested by comparing single GPSS items to standardized geriatric assessment instruments for depression, mental status and functional status, as well as direct questions regarding falls, urinary incontinence, and use of medications. Validity was also tested against clinician evaluation of the specific geriatric conditions. Predictive validity was tested by comparing GPSS score with 1-year follow-up data on functional status, survival, and healthcare use. RESULTS: Respondents identified as high risk by the GPSS had scores that indicated significantly greater impairment on structured assessment instruments than those identified as lower risk by GPSS. The overall mean percentage agreement between the test and retest surveys was 88.3%, with a mean weighted kappa of 0.70. In comparison with a structured telephone interview and with a clinical assessment, individual items of the GPSS showed good accuracy (range 0.71-0.78) for identifying symptoms of depression, falls, and urinary incontinence. Over a 1-year follow-up period, the GPSS-identified high-risk group had significantly (P <.05) more hospital admissions, hospital days and nursing home admissions than the lower-risk group. CONCLUSION: A brief postal screening survey can successfully target patients for geriatric assessment services. In screening for symptoms of common geriatric conditions, the GPSS identified a subgroup of older outpatients with multiple geriatric syndromes who were at increased risk for hospital use and nursing home admission and who could potentially benefit from geriatric intervention.

Aged↗

Validity and reliability comparison of 4 mobility measures in patients presenting with neurologic impairment.

OBJECTIVE: To establish the reliability and validity of 4 mobility measures in neurologically impaired adults undergoing rehabilitation. DESIGN: Repeated assessment of same patients. SETTING: Two specialized neurologic centers in England. PATIENTS: Forty-six patients with neurologic disabilities selected from inpatient and outpatient rehabilitation centers who were able to stand and walk at least 10 meters, with some aid if needed. INTERVENTIONS: Patients were assessed twice, at an interval of 7 days, by the same person at the same location. Validity and reliability of each measure were compared by means of scatterplots, Bland-Altman method, and correlation coefficients. Validity was also established by comparing groups of patients expected to differ in mobility. MAIN OUTCOME MEASURES: The Rivermead Mobility Index (RMI) standard version and a version with 4 levels of answer, the 10-meter timed walk, and the 2-minute walk test. RESULTS: The measures showed significant intercorrelation, suggesting that all were valid mobility measures. Each was reasonably reliable, with no evidence of systematic bias. The revised RMI was less sensitive to differences. The distance covered in the 2-minute walk test was significantly decreased for patients using aids (p <.0005) and those with impaired leg sensation (p =.02). CONCLUSIONS: All 4 measures tested (2 RMI versions, 1-meter timed walk, 2-minute walk test) showed similar validity and reliability, and the 4-level RMI version failed to show an increased ability to detect differences. All measures showed more disability in patients using aids and those with sensory impairment.

Activities of Daily Living↗

Staging functional independence validity and applications.

OBJECTIVES: To establish construct and predictive validity of the activities of daily living, sphincter-management, mobility, and executive-function (ASME) staging system of functional independence and to describe potential applications. DESIGN: National data were used to validate the stages. Sensitivity to functional change was addressed by comparing patients' stages at discharge to their stages at admission. Construct validity was assessed by examining stage distribution differences among groups of patients classified by impairment category. Predictive validity was determined by the degree to which high stages at admission predict discharge to the community and low stages at admission predict serious morbidity or mortality. SETTING: Inpatient rehabilitation facilities. PARTICIPANTS: Data from 231,686 individuals discharged from 560 US inpatient rehabilitation facilities in 1995. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Stage at rehabilitation discharge, community discharge, acute hospital discharge, or death while in rehabilitation. RESULTS: More than 90% of patients were discharged at a higher stage in at least 1 domain while not declining in any other domain. The odds (95% confidence interval) of community discharge for patients admitted at the highest compared with the lowest stage varied from 2.1 (1.9-2.2) to 3.1 (2.9-3.2), depending on the domain. The odds of acute hospitalization or death were reduced at the highest stages, compared with the lowest, by a factor ranging from .33 (.22-.49) to .65 (.61-.69). CONCLUSIONS: The ASME stages appear valid and sensitive to change. Functional Independence Staging (FIS) has relevance in establishing prognoses and in selecting among therapeutic modalities. FIS will facilitate the identification of meaningful functional goals and interpretable clinical trial endpoints. One of its most important applications could be in the establishment of outcome indicators for quality monitoring under the prospective payment system.

Activities of Daily Living↗

Validation and refinement of survival models for liver retransplantation.

Orthotopic liver retransplantation (re-OLT) is highly controversial. The objectives of this study were to determine the validity of a recently developed United Network for Organ Sharing (UNOS) multivariate model using an independent cohort of patients undergoing re-OLT outside the United States, to determine whether incorporation of other variables that were incomplete in the UNOS registry would provide additional prognostic information, to develop new models combining data sets from both cohorts, and to evaluate the validity of the model for end-stage liver disease (MELD) in patients undergoing re-OLT. Two hundred eighty-one adult patients undergoing re-OLT (between 1986 and 1999) at 6 foreign transplant centers comprised the validation cohort. We found good agreement between actual survival and predicted survival in the validation cohort; 1-year patient survival rates in the low-, intermediate-, and high-risk groups (as assigned by the original UNOS model) were 72%, 68%, and 36%, respectively (P <.0001). In the patients for whom the international normalized ratio (INR) of prothrombin time was available, MELD correlated with outcome following re-OLT; the median MELD scores for patients surviving at least 90 days compared with those dying within 90 days were 20.75 versus 25.9, respectively (P =.004). Utilizing both patient cohorts (n = 979), a new model, based on recipient age, total serum bilirubin, creatinine, and interval to re-OLT, was constructed (whole model chi(2) = 105, P <.0001). Using the c-statistic with 30-day, 90-day, 1-year, and 3-year mortality as the end points, the area under the receiver operating characteristic (ROC) curves for 4 different models were compared. In conclusion, prospective validation and use of these models as adjuncts to clinical decision making in the management of patients being considered for re-OLT are warranted.

Adult↗

Validity and reliability of the PowerTap mobile cycling powermeter when compared with the SRM Device.

The SRM power measuring crank system is nowadays a popular device for cycling power output (PO) measurements in the field and in laboratories. The PowerTap (CycleOps, Madison, USA) is a more recent and less well-known device that allows mobile PO measurements of cycling via the rear wheel hub. The aim of this study is to test the validity and reliability of the PowerTap by comparing it with the most accurate (i.e. the scientific model) of the SRM system. The validity of the PowerTap is tested during i) sub-maximal incremental intensities (ranging from 100 to 420 W) on a treadmill with different pedalling cadences (45 to 120 rpm) and cycling positions (standing and seated) on different grades, ii) a continuous sub-maximal intensity lasting 30 min, iii) a maximal intensity (8-s sprint), and iiii) real road cycling. The reliability is assessed by repeating ten times the sub-maximal incremental and continuous tests. The results show a good validity of the PowerTap during sub-maximal intensities between 100 and 450 W (mean PO difference -1.2 +/- 1.3 %) when it is compared to the scientific SRM model, but less validity for the maximal PO during sprint exercise, where the validity appears to depend on the gear ratio. The reliability of the PowerTap during the sub-maximal intensities is similar to the scientific SRM model (the coefficient of variation is respectively 0.9 to 2.9 % and 0.7 to 2.1 % for PowerTap and SRM). The PowerTap must be considered as a suitable device for PO measurements during sub-maximal real road cycling and in sub-maximal laboratory tests.

Adult↗

Pediatric asthma assessment: validation of 2 symptom diaries.

Accurate assessment of the value of asthma interventions in pediatric clinical trials is an essential step toward the improvement of the treatment of this disorder in children. Conventional pulmonary function measures can be infeasible and unreliable in younger children, particularly for use in multisite studies. As an alternative or supplemental approach, diary questionnaires completed by the patients or their caregivers may provide valuable data regarding the efficacy of asthma interventions in pediatric clinical trials. These questionnaires, however, have routinely not been validated for use in pediatric populations. Two pediatric diary questionnaires (the child-completed Pediatric Asthma Diary [PAD] and the parent/caregiver-completed Pediatric Asthma Caregiver Diary [PACD]) were designed to evaluate asthma symptoms in children aged 6 to 14 years and 2 to 5 years, respectively. The validity of these diary questionnaires was evaluated in 2 separate prospective studies that included children who were divided into 2 asthma groups: stable (requiring no additional asthma medication) and unstable (requiring either an increase in or the addition of asthma medication). Both scales displayed significant discriminant validity, construct validity, and responsiveness to change in asthma therapy. Only the PACD detected differences between groups in nighttime symptoms, such as awakenings caused by asthma. These validity studies suggest that diary questionnaires such as the PAD and PACD can be valuable as an alternative for the evaluation of interventions in pediatric asthma when pulmonary function testing is inappropriate or as an adjunct to such objective measures.

Asthma↗

Issues in assessing the validity of nutrient data obtained from a food-frequency questionnaire: folate and vitamin B12 examples.

OBJECTIVE: To compare methods used to assess the validity of nutrient intake data obtained from a food-frequency questionnaire (FFQ), using folate and vitamin B12 as nutrient examples. DESIGN: Cross-sectional sample from a population cohort. SETTING: Two postcode areas west of Sydney, Australia. SUBJECTS: In total, 2895 people aged 49 years and older provided dietary data using a semi-quantitative FFQ (79% of 3654 subjects examined). The validity of the FFQ was assessed against three 4-day weighed food records (WFRs) completed by 78 people (mean age 70 years). RESULTS: Folate and vitamin B12 validity data were assessed using different methods. The Spearman ranked correlations (energy-adjusted) were 0.66 for folate and 0.38 for vitamin B12. Using the Bland-Altman method, following loge transformation, no linear trend existed between the differences and means for folate and vitamin B12. Large differences existed between the FFQ and WFR in individual cases, particularly for vitamin B12. Finally, data were divided into quintile categories for the test and reference method: 79% classified folate within one quintile, 65% classified vitamin B12 within one quintile; there was no gross misclassification for folate and only 3% misclassification for vitamin B12. CONCLUSIONS: Different methods of analysis provided different information about the validity of the FFQ. Correlation coefficients should not be used alone to assess the validity of nutrient data, but should be used in conjunction with Bland-Altman analyses. Depending on the use of the data, additional assessment of classification categories is recommended. This worked example demonstrates that absolute intakes of folate and vitamin B12 should be used with caution.

Aged↗

Validation of the Spanish version of the physical activity questionnaire used in the Nurses' Health Study and the Health Professionals' Follow-up Study.

OBJECTIVE: The objective of this analysis was to test the validity of the estimates of energy expenditure and sedentary lifestyle obtained through a self-administered questionnaire of physical activity for Spanish-speaking people adapted from US questionnaires (Nurses' Health Study and Health Professionals' Follow-up Study) using a triaxial accelerometer (RT3 Triaxial Research Tracker) as the reference. DESIGN AND SETTING: Validation study, calculating the non-parametric correlation coefficients between the level of physical activity and sedentary lifestyle collected by the self-administered questionnaire and the triaxial accelerometer measurements. Percentage of misclassification and kappa coefficients were also calculated. SUBJECTS: The study population consisted of a sample of 40 obese women who were participants of the SUN (Seguimiento Universidad de Navarra) project (a prospective cohort study among Spanish university alumni). They were selected because of their peculiar metabolic characteristics, in the search for a sub-optimal scenario for validity. RESULTS: Physical activity during leisure time (estimated as MET-h week(-1)) derived from the self-administered questionnaire moderately correlated with kcal day(-1) assessed through the accelerometer (Spearman's rho = 0.507, 95% confidence interval (CI) 0.232, 0.707). The Spearman correlation between the ratio of sedentary lifestyle to physical activity obtained through the questionnaire and the direct estimation (RT3) was -0.578 (95% CI -0.754, -0.325). The kappa index was 0.25 (P = 0.002) when assessing the cross-classification into quintiles and 0.41 for the dichotomous estimation of a sedentary lifestyle. Only 2.5% of participants were misclassified by the questionnaire more than two quintiles apart from the estimates of the RT3. CONCLUSIONS: The moderate values obtained for correlation in a sub-optimal scenario for validity and the low percentage of extreme misclassification suggest the validity of the questionnaire to assess physical activity in Spanish-speaking women aged 20-50 years.

Adult↗

Validity of protein, retinol, folic acid and n-3 fatty acid intakes estimated from the food-frequency questionnaire used in the Danish National Birth Cohort.

OBJECTIVE: To validate intakes of protein, folic acid, retinol and n-3 fatty acids estimated from a food-frequency questionnaire in week 25 of pregnancy (FFQ-25). DESIGN: Validation was done against a 7-day weighed food diary (FD) and biomarkers of the nutrients in gestation week 32-38. SUBJECTS AND SETTING: The FFQ-25 to be validated was used in the Danish National Birth Cohort comprising 101 042 pregnant Danish women, of whom 88 participated in the present validation study. RESULTS: Estimated intakes of protein, retinol and folic acid did not differ significantly between the two dietary methods, but intake of n-3 fatty acids was one third larger when estimated from the FFQ-25. The intakes estimated from the two dietary methods were all significantly correlated, ranging from 0.20 for retinol intake to 0.57 for folic acid intake. Sensitivities of being correctly classified into low and high quintiles were between 0.22 and 0.77, and specificities were between 0.62 and 0.89. Urinary protein content did not correlate significantly with protein estimated from the FFQ (r = 0.17, P > 0.05), but did with intake estimated from the FD (r = 0.56, P < 0.0001). Erythrocyte folate correlated significantly with the estimated total intake from the FFQ (r = 0.55, P < 0.0001) and the FD (r = 0.52, P < 0.0001). No correlations with plasma retinol were found. Erythrocyte eicosapentaenoic acid (C20:5n-3) correlated significantly with n-3 fatty acids intake estimated from both the FFQ-25 (r = 0.37, P < 0.001) and the FD (r = 0.62, P < 0.0001). CONCLUSION: The FFQ-25 gives reasonable valid estimates of protein, retinol and folic acid intakes, but seems to overestimate intake of n-3 fatty acids.

Adult↗

The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity.

INTRODUCTION: The International Physical Activity Questionnaire (IPAQ) was developed to measure health-related physical activity (PA) in populations. The short version of the IPAQ has been tested extensively and is now used in many international studies. The present study aimed to explore the validity characteristics of the long-version IPAQ. SUBJECTS AND METHODS: Forty-six voluntary healthy male and female subjects (age, mean +/- standard deviation: 40.7 +/- 10.3 years) participated in the study. PA indicators derived from the long, self-administered IPAQ were compared with data from an activity monitor and a PA log book for concurrent validity, and with aerobic fitness, body mass index (BMI) and percentage body fat for construct validity. RESULTS: Strong positive relationships were observed between the activity monitor data and the IPAQ data for total PA (rho = 0.55, P < 0.001) and vigorous PA (rho = 0.71, P < 0.001), but a weaker relationship for moderate PA (rho = 0.21, P = 0.051). Calculated MET-h day(-1) from the PA log book was significantly correlated with MET-h day(-1) from the IPAQ (rho = 0.67, P < 0.001). A weak correlation was observed between IPAQ data for total PA and both aerobic fitness (rho = 0.21, P = 0.051) and BMI (rho = 0.25, P = 0.009). No significant correlation was observed between percentage body fat and IPAQ variables. Bland-Altman analysis suggested that the inability of activity monitors to detect certain types of activities might introduce a source of error in criterion validation studies. CONCLUSIONS: The long, self-administered IPAQ questionnaire has acceptable validity when assessing levels and patterns of PA in healthy adults.

Adipose Tissue↗

Validity of simple mucosal biopsy criteria combined with endoscopy predicting patients with ulcerative colitis ultimately requiring surgery: a multicenter study.

BACKGROUND: Recent mucosal biopsy criteria combined with endoscopy effectively differentiate patients with ulcerative colitis ultimately requiring surgery (UC-S) from those receiving medication alone (UC-M). However, the criteria were inconvenient in practical use because of the need for complicated calculations, and the validity has not been verified in other institutes where the indications for surgery may differ. The aims of this multicenter study were to propose simple criteria in which calculation can be performed by mental arithmetic and to measure their validity. METHODS: Based on the above original criteria, we constructed simple criteria in which coefficients and constant were simplified to integral numbers. The criteria consisted of the diagnostic categories, highest-risk, high-risk, unpredictable, low-risk, and lowest-risk of surgery. The validity of these proposed criteria was evaluated in 121 patients with UC-S and 186 with UC-M from 11 institutes. RESULTS: The categories of high-risk and low-risk had sensitivities exceeding 86.0% and specificities exceeding 95.2%, and the validities were maintained at high levels in most individual institutes. There was little difference in validity between the proposed and original criteria when testing using the same patients. CONCLUSIONS: Despite simplified coefficients and constant, the proposed criteria reliably predicted the eventual clinical outcome of patients with ulcerative colitis and would be helpful in determining the necessity of surgery.

Adolescent↗

Digestive symptoms and their psychosocial impact: validation of a questionnaire.

OBJECTIVE: Questionnaires evaluating digestive symptoms and their psychosocial impact have not been extensively validated in Norwegian populations. In this study a self-administered questionnaire developed in Norway is evaluated for this purpose. MATERIAL AND METHODS: The questionnaire, the Digestive Symptoms and Impact Questionnaire, DSIQ, was developed by a cooperative group of general practitioners and gastroenterologists. The DSIQ contains 18 similarly structured global-type questions focusing on the patient's own judgement. The validation was based on 567 patients with dyspeptic symptoms or reflux symptoms referred to gastroscopy from general practice. RESULTS: Eighty percent of the patients responded to all the questions. All response categories were used for all questions. Factor analysis revealed 4 subscales: abdominal pain and bowel symptoms; gastric dysfunction; health impairment and impairment of everyday life. A question about reflux symptoms was retained as a subscale on its own. Overall score was established by calculating the mean of all question responses. Test-retest reliability in stable patients (intraclass correlation coefficient, range 0.80- 0.91) and internal consistency reliability (Cronbach's alpha, range 0.65-0.91) were satisfactory. Criterion validity was supported by significant correlations to patients' globally estimated quality of life and the General Health Questionnaire (GHQ-30). Responsiveness in spontaneously improved patients or patients given effective treatment ranged from moderate to highly responsive (responsiveness statistic range from 0.54 to 2.83). CONCLUSIONS: The DSIQ is a self-administered, simple and well-validated method for evaluating digestive symptoms and their psychosocial impact. The DSIQ shows satisfactory internal consistency reliability, test-retest reliability, responsiveness and criterion validity.

Adult↗

Validation of the profile of female sexual function (PFSF) in surgically and naturally menopausal women.

The Profile of Female Sexual Function (PFSF) is a patient-based instrument for the measuring of loss of sexual function in menopausal women with low libido (hypoactive female sexual desire disorder). The instrument, which contains 37 items in seven domains (sexual desire, arousal, orgasm, sexual pleasure, sexual concerns, sexual responsiveness, and sexual self-image) and a single-item measure of overall satisfaction with sexuality, has been extensively developed and initially validated in over 500 oophorectomized women with low libido in North America, Europe, and Australia. Initial validation results showed the PFSF is capable of discriminating these patients from age-matched controls and produced consistent responses and sensitivity across geographies. The objective of this nonrandomized, parallel-group study was to examine the psychometric properties of the final PFSF in an independent group of surgically menopausal women with low libido and to extend validation to naturally menopausal women with low libido. Participants from 16 study centers in North America included surgically (n = 59) and naturally (n = 88) menopausal women with low libido and their age-matched control subjects, both premenopausal (n = 57) and naturally menopausal (n = 47), who reported no problems with libido. Subjects completed the PFSF at baseline and again 4 weeks later. Adjusted mean scores for each of the seven domains were statistically significantly lower (P < 0.0001) in surgically menopausal women with low libido compared with age-matched control women, and in naturally menopausal women with low libido compared with naturally menopausal control women, demonstrating excellent discriminant validity. Test-retest reliability ranged from 0.57 to 0.91 for the seven domain scores, whereas internal-consistency reliability ranged from 0.74 to 0.95. Results of this research support the conclusion that the PFSF is a valid and reliable instrument for measurement of loss of sexual function in both naturally and surgically menopausal women with low libido.

Aged↗

The Marijuana Screening Inventory (MSI-X): concurrent, convergent and discriminant validity with multiple measures.

This study evaluates the concurrent, convergent and discriminant validity between the MSI-X and five other instruments completed by 107 adults. Pearson correlation analysis with follow-up t-tests found concurrent validity between the MSI-X, Drug Abuse Screening Test (DAST-20), five Substance Abuse Subtle Screening Inventory (SASSI-3) subscales, a Diagnostic Statistical Manual (DSM) IV-TR Guided Marijuana Inventory, and two Addiction Severity Index variables. As evidence of MSI-X discriminant validity, no correlations were found with three alcohol measures. Convergent validity, determined by t-test associations between MSI-X total problems with SASSI-3 substance dependence scores, supported the MSI-X > or =6 scoring cutoff. Overall, the findings support MSI-X concurrent, convergent and discriminant validity.

Adolescent↗

Validation and regulatory acceptance of new carcinogenicity tests.

The 3 Rs concept, which was developed by Russell and Burch in 1959, was implemented into the legal framework in the European Union(EU) for the protection of vertebrate animals used for experimental and other scientific purposes, when Directive 86/609/EEC was adopted in 1986. To reduce or replace animal testing for regulatory purposes, nonanimal tests must be independently validated to prove that they can provide information that is relevant and reliable for hazard prediction in vivo. At the end of the 1980s, no scientific concept existed for the formal validation ofin vitro toxicity tests, so a small group of European and American scientists developed a set of principles for experimental validation, which was accepted internationally by the OECD in 1996. A major breakthrough was the acceptance in the EU of the scientifically validated in vitro toxicity test for phototoxic potential in 2000, which was accepted by the OECD at the worldwide level in 2002. Taking the progress in the development and validation of alternative toxicity tests during the past decade into account, the current concepts of developing alternatives to the standard 2-year rodent bioassay for carcinogenicity testing are discussed.

Animal Testing Alternatives↗

Validation analysis of probabilistic models of dietary exposure to food additives.

The validity of a range of simple conceptual models designed specifically for the estimation of food additive intakes using probabilistic analysis was assessed. Modelled intake estimates that fell below traditional conservative point estimates of intake and above 'true' additive intakes (calculated from a reference database at brand level) were considered to be in a valid region. Models were developed for 10 food additives by combining food intake data, the probability of an additive being present in a food group and additive concentration data. Food intake and additive concentration data were entered as raw data or as a lognormal distribution, and the probability of an additive being present was entered based on the per cent brands or the per cent eating occasions within a food group that contained an additive. Since the three model components assumed two possible modes of input, the validity of eight (2(3)) model combinations was assessed. All model inputs were derived from the reference database. An iterative approach was employed in which the validity of individual model components was assessed first, followed by validation of full conceptual models. While the distribution of intake estimates from models fell below conservative intakes, which assume that the additive is present at maximum permitted levels (MPLs) in all foods in which it is permitted, intake estimates were not consistently above 'true' intakes. These analyses indicate the need for more complex models for the estimation of food additive intakes using probabilistic analysis. Such models should incorporate information on market share and/or brand loyalty.

Databases, Factual↗