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PubMedDate not supplied

[Validity of the BVAQ: a study in eating disorder patients and controls].

UNLABELLED: Alexithymia core features are the difficulties in identifying and describing feelings; the difficulties in distinguishing feelings from the bodily sensations of emotional arousal; an impaired symbolization, as evidenced by a paucity of fantasies and other imaginative activity; and a tendency to focus on external events rather than inner experience. Several measures of alexithymia have been developed, including interviewer-rated questionnaires and self-report questionnaires. Among the self-report questionnaires, the 20-item Toronto Alexithymia scale (TAS-20) is the most commonly used, but it fails to measure all the core features of alexithymia. A recently developed instrument, the Bermond-Vorst Alexithymia Questionnaire (BVAQ), allows the measurement of the alexithymia core features, as well as an additional one. It appeared to present good psychometric properties, notably the abbreviated BVAQ-form B. The results of recent studies comparing the psychometric properties of the TAS-20 and the BVAQ have recommended the BVAQ over the TAS-20. However, this questionnaire needed further validation. OBJECTIVES: Thus, the aim of the present study was to determine the convergent, discriminant and concurrent validity of the Bermond-Vorst Alexithymia Questionnaire -- form B (BVAQ-B) in a clinical sample of 59 eating disorder patients, as well as in 191 controls. The TAS-20 constituted the gold standard for the assessment of the BVAQ-B' convergent validity. To compare the concurrent validity of the BVAQ-B and the TAS-20, participants also completed several self-reports investigating different dimensions of emotion regulation capacities: the 13-item Beck Depression Inventory (BDI), the Spielberger State and Trait Anxiety Inventory (STAI-form Y), as well as the Chapman and Chapman Physical and Social Anhedonia Scales (PAS and SAS). One way analyses of variance were used for mean scores comparisons. Convergent validity was determined using Pearson coefficients of correlation. RESULTS: Results of the analyses suggested the BVAQ-B has a satisfying convergent and discriminant validity. This was observed in both the clinical and control samples. Moreover, the comparison of the convergent validity of the BVAQ-B and the TAS-20 revealed several differences between these two alexithymia self-report questionnaires. The BVAQ-B appeared less sensitive to the subjective emotional state of the participants than the TAS-20. Whereas it was argued the TAS-20 overlaps with other emotional state scores, the BVAQ-B would allow to measure alexithymia more specifically. In addition, the present results allowed to further determine the relations between alexithymia and other dimensions of emotion regulation capacities. The analyses confirmed that alexithymia is linked to other emotion regulation dimensions such as depression and anxiety. Moreover, alexithymia was associated with physical and social anhedonia, two dimensions that received less interest in the alexithymia literature to date. This study also showed that control and clinical sample have different emotion regulation capacities. Eating disorder patients were not only more alexithymic and more depressed, but also more anxious and more anhedonic than the controls. Finally, this study revealed that alexithymia differs whether the alexithymic individuals are patients or controls. Healthy alexithymic individuals (ie, individuals categorized as alexithymic in the control group) seemed characterised by a selective deficit of emotional cognition, with sparing of emotional experience (Bermond's type II alexithymia). Alexithymics individuals of the eating -disorder group seemed particularly unabled to experience affect. This pattern could correspond to Bermond's type I alexithymia, which is characterised by the absence of emotional experience and, consequently, by the absence of the cognition accompanying the emotion. In summary, results of the present study add to the literature debating on whether alexithymia is similar in different types of population.

Adolescent↗
PubMedDate not supplied

[Validation of the French version of the Body Shape Questionnaire].

UNLABELLED: In today's societies, pressures from the idea of thinness are omnipresent and lead to a corporal dissatisfaction with an excessive preoccupation of the body's image. It seems important to have, in France, a device that can evaluate the corporal dissatisfaction degree, for the reason that the troubles of the body's image is a common diagnostical category to the anorexia and bulimia (DSM IV, 1994). Cooper et al. (1987) have developed one-dimensional questionnaire of 34 items in order to measure the worries towards the weight and the shape of the body, called the "Body Shape Questionnaire" (BSQ). Its concurrent validity has been shown with the using of the corporal dissatisfaction under-scale of the Eating Disorders Inventory (EDI; Garner et Olmsted, 1984) and the using of the diagnostical questionnaire: Eating Attitude Test (EAT; Garner et Garfinkel, 1979). The BSQ gives us a way to explore the role of extreme worries towards the body's apparence in the development, the keeping and the treatment of eating disorders. From this point the BSQ is a tool widely used on an international level in researches on the eating disorders. It has been validited in Spain and in Germany whereas it has not been yet subject to a validation in France. For this reason, we proposed to use the BSQ on the french population. METHODOLOGY: The sample is made of 242 university girl students. The average age is 20.7 years old with an standard deviation of 2.26. The size and the weight helped us to calculate the Body Mass Index (BMI) which is in fact the weight divided by the size squared. The average BMI is 21.06 kg/m2 +/- 2.87. Regarding the evaluating devices, the BSQ is presented as a scale of 34 items marked by 6 different points: 1 never, 2 barely, 3 sometimes, 4 often, 5 very often, 6 always. After getting the authorization form the authors to respect during these kinds of procedures, we have started validation. The corporal dissatisfaction under-scale of Eating Disorder Inventory (EDI, Garner et al., 1991) is made of 9 items and has a scale of 6 points going from "never" to "always". In order to evaluate the accuracy of the Body Shape Questionnaire (BSQ) in France, we made a test/retest. The concurrent validity of the BSQ has been evaluated by the EDI. The 242 subjects have been asked to fill in both questionnaires during the test and the re-test (4 weeks after the test). We have evaluated the accuracy of the BSQ with the calculation of the constancy test/retest (Pearson's r) and the measure of the internal consistency (Cronbach's alpha). Then, we tested the validity regarding an external criteria. The validation procedure is based here on an examination of the correlations between the tests results (BSQ) and another measure taken as criteria (EDI). The solutions proposed by the factorial exploratory analysis have been tested by confirmatory analysis using the 2 index of adjustment: the GFI ("Goodness of Fit Index") and the CFI (Comparative Index of Bentler) which, greater than 0.85, shows a satisfying adjustment and the RMC (redidue) which has to be less than 0.10 for a satisfying adjustment. Finally, inferential statistical analysis have studied the relations between the weight's category and the total result at the BSQ and the results of the factors sprung from factorial analysis. RESULTS: Correlations between the items of test/re-test BSQ are greater than 0.93. The alpha coefficient is high for the test (0.95) and also for the re-test (0.94). This shows a very good internal consistency between the 34 items of the BSQ. Concerning the EDI, the correlation between the test/re-test are greater than 0.98. The alpha coefficient of Cronbach is high: 0.85 for the test and 0.84 for the re-test. The Pearson's r of the BSQ/EDI test and the BSQ/EDI re-test greater than 0.7 point out the concomitant validity of the BSQ with the EDI. We made a factorial analysis of the BSQ (test) on the 242 subjects. We used the extraction of the main components method with the extraction's rule of the curve for the real values. The transformation method used here is the normalised Varimax. The factorial analysis shows four factors with their own value greater or equal to 1 (15.1; 1.77; 1.48; 1.08). This solution concerning these four factors explains 55.2% of the total variance. The oblical rotations analysis of the four factors seems to point out a high correlation between these latters (from 0.54 to 0.77), this suggests a hierarchical pattern with a single factor which is confirmed with an Cronbach's alpha of 0.95. Then, we chose to gather around each selected factors the items presenting a substantial saturation, greater than or equal to 0.5 and which are saturated by only one factor. The first factor obtained by the factorial analysis of the BSQ has been called "social avoidance and shame of the exposure of the body". The internal coherence of this factor is satisfactory (Cronbach's alpha = 0.87). The second factor obtained has been called "body dissatisfaction compared to the lower parts ot the body (Cronbach's alpha = 0.90). The third factor has been called "using laxatives and vomiting in order to reduce body dissatisfaction" The fourth factor has been called "unsuited cognitions and behaviours in order to control the weight (Cronbach's alpha = 0.76). The solution with 1 and 4 factors has been tested by a confirmatory analysis. The adjustment parameters of the unifactorial pattern were not satisfactory (GFI = 0.76, CFI = 0.83, RMC = 0.5). The 4 factors pattern adjusted better to the data (GFI = 0.86, CFI = 0.90, RMC = 0.5). In order to determinate the differences between the weight/score categories to the BSQ) score in comparison to the 4 factors (coming from the factorial analysis), several Anova have been released as well as post-hoc tests (test of Sheffé). There is a significant effect of the weight category on the corporal dissatisfaction (BSQ result), F (2.230) = 11.34; p < 0.0001. Scheffe's test placed in a prominent position the fact that the subjects having an overweight (99.85 +/- 31.34) have a corporal dissatisfaction significantly greater than the subjects having a normal weight (74.08 +/- 27.94) and presenting a thinness (63.19 +/- 23.61). We pointed out a significant effect of the weight category on factor one "social avoidance and shame of the exposure of the body" [F (2.232) = 20.18; p < 0.001], on factor 2 "body dissatisfaction compared to the lower parts of the body" [F (2.232) = 6.38; p < 0.005] and factor 4 "reduce body dissatisfaction and unsuited cognitions and behaviours in order to control the weight" [F (2.232) = 5.67; p < 0.005]. However, there is no effect in the weight category for factor 3 "using laxatives and cominting in order to reduce the corporal dissatisfaction" [F (2.232) = 5.67; p > 0.05]. Sheffe's test highlighted the fact that the subjects having overweight have a result more important than the ones having a normal weight and presenting a thinness for factor 1.2 and 4. DISCUSSION: The BSQ "French version" seems in fact to present the same metrical qualities than its original Anglo-Saxon and Spanish versions. The concluding results invite us to continue our study of the BSQ including in our patients, the bulimic subjects and the ones who are worried about corporal aspect. Its implications on the clinical field could be really interesting especially on people suffering from the eating disorders. Then, the BSQ could provide us a way to explore the role of an extreme worry of the body's appearance in the development, the maintenance and the treatment of the eating disorders.

Adult↗
PubMed2001

[Dyspepsia-related quality of life. Spanish adaptation and validation of the questionnaire Dyspepsia-Related Health Scale].

BACKGROUND: Dyspepsia affects about 25 % of the population and may cause an important decrease in quality of life. The aim of this work was to perform a Spanish validation and adaptation of the questionnaire DRHS (Dyspepsia Related Health Scale), a tool that assesses dyspepsia-related quality of life. PATIENTS AND METHOD: The study was carried out in 234 subjects, 163 with symptoms of dyspepsia and 71 health volunteers. Two rheumatologists, 2 general practitioners, 1 gastroenterologist, 1 clinical pharmacologist, 1 pharmacoepidemiologist and 1 psychologist were involved in the work. The process of adaptation and validation included translation and re-translation, pilot study in 16 patients, dimensionality, reliability and validity (of content, of construct, convergent, predictive and discriminative). RESULTS: The mean age was 49.1 years (SD: 18) and 60.7 % were females. The between-judges agreement rate of Hambleton and Rovinelli, which evaluates the content validity, was lower than 0.41. The construct validity assessed by the factorial analysis of responses showed that each subscale may be considered unidimensional in both health volunteers and individuals with dyspepsia. Reliability was satisfactory (Cronbach's alpha = 0.92) and stability of measures (test-retest) was excellent with a correlation coefficient of 0.95. The convergent validity, assessed by means of the EuroQoL, was only moderate with a correlation coefficient of 0.54 (p < 0.001). The predictive validity, assessed by administering the questionnaire 12 days after treating dyspepsia, showed a correlation coefficient of 0.47 between the two measures (p < 0.001). There was also a relationship between scores variation and outcome. CONCLUSIONS: The Spanish version of the DRHS, so-called QoL-PEI (questionnaire of quality of life related with problems of stomach and intestine), displays good metric properties and is able to predict the evolution of dyspepsia. The results of this study show that this tool is essentially unidimensional, yet it can be used on a multidimensional form to perform a differentiated assessment of each evaluated case.

Adolescent↗
PubMed1998

Validation of the process control system of an automated large scale manufacturing plant.

The validation procedure for the process control system of a plant for the large scale production of human albumin from plasma fractions is described. A validation master plan is developed, defining the system and elements to be validated, the interfaces with other systems with the validation limits, a general validation concept and supporting documentation. Based on this master plan, the validation protocols are developed. For the validation, the system is subdivided into a field level, which is the equipment part, and an automation level. The automation level is further subdivided into sections according to the different software modules. Based on a risk categorization of the modules, the qualification activities are defined. The test scripts for the different qualification levels (installation, operational and performance qualification) are developed according to a previously performed risk analysis.

Computer Systems↗
PubMed2000

Stages of change for adherence with medication regimens for chronic disease: development and validation of a measure.

BACKGROUND: The stages-of-change (SOC) model has been used to explain and predict how behavior change occurs, but it is new as an approach to understanding why patients fail to take their medications as prescribed. OBJECTIVE: This study validated a 2-item measure of SOC for adherence with medication regimens in 2 groups of patients prescribed pharmacologic therapy for chronic conditions. METHODS: Two cross-sectional studies of attitudes toward medication adherence included the same measure of SOC for medication adherence. One was a sample of 161 HIV-positive patients in the United States, and the other was an international sample of 731 patients with hypertension. The validity of the measure of SOC for medication adherence was examined in both convenience samples using previously validated self-reported measures of adherence (the Medication Adherence Scale and a measure of adherence from the Medical Outcomes Study), and in the HIV sample using electronic monitoring of adherence behavior in 85 patients. RESULTS: Construct validity was demonstrated in both samples by associations between SOC and the previously validated measures of adherence (P < 0.001), and predictive validity was supported by significant associations between SOC for medication adherence and electronically monitored medication-taking behavior during the next 30 days (P < 0.03). CONCLUSIONS: Behavior-change theory suggests that stage-tailored communication strategies are more effective than uniform health-promotion messages. Our results provide a foundation for the development of interventions for medication adherence that are tailored to patients' readiness for change. Our validated 2-item measure of SOC for medication adherence can be used to match communication strategies to individual motivation and readiness for adherence with chronic disease medication regimens.

Anti-HIV Agents↗
PubMed2003

An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progress and limitations.

The Société Française des Sciences et Techniques Pharmaceutiques (SFSTP) published in 1997 a guide on the validation of chromatographic bio-analytical methods, which introduces new concepts in three different areas: stages of the validation, test of acceptability of a method and design of experiments to perform. In 'stages of validation', the SFSTP guide requires two phases to validate a method. The first phase, called 'prevalidation', is intended to (1) identify the model to use for the calibration curve; (2) evaluate the limits of quantitation; and (3) provide good estimates of the precision and bias of the method before designing the 'validation' phase per se. In the 'test of acceptability', the use of the interval hypotheses is envisaged by the SFSTP guide, not on the parameters of bias and precision, but on individual results by mixing mean bias and intermediate precision in a single test. The SFSTP guide also avoids the use of Satterthwaite's df for testing the acceptability. The reasons for those choices are discussed extensively. In 'design of experiments', much effort has been devoted to improving the quality of results by optimally designing and sizing the experiments to perform in validation. The rationale for using near D-optimal designs for the calibration curve is demonstrated and sample sizes are proposed to correctly size the validation experiments.

Chromatography↗
PubMed2003

Development and validation of a knowledge test for health professionals regarding lifestyle modification.

OBJECTIVES: We wanted to develop and validate a test that assesses the knowledge and practices of health professionals (HPs) with regard to the role of nutrition, physical activity, and smoking cessation (lifestyle modification) in chronic diseases of lifestyle. METHODS: A descriptive cross-sectional validation study was carried out. The validation design consisted of two phases, namely 1) test planning and development and 2) test evaluation. The study sample consisted of five groups of HPs: dietitians, dietetic interns, general practitioners, medical students, and nurses. The overall response rate was 58%, resulting in a sample size of 186 participants. A test was designed to evaluate the knowledge and practices of HPs. The test was first evaluated by an expert group to ensure content, construct, and face validity. Thereafter, the questionnaire was tested on five groups of HPs to test for criterion validity. Internal consistency was evaluated by Cronbach's alpha. RESULTS: An expert panel ensured content, construct, and face validity of the test. Groups with the most training and exposure to nutrition (dietitians and dietetic interns) had the highest group mean score, ranging from 61% to 88%, whereas those with limited nutrition training (general practitioners, medical students, and nurses) had significantly lower scores, ranging from 26% to 80%. This result demonstrated criterion validity. Internal consistency of the overall test demonstrated a Cronbach's alpha of 0.99. Most HPs identified the mass media as their main source of information on lifestyle modification. These HPs also identified lack of time, lack of patient compliance, and lack of knowledge as barriers that prevent them from providing counseling on lifestyle modification. CONCLUSIONS: The results of this study showed that this test instrument identifies groups of health professionals with adequate training (knowledge) in lifestyle modification and those who require further training (knowledge).

Chronic Disease↗
PubMed2003

Internal consistency and validity of the Stroke Impact Scale 2.0 (SIS 2.0) and SIS-16 in an Australian sample.

BACKGROUND AND PURPOSE: The impact of stroke is multidimensional however standard stroke measures do not discriminate well when stroke patients are less physically impaired. The Stroke Impact Scale 2.0 (SIS 2.0) is a multidimensional measure of the impact of stroke but its' psychometric properties require further testing. The SIS-16 is a measure of physical functioning designed to be more sensitive to differences in physical functioning than current stroke outcome measures but there is only preliminary information detailing its' reliability and validity. The current study examined the internal consistency and validity of the SIS 2.0 and SIS-16 in an Australian sample of stroke patients. METHODS: The SIS 2.0, SIS-16, World Health Organization Bref-Scale (WHOQOL-BREF) and Zung's Self-Rating Depression Scale (SDS) were completed by 74 stroke patients in rural Victoria, Australia. RESULTS: The item convergent validity index indicated good item convergence of the SIS-16 and SIS 2.0 domains. The item discriminant validity index had only adequate divergence for most SIS 2.0 domains. Internal consistencies of the SIS-16 and SIS 2.0 domains were acceptable (alpha = 0.87-0.95). Correlations between the SIS-16 and SIS 2.0 and the WHOQOL-BREF and SDS supported the convergent and discriminant validity of the SIS-16 and all the dimensions of the SIS 2.0 except 'Participation' which lacked discriminant validity. CONCLUSIONS: The SIS 2.0 and SIS-16 had good psychometric properties with support for the internal consistency and validity of both measures.

Activities of Daily Living↗
PubMed2002

Randomized clinical trial of total vs. subtotal hysterectomy: validity of the trial questionnaire.

BACKGROUND: To ensure the internal validity of a trial it is recommended to undertake a validation study of the method measuring the outcome. AIMS: To validate a self-administered, postal questionnaire (http://www.gyncph.suite.dk/praes/gimbel/gihtm) used for measuring the outcomes of a randomized clinical trial of total vs. subtotal abdominal hysterectomy. METHODS: A study of the content validity (10 patients) and a combined qualitative and quantitative validation study (20 patients) were performed. RESULTS: The median kappa of the 74 questions was 0.71 (range 0.22-1.00) and the median overall agreement was 0.76 (range 0.25-1.00). Five questions (7%) had kappa values below 0.40, 11 questions (15%) between 0.40 and 0.60, and 58 questions (78%) above 0.61. Three questions with a kappa value below 0.40 had an overall agreement of 0.75 or more. Significant logical inconsistencies were found in five questions, where the operation method was expected to be known. The qualitative validation resulted in a total of 80 comments. The number of comments for any given subject ranged from 0 to 12. The comments could be grouped and processed into four categories. CONCLUSIONS: The agreement was high. Inconsistencies regarding questions on the operation methods were found. Potential problems were identified in five questions (7%). The validation studies resulted in some changes to the questionnaire and we became aware of areas in which caution should be taken in the interpretation of the results of the randomized trial.

Female↗
PubMed2004

A depressive symptom scale for the California Psychological Inventory: construct validation of the CPI-D.

To facilitate life span research on depressive symptomatology, a depressive symptom scale for the California Psychological Inventory (CPI) is needed. The authors constructed such a scale (the CPI-D) and compared its psychometric properties with 2 widely used self-report depression scales: the Beck Depression Inventory and the Center for Epidemiological Studies Depression Scale. Construct validity of the CPI-D was examined in 3 studies. Study 1 established content validity, classifying CPI-D items into Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition depressive symptoms. Study 2 used 3 large samples to gather evidence for reliability and validity: correlational analyses demonstrated alpha reliability and convergent and discriminant validity; factor analysis provided evidence for discriminant validity with anxiety; and regression analyses demonstrated comparative validity with existing standard PI scales. Study 3 used clinician ratings of depression and anxiety as criteria for external validity.

Adult↗
PubMed2004

Assessment of fecal output in patients receiving enteral tube feeding: validation of a novel chart.

OBJECTIVE: To develop a practical, valid and reliable chart to assist in the accurate visual characterization of fecal output in patients receiving enteral tube feeding (ETF). DESIGN: A chart incorporating verbal and pictorial descriptors of fecal output was developed. Validity and reliability were assessed by a questionnaire survey of health professionals and a clinical study of patients commencing ETF. Content validity was assessed from the results of the questionnaire, construct validity by contrasting groups analysis, concurrent validity by comparison of the chart with actual fecal weight and inter-rater reliability by independent characterization of the same fecal sample by two nurses. SETTING: St George's Hospital, London, UK. SUBJECTS: In all, 35 health professionals completed a questionnaire with respect to the chart. The chart was then used to monitor fecal output in 36 patients commencing ETF for a total of 171 patient-days, during which time nurses used the chart to characterize 269 fecal samples, of which 59 were subsequently weighed. RESULTS: The results of the questionnaire suggested good content validity. The chart demonstrated statistically significant differences in fecal frequency, fecal consistency, fecal score and incidence of diarrhea for contrasting patient groups expected to have different fecal output (P < 0.05). The inter-rater reliability was almost perfect for fecal consistency (95% agreement, kappa = 0.91) and substantial for fecal weight (83%, kappa = 0.75). In all, 83% of fecal samples were assigned to the correct weight category (kappa = 0.75). CONCLUSION: The chart has good content, construct and concurrent validity and inter-rater reliability, and is suitable for both research and clinical use. SPONSORSHIP: This research was jointly supported by King's College London and Nestlé, UK.

Diarrhea↗
PubMed2003

Validation of the French 'multidimensional fatigue inventory' (MFI 20).

Fatigue has become an important symptom in research and also for clinical diagnosis and follow up. Many physical illnesses, in particular chronic ones such as cancer, are highly associated with fatigue. Various questionnaires for measuring fatigue have been developed, but currently no validated questionnaire exists in French language. We selected the 'Multidimensional Fatigue Inventory' (MFI) which has been validated in its English version and then translated into French by the designers. This study describes the validation step of the French version of MFI and presents the psychometric properties of this instrument. A sample of 225 patients was divided into three groups 'Tired' (82 subjects), 'Moderately tired' (36) and 'Not tired' (107). The analysis of the structure validity found four dimensions: 'General Fatigue', 'Mental Fatigue', 'Reduced Activities' and 'Motivation'. The convergent validity showed highly significant correlation (P < 0.001) with a visual analogue scale. The French MFI has been able to distinguish patients with different fatigue levels. Cronbach's alpha measurement of the scale and the subscales are good, cronbach alpha > 0.70. The reproducibility and sensitivity to change in patients who were followed up one month later show satisfactory results. This validation study of the French version of MFI shows that this instrument is valid for clinical application and allows different dimensions of fatigue to be assessed which is of particular interest for physicians, especially for cancer carers, where fatigue assessment is an important aspect of the follow up.

Adolescent↗
PubMed2003

The Finnish version of The National Institutes Of Health Chronic Prostatitis Symptom Index correlates well with the visual pain scale: translation and results of a modified linguistic validation study.

UNLABELLED: Authors from Finland have assessed a version in their language of the National Institutes of Health-Chronic Prostatitis Symptom Index; they found that their translated version was valid and easily understandable in the management of the symptoms of chronic pelvic pain syndrome. They felt it should be used as a primary outcome measure in studies with these patients. There are three papers in this issue relating to the effect of drugs on LUTS; the first of these is a pooled analysis of three double-blind placebo-controlled studies into the safety and efficacy of the 10 mg dose of alfuzosin. The second evaluates the effect on quality-of-life issues of treatment with dutasteride. Finally, authors from Australia compare the effect of a Serenoa repens extract with placebo for LUTS. OBJECTIVES: To provide a fluent and easily comprehensible Finnish version of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) and to study its linguistic validity and correlation with a visual pain scale (VAS). PATIENTS AND METHODS: The double-back translation method with two interim modifications was used to produce the Finnish version of the NIH-CPSI. The validity was tested by presenting the questionnaire to 155 men with clinically confirmed chronic pelvic pain syndrome (CPPS) and 12 controls with no previous urological symptoms. Convergent validity of the NIH-CPSI was tested by determining the correlation between the Finnish NIH-CPSI and VAS. Patients' and urologists' opinions about the utility of the Finnish NIH-CPSI were also reviewed. RESULTS: The total Finnish NIH-CPSI scores and the pain domain and voiding symptom domain scores differed significantly (P < 0.001) between the groups, suggesting good discriminant validity of the symptom index. The NIH-CPSI scores correlated well with the VAS (Pearson's correlation 0.76). The preciseness and comprehensibility of the questionnaire were consistently evaluated to be 'good' or 'excellent' both by patients and urologists. CONCLUSIONS: The Finnish version of the NIH-CPSI is valid and easily comprehensible for measuring CPPS symptoms. In addition, it provides good discriminant and convergent validity in distinguishing CPPS symptoms and should be used as primary outcome measure in CPPS studies.

Case-Control Studies↗
PubMed2002

Validity and reproducibility of histologic diagnosis and grading for adult soft-tissue sarcomas.

Soft-tissue sarcomas in adults show great variations in histologic type and grade. A valid and reproducible prognostication system is needed to select patients with soft-tissue sarcomas who could benefit from adjuvant chemotherapy. This study was conducted to assess the validity and reproducibility of diagnosis of the histologic type, MIB-1 grade, and mitosis grade, as well as of the 3 components of these grading systems. MIB-1 grade is a recently proposed grading system for predicting the prognosis of patients with adult soft-tissue sarcomas on the basis of 3 criteria (tumor differentiation, necrosis, and MIB-1 score) and replaces the mitotic count in the French system with MIB-1 immunohistochemical staining. Four surgical pathologists from 4 institutions who had experience in diagnostic soft-tissue tumor pathology reviewed 130 cases of soft-tissue sarcoma and independently determined histologic type and grade. The validity of histologic diagnosis was measured by sensitivity and specificity, and that of grading was measured by kappa statistics and percentage agreement with the diagnosis of the expert panel at the National Cancer Center, which was defined as a gold standard. Interobserver reproducibility was measured by kappa and by percentage agreement between the diagnoses of the 4 pathologists. The validity of the diagnosis of histologic type was high for synovial sarcoma, small round-cell sarcoma, and liposarcoma (sensitivity 89% to 100%; specificity, 98% to 100%) but low for malignant fibrous histiocytoma (MFH) and spindle-cell sarcoma (73% to 75%; 93% to 95%). For the grading, the validity of the MIB-1 grade was substantial (kappa = 0.68; agreement, 79%) and higher than that of the mitosis grade (0.54; 69%). The most valid component was tumor differentiation (kappa = 0.79), followed by tumor necrosis (0.66), MIB-1 score (0.59), and mitotic score (0.37). Interobserver reproducibility of histologic diagnosis was high for small round-cell sarcoma, synovial sarcoma, and liposarcoma (kappa = 0.92, 0.90, 0.87; percentage agreement = 99%, 97%, 96%, respectively); for grading, reproducibility was highest for tumor differentiation (0.78; 87%) and second highest for MIB-1 grade (0.68; 79%). We conclude that diagnosis of the type of soft-tissue sarcoma for synovial sarcoma, small round-cell sarcoma, and liposarcoma and the MIB-1 grading system based on tumor differentiation are highly valid and reproducible among Japanese pathologists who are familiar with the grading system, whereas re-evaluation of histologic criteria is essential for other histologic types such as MFH and spindle-cell sarcoma.

Antigens, Nuclear↗
PubMed2001

Mental disorders and burden of disease: how was disability estimated and is it valid?

OBJECTIVE: The Global Burden of Disease study found mental disorders to be the world's leading cause of disability. Few studies have examined the validity of the novel approach used to estimate disability, the person trade-off preference method. This paper describes, and examines the validity of, the burden of disease person trade-off protocol. METHOD: The person trade-off provides preferences for health states (how good or bad you think it is in relation to perfect health). General practitioners (n = 20) with training in mental health provided preferences for 19 mental disorders using the person trade-off method. Descriptions for the mental disorders were derived from the average symptom severity and disability observed in the Australian National Survey of Mental Health and Wellbeing. Validity was investigated by comparison with two other methods (rating scale and rank order). RESULTS: The general practitioners found the person trade-off complex and affronting. Only a moderate concordance was observed with two validity comparisons; however, validity was significantly increased following the opportunity for group discussion among the clinicians. The disability weights were higher than those used in the global study, a possible consequence of differences in disorder descriptions. CONCLUSIONS: The present study is limited by small subject numbers and by using only one type of key informant (clinicians). While this study provided some evidence for the validity of the person trade-off, it also echoes concerns from recent commentaries about the feasibility of this method. These concerns are particularly relevant for mental disorder burden, which relies heavily on the magnitude of the disability weights. Further work is required to ensure that disability burden is validly estimated, and thus can appropriately be used to inform mental health policy.

Cost of Illness↗
PubMed2001

Validation of the inflammatory bowel disease questionnaire in Swedish patients with ulcerative colitis.

BACKGROUND: The Inflammatory Bowel Disease Questionnaire (IBDQ) is a disease-specific health-related quality of life (HRQOL) questionnaire including four dimensions and a sum score. The aim of this study was to assess the internal and external validity, reliability, and sensitivity of a Swedish version of the IBDQ. METHODS: Three hundred consecutive patients with ulcerative colitis completed the IBDQ and three other health-related quality of life questionnaires (the Rating Form of IBD Patient Concerns (RFIPC), the Short Form-36 (SF-36) and the Psychological General Well-Being (PGWB) index). Disease activity was evaluated using a 1-week symptom diary, blood tests and rigid sigmoidoscopy. One hundred and fourteen patients filled in the questionnaire a second time, of whom 75 had been in stable remission for over 6 months and 39 had a significant clinical change in disease activity. RESULTS: Factor analysis of the 32 IBDQ items did not support the four dimensional scores. The dimensional scores had sufficient convergent validity, but low discriminative validity and homogeneity. The homogeneity was also low for the sum score. The inter-dimensional correlations were high. The concurrent validity was supported by correlations between the dimensional scores and other measures of disease activity and HRQOL. Patients in relapse scored significantly less on the sum score and the four dimensions compared to patients in remission. The test-retest correlations for the dimensional scores were 0.40-0.76. Patients with a change in disease activity during the 6-month follow-up period had a significant change in IBDQ scores not found in those who remained in remission. CONCLUSIONS: The Swedish version of the IBDQ had external validity and was shown to be a reliable and sensitive measure of HRQOL in ulcerative colitis, though there are some concerns regarding the internal validity. The use of a sum score was not supported and the questionnaire may benefit from a redivision of items into dimensions with better homogeneity and discriminative validity.

Colitis, Ulcerative↗
PubMedDate not supplied

Good design practice for medical devices and equipment, Part II: Design for validation.

Medical devices and their associated process equipment must be reliable and fit for purpose. In light of the recent changes to the medical device regulations, manufacturers must now take an integrated approach to design, development and validation. Good design practice encourages this integrated approach while ensuring fitness for purpose within commercial reality. A review of current literature related to good design practice carried out in Part I of this paper showed that there is inadequate guidance regarding the integration of validation with design. This paper proposes a practical approach to design for validation aimed at making devices easier and more economic to validate. The approach comes in the form of a model of design for validation that illustrates the basic relationship between design, development and validation and a series of design tactics that were formulated in order to help designers take a more proactive approach to validation during design.

Biomedical Engineering↗
PubMedDate not supplied

Required steps for the validation of a Laboratory Information Management System.

The task of managing laboratory data is not a new one. Over the past two decades, the use of Laboratory Information Management Systems (LIMS) has revolutionized how laboratories manage their data. A LIMS is more than software; it has become the workhorse of the laboratory, encompassing laboratory work-flow combined with user input, data collection, instrument integration, data analysis, user notification, and delivery of information and reporting. Types of organizations that utilize LIMS vary greatly from research laboratories to manufacturing laboratories to environmental testing laboratories. Commercially-available LIMS have been around since the 1980s. In addition, many laboratories have designed, implemented, and maintained in-house LIMS. The heart of any LIMS is the software. Like other laboratory systems, the LIMS software is subject to quality control and quality assurance checks. In regulatory environments this associated QA/QC is referred to as "system validation." The primary purpose of system validation is to ensure that the software is performing in a manner for which it was designed. For example, the system acceptance criteria should be established and tested against quantifiable tasks to determine if the desired outcome has been achieved. LIMS features, such as autoreporting, reproducibility, throughput, and accuracy must be quantifiable and verifiable. System validation ensures that the entire system has been properly tested, incorporates required controls, and maintains and will continue to maintain data integrity. Laboratories must establish protocols and standards for the validation process and associated documentation. Although vendors of commercial LIMS perform initial internal system validations, the system must be revalidated whenever the end user, vendor or third party adds modifications or customizations to the LIMS. Currently, detailed guidance regarding system validation of LIMS is not available to the user. The issue is addressed in Good Automated Laboratory Practices (GALP) and National Environmental Laboratory Accreditation Conference (NELAC) documents which indicate specific requirements or recommendations for operational checks and periodic testing; however, it is up to the laboratory to determine suitable methods to accomplish these tasks. Proper validation of a LIMS will allow a laboratory to comply with regulations and also provide comprehensive documentation on the system that is necessary to troubleshoot future problems.

Clinical Laboratory Information Systems↗