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PubMed1996

[Quality of life in chronic inflammatory bowel diseases. Validation of a questionnaire and first French data].

UNLABELLED: Inflammatory bowel diseases have an important impact on the daily life of patients. This impact can be measured by the evaluation of the health related quality of life. The aim of this study was to develop and to validate a questionnaire of quality of life in a French population. METHODS: The questionnaire comprised 70 items and was completed in 15 min. It was made up of a) a general questionnaire of 36 items (SF-36) exploring daily physical and social functioning, mental and general health, body pain and vitality. A sleep module of 6 items was added. b) a specific questionnaire of 28 items (RFIPC), exploring the concerns of the patients. The questionnaire was self-administered to 101 patients with Crohn's disease (57 F. 44 M. mean age: 35 years, acute disease: 28%, inpatients: 27%), 96 patients with ulcerative colitis (38 F. 58 M. mean age: 39 years, acute disease: 53%, inpatients: 21%). Each patient was sex and age matched with a healthy control. RESULTS: The psychometric analysis confirmed the validation of the questionnaire for the item's convergent validity, internal consistency (Cronbach's coefficient being > 0.70), analyses of discrimination. Scores of each scale of SF-36 were worse in patients than in controls. Scores of patients with active disease were worse than those of patients with quiescent disease. Scores were comparable in patients with Crohn's disease and with ulcerative colitis except for score of pain which was worse in acute Crohn's disease. The most important concerns of patients were the uncertain nature of the disease, energy level and having surgery. CONCLUSION: This study allowed the validation of a questionnaire for the evaluation of the quality of life in French patients with inflammatory bowel disease and provides first indications which need to be confirmed by future epidemiological studies.

Adult↗
PubMed1997

A self-administered questionnaire for assessment of symptoms and function of the shoulder.

A self-administered questionnaire was designed to assess the severity of symptoms related to and the functional status of the shoulder. It includes domains of global assessment, pain, daily activities, recreational and athletic activities, work, satisfaction, and areas for improvement. Each domain is graded separately and is weighted to arrive at the total score. The over-all scale and each domain were prospectively tested for validity, reliability, and responsiveness to clinical change. One hundred patients who were seen for evaluation of the shoulder were enrolled in the study. The validity of the scale was demonstrated by moderate-to-high correlation of the domains and individual questions of the Shoulder Rating Questionnaire with those of the Arthritis Impact Measurement Scales 2. Validity was supported further by significant correlation of the scores in each domain with the level of satisfaction in that domain and by significantly lower scores in domains that patients selected as areas important for improvement. The over-all scale and each domain were internally consistent (Cronbach alpha, 0.71 to 0.90). Reproducibility was evaluated by repeated administration of the questionnaire after a mean of three days to forty patients whose condition was clinically stable. Reproducibility of the over-all questionnaire and individual domains was excellent (Spearman-Brown index, 0.94 to 0.98). Individual questions were reproducible, with a weighted kappa value of more than 0.7 for each. Responsiveness was evaluated by comparison of the preoperative and postoperative scores of thirty patients who had a satisfactory result one year after an operation on the shoulder. The over-all Shoulder Rating Questionnaire and each domain were responsive to clinical change as demonstrated by favorable standardized response means (range, 1.1 to 1.9) and indices of responsiveness (range, 1.1 to 2.0). Similar analysis performed for individual diagnostic groups supported the validity, reliability, and responsiveness of the questionnaire in each group. The self-administered shoulder questionnaire was found to be valid, reliable, and responsive to clinical change. These qualities should make it a useful instrument for the prospective assessment of the outcome of treatment of disorders related to the shoulder.

Activities of Daily Living↗
PubMed1997

Alcohol disorders in Canada as indicated by the CAGE questionnaire.

OBJECTIVE: To describe alcohol disorders in the general Canadian population, using as a standard indicator the CAGE questionnaire (Have you felt you needed to cut down on your drinking? Have you felt annoyed by criticism of your drinking? Have you felt guilty about drinking? Have you felt you needed a drink first thing in the morning [eye-opener]?). DESIGN: Secondary analysis of data from Canada's Alcohol and Other Drugs Survey (CADS), a national telephone survey conducted in 1994 of a representative sample of 12,155 people aged 15 years or more. PARTICIPANTS: The CAGE questionnaire was administered to 5894 drinkers who had consumed alcohol in the 12 months before the CADS survey. MAIN OUTCOME MEASURES: Respondents with positive (2 or more affirmative responses) and negative results on the CAGE questionnaire were compared as to demographic characteristics, alcohol consumption and harmful consequences of their drinking. Independent predictors of a positive result were identified by means of logistic regression analysis. RESULTS: A total of 5.8% of CAGE-tested current drinkers had a positive result on the past-year CAGE in 1994. The proportion of respondents reporting alcohol-related problems in one or more areas of their life was 7 times greater among drinkers with a positive result on the CAGE questionnaire than among those with a negative result (66.8% v. 9.5%) (p < 0.0001). When all demographic characteristics were controlled for simultaneously, male sex, residence in the Atlantic provinces, Quebec or the Prairies, single/never married or divorced/separated marital status, and low education level were found to be independent risk factors for a positive result on the CAGE questionnaire. About 85% of the respondents with a positive result had not sought help for their drinking. Applying the estimated sensitivity and specificity of the CAGE questionnaire in detecting alcohol dependence, as per criteria of the Diagnostic and Statistical Manual, in a general US population, the authors estimated that 4.1% of Canadians had an alcohol dependence in 1994. CONCLUSION: The large proportion of current drinkers with a positive result on the CAGE questionnaire who did not seek help for their drinking underscores the need for identification and brief interventions by physicians. Further research is needed to elucidate the underlying reasons for regional differences in CAGE status.

Adolescent↗
PubMed1997

The failure of CDC screening questionnaire to efficiently detect elevated lead levels in a rural population of children.

BACKGROUND: In 1991, the Centers for Disease Control and Prevention (CDC) lowered the level for lead toxicity from 25 micrograms/dL to 10 micrograms/dL and published guidelines recommending that all children be tested for blood lead level at 12 months of age and again, if possible, at 24 months. The guidelines also called for periodic universal screening of children between the ages of 6 and 72 months using the CDC's lead screening questionnaire. However, blindly following these recommendations may result in unnecessary patient discomfort, wasted time, and extra expense. According to the CDC guidelines, deviation from this practice requires the determination of the local prevalence of lead poisoning. The purpose of this study was to measure the local prevalence of elevated blood lead levels (EBLL) and to assess the utility of the CDC's lead screening questionnaire in a rural setting. METHODS: Three hundred seventy-six children living on the Navajo Reservation in Arizona were studied. A consecutive series evaluation at well-child visits between the ages of 6 and 72 months was conducted using the CDC lead screening questionnaire and blood lead levels measured by anodic voltammetry. RESULTS: Of 376 children, 368 had their blood levels tested. Eight children tested positively with an EBLL of > or = 10 micrograms/dL for a prevalence of 2.2%. Three hundred twenty-three completed questionnaires; 83 (25.7%) of these children had false-positive results. The sensitivity and specificity of the CDC lead screening questionnaire were 42.9% and 73.7%, respectively. The positive predictive value of the questionnaire was 3.5%. CONCLUSIONS: In this rural population of children, the prevalence of lead poisoning was low, and the CDC lead screening questionnaire failed to efficiently identify those children with lead toxicity. Screening such a population using the CDC guidelines will result in unnecessary discomfort for children and will squander limited resources of time and money. Physicians who care for children should know the local prevalence of EBLL in order to effectively follow the CDC's recommendations for lead screening.

Arizona↗
PubMed1998

[Evaluation study of the chronic headache questionnaire].

INTRODUCTION: Semi-structured questionnaires, based on clinical criteria are used in the diagnosis of headache, but none has been used to study the two commonest types of chronic headache. The first step, before clinical application, is to carry out a study of the questionnaire's validity and predictive value. OBJECTIVE: The objectives of our study were to evaluate the validity and determine the effectiveness of the ZZA questionnaire in the differential diagnosis between transformed migraine (TM) and chronic tension headache (CTH), in a specialist Neurology Clinic. MATERIAL AND METHODS: The ZZA questionnaire, elaborated by one of the investigators, was made up of 20 questions aimed at TM, CTH or the chronicity of the headache. An observer, who did not know the diagnosis, gave the questionnaire to patients who had previously been diagnosed by the head of the Headache Clinic as having TM or CTH. The process of validation of the questionnaire consisted in showing that it was reliable, with valid contents and valid criteria. RESULTS: On analysis of reliability, the items ZZA1, ZZA15, ZZA16 and ZZA18 gave the highest indices. The Cochran Q test showed lack of uniformity of replies. Only ZZA1, ZZA15 and ZZA18 were predictive items showing MT. None of the questions to show CTH were predictive. After final adjustment the definitive model was made up of ZZA1, ZZA15 and ZZA18. CONCLUSIONS: The proposed questionnaire was not found to be useful for differential diagnosis between TM and CTH. Only 3 of the 20 questions were accepted as having some degree of validity and effectiveness. Two of these 3 questions, based on clinical impressions of the author, might well be included in the diagnostic criteria of TM.

Adult↗
PubMed2000

Validity and test-retest reliability of a disability questionnaire for essential tremor.

BACKGROUND: One important outcome in clinical trials is patients' own opinions about whether the medication alleviates their symptoms and improves their ability to function. A valid and reliable method with which to assess this subjective information is important. OBJECTIVE: To determine the validity and test-retest reliability of the Columbia University Disability Questionnaire for Essential Tremor (ET). METHODS: Patients with ET underwent a 2.5-hour evaluation, including a 36-item tremor disability questionnaire, to assess the functional impact of tremor, a 26-item videotaped tremor examination rated by a neurologist, a 15-item performance-based test, and quantitative computerized tremor analysis. We determined the validity and test-retest reliability of the tremor disability questionnaire. Correlations between variables were assessed using Pearson's correlation coefficients and test-retest reliability with the weighted kappa statistic. RESULTS: Ninety-five patients with ET participated. The score on tremor disability questionnaire correlated with the neurologist's clinical ratings (r = 0.57, p <0.001) and the total score on the performance-based test (r = 0.69, p < 0.001). Correlations with quantitative computerized tremor analysis results were less robust, but each remained significant, including mean amplitude of dominant arm tremor while arms were extended (r = 0.56, p <0.001), while drawing a spiral (r = 0.42, p = 0.01), and while pouring (r = 0.34, p = 0.04). The questionnaire was readministered to 32 subjects, and the test-retest reliability was substantial (weighted kappa = 0.67). CONCLUSIONS: This Tremor Disability Questionnaire demonstrated substantial reliability, and it correlated with multiple measures of tremor severity, including a neurologist's clinical ratings, a performance-based test of function, and quantitative computerized tremor analysis results. The questionnaire would be useful in clinical trials in which it could be used as a reliable and valid tool to assess disability in ET.

Activities of Daily Living↗
PubMed2004

[Development of a questionnaire based on the Constant-Murley-Score for self-evaluation of shoulder function by patients].

The aim was to develop a German questionnaire for self-assessment of shoulder function equivalent to the Constant-Score (CS). To evaluate the retest reliability, the CS questionnaire was completed twice within 1 week by 47 patients prior to shoulder surgery. For validation the CS was assessed by the physician after the second self-test. The medium selectivity of the CS questionnaire at hospital admission was 0.47, the medium item difficulty 0.40, the test-retest reliability 0.675 ( p=0.000), the internal consistency of the questionnaire 0.80, and of the physician's CS evaluation 0.85. Construct, content, and discriminative validity of the questionnaire could be demonstrated. A high correlation of the patient-based questionnaire with the physician-assessed CS was found ( p=0.82). The statistical analyses demonstrated that the CS questionnaire is a reliable and valid instrument to evaluate the CS and can therefore be used for follow-up studies.

Adult↗
PubMed1992

Effects of different designs and extension of a food frequency questionnaire on response rate, completeness of data and food frequency responses.

The authors studied how the introduction of several modifications to a basic food frequency questionnaire can influence the results of dietary surveys. Modifications covered eight combinations based on three levels: increasing versus decreasing order of frequency categories; questionnaires without versus with questions about portion sizes, and questionnaires without versus with extra non-dietary questions. The sample included 6783 women between the ages of 40 and 70 years who took part in mammography screening. The women were randomly assigned to one of the eight study groups. All of the women in each group received one of the eight differently modified questionnaires. The forms extended in length by extra non-dietary questions and portion size categories resulted in a 20% higher total non-response compared to the shorter basic form. Partial non-response was significantly lower for all four questionnaire types that included portion sizes. When portion sizes were included in the questionnaire, the reported mean frequency of consumption was significantly reduced for fat (-10 times per month), milk (-6), bread (-5), vegetables (-2) and fish (-0.4). The decreasing order of responses to the frequency categories was associated with a statistically significant increase in the frequency responses for bread (2.6 times per month), vegetables (2) and fish (0.6). These data provide evidence that the design and extension of food frequency questionnaires influence the results of dietary studies.

Adult↗
PubMed1990

Fear questionnaires for simple phobias: psychometric evaluations of a Norwegian sample.

The present study presents psychometric data for four different phobic fear questionnaires in a Norwegian sample of 284 subjects. The questionnaires concerned fear of flying, snakes, spiders and a questionnaire of general phobic complaints. The results showed a high estimate of internal consistency, and a very high test-retest reliability for all questionnaires. A low to moderate degree of intercorrelation between the questionnaires appeared. A clear sex difference emerged in responding to all four questionnaires. In addition, a clinical sample of phobics with fear of flying as the main symptom was compared to the larger sample on a fear of flying scale. The results showed a clear difference in responding between the samples. The present study concludes that the four different fear questionnaires yielded a high degree of reliability, and their use in clinical practice is encouraged.

Adult↗
PubMed1985

Nature of questionnaire options affects estimates of alcohol intake.

To estimate the degree of underreporting of alcohol consumption caused by questionnaire options for the frequency and quantity of drinking, two questionnaires (one oriented toward light alcohol consumption and the other toward heavy consumption) were administered to each of 86 patients (13 women) admitted for withdrawal treatment. The estimated mean daily alcohol intake was 137 g of absolute alcohol as measured by the "light" questionnaire and 302 g as measured by the "heavy" one. The Spearman correlation coefficient between individual mean intakes recorded by the two questionnaires was .58, indicating some influence on the rank ordering of drinkers. The intake estimate based on the heavy questionnaire correlated better with the number of drinks needed to overcome the subjective feelings of hangover than did the estimate based on the light questionnaire. A good deal of the underreporting commonly found in general population surveys might be related to the nature of questionnaire options. More detailed options for heavy intake might reveal previously unnoticed correlations between alcohol intake and various health hazards.

Adult↗
PubMed2005

Performance of screening questionnaires and risk scores for undiagnosed diabetes: the KORA Survey 2000.

BACKGROUND: Validation of published screening questionnaires and risk scores for undiagnosed diabetes has typically not been performed in independent population samples. METHODS: Oral glucose tolerance tests were performed in 1353 participants (aged 55-74 years) without known diabetes in the Cooperative Health Research in the Region of Augsburg (KORA) Survey 2000, Augsburg, Germany. Sensitivity, specificity, and the area under the receiver operating characteristic curve (AUC) for undiagnosed diabetes were calculated for various screening questionnaires. RESULTS: Four screening tests (Rotterdam Diabetes Study, Cambridge Risk Score, San Antonio Heart Study, and Finnish Diabetes Risk Score) were applied to the KORA data. The AUCs were 61% (95% confidence interval [CI], 56%-66%) for the Rotterdam Diabetes Study, 65% (95% CI, 60%-69%) for the Finnish Diabetes Risk Score (P=.10 vs Rotterdam), and 67% (95% CI, 62%-72%) for the Cambridge Risk Score (P<.001 vs Rotterdam). A predictive model including fasting glucose level (San Antonio Heart Study) yielded an AUC of 90% (P<.01 vs all 3 questionnaires); however, this was not significantly different from fasting glucose level alone (AUC, 89%; P=.46). The sensitivities, specificities, and predictive values of questionnaires were substantially lower than originally described, which was mainly due to population variation of risk factors compared with the KORA sample (age, body mass index, antihypertensive medication, and smoking). CONCLUSIONS: Currently proposed questionnaires yielded low validity when applied to a new population, most likely due to differences in population characteristics. Performance of diabetes risk questionnaires or scores must be assessed in the target population where they will be applied.

Adult↗
PubMedDate not supplied

Evaluation of a risk assessment questionnaire used to target tuberculin skin testing in children.

CONTEXT: Universal tuberculin skin testing of children has been shown to be costly and inefficient. In response, several authorities have recommended targeted screening based on epidemiological risk. In 1996, the New York City Department of Health (NYCDOH) developed questions to identify children who require a tuberculin skin test. OBJECTIVE: To determine the sensitivity, specificity, and predictive validity of the NYCDOH tuberculosis risk assessment questionnaire. DESIGN: Prospective criterion standard study in which tuberculin skin tests and the NYCDOH questionnaire were administered simultaneously between August 1996 and January 1998. Specific questions asked about contact with a tuberculosis case, birth in or travel to endemic areas, regular contact with high-risk adults, and human immunodeficiency virus infection in the child. SETTING: Ambulatory clinic in South Bronx, New York, NY. PARTICIPANTS: Consecutive sample of 2920 children aged 1 to 18 years. MAIN OUTCOME MEASURES: Sensitivity, specificity, positive and negative predictive values of the questionnaire, and odds ratio (OR) of reactive skin test results. RESULTS: The NYCDOH questionnaire identified 413 children (14%) as having at least 1 risk factor. Of these, 23 (5.6%) had a positive skin test result; 4 (0.16%) of the 2507 without risk factors had a positive result. Results for the full NYCDOH questionnaire were sensitivity, 85.2%; specificity, 86.0%; negative predictive value, 99.8%; positive predictive value, 5.4%; and OR, 35.2 (95% confidence interval, 12.1-102.4). CONCLUSION: The NYCDOH questionnaire is a valid instrument for identifying children for tuberculin skin testing.

Adolescent↗
PubMed1999

Translation to Spanish, reproducibility, and cross-cultural adaptation of the Miller-Rahe Recent Life Change Questionnaire in Venezuela.

OBJECTIVE: To translate into Spanish a version of the Miller-Rahe Recent Life Change Questionnaire and to adapt it to Venezuelan cultural values. METHODS: The Spanish version and cross-cultural adaptation of the Miller-Rahe Recent Life Change Questionnaire was done following recently proposed guidelines to preserve semantic, idiomatic, and conceptual equivalence in translations of health assessment instruments. We performed one or more translations into the new language, as well as back-translation, test-retest reliability, and weighting score for the translated instrument. RESULTS: A Spanish version of the Recent Life Change Questionnaire was obtained. Validity of translations was demonstrated with a significant agreement for the nonliteral translations (kappa value = 0.97, P < 0.05). The conceptual equivalence was demonstrated by significant agreement in the back-translations (kappa value = 0.84, P < 0.05). The translated instrument met acceptable levels of reliability, as assessed by Spearman's rank correlation coefficients (> 0.60 for all categories of the questionnaire). The cross-cultural adaptation of the translated instrument required addition and exclusion of items as well as changes of the ranking and scaling of life units in the original questionnaire. CONCLUSION: A valid and reliable Spanish version of the Miller-Rahe Recent Life Change Questionnaire was produced and adapted to Venezuelan cultural values.

Adult↗
PubMed2004

Psychometric refinement of an outpatient, visit-specific satisfaction with doctor questionnaire.

Measuring patient's satisfaction with their physician is gaining interest but requires a questionnaire that is valid, reliable and acceptable to patients. We previously published a self-administered visit-specific satisfaction with physician questionnaire for cancer patients. Eighty outpatients at a Canadian Cancer Center completed the Princess Margaret Hospital Patient Satisfaction with Doctor Questionnaire and the FACT-G questionnaires along with demographic information just after clinic visit and again 3-5 days later. Exploratory factor analysis extracted two factors, labeled 'physician disengagement' and 'perceived support,' with average coefficient alpha values of 0.93 and 0.90. Test-retest reliability was 0.83 and 0.73, respectively, for the two factors. Confirmatory factor analysis applied to the data from 174 patients in the original study indicated excellent goodness of fit. PMH/PSQ-MD correlated moderately with FACT-G (average r=0.37, p<0.005). The PMH/PSQ-MD questionnaire is a brief, valid and reliable questionnaire that taps two complementary facets of patient satisfaction.

Adult↗
PubMed2004

Measurement of headache frequency, intensity and duration: comparison of patient report by questionnaire and headache diary.

BACKGROUND AND PURPOSE: The efficacy of interventions for headache is often based on patient estimates of the headache parameters of frequency, intensity and duration, which can be ascertained from interview, by questionnaire or from a headache diary. The aim of the present study was to test the accuracy of retrospective patient reports of headache frequency, intensity and duration, with respect to measures derived from a daily headache diary. METHOD: Forty participants suffering from least one headache per month completed a daily headache diary for four weeks. At the end of the four-week period participants completed a questionnaire requiring them to estimate the frequency, usual duration and usual intensity of their headaches. Spearman rank correlation coefficients were calculated to determine the relationship between diary and questionnaire data. RESULTS: Correlation coefficients (Spearman's rho) for questionnaire and diary data for headache frequency and duration were 0.80 and 0.72, respectively, whereas that for intensity was 0.51. CONCLUSIONS: The findings suggest that when compared with the use of a headache diary, patient estimations of headache frequency and duration by questionnaire are reasonably accurate. Headache intensity appears to be more difficult to remember and report, possibly because of the multidimensional nature of pain, as opposed to the temporal characteristics of frequency and duration. It is recommended that frequency and duration be preferred over intensity as outcome measures if questionnaires or retrospective reports are used.

Adult↗
PubMed2002

Outcomes of hemisphericity questionnaires correlate with unilateral dichotic deafness.

Using the Dichotic Deafness Test, 145 university workers were separated into dichotic deafness and hearing groups based on minor ear responses to dichotic consonant-vowel stimuli. They were also separated into putative right and left brain-oriented groups by Zenhausern's Preference Questionnaire. Interestingly, members of the dichotically hearing group chose mainly right brain-oriented answers and vice versa. A correlation coefficient twice that obtained for Zenhausern's Preference Questionnaire resulted when subject groups separated by the novel Polarity Questionnaire were compared to Dichotic Deafness Test groups. Only 30% of Preference Questionnaire items, versus 90% of Polarity Questionnaire items, were significantly correlated with Dichotic Deafness Test groups. This is the first report of hemisphericity-type questionnaires showing significant correlations with a biophysical measure of brain laterality.

Auditory Perceptual Disorders↗
PubMed1997

Validation of a self-administered lead exposure questionnaire among suburban teenagers.

Teenagers represent a unique population in which to evaluate lead exposure. A self-administered questionnaire was developed to evaluate the current and historic lead exposures of teenagers. This work evaluates the exposure questionnaire for both its ability to predict lead exposure and the accuracy of the teenage respondents. Subjects received the survey at school and were instructed to get assistance from their parents in questionnaire completion. Environmental samples (dust, soil, and water) were collected from 30 suburban Boston homes to evaluate the questionnaire's predictiveness. To evaluate the accuracy of subjects' responses, independent information about housing was obtained. The questionnaire was effective in identifying predictors of dust and soil lead levels, but not for water lead levels. Fine dust lead loading (< 150 microns) varied significantly among the six housing age categories (pre-1940, 1940-1949, 1950-1959, 1960-1969, 1970-1979, and > 1979) and traffic levels. Fine dust lead concentrations varied significantly with decade of housing construction. Mean soil lead levels varied significantly among housing age categories, traffic levels, and exterior construction materials. For the important predictors, there was excellent agreement between the teenagers' self-report and confirmatory information. For housing age categories, the observed agreement was 69%; for traffic level, the observed agreement was 88%. These results illustrate that questionnaires continue to be useful in evaluating home lead levels even in suburban homes and that teenagers are accurate respondents.

Adolescent↗
PubMed1996

Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ).

Quality of life may be considerably reduced in patients who are suffering from chronic lower limb venous insufficiency, although existing generic quality of life instruments (NHP, SF-36 or SIP) cannot completely identify their specific complaints. The Chronic Venous Insufficiency Questionnaire (CIVIQ) has been developed by iterative process. First, a pilot group of 20 patients was used to identify a number of important features of quality of life affected by venous insufficiency, other than physical symptoms of discomfort. A second study involving 2,001 subjects was used to reduce the number of items. Subjects were asked to score both the severity of their problems and the importance they attributed to each problem on a 5-point Likert scale. The importance items found in patients with venous insufficiency were subjected to factorial analyses (PCA, PAF). The final version is a 20-item self-administered questionnaire which explores four dimensions: psychological, physical and social functioning and pain. Internal consistency of the questionnaire was validated for each dimension (Cronbach's alpha > 0.820 for three out of four factors). Reproducibility was confirmed in a 60 patient test-retest study. Pearson's correlation coefficients for both the four dimension subscales and for the global score at 2-week intervals were greater than 0.940. Finally, the questionnaire was tested in a randomized clinical trial of 934 patients in order to assess responsiveness and the convergent validity of the instrument, together with the patient's own quality of life. This study demonstrated that convergence was valid: Pearson's correlation coefficients between clinical score differences and quality of life score differences were small (from 0.199-0.564) but were statistically different from 0 (p < 0.001). Standardized response mean (SRM) and effect size (ES) were calculated to assess sensitivity to change. SRM and ES both demonstrated considerable responsiveness to change (> 0.80). Reliability, face, content, construct validity and responsiveness were also determined for this specific quality of life questionnaire relating to venous insufficiency. Results suggest that this questionnaire may be used with confidence to assess quality of life in clinical trials on chronic venous insufficiency.

Factor Analysis, Statistical↗