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PubMed1998

Comparison of responses to an asthma symptom questionnaire (ISAAC core questions) completed by adolescents and their parents. SCARPOL-Team. Swiss Study on Childhood Allergy and Respiratory Symptoms with respect to Air Pollution.

The primary objective of the study was to determine the impact of the identity of the respondent (parents versus adolescents) on prevalence estimates of asthma symptoms in Swiss adolescents. In addition, factors influencing agreement between parents' and adolescents' responses to the same questions were analysed. One thousand three hundred and seventy-four (78.4%) adolescents, aged 14 years, self-completed a questionnaire at school based on the International Study of Asthma and Allergy in Childhood (ISAAC) core questions on wheezing and asthma. The same questions were incorporated into a questionnaire to be completed by the parents at home. The adolescents' self-reported prevalence rates of current asthma symptoms and "asthma ever" were significantly higher than those obtained from the parental questionnaires. 856 (62.6%) parental questionnaires were filled in by parents without the help of the adolescents, 460 (37.4%) were completed by parents and adolescents and 51 (3.7%) were completed by the adolescents without the parents. Prevalence rates were higher when parents and adolescents completed the questionnaire jointly than when questionnaires were completed by parents alone. The level of agreement between parental and self-completed questionnaires was moderate to low (kappa coefficients 0.22-0.68). Agreement between parental and adolescents reports of asthma symptoms was best when questionnaires were completed jointly by parents and adolescents, when the adolescent was a girl, when a family history of asthma was recorded, when the adolescent was a non-smoker, and when the parental education was high. We conclude that the higher reporting of prevalence rates of current asthma symptoms by adolescents compared to reporting by their parents demonstrates the need to take the respondent to a questionnaire into account when comparisons are made between prevalence studies. The results also suggest that factors related to the family milieu influence symptom reporting.

Adolescent↗
PubMed2000

Limited agreement between written and video asthma symptom questionnaires.

The prevalence of asthma remains difficult to determine with precision with no absolute or "gold" standard for diagnosis. A recently developed video questionnaire for epidemiological studies with less reliance on understanding written questions provides another tool for determining prevalence and severity of asthma. This report from the International Study of Asthma and Allergies in Childhood (ISAAC) examines the agreement between the ISAAC video questionnaires on respiratory symptoms and reported asthma. Between December 1993 and April 1995, 4952 children aged 13-14 years in two Canadian communities completed sequentially the ISAAC written and video questionnaires at school. The agreement between responses to the two questionnaires for reported wheeze ever, current wheeze, wheeze on exercise, and nocturnal wheeze (the latter three questions relating to symptoms in the last 12 months), and to any combination of the latter three questions was examined in the full sample and in those reporting diagnosed asthma, using concordance and kappa coefficients as measures of agreement. The prevalences of wheeze ever, current wheeze, wheeze on exercise, and nocturnal wheeze were significantly lower based on responses to the video questionnaire compared with the written questionnaire in both regions in the full sample and in those labeled as having asthma. Although concordance between video and written questionnaires always exceeded 60% and often exceeded 70% for related questions, agreement measured by the kappa statistic for each question was only fair to moderate (kappa = 0.22-0.51). We conclude that the video questionnaire yields lower reported prevalence rates for asthma symptoms, and that there is limited agreement between responses to the two questionnaires that is not explained by issues of language, culture, or literacy.

Asthma↗
PubMed1994

[Development and validation of a semi-quantitative food questionnaire based on a population survey].

An auto-administered, semi-quantitative food frequency questionnaire was developed to assess evolution of dietary habits in the Geneva population. For this purpose 626 adults, aged 35 years or more and residents of Canton Geneva, were interviewed using a 24 hour recall technique. The questionnaire comprises the 80 food items or homogeneous food groups contributing to more than 90% of the intake in calories, proteins, lipids, carbohydrates, alcohol, cholesterol, calcium, vitamin D and retinol, and to more than 85% of dietary fibers, carotene and iron. To complete the food frequency questionnaire, participants indicate for each of the 80 food items or groups their frequency of consumption and whether their usual portion is equivalent to a reference portion listed in the questionnaire (median portion in the sample), smaller (first quartile of the portion distribution in the sample) or larger (third quartile of the portion distribution in the sample). The questionnaire can be filled in about 20 minutes. To test the new questionnaire we submitted it to a sample of 27 men and 29 women randomly selected from the 626 subjects who participated to the original survey. Mean intakes obtained using the food frequency questionnaire agree well with those obtained using the 24 hour recall for all subgroups defined by age, sex or nationality. The food frequency questionnaire tends to slightly underestimate the absolute intakes of alcohol, fibers and calcium since it is based on a subsample of all food items consumed according to the 24 hour recall interviews. These results suggest that the semi-quantitative food frequency questionnaire is a good alternative to 24 hour recalls to assess mean nutrient intakes in the adult population of Canton Geneva.

Adult↗
PubMed2006

Evaluation of a gastrointestinal symptoms questionnaire.

Questionnaires are widely used instruments to monitor gastrointestinal (GI) symptoms. However, few of these questionnaires have been formally evaluated. We sought to evaluate our GI symptoms questionnaire in terms of clarity and reproducibility. Primary care patients referred for open access Helicobacter pylori urea breath testing reported GI symptoms (type+severity) and demographic information by written questionnaire. In an interview, patients gave a personal description of the meaning of the GI symptoms on the questionnaire. Patients' descriptions of GI symptoms were compared with current definitions. Symptom severity scores were compared before and after, interview versus questionnaire. Of the 45 patients included, 19 (42%) described all symptoms correctly, whereas 17 (38%) described one symptom incorrectly. None of the patients made more than three mistakes. Regurgitation was the most common incorrectly described symptom (16 patients [36%]), whereas the other individual symptoms were well explained. Symptom severities before the interview, after the interview and reported by questionnaire (mean value+/-SEM) were 2.1 +/- 0.2, 2.1 +/- 0.2, and 1.5 +/- 0.2 points on a 7-point Likert scale (0-6), respectively. Mean severity reported by interview (95% CI) was 1.4 (1.3-1.5) times higher than reported by questionnaire (P < .05). In conclusion, the GI symptom questionnaire is understandable and has good reproducibility for measuring the presence of GI symptoms, although symptom severity is consistently rated higher when reported by interview.

Breath Tests↗
PubMed1991

Reliability of questionnaire responses as compared with interview in the elderly: views of the outcome of transurethral resection of the prostate.

Three hundred and eighty-eight men undergoing transurethral resection of the prostate for benign prostatic hypertrophy completed a presurgical questionnaire and three follow-up questionnaires 3, 6 and 12 months after surgery. The questionnaires covered details of prostatic symptoms, general health, and expectations and results of surgery. At each follow-up point 40 randomly selected patients were interviewed by two female research assistants. The response rate to the questionnaires was over 90% at each follow-up point while that for the interviews was lower at around 80%. We examine the reliability of the postal questionnaires in assessing health status by comparing questionnaire and interview responses, with a view to the wider employment of such a method in the follow-up of surgical patients. In general, and as reported elsewhere, responses to questions on easily defined topics are highly comparable between questionnaire and interview. Responses to more subjective questions are moderately reliable, but with a tendency for postal questionnaires to underestimate a patient's health problems. It is difficult to assess the reliability of the questionnaires with regard to questions of an intimate nature since such questions caused embarrassment during interview with consequent incomplete responses.

Adult↗
PubMed1992

Comparison of "Rose Questionnaire Angina" to exercise thallium scintigraphy: different findings in males and females.

Validation of the London School of Hygiene (Rose) Questionnaire with objective measures of myocardial ischemia is incomplete. Therefore, we compared the Rose Questionnaire with exercise thallium-201 myocardial scintigraphy in 147 male and 97 female patients with chest pain referred for clinical exercise testing. Of those with "Rose Questionnaire angina", 26% of the females and 73% of the males had positive thallium-201 scans. Negative results on both the Rose Questionnaire and thallium-201 scintigraphy were observed in 71% of the females and 47% of the males. The sensitivity of the Rose Questionnaire was similar in females (41%) and males (44%). The specificity was 77% in males, while in females it was significantly lower at 56%. The specificity values reflect the higher (p less than 0.05) prevalence of "false positive" Rose Questionnaire results in females (75%) compared with males (27%). In addition, males had a greater (p less than 0.05) number of "false negative" results (53%) than females (29%). The accuracy of the Rose Questionnaire for myocardial ischemia was 0.19 in females, 0.48 in males, and 0.29 overall when including both males and females. Our results indicate a generally poor relationship between Rose Questionnaire angina and thallium-201 scintigraphy, an objective measure of myocardial ischemia in patients with chest pain referred to clinical exercise testing. Further, there are gender-specific differences in this relationship between the questionnaire and exercise thallium-201 imaging.

Aged↗
PubMed1992

Comparison of two physical activity questionnaires, with a diary, for assessing physical activity in an elderly population.

Measurement of physical activity in epidemiological studies is usually achieved by means of a questionnaire. Little work has been done to determine which questionnaire format has greater validity in an elderly population. In this study of elderly subjects, physical activity as reported in two self-administered questionnaires (A and B), which differed in format and length, were compared to activity reported in a 4 day diary. As compared with the diary, moderate/heavy activity was more accurately reported in Questionnaire A (mean difference 5 min), the longer more detailed questionnaire, than B (mean difference 170 min). Light activity was under reported in Questionnaire A (mean difference 68 min) and over reported in B (mean difference 88 min) as compared with the diary. In contrast, time spent sitting was more accurately reported in Questionnaire B (mean difference 40 min) than in A (mean difference 230 min) as compared with the diary. The longer more detailed questionnaire was the more accurate instrument for assessing moderate/heavy activity in this elderly population. The shorter questionnaire was more accurate for assessing time spent sitting.

Activities of Daily Living↗
PubMed1994

The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life.

The EORTC Study Group on Quality of Life has developed a modular system for assessing the quality of life of cancer patients in clinical trials composed of two basic elements: (1) a core quality of life questionnaire, the EORTC QLQ-C30, covering general aspects of health-related quality of life, and (2) additional disease- or treatment-specific questionnaire modules. Two international field studies were carried out to evaluate the practicality, reliability and validity of the core questionnaire, supplemented by a 13-item lung cancer-specific questionnaire module, the EORTC QLQ-LC13. In this paper, the results of an evaluation of the QLQ-LC13 are reported. The lung cancer questionnaire module comprises both multi-item and single-item measures of lung cancer-associated symptoms (i.e. coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia). It was administered to patients with non-resectable lung cancer recruited from 17 countries. In total, 883 and 735 patients, respectively, completed the questionnaire prior to and once during treatment. The symptom measures discriminated clearly between patients differing in performance status. All item scores changed significantly in the expected direction (i.e. lung cancer symptoms decreased and treatment toxicities increased) during treatment. With one exception (problems with a sore mouth), the change of toxicity measures over time was related specifically to either chemo- or radiotherapy. However, the single item on neuropathy did not measure adequately the full range of symptoms. The hypothesised scale structure of the questionnaire was partially supported by the data. The multi-item dyspnoea scale met the minimal standards for reliability (Cronbach alpha coefficient > 0.70), while the pain items did not form a scale with reliability estimates acceptable for group comparisons. In conclusion, the results form international field testing lend support to the EORTC QLQ-LC13 as a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer patients participating in clinical trials, when combined with the EORTC core quality of life questionnaire. In a few areas, however, the questionnaire module could benefit from further refinements. In addition, its performance over a longer period of time still needs to be investigated.

Adult↗
PubMed2004

Mode of delivery, but not questionnaire length, affected response in an epidemiological study of eating-disordered behavior.

BACKGROUND AND OBJECTIVES: The effects of questionnaire length and mode of delivery on response rates were examined in an epidemiological study of eating-disordered behavior. METHODS: Short (8 pages) and long (14 pages) questionnaires were posted or hand-delivered to a community sample of 802 women. Nonrespondents who received the first questionnaire by hand delivery received a reminder letter and replacement questionnaire by post; those who received the initial questionnaire by post were further randomized to receive the first reminder by hand delivery or by post, in short or long form. A second reminder letter and questionnaire (in short or long form) were posted to all remaining nonrespondents. RESULTS: The overall response rate was 52.9%. This is a conservative estimate of true response, because in a substantial proportion of cases (12.2%) individuals were no longer resident at the listed address. There was a significant effect of mode of delivery on response, favoring hand delivery, at both the initial mailout and first reminder. There was no effect of questionnaire length on response to the initial mailout, although overall response was significantly higher for the longer form. It was estimated that an overall response of 58.0% would have been achieved had first reminders been hand-delivered to all nonrespondents who received the initial mailout by post. CONCLUSIONS: Delivery of questionnaires by hand may be an effective way to increase response rates in epidemiological research, but little is to be gained by reducing questionnaire length.

Adult↗
PubMed2005

Comparison of generic and disease-specific questionnaires for the assessment of quality of life in patients with peripheral arterial disease.

OBJECTIVE: This study compared the ability of generic and disease-specific questionnaires to assess quality of life (QOL) at baseline and to detect change in QOL after treatment in patients with peripheral arterial disease (PAD). METHODS: This prospective multicenter trial recruited 514 patients with PAD who needed an imaging workup and had an ankle brachial pressure index of less than 0.90. Patients with severe comorbidity were excluded, leaving a study population of 450 patients. Patients completed two generic questionnaires, the Short Form 36 (SF-36) and the European Quality of Life 5D (EuroQol-5D), and one disease-specific questionnaire, the Vascular Quality of Life (VascuQol) at baseline and after 6 months of follow-up. Rutherford classification and treadmill walking distance were determined at baseline and after 6 months of follow-up and were considered indicators of disease severity. Receiver operating characteristic (ROC) curves and areas under the curves (AUCs) were used to evaluate each of the three questionnaires for its ability to discriminate between severe and mild disease at baseline and to discriminate between a large and small change in disease severity after follow-up. The underlying assumption was that disease severity is a major determinant of QOL. This implies that the validity of a QOL questionnaire is reflected by its ability to discriminate between mildly and severely diseased patients. RESULTS: At baseline, 443 patients and after follow-up, 386 patients completed questionnaires. At baseline, no significant ( P >.05) differences were observed among AUCs for the total scores of the three questionnaires, indicating that all three questionnaires assessed the disease severity equally well. After follow-up, the AUCs for the VascuQol were significantly higher than the AUCs for the SF-36 and EuroQol-5D with respect to detection of improvement in Rutherford classification ( P < .05), indicating that change in disease severity after follow-up was best detected by the VascuQol. CONCLUSION: The VascuQol is the preferred questionnaire as outcome measure for QOL in future trials and clinical follow-up of patients with PAD.

Aged↗
PubMed2002

The Sexual and Physical Abuse Questionnaire (SPAQ). A screening instrument for adults to assess past and current experiences of abuse.

OBJECTIVE: We reconstructed and validated a simple questionnaire to be completed by adult respondents for the assessment of sexual and physical abuse during childhood and later life, the Sexual and Physical Abuse Questionnaire (SPAQ). METHOD: The criterion validity of the questionnaire was investigated in a population of psychiatric outpatients (n = 134) using the Structured Trauma Interview [Am. J. Psychiatr. 156 (1999) 379] as gold standard for the assessment of sexual and physical abuse. RESULTS: All questionnaires were returned fully completed. The measures of agreement and the predictive measures of the questionnaire were satisfactory, in particular with respect to experiences of sexual abuse. Positive answering of the questionnaire increased the odds for sexual abuse by a factor of 12-17.5, and negative answering of the questionnaire reduced the odds by a third. The odds for physical abuse were increased by a factor of 8 with positive answering of the questionnaire, and reduced by a third with negative answering. CONCLUSION: The questionnaire may be a useful screening instrument in research and in clinical practice to assess sexual abuse during childhood and later years. As a screening instrument for physical abuse it is less satisfactory.

Adolescent↗
PubMed1997

Validation of a questionnaire for comparing the tolerability of ophthalmic medications.

PURPOSE: The Comparison of Ophthalmic Medications for Tolerability (COMTOL) questionnaire was developed for use in clinical trials to compare the tolerability of topical ophthalmic medications used in the treatment of glaucoma. The questionnaire captures the frequency and bother of common side effects (i.e., ocular and other local effects, and effects on visual function) of topical therapy for lowering intraocular pressure. In addition, the questionnaire measures the extent to which these side effects and any associated limitations in routine living activities interfere with health-related quality of life, medication compliance, and patient satisfaction with the medication. This study was designed to assess the measurement characteristics of the COMTOL questionnaire. METHODS: The internal consistency, reliability, reproducibility, construct validity, discriminant validity, and responsiveness of the questionnaire were assessed in 70 adult patients with glaucoma in a clinical trial comparing timolol and pilocarpine. RESULTS: The questionnaire showed good-to-excellent internal consistency (0.73 to 0.98), reliability (0.76 to 0.94), and reproducibility (0.75 to 0.93). In general, there was a strong correlation in the expected direction between the frequency and bother of side effects and patient-perceived global measures. The questionnaire discriminated between patients receiving timolol and patients receiving pilocarpine. The questionnaire demonstrated significant responsiveness to change. CONCLUSIONS: The COMTOL questionnaire showed acceptable measurement characteristics for inclusion as a tolerability measure to supplement spontaneous adverse event reporting in clinical trials of topical ophthalmic therapy.

Adrenergic beta-Antagonists↗
PubMed2006

Febrile convulsions: development and validation of a questionnaire to measure parental knowledge, attitudes, concerns and practices.

BACKGROUND: The best medicine for febrile convulsions (FCs) is not prescription medications but effective communication of related information to parents. Therefore, a quick assessment tool for obtaining information about parental responses to FCs is essential for educating parents, clinical practice and research. This paper describes the development and psychometric testing of a questionnaire on parental knowledge, attitudes, concerns and practices (KACP) toward FC. METHODS: Questionnaire items were created via literature review, interview, and expert consultation. Ten parents were interviewed to develop the questionnaire contents. Nine experts and seven parents were consulted to review the content and face validity of the questionnaire. Of the 326 parents of children with FC visiting 11 emergency departments in southern Taiwan, 216 parents completed the questionnaire, and 64 completed the questionnaire again 2 weeks later. Content validity, internal consistency, test-retest reliability, and item analysis were evaluated. RESULTS: Cronbach's alpha exceeded 0.72 for the knowledge, attitudes and concerns domains. The item-total correlations in the knowledge and concerns domains ranged from 0.40 to 0.73, but were lower in the attitudes domain (only 4 in 10 items were within 0.40-0.70). The intraclass correlation coefficients (ICC) for the test-retest reliability of the knowledge, attitudes and concerns domains were 0.65, 0.68 and 0.58, respectively. The correlation coefficients between KACP domains were tested and significantly supported the theoretical basis of the questionnaire. CONCLUSION: For research purposes, the KACP questionnaire measures parental responses with a moderate level of reliability and validity. Cross-cultural investigation of the questionnaire is needed to facilitate its use in other countries.

Adult↗
PubMed2004

Ethnicity, but not cancer family history, is related to response to a population-based mailed questionnaire.

PURPOSE: To determine if family history and ethnic background are factors affecting response to a mailed cancer family history questionnaire from the Ontario Familial Breast Cancer Registry. METHODS: Individuals diagnosed with primary invasive breast carcinomas (probands) were mailed a family history questionnaire, the first contact in a multi-stage process. This questionnaire obtained cancer family history and ethnicity data. After one month, a follow up telephone call was made to those who did not return this questionnaire and attempts were made to ask similar questions by telephone interview. Characteristics of those responding to the mailed questionnaire were compared to those who responded to the telephone interview only. RESULTS: 339 probands were included in this study: 242 returned a mailed version of the questionnaire; 57 completed the questionnaire over the phone. Cancer family history/genetic risk criteria was not significantly related to type of response. Probands identifying themselves as visible minorities were significantly less likely to respond to the mailed questionnaire than the telephone interview (11.6% vs. 22.8%, P=0.03). CONCLUSIONS: Having a family history of cancer did not appear to influence response to a mailed questionnaire, but those reporting an ethnic/racial background other than White were more likely to respond to a telephone interview.

Adult↗
PubMed2006

Validation of a quality-of-life questionnaire for patients with pituitary adenoma.

BACKGROUND: The purpose of this study was to develop and validate a self-administered questionnaire to measure the health-related quality of life of patients with pituitary adenoma. METHODS: A patient-centred iterative process, involving a literature review and focus group interviews with 84 patients, was used to develop a preliminary 106-item questionnaire and to validate it. The final questionnaire comprised the 30 most important items chosen by 20 patients and 17 items considered important by health care professionals. For assessment of its validity and reliability, 55 patients were asked to complete the final questionnaire, RAND-36, FACT- G/FACT-Br, and Karnofsky Performance Scale (KPS). Concurrent validity of the results of our questionnaire with those of the other instruments was assessed with Pearson correlation coefficients. Known-group validity for the scores of extreme groups was assessed with a Student's t test. Test-retest reliability was determined with Pearson correlation coefficients and a Student's t test for two sets of scores obtained one month apart. RESULTS: Forty-seven (85.5%) of the 55 questionnaires were completed. Our questionnaire was well correlated with the RAND-36, the FACT-Br, the FACT-G, and the KPS in the general health domain, but not with the KPS overall. Extreme groups (n = 20) were significantly different. Test-retest reliability (n = 24) was 0.88, and scores one month apart were not significantly different. CONCLUSION: Our patient-centred health-related quality of life questionnaire developed for patients with pituitary adenoma had good validity and reliability. This questionnaire could be used as a patient-centred outcome measure in clinical trials and for assessment of disease progression.

Adenoma↗
PubMed2001

Validation of a migraine-specific questionnaire for use in family studies.

The availability of valid migraine-specific questionnaires is important when large numbers of migraine patients have to be analysed. The Finnish Migraine-Specific Questionnaire has been validated in two stages. In the first, a clinical diagnosis of migraine was reached, using International Headache Society criteria, in 100 consecutive patients. Migraine was then diagnosed independently on the basis of responses to the Finnish Migraine-Specific Questionnaire. In the second stage, responses to 100 questionnaires returned consecutively in a family study in progress were analysed, and respondents were contacted by telephone for interview and diagnosis of migraine. Contact proved impossible in six cases. The sensitivity of the questionnaire for migraine was 0.99 (167 out of 168; validation stages 1 and 2 combined) and specificity was 0.96 (25 out of 26 cases; validation stage 2). It also proved possible to differentiate between migraine with and without aura on the basis of responses to the Finnish Migraine-Specific Questionnaire: chance-corrected agreement (Cohen's kappa) was 0.804 in relation to diagnoses reached on the basis of responses to the Finnish Migraine-Specific Questionnaire and clinically was 0.858 in relation to diagnoses reached on the basis of responses to the Finnish Migraine-Specific Questionnaire combined with the results of the telephone interviews. A value for Cohen's kappa > 0.75 indicates good agreement. Therefore, use of the Finnish Migraine-Specific Questionnaire in research into migraine genetics is justified.

Humans↗
PubMed2003

The Eating Behavior Patterns Questionnaire predicts dietary fat intake in African American women.

OBJECTIVE: To develop a behavioral assessment of eating that would be predictive of fat intake in African American women. DESIGN: Questionnaires were developed using a three-stage design, involving item generation, item refinement, and questionnaire validation. SUBJECTS: Focus groups sessions were conducted with 40 African American women, initial questionnaire development employed 80 African American women, and questionnaire validation involved 310 African American women from diverse socioeconomic backgrounds. Statistical analyses Transcripts of focus groups were used to generate 113 behavioral questionnaire items. The initial questionnaire was administered along with a food frequency questionnaire, and the item pool was reduced to 51 items. Factor analysis was used to create subscales. Correlation (r) and multiple regression analysis (R) were used to evaluate construct validity. RESULTS: Factor analysis revealed six subscales: low-fat eating, emotional eating, snacking on sweets, cultural/ethnic, haphazard planning, and meal skipping. The scales are significant predictors of micronutrient (R values from 0.22 to 0.47) and macronutrient intakes (R values from 0.33 to 0.58) assessed using a food frequency questionnaire and show construct validity in relationship to other measures of eating behavior (r values from 0.22 to 0.65). APPLICATIONS: The Eating Behavior Patterns Questionnaire (EBPQ) may be a useful tool for clinical assessment, clinical and community nutrition intervention studies, and epidemiologic research with African American women.

Adult↗
PubMed2001

Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia.

AIMS: The purpose of this study was to develop and validate an easily used disease-specific quality of life (QOL) measure for patients with chronic lower limb ischemia and to design an evaluative instrument, responsive to within-subject change, that adds to clinical measures of outcome when comparing treatment options in the management of lower limb ischemia. METHODS: The first phase consisted of item generation, item reduction, formulating, and pretesting in patients with ischemia. The proportion of patients who selected an item as troublesome and the mean importance they attached to it were combined to give a clinical impact factor. Items with the highest clinical impact factor were used to formulate a new 25-item questionnaire that was then pretested in 20 patients with lower limb ischemia. In the second phase, reliability, validity, and responsiveness of the new questionnaire were assessed in 39 patients with lower limb ischemia who were tested at 0 and 4 weeks. The King's College Hospital's Vascular Quality of Life Questionnaire and the Short-Form 36 were administered at each visit, and treadmill walking distance and ankle/brachial pressure indices were recorded. The new questionnaire's reliability, internal consistency, responsiveness, and validity were determined. RESULTS: Areas of QOL impairment were consistent through the ranges of disease severity and age, with no apparent differences between the men and women. Therefore, a single questionnaire is applicable to all patients with chronic lower limb ischemia. In stable patients test-retest scores demonstrated a reliability of r more than 0.90. Each item had internal consistency (item-domain Cronbach alpha =.7-.9). The questionnaire was responsive to change, with correlation between change in the questionnaire's total score and both global and clinical indicators of change (P <.001). The questionnaire showed face and construct validity. CONCLUSIONS: This disease-specific questionnaire is reliable, responsive, valid, and ready for use as an outcome measure in clinical trials. It is sensitive to the concerns of patients with lower limb ischemia, offering a simple method to measure the effect of interventions on their QOL.

Adult↗