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Questionnaire as diagnostic tool in chronic pelvic pain (CPP): a pilot study.

OBJECTIVES: No standard screening instrument is available enabling physicians to assign the diagnosis chronic pelvic pain (CPP) to women with lower abdominal pain. Therefore, our aim was to evaluate an easy-to-use questionnaire, which can be applied as a validated primary screening test for diagnosing CPP. STUDY DESIGN: From the general female population, 577 women completed a questionnaire addressing chronic symptoms in the pelvic region. Included were (amongst others) questions on lower abdominal pain, low back pain, voiding symptoms, dyspareunia, pelveo-perineal dysesthetic feelings and evacuation problems. Serious chronic lower abdominal pain of unknown origin was considered as CPP. Three criteria were applied to validate the questionnaire: construct validity, comparison with results of a previous study and content validity. In addition, the internal consistency was checked to ascertain the reliability of the questionnaire. RESULTS: All items, with the exception of those concerning voiding symptoms and dyspareunia, withstood the validity tests applied, were interrelated and occurred significantly more often in women with CPP than those without. There were no significant differences in the frequency of the occurrence of low back pain, dyspareunia and evacuation problems between CPP women in the current community study and outpatients diagnosed with CPP in an earlier study performed at the University Hospital Rotterdam. Compared to our current study group, pelveo-perineal dysesthesia (PPD) and voiding symptoms were significantly more often reported by the CPP outpatients. CONCLUSION: The CPP questionnaire can be considered as a validated tool for primary screening of CPP.

Adult↗

Validation of an Italian version of the prolapse quality of life questionnaire.

OBJECTIVE: To validate the italian translated version of the prolapse quality of life questionnaire (P-QOL). STUDY DESIGN: The P-QOL questionnaire was translated into Italian and administered to women recruited from a gynaecology outpatient clinic. All women completed a P-QOL questionnaire at the time of the visit, and were examined in left lateral position using the ICS prolapse score. A second P-QOL questionnaire was posted and completed by women 1 week later. The validity was assessed by measuring levels of missing data, comparing symptom scores with objective prolapse stages and between affected and asymptomatic women. The reliability was assessed by testing internal consistency and stability using 1-week test retest analysis. RESULTS: 132 symptomatic and 61 asymptomatic women were studied. The number of missing items was 2%. P-QOL domain scores were significantly different between symptomatic and asymptomatic women (P<0.001). Severity according to P-QOL strongly correlated with the prolapse size (P<0.01, rho>0.5). All items achieved a Cronbach alpha greater than 0.8. The test retest reliability confirmed a highly significant correlation between the total scores for each domain. CONCLUSION: The Italian version of the P-QOL questionnaire has been validated, providing a reliable, easily comprehensible and valid instrument for the symptomatic assessment of Italian-speaking women with uterovaginal prolapse.

Adult↗

Some empirical evidence regarding the validity of the Spanish version of the McGill Pain Questionnaire (MPQ-SV).

Despite the fact that the McGill Pain Questionnaire (MPQ) is a useful pain assessment tool with widespread acceptance, empirical analyses have questioned its validity because they have not consistently supported the three a priori factors that guided its construction. The Spanish version that has followed the most systematic and rigorous reconstruction process (Lázaro C, Bosch F, Torrubia R, Banos JE. The development of a Spanish Questionnaire for assessing pain: preliminary data concerning reliability and validity. Eur J Psychol Assess, 1994;10:145-151) lacks evidence to support its construct validity. In the present study, the internal structure of the Spanish version of the McGill Pain Questionnaire (Lázaro C, Bosch F, Torrubia R, Banos JE. The development of a Spanish Questionnaire for assessing pain: preliminary data concerning reliability and validity. Eur J Psychol Assess, 1994;10:145-151) was examined in a sample of 202 acute pain patients and 207 chronic pain patients. Confirmatory factor analyses were carried out to compare alternative models postulating different internal structures (one-factor model, the classic three-factor model, and the semantic model inspired by the alternative structure found by Donaldson in 1995 (Donaldson GW. The factorial structure and stability of the McGill Pain Questionnaire in patients experiencing oral mucositis following bone marrow transplantation. Pain 1995;62:101-109)). Results from the LISREL CFA analysis indicated that the semantic model fitted better than the other models. On the other hand, intercorrelations between scales were smaller than the reliability indexes. In relation to concurrent evidence, significant correlations (0.001) were found between each subscale and the criteria measurements of every pain dimension. Only the affective subscale presented discriminant validity. Evidence supports the validity of the affective and sensory subscales but not the evaluative scale.

Adolescent↗

Psychometric validation of two Italian quality of life questionnaires in menopausal women.

OBJECTIVE: To establish the psychometric properties of the Italian version of two quality of life (QOL) questionnaires in menopausal women: the psychological general well being index (PGWBI) and the women's health questionnaire (WHQ). METHOD: These questionnaires were translated into Italian and then self-administered to out-patient women a first time, 1 week later in stable women to assess reproducibility, and 3 months later to evaluate responsiveness over time. Baseline analyses included: factorial structure, multitrait analysis, internal consistency reliability, and clinical validity. RESULTS: Questionnaires were returned by 155 women (median age: 54 years, median duration of amenorrhoea: 56 months, median Kupperman index 26). Principal component analysis (PCA) of the PGWBI showed an important general factor and then, after rotation, three factors. The PCA of the WHQ showed ten factors. Only five reproduced the dimensions postulated à priori quite well. The item convergent validity was confirmed for all items of the major dimension of the two questionnaires, and the item divergent validity, although acceptable, was less satisfying for the PGWBI than the WHQ. The internal reliability was good (Cronbach's alpha > or = 0.70) for the PGWBI and for nine scales out of ten for the WHQ. The six dimensions of the PGWBI and most of the dimensions of the WHQ were significantly correlated to the Kupperman index, indicating the clinical validity of the instruments. The responsiveness to change in clinical status at 3 months was better in the PGWBI than in the WHQ with moderate effect size (around 0.5). CONCLUSION: The Italian versions of the PGWBI and the WHQ are reliable and useful for HRT clinical trials but the dimensional scores must be calculated bearing in mind the limitations in the structure. Other studies are needed to improve the factorial stability of certain WHQ dimensions. For the Italian version of the PGWBI, the validation process is to be completed by studies of mixed populations suffering from other types of disease.

Adult↗

A menopause-specific quality of life questionnaire: development and psychometric properties.

OBJECTIVE: To develop a condition-specific quality of life questionnaire for the menopause with documented psychometric properties, based on women's experience. METHODS SUBJECTS: Women 2-7 years post-menopause with a uterus and not currently on hormone replacement therapy. Questionnaire development: A list of 106 menopause symptoms was reduced using the importance score method. Replies to the item-reduction questionnaire from 88 women resulted in a 30-item questionnaire with four domains, vasomotor, physical, psychosocial and sexual, and a global quality of life question. Psychometric properties: A separate sample of 20 women was used to determine face validity, and a panel of experts was used to confirm content validity. Reliability, responsiveness and construct validity were determined within the context of a randomized controlled trial. Construct validation involved comparison with the Neugarten and Kraines'Somatic, Psychosomatic and Psychologic subscales, the reported intensity of hot flushes, the General Well-Being Schedule, Channon and Ballinger's Vaginal Symptoms Score and Libido Index, and the Life Satisfaction Index. RESULTS: The face validity score was 4.7 out of a possible 5. Content validity was confirmed. Test-retest reliability measures, using intraclass correlation coefficients were 0.81, 0.79, 0.70 and 0.55 for the physical, psychosocial, sexual domains and the quality of life question. The intraclass correlation coefficient for the vasomotor domain was 0.37 but there is evidence of systematic change. Discriminative construct validity showed correlation coefficients of 0.69 for the physical domain, 0.66 and 0.40 for the vasomotor domain, 0.65 and -0.71 for the psychosocial domain, 0.48 and 0.38 for the sexual domain, and 0.57 for the quality of life question. Evaluative construct validity showed correlation coefficients of 0.60 for the physical domain, 0.28 for the vasomotor domain, 0.55 and -0.54 for the psychosocial domain, 0.54 and 0.32 for the sexual domain, and 0.12 for the quality of life question. Responsiveness scores ranged from 0.78 to 1.34. CONCLUSIONS: The MENQOL (Menopause-Specific Quality of Life) questionnaire is a self-administered instrument which functions well in differentiating between women according to their quality of life and in measuring changes in their quality of life.

Attitude to Health↗

Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure.

OBJECTIVES: To create a valid, sensitive, disease-specific health status measure for patients with congestive heart failure (CHF). BACKGROUND: Quantifying health status is becoming increasingly important for CHF. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. METHODS: To establish the performance characteristics of the KCCQ, two distinct patient cohorts were recruited: 70 stable and 59 decompensated CHF patients with ejection fractions of <40. Upon entry into the study, patients were administered the KCCQ, the Minnesota Living with Heart Failure Questionnaire and the Short Form-36 (SF-36). Questionnaires were repeated three months later. RESULTS: Convergent validity of each KCCQ domain was documented by comparison with available criterion standards (r = 0.46 to 0.74; p < 0.001 for all). Among those with stable CHF who remained stable by predefined criteria (n = 39), minimal changes in KCCQ domains were detected over three months of observation (mean change = 0.8 to 4.0 points, p = NS for all). In contrast, large changes in score were observed among patients whose decompensated CHF improved three months later (n = 39; mean change = 15.4 to 40.4 points, p < 0.01 for all). The sensitivity of the KCCQwas substantially greater than that of the Minnesota Living with Heart Failure and the SF-36 questionnaires. CONCLUSIONS: The KCCQis a valid, reliable and responsive health status measure for patients with CHF and may serve as a clinically meaningful outcome in cardiovascular research, patient management and quality assessment.

Activities of Daily Living↗

Comparing physical activity questionnaires for youth: seasonal vs annual format.

BACKGROUND: In large cohort studies of older children, self-report is the only practical way to assess physical activity. Assessing usual activity over the entire year is desirable, but children and adolescents may overestimate activities with high seasonal variability. Use of questionnaires in which individuals report each activity by season may improve accuracy. METHODS: A total of 6782 girls and 5110 boys, aged 9-14 years in 1996, completed self-administered activity questionnaires in 1996 and in 1997. In 1996, participants reported the average time spent in each of 17 activities during the previous 12 months; in 1997, we also asked for the average time spent in the previous year, but within each of the four seasons. RESULTS: Girls reported a median of 12.8 hours/week total activity in 1996 and 10.4 hours/week in 1997. For boys, the estimates were 15.5 hours/week and 13.4 hours/week, respectively. Girls and boys within 1-year age strata (e.g., comparison of 10-year olds in 1996 with 10-year olds in 1997) reported an average of 3.7 and 3.1 fewer hours per week, respectively, on the 1997 seasonal format versus the 1996 annual format questionnaire. In longitudinal analyses, the difference between the annual and the seasonal estimates was greater if participants did the activity in fewer seasons in 1997. CONCLUSIONS: In comparison to an annual format questionnaire, a seasonal format questionnaire may improve accuracy of self-report of physical activity by reducing over-reporting of activities in which pre-adolescents and adolescents engage in fewer seasons.

Adolescent↗

Correlation of patient questionnaire responses and physician history in grading clinical outcome following hip and knee arthroplasty. A prospective study of 201 joint arthroplasties.

Questionnaires are commonly used in orthopaedic outcome studies. This study sought to determine if responses to a simple standardized questionnaire correlated with responses obtained during a physician interview in evaluation of clinical outcome following hip and knee arthroplasty. One hundred sixty-two patients with 201 hip and knee arthroplasties were asked to fill out a questionnaire prior to returning for routine follow-up evaluation. There was a highly significant correlation (P < .0001, r = .74) between scores calculated from patient responses on the questionnaire and those calculated from responses recorded during the subsequent physician visit. There was no significant difference between patient and physician clinical hip scores, but physicians gave significantly higher knee scores than patients for both long- ( > 4.5 years, P < .05) and short-term ( < or = 4.5 years, P < .0001) follow-up periods; however, 97% of patient responses were within one grade of physician-recorded answers to the same questions. Eight and one-half percent of scores differed in overall evaluation from good-excellent to fair-poor categories. This study both validates and defines more clearly the limitations of questionnaires for follow-up evaluation of clinical results following total hip and knee arthroplasty.

Aged↗

Development of a short osteoporosis quality of life questionnaire by equating items from two existing instruments.

This study aimed to develop a short Osteoporosis-Specific Quality of Life Questionnaire based on the assemblage (equating) of the items of two existing questionnaires (OQLQ and QUALEFFO). For this purpose, each questionnaire was administered by random assignment to a different group of female patients (OQLQ, n = 172; QUALEFFO, n = 166) with vertebral fractures due to osteoporosis. A common anchor test (SF-36) was also given to both groups. Seven different sets of OQLQ-QUALEFFO common items were defined by inspecting their own correlation with the scores of the eight dimensions of the SF-36. Within each set, equating consisted in connecting the OQLQ and QUALEFFO through their link with the SF-36. Equating was carried out through the Rasch mathematical model. Quantitative (item statistics) and qualitative reductions (expert opinion) of the equated sets resulted in a 16-item questionnaire. Although the new instrument requires further empirical validation, it provides a promising alternative to currently existing longer questionnaires for use in clinical practice.

Activities of Daily Living↗

A short psychosocial questionnaire for patients with Parkinson's disease: the SCOPA-PS.

The purpose of this study was to develop a short questionnaire for psychosocial functioning in patients with Parkinson's Disease (PD). The SCales for Outcomes in Parkinson's disease-PsychoSocial questionnaire (SCOPA-PS) was tested in a survey and compared with other instruments and with medical information. This survey was sent to 205 patents with idiopathic PD. Eighty-six percent of the questionnaires were returned. Cronbach's alpha was 0.83. Two-week test-retest reliability was 0.85 (intraclass correlation coefficient). Construct validity with other scales (Spearman's rho) was 0.82 for the Parkinson's Disease Questionnaire-39-item version (PDQ-39), 0.76 for the PDQ-8, 0.69 for the Hospital Anxiety and Depression Scale, -0.61 for the Euroqol, and -0.60 for a visual analogue scale evaluating Quality-of-Life. The summary index revealed a significant increase with increasing disease severity. The SCOPA-PS is a new, short psychosocial questionnaire for patients with PD with good clinimetric properties.

Activities of Daily Living↗

Reliability of the Wisconsin Sleep Questionnaire: a French contribution to international validation.

We evaluated the reliability of a French version of the Wisconsin Sleep Questionnaire designed to investigate snoring, obstructive apnoeas, and sleeping problems. The assessment of reliability included the study of internal consistency and the 3 months repeatability of the questionnaire. The questionnaire was first completed at a Center of Preventive Medicine by a random sample of 122 subjects from the community. Three months later the same form was mailed and 82 questionnaires were returned (67.2%). No significant differences existed between responders and nonresponders for anthropometric data or life habits. The internal consistency in each domain was good or satisfactory (Cronbach's alpha=0.67 to 0.81). The concordance between the answers at a 3-month interval was excellent for questions on ever snoring, frequency of snoring, gasping/choking during sleep, and breathing stops during sleep (Cohen kappa>0.60). The questions on snoring loudness, a history of sleep apnoea, and excessive daytime sleepiness were fairly reproducible (kappa 0.28 to 0.60). We found no difference in reproducibility by gender or age. In conclusion, this reliability assessment in a sample of middle-aged subjects from the community in northeastern France showed satisfactory internal consistency and 3-months reproducibility of the main questions of a French translation of the Wisconsin Sleep Questionnaire.

Age Factors↗

Validation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer agreement.

Patient-rated questionnaires are increasingly used to assess health-related quality of life. We studied one aspect of the validity of such measures that has rarely been investigated do patients interpret questionnaires in the same way as do the researchers reporting the results? If not, there may be a problem. We employed the EORTC QLQ-C30 quality-of-life questionnaire to study 95 cancer patients and measured the agreement between (1) the patient's self-assessment and (2) an observer's rating of the patient's open-ended responses to the same questionnaire administered as an interview. The observer made qualitative recordings describing potential misinterpretations. The agreement between patients' and observers' ratings was high (median kappa = 0.85, range 0.49-1.00). The qualitative data revealed a few minor validity problems. One of these, selective reporting, may lead to systematic errors; some patients reported only what they considered "relevant" symptoms. The combination of quantitative and qualitative methods proved useful for questionnaire validation.

Adult↗

Bayesian estimation of asthma prevalence, and comparison of exercise and questionnaire diagnostics in the absence of a gold standard.

PURPOSE: To estimate the sensitivities, specificities, and predictive values of exercise challenge and questionnaire, when these tests are used to diagnose asthma in children. METHODS: Participants were children, predominantly aged 6 to 12 years, selected from three primary school grades among 18 different schools in Montreal. Of 1111 participants, 989 successfully completed a six-minute free running test at school and returned a respiratory questionnaire. A total of 952 children had complete information that could be used for analysis. A history of wheezing in the past year in conjunction with a past diagnosis of asthma defined current asthma by questionnaire. Exercise responsiveness was defined as a > or = 10% fall in FEV1 after a six-minute free run. As there is no perfectly accurate diagnostic test for asthma, we analyzed the data using a previously published Bayesian method that allows for the estimation of test properties when no gold standard test is available. RESULTS: Current asthma by questionnaire was found to have significantly higher specificity (94.9%, 95% credible interval (CI): 93.2-96.5 versus 82.6%, 95% CI: 79.9-85.1) and positive predictive value (53.8%, 95% CI: 41.0-66.7 versus 19.2%, 95% CI: 12.3-27.8) in comparison to exercise challenge. While there was no statistically significant difference between the two tests with respect to sensitivity and negative predictive values, the estimates were higher for current asthma (64.4%, 95% CI: 50.9-76.6 and 96.7%, 95% CI: 94.6-98.1, respectively) in comparison to exercise challenge (51.3%, 95% CI: 37.8-64.5 and 95.4%, 95% CI: 93.2-97.1, respectively). Agreement between the two diagnostic methods was poor and the combined use of the two tests did not significantly improve the likelihood of correctly identifying children with asthma. CONCLUSIONS: Our findings support the view that exercise testing adds little to a well designed questionnaire in identifying subjects with asthma in community based studies.

Asthma↗

Validation of the rhinitis outcomes questionnaire (ROQ).

BACKGROUND: Currently, there is no easy-to-use and comprehensive questionnaire that measures the effectiveness of treatment of rhinitis-related symptoms in a private practice setting. OBJECTIVE: To validate a brief, effective, self-administered rhinitis symptoms questionnaire that can easily be used in a private practice setting for tracking treatment outcomes. METHODS: One hundred seventy-five patients were randomly chosen from three private practices nationwide and were surveyed regarding systemic problems, nasal, eye, and chest symptoms, as well as medical treatment obtained. This survey was administered twice in one sitting with the first administration a recall of symptoms before immunotherapy, and the second administration an evaluation of current symptoms. Appropriate statistical methods were used to evaluate the validity, reliability, and responsiveness of the questionnaire presented. The validation of this instrument included content, statistical, construct, and predictive validity. RESULTS: Both the content and statistical validity were very good in that the questionnaire was easily understood and covered required domains. Construct validity revealed that the items were sensibly related to the domains that contained them and had less association with items from different domains. The reliability of the scales was very good (Cronbach's alpha = 0.80) to outstanding (Cronbach's alpha = 0.92). CONCLUSIONS: Functionality was established for the rhinitis outcomes questionnaire (ROQ) for use in a private practice setting. This allows private practice allergists to collect reliable data with the ROQ.

Adult↗

Cross-cultural adaptation and validation of an Arabic Health Assessment Questionnaire for use in rheumatoid arthritis patients.

OBJECTIVE: To test the reliability and validity of a modified and translated version of the original Health Assessment Questionnaire (HAQ) on patients with rheumatoid arthritis (RA). METHOD: A cohort of 184 RA patients from different Arabic countries (Egypt, Saudi Arabia, Sudan, Syria, Bahrain, Kuwait and Morocco) were recruited and asked to participate in the study. Two questions had been changed to suit the Arabic culture and to tackle some aspects that are commoner to be performed in the Arabic culture. After modification, translation and retranslation of the questionnaire, it was administered to the selected patients and tested for internal consistency, reliability and construct validity by correlating the yield of the questionnaire with other disease activity parameters. The questionnaire was administered again after a 1-week interval for evaluation of the reliability of this test. The modified questions were tested for their loyalty to the principal component and comparing their correlation with that of the other unchanged items. RESULTS: Test-retest showed strong reliability with a high percentage of agreement and high values for Kappa. Internal consistency showed a high value for standardized alpha (Cronbach's): 0.979 that did not show any significant change if any of the 20 items had been eliminated. The modified questionnaire had shown a strong validity when correlating its results with other disease activity parameters. This correlation was the strongest with tender joint count (TJC), Ritchie articular index (RAI), morning stiffness (MS) and visual analogue scale (VAS) and the least (but still significant) with rheumatoid factor (RF). CONCLUSION: The Arabic HAQ is a reliable and valid instrument that can be self-administered to Arabic RA patients to evaluate their functional disability. Its measurement properties were comparable to versions in other languages.

Activities of Daily Living↗

[Validation of an asthma knowledge questionnaire for use in parents or guardians of children with asthma].

OBJECTIVE: Interventions to increase asthma knowledge enable children and/or their parents to acquire skills needed for the prevention and/or appropriate management of crises. Periods of illness caused by the disease can thereby be reduced. However, no validated instrument for quantifying knowledge of asthma is available in Spanish. The aim of the present study was to develop and validate an asthma knowledge questionnaire that could be self-administered by parents and/or persons charged with caring for asthmatic children. MATERIAL AND METHODS: The 17 items that make up the questionnaire were obtained on the basis of a review of the literature, focus group discussions, the professional experience of the researchers, and pilot studies. We evaluated the instrument's face, content, and concurrent validity and analyzed its factorial structure. The test-retest reliability of the questionnaire and its sensitivity to change were also assessed. RESULTS: A total of 120 pediatric patients with a mean (SD) age of 4.5 (3.7) years participated. Factor analysis demonstrated a probable structure of 3 factors that together explained 85% of the total variance in results. The opinion of an interdisciplinary group of experts on asthma confirmed the face validity of the instrument. The questionnaire's ability to distinguish between parents with high and low asthma knowledge demonstrated its concurrent validity. Test-retest reliability was demonstrated, as was sensitivity to change between 2 different testing moments. CONCLUSIONS: The asthma knowledge questionnaire developed is useful and reliable for quantifying the baseline level of asthma knowledge of parents of asthmatic children as well as to assess the efficacy of an educational intervention aiming to increase knowledge and understanding of the disease.

Adult↗

Questionnaire for assessing parents' concerns about their child with hydrocephalus.

The many concerns of parents of children with hydrocephalus have not previously been assessed using a reliable, quantitative measurement. The development and preliminary use of a questionnaire to measure the concerns of these parents is reported. A general health status measure for hydrocephalus was developed concurrently. Items were generated primarily from parent focus groups resulting in a comprehensive list of 22 unique parental concern items. The most important of these items, as selected by another sample of parents of 60 children (27 females, 33 males; mean age 8y 4mo, [SD 4y 6mo]) were retained for the final questionnaire. This 9-item parental concerns questionnaire was tested for reliability and construct validity (by assessing correlations with various independent measures of health status, including Health Utilities Index-2 and Impact-on-Family Scale) using a cohort consisting of the parents of 80 children (39 females, 41 males; mean age 10y, [SD 3y 6mo]). An exploratory analysis was performed to determine which patient variables were associated with greater parental concern. The parental concerns questionnaire demonstrated excellent test-retest reliability (0.86, 95% CI 0.77-0.92) and internal consistency (Cronbach's alpha=0.89). As expected, interrater reliability was somewhat lower (0.67, 95% CI 0.49-0.79). Construct validity was demonstrated by consistently moderate Pearson's correlations with several independent measures of the child's health. The presence of epilepsy and younger patient age appeared to be significantly associated with greater parental concern. This new questionnaire has demonstrated very good psychometric properties. It can be used to broaden the scope of future clinical research in pediatric hydrocephalus to include the impact on parents.

Adult↗

Psychometric properties of the EORTC Quality of Life Questionnaire in inpatient cancer rehabilitation in Germany.

OBJECTIVE: Recent years have shown an increase in the use of questionnaires measuring health-related quality of life to verify the quality of treatment in the field of oncology. An often used cancer-specific questionnaire is the "Quality of Life Core Questionnaire of the European Organization for the Research and Treatment of Cancer" (EORTC QLQ-C30). The purpose of this study is to analyze the psychometric properties of the EORTC QLQ-C30 (version 1) in order to determine the feasibility and appropriateness for its use in inpatient cancer rehabilitation in Germany with heterogeneous diagnoses. METHODS: The questionnaire was administrated to a sample of 972 cancer patients at the beginning of treatment and to 892 patients after treatment. Besides descriptive analysis, the statistical analyses include confirmatory analysis and the multitrait/multimethod approach to test the questionnaire's postulated scale structure (factorial validity) and its reliability (internal consistencies). The analysis also includes a comparison of responsiveness indices (effect size, reliable change index) to test the sensitivity of the instrument. RESULTS: The EORTC QLQ-C30 showed satisfactory levels of reliability and sensitivity, but the postulated scale structure could not be confirmed. The results illustrate that the varimax-rotated solution of a principal component analysis does not confirm the scale structure postulated by the authors. Correspondingly, the selected fit indices within the scope of the confirmatory factor analysis do not show satisfactory results either. SIGNIFICANCE OF RESULTS: We therefore consider version 1 of the EORTC QLQ-C30 to be only limitedly useful for the routine assessment of changes in the quality of life of cancer patients in inpatient rehabilitation in Germany, especially because of the instrument's length and possible redundancies. For this reason, a scoring procedure limited to a subset of items is suggested, revealing satisfactory to good psychometric indices. However, further psychometric tests are necessary, especially with regard to validity and sensitivity.

Female↗