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Evaluation of the EORTC QLQ-C30 questionnaire: a comparison with SF-36 Health Survey in a cohort of Italian long-survival cancer patients.

BACKGROUND: Despite the large amount of data available about the EORTC QLQ-C30 questionnaire, there have been very few studies focussed on long-survival cancer patients, and no data are available on its performance in the Italian setting. PATIENTS AND METHODS: Within the framework of a project aimed at evaluating the characteristics of available HR-QOL questionnaires in the Italian language, the EORTC QLQ-C30 questionnaire together with the Short Form 36-item Health Survey (SF-36) were mail-administered to a sample of patients previously recruited in two large multicenter randomized clinical trials on early breast and colon cancers. The properties of the questionnaire were evaluated using standard psychometric techniques and correlation analyses with demographic and clinical independent variables. RESULTS: In the sample of patients who sent back the questionnaires under evaluation, the EORTC QLQ-C30 showed satisfactory acceptability (response rate = 64% and very low prevalence of missing at item and scale level), and the psychometric analyses confirmed the multi-dimensional conceptualisation in terms of convergent and discriminant validity. Moreover, EORTC QLQ-C30 scales showed substantial correlation with the homologous SF-36 scales. Few socio-demographic (age, gender, schooling) and clinical (type of cancer disease) variables were associated with HR-QOL. Breast cancer patients reported, on average, worse physical health-related scores, but after adjustment for age and education, most of the differences disappeared. CONCLUSIONS: These findings confirm the validity and robustness of the EORTC QLQ-C30 in this sample of long-survival Italian cancer patients. Further ad hoc validation studies are required to evaluate its significance in these particular patients.

Adult↗

Functional gastrointestinal disorders in Canada: first population-based survey using Rome II criteria with suggestions for improving the questionnaire.

The Rome II criteria and questionnaires developed to identify functional gastrointestinal disorders have not been evaluated. Our objectives were to determine the prevalence of functional gastrointestinal disorders in Canada, compare our results with data from other published studies, assess concordance of Rome I and Rome II criteria for irritable bowel syndrome, and suggest improvements in the Rome II questionnaire. An independent research firm was employed to conduct a random digit dial national survey, inviting household members > or = 18 years of age to participate in a study examining personal health issues. Subjects recruited by telephone, who agreed to participate, were mailed a questionnaire, and the data were retrieved by a follow-up phone call. The Rome II questionnaire and algorithms were used and where possible Rome I algorithms were also applied. At least one functional gastrointestinal disorder occurred in 61.7% of 1149 respondents (65.6% female versus 57.6% male; P < 0.05). The most prevalent were the functional bowel disorders at 41.6% followed by esophageal disorders at 28.9%. Irritable bowel syndrome prevalence by Rome II and I criteria were 12.1% and 13.5%, respectively (kappa = 0.76). Because the Rome II criteria have added exclusion items that are not present in the Rome I criteria, the prevalence of esophageal, gastroduodenal, and anorectal disorders is lower than the figures from a US market survey. In conclusion, functional gastrointestinal disorders are highly prevalent in Canada, with a significantly higher rate in women. There is substantial agreement between Rome I and Rome II criteria for irritable bowel syndrome. Rome criteria and questionnaire remain works in progress.

Adolescent↗

The quality of life questionnaire for cancer patients treated with anticancer drugs (QOL-ACD): validity and reliability in japanese patients with advanced non-small-cell lung cancer.

The quality of life questionnaire for cancer patients treated with anticancer drugs (QOL-ACD), which consists of four domains (functional, physical, mental, and psychosocial) and a global face scale, was developed as a generic questionnaire for Japanese cancer patients undergoing chemotherapy. We examined the validity and reliability of this questionnaire in Japanese patients with advanced non-small-cell lung cancer (NSCLC), who participated in two randomized phase III trials. After excluding two items, one showing low test-retest reliability and the other showing poor convergent validity for the target population, Cronbach's alpha coefficients ranged from 0.795 to 0.897 and the intra-class correlation coefficients ranged from 0.612 to 0.866. These results confirmed the high reliability of the questionnaire. The results of factor analysis provided strong support for the domain structure used in the questionnaire. Each of the four domains had a moderate to strong association with important clinical variables, such as performance status or weight loss, and correlation analysis showed that the face scale provided an appropriate measure of the global quality of life. These results indicated that the QOL-ACD is potentially useful for clinical research on Japanese patients with advanced NSCLC.

Activities of Daily Living↗

The EORTC quality of life questionnaire-head and neck 35 in Italian laryngectomized patients. European organization for research and treatment of cancer.

The aim of this study was to test the validity and reliability of the European organization for research and treatment of cancer (EORTC) quality of life questionnaire (QLQ)-head and neck (H&N) 35 in Italian laryngeal cancer patients. The original questionnaire was developed by the EORTC quality of life (QoL) study group and tested in H&N cancer patients from Norway, Sweden, and the Netherlands. The Italian translation of the questionnaire used in this study was made by a team of the CRO, National Cancer Institute, using a double-back translation method between independent translators. The translated EORTC QLQ-H&N35 was given to 99 patients with H&N cancer who had undergone total laryngectomy 1-26 years before and had been then treated with radiotherapy and, in some cases, chemotherapy. The questionnaire was re-administrated to 33 patients after 1 month to test its stability over time. It was structurally made up of seven scales (pain, swallowing, sense, speech, social eating, social contact, and sexuality) and 11 single items that considered the most important clinical aspects characterizing the QoL in H&N cancer patients. The statistical analysis of the indexes of validity and reliability confirmed the results obtained with other linguistic versions of the questionnaire. Our Italian version of the EORTC QLQ-H&N35 proved to be a statistically valid instrument to assess QoL in laryngectomized patients.

Aged↗

A new measure for assessing the health-related quality of life of patients with vertigo, dizziness or imbalance: the VDI questionnaire.

Vertigo, dizziness and imbalance are frequent symptoms among patients in clinical practice. We present the development of a new multipurpose measure specific to patients with these symptoms: the VDI questionnaire. Items of the VDI questionnaire were generated through an international panel of clinicians, in-depth interviews with 25 patients and an extensive literature search. Items were reduced by qualitative and quantitative methods. Psychometric properties were tested in 130 patients recruited in primary care general practices, neurologists and ENT out-patient clinics. Patients were clinically evaluated and administered several specific and generic health status instruments: the Balance Scale, the SF-12 Health Survey and the General Health Questionnaire 12 items. The VDI symptoms and the VDI health related quality of life (HRQoL) scales were administered during the visit and some weeks after. Correlation and confirmatory factor analysis were used. Reliability of the VDI was high (0.92 for VDI HRQoL scale and 0.86 for VDI symptoms). VDI scores were more correlated with Balance Scale scores than with mental health indicators. All factor loadings were significantly different from zero and confirmed the expected relations. In the second administration, VDI scores showed a deterioration among those reporting a worsening in their symptoms and an improvement among those reporting feeling better. The data presented suggest that the VDI questionnaire is a reliable, valid and responsive instrument for patients with vertigo, dizziness or imbalance. The VDI questionnaire could be a useful complement of the clinical evaluation of these patients at both group and individual level.

Activities of Daily Living↗

Development, validation and clinical use of the FLQA-I, a disease-specific quality of life questionnaire for patients with lymphedema.

BACKGROUND: It is known from clinical practice that lymphatic diseases can be associated with reductions of quality of life (QoL). Due to the lack of validated methods, only few studies however have systematically investigated the QoL in lymphedema. The aim of the study was 1) to develop a standardized QoL questionnaire specific for lymphedema and 2) to assess the QoL in these patients. PATIENTS AND METHODS: We developed and tested the FLQA-l, a novel QoL questionnaire developed specific for use in lymphedema on the basis of the previously validated FLQA vein questionnaire. The questionnaire consists of 92 items that refer to the following scales: Physical status, everyday life, social life, emotional well-being, treatment, satisfaction and profession/household. 392 patients with primary (n = 246) and secondary (n = 146) lymphedema were included in the validation study. RESULTS: The FLQA-l showed good internal consistency; Cronbach's alpha was higher than 0.75 in all scales. There were no floor and ceiling effects and satisfactory item selectivity. The test-retest reliability, sensitivity to change and convergent validity with other psychometric instruments were satisfactory. Clinically, patients with lymphedema showed markedly impaired QoL in all fields, compared to persons with early stage venous insufficiency, and comparable reductions of QoL, compared to patients with venous leg ulcer. CONCLUSION: These data indicate that the FLQA-l is a reliable and valid questionnaire for the assessment of QoL in lymphedema. Since the QoL is impaired in many patients with lymphedema, QoL evaluation may be helpful for clinical diagnostics as well as for outcome measurement of specific edema therapy.

Activities of Daily Living↗

Development and validation of the Mini Asthma Quality of Life Questionnaire.

The 32-item Asthma Quality of Life Questionnaire (AQLQ) has shown good responsiveness, reliability and construct validity; properties that are essential for use in clinical trials, clinical practice and surveys. However, to meet the needs of large clinical trials and long-term monitoring, where efficiency may take precedent over precision of measurement, the 15-item self-administered MiniAQLQ has been developed. The MiniAQLQ was tested in a 9-week observational study of 40 adults with symptomatic asthma. Patients completed the MiniAQLQ, the AQLQ, the Short Form (SF)-36, the Asthma Control Questionnaire and spirometry at baseline, 1, 5 and 9 weeks. In patients whose asthma was stable between clinic visits, reliability was very acceptable for the MiniAQLQ (intraclass correlation coefficient (ICC)=0.83), but not quite as good as for the AQLQ (ICC=0.95). Similarly, responsiveness in the MiniAQLQ (p=0.0007) was good but not quite so good as for the AQLQ (p<0.0001). Construct validity (correlation with other indices of health status) was strong for both the MiniAQLQ and the AQLQ. Criterion validity showed that there was no bias between the instruments (p=0.61) and the correlation between them was high (r=0.90). The Mini Asthma Quality of Life Questionnaire has good measurement properties but they are not quite as strong as those of the original Asthma Quality of Life Questionnaire. The choice of questionnaire should depend on the task at hand.

Adolescent↗

The role of a questionnaire and four biochemical markers to detect cancer risk in a symptomatic population.

The roles of a self-completed symptom questionnaire and four biochemical markers of disease were assessed to determine risk for gastric and colorectal cancer from within a hospital population and a random population. Eight-six patients with cancer, 168 subjects with benign conditions of the stomach and large bowel and 720 individuals from the community at large were investigated. Multivariate analyses of the questionnaire and biochemical data were performed individually and in combination using a data set comprising 54 cancer subjects, 80 patients with benign disease and 200 random individuals. The most favourable predictive equation derived was then applied to the remaining data set to determine its efficacy. In the primary analyses the questionnaire data identified 32 (60%) cancers successfully and using the biochemical markers alone 36 (67%) patients were also correctly classified as cancer bearing. However, the combination of the questionnaire and marker data improved the sensitivity for cancer to 50 cancers detected (92%) (P less than 0.02). Using the predictive equation from this combination of data to identify risk in the second data set 28/32 (88%) cancers were correctly identified with only an 11% false positive rate. An 18 month follow-up for the non-cancer group has to date revealed only one cancer (ca. pancreas). In this limited study, multivariate analysis of questionnaire and biochemical marker data does successfully identify individuals at "high risk' of harbouring gastric or colorectal cancer within a symptomatic population and may have a role in determining priority for investigation for a symptomatic individual.

Aged↗

Comparison of the traditional paper visual analogue scale questionnaire with an Apple Newton electronic appetite rating system (EARS) in free living subjects feeding ad libitum.

OBJECTIVE: Assessing the value of a newly developed electronic visual analogue scale questionnaire (Apple Newton Message Pad) with the traditional paper method for appetite rating. DESIGN: In a random, crossover design, subjects completed both electronic and paper questionnaires to compare results obtained by the two methods; individual methods were completed consecutively to assess test-retest reliability; preference was established using a questionnaire. SETTING/SUBJECTS: Healthy, free-living adults were studied for comparison of methods (n = 12), test-retest reliability (n = 8) and preference (n = 13). INTERVENTION: Visual analogue scales were completed each waking hour to assess appetite. Preference was assessed after both methods were completed. RESULTS: There was no significant difference in the hourly results obtained by the paper and electronic methods for 'desire to eat', 'how much can you eat now', 'urge to eat' and 'preoccupation with thoughts of food'. Small differences in 'hunger' and 'fullness' ratings were noted (approximately 5% mean difference between methods, P < 0.05), but patterns of change and sensitivity for these and all other parameters remained similar for both methods across the visual analogue scale. Test-retest reliability demonstrated was similar for both methods. Seven (54%) subjects preferred to use the paper questionnaire, five (38%) the electronic method and one (8%) had no preference. CONCLUSIONS: The electronic Apple Newton questionnaire is as sensitive and reliable as the paper method, has the advantage that it automatically records the time of data acquisition and data collection and processing are more efficient for the researcher. The two methods should not be used interchangeably.

Adult↗

Reliability of a dietary questionnaire on food habits, eating behaviour and nutritional knowledge of adolescents.

OBJECTIVE: To develop a dietary questionnaire on food habits, eating behaviour and nutrition knowledge of adolescents and to examine its reliability. DESIGN: A cross-sectional baseline survey. The questionnaire was self-administered to study participants twice with 7 days between each administration. SETTING: A school community in Pavia, Italy. SUBJECTS: A group of students (n=72, aged 14-17 y, both sexes) studying in a secondary school in the second year of the course were invited to compile a dietary questionnaire during school time. Informed written consent was obtained from each subject and their parents. Subjects were initially recruited for a nutrition intervention; recruitment was opportunistic and school based. STATISTICAL ANALYSES: Reliability was assessed using the Cronbach's alpha and the Pearson correlation coefficients. RESULTS: Cronbach's alpha ranges from a minimum of 0.55 to a maximum of 0.75, indicating that only two sections have a poor internal consistency. The Pearson correlation coefficients range from a minimum of 0.78 to a maximum of 0.88, indicating a very good temporal stability of the questionnaire. All the Pearson correlation coefficients are statistically significant with P<0.01. CONCLUSIONS: The present questionnaire has the potential to measure the effects of nutrition interventions on adolescents because of its stability in making comparisons over time. The instruments is low in cost and easy to administer and analyse; moreover, it could be modified appropriately to fit the needs of other populations as well.

Adolescent↗

Identifying mothers at risk for postnatal emotional distress: further evidence for the validity of the perinatal posttraumatic stress disorder questionnaire.

OBJECTIVE: We evaluated the construct validity of the Perinatal Posttraumatic Stress Disorder Questionnaire. STUDY DESIGN: Using a convergent/divergent validity design and two data sources (traditional survey and World Wide Web), 121 high-risk and 52 low-risk mothers answered four questionnaires. RESULTS: High-risk mothers scored higher than low-risk mothers on all measures of emotional distress. There were significant positive correlations among the convergent measures of emotional distress, which were significantly larger than any correlation of the divergent measure with a convergent measure. Scores on the Perinatal Posttraumatic Stress Disorder Questionnaire were positively related to mothers seeking formal psychotherapy for their childbirth experiences. Questionnaire responses were not related to data source. CONCLUSION: The Perinatal Posttraumatic Stress Disorder Questionnaire is a useful tool for identifying significant emotional distress in mothers during the postnatal period.

Adult↗

Reproducibility and validity of a questionnaire filled in by spinal cord lesioned individuals before regular follow-up.

OBJECTIVE: To speed up and focus (biennial) check-ups of out-patients with spinal cord lesions by means of a brief mail questionnaire concerning specific impairments as well as general life conditions. METHOD: A trial 69-item questionnaire was filled in twice, at home and on arrival for check-up, and, for a third time, by the physician during the consultation. Out of 115 check-ups, 107 and 105 could be included in a reproducibility and validity assessment respectively. RESULTS: Excellent agreement between the first two completions ('reproducibility') and between the markings made at home and those made by the physician ('validity') was obtained for the majority of the items. Those items not performing satisfactorily, not least those relating to defecation, were scrutinised. CONCLUSION: After revision, the questionnaire can serve the above mentioned purposes in a cost-effective and clinically satisfying manner. Further benefits are envisaged by computerised longitudinal monitoring of the patients' answers. Finally, we have pointed towards weak items/questions in our questionnaire, and we hope this can be of help to others who want to use similar questionnaires in their daily practice.

Activities of Daily Living↗

Value of a structured participant evaluation questionnaire in the development of a surgical education program.

OBJECTIVE: To describe how the summative evaluation of attitudes and perceptions of participants at a surgical skills workshop influences and contributes to the development of the workshop. MATERIALS AND METHODS: One hundred participants from 11 workshops were invited to complete a structured scored anonymous questionnaire with 18 statements, at the end of each workshop. Space was provided for free comment next to each statement. The questionnaire covered all aspects of the workshop including the practical modules, learning materials, organisation, facilitators and the relevance of the workshop to their needs. Ninety-eight of the 100 participants returned the questionnaire and this analysis is based on their responses. RESULTS: All respondents considered the workshop content, structure and facilities enabled the educational objectives to be achieved. The scored responses to the structured statements helped to determine the degree of satisfaction with the workshop domains, but did not give direction for change. The informal 'free' comments gave insight as to how improvements could be achieved in specific domains. Numerous changes suggested by participants have been included in subsequent workshops. CONCLUSION: Summative evaluation of an educational program is important to determine participant satisfaction and to determine areas needing improvement. Structured scored questionnaires are helpful in determining levels of satisfaction with the various domains of the program. Informal written comments allow insight into specific areas requiring improvement and may provide guidance as to how improvement can be achieved. Space for such comment should be encouraged in any program evaluation questionnaire.

Clinical Competence↗

A short questionnaire (IRQ) to assess injecting risk behaviour.

AIM: To develop a short injecting risk questionnaire (IRQ) to measure sharing of injecting equipment. DESIGN: Matrix design with quota assignment, designed to compare the questionnaire when used by interview and self-completion, in agency and community settings, by agency staff and fieldworkers, with different injectors (age < 26 vs. 26+; male vs. female, opiate vs stimulant injectors), and in different geographical areas. SETTINGS: Drug treatment and helping agencies, and community settings, in England. PARTICIPANTS: Drug users who had injected in the last 4 weeks. MEASUREMENTS: Questions measured different aspects of equipment sharing. Questionnaire performance assessed by question acceptability, test-retest (parallel forms) reliability, inter-rater reliability, inter-instrument reliability, internal reliability, construct validity and internal collateral validity. Statistical tests included product moment correlation, principal components analysis, and Cronbach's alpha. FINDINGS: The questionnaire was highly acceptable. Test-retest correlations were all high and significant, questions performed well in all conditions, with no differences by site (agency vs. out-of-contact), order (interview or self-completion first), administration (staff vs. fieldworker), elapsed time or subject characteristics. The questionnaire had high internal reliability (Cronbach's alpha > +0.86), and items measured a similar domain with all questions loading highly (> 0.32) on a single factor which accounted for > 42% of the variance. The complete IRQ elicited higher reports of equipment sharing (77%) than a single question (56%). CONCLUSIONS: IRQ performs well in a variety of settings, when administered in different ways to different kinds of IDUs. A single question on 'sharing' elicits fewer positive responses than the use of multiple questions about different sharing practices.

Adult↗

A comparison of two alcohol craving questionnaires.

AIM: To compare two multi-dimensional questionnaires to measure cravings and urges for alcohol: the Alcohol Craving Questionnaire (ACQ: Singleton, Henningfield and Tiffany, 1994a) and the Desires for Alcohol Questionnaire (DAQ: Clark et al., 1996). DESIGN, SETTING, AND PARTICIPANTS: Both questionnaires were administered, in a counterbalanced order, to a total of 380 recreational drinkers. In a further study, a shortened version of the DAQ was administered to a sample of 131 drinkers attending AA or a treatment centre. Exploratory factor analyses were carried out on the data and relationships between questionnaire score and other variables were assessed. FINDINGS: In recreational drinkers both instruments appeared to have a three-factor structure. The DAQ appeared superior to the ACQ in a number of respects: it produced more reliable factors; its structure accounted for a higher proportion of the variance; the factor inter-correlations were somewhat lower; in a combined analysis of both instruments most of the factors retained came from the DAQ; and the DAQ discriminated better between bing and non-binge drinkers and excessive and moderate drinkers. A similar factor structure was found for the DAQ in the alcoholic subjects with addition of a factor of "controllability". CONCLUSIONS: The results support a multifactorial account of alcohol craving, and indicate that the DAQ has some advantages over the ACQ as a research tool.

Adolescent↗

Ill-health reported by schoolchildren during questionnaire surveys in Ghana, Mozambique and Tanzania.

BACKGROUND: Insufficient attention has been paid to the health problems of school-age children in sub-Saharan Africa. A questionnaire administered to schoolchildren about their ill-health has been developed to identify schools in which urinary schistosomiasis occurs. The data collected during the interviews can also be used to assess other common health problems. OBJECTIVES: To analyse data collected during health questionnaires in schools to assess how schoolchildren perceive their own health, and to compare the findings between three countries in sub-Saharan Africa. METHODS: Questionnaires asking about recent health problems were administered by teachers to schoolchildren in 120 primary schools in Mozambique, 52 primary schools in Tanzania and 298 primary schools in Ghana. A total of 67 002 children aged 8-15 years took part. RESULTS: Of the 10 health problems asked about in all questionnaires, the average number reported by each child was 3.9 in Ghana, 3.4 in Mozambique and 3.1 in Tanzania. The distributions of the prevalence of each condition among schools were similar and the prevalence of all conditions showed a similar ranking. For most conditions a greater percentage of girls than boys reported each health problem. CONCLUSIONS: Schoolchildren in Ghana, Mozambique and Tanzania do not perceive themselves to be healthy. The pattern of reported health problems was similar in each country. School health questionnaires are worthy of further study and validation.

Adolescent↗

Development of an EORTC questionnaire module to be used in health-related quality-of-life assessment for patients with multiple myeloma. European Organization for Research and Treatment of Cancer Study Group on Quality of Life.

A multiple myeloma-specific quality-of-life questionnaire module has been designed in collaboration with the EORTC Quality-of-Life Study Group to be used in clinical trials with the EORTC QLQ-C30, a general cancer questionnaire. Strict methodology was employed to ensure thorough and appropriate development of the module. An extensive literature review was performed to identify health-related quality-of-life issues relevant to patients with multiple myeloma. Semi-structured interviews were then carried out in several European countries with health-care providers experienced in the treatment of patients with multiple myeloma, and with a group of patients with multiple myeloma, to identify the issues which were most important to patients. A questionnaire was devised from the list of issues, using a 1-week time-frame and response categories consistent with the EORTC QLQ-C30. The provisional questionnaire and the EORTC QLQ-C30 were administered to patients with multiple myeloma in each participating country with further semi-structured interviews to refine the content and design of the questionnaire. A review of the results obtained in each stage of development resulted in a 24-item myeloma-specific module, the EORTC QLQ-MY24, which assesses disease-specific symptoms and their impact on everyday life, treatment side-effects, social support, and future perspective. The module is currently undergoing further international field-testing to assess its psychometric properties.

Adult↗

A questionnaire to measure satisfaction with community services for informal carers of stroke patients: construction and initial piloting.

Stroke affects 120 000 people each year in the UK and is the most common cause of adult-onset disability. Most stroke patients are cared for at home by informal carers. Support for these carers is provided by the community services, but although single-item measures have shown that there is a relatively high level of dissatisfaction with those services, there is no specific satisfaction measurement instrument. The present study aimed to construct and initially validate a questionnaire to measure carers' satisfaction with community services for clinical and research purposes. Qualitative interviews with a purposive sample of informal carers of stroke patients identified via stroke unit discharge records gave information about content, context and language. Together with information from the carers' literature, this formed the basis of the questionnaire. A self-completion questionnaire proved unacceptable to carers with a very poor response rate (20%). Face-to-face interviews were more acceptable, with the questionnaire taking approximately 10 minutes to administer. All carers approached agreed to take part and only three carers dropped out from follow up, all because of reasons not related to the study. Initial validity and reliability testing with a sample of 44 carers identified through stroke groups and general practice showed good correlation with a single-item satisfaction measure (RHO = 0.797), test-retest reliability (RHO = 0.885) and inter-rater reliability (RHO = 0.868), and a high degree of internal consistency (Cronbach's alpha = 0.859). Further validation with larger and more diverse groups of informal carers is needed before the questionnaire can be considered to be a robust and reliable tool. Factor analysis revealed seven factors: information about community support and involving the carer; amount, appropriateness and coordination of services; information about stroke; speed of change and concern about the carer; listening to the carer and being heard; problem management; and confidence in and accuracy of information. These factors have marked similarities to those found in the field of patient satisfaction with community services.

Aged↗