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Development and validation of a functional dyspepsia-related quality of life (FD-QOL) scale in South Korea.

BACKGROUND: Quality of life (QOL) in patients with functional dyspepsia in South Korea has never been studied, mostly due to the lack of a psychometrically validated disease-specific instrument for measuring the QOL. The aim of the present study was to develop and validate a QOL scale for patients with functional dyspepsia. METHODS: A Functional Dyspepsia-Related QOL (FD-QOL) scale was developed and validated as follows: item generation, pilot test, and psychometric test. Patients with functional dyspepsia (n = 220) were recruited from seven university hospitals. The participants were asked to complete the preliminary item-generated FD-QOL, the Short Form-36 (SF-36), and the Index of Dyspepsia Symptoms-Korean (IDS-K). The data were analyzed using factor analysis, correlation, anova, and Cronbach's alpha. RESULTS: Twenty-three items were generated based upon content validity. Factor analysis extracted a four-factor solution, and two items were deleted because they were not loaded significantly on any factor. The FD-QOL was correlated with the SF-36 subscales, of which scores were differentiated according to the levels of dyspepsia symptoms. Cronbach's alpha of the FD-QOL was 0.94. CONCLUSIONS: The FD-QOL scale is a rapid and easily applicable instrument with excellent psychometric properties of content, factorial, convergent, and known-groups validity, and internal consistency reliability in Korean patients with functional dyspepsia.

Adult↗

Assessing attachment security with the Attachment Q Sort: meta-analytic evidence for the validity of the observer AQS.

The reliability and validity of the Attachment Q Sort (AQS; Waters & Deane, 1985) was tested in a series of meta-analyses on 139 studies with 13,835 children. The observer AQS security score showed convergent validity with Strange Situation procedure (SSP) security (r = .31) and excellent predictive validity with sensitivity measures (r = .39). Its association with temperament was weaker (r = .16), which supports the discriminant validity of the observer AQS. Studies on the stability of the observer AQS are still relatively scarce but they have yielded promising results (mean r = .28; k = 4, n = 162). It is concluded that the observer AQS, but not the self-reported AQS, is a valid measure of attachment.

Child↗

The validation of patient-rated global assessments of treatment benefit, satisfaction, and willingness to continue--the BSW.

OBJECTIVE: This study evaluated the validity of three single-item, patient-rated, interviewer-administered, global assessments of treatment benefit, satisfaction with treatment and willingness to continue treatment, collectively referred to as the BSW. METHODS: The BSW, micturition diaries, the Overactive Bladder Questionnaire (OAB-q) and the King's Health Questionnaire (KHQ) were included in part or in total in three OAB clinical trials. Discriminant validity for full and dichotomized responses was assessed with anovas models and correlations were used to evaluate construct validity. RESULTS: The BSW demonstrated significant differences among the majority of the response levels on all measures of micturitions in all studies. The BSW also demonstrated discriminant validity with the OAB-q and the KHQ. BSW measures demonstrated significant differences among the change scores for all subscales of the OAB-q and the majority of the KHQ domains with both full and dichotomized responses. Patients who were dissatisfied with treatment and those unwilling to continue treatment also reported significantly worse OAB-q and KHQ scores compared with those who were satisfied with treatment or willing to continue treatment. BSW measures were moderately correlated with the micturition variables, moderate to strongly correlated with the OAB-q and weak to moderately with the KHQ, providing support for the construct validity of the BSW measures. CONCLUSIONS: The BSW is a useful tool to capture patients' global impressions of three key elements of treatment outcome: a perceived benefit, satisfaction with treatment, and the willingness to continue treatment, and can facilitate patient-physician communication as well as be informative to researchers.

Aged↗

Validity and reliability of the Turkish Migraine Disability Assessment (MIDAS) questionnaire.

OBJECTIVES: The aim of this study is to assess the comprehensibility, internal consistency, patient-physician reliability, test-retest reliability, and validity of Turkish version of Migraine Disability Assessment (MIDAS) questionnaire in patients with headache. BACKGROUND: MIDAS questionnaire has been developed by Stewart et al and shown to be reliable and valid to determine the degree of disability caused by migraine. DESIGN AND METHODS: This study was designed as a national multicenter study to demonstrate the reliability and validity of Turkish version of MIDAS questionnaire. Patients applying to 17 Neurology Clinics in Turkey were evaluated at the baseline (visit 1), week 4 (visit 2), and week 12 (visit 3) visits in terms of disease severity and comprehensibility, internal consistency, test-retest reliability, and validity of MIDAS. Since the severity of the disease has been found to change significantly at visit 2 compared to visit 1, test-retest reliability was assessed using the MIDAS scores of a subgroup of patients whose disease severity remained unchanged (up to +/-3 days difference in the number of days with headache between visits 1 and 2). RESULTS: A total of 306 patients (86.2% female, mean age: 35.0 +/- 9.8 years) were enrolled into the study. A total of 65.7%, 77.5%, 82.0% of patients reported that "they had fully understood the MIDAS questionnaire" in visits 1, 2, and 3, respectively. A highly positive correlation was found between physician and patient and the applied total MIDAS scores in all three visits (Spearman correlation coefficients were R= 0.87, 0.83, and 0.90, respectively, P <.001). Internal consistency of MIDAS was assessed using Cronbach's alpha and was found at acceptable (>0.7) or excellent (>0.8) levels in both patient and physician applied MIDAS scores, respectively. Total MIDAS score showed good test-retest reliability (R= 0.68). Both the number of days with headache and the total MIDAS scores were positively correlated at all visits with correlation coefficients between 0.47 and 0.63. There was also a moderate degree of correlation (R= 0.54) between the total MIDAS score at week 12 and the number of days with headache at visit 2 + visit 3, which quantify headache-related disability over a 3-month period similar to MIDAS questionnaire. CONCLUSION: These findings demonstrated that the Turkish translation is equivalent to the English version of MIDAS in terms of internal consistency, test-retest reliability, and validity. Physicians can reliably use the Turkish translation of the MIDAS questionnaire in defining the severity of illness and its treatment strategy when applied as a self-administered report by migraine patients themselves.

Adolescent↗

Reliability, validity, and clinical utility of the Migraine-ACT questionnaire.

BACKGROUND: The 4-item Migraine-ACT questionnaire is an assessment tool for use by primary care physicians to identify patients who require a change in their current acute migraine treatment. It has been shown to be easy to use, and to be reliable and accurate in its assessments. OBJECTIVES: To further analyze the Migraine-ACT study database, providing additional information on the reliability, validity, and potential clinical utility of the questionnaire. METHODS: Reliability was assessed by recording the distribution of Migraine-ACT scores recorded at baseline and 1 week later (test-retest reliability). Analyses of consistency of Migraine-ACT scores were conducted on the total sample of patients and for the separate centers, using Pearson and Spearman correlations. Validity was assessed by comparing the t-discrimination values for clinically relevant questions within domains of the original 27-item questionnaire. Reliability and validity were also assessed by constructing an "alternative" (Form B) Migraine-ACT questionnaire, derived from an analysis of the second-best items in each domain in the original study data. Clinical utility was assessed using Pearson pairwise correlations to compare Migraine-ACT scores with clinically defined criteria as analyzed by the SF-36 Quality of Life questionnaire, the Migraine Disability Assessment (MIDAS) questionnaire, and the Migraine Therapy Assessment (MTAQ) questionnaire. RESULTS: The distribution of Migraine-ACT scores between the 2 completions of the questionnaire was consistent for the total sample (test-retest reliability, r= .81) and between the individual countries (r= .61 to .92). In this study, the validity (assessed as t-discrimination) of the Migraine-ACT "impact" and "global assessment of relief" questions were markedly higher than those of other endpoints used in migraine clinical studies. The Form B Migraine-ACT questionnaire was almost as reliable and accurate as the original Form A questionnaire. The distribution of Migraine-ACT scores was: 0 = 12.6%, 1 = 13.7%, 2 = 14.7%, 3 = 20.5%, and 4 = 38.4%. The change in Migraine-ACT score correlated with, and had a linear relationship with changes in SF-36, MIDAS, and MTAQ scores, and indicated that a Migraine-ACT score of <or=2 corresponded with a need to consider changing the patient's acute medication. About 40% of the migraine patients in the study scored <or=2 and may have had significant unmet treatment needs. CONCLUSIONS: These data confirm the excellent reliability and validity of the Migraine-ACT questionnaire and provide further evidence for its utility in clinical practice.

Acute Disease↗

Evaluating chronic pain impact among patients in primary care: further validation of a brief assessment instrument.

OBJECTIVE: To evaluate the psychometric properties of the Profile of Chronic Pain: Screen (PCP:S) in primary care. The PCP:S is a brief assessment device designed to gauge pain severity, interference, and emotional burden. DESIGN: Questionnaire survey with short-term reliability and validity follow-up. METHODS: Two hundred and forty-four outpatients (52% female) with chronic pain recruited from five primary care settings completed the 15-item PCP:S at an initial testing session. Approximately 1 week later, two subgroups participated in a retest reliability and validity follow-up. The battery of follow-up questionnaires included a measure of social desirability response bias and several instruments designed to provide convergent validity for the PCP:S. RESULTS: Retest reliability, internal consistency, factor structure, and social desirability bias were all found to be acceptable. Likewise, preliminary evidence suggests that, by virtue of its correlation with established measures of pain adjustment, the PCP:S is a valid pain assessment device. CONCLUSIONS: Although the PCP:S was initially developed and validated using a national community sample of adults with chronic pain who provided data via telephone interviews, the present findings support its use as a brief and psychometrically sound paper-and-pencil measure for the assessment of three key components of chronic pain in primary care.

Chronic Disease↗

Development and validation of Transfusion Risk Understanding Scoring Tool (TRUST) to stratify cardiac surgery patients according to their blood transfusion needs.

BACKGROUND: Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The objective of this study was to develop and validate an accurate and simple clinical index to stratify cardiac surgery patients according to their blood transfusion needs. METHODS AND RESULTS: Data on consecutive adult patients who underwent cardiac surgery at Toronto General Hospital (n = 11,113) and Sunnybrook and Women's College Health Sciences Center (n = 5316) between May 1999 and June 2004 were collected for the development, validation, and external validation of the index. Primary outcome was the exposure to blood transfusion in the operative and first postoperative days. Multivariable logistic regression modeling techniques were used to determine the relationship between each independent variable and the exposure to allogeneic blood transfusion. Score assignment for each predictor variable was based on its regression coefficient. The predicted probabilities at each total score were compared to the observed proportions of patients exposed to blood transfusion. The clinical tool consists of eight preoperative variables: preoperative hemoglobin, weight, female sex, age, nonelective procedure, preoperative creatinine, previous cardiac surgical procedure, and nonisolated procedure. CONCLUSIONS: Based on the standards of measurement in clinical research, a valid clinical tool was developed for predicting the need for blood transfusion in patients undergoing cardiac surgery. The clinical tool was internally and externally validated, and the results suggest that it should perform well at other institutions.

Aged↗

Content validity and nursing sensitivity of community-level outcomes from the Nursing Outcomes Classification (NOC).

PURPOSE: To evaluate the content validity and nursing sensitivity of six community-level outcomes from the Nursing Outcomes Classification (NOC; Johnson, Maas, & Moorhead, 2000). DESIGN AND METHODS: A survey research design was used. Questionnaires were mailed to 300 public health nursing experts; 102 nurses responded. Experts evaluated between 11 and 30 indicators for each of the six outcomes for: (a) importance of the indicators for measuring the outcome, and (b) influence of nursing on the indicators. Content validity and nursing sensitivity of the outcomes were estimated with a modified Fehring technique. FINDINGS: All outcomes were deemed important; only Community Competence had an outcome content validity score < .80. The outcome sensitivity score for Community Health: Immunity was .80; other outcome scores ranged from .62-.70. Indicator ratios for all 102 indicators met the study criterion for importance, with 87% designated as critical and 13% as supplemental. Sensitivity ratios reflected judgments that 45% of the indicators were sensitive to nursing intervention. CONCLUSIONS: The study provided evidence of outcome content validity and nursing sensitivity of the study outcomes; further validation research is recommended, followed by testing of the study outcomes in clinical practice. Community-level nursing-sensitive outcomes will potentially enable study of the efficacy and effectiveness of public health interventions focused on improving health of populations and communities.

Attitude of Health Personnel↗

Validation of the pulmonary score: an asthma severity score for children.

OBJECTIVES: In the absence of a validated "user-friendly" method of scoring asthma severity, the authors derived the pulmonary score (PS). The purpose of this study was to begin validation trials of the PS by comparing it with the peak expiratory flow rate (PEFR). METHODS: The study enrolled a convenience sample of children, aged 5-17 years, who came to the emergency department (ED) for treatment of an acute asthma exacerbation. The PEFR (best of three attempts) and the PS were measured before and after the first albuterol treatment by a physician and a nurse from a pool of 45 trained observers. The PS includes respiratory rate, wheezing, and retractions, each rated on a 0-3 scale. Decreasing PS and increasing PEFR indicate clinical improvement. Pre- and post-treatment PEFRs and PSs were compared using paired t-tests to establish construct validity. Correlation of pre- and post-treatment PSs with PEFRs was measured to establish criterion validity. RESULTS: Forty-six subjects completed the study. Mean percent predicted PEFR improved after treatment by 20.7% (p = 0.0001), and mean PS by 1.5 for nursing-obtained scores (p < 0.0001) and 1.9 for physician-obtained scores (p < 0.0001). Pre- and post-treatment PSs were significantly correlated with PEFRs. Correlations for the nursing-obtained scores were pre-treatment r = -0.57 (p = 0.0003) and post-treatment r = -0.67 (p = 0.0001), and for the physician-obtained scores were pre-treatment r = -0.44 (p = 0.003) and post-treatment r = -0.56 (p = 0.0001). The pre-treatment interrater reliability was 0.62 and the post-treatment was 0.53. CONCLUSIONS: These data support the construct and criterion validities of the PS as a measure of asthma severity among children in the ED. The PS is a practical substitute to estimate airway obstruction in children who are too young or too sick to obtain PEFRs.

Acute Disease↗

Development and validation of a new questionnaire to assess sexual satisfaction, control, and distress associated with premature ejaculation.

INTRODUCTION: No validated questionnaires to assess the subjective aspects of premature ejaculation (PE) are currently in use. Clinical trials have generally only considered time, measured by ejaculatory latency, as an indicator of efficacy, but ejaculatory control, sexual satisfaction, and distress are important aspects of PE, which impact both the patient and his partner. The objective of this study was to develop and validate a new questionnaire to measure the overall experience of PE. METHODS: The questionnaire was developed using four stages: item pool development, initial psychometric analyses, patient interviews, and final psychometric analyses. RESULTS: An item pool of 17 was generated and reduced to 10 items through the initial psychometric analyses. Patient interviews did not require addition of further items and resulted in only minor modifications to item wording for clarity. Final psychometric analyses of the 10-item measure confirmed a three-factor solution: sexual satisfaction, control, and distress. Reliability was good, both internal consistency and test-retest reliability. Convergent validity using intravaginal ejaculatory latency time was excellent: control domain (0.75), sexual satisfaction domain (0.60), and distress domain (0.68). Known-groups validity was very good, all domain mean scores being statistically significantly worse in men with PE compared with the men reporting no PE problems. CONCLUSION: The Index of Premature Ejaculation is a reliable and valid questionnaire for the assessment of control over ejaculation, satisfaction with sex life, and distress in men with PE. This tool has the potential to add value to interpretations of improvements in ejaculation latency resulting from new treatments of PE.

Adult↗

Reliability and validity of the Outcome Expectations for Exercise Scale-2.

Development of a reliable and valid measure of outcome expectations for exercise for older adults will help establish the relationship between outcome expectations and exercise and facilitate the development of interventions to increase physical activity in older adults. The purpose of this study was to test the reliability and validity of the Outcome Expectations for Exercise-2 Scale (OEE-2), a 13-item measure with two subscales: positive OEE (POEE) and negative OEE (NOEE). The OEE-2 scale was given to 161 residents in a continuing-care retirement community. There was some evidence of validity based on confirmatory factor analysis, Rasch-analysis INFIT and OUTFIT statistics, and convergent validity and test criterion relationships. There was some evidence for reliability of the OEE-2 based on alpha coefficients, person- and item-separation reliability indexes, and R(2)values. Based on analyses, suggested revisions are provided for future use of the OEE-2. Although ongoing reliability and validity testing are needed, the OEE-2 scale can be used to identify older adults with low outcome expectations for exercise, and interventions can then be implemented to strengthen these expectations and improve exercise behavior.

Aged, 80 and over↗

Validity and reliability of acoustic analysis of respiratory sounds in infants.

OBJECTIVE: To investigate the validity and reliability of computerised acoustic analysis in the detection of abnormal respiratory noises in infants. METHODS: Blinded, prospective comparison of acoustic analysis with stethoscope examination. Validity and reliability of acoustic analysis were assessed by calculating the degree of observer agreement using the kappa statistic with 95% confidence intervals (CI). RESULTS: 102 infants under 18 months were recruited. Convergent validity for agreement between stethoscope examination and acoustic analysis was poor for wheeze (kappa = 0.07 (95% CI, -0.13 to 0.26)) and rattles (kappa = 0.11 (-0.05 to 0.27)) and fair for crackles (kappa = 0.36 (0.18 to 0.54)). Both the stethoscope and acoustic analysis distinguished well between sounds (discriminant validity). Agreement between observers for the presence of wheeze was poor for both stethoscope examination and acoustic analysis. Agreement for rattles was moderate for the stethoscope but poor for acoustic analysis. Agreement for crackles was moderate using both techniques. Within-observer reliability for all sounds using acoustic analysis was moderate to good. CONCLUSIONS: The stethoscope is unreliable for assessing respiratory sounds in infants. This has important implications for its use as a diagnostic tool for lung disorders in infants, and confirms that it cannot be used as a gold standard. Because of the unreliability of the stethoscope, the validity of acoustic analysis could not be demonstrated, although it could discriminate between sounds well and showed good within-observer reliability. For acoustic analysis, targeted training and the development of computerised pattern recognition systems may improve reliability so that it can be used in clinical practice.

Acoustics↗

Validity and reliability of three definitions of hip osteoarthritis: cross sectional and longitudinal approach.

OBJECTIVES: To compare the reliability and validity in a large open population of three frequently used radiological definitions of hip osteoarthritis (OA): Kellgren and Lawrence grade, minimal joint space (MJS), and Croft grade; and to investigate whether the validity of the three definitions of hip OA is sex dependent. METHODS SUBJECTS: from the Rotterdam study (aged > or= 55 years, n = 3585) were evaluated. The inter-rater reliability was tested in a random set of 148 x rays. The validity was expressed as the ability to identify patients who show clinical symptoms of hip OA (construct validity) and as the ability to predict total hip replacement (THR) at follow up (predictive validity). RESULTS: Inter-rater reliability was similar for the Kellgren and Lawrence grade and MJS (kappa statistics 0.68 and 0.62, respectively) but lower for Croft's grade (kappa statistic, 0.51). The Kellgren and Lawrence grade and MJS showed the strongest associations with clinical symptoms of hip OA. Sex appeared to be an effect modifier for Kellgren and Lawrence and MJS definitions, women showing a stronger association between grading and symptoms than men. However, the sex dependency was attributed to differences in height between women and men. The Kellgren and Lawrence grade showed the highest predictive value for THR at follow up. CONCLUSIONS: Based on these findings, Kellgren and Lawrence still appears to be a useful OA definition for epidemiological studies focusing on the presence of hip OA.

Aged↗

Coronary revascularisation outcome questionnaire (CROQ): development and validation of a new, patient based measure of outcome in coronary bypass surgery and angioplasty.

OBJECTIVE: To describe the development and scientific validation of a new patient based measure, the coronary revascularisation outcome questionnaire (CROQ), to evaluate health outcomes and quality of life before and after coronary artery bypass grafting and percutaneous transluminal coronary angioplasty. DESIGN AND SETTING: Psychometric validation study conducted with patients from three hospitals in the UK. PATIENTS: Two independent field tests were conducted by postal survey of 714 patients before and 1329 patients after coronary revascularisation to evaluate the measurement properties of the CROQ. METHODS: Qualitative methods including patient interviews were used to develop questionnaire content. A full psychometric evaluation was performed on the survey data. RESULTS: Psychometric tests with the application of stringent criteria confirmed the acceptability (low missing data, good response rates), scaling assumptions (good item convergent and discriminant validity), reliability (good internal consistency and reproducibility), validity (good content and construct validity), and responsiveness of the CROQ. CONCLUSIONS: The CROQ is a practical and scientifically sound patient based measure of outcome developed using psychometric methods. It captures aspects of recovery not addressed in other cardiac questionnaires and has been shown to be a highly responsive instrument that will be useful in evaluating outcomes in clinical trials.

Adult↗

Internal consistency and validity of a new physical workload questionnaire.

AIMS: To examine the dimensionality, internal consistency, and construct validity of a new physical workload questionnaire in employees with musculoskeletal complaints. METHODS: Factor analysis was applied to the responses in three study populations with musculoskeletal disorders (n = 406, 300, and 557) on 26 items related to physical workload. The internal consistency of the resulting subscales was examined. It was hypothesised that physical workload would vary among different occupational groups. The occupations of all subjects were classified into four groups on the basis of expected workload (heavy physical load; long lasting postures and repetitive movements; both; no physical load). Construct validity of the subscales created was tested by comparing the subscale scores among these occupational groups. RESULTS: The pattern of the factor loadings of items was almost identical for the three study populations. Two interpretable factors were found: items related to heavy physical workload loaded highly on the first factor, and items related to static postures or repetitive work loaded highly on the second factor. The first constructed subscale "heavy physical work" had a Cronbach's alpha of 0.92 to 0.93 and the second subscale "long lasting postures and repetitive movements", of 0.86 to 0.87. Six of eight hypotheses regarding the construct validity of the subscales were confirmed. CONCLUSIONS: The results support the internal structure, internal consistency, and validity of the new physical workload questionnaire. Testing this questionnaire in non-symptomatic employees and comparing its performance with objective assessments of physical workload are important next steps in the validation process.

Adult↗

The validity of diagnosing chronic obstructive pulmonary disease from a large administrative database.

BACKGROUND: Health authorities create and maintain administrative databases. Despite the potential advantages of these databases, the validity of the information they include must be considered. OBJECTIVE: To examine the validity of diagnosing chronic obstructive pulmonary disease (COPD) from a large administrative database. METHODS: Physician services and prescription claims data related to COPD and asthma were extracted from the Quebec universal medical insurance register (Régie de l'assurance-maladie du Québec; RAMQ) from the period of April 1, 1994 to March 31, 1999. Before obtaining the data, criteria for the validity of the COPD diagnosis in the database were formulated based on the epidemiology of COPD in the province. The extent to which the database satisfied these criteria are described within the present paper. RESULTS: For patients aged 65 years or older, COPD was two times more prevalent in the RAMQ database than in the 1994/1995 National Population Health Survey. One in three patients with a RAMQ-diagnosis of COPD also had a RAMQ-diagnosis of asthma, and 47% of patients aged 65 years or older with a RAMQ-diagnosis of COPD did not fill any prescription for beta-2-agonists. In addition, 42% of patients with a RAMQ-diagnosis of COPD who never had a RAMQ-diagnosis of asthma appeared only once with that diagnosis in the database. Of all patients aged 65 years or older with a RAMQ-diagnosis of COPD, 37% and 23% met the operational definitions of 'possible COPD' and 'probable COPD', respectively. CONCLUSIONS: Most RAMQ-diagnoses of COPD lack validity; therefore, the validity of database diagnoses should be routinely ascertained before using administrative databases in clinical and health services research.

Adult↗

[Linguistic adaptation into Spanish and validation of the Arthritis Treatment Satisfaction Questionnaire].

BACKGROUND AND OBJECTIVE: Linguistic adaptation and validation into Spanish of the ARTS questionnaire, a self reported instrument designed to measure four osteoarthritis treatment satisfaction dimensions: treatment advantages, treatment convenience, apprehension about treatment and satisfaction with medical care. MATERIAL AND METHOD: Adaptation was performed using conceptual equivalence, supervised by a panel of 6 experts and 4 independent translators, who were in charge of performing translation and back-translation of the items. A sample of patients suffering from knee, hip or column osteoarthritis was used to estimate the psychometric properties of feasibility, reliability, validity and sensitivity to change. Three groups were identified: adequate analgesic effect and tolerability, treatment-switch because of a weak analgesic effect, and treatment- switch due to poor tolerability. The ARTS was administered at baseline, 1 week later for retest, and after 4 weeks of treatment with NSAIDs or Cox II-inhibitors. RESULTS: A sample of 163 patients was formed (67.7 [9.2] years old). No floor or ceiling effects were found, items were well understood and non- response rates were below 1%. Cronbach's alpha for the total scales was 0.85, and the intraclass correlation coefficient was 0.81. Exploratory factor analysis yielded 4 dimensions which were coherent with those proposed by the original authors. Concurrent validity was measured with SF-36, a pain VAS instrument, a treatment compliance VAS, and the Morisky-Green compliance questionnaire. The adapted instrument showed a good discriminatory validity, and it was able to distinguish between patients needing a change in treatment and those who did not need it. It was also sensitive to changes in patients' treatment effectiveness after a 30 days follow up. CONCLUSIONS: A psychometrically valid and conceptually equivalent ARTS questionnaire has been produced to explore satisfaction with treatment in patients with osteoarthritis in Spanish speaking countries.

Humans↗

Quality of life in spinal cord injury patients with urinary difficulties. Development and validation of qualiveen.

BACKGROUND: Quality of life (QoL) may be severely affected in patients with spinal cord injury (SCI) and resulting urinary difficulties (UD). There is, however, a need for instruments capable of measuring QoL in these patients. The aim of this study was to develop and validate a questionnaire suitable for use in SCI patients with urinary disorders. METHODS: Following patient interviews, a questionnaire was developed in French that was subjected to item reduction and cross-sectional validation. The resulting Qualiveen (Qualiveen is a pending registration trade mark of Coloplast A/S, DK-3050 Humlebaek, Denmark) questionnaire underwent multi-trait and principal component analysis and the test-retest reliability of the questionnaire was examined in stable patients. RESULTS: Patient interviews identified 257 concepts relevant to SCI patients with urinary disorders. Item reduction led to a 30-item questionnaire, which was psychometrically validated in 281 SCI patients with UD. The median age of patients was 41 years, 78% were male and the majority were paraplegic (55%). The construct and clinical validity of the Qualiveen was confirmed, as well as its reliability in patients whose condition was stable over a 15-day period. Patients confirmed that it was easy to understand, complete and comprehensive. CONCLUSIONS: The Qualiveen is a reliable and psychometrically validated instrument that may be used to measure the QoL of SCI patients with UD.

Adult↗