SEARCH · PubMed Health

Results for “Validity”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,135 records · Page 63Linked to original sources

PubMed2004

Validation of the CORE Diabetes Model against epidemiological and clinical studies.

OBJECTIVES: The aim of this study was to assess the validity of the CORE Diabetes Model by comparing results from model simulations with observed outcomes from published epidemiological and clinical studies in type 1 and type 2 diabetes. METHODS: A total of 66 second- (internal) and third- (external) order validation analyses were performed across a range of complications and outcomes simulated by the CORE Diabetes Model (amputation, cataract, hypoglycaemia, ketoacidosis, macular oedema, myocardial infarction, nephropathy, neuropathy, retinopathy, stroke and mortality). Published studies were reproduced in the model by recreating cohorts in terms of demographics, baseline risk factors and complications, treatment patterns and patient management strategies, and simulating the progress of the cohort to an equivalent time horizon. RESULTS: Correlation analysis on results from 66 validation simulations produced an R2 value of 0.9224 (perfect fit = 1). A correlation plot of published study data versus values simulated by the CORE Diabetes Model had a trend line with a gradient of 1.0187 (perfect fit = 1). Validation analyses in type 1 and type 2 diabetes were associated with R2 values of 0.9778 and 0.8861 respectively. Correlation of second-order validation analyses (model predictions versus observed outcomes in studies used to construct the model) produced an R2 value of 0.9574, and the value for third-order analyses (model predictions versus observed outcomes in studies not used to construct the model) was 0.9023. CONCLUSIONS: The CORE Diabetes Model provides an accurate representation of patient outcomes when compared to 66 studies of diabetes and its complications. Model flexibility ensures it can be used to compare diabetes management strategies in different cohorts across a variety of clinical settings.

Computer Simulation↗

PubMed2004

An application of conditional logistic regression and multifactor dimensionality reduction for detecting gene-gene interactions on risk of myocardial infarction: the importance of model validation.

BACKGROUND: To examine interactions among the angiotensin converting enzyme (ACE) insertion/deletion, plasminogen activator inhibitor-1 (PAI-1) 4G/5G, and tissue plasminogen activator (t-PA) insertion/deletion gene polymorphisms on risk of myocardial infarction using data from 343 matched case-control pairs from the Physicians Health Study. We examined the data using both conditional logistic regression and the multifactor dimensionality reduction (MDR) method. One advantage of the MDR method is that it provides an internal prediction error for validation. We summarize our use of this internal prediction error for model validation. RESULTS: The overall results for the two methods were consistent, with both suggesting an interaction between the ACE I/D and PAI-1 4G/5G polymorphisms. However, using ten-fold cross validation, the 46% prediction error for the final MDR model was not significantly lower than that expected by chance. CONCLUSIONS: The significant interaction initially observed does not validate and may represent a type I error. As data-driven analytic methods continue to be developed and used to examine complex genetic interactions, it will become increasingly important to stress model validation in order to ensure that significant effects represent true relationships rather than chance findings.

Gene Expression Regulation↗

PubMed2004

An investigation into the validity of cervical spine motion palpation using subjects with congenital block vertebrae as a 'gold standard'.

BACKGROUND: Although the effectiveness of manipulative therapy for treating back and neck pain has been demonstrated, the validity of many of the procedures used to detect joint dysfunction has not been confirmed. Practitioners of manual medicine frequently employ motion palpation as a diagnostic tool, despite conflicting evidence regarding its utility and reliability. The introduction of various spinal models with artificially introduced 'fixations' as an attempt to introduce a 'gold standard' has met with frustration and frequent mechanical failure. Because direct comparison against a 'gold standard' allows the validity, specificity and sensitivity of a test to be calculated, the identification of a realistic 'gold standard' against which motion palpation can be evaluated is essential. The objective of this study was to introduce a new, realistic, 'gold standard', the congenital block vertebra (CBV) to assess the validity of motion palpation in detecting a true fixation. METHODS: Twenty fourth year chiropractic students examined the cervical spines of three subjects with single level congenital block vertebrae, using two commonly employed motion palpation tests. The examiners, who were blinded to the presence of congenital block vertebrae, were asked to identify the most hypomobile segment(s). The congenital block segments included two subjects with fusion at the C2-3 level and one with fusion at C5-6. Exclusion criteria included subjects who were frankly symptomatic, had moderate or severe degenerative changes in their cervical spines, or displayed signs of cervical instability. Spinal levels were marked on the subject's skin overlying the facet joints from C1 to C7 bilaterally and the motion segments were then marked alphabetically with 'A' corresponding to C1-2.Kappa coefficients (K) were calculated to determine the validity of motion palpation to detect the congenitally fused segments as the 'most hypomobile' segments. Sensitivity and specificity of the diagnostic procedure were also calculated. RESULTS: Kappa coefficients (K) showed substantial overall agreement for identification of the segment of greatest hypomobility (K = 0.65), with substantial (K = 0.76) and moderate (K = 0.46) agreement for hypomobility at C2-3 and C5-6 respectively. Sensitivity ranged from 55% at the C5-6 CBV to 78% at the C2-3 level. Specificity of the procedure was high (91 - 98%). CONCLUSION: This study indicates that relatively inexperienced examiners are capable of correctly identifying inter-segmental fixations (CBV) in the cervical spine using 2 commonly employed motion palpation tests. The use of a 'gold standard' (CBV) in this study and the substantial agreement achieved lends support to the validity of motion palpation in detecting major spinal fixations in the cervical spine.

Cervical Vertebrae↗

PubMed2005

Lumbar segmental instability: a criterion-related validity study of manual therapy assessment.

BACKGROUND: Musculoskeletal physiotherapists routinely assess lumbar segmental motion during the clinical examination of a patient with low back pain. The validity of manual assessment of segmental motion has not, however, been adequately investigated. METHODS: In this prospective, multi-centre, pragmatic, diagnostic validity study, 138 consecutive patients with recurrent or chronic low back pain (R/CLBP) were recruited. Physiotherapists with post-graduate training in manual therapy performed passive accessory intervertebral motion tests (PAIVMs) and passive physiological intervertebral motion tests (PPIVMs). Consenting patients were referred for flexion-extension radiographs. Sagittal angular rotation and sagittal translation of each lumbar spinal motion segment was measured from these radiographs, and compared to a reference range derived from a study of 30 asymptomatic volunteers. Motion beyond two standard deviations from the reference mean was considered diagnostic of rotational lumbar segmental instability (LSI) and translational LSI. Accuracy and validity of the clinical assessments were expressed using sensitivity, specificity, and likelihood ratio statistics with 95% confidence intervals (CI). RESULTS: Only translation LSI was found to be significantly associated with R/CLBP (p < 0.05). PAIVMs were specific for the diagnosis of translation LSI (specificity 89%, CI 83-93%), but showed poor sensitivity (29%, CI 14-50%). A positive test results in a likelihood ratio (LR+) of 2.52 (95% CI 1.15-5.53). Flexion PPIVMs were highly specific for the diagnosis of translation LSI (specificity 99.5%; CI 97-100%), but showed very poor sensitivity (5%; CI 1-22%). Likelihood ratio statistics for flexion PPIVMs were not statistically significant. Extension PPIVMs performed better than flexion PPIVMs, with slightly higher sensitivity (16%; CI 6-38%) resulting in a likelihood ratio for a positive test of 7.1 (95% CI 1.7 to 29.2) for translation LSI. CONCLUSION: This study provides the first evidence reporting the concurrent validity of manual tests for the detection of abnormal sagittal planar motion. PAIVMs and PPIVMs are highly specific, but not sensitive, for the detection of translation LSI. Likelihood ratios resulting from positive test results were only moderate. This research indicates that manual clinical examination procedures have moderate validity for detecting segmental motion abnormality.

Adult↗

PubMed2006

Cross-sectional and longitudinal construct validity of two rotator cuff disease-specific outcome measures.

BACKGROUND: Disease-specific Quality Of Life (QOL) measures are devised to assess the impact of a specific disease across a spectrum of important domains of life. The purpose of this study was to examine the cross-sectional and longitudinal construct validity (sensitivity to change) of two rotator cuff disease-specific measures, the Rotator Cuff-Quality Of Life (RC-QOL) and the Western Ontario Rotator Cuff (WORC) index, in relation to one another and to other joint and limb specific measures in the same population of the patients suffering from rotator cuff pathology. METHODS: Participants enrolled were consecutive patients who received physical therapy for management of impingement syndrome or received treatment following rotator cuff repair, acromioplasty or decompression surgeries. All subjects received physical therapy treatment and completed four outcome measures at 3 single points (initial, interim, and final). Cross-sectional convergent validity was assessed at each of the 3 time-points by correlating the WORC and RC-QOL's scores to each other and to two alternative scales; a joint-specific scale, the American Shoulder and Elbow Surgeons (ASES) standardized shoulder assessment form and a limb-specific measure, the Upper Extremity Functional Index (UEFI). Non-parametric statistics (Spearman's rho and Wilcoxon-Mann-Whitney tests) examined the construct validity. The standardized response mean (SRM) was used to examine sensitivity to change. RESULTS: Forty-one participants entered the study and their scores were compared at 3 cross sectional single points. The correlation coefficients among the 4 measures varied from 0.60 to 0.91. Correlation between corresponding domains of the WORC and RC-QOL varied from 0.45 to 0.85. The known group validity was not significantly different among individual sub-scores and total scores. The final SRMs were (1.42), (1.43), (1.44), and (1.54) for the ASES, RCQOL, WORC, and UEFI respectively. CONCLUSION: The WORC and RC-QOL exhibit similar cross-sectional convergent validity in patients suffering from rotator cuff pathology. The sensitivity to change was very close among all scores, with the UEFI having the highest sensitivity. Further research is needed to examine the extent to which each physical or emotional domain contributes to prognostic or therapeutic decision-making.

Adult↗

PubMed2005

Reliability and validity of the AGREE instrument used by physical therapists in assessment of clinical practice guidelines.

BACKGROUND: The AGREE instrument has been validated for evaluating Clinical Practice Guidelines (CPG) pertaining to medical care. This study evaluated the reliability and validity of physical therapists using the AGREE to assess quality of CPGs relevant to physical therapy practice. METHODS: A total of 69 physical therapists participated and were classified as generalists, specialist or researchers. Pairs of appraisers within each category evaluated independently, a set of 6 CPG selected at random from a pool of 55 CPGs. RESULTS: Reliability between pairs of appraisers indicated low to high reliability depending on the domain and number of appraisers (0.17-0.81 for single appraiser; 0.30-0.96 when score averaged across a pair of appraisers). The highest reliability was achieved for Rigour of Development, which exceeded ICC> 0.79, if scores from pairs of appraisers were pooled. Adding more than 3 appraisers did not consistently improve reliability. Appraiser type did not determine reliability scores. End-users, including study participants and a separate sample of 102 physical therapy students, found the AGREE useful to guide critical appraisal. The construct validity of the AGREE was supported in that expected differences on Rigour of Development domains were observed between expert panels versus those with no/uncertain expertise (differences of 10-21% p = 0.09-0.001). Factor analysis with varimax rotation, produced a 4-factor solution that was similar, although not in exact agreement with the AGREE Domains. Validity was also supported by the correlation observed (Kendall-tao = 0.69) between Overall Assessment and the Rigour of Development domain. CONCLUSION: These findings suggest that the AGREE instrument is reliable and valid when used by physiotherapists to assess the quality of CPG pertaining to physical therapy health services.

Cardiology↗

PubMed2006

Development and preliminary validation of a Greek-language outpatient satisfaction questionnaire with principal components and multi-trait analyses.

BACKGROUND: In the recent years there is a growing interest in Greece concerning the measurement of the satisfaction of patients who are visiting the outpatient clinics of National Health System (NHS) general acute hospitals. The aim of this study is therefore to develop a patient satisfaction questionnaire and provide its preliminary validation. METHODS: A questionnaire in Greek has been developed by literature review, researchers' on the spot observation and interviews. Pretesting has been followed by telephone surveys in two short-term general NHS hospitals in Macedonia, Greece. A proportional stratified random sample of 285 subjects and a second random sample of 100 outpatients, drawn on March 2004, have been employed for the analysis. These have resulted in scale creation via Principal Components Analysis and psychometric testing for internal consistency, test-retest and interrater reliability as well as construct validity. RESULTS: Four summated scales have emerged regarding the pure outpatient component of the patients' visits, namely medical examination, hospital environment, comfort and appointment time. Cronbach's alpha coefficients and Pearson, Spearman and intraclass correlations indicate a high degree of scale reliability and validity. Two other scales--lab appointment time and lab experience--capture the apparently distinct yet complementary visitor experience related to the radiographic and laboratory tests. Psychometric tests are equally promising, however, some discriminant validity differences lack statistical significance. CONCLUSION: The instrument appears to be reliable and valid regarding the pure outpatient experience, whereas more research employing larger samples is required in order to establish the apparent psychometric properties of the complementary radiographic and laboratory-testing process, which is only relevant to about 25% of the subjects analysed here.

Data Collection↗

PubMed2003

The Hospital Anxiety and Depression Scale (HADS): translation and validation study of the Iranian version.

BACKGROUND: The Hospital Anxiety and Depression Scale (HADS) is a widely used instrument to measure psychological morbidity in cancer patients. This study aimed to translate and test the reliability and validity of the Iranian version of the HADS. METHODS: The English language version of the HADS was translated into Persian (Iranian language) and was used in this study. The questionnaire was administered to a consecutive sample of 167 breast cancer patients and statistical analysis was performed to test the reliability and validity of the HADS. RESULTS: In general the Iranian version of the HADS was found to be acceptable to almost all patients (99%). Cronbach's alpha coefficient (to test reliability) has been found to be 0.78 for the HADS anxiety sub-scale and 0.86 for the HADS depression sub-scale. Validity as performed using known groups comparison analysis showed satisfactory results. Both anxiety and depression sub-scales discriminated well between sub-groups of patients differing in clinical status as defined by their disease stage. CONCLUSION: This preliminary validation study of the Iranian version of the HADS proved that it is an acceptable, a reliable and valid measure of psychological distress among cancer patients.

Adult↗

PubMed2003

The 12-item General Health Questionnaire (GHQ-12): translation and validation study of the Iranian version.

BACKGROUND: The objective of this study was to translate and to test the reliability and validity of the 12-item General Health Questionnaire (GHQ-12) in Iran. METHODS: Using a standard 'forward-backward' translation procedure, the English language version of the questionnaire was translated into Persian (Iranian language). Then a sample of young people aged 18 to 25 years old completed the questionnaire. In addition, a short questionnaire containing demographic questions and a single measure of global quality of life was administered. To test reliability the internal consistency was assessed by Cronbach's alpha coefficient. Validity was performed using convergent validity. Finally, the factor structure of the questionnaire was extracted by performing principal component analysis using oblique factor solution. RESULTS: In all 748 young people entered into the study. The mean age of respondents was 21.1 (SD = 2.1) years. Employing the recommended method of scoring (ranging from 0 to 12), the mean GHQ score was 3.7 (SD = 3.5). Reliability analysis showed satisfactory result (Cronbach's alpha coefficient = 0.87). Convergent validity indicated a significant negative correlation between the GHQ-12 and global quality of life scores as expected (r = -0.56, P < 0.0001). The principal component analysis with oblique rotation solution showed that the GHQ-12 was a measure of psychological morbidity with two-factor structure that jointly accounted for 51% of the variance. CONCLUSION: The study findings showed that the Iranian version of the GHQ-12 has a good structural characteristic and is a reliable and valid instrument that can be used for measuring psychological well being in Iran.

Adolescent↗

PubMed2005

The Herdecke Questionnaire on Quality of Life (HLQ): validation of factorial structure and development of a short form within a naturopathy treated in-patient collective.

BACKGROUND: Quality of life (QoL) of patients has become a central evaluation parameter that also acts as an aid for decisions related to treatment strategies particularly for patients with chronic illnesses. In Germany, one of the newer instruments attempting to measure distinct QoL aspects is the "Herdecke Questionnaire for Quality of Life" (HLQ). In this study, we aimed to validate the HLQ with respect to its factorial structure, and to develop a short form. The validation has been carried out in relation to other questionnaires including the SF-36 Health Survey, the Mood-Scale Bf-S, the Giessen Physical Complaints Questionnaire GBB-24 and McGill's Pain Perception Scale SES. METHODS: Data for this study derived from a model project on the treatment of patients using naturopathy methods in Blankenstein Hospital, Hattingen. In total, 2,461 patients between the ages of 16 and 92 years (mean age: 58.0 +/- 13.4 years) were included in this study. Most of the patients (62%) suffered from rheumatic diseases. Factorial validation of the HLQ, it's reliability and external consistency analysis and the development of a short form were carried out using the SPSS software. RESULTS: Structural analysis of the HLQ-items pointed to a 6-factor model. The internal consistency of both the long and the short version is excellent (Cronbach's alpha is 0.935 for the HLQ-L and 0.862 for the HLQ-S). The highest reliability in the HLQ-L was obtained for the "Initiative Power and Interest" scale, the lowest for the 2-item scales "Digestive Well-Being" and the "Physical Complaints". However, the scales found by factor analysis herein were only in part congruent with the original 5-scale model which was approved a multitrait analysis approach. The new instrument shows good correlations with several scales of other relevant QoL instruments. The scales "Initiative Power and Interest", "Social Interaction", "Mental Balance", "Motility", "Physical Complaints", "Digestive Well-Being" sufficiently differentiate the diagnostic groups, particularly between the patients suffering on connective tissue and soft tissue disorders from those with metabolic and nutritional disorders or hypersensitivity reactions. CONCLUSION: Both the factorial validation and the development of a consistent short-form of the HLQ are important steps forward for researchers in the field of QoL who wish to use the HLQ as a reliable and valid instrument. The results indicate that the HLQ is a unique QoL-instrument that can be used for both in-patient and out-patient-treatment. However, to improve to profile of the HLQ, there is still the need for strengthening the Questionnaire in the dimensions of physical well-being. This is the subject of a separate ongoing study.

Adolescent↗

PubMed2005

The reliability, validity and responsiveness of the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) in a trial population.

BACKGROUND: The aim of this study was to determine the reliability, validity and responsiveness of the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) in a clinical trial setting. METHODS: Two matching, placebo-controlled, multinational studies assessing the effectiveness and safety of ropinirole for treating moderate-to-severe Restless Legs Syndrome (RLS) formed the basis of this psychometric assessment. Validity and reliability were assessed using baseline data. Responsiveness was determined using longitudinal data collected at baseline and 12 weeks. RESULTS: A total of 547 subjects formed the baseline validation population; 519 were used for assessing responsiveness (n = 284/263 and 271/248 for both studies, respectively). Construct validity assessment confirmed that an overall life impact score could be calculated. All item-scale correlations were = 0.4, except items 1 (r = 0.36) and 5 (r = 0.35) in one study. Floor and ceiling effects were minimal. Cronbach's alpha values were 0.82 and 0.87, respectively, confirming internal consistency reliability. Correlations with the International Restless Legs Syndrome Study Group's severity rating scale (International Restless Legs Scale; IRLS) were moderate (r = -0.68 and -0.67, respectively; p < 0.0001). The RLSQoL was able to discriminate between levels of sleep problems (p < 0.0001) and between levels of global health status determined by a Clinical Global Impression of severity (CGI-S) (p < 0.0001). Responsiveness was demonstrated by significant differences in overall life impact change scores between CGI improvement levels after 12 weeks (p < 0.0001). CONCLUSION: The RLSQoL is a valid, reliable and responsive measure of quality of life for patients with RLS, in a clinical trial setting where group comparisons are anticipated.

Adult↗

PubMed2005

Validation of the Clinical COPD questionnaire in Italian language.

BACKGROUND: The development and validation study of the Clinical Chronic Obstructive Disease (COPD) Questionnaire (CCQ) has recently been published in this journal. The CCQ is the first questionnaire that incorporates both clinician and patient guideline goals in the clinical control evaluation of patients with COPD in general clinical practice. The aim of this study is the validation of the CCQ questionnaire in Italian, in specific pulmonary disease clinical practice. METHODS: Validity was tested on a population of healthy subjects and patients with COPD, using the Italian validated version of the Short Form Health Survey (SF-36) and guideline recommended routine measurement in COPD patients (FEV1, FVC, BMI and functional dyspnoea). Test-retest reliability was tested by re-administering the CCQ after 2 weeks. Responsiveness was tested by re-administering the CCQ after three weeks of hospital pulmonary rehabilitation. Distance walked and Borg breathlessness rating were measured at the end of the six-minute walking test (6 MWT), before and after rehabilitation. RESULTS: Cross-sectional data were collected from 175 subjects (55 healthy; 40 mild-moderate, 50 severe and 25 very severe COPD). Cronbach's alpha was high (0.89). The CCQ scores in patients were significantly worse than in healthy subjects. The CCQ total score in patients with COPD was significantly worse in those with BMI < or = 21. Significant correlations were found between the CCQ total score and domains of the SF-36 (rho = -0.43 to rho = -0.72). The correlation between the CCQ and FEV1 % predicted was rho = -0.57. The correlation between the CCQ and MRC was rho = 0.63. Test-retest reliability was determined in 112 subjects over a period of two weeks (Intra Class Coefficient = 0.99). Forty-six patients with COPD showed significant improvement in CCQ scores, distance-walked and Borg breathlessness rating after 3 weeks of pulmonary rehabilitation, indicating CCQ responsiveness. CONCLUSIONS: The CCQ is self-administered and has been specially developed to measure clinical control in patients with COPD. Data support its validity, reliability and responsiveness in Italian and in specific pulmonary disease clinical practice.

Adult↗

PubMed2006

Validation of a patient satisfaction questionnaire for anemia treatment, the PSQ-An.

BACKGROUND: Treating anemia associated with chemotherapy and many cancers is often necessary. However, patient satisfaction with anemia treatment is limited by the lack of validated instruments. We developed and validated a new treatment-specific patient satisfaction instrument: the Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-An). Treatment burden and overall satisfaction scales were designed for ease of use in clinical practice. METHODS: 312 cancer patients (141 breast, 69 gynecological, and 102 non-small cell lung) were targeted to complete the PSQ-An at 4 week intervals. Data from weeks 5 and 9 were analyzed. Patients also completed the MOS SF-36 Global Health assessment and questions concerning resources devoted to anemia treatment. Item reduction used endorsement rates, floor/ceiling effects, and item-item correlations. Factor analysis identified meaningful subscales. Test-retest reliability was assessed. Construct validity was tested, using Pearson's correlations, by comparing subscale scores to Global Health, hemoglobin levels, and resources devoted to anemia treatment. RESULTS: The overall response rate was 92.9% (264/284) at week 5. Most (84.2%) of the patients were female, and the mean (SD) age was 60.2 (+/- 11.8) years. Two distinct subscales were identified measuring treatment burden (7 items) and overall satisfaction (2 items). Test-retest reliability was examined (ICC: 0.45-0.67); both were internally consistent (alpha = 0.83). Both subscales exhibited convergent and divergent validity with independent measures of health. ANOVA results indicated that the PSQ-An Satisfaction subscale discriminated between 5 levels of MOS SF-36 Global Health (P = 0.006). CONCLUSION: The PSQ-An is a validated, treatment-specific instrument for measuring satisfaction with anemia treatment for cancer patients. PSQ-An subscales reflect the burden of injection anemia treatment on cancer patients and their assessment of the overall treatment value.

Aged↗

PubMed2007

How young can children reliably and validly self-report their health-related quality of life?: an analysis of 8,591 children across age subgroups with the PedsQL 4.0 Generic Core Scales.

BACKGROUND: The last decade has evidenced a dramatic increase in the development and utilization of pediatric health-related quality of life (HRQOL) measures in an effort to improve pediatric patient health and well-being and determine the value of healthcare services. The emerging paradigm shift toward patient-reported outcomes (PROs) in clinical trials has provided the opportunity to further emphasize the value and essential need for pediatric patient self-reported outcomes measurement. Data from the PedsQL DatabaseSM were utilized to test the hypothesis that children as young as 5 years of age can reliably and validly report their HRQOL. METHODS: The sample analyzed represented child self-report age data on 8,591 children ages 5 to 16 years from the PedsQL 4.0 Generic Core Scales DatabaseSM. Participants were recruited from general pediatric clinics, subspecialty clinics, and hospitals in which children were being seen for well-child checks, mild acute illness, or chronic illness care (n = 2,603, 30.3%), and from a State Children's Health Insurance Program (SCHIP) in California (n = 5,988, 69.7%). RESULTS: Items on the PedsQL 4.0 Generic Core Scales had minimal missing responses for children as young as 5 years old, supporting feasibility. The majority of the child self-report scales across the age subgroups, including for children as young as 5 years, exceeded the minimum internal consistency reliability standard of 0.70 required for group comparisons, while the Total Scale Scores across the age subgroups approached or exceeded the reliability criterion of 0.90 recommended for analyzing individual patient scale scores. Construct validity was demonstrated utilizing the known groups approach. For each PedsQL scale and summary score, across age subgroups, including children as young as 5 years, healthy children demonstrated a statistically significant difference in HRQOL (better HRQOL) than children with a known chronic health condition, with most effect sizes in the medium to large effect size range. CONCLUSION: The results demonstrate that children as young as the 5 year old age subgroup can reliably and validly self-report their HRQOL when given the opportunity to do so with an age-appropriate instrument. These analyses are consistent with recent FDA guidelines which require instrument development and validation testing for children and adolescents within fairly narrow age groupings and which determine the lower age limit at which children can provide reliable and valid responses across age categories.

Adolescent↗

PubMed2002

Development and validation of two new sensory tests of the hand for patients with stroke.

OBJECTIVE: To establish validity and reliability of two new sensory tests evaluating moving (MTP) and sustained (STP) touch-pressure and their relationship to hand function for patients with stroke. The STP had four components in which a light or heavy ball was applied passively or held actively. PARTICIPANTS: Twenty-eight participants with hemiparesis (1-109 months) from rehabilitation hospitals or outpatient programmes. DESIGN: Content validity was established. Then reliability and concurrent and construct validity were determined. Sensation was compared with hand functional ability using the Modified Moberg recognition task, the Box and Block test and one task of the TEMPA test. RESULTS: Reliability: Both types of reliability were significant for MTP (ICC = 0.92) and all components of STP (ICC = 0.62 to 0.92). Concurrent validity: MTP and STP correlated significantly (r = -0.39 to -0.83) with the Semmes-Weinstein Monofilament test used as a 'gold standard' comparison. Construct validity: MTP was significantly related to Moberg (r = 0.49). Three of four components of STP correlated with TEMPA (r = 0.49-0.53) and Moberg (0.45-0.71). Only STP (heavy ball) correlated with Box and Block (0.42-0.48). Of the four components of STP, only the passive STP (light ball) was not related to hand function. CONCLUSION: The new sensory tests of moving, and three components of sustained touch-pressure were reliable. The passive STP (light ball) was discarded. All but this test were relevant to the two functional roles of sensation: exploration for MTP and dexterity during holding for STP.

Adult↗

PubMed2005

Validation of the NARCOMS Registry: pain assessment.

The North American Research Committee on Multiple Sclerosis (NARCOMS) Registry is a multiple sclerosis (MS) self-report registry with more than 24,000 participants. Participants report disability status upon enrollment, and semi-annually using Performance Scales (PS), Patient Determined Disease Steps (PDDS) and a pain question. In November 2000 and 2001, we also collected the Pain Effects Scale (PES). Our aim was to validate the NARCOMS pain question using the PES as our criterion measure. We measured correlations between the pain question and age, disease duration, various PS subscales and PDDS to assess construct validity. We correlated pain question responses in participants who reported no change in PDSS or the PS subscales between questionnaires to determine test-retest reliability. We measured responsiveness in participants who reported a substantial change in the sensory, spasticity PS subscales. The correlation between the pain question and PES was r = 0.61 in November 2000, and r = 0.64 in November 2001 (both P < 0.0001). Correlations between the pain question and age, and disease duration were low, indicating divergent validity. Correlations between the pain question and spasticity, sensory PS subscales and PDSS were moderate, indicating convergent validity. Test-retest reliability was r = 0.84 (P < 0.0001). Responsiveness was 70.7%. The pain question is a valid self-report measure of pain in MS.

Adult↗

PubMed2005

Validation of the NARCOMS registry: fatigue assessment.

Participants in the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry report disability using Performance Scales (PS), which assess eight domains. We aimed to validate the PS fatigue subscale (PSF) using the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS) as external criteria. We measured correlations between the PSF and age, disease duration and PS subscales to assess construct validity. The PSF correlated strongly with the MFIS (r =0.72, P <0.0001) and FSS (r =0.75, P <0.0001). Correlations between the PSF and age, disease duration were low, indicating divergent validity. Correlations between the PSF and spasticity, sensory and mobility PS scales were moderate, indicating convergent validity. The PSF has adequate criterion and construct validity in MS.

Disability Evaluation↗

PubMed2005

A population-based validation of the American Joint Committee on Cancer melanoma staging system.

PURPOSE: A major revision of the American Joint Committee on Cancer (AJCC) stages for melanoma was implemented in 2002 after its validation in multinational cohorts including patients from cancer centers and cooperative groups. This staging system has not been validated in a US population-based cohort. PATIENTS AND METHODS: We used 41,417 patients with primary invasive cutaneous melanoma diagnosed between 1988 and 2001 from the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) cancer registry to validate the revised AJCC staging system. Survival rates computed from stage-specific Kaplan-Meier curves (time to melanoma-specific death) were compared with the survival rates from 17,600 patients in the original AJCC validation study. RESULTS: In the SEER cohort, 65% of reported melanomas were < or = 1.00 mm in thickness and 8.7% were more than 4.00 mm compared with 39% and 10% in the AJCC cohort (P < .001), respectively. AJCC stages were able to discriminate among SEER patient groups with different prognosis. However, SEER survival rates were significantly higher than those in the AJCC study and notably so in patients with T1a lesions (< or = 1 mm without ulceration). This population-specific effect remained significant after controlling for lesion thickness in all substages except stage IIA. CONCLUSION: Although this national population-based study validates the most recent revision of AJCC stages for melanoma, it emphasizes that survival rates are population specific and found them to be generally higher for SEER compared with AJCC patients. Population-specific survival rates should be used in study designs and decisions about patient-specific interventions.

Adolescent↗