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Clinical Validity (clinical + validity)
Selected AbstractsDevelopment of a disease specific questionnaire to supplement a generic tool for QoL in colorectal cancerPSYCHO-ONCOLOGY, Issue 7 2003J. Davidson-Homewood The need for disease-specific quality of life measures is highlighted in the literature. The psychometric properties of a supplementary disease-specific quality of life questionnaire developed for use with a generic Quality of Life tool in colorectal cancer patients are explored. Originally developed and tested in a German sample, the English translation was tested on a cohort of UK colorectal cancer patients. Relevance and acceptability was previously established in Germany. A rigorous factor analysis ascertained the underlying structure of two factors with a number of single items that were retained as clinically important symptom indicators. In considering validity, four conditions were assessed: Reliability using Cronbach's alpha; Construct validity by comparing patient subgroups; Clinical Validity, by testing the hypothesis that some patient subgroups experience worse quality of life; Construct Reliability using second order factor analysis with the EORTC QOLQ-C30 scales, confirming that the factors retained provide an excellent measure of physical discomfort and a good measure of physical well being. Two other such questionnaires were developed in parallel with this one and reported in the literature (FACT-C and QOLQ-CR38). However, this questionnaire provides a useful alternative tool for use in clinical trials of colorectal cancer treatments alongside a core QoL questionnaire especially when brevity is an important consideration. Copyright © 2003 John Wiley & Sons, Ltd. [source] Accuracy of Tissue Doppler Echocardiography in the Diagnosis of New-Onset Congestive Heart Failure in Patients with Levels of B-Type Natriuretic Peptide in the Midrange and Normal Left Ventricular Ejection FractionECHOCARDIOGRAPHY, Issue 8 2006Stephane Arques M.D. Background: Based on the hypothesis that it reflects left ventricular (LV) diastolic pressures, B-type natriuretic peptide (BNP) is largely utilized as first-line diagnostic complement in the emergency diagnosis of congestive heart failure (HF). The incremental diagnostic value of tissue Doppler echocardiography, a reliable noninvasive estimate of LV filling pressures, has been reported in patients with preserved LV ejection fraction and discrepancy between BNP levels and the clinical judgment, however, its clinical validity in such patients in the presence of BNP concentrations in the midrange, which may reflect intermediate, nondiagnostic levels of LV filling pressures, is unknown. Methods: 34 patients without history of HF, presenting with acute dyspnea at rest, BNP levels of 100,400 pg/ml and normal LV ejection fraction were prospectively enrolled (17 with congestive HF and 17 with noncardiac cause). Tissue Doppler echocardiography was performed within 3 hours after admission. Results: unlike BNP (P = 0.78), Boston criteria (P = 0.0129), radiographic pulmonary edema (P = 0.0036) and average E/Ea ratio (P = 0.0032) were predictive of congestive HF by logistic regression analysis. In this clinical setting, radiographic pulmonary edema had a positive predictive value of 80% in the diagnosis of congestive HF. In patients without evidence of radiographic pulmonary edema, average E/Ea > 10 was a powerful predictor of congestive HF (area under the ROC curve of 0.886, P < 0.001, sensitivity 100% and specificity 78.6%). Conclusion: by better reflecting LV filling pressures, bedside tissue Doppler echocardiography accurately differentiates congestive HF from noncardiac cause in dyspneic patients with intermediate, nondiagnostic BNP levels and normal LV ejection fraction. [source] Bench to Bedside: Electrophysiologic and Clinical Principles of Noninvasive Hemodynamic Monitoring Using Impedance CardiographyACADEMIC EMERGENCY MEDICINE, Issue 6 2003Richard L. Summers MD Abstract The evaluation of the hemodynamic state of the severely ill patient is a common problem in emergency medicine. While conventional vital signs offer some insight into delineating the circulatory pathophysiology, it is often impossible to determine the true clinical state from an analysis of blood pressure and heart rate alone. Cardiac output measurements by thermodilution have been the criterion standard for the evaluation of hemodynamics. However, this technology is invasive, expensive, time-consuming, and impractical for most emergency department environments. Impedance cardiography (ICG) is a noninvasive method of obtaining continuous measurements of hemodynamic data such as cardiac output that requires little technical expertise. ICG technology was first developed by NASA in the 1960s and is based on the idea that the human thorax is electrically a nonhomogeneous, bulk conductor. Variation in the impedance to flow of a high-frequency, low-magnitude alternating current across the thorax results in the generation of a measured waveform from which stroke volume can be calculated by a modification of the pulse contour method. To adequately judge the possible role of this technology in the practice of emergency medicine, it is important to have a sufficient understanding of the basic scientific principles involved as well as the clinical validity and limitations of the technique. [source] Behaviour of haematological parameters in athletes performing marathons and ultramarathons in altitude (,skyrunners')INTERNATIONAL JOURNAL OF LABORATORY HEMATOLOGY, Issue 6 2004G. BANFI Summary We observed athletes performing marathons and ultramarathons in altitude over several years to study the behaviour of haematological parameters in order to screen eventual paraphysiological or pathological conditions (sports anaemia). We collected samples from 124 athletes participating in seven races; 23 athletes were recruited in different races: 16 for four times, four for three times, and three for two times. The pre- and post-race values of erythrocytes, haemoglobin and packed cell volume did not show statistically significant differences in the studied athletes. The erythrocytes' indices (MCV, MCH, MCHC) and red cell distribution width (RDW) also were not significantly modified by the strenuous effort. The leukocytes were significantly increased because of immunological involvement during the endurance performance. Platelets and relative indices were not significantly modified. The stability of packed cell volume and haemoglobin in athletes performing training and races in altitude is strong evidence for the use of these parameters as an index of general health status and for illustrating possible abnormal increase because of exogenous stimulation of bone marrow. The preanalytical and analytical accuracy is crucial to assure clinical validity of the collected data: we strictly observed international recommendations in this field. [source] Capturing coping with symptoms in people with a diagnosis of schizophrenia: introducing the MACS-24INTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH, Issue 1 2009Maarten Bak Abstract In order to assess coping with psychotic symptoms, the Maastricht Assessment of Coping Strategies (MACS), 24 symptom version, was developed as a refinement of the previous MACS-13. Associations between type of coping and the experienced level of control over psychotic symptoms were examined using MACS-24. MACS-24 was administered to 32 individuals with a diagnosis of schizophrenia. For each of 24 symptoms, experience of distress, type of coping and the resulting degree of perceived control were assessed. Coping types were reduced to two contrasting coping factors: symptomatic coping and non-symptomatic coping (combining active problem solving, passive illness behaviour, active problem avoiding, and passive problem avoiding). Mean level of distress and perceived control (range: 1,7) were, respectively, 4.2 [standard deviation (SD) = 1.9] and 4.2 (SD = 1.9). The association between distress and perceived control was negative [, = ,0.28; 95% confidence interval (95%CI) = ,0.41 to ,0.15]. Type of coping interacted with perceived control (p = 0.005), in that symptomatic coping was negatively associated with perceived control [odds ratio (OR) over seven levels = 0.82, 95%CI = 0.71,0.94], whereas for non-symptomatic coping a positive association was apparent (OR over seven levels = 1.10, 95% CI = 1.03,1.19). Previous contrasts between symptomatic and non-symptomatic coping were replicated using MACS-24, suggesting clinical validity and utility. Copyright © 2009 John Wiley & Sons, Ltd. [source] CONTEXTUAL ASSESSMENT OF COUPLES THERAPY: THE CLINICAL DISCOURSE Q-SETSJOURNAL OF MARITAL AND FAMILY THERAPY, Issue 4 2002Steven M. Kogan This article describes a method for creating highly contextual assessments of couples therapy interaction using concepts from Systemic Functional Linguistics (SFL). According to SFL, talk in interaction serves three primary functions: to mediate social relations, to negotiate representations of reality, and to organize and structure the event as coherent. These concepts are operationalized using observational q-methodology. The Clinical Discourse Q-Sets (CDQS) include three separate q-sets for use by trained observers in rating 12-min segments of couples therapy conversation. Each q-set captures one aspect of the communication process as defined by Systemic Functional theory. Good-to-high reliabilities for the q-set profiles over various (n=16) couples therapy episodes were found. Preliminary evidence for the conceptual structure and clinical validity of the system was found. [source] Classifying degenerative joint disease by the RDC/TMD and by panoramic imaging: a retrospective analysisJOURNAL OF ORAL REHABILITATION, Issue 3 2010E. WINOCUR Summary, The purposes of the study were to evaluate the utility of diagnosing degenerative joint disease (DJD) by the clinical finding of coarse crepitus alone, without supporting imaging studies, as defined by the RDC/TMD, and to evaluate the contribution of panoramic radiography as an aid in the diagnosis of DJD. A retrospective analysis of 372 consecutive patients with TMD was conducted. Their panoramic radiographs were evaluated for the extent of their contribution to the final diagnosis. Panoramic radiography was of no diagnostic value in 94·4% of the cases when the group was considered as a whole. When patients diagnosed with DJD were considered separately, panoramic radiography was completely sufficient for reaching the final diagnosis in 20·0% of the cases. In almost 90% of these patients, however, the clinical examination did not support the diagnosis of DJD (no coarse crepitus was found). This raises some doubts about the effectiveness of the clinical examination according to the RDC/TMD and about the utility of panoramic radiography in the definitive diagnosis of DJD, because both techniques have low accuracy (11·1% and 20%, respectively). The present study supports the current recommendations that panoramic radiography should not be ordered routinely to assess DJD, but still it is first choice when any dental problem is suspected. Further additional imaging (computerized tomography, magnetic resonance imaging) should be considered only if there is reason to expect that the findings might affect diagnosis and management. This study adds to recent criticisms of the clinical validity of the RDC/TMD, with regard to DJD. [source] Validation of 2 Techniques for Electrocardiographic Recording in Dogs and CatsJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 4 2006Luca Ferasin Background: Standard electrocardiographic (ECG) recording in the dog and cat is commonly performed in right lateral recumbency, by connecting the ECG leads to the skin of the patient via metallic alligator clips. The jaws of the alligator clips are usually filed or flattened to reduce their uncomfortable pressure on the patient's skin. However, filed and flattened alligator clips can occasionally lose their grip to the skin, causing lead detachment during standard ECG recording. Hypothesis: The aim of the study was to validate two novel ECG recording techniques ("gel" and "pads"). Animals: Six-lead standard ECG recording was obtained from 42 dogs and 40 cats using the standard technique, as well as the two novel methods. Methods: Measurements were taken of the amplitude and duration of P waves and QRS complexes, duration of PQ and QT intervals, and mean electrical axis (MEA). In each recording, five representative complexes were measured, and the results were averaged for each parameter. Results: A good quality ECG recording was obtained with all the three different techniques, although a degree of wandering trace was observed in one third of cats with the "pads" technique. Bland-Altman analysis showed good agreement between the ECG values recorded with the two novel techniques and those recorded with the standard traditional technique. Furthermore, the observed differences were not clinically relevant, except for the R wave amplitude recorded with the "pads" method in cats (-0.35 to 0.37 mV). Conclusions and Clinical Importance: In conclusion, this study supports the reliability and clinical validity of the "gel" and "pads" techniques for ECG recording both in the dog and the cat, with some limitations for the "pads" technique in cats. [source] The quality of life for cancer children (QOLCC) for Taiwanese children with cancer (part II): Feasibility, cross-informants variance and clinical validityPSYCHO-ONCOLOGY, Issue 3 2004Chao-Hsing Yeh The quality of life in childhood cancer (QOLCC) is a research instrument that has been developed to assess the quality of life for children and adolescents who suffer from cancer in Taiwan. The current paper is the second of a two-part series of research reports. Part I is reported in this journal (Yeh et al., 2003). Part II describes the range of measurement, concordance of cross-informants reports, and clinical validity of Taiwanese pediatric cancer children (7,12 years) and adolescents (13,18 years) and their parents/caregivers. Due to the cognitive ability of children and adolescents, data were analyzed for children and adolescent separately. The validity of cross-referenced information between parent and child forms was subsequently examined using Pearson product correlation. The feasibility (percentage of missing values per item) and range of measurement [percentage of minimum (floor effect) and maximum (ceiling effect) possible scores] was calculated for the five QOLCC and the total scale score. The findings of medium to high correlation of the patient/parent responses strongly imply that relevant information might be obtainable through parents when children are unable or unwilling to complete the assessment instrument. Feasibility for the QOLCC was very good. Copyright © 2003 John Wiley & Sons, Ltd. [source] Reliability of the anaerobic threshold in cardiopulmonary exercise testing of patients with abdominal aortic aneurysms,ANAESTHESIA, Issue 1 2009E. Kothmann Summary Anaerobic threshold (AT), determined by cardiopulmonary exercise testing (CPET), is a well-documented measure of pre-operative fitness, although its reliability in patient populations is uncertain. Our aim was to assess the reliability of AT measurement in patients with abdominal aortic aneurysms. Eighteen patients were recruited. CPET was performed four times over a 6-week period. We examined shifts in the mean AT to evaluate systematic bias with random measurement error assessed using typical within-patient error and intraclass correlation coefficient (ICC, 3,1) statistics. There was no significant or clinically substantial change in mean AT across the tests (p = 0.68). The typical within-patient error expressed as a percentage coefficient of variation was 10% (95% CI, 8,13%), with an ICC of 0.74 (95% CI, 0.55,0.89). We consider the reliability of the AT to be acceptable, supporting its clinical validity and utility as an objective marker of pre-operative fitness in this population. [source] A new bipolar spectrum concept: a brief reviewBIPOLAR DISORDERS, Issue 2002Jules Angst Angst J, Gamma A. A new bipolar spectrum concept: a brief review. Bipolar Disord 2002: 4(Suppl. 1): 11,14. © Blackwell Munksgaard, 2002 Research on the broad bipolar spectrum is dependent on the definition of hypomania. We recently proposed a new, softer syndromal definition with clinical validity. This broadens the diagnosis of bipolar II (BP-II) disorder at the expense of major depressive disorder (MDD). There is evidence for a third group of suspected BP-II manifesting major depression plus hypomanic symptoms. The two bipolar-II groups together are as prevalent as MDD. A new concept of minor bipolar disorder embracing dysthymia, minor and recurrent brief depression with hypomanic syndromes and symptoms is discussed. Some methodological pitfalls of research on drug-induced hypomania as an element of the bipolar spectrum are also summarized. [source] Development and validation of a questionnaire for the assessment of bowel and lower urinary tract symptoms in womenBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 4 2002L. Hiller Objective To develop a simple but sensitive instrument to evaluate and document symptoms of both bowel and urinary dysfunction in women. Design A 22-item questionnaire covering a range of bowel and urinary symptoms was developed and underwent rigorous psychometric testing. Setting The gynaecology departments of three hospitals, a urogynaecology clinic, a functional bowel clinic and a general practice. Population Six hundred and thirty women, comprising four groups: 1. women awaiting hysterectomy (n= 379), 2. women following hysterectomy (n= 45), 3. women referred with functional bowel and/or urinary symptoms (n= 65), 4. asymptomatic controls (n= 141). Main outcome measures The content, construct and criterion validity, internal consistency, reliability and responsiveness of the questionnaire were measured. Results Peer and patient reports and missing data patterns supported face and content validity. Factor analysis showed a clinically relevant four-factor structure with low content replication able to distinguish between patient groups, indicating good internal structure. Comparison with clinical, anorectal physiological, videoproctographic, transit time and urodynamic test results provide provisional indication of criterion validity. Key domain question analysis and Cronbach's alphas showed internal consistency. Kappa values demonstrated good test,retest reliability and key question correlation over time proved responsiveness. Conclusions Our findings support the suitability, clinical validity, reliability and responsiveness of a simple questionnaire, which is sensitive to the constraints of clinical practice. The authors recommend its use in health care evaluation research assessing the effects of pelvic surgery and as a useful tool in comparing treatment efficacy. [source] | ||||||||||