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Reliability and validity of the Faces and Word Descriptor Scales to measure procedural pain.

Reliability and validity of the Faces and Word Descriptor Scales to measure pain in verbal children undergoing painful procedures were assessed. Test-retest reliability and construct and discriminant validity were supported for both instruments among a sample of 118 children in three age groups (3-7, 8-12, 13-18). Construct validity was determined by comparisons with a visual analogue scale and a numerical scale with known validity. A majority of the children preferred to use the Faces scale when providing self-report of pain regardless of age. The Faces and Word Descriptor Scales are valid and reliable instruments to measure procedural pain intensity.

Adolescent↗

The reliability and validity of the Vancouver classification of femoral fractures after hip replacement.

This study assessed the reliability and validity of a new classification system for fractures of the femur after hip arthroplasty. Forty radiographs were evaluated by 6 observers, 3 experts and 3 nonexperts. Each observer read the radiographs on 2 separate occasions and classified each case as to its type (A, B, C) and subtype (B1, B2, B3). Reliability was assessed by looking at the intraobserver and interobserver agreement using the kappa statistic. Validity was assessed within the B group by looking at the agreement between the radiographic classification and the intraoperative findings. Our findings suggest that this classification system is reliable and valid. Intraobserver agreement was consistent across observers, ranging from 0.73 to 0.83. There was a negligible difference between experts and nonexperts. Interobserver agreement was 0.61 for the first reading and 0.64 for the second reading by kappa analysis, indicating substantial agreement between observers. Validity analysis revealed an observed agreement kappa value of 0.78, indicating substantial agreement. This study has shown that this classification is reliable and valid.

Arthroplasty, Replacement, Hip↗

Development and validation of the cancer fatigue scale: a brief, three-dimensional, self-rating scale for assessment of fatigue in cancer patients.

We herein describe the development and validation of the Cancer Fatigue Scale (CFS) for assessment of fatigue in cancer patients. We designed this scale specifically to reflect the nature of fatigue experienced by cancer patients, by using factor analysis; the CFS is a 15-item scale composed of 3 subscales (physical, affective, and cognitive subscales). Three hundred seven cancer patients participated in the validation phase. Construct validity, confirmed by repeating factor analysis, was good. Convergent validity, confirmed by a correlation between CFS and a visual analogue scale for fatigue, was also shown to be good (r = 0.67, P < 0.001). The CFS had good stability (average test-retest reliability r = 0.69, P < 0.001) and good internal consistency (Cronbach's alpha coefficient for all 15 items = 0.88). The present study indicates that the CFS is a brief, valid, and feasible measure of fatigue for use with cancer patients.

Adolescent↗

The UK IBDQ-a British version of the inflammatory bowel disease questionnaire. development and validation.

Measurement of health-related quality of life (HRQL) is becoming more important in studies of patients with inflammatory bowel disease. The McMaster IBDQ is the most widely used HRQL instrument for these patients. However, its use with patients in the United Kingdom has not been validated. This study develops and validates a UK version of the McMaster IBDQ (UK IBDQ). The UK IBDQ was tested with two samples of patients for its reliability, validity, reproducibility, and responsiveness. The first sample consisted of 180 patients participating in a randomized clinical trial. The second was recruited from members of the National Association for Colitis and Crohns Disease. Reliability of the subscales and the summary score of the UK IBDQ is demonstrated by Cronbach's alpha and item-total correlations. Their validity is demonstrated by their correlations with SF-36 subscales and an empirical index of disease activity. Good intraclass correlations and responsiveness ratios show their reproducibility and responsiveness. The findings support the reliability, validity, reproducibility, and responsiveness of the UK IBDQ and its acceptability to patients in UK.

Emotions↗

The structured interview for anorexic and bulimic disorders for DSM-IV and ICD-10 (SIAB-EX): reliability and validity.

OBJECTIVE: For reliable and valid assessment and diagnostic categorization of eating disorders, self-report measures have considerable limitations. A semi-structured interview - the SIAB-EX - was developed for a more reliable and valid assessment of eating disorders. METHODS: One study (videotapes of 31 inpatients, seven raters) was made to establish inter-rater reliability; in another study with 80 patients the SIAB-EX was compared to another semi-structured interview designed for comparable purposes (EDE). In a third study data was obtained on 377 eating disorder patients seeking treatment to explore discriminant and convergent (construct) validity using the following self-rating scales: EDI, TFEQ, SCL-90, BDI, and the PERI Demoralization Scale. RESULTS: Inter-rater reliability of dichotomous ratings was good with mean kappa values of.81 (current) and.85 (past). Comparison of the SIAB-EX with the EDE generally showed quite similar results and higher intercorrelation of the total scale (.77). There are, however, a number of differences between the two scales, which are discussed in detail. Construct validity of the SIAB-EX was established. CONCLUSION: Inter-rater reliability was good. Convergent and discriminant (construct) validity of the SIAB-EX was demonstrated. The constructs assessed by the SIAB and its subscales and items are discussed in the context of their correlations with other well-known scales.

Adaptation, Psychological↗

Validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) as a measure of psychosocial function in breast cancer patients.

The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire QLQ-C30 has been developed as a quantitative measure of health-related quality of life for use in clinical trials of cancer patients. Validity is an important measurement property of all scientific tests. This study contributes to the iterative process of validating the questionnaire by focusing on the psychosocial subscales of the QLQ-C30, using baseline data from 150 patients participating in a randomised trial of supportive group therapy for metastatic breast cancer. The results provide strong support for the discriminative validity of the global health/quality of life, role function and social function subscales of the QLQ-C30, in patients differing according to clinical criteria. The psychosocial focus of the trial enabled expansion of criteria used to form patient subgroups, beyond medical factors, and consequently support was demonstrated for the discriminative validity of the emotional and cognitive function subscales. The degree of support for these subscales was less substantial than for the other QLQ-C30 subscales as there were fewer relevant criteria. Convergence assessed by correlations with independent measures of psychosocial function provides strong support for the convergent validity of the emotional function, role function and global health/quality of life subscales of the QLQ-C30, and moderate support for the social function subscales. There was little opportunity for the cognitive function subscale to associate with conceptually analogous subscales. Further testing is recommended with more comprehensive and specific measures of cognitive status. In general, the psychosocial subscales of the QLQ-C30 appear to be measuring the concepts they are purported to measure.

Adult↗

Concurrent related validity of the GAITRite walkway system for quantification of the spatial and temporal parameters of gait.

The GAITRite is a portable gait analysis tool for automated measurement of spatiotemporal gait parameters. Although frequently used for clinical and research purposes, the concurrent validity of GAITRite has not been validated against a criterion measure. The aim of this experiment was to investigate the concurrent validity and test retest reliability of the GAITRite carpet walkway system for quantification of spatial and temporal parameters of the footstep pattern. Twenty-five healthy adults aged 21-71 years (mean 40.5 years, S.D. 17.2) performed three walk trials at self-selected pace, three at fast pace and three at slow pace. For each trial, data were simultaneously collected from the GAITRite and a Clinical Stride Analyzer, which has established reliability and validity. At preferred, slow and fast walking pace there were very high correlations between the two measurement systems for gait speed (ICC (2,1)=0.99), stride length (ICC (2,1)=0.99) and cadence (ICC (2,1)=0.99). Correlations between the electronic carpet and the stride analyser were moderate to high for single limb support (SLS) time (ICC (2,1)=0.69-0.91) and weak for the proportion of the gait cycle spent in double limb support (ICC (2,1)=0.44-0.57). The reliability of repeated measures for the GAITRite was good at preferred and fast speed for speed (ICC (3,1)=0.93-0.94), cadence (ICC (3,1)=0.92-0.94), stride length (ICC (3,1)=0.97), single support (ICC (3,1)=0.85-0.93) and the proportion of the gait cycle spent in double limb support (ICC (3,1)=0.89-0.92). The repeatability of the GAITRite measures were more variable at slow speed (ICC (3,1)=0.76-0.91). These results indicate that the GAITRite system has strong concurrent validity and test retest reliability, in addition to being a portable, simple clinical tool for the objective assessment of gait.

Adult↗

Validity and coverage of estimates of relative accuracy.

PURPOSE: Studies comparing test accuracy often restrict the confirmation procedure to subjects classified as positive by either test. Relative sensitivity (RSN) and relative false-positive rate (RFP) are two estimable comparative measures of accuracy. This article evaluates the influence of sample size, disease prevalence, and test accuracy on the validity of point estimates of RSN and RFP, and on the coverage of their confidence intervals (CI). METHODS: For each combination of sample size, disease prevalence, test accuracy, and interdependence between tests 1,000 samples were generated using computer simulations. The percent bias in the RSN and RFP estimates was measured by comparing the means of the 1,000 values computed in each simulation (log-transformed) with their theoretical values. Coverage of the estimated CI was measured by computing the proportion that actually included the theoretical values. Application of these methods was illustrated with data from a study comparing mammography and physical examination in screening for breast cancer. RESULTS: RSN estimates were valid if the true number of diseased cases exceeded 30, and RFP estimates were valid if the number of nondiseased subjects exceeded 200. When the numbers of diseased and nondiseased subjects exceeded 150 each, the 95% CI of RSN and RFP provided adequate coverage of the parameters (95 +/- 2%). CONCLUSION: Sample size is the most important variable for the validity and coverage of RSN and RFP estimates. For small samples, validity and coverage of RSN and RFP also depend on the accuracy of each test and on the degree of interdependence between the tests.

Adult↗

Validating clinical reasoning: a question of perspective, but whose perspective?

This paper explores the notion of validity from different perspectives and addresses its integration with clinical reasoning. Whilst valuing the evidence-based practice (EBP) perspective in our quest for validation of practice, the authors posit that other perspectives may provide added value through their potential for offering validity in differing circumstances. The reality of the EBP aspiration is discussed and nuances within the evolved term 'research-enhanced practice' are shared. Validity theory applied through different perspectives may, it is argued help to get to grips with the balancing act of validating manual therapy practice.

Attitude of Health Personnel↗

Validation of the Johns Hopkins restless legs severity scale.

Determine reliability and validity of the Johns Hopkins restless legs severity scale (JHRLSS), an easily used clinical scale assessing severity of the restless legs syndrome (RLS). There is, prior to this study, no validated scale assessing the wide range of RLS severity. The JHRLSS has been used in prior studies to assess RLS severity, but has not previously been validated in relation to direct measures of the morbidity associated with RLS. A consecutive case series of 31 RLS patients was used in the study. The JHRLSS was validated by its correlation with objective measures by a polysomnogram of the sleep disturbances associated with RLS (periodic leg movements of sleep per hour (PLMS/h), and sleep efficiency). Reliability was determined from the independent ratings of two clinicians. Reliability measures for the JHRLSS based on inter-rater agreement were 0.91 (Spearman Rho) and 0.87 (Cramers V). The subjective JHRLSS correlated significantly with both objective measures of sleep: sleep efficiency (R=0.60, P<0.01) and PLMS/h (R=0.45, P=0.01). The JHRLSS provides a reliable, valid, easily used clinical assessment of RLS severity.

Journal Article↗

4-year mortality in patients with non-small-cell lung cancer: development and validation of a prognostic index.

BACKGROUND: Lung cancer is the commonest cause of death due to cancer in the world. Non-small-cell lung carcinoma (NSCLC) represents about 80% of overall lung cancer cases worldwide. An accurate predictive model of mortality in patients with NSCLC could be useful to clinicians, policy makers, and researchers involved in risk stratification. The objective of this study was to develop and validate a simple prognostic index for 4-year mortality in patients with NSCLC by use of information obtained at the time of lung cancer diagnosis. METHODS: In 2000, 4669 patients with histologically or cytologically proven NSCLC were enrolled prospectively from 137 pneumology departments in French general hospitals. Patients not lost to follow-up (n=4479) were randomly assigned to the development cohort (n=2979) or the validation cohort (n=1500). Every patient's physician completed a standard and anonymous questionnaire. We used a Cox model to identify variables independently associated with mortality and weighted the variables to create a prognostic index. FINDINGS: Median follow-up for survivors was 49 months (IQR 46-51). There were 2585 deaths (87%) in the development cohort and 1310 deaths (87%) in the validation cohort. Five independent predictors of mortality were identified: age (>70 years, 1 point); sex (male, 1 point); performance status at diagnosis (reduced activity, 3 points; active >50%, 5 points; inactive >50%, 8 points; and total incapacity, 10 points); histological type (large-cell carcinoma, 2 points); and tumour-node-metastasis (TNM) staging system (IIA or IIB, 3 points; IIIA or IIIB, 6 points; and IV, 8 points). The minimum and maximum possible point scores were 0 and 22, respectively. Scores of the prognostic index were strongly associated with 4-year mortality in the development cohort: 0-1 points predicted a 35% (95% CI 28-43) risk, 2-4 points a 59% (52-66) risk, 5-7 points a 77% (72-81) risk, 8-10 points an 88% (85-90) risk, 11-14 points a 97% (96-98) risk, and 15-22 points a 99% (97-100) risk. The corresponding percentages in the validation cohort were 36% (24-47), 60% (50-70), 77% (71-83), 89% (86-93), 96% (95-98), and 99% (98-100), respectively. The prognostic index showed good discrimination, with mean bootstrap c statistics of 0.85 (95% CI 0.84-0.86) in the development cohort and 0.86 (95% CI 0.85-0.87) in the validation cohort. INTERPRETATION: This prognostic index, incorporating personal, tumour, and functional information would be helpful in guiding patient management, resource use, and the design of clinical trials.

Adult↗

Validation of decisional balance and situational temptations measures for dietary fat reduction in a large school-based population of adolescents.

Brief, validated, and reliable theory-based measures specifically designed for use in large survey research with adolescent populations are needed to assess attitudes and behaviors about dietary fat consumption. This study validated two transtheoretical model (TTM)-based instruments in 2639 ninth graders from 12 Rhode Island high schools. The Decisional Balance Questionnaire for Adolescent Dietary Fat Reduction (DBQA) measures the importance adolescents assign to the pros and cons of reducing dietary fat consumption, while the Situational Temptations Questionnaire for Adolescents (STQA) measures temptations to eat high-fat foods as both a global construct and across three categories of challenging situations. Four competing models were compared for each instrument. An eight-item, correlated two-factor Pros and Cons model was validated for the decisional balance measure and a nine-item, three-factor hierarchical model was validated for situational temptations. The theoretically predicted relationships between stage of change and the pros and cons, as well as stage and situational temptations were supported. These results demonstrate that both measures have sound psychometric properties and are externally valid.

Journal Article↗

The Health Anxiety Inventory: development and validation of scales for the measurement of health anxiety and hypochondriasis.

BACKGROUND: A self-rated measure of health anxiety should be sensitive across the full range of intensity (from mild concern to frank hypochondriasis) and should differentiate people suffering from health anxiety from those who have actual physical illness but who are not excessively concerned about their health. It should also encompass the full range of clinical symptoms characteristic of clinical hypochondriasis. The development and validation of such a scale is described. METHOD: Three studies were conducted. First, the questionnaire was validated by comparing the responses of patients suffering from hypochondriasis with those suffering from hypochondriasis and panic disorder, panic disorder, social phobia and non-patient controls. Secondly, a state version of the questionnaire was administered to patients undergoing cognitive-behavioural treatment or wait-list in order to examine the measure's sensitivity to change. In the third study, a shortened version was developed and validated in similar types of sample, and in a range of samples of people seeking medical help for physical illness. RESULTS: The scale was found to be reliable and to have a high internal consistency. Hypochondriacal patients scored significantly higher than anxiety disorder patients, including both social phobic patients and panic disorder patients as well as normal controls. In the second study, a 'state' version of the scale was found to be sensitive to treatment effects, and to correlate very highly with a clinician rating based on an interview of present clinical state. A development and refinement of the scale (intended to reflect more fully the range of symptoms of and reactions to hypochondriasis) was found to be reliable and valid. A very short (14 item) version of the scale was found to have comparable properties to the full length scale. CONCLUSIONS: The HAI is a reliable and valid measure of health anxiety. It is likely to be useful as a brief screening instrument, as there is a short form which correlates highly with the longer version.

Adult↗

Measuring quality of life: the development and initial validation of the patient-reported erectile function assessment instrument.

OBJECTIVES: Erectile dysfunction (ED) is a complex condition, which is variously influenced by physical, emotional, societal, and relationship factors. ED has serious implications for the quality of life (QoL) enjoyed by an affected male and his partner. It is very important, therefore, to understand the impact of ED on the QoL of those affected by it. Our objective was to determine if the eight-question Patient Reported Erectile Function Assessment (PREFA) could act as an independent, comprehensive disease-specific instrument in the assessment of QoL as it is impacted by ED. METHODS: During the development and validation of the Erectile Function-Visual Analog Scale (EF-VAS) (14), a new ED-specific preference-based instrument, a series of questions were included at the beginning of the assessment that would act as a way to encourage respondents to focus on their own experience with ED. Upon analysis of the EF-VAS data, it became apparent that the eight-question "warm up" section might act as a stand-alone assessment. Accordingly, the eight questions were named PREFA, and a validation analysis was undertaken to determine their consistency, feasibility, reliability, validity, and responsiveness. RESULTS: The PREFA questionnaire was found to be feasible and simple to complete, reliable, and valid, with excellent responsiveness. Overall, the PREFA has demonstrated that it can perform as a stand alone, validated assessment of the impact of ED on QoL, assessing areas of QoL not previously captured in existing instruments. CONCLUSIONS: The PREFA is suitable for use in clinical and research settings as a disease-specific QoL assessment tool.

Erectile Dysfunction↗

The Carers' Needs Assessment for Dementia (CNA-D): development, validity and reliability.

BACKGROUND: A variety of interventions are available to support the caregivers of dementia patients. For the purposes of service planning, we developed an instrument to assess the needs of these caregivers and to determine whether needs are met. The reliability and validity of this new instrument was also investigated. METHODS: The development of the Carers' Needs Assessment for Dementia (CNA-D), was based on in-depth interviews and a focus group. The combined inter-rater and test-retest reliability was investigated among 45 dementia caregivers. Correlations of the CNA-D with the Zarit Burden Inventory were used to analyze concurrent validity. Content validity was investigated by performing a separate survey among 40 caregivers and 40 professionals. RESULTS: The CNA-D is a semi-structured research interview including 18 problem areas. For each problem area, the CNA-D offers several possible interventions. The relevance of the problem areas and the interventions (content validity) was confirmed by most of the study participants. Significant positive associations were found between the total score of the Zarit Burden Inventory and the number of problems and the number of unmet needs according to the CNA-D. The agreement between the interviewers was "excellent" (kappa above 0.75) in 73.7% of the problem areas and in 69.9% of the interventions. CONCLUSIONS: The CNA-D is a valid and reliable instrument for comprehensively assessing the needs of dementia caregivers.

Adult↗

[Construction and validation of a new screnning questionnaires for eating disorders: the inventory for the screening of eating disorders/(ISED)].

OBJECTIVE: The study aims to construct and validate a new screening questionnaire for the identification of cases at risk for eating disorders. SETTING AND SAMPLE: We assessed 218 female adolescent students recruited in a vocational school in Mestre (VE) and 88 patients consecutively referred to the Eating Disorders Unit of the University of Padova. PROCEDURE AND MAIN OUTCOME MEASURES: All subjects completed the new questionnaire, the Inventory for the Screening of Eating Disorders (ISED), and the Eating Attitudes Test (EAT). Sixty-two percent of female students and all the patients underwent a structured diagnostic interview (SCID for DSM-IV) for the diagnosis of eating disorders. The reliability, validity and screening ability of the questionnaire have been assessed. RESULTS: The reliability of the ISED, measured by Cronbach's alpha, is good (alpha = 0.87), as is the convergent validity (correlations with EAT). In order to improve the screening ability, the questionnaire has been further divided in two subscales: one for the identification of cases at risk for anorexia nervosa (ISED-AN) and the other for cases at risk for bulimia nervosa (ISED-BN). The screening ability of the two subscales is greater than that of EAT, although the difference is not statistically significant. The ISED cutoff points have greater positive predictive values than those of EAT in the screening of both anorexia nervosa and bulimia nervosa. CONCLUSIONS: The ISED appears to be a valid and reliable questionnaire among female adolescents. Its use might improve the identification of cases at risk for eating disorders and in particular those at risk for anorexia nervosa. Other studies are needed to confirm the validity and performance of the questionnaire among samples of different ages and socio-economic status.

Adult↗

[Quality of life assessment: validation of the Italian version of the WHOQOL-Brief].

OBJECTIVE: To test the psychometric properties of the Italian version of the WHOQOL-BRIEF (e.g., construct and internal validity, concurrent validity with the MOS SF-36 and test-retest reliability). The WHOQOL-BRIEF is a 26-items self-report instrument which assesses four domains assumed to represent the Quality Of Life (QOL) construct: physical domain, psychological domain, social relationships domain and environment domain, plus two facets for assessing overall QOL and general health. METHODS: Data have been collected in three sites (Bologna, Modena and Padua), located in the North of Italy, in the framework of the international WHOQOL project. According to the study design, the sample had to include about 50% males and 50% females, 50% of subjects below and 50% above the age of 45, all in contact with various health services. A subsample has been re-interviewed after 2-3 weeks in order to study test-retest reliability. After the WHOQOL-BRIEF, most subjects have also been administered the MOS-SF36 in order to test the concurrent validity between these two instruments. RESULTS: The instrument was administered to 379 subjects (1/6 healthy and 1/6 sick), chosen to be representative of a variety of different medical conditions. Seventy patients, who displayed stable health conditions, have been reassessed after 2-3 weeks to study test-retest reliability. The WHOQOL-BRIEF domains has shown good internal consistency, ranging from 0.65 for the social relationships domain to 0.80 for the physical domain; it has been able to discriminate between in- and out-patients and between the two age groups considered in the present study (< 45, > or = 45 years). Only physical and psychological domains were found to discriminate between healthy and ill subjects. No gender differences in the mean scores for the four domains were found. Concurrent validity between the WHOQOL-Brief and the MOS-SF-36 was satisfactory, and specific for the physical and psychological health domains. Test-retest reliability values were also good, ranging from 0.76 for the environment domain to 0.93 for the psychological domain. CONCLUSIONS: This study shows that the WHOQOL-BRIEF is psychometrically valid and reliable, and that it is also potentially useful in discriminating between subjects with different health conditions in clinical settings.

Aged↗

PTSD scale of the Child Behavior Checklist: concurrent and discriminant validity with non-clinic-referred sexually abused children.

Several assessment instruments include measures that are purported to assess characteristics of posttraumatic stress disorder (PTSD). Although these measures are used often by researchers and clinicians, few are supported by extensive validity data. The PTSD scale of the Child Behavior Checklist (CBCL) is one that has not yet encountered significant challenges to its validity. We examine the concurrent and discriminant validity of the CBCL-PTSD scale. Participants included 63 non-clinic-referred sexually abused (SA) children, 60 non-SA psychiatric outpatient children, and 61 non-SA, non-clinic-referred schoolchildren. Results revealed questionable concurrent validity for this scale, and suggest poor discriminant validity between SA children and non-SA psychiatric outpatients.

Adolescent↗