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Development and validation of Cedars-Sinai Health-Related Quality of Life in Rheumatoid Arthritis (CSHQ-RA) short form instrument.

OBJECTIVE: To develop an abridged version of the 33-item Cedars-Sinai Health-Related Quality of Life in Rheumatoid Arthritis instrument (CSHQ-RA) and test the validity and reliability of the abridged instrument. METHODS: Items from the original 33-item, 5-domain CSHQ-RA were assessed using psychometric and regression analyses of survey responses from 274 patients with rheumatoid arthritis. Items were retained in the final instrument based on statistical analysis and evaluation by an expert panel. Test-retest reliability, internal consistency, convergent and discriminant validity, and ceiling and floor effects were examined for the shortened CSHQ-RA. RESULTS: Statistical analysis and expert assessment yielded an 11-item instrument including questions in 4 domains. Test-retest reliability and internal consistency were high and the instrument showed good convergent and discriminant validity. CONCLUSION: The abridged CSHQ-RA short form is a valid and reliable instrument that can be used to examine the impact of RA on patients' health-related quality of life. Prospective validation in clinical trial settings is warranted.

Adult↗

The Pediatric Rheumatology International Trials Organization criteria for the evaluation of response to therapy in juvenile systemic lupus erythematosus: prospective validation of the disease activity core set.

OBJECTIVE: To validate and promulgate a core set of outcome measures for the evaluation of response to treatment in patients with juvenile systemic lupus erythematosus (SLE). METHODS: In 2001, a preliminary consensus-derived core set of measures for evaluating the response to therapy in juvenile SLE was established. In the present study, the core set was validated through an evidence-based, large-scale data collection process that led to the enrollment of 557 patients from 39 different countries. Consecutive patients with active disease were assessed at baseline and after 6 months. The validation procedures included assessment of feasibility, responsiveness, discriminant and construct ability, agreement in the evaluation of response to therapy between physicians and parents, redundancy, internal consistency, and ability to predict a therapeutic response. RESULTS: The following clinical measures were found to be feasible and to have good construct validity, discriminative ability, and internal consistency; furthermore, they were not redundant, proved responsive to clinically important changes in disease activity, and were associated strongly with treatment outcome and thus were included in the final core set: 1) physician's global assessment of disease activity, 2) global disease activity measure, 3) 24-hour proteinuria, 4) parent's global assessment of the patient's overall well-being, and 5) health-related quality of life assessment. CONCLUSION: The members of PRINTO propose a core set of criteria for the evaluation of response to therapy that is scientifically and clinically relevant and statistically validated. The core set will help standardize the conduct and reporting of clinical trials and assist practitioners in deciding whether a patient with juvenile SLE has responded adequately to therapy.

Activities of Daily Living↗

Using the SWAP-200 in a personality-disordered forensic population: is it valid, reliable and useful?

BACKGROUND: Treatment and risk management of forensic patients relies heavily on diagnosing psychopathology, yet the reliability of clinical diagnoses of personality disorder has been found to be only fair to low. Structured instruments for the global assessment of personality disorder are infrequently used in clinical assessments possibly due to their limited validity and clinical utility. AIMS/METHODS: The Shedler-Westen Assessment Procedure-200 (SWAP-200) was developed in an effort to address these limitations. Although good reliability and validity in relation to clinicians' diagnosis of personality disorder has been reported, to date the validity of this instrument has not been assessed in relation to other standardized instruments or in a personality-disordered, forensic population. This study aims to establish the reliability and validity of the SWAP-200 against other diagnostic instruments and measures of interpersonal functioning in a personality disordered forensic population. RESULTS: This paper reports the results of 30 subjects from a high secure hospital in the UK who were assessed with the SWAP-200, the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II), the Adult Attachment Interview (AAI) and the Chart of Interpersonal Reactions in Closed Living Environments (CIRCLE). Preliminary results suggest that the SWAP-200 is a reliable instrument for the diagnosis of personality disorder in forensic patients. CONCLUSIONS: Although the small sample size allows only preliminary conclusions about the validity of this instrument, early results show a reduction of the diagnosis of comorbidity compared with the SCID-II, together with an increased number of expected associations between independent measures of interpersonal functioning and categories of personality disorder.

Adult↗

Psychometric validation of a monitoring-blunting measure for social anxiety disorder: the coping styles questionnaire for social situations (CSQSS).

The purpose of this investigation was to conduct a psychometric validation of the Coping Styles Questionnaire for Social Situations (CSQSS). The CSQSS was developed to measure monitoring and blunting coping styles in social situations based on Miller's conceptualization of how individuals cope with threat-related information. Study 1 evaluated the content validity of the CSQSS monitoring and blunting items. Study 2 examined factor structure, reliability, and construct validity of the CSQSS in a sample of 443 college students. Evidence supported the content and face validity of the CSQSS. In addition, an exploratory factor analysis revealed a two-factor solution consistent with the monitoring and blunting constructs. Both monitoring and blunting scores were positively correlated with measures of social anxiety, with blunting having a stronger relationship. Moreover, individuals with high social anxiety engaged in a significantly higher degree of monitoring and blunting than did individuals with low social anxiety. Taken together, these results provide support for the reliability and validity of the CSQSS. The CSQSS may serve as a useful measure for further examination of monitoring and blunting coping styles in a social anxiety disorder sample.

Adaptation, Psychological↗

Agitated behaviours among the institutionalized elderly with dementia: validation of the Korean version of the Cohen-Mansfield Agitation Inventory.

OBJECTIVES: To analyze the factor structure, the criterion validity, the internal consistency, inter-rater reliability and test-retest reliability of the Korean version of Cohen-Mansfield Agitation Inventory, to provide data on the frequency and distribution of agitated behaviours, and to compare patterns of agitated behaviours among the institutionalized elderly with Alzheimer's disease (AD) or Vascular dementia (VaD). METHODS: The Korean version of the Cohen-Mansfield Agitation Inventory (CMAI-K) was administered to a total of 257 elderly with AD or VaD in a nursing home in Seoul, Korea. Three kinds of reliability and criterion validity were tested. Factor analysis using principal component analysis with the varimax rotation was performed. To identify different patterns of agitated behaviours, multiple logistic regression analysis was used. RESULTS: This study demonstrated satisfactory reliability and validity for the CMAI-K as an instrument measuring agitation in Korean dementia sufferers in nursing homes. Eighty-three percent of the subjects manifested one or more agitated behaviours at least once a week. Factor analysis yielded four subtypes of agitation: physically aggressive behaviours, physically nonaggressive behaviours, verbally agitated behaviours, and hiding/hoarding behaviours. CONCLUSION: These results indicate that the CMAI-K is a reliable and valid instrument to measure agitated behaviours in Korean elderly with AD or VaD. These results validate and expand previous research on the agitation in dementia, and guide in the development of interventions.

Aged↗

The validity and reliability of the Turkish version of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) in patients with mild and moderate Alzheimer's disease and normal subjects.

OBJECTIVES: The cognitive subscale of the Alzheimer's Disease Assesment Scale (ADAS-Cog) is the most widely used test in clinical trials dealing with Alzheimer's disease (AD). The aim of this study was to investigate the validity and reliability of the Turkish version of ADAS-Cog. METHODS: Twenty-nine patients with AD, fulfilling NINCDS-ADRDA criteria of probable AD, who were in stage 3-5 according to the Global Deterioration Scale (GDS), and 27 non-demented control subjects with similar age, gender and educational status were recruited for the study. The Turkish version of ADAS-Cog, Standardized Mini Mental Status Examination (MMSE) and Short Orientation-Memory-Concentration Test (SOMCT) were applied to both of the groups. Inter-rater reliability, internal consistency, test-retest reliability; face validity, differential validity and convergent validity were statistically analyzed. RESULTS: Both MMSE and ADAS-Cog have significantly differentiated patients with AD and control subjects (p < 0.001). A significant correlation was established between MMSE and ADAS-Cog scores in AD group (r: -0.739). ADAS-Cog was also highly significantly correlated with GDS (r: 0.720) and SOMCT (r: 0.738). For the group with AD, control and whole cohort coefficients of internal consistency, Cronbach's alpha: 0.800, 0.515, 0.873 were found respectively. Inter-rater reliability for total ADAS-Cog score was found as ICC: 0.99 and 0.98 and test-retest reliability was found as ICC: 0.91 and 0.95 for demented and nondemented subjects, respectively. CONCLUSION: The Turkish version of ADAS-Cog has been found to be highly reliable and valid in differentiating patients with mild and moderate AD from nondemented subjects.

Aged↗

Validation of the Retardation Rating Scale for detecting depression in geriatric inpatients.

OBJECTIVES: Validation in the elderly of the Retardation Rating Scale (RRS), which includes items related to motor and mental retardation but not vegetative items, and may be particularly well-suited for the diagnosis of depression in the elderly. METHODS: One hundred and sixty-five geriatric inpatients (105 depressed), aged 65 and over, without dementia, neuroleptic medication and increased risk of slowed mobility, were assessed with the RRS and three validated 'gold-standard' scales for geriatric depression (Hamilton Depression Rating Scale, Montgomery and Asberg Depression Rating Scale, Geriatric Depression Scale). Factor analysis used varimax rotation, Cronbach's, Spearman's and Ferguson's coefficients and the Mann-Whitney U-test to evaluate construct and internal consistency. Convergent validity and Receiver Operating Characteristics curves were also analyzed. RESULTS: Factor analysis retained three interpretable domains: (1) motor items (45% of the variance); (2) mental items and (3) the cognitive items. Internal consistency was high (alpha = 0.91). Each item was strongly correlated with the total RRS score and associated with depression. The RRS showed good convergent validity and its total score increased with depression severity. A cut-off score of 10 yielded 79% sensitivity and 80% specificity, with 80% of the patients properly classified, that is 15% more than standard observer scales. CONCLUSION: RRS is a valid screening tool for depression and improves recognition of depression in geriatric inpatients.

Aged↗

Validation and normative data of health status measures in older people: the Islington study.

BACKGROUND: Health related quality of life scales have been developed to measure a global picture of health and well-being from the patient's perspective. Separate validation of these measures in older people is important, as different areas of life are prioritized as important in older people and population norms for health status measures can differ with age. OBJECTIVES: The aims of this paper were to examine the validity and acceptability of two health status measures the 12-item Health Status Questionnaire (HSQ-12) and 12-item Short Form Health Survey SF-12, and to present population norms in older people. SETTING: A door-to-door survey in Islington, a borough of inner London. SUBJECTS AND METHODS: The subjects were allocated to complete either the SF-12 (n = 541) or the HSQ-12 (n = 544) by alternating the questionnaires with each household visited. The first 135 people who completed the HSQ-12 were visited approximately 18 months later. Acceptability was measured examining the completion rate of the scales, and on a three-point scale. The short-CARE was used to elicit psychiatric symptoms and diagnoses. We collected data on health and social care, and subjective health problems. RESULTS: Both scales distinguished between subjects with and without a variety of health states, including self-defined health problems, health problems diagnosed by valid scales, problems with vision and hearing, and receipt of health or social services. The HSQ-12, but not the SF-12, could distinguish between people with and without dementia, and had high completion rates for those living in the community but not in 24-hour care. Linear regression models demonstrated sensitivity to change in health status for the HSQ-12. CONCLUSION: The SF-12 and HSQ-12 are acceptable and valid as health status instruments in large community-based studies of older people. The HSQ-12, but not the SF-12, is acceptable and valid for people with dementia.

Aged↗

Use of modified Northwick Park Neck Pain Questionnaire in patients with postirradiation neck disability: validation study.

BACKGROUND: No available measure exists for postirradiation neck disability. Adoption of the Chinese Northwick Park Neck Pain Questionnaire (NPQ) for patients with postirradiation neck disability was examined in this study. METHODS: Eight physiotherapists and five patients were invited to test the validity of the content. Forty-three patients with neck disability were recruited to evaluate test-retest reliability and internal consistency. The level of neck discomfort, range of neck motion and maximal isometric neck muscle strength, and SF-36 health score were measured for construct validity testing. RESULTS: The questionnaire had good content validity, a high degree of test-retest reliability, internal consistency (intraclass correlation coefficient [ICC], 0.94; Cronbach's alpha, 0.88), and good construct validity. NPQ correlated significantly with most of the subscores of SF-36 (r(s), -0.43 to - 0.71) and numeric rating scale (r(s) = 0.69). CONCLUSION: The modified Chinese NPQ was found to be reliable and valid for the evaluation of postirradiation neck disability.

Adult↗

Development and preliminary validation of a new measure to assess satisfaction with information among head and neck cancer patients: the satisfaction with cancer information profile (SCIP).

BACKGROUND: Our objective was to develop and examine the psychometric properties of the Satisfaction With Cancer Information Profile (SCIP), a new measure designed to assess the extent to which patients with head and neck cancer (HNC) are satisfied with information received about their treatment. METHODS: Patients with head and neck cancer (HNC) from 4 hospitals in the UK completed the SCIP before treatment and again 1 month after treatment. Psychometric properties of the measure were evaluated: internal consistency, subscale intercorrelations, discriminant validity, concurrent validity, and predictive validity. The responsiveness of the measure to change and ease of completion was also assessed. RESULTS: The SCIP performed well on all the psychometric tests; level of satisfaction with information was related to a number of key outcomes and patient beliefs, demonstrating criterion-related validity. CONCLUSIONS: The SCIP was developed to assess HNC patient satisfaction with treatment information and has demonstrated good reliability and validity. This measure may prove appropriate for use with patients with different types of cancer due to its applicability with a variety of treatment modalities. Preliminary psychometric testing has demonstrated its potential for use in routine clinical settings and research settings as a predictive tool or for audit, in addition to assessing individual patient satisfaction with information.

Adult↗

Derivation and validation of a new global method for assessing nutritional status in patients with cirrhosis.

Accurate assessments of nutritional status are difficult to obtain in patients with cirrhosis. The aim of this study was to devise and validate a global nutritional assessment scheme for use in this patient population. Measures of body mass index (BMI) and mid-arm muscle circumference (MAMC) were combined with details of dietary intake in a semistructured, algorithmic construct to provide a nutritional assessment scheme for use in patients with cirrhosis; evaluated individuals were classified as adequately nourished, moderately malnourished (or suspected to be), or severely malnourished. There was good interobserver agreement in the nutritional categorization of 50 patients with cirrhosis (34 men, 16 women) using this scheme (kappa = 0.79) and significant associations with the contributing objective variables--namely, BMI (Spearman's correlation r = -0.78; P < .001) and relative MAMC (r = -0.69; P < .001)--confirming its internal validity. There was a significant association between nutritional categorization in 20 patients with cirrhosis (10 men, 10 women) and estimates of total body protein obtained using a four-component model (r = -0.45; P = .046), confirming the external validity of the scheme. Finally, a significant association was found between poor nutritional status in 116 patients with cirrhosis (65 men, 51 women), followed for 14 to 52 months, and shorter subsequent survival (P = .0005), confirming the scheme's predictive validity. In conclusion, a global assessment scheme has been devised that provides a simple, reproducible, valid, and predictive method of assessing nutritional status in patients with cirrhosis.

Adult↗

Reliability and validity of King's Health Questionnaire in patients with symptoms of overactive bladder with urge incontinence in Japan.

AIMS: The purpose of this study is to evaluate the psychometric properties of the Japanese version of the King's Health Questionnaire (KHQ) in patients with symptoms of overactive bladder (OAB) with urge incontinence. METHODS: Data from a 12-week, randomized, double-blind, placebo-controlled clinical trial comparing tolterodine with oxybutynin in patients with symptoms of OAB in Japan were analyzed. Cronbach's alpha coefficient was calculated as a reliability index. Inter-domain correlation was calculated for convergent and discriminant validity assessment. A factor analysis was conducted to explore the underlying factor structure of the KHQ. Sensitivity to clinical change was also evaluated. RESULTS: The psychometric properties and clinical validity of the KHQ Japanese version were confirmed in this study population, and were similar between males and females. The KHQ's good reliability was evidenced by Cronbach's alpha coefficients of >0.60, indicating reasonable consistency except for the personal relationship domain in males (0.47) and severity (coping) measure domain in females (0.59). Discriminant, convergent, and construct validity of the KHQ were also good, with the factor analysis identifying those factors which the KHQ was intended to measure. Finally, KHQ domains were generally responsive to clinical efficacy variables; the KHQ also showed statistically significant sensitivity to change in patients' perception of bladder condition in all domains, except General Health Perception. CONCLUSIONS: Our analyses confirm psychometric properties and clinical validity of the KHQ Japanese version, which appears to offer a valid and reliable HRQoL instrument for use in clinical trials of antimuscarinics in Japan.

Adult↗

Psychometric properties and validation of the German-language King's Health Questionnaire in women with stress urinary incontinence.

AIMS: The purpose of this study was to evaluate the psychometric properties of and validate the German-language version of the King's Health Questionnaire (KHQ) in women with stress urinary incontinence (SUI). METHODS: A total of 145 women treated for stress incontinence with surgery or physiotherapy completed the the KHQ and the SF-36 before and after treatment. Psychometric analyses of the quality of life (QoL) instruments determined the reliability (Cronbach's alpha), internal and external validity, and responsiveness of the KHQ subscales. RESULTS: The KHQ showed good internal consistency, content validity, and criterion validity as measured by correlation with scores on the SF-36. Cronbach's alpha coefficient ranged from 0.76 to 0.86, indicating a high internal consistency of the subscales. Concerning criterion validity, correlations between the KHQ subscales and the SF-36 were low to moderate. The highest correlation was found between the general health perception subscales of both questionnaires. CONCLUSIONS: The results indicate good psychometric properties for the German-language KHQ.

Adult↗

Validation of DNA probes for preimplantation genetic diagnosis (PGD) by fluorescence in situ hybridization (FISH) R1.

BACKGROUND: Preimplantation genetic diagnosis (PGD) by fluorescence in situ hybridization (FISH) is being employed increasingly by medical centers and private companies. Validation of any clinical assay, particularly one with novel applications such as PGD by FISH, is of critical importance in the clinical setting. This importance is recognized by both the College of American Pathologists (CAP) and the American College of Medical Genetics (ACMG), who recommend validation of FISH assays in the clinical setting. Validation of FISH assays for PGD is especially significant, as only one or two cells (blastomeres) will be available for testing of a given embryo. METHODS: We have developed validation protocols for a variety of FISH assays, including sex identification, structural chromosomal aneusomy, and aneuploidy screening with the Vysis, Inc., PGT probe panel. RESULTS: Our validation results show good individual performance of commercially available probes, and decreasing overall efficiency as the number of probes included in an assay increases.

DNA Probes↗

[Quality of life in patients with chronic rhinosinusitis: validation of the Sino-Nasal Outcome Test-20 German Adapted Version].

BACKGROUND: No validated German instrument for measuring health-related quality of life (QOL) in patients with chronic rhinosinusitis (CRS) has been available to date. METHODS: The Sino-Nasal Outcome Test-20 German Adapted Version (SNOT-20 GAV) is a translated and adapted version of SNOT-20. To validate this instrument, we evaluated its reliability, validity and sensitivity. SNOT-20 GAV was completed by 163, 123, and 82 patients at the initial visit and at 3 months and 1 year after treatment commencement, respectively. RESULTS: Cronbach's alpha indicated good internal consistency. Test-retest scores in 38 patients were highly correlated. Discrimination validity was demonstrated by a comparison with healthy controls. Sensitivity to change showed medium to large effects. CONCLUSIONS: SNOT-20 GAV is the first reliable, validated and sensitive German instrument for measuring health-related QOL in patients with CRS.

Adult↗

Cross-cultural differences in the conceptualisation of patients' satisfaction with psychiatric services--content validity of the English version of the Verona Service Satisfaction Scale.

BACKGROUND: The VSSS is a multi-dimensional questionnaire developed to address methodological concerns about measurement of satisfaction with services on the part of psychiatric patients. The acceptability, sensitivity, content validity and test-retest reliability of the original version of the VSSS, in Italian, have already been demonstrated [1, 2]. The internal consistency [3] and test-retest reliability [4] of the English translation have been shown to be within acceptable ranges. The content validity of the original 82-item and the 54-item English version has not yet been assessed. AIMS: The aims of this study were to assess the content validity of the English translation of the VSSS and to compare it with that of the original version in Italian. METHOD: We used data collected as part of the first wave (T1) of the PRiSM Psychosis Study [5] and repeated the methods used to assess the content validity of the original Italian version of the VSSS [1, 2]. Content elements derived from answers to four open questions were rated independently by CH and HH in terms of their equivalence to VSSS items or dimensions. RESULTS: were compared to those from the content validity study of the Italian version. Results Inter-rater agreement was very high. The largest proportion of the content elements of the answers were rated as equivalent or related to a questionnaire item or a dimension of the VSSS. The dimension 'Professionals' Skills and Behaviour' appears the most significant contributor to satisfaction, as it was most often related to content elements in answers to all four key questions (39.1 %). The second most frequently mentioned dimension was that of 'Types of Intervention' for three out of four open questions, while 'Access' was second most frequent for the fourth. Of the content elements, 17.2 % did not include items or dimensions covered by the VSSS; the three most frequently mentioned were other patients, food and security. CONCLUSIONS: The 82-item English version of the VSSS captures sharply most contents relevant to patients' satisfaction. Consideration of contributors to satisfaction so far neglected may refine the conceptualisation of satisfaction.

Catchment Area, Health↗

Validation and application of the sentinel lymph node concept in malignant vulvar tumours.

PURPOSE: Inguinal lymphadenectomy, unilateral or bilateral, is widely used in cases of vulvar squamous cell carcinoma and melanoma but has a high morbidity. Sentinel lymph node (SLN) biopsy may be used in the management of these patients. The aims of this study were firstly to determine the reliability of SLN biopsy in predicting regional lymph node status and secondly to apply this technique in the routine clinical setting. METHODS: We prospectively studied 70 women with vulvar malignancies. The first 50 cases were of squamous vulvar cancer and were used to validate the SLN technique in this clinical setting (validation group). Once a satisfactory success rate had been achieved in the validation group, the SLN technique was applied to a further 20 patients with vulvar malignancies, i.e. squamous cell carcinoma (n=12) and melanomas (n=8) (application group). Dynamic and static images were acquired after the injection of 74-148 MBq of a colloidal albumin, and continued until SLN identification. Fifteen minutes before surgery, blue dye injection was administered in a similar manner to the radiocolloid. After incision, a hand-held gamma probe was used to find the SLN. In the validation group, dissection of the SLN was always followed by lymphadenectomy. In the application group, this procedure was only performed if the SLN was positive for metastases. For pathological staging, samples were evaluated using haematoxylin and eosin and immunohistochemistry. RESULTS: In the validation group, lymphoscintigraphy allowed SLN detection in 49/50 patients (98%). Blue dye detected the SLN in 40/50 patients (80%). In 16 patients (33%), the SLN showed metastases in the pathology study. All 33 patients with negative SLN had regional lymph nodes negative for metastases (negative predictive value 100%). In the application group, lymphoscintigraphy showed drainage to an SLN in 19 out of 20 patients (95%) and blue dye demonstrated a stained SLN in 17/20 patients (85%). Seven of the 19 SLN-identified nodes (37%) were positive for metastases. CONCLUSION: SLN identification permits the accurate pathological study of regional nodes and could reduce the high morbidity of current surgical treatment in vulvar tumour patients if the technique were to be adopted on a routine clinical basis.

Adult↗

Validation of the German prostate-specific module.

Theoretically, all patients newly diagnosed with prostate cancer are faced with a choice of treatment options: radical prostatectomy or radio therapy. Although these different treatments may have no differences in terms of survival, they may have very different consequences on the subsequent quality of life (QoL). Prerequisite to analyze QoL is a reliable and valid instrument to assess these differences not only in terms of general QoL (EORTC QLQ-C30) but prostate specific symptoms with a prostate specific module as well. Therefore, the aim of this study was a psychometric evaluation (validation) of the prostate-specific module (PSM). Five historical cohort studies were put together for an empirical meta-analysis. The main objective was to analyze the module's psychometric properties. The total sample consisted of 1,185 patients, of whom 950 completed the QoL questionnaires (EORTC QLQ-C30 and a prostate specific module developed by Kuechler et al.). First step of analysis was a principal component analysis that revealed the following scales: urinary problems, incontinence, erectile dysfunction, sexual problems, problems with partner, pain, heat, nutrition, and psychic strain. The module showed good reliability and concurrent validity and very good construct validity, since the module is able to discriminate between different treatment regimes, tumor stages and age. The German PSM is a reliable, valid and applicable tool for QoL in patients with prostate cancer.

Adaptation, Psychological↗