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PubMed2001

A preliminary report on the Chinese Cancer Pain Assessment Tool (CCPAT): reliability and validity.

BACKGROUND: This study was to establish the validity and reliability of the Chinese Cancer Pain Assessment Tool (CCPAT) for Chinese patients with cancer pain in Hong Kong. METHODS: It was a quasi-experimental study. The CCPAT was tested for its reliability and validity by 26 cancer pain patients and 26 chronic non-cancer pain patients. McGill Pain Questionnaire (MPQ), with its established reliability and validity, was used as the criterion tool for comparison. RESULTS: An internal consistency of 0.88 and the inter-rater reliability of 0.96 were obtained for the CCPAT. The Spearman's Rho correlations between the functional and emotional dimensions of the CCPAT and the present pain intensity of the MPQ positively correlated. This indicated a satisfactory concurrent validity. Discriminant validity was performed with MANOVA. The CCPAT was able to predict 80.8% of the subjects correctly as cancer pain patient from the cancer pain group. CONCLUSIONS: The constructed CCPAT is a valid and reliable cancer pain assessment tool in a Chinese context. The developed CCPAT is the first of its kind for the Chinese community in Hong Kong. It is anticipated that the results can provide the health care professionals with the best possible instrument and indicator. The CCPAT also lays the theoretical construct for the professionals with a better understanding of the experience of cancer pain from a multidimensional perspective.

Adult↗

PubMed2001

Ensuring content validity: an illustration of the process.

Assessing content validity is one of the most critical steps in instrument development. Neither statistical elegance nor sophisticated measurement strategies are substitutes for validity. Systematic in-depth approaches to the assessment of content validity are needed, including a priori and a posteriori procedures. In this manuscript the a priori approach of specifying an instrument's content domain is addressed along with the a posteriori procedure of having a panel of judges assess the validation of the items. This article focuses on the process used to assess the content validity. Data from the psychometric testing of the Postpartum Depression Screening Scale (PDSS) are used to illustrate this process. The PDSS is a Likert-type self-report composed of seven dimensions: Sleeping/Eating Disturbances, Anxiety/Insecurity, Emotional Lability, Cognitive Impairment, Loss of Self, Guilt/Shame, and Contemplating Harming Oneself. Items on the PDSS were generated from a series of qualitative research studies on postpartum depression. Content validity was assessed using two approaches to review the scale: (a) a panel of five content experts with professional expertise in postpartum depression, and (b) a focus group of 15 nurses knowledgeable in the field.

Anxiety↗

PubMed2001

Malingering assessment: evaluation of validity of performance.

Consideration of symptom exaggeration or overt malingering is of particular importance in assessment of alleged mild head trauma and other mild or questionable personal injury situations. Validity is the extent to which tests assess what they were designed to measure. The determination of invalidity is part of the overall neuropsychological interpretation process. In neuropsychology a line of validity assessment research has developed, leading to three general approaches to validity and/or malingering assessment: (a) symptom validity measures, (b) invalid patterns of performance on clinical neuropsychological measures, and (c) concomitant extra-test behavioral information or observations. In each case some aspect of behavior is compared to an external standard or to other intra-subject behavior. Inconsistencies and discrepant comparisons are cause for validity concerns. These approaches are described and recommendations are provided based on the extant literature. However, validity assessment is difficult and at times ambiguous in part because real and feigned deficits are not mutually exclusive. In some clinical situations the most that can be said about an invalid performance is that it is not indicative of the true neurobehavioral capabilities of the person being evaluated, and is not consistent with the presumed etiologic event.

Humans↗

PubMed2002

Translation and validation assessment of the Chinese version of the chronic sinusitis survey.

BACKGROUND: The Chronic Sinusitis Survey (CSS) is a valid, disease-specific measure for evaluating the health status and treatment effectiveness of adults with chronic rhinosinusitis (CRS). In this study, we developed a Chinese version of the CSS (CCSS) which provides the psychometric properties of the Chinese CSS. METHODS: The CSS was translated into Chinese using a parallel model. The CCSS was administered to 198 patients in a prospective manner, and was validated in order to establish its reliability and validity. RESULTS: The CCSS demonstrated good test-retest reliability (correlation coefficient = 0.6-0.89, p=0.0001) and internal consistency (Cronbach's alpha =0.76). The CCSS results were significantly correlated with bodily pain (BP), general health (GH), role-emotional (RE), and mental health (MH) subscales of the Chinese (Taiwan) version of the generic 36-item Short-Form Health Survey (TSF-36). The standardized response mean for the CCSS total score was 0.75, indicating good sensitivity to clinical change. CONCLUSIONS: This validation study demonstrates that the performance characteristics of the CCSS meet the criteria for a valid measure. The CCSS is a valid tool to evaluate adults with CRS among Mandarin-speaking populations.

Chronic Disease↗

PubMedDate not supplied

Assessment of the validity and reliability of the University of Wisconsin Children's Hospital Pain scale for Preverbal and Nonverbal Children.

PURPOSE: This study tested the reliability and validity of a pain scale that was developed at University of Wisconsin Children's Hospital for the preverbal child (less than 3 years old) and the nonverbal child (children who cognitively were not able to communicate a pain rating on traditional pain scales). METHOD: Content validity was established by expert review. Construct validity was demonstrated by having the nurse rate the child's pain before and after analgesic and during a procedure. Inter-rater reliability was achieved by two nurses simultaneously and independently rating the child's pain. Criterion validity was determined by comparing ratings with those obtained on the Wong-Baker Faces scale. Internal consistency was calculated using Cronbach's alpha. FINDINGS: Seventy-four patients provided data for 124 observation times. At 58 of the observation times, two nurses independently used the newly developed University of Wisconsin Children's Hospital (UWCH) scale, resulting in 182 pain ratings. Internal consistency of the scale (Cronbach's alpha) was 0.93. Mean pain scores were significantly higher prior to pain medication administration and during procedures than following analgesic administration. Inter-rater reliability was 0.92. Correlation of the new scale with the Wong-Baker Faces Scale was r = .62. CONCLUSIONS: Initial testing of the construct validity, internal reliability, and internal consistency of the UWCH Pain Scale for Preverbal and Nonverbal Children were acceptable. Parents provided ratings for most of the faces scale, which could account for the low correlation in the construct validity testing.

Child Behavior↗

PubMedDate not supplied

[Self-rating scales in schizophrenia: validity assessment of the Paranoid-Depression Scale (PD-S), the Frankfurt Self-feeling Scale (FBS) and of two visual analogy scales].

AIM: To assess the validity of the Paranoid-Depressivity Scale (PD-S, Paranoid-Depresivitäts-Skala), the Frankfurt Self-feeling Scale (FBS, Frankfurter Befindlichkeitsskala), and of two visual analogy scales: the Sense of Illness Scale (WAC) and the Self-feeling Scale (WAS). METHOD: 210 patients with schizophrenia of various clinical courses. Diagnostic validity was evaluated by comparing the results of self-rating with clinical assessment using the CGI, KOSS-C, BPRS, and KOSS-W scales. Content validity was evaluated by analysis of the results' correlation with given clinical and social-demographic variables. Theoretical (construct) validity was evaluated through factorial analysis with Varimax rotation of the principal elements. RESULTS: The correlation between the self-rating scales and the clinical assessment scales was moderate in the case of questionnaire scales and low for the visual analogy scales. Scales of a similar type were found to correlate to a very high degree. Correlation with clinical assessment depended significantly on the phase and degree of disorder--it was lower in periods of exacerbation and higher during remission. The results of the complex questionnaire scales en somme, correlate better with symptoms considered as typical for schizophrenia, than with others, whereas the isolated self-rating constructs (paranoid, depressive) correlate well with the appropriate dimensions of clinical assessment. There was no significant correlation between the clinical symptoms and dimensions, and the results of self-rating using the two visual analogy scales. Factorial analysis revealed that the internal structure of the basic constructs of the questionnaire scales (general attitude, mood, self-feeling) was based on a very rational concept, as well as the fact that the factors isolated have a rational foundation within the theoretical and clinical picture of schizophrenic disorders. CONCLUSIONS: The validity of self-rating scales remains a complex question; analysis of diagnostic, content and theoretical validity seems to confine this method to the role of a complementary, albeit interesting, diagnostic tool; the extent and importance of this role, however, is still to be investigated.

Adult↗

PubMed2002

A validity index for the MMPI-2.

There have been numerous methods developed for the detection of valid profiles on the Minnesota Multiphasic Personality Inventory (MMPI)-2. The current study examined a method of combining seven different validity scales of the MMPI-2 into a common weighted method in assessing malingering in chronic pain patients. The weighted method was able to correctly classify 100% of nonlitigants, using a cutoff score of > or =5. The findings of this study suggest that chronic pain patients in litigation produce a different profile on the MMPI-2 validity scales than do nonlitigants. In a group of knowledgeable actors (malingerers), 86% was correctly classified. The overall finding showed 100% specificity and 86% sensitivity. The findings support the need for multiple validity scales to be examined in determining a valid profile. The weighted validity scales method was robust enough to account for "emotional distress" and still identify invalid MMPI-2 performance.

Journal Article↗

PubMed2004

Validity of the self-report version of the strengths and difficulties questionnaire in Yemen.

OBJECTIVE: The main objective of the study was to determine the validity of the Arabic version of the Strengths and Difficulties Questionnaire (SDQ) Self-Report version in Yemen. METHODS: Following translation and back translation of the scale into the Arabic language by a panel of experts, psychometric properties were assessed using 600 students from schools (low risk group) and 57 patients attending the Mental Health Hospital in Sana'a, Republic of Yemen (high risk group) from January through to April 2002. The age range of the 2 groups was from 12-17-years-old. Discriminative validity, concurrent validity and factorial validity were studied. RESULTS: The difference between the means of the "total difficulties"scores in both groups was highly significant (p<0.001); the area under the curve (AUC) of the total scores and subscales scores were ranged from 0.77-0.89. The chance corrected agreements between the clinical diagnosis and SRQ subscales' prediction were significant. The sensitivity and specificity were 72% and 55%. Factor analysis yielded 5 dimensions of emotional symptoms, conduct disorders, hyperactivity, peer problems, and pro-social items. CONCLUSION: Results of this validation study suggest that the Arabic version of the SRQ of SDQ is valid in Yemen; and it can be a useful tool for investigating childhood behavioral and emotional disorders at clinical settings.

Adolescent↗

PubMedDate not supplied

Industry perspective on the validation of column-based separation processes for the purification of proteins. Parenteral Drug Association.

Validation of column-based separations is necessary to ensure the quality and safety of protein and peptide products produced by rDNA, peptide synthesis, and hybridoma technologies. Process validation for column-based separations includes qualification of raw materials, equipment, and the purification process. Combined with in-process control and quality control of the final product, column validation ensures that a uniform product is produced consistently from batch to batch. In the best case, validation is designed into the process. During process design, techniques are selected which can remove impurities and contaminants. Equipment and chromatographic media which can perform reproducibly are selected. Column performance standards, cleaning and regeneration routines, and column life should be considered as early as possible. Clearance studies should be planned and implemented to ensure that a product is produced with the requisite purity. There are no explicit rules for process validation of column-based separation processes. This document is intended to serve as a starting point for those needing to validate column-based separation processes.

Chromatography↗

PubMed2004

Psychometric validation of the French version of the quality of life in epilepsy inventory (QOLIE-31): comparison with a generic health-related quality of life questionnaire.

A psychometric evaluation of a French transcultural version of the quality of life in epilepsy inventory-31 (QOLIE-31) was carried out. QOLIE-31 was compared to a generic health-related quality of life questionnaire, the Nottingham health profile (NHP). The psychometric properties of QOLIE-31, assessed in 190 adults with epilepsy, included: acceptability, test-retest reliability and validity (multi-trait analysis including internal consistency and item-to-scale correlations, construct validity using factor analysis, discriminative validity using relationship with disease characteristics, treatment effects, divergent and convergent validity using correlations with NHP scores). Both acceptability and reproducibility were good and internal consistency was high (Cronbach's alpha coefficient = 0.86). Factor analysis with varimax rotation identified seven factors with eigenvalues > 1, with two factors, related to cognitive function and mood, accounting for 46.5% of the variance. However, goodness of fit indices revealed that a model with four factors best fitted the data. The first factor corresponds to a generic mental dimension, the second is equivalent to the cognitive functioning dimension, the third to medication effects including social functioning, and the fourth to seizure worry. Discriminative validity was good for seizure control and treatment tolerability. High correlations between QOLIE-31 and pertinent NHP scales (emotional reactions, energy and social isolation) were observed. The French version of QOLIE-31 thus meets established psychometric criteria for reliability and validity.

Activities of Daily Living↗

PubMedDate not supplied

[Colombian validation of the Pittsburgh Sleep Quality Index].

INTRODUCTION: Many studies establish an elevated frequency of sleep disorders. The prevalence during life is of 35%. This situation has lead to develop a great number of instruments with the intention to evaluate better these alterations. Nevertheless, the majority lacks a suitable and national validation. Buysse et al designed the Pittsburgh Sleep Quality Index (PSQI) considered the most able instrument to establish the quality of the sleep. This has been used and validated widely. Nor it exists a version validated to the Castilian for Colombia, nor similar instruments that allow making studies in sleep. AIM: Validation of the Pittsburg Sleep Quality Index in Colombia (ICSP-VC). SUBJECTS AND METHODS: Experts consensus for face validity, pilots studies for evaluating understanding of the questionnaire, with double interview method. Evaluation of internal consistency. RESULTS. Internal consistency was Cronbach's alpha = 0.78. There were different scores between subjects that mentioned some subjective sleep disturbance (U Mann Whitney z = -5.635, p = 0.000), between them that qualify as 'so bad' or not their sleep quality (U Mann Whitney z = -2.90, p = 0.0037), between they that were consuming or not, habitually hypnotics (U Mann Whitney z = -4.289, p = 0.0000) and between they that referred conciliation insomnia or not (U Mann Whitney z = -4.769, p = 0.0000). There were clinical differences in ICSP-VC scores between adult older and younger (U Mann Whitney z = -1.926, p = 0.0542). There were not differences by gender. Subjects with extreme values scores had clinical differences with others. CONCLUSIONS: ICSP-VC is a valid version of PQSI useful for studying sleep disorders.

Adult↗

PubMedDate not supplied

Global clinical performance rating, reliability and validity in an undergraduate clerkship.

BACKGROUND: Global performance rating is frequently used in clinical training despite its known psychometric drawbacks. Inter-rater reliability is low in undergraduate training but better in residency training, possibly because residency offers more opportunities for supervision. The low or moderate predictive validity of global performance ratings in undergraduate and residency training may be due to low or unknown reliability of both global performance ratings and criterion measures. In an undergraduate clerkship, we investigated whether reliability improves when raters are more familiar with students' work and whether validity improves with increased reliability of the predictor and criterion instrument. METHODS: Inter-rater reliability was determined in a clerkship with more student-rater contacts than usual. The in-training assessment programme of the clerkship that immediately followed was used as the criterion measure to determine predictive validity. RESULTS: With four ratings, inter-rater reliability was 0.41 and predictive validity was 0.32. Reliability was lower and validity slightly higher than similar results published for residency training. CONCLUSION: Even with increased student-rater interaction, the reliability and validity of global performance ratings were too low to warrant the usage of global performance ratings as individual assessment format. However, combined with other assessment measures, global performance ratings may lead to improved integral assessment.

Clinical Clerkship↗

PubMedDate not supplied

[Stroke-specific quality of life scale (ECVI-38): an evaluation of its acceptance, reliability and validity].

INTRODUCTION AND AIMS: Health-related quality of life (HRQL) is currently essential in the evaluation of stroke-related clinical trials. Existing stroke-specific scales were developed in English-speaking countries and most of them do not satisfy the necessary standards of validity. In consequence, the first Spanish-language scale for evaluating the quality of life (QL) of stroke survivors was developed (ECVI-38). In this work the psychometric properties of this summary measure were assessed. PATIENTS AND METHODS: A group of 63 stroke patients were studied, between 2 months and 2 years after the event, to evaluate the acceptability, reliability and validity of the ECVI-38, using standardised psychometric methods. RESULTS: The ECVI-38 proved to have an important degree of acceptability; only three elements showed a high percentage of data loss due to the age of the patients in the sample; the floor and ceiling effects were within the accepted limits. The scale displayed good internal consistency (Cronbach's alpha 0.79-0.97, correlations between elements 0.53-0.90) and good stability in the test-retest trial (intraclass correlation coefficients 0.89-0.98). As regards its construct validity (total correlations among correct domains, convergent r = 0.57-0.90, discriminating r = 0.19-0.39), the results were very good, as were the findings of the studies of validity vs. external criteria (difference between groups with a known neurological status, and convergence validity). CONCLUSIONS: The ECVI-38 is a measure that is acceptable, reliable and valid for evaluating QL in patients who have had a stroke. Further tests are needed to evaluate its sensitivity and to explore its value in both clinical and research practice.

Activities of Daily Living↗

PubMed2005

[Neuropsychiatric Inventory-Nursing Home version (NPI-NH): Spanish validation].

INTRODUCTION: The Neuropsychiatric Inventory-Nursing Home version (NPI-NH) is a screening instrument to be used by the nursing staff to evaluate neuropsychiatric symptoms in dementia patients in the nursing home setting. The aim of the present study was to validate the NPI-NH in Spanish. METHODS: We assessed the validity of the NPI-NH in 80 patients who were also nursing home residents, comparing the responses of nursing home staff on the NPI-NH with that filled out by the external observer. We developed a crossed validated form between the Neuropsychiatric Inventory-Questionnaire (NPI-Q) and both NPI-NH. We determined the concurrent validity of the domains "depression" and "agitation/aggression" of the NPI-NH with the Cohen-Mansfield Agitation Inventory (IAACM, Spanish version) and the Hamilton Depression Rating Scale (HDRS). RESULTS: Among the totals of the NPI-NH of the nursing staff and the NPI-Q, the convergent validity was r = 0.536 and r = 0.669 for the occupational disruptiveness scale (distress in NPI-Q). The Pearson correlation index between the NPI-Q and NPI-NH of the observations was r = 0.342. The convergent validity between the NPINH of the nursing home staff and NPI-NH of the observers with the Pearson correlation index was r = 0.274. CONCLUSIONS: The NPI-NH Spanish version offers the possibility to use a screening tool for detecting neuropsychiatric symptoms in dementia patients in the nursing home setting. It should be administered by adequately trained staff to avoid limitations in the evolutive control of behavioral changes.

Aged↗

PubMed2006

Statistical methods for the validation of questionnaires--discrepancy between theory and practice.

OBJECTIVES: Questionnaires used in epidemiological studies should be validated. However, unclarity exists about the appropriate statistical methods and interpretation of validation studies. Thus, we investigated the theory and practice of statistical evaluation approaches. METHODS: Using three platforms, a literature review, own simulations, and a validation study performed by ourselves, we worked out relevant limitations, advantages, and new important aspects of evaluation methods. RESULTS: Our systematic literature review, based on physical activity questionnaires, revealed that correlation coefficients are still the common approach in validation studies, found in 41 of 46 reviewed publications (89.1%). This practice has been criticized in the theoretically oriented literature for more than 20 years. Appropriate evaluation methods as recommended by Bland and Altman were found in only ten publications (21.7%). We showed that serious bias in questionnaires can be revealed by Bland-Altman plots but may remain undetected by correlation coefficients. With our simulations we refuted the argument that correlation coefficients properly investigate whether a questionnaire ranks the subjects sufficiently well. Further, with Bland-Altman analyses we could evaluate differential errors with respect to case-control status in our validation study. Yet, this was not possible with correlation coefficients, because they generally do not identify systematic bias. In addition, we show a potential pitfall in the interpretation of Bland-Altman plots that might occur in specific rare instances. CONCLUSIONS: The commonly used correlation approach can yield misleading conclusions in validation studies. A more frequent and proper use of the Bland-Altman methods would be desirable to improve epidemiological data quality.

Data Interpretation, Statistical↗

PubMed2006

Initial linguistic and psychometric validation of the Arabic version of Nepean Dyspepsia Index.

OBJECTIVE: To report the initial evaluation of the linguistic and psychometric validation of the Nepean Dyspepsia Index (NDI), as part of the ongoing research of quality of life among dyspeptic patients. METHODS: The Arabic version of the NDI was administered to 158 subjects (54 with non-ulcer dyspeptic [NUD]), 50 with gastro-esophageal reflux disease (GERD) and 54 with no history of gastroenteritis disease), with a mean age of 46.6 and SD 10.7. All subjects answered the Arabic versions of the General Health Questionnaire (GHQ), the Self-Report Questionnaire (SRQ), and the Short Form-12 Quality of Life (QOL) scale. We administered the final translation of the NDI by consensus. The study was conducted in King Fahad Hospital of the University, Al-Khobar, Saudi Arabia, between December 2002 and January 2004. RESULTS: The NDI has shown adequate internal consistency. Cronbach Alpha coefficient ranged between 0.88 to 0.93, and Split-half correlation reliability ranged between 0.82 and 0.94. Correlations between NDI subscales and total scores were high and significant. Adequate Face and content validity was demonstrated by consultation with gastroenterologists and clinical psychologists. Convergent validity was shown in the moderate and significant correlation of the NDI subscales and global index with the indices of the SF-12. Divergent validity was shown in that subscales of the NDI revealed low correlation with scales which measure other dimensions; thus, both QOL subscales and symptom checklist have discriminated patients from non-patients groups (p > 0.01). The factorial structure of the NDI was also examined, and it revealed 4 factors, which is similarly the same with other studies. CONCLUSION: The initial validation of the Arabic version of the NDI has shown that this scale has adequate psychometric and linguistic property and can represent a good addition to health outcome measures in dyspepsia research. Further validation studies are recommended.

Dyspepsia↗

PubMed1991

Establishing the reliability and developmental validity of a neurobehavioral assessment for preterm infants: a methodological process.

The Neurobehavioral Assessment of the Preterm Infant was developed in 3 phases: a pilot study, an exploratory study, and a validation study. In the exploratory study, clusters characterized by conceptual cohesion and face validity were systematically subjected to statistical analyses to determine whether they also had high test-retest reliability and developmental validity. In the validation study, a shortened version of the test was used with an independent cohort of 290 preterm infants. A step-by-step methodological process was used to test whether the results from the exploratory study would generalize over cohorts, different versions of the test, different hospitals, and changes in examiners. This process yielded 7 highly stable, developmentally valid, and representative preterm neurobehavioral functions that generalized over the exploratory and the validation studies. These were: motor development and vigor, scarf sign, popliteal angle, alertness and orientation, percent asleep ratings, irritability, and vigor of crying.

Apgar Score↗

PubMed1991

Validation of removal of human retroviruses.

Validation of virus removal during product manufacture is one of several techniques which can be used to help establish product safety. The usefulness of the validation technique will be illustrated for the manufacture of immunoglobulins by the Cohn-Oncley ethanol fractionation procedure in which the partitioning and inactivation of HIV were studied, and for the manufacture of Factor VIII. In the case of Factor VIII which was contaminated with HIV and transmitted infection to product recipients, several manufacturers explored means of eliminating infectious virus by using a validation procedure involving a scaled-down manufacturing process and the spiking of individual steps to determine the extent of removal from the product and the inactivation of virus during manufacture. Assays for virus remaining after each step were performed in tissue culture. Some products were also tested in chimpanzees. Results of tissue culture assays could be correlated with safety testing in animals, and also with subsequent retrospective analysis of actual product use in patients. Correlation was good, suggesting that process validation is useful. Current use of virus validation to assess virus removal from products made from continuous cell lines such as human hybridomas which could potentially contain viruses infectious for humans, as well as some limitations of these validation techniques are also discussed.

Animals↗