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PubMed2004

A meta-analysis of prior corticosteroid use and fracture risk.

UNLABELLED: The relationship between use of corticosteroids and fracture risk was estimated in a meta-analysis of data from seven cohort studies of approximately 42,000 men and women. Current and past use of corticosteroids was an important predictor of fracture risk that was independent of prior fracture and BMD. INTRODUCTION: The aims of this study were to validate that corticosteroid use is a significant risk factor for fracture in an international setting and to explore the effects of age and sex on this risk. MATERIALS AND METHODS: We studied 42,500 men and women from seven prospectively studied cohorts followed for 176,000 patient-years. The cohorts comprised the EPOS/EVOS study, CaMos, the Rotterdam Study, Dubbo Osteoporosis Epidemiology Study (DOES), and prospective cohorts at Sheffield, Rochester, and Gothenburg. The effect of ever use of corticosteroids, BMD, age, and sex on all fracture, osteoporotic fracture, and hip fracture risk alone was examined using Poisson regression in each cohort and for each sex. The results of the different studies were merged from the weighted beta coefficients. RESULTS: Previous corticosteroid use was associated with a significantly increased risk of any fracture, osteoporotic fracture, and hip fracture when adjusted for BMD. Relative risk of any fracture ranged from 1.98 at the age of 50 years to 1.66 at the age of 85 years. For osteoporotic fracture, the range of relative risk was 2.63-1.71, and for hip fracture 4.42-2.48. The estimate of relative risk was higher at younger ages, but not significantly so. No significant difference in risk was seen between men and women. The risk was marginally and not significantly upwardly adjusted when BMD was excluded from the model. The risk was independent of prior fracture. In the three cohorts that documented current corticosteroid use, BMD was significantly reduced at the femoral neck, but fracture risk was still only partly explained by BMD. CONCLUSION: We conclude that prior and current exposure to corticosteroids confers an increased risk of fracture that is of substantial importance beyond that explained by the measurement of BMD. Its identification on an international basis validates the use of this risk factor in case-finding strategies.

Adrenal Cortex Hormones↗

PubMed1998

[ERGATT/ECVAM Workshop on Acceptance of Validated Alternative Methods: Amden III]

Since validated in vitro toxicity tests have so far not been accepted by regulators the third international ERGATT/ECVAM validation workshop was held from January 26-30, 1998, in Amden/Switzerland. Scientific and political reasons for a delay of the acceptance of alternative methods were identified in the areas of phototoxicity, skin penetration and skin corrosivity and strategies to promote the acceptance were suggested. The OECD will harmonise the formal of criteria for the regulatory acceptance of new experimentally validated tests and of established tests from industry for which in-house and literature data exist. In vitro tests for phototoxicity and skin penetration will be accepted shortly by the OECD. For skin corrosivity two in vitro tests will be put forward to the OECD later this year. The Amden III workshop suggests that, the same acceptance criteria must be used for animal and in vitro tests. Finally, the OECD should remove tests that cause pain and distress to test animals from the official OECD list of official test guidelines if validated alternative methods exist. When obsolete animal tests are taken from the list of official OECD test guidelines, they will not any longer be accepted at the international level. Thus, the third Amden workshop has contributed new concepts for the regulatory acceptance of alternative toxicity tests which are supported by regulators in Europe, the USA and the OECD.

Journal Article↗

PubMedDate not supplied

Update on validation of microbiological methods by AOAC International.

An update is presented of the microbiological methods validated by AOAC since 1983. A sequential listing of the microbiological methods adopted first action between 1939 and 1993 gives the permanent new numbers of each, as introduced in Official Methods of Analysis, 15th Edition. Consideration is given to the expanded applicability of approved methods with respect to food matrix; the predominance of methods for the detection, identification, and serological testing of Salmonella spp.; and the procedures for coliforms and Escherichia coli, which were most frequently approved between 1973 and 1993. The substantial increase in validation of test kits is discussed, and categories of methods for the modification of test kits already approved are defined.

Enterobacteriaceae↗

PubMed1996

The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus.

OBJECTIVE: To develop and perform an initial validation of a damage index for systemic lupus erythematosus (SLE). METHODS: A list of items considered to reflect damage in SLE was generated through a nominal group process. A consensus as to which items to be included in an index was reached, together with rules for ascertainment. Each center submitted 2 assessments, 5 years apart, on 2 patients with active and 2 with inactive disease, of whom 1 had increased damage and the other had stable disease. Analysis of variance was used to test the factors physician, time, amount of damage, and activity status. RESULTS: Nineteen physicians completed the damage index on 42 case scenarios. The analysis revealed that the damage index could identify changes in damage seen in patients with both active and inactive disease. Patients who had active disease at both time points had a higher increase in damage. There was good agreement among the physicians on the assessment of damage in these patients. CONCLUSION: This damage index for SLE records damage occurring in patients with SLE regardless of its cause. The index was demonstrated to have content, face, criterion, and discriminant validity.

Health Status Indicators↗

PubMed2001

Psychometrics of a Chinese translation of the swallowing questionnaire.

AIMS OF THE STUDY: The purpose of this study was to determine the psychometric properties of a Chinese version of a swallowing questionnaire. BACKGROUND/RATIONALE: Impaired swallowing may lead to serious complications if health care professionals do not accurately assess the problem and promptly intervene. The recognition of symptoms indicative of a swallowing problem is essential for nurses. The swallowing questionnaire could provide nurses with a valid instrument to assess patients' impaired swallowing. DESIGNS/METHODS: Phase I consisted of experts doing the initial translation into Chinese and back-translations of the questionnaire. Five experts then determined content validity of the Chinese version, and 35 bilingual subjects determined equivalence of the Chinese translation and English version. Phase II determined concurrent validity and internal consistency using 113 screened medical patients as subjects. Phase III used 105 screened long-term care subjects to determine construct validity. RESULTS/FINDINGS: In Phase I, rating on the appropriateness of items on the Chinese version yielding a content validity index of 0.988. The coefficient of equivalence between the Chinese and English versions of the instrument was 0.81, while per cent agreement for all items on the two versions ranged from 0.80--1.00. Phase II established internal consistency with a K-R20 of 0.74, and concurrent validity yielded a correlation between the swallowing questionnaire and the neurological swallowing exam of 0.675 (P < 0.01). Phase III determined construct validity with significant positive correlations found between the swallowing questionnaire and stroke history and masticatory ability. Significant negative correlations were found between swallowing and cognitive status, functional status and albumin. CONCLUSIONS: Although useful as a tool for nursing assessment and intervention, further work on the swallowing questionnaire such as conducting video fluoroscopy and a swallowing speed test, are recommended to further validate its accuracy.

Activities of Daily Living↗

PubMed2002

Patient-assessed health outcome measures for diabetes: a structured review.

AIMS: To identify available disease-specific measures of health-related quality of life (HRQL) for diabetes and to review evidence for the reliability, validity and responsiveness of instruments. METHODS: Systematic searches were used to identify instruments. Instruments were assessed against predefined inclusion and exclusion criteria. Letters were sent to authors requesting details of further instrument evaluation. Information relating to instrument content, patients, reliability, validity and responsiveness to change was extracted from published papers. RESULTS: The search produced 252 references. Nine instruments met the inclusion criteria: Appraisal of Diabetes Scale (ADS), Audit of Diabetes-Dependent Quality of Life (ADDQoL), Diabetes Health Profile (DHP-1, DHP-18), Diabetes Impact Measurement Scales (DIMS), Diabetes Quality of Life Measure (DQOL), Diabetes-Specific Quality of Life Scale (DSQOLS), Questionnaire on Stress in Diabetic Patients-Revised (QSD-R), Diabetes-39 (D-39) and Well-being Enquiry for Diabetics (WED). The shortest instrument (ADS) has seven items and the longest (WED) has 50 items. The ADS and ADDQoL are single-index measures. The seven multidimensional instruments have dimensions covering psychological well-being and social functioning but vary in the remainder of their content. The DHP-1 and DSQOLS are specific to Type 1 diabetes patients. The DHP-18 is specific to Type 2 diabetes patients. The DIMS and DQOL have weaker evidence for reliability and internal construct validity. Patients contributed to the content of the ADDQoL, DHP-1/18, DQOL, DSQOLS, D-39, QSD-R and WED. The authors of the ADDQoL, DHP-1/18, DQOL, DSQOLS gave explicit consideration to content validity. The construct validity of instruments was assessed through comparisons with instruments measuring related constructs and clinical and sociodemographic variables. None of the instruments has been formally assessed for responsiveness to changes in health. CONCLUSIONS: Five of the diabetes-specific instruments have good evidence for reliability and internal and external construct validity: the ADDQoL, DHP-1/18, DSQOLS, D-39 and QSD-R. Instrument content should be assessed for relevance before application. The instruments should be evaluated concurrently for validity and responsiveness to important changes in health.

Diabetes Mellitus↗

PubMed2001

Psychometric characteristics of the Barthel activities of daily living index in stroke patients.

BACKGROUND AND PURPOSE: Although the Barthel activities of daily living (ADL) index (BI) is widely used to measure disability in Taiwan, the usage of the BI has not been scientifically justified. This study examined the reliability, validity, and responsiveness of the BI in a cohort of stroke patients who were followed for half a year after stroke. METHODS: One hundred and twenty-one patients were assessed using the BI at 14, 30, 90, and 180 days after stroke (DAS). Reliability of the BI was determined by estimation of inter-rater agreement and internal consistency. Validity of the BI was determined by examining convergent construct validity and predictive validity. Responsiveness was determined using effect size and t-statistics calculations. RESULTS: There was moderate to excellent agreement between raters for individual items (kappa value range, 0.53-0.94) and total score (ICC = 0.94). An excellent internal consistency was found within the BI at four DAS points (alpha value range, 0.89-0.92). The BI scores closely correlated with scores of the Fugl-Meyer motor assessment (measuring impairment) and the Berg balance scale (measuring balance) (Pearson's r > or = 0.78, p < 0.0001). The Frenchay activities index (measuring instrumental ADL) at 180 DAS showed moderate correlation with the BI scores obtained at 14, 30, and 90 DAS (Pearson's r > or = 0.59, p < 0.0001). The effect size d, standardized response mean, t-statistics, and p-values showed that the BI was moderately to highly responsive at each stage of stroke recovery except the late stage (90-180 DAS). CONCLUSION: This study has demonstrated that the BI is a useful instrument with high inter-rater reliability, internal consistency, convergent and predictive validity, and adequate responsiveness in assessing ADL functions in stroke patients in Taiwan.

Activities of Daily Living↗

PubMed2002

Reliability and validity of the Malay version of the International Prostate Symptom Score in the Malaysian population.

PURPOSE: We validated the Malay version of the International Prostate Symptom Score in patients with and without urinary symptoms in the Malaysian population. MATERIALS AND METHODS: Validity and reliability were studied in patients with and without lower urinary tract symptoms. Reliability was evaluated using the test-retest method and internal consistency was assessed by Cronbach's alpha. Sensitivity to change was expressed as the effect size in the pre-intervention versus post-intervention score in additional patients with lower urinary tract symptoms who underwent transurethral prostate resection. RESULTS: Internal consistency was excellent. A high degree of internal consistency was observed for each of the 7 items and for the total score (Cronbach's alpha 0.53 and greater, and 0.68, respectively). The test-retest correlation coefficients of the 7 items were highly significant. The intraclass correlation coefficient was high at 0.51 and greater. There was a high degree of sensitivity and specificity to the effects of treatment. Significant change from baseline to posttreatment scores was observed in all 8 items in the treated but not in the control group. CONCLUSIONS: The Malay International Prostate Symptom Score is a suitable, reliable, valid instrument that is sensitive to clinical change in the Malaysian population.

Aged↗

PubMed1999

A psychometric evaluation of the Swedish version of the Multidimensional Pain Inventory (MPI-S): a gender differentiated evaluation.

A need to consider possible gender differences in pain research has been recognized by researchers during the last decades. As part of a psychometric evaluation of the Swedish version of the Multidimensional Pain Inventory (MPI-S), we performed gender-differentiated analyses of the internal consistency, validity and sensitivity to change of the MPI-S in a sample of 235 individuals (129 females, 106 males) suffering from long-term non-specific pain from the lower back and/or neck region. The construct validation and sensitivity analyses were performed by using validated self-report measures and direct observational assessment techniques as external constructs. For sections 1 and 2 of the MPI-S, the results support the internal consistency (alpha coefficients ranged from 0.74 to 0.85 for females and 0.62 to 0.89 for males) and construct validity across gender. The General Activity (GA) scale of section 3 of the MPI-S displayed acceptable internal consistency across gender (alpha = 0.79 for females, 0.80 for males) but not a satisfactory construct validity. Furthermore, the results yielded some support for the sensitivity to change of the Pain Severity (PS), Interference (I), Life Control (LC) and Affective Distress (AD) scales (from section 1) across gender. Unfortunately, the GA scale did not display a satisfactory sensitivity either for females or males. Altogether, the results showed a similar pattern across gender, although some divergences were detected, such as the substantially weaker negative correlation between perceived supportive behaviour from significant others and punishing responses for males compared to females. In conclusion, we recommend the use of sections 1 and 2 of the MPI-S as a psychometrically evaluated and comprehensive instrument in the assessment of individuals suffering from chronic non-specific low back pain or neck pain. Copyright 1999 European Federation of Chapters of the International Association for the Study of Pain.

Journal Article↗

PubMed1984

[Quality of coding of causes of death in Switzerland].

This article summarizes the results of a recoding study, the design of which has been presented elsewhere (ref. 4). Results on underlying cause of death are presented as validity (comparison with coding of a medical expert) and reliability (comparison of repeated FSO internal codings). Validity problems occur chiefly with cardiopathies and cerebrovascular disease and in old age. Valitity of coding of cancer is generally satisfactory, although an estimated 7% overcoding occurs. An estimated 63% of deaths fall into reliably coded cause-of-death categories, but again problems occur with cardiopathies and old agegroups. For the analysis of trends in cardiopathies, ne needs to consider simultaneously the evolution of the numbers of deaths with cancer of breast and prostate, hypertension and arteriosclerosis, and diseases of connective tissue, skin and skeleton.

Age Factors↗

PubMed2001

Disease specific quality of life instruments in multiple sclerosis: validation of the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS).

Quality of life (QoL) is discussed as an additional outcome measure in multiple sclerosis (MS). However, few questionnaires assessing disease specific QoL in MS have been published. On the basis of the literature and interviews with clinicians and MS patients, we have developed a disease specific QoL instrument and validated it in a broad range of patients with MS. In this study, a heterogeneous sample of n = 237 MS patients completed the newly developed Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS, in German language) and a battery of already validated questionnaires. They further underwent neurological scoring and objective tests. By these means, we investigated its validity, appropriateness, internal consistency, and retest reliability. Internal consistency and retest coefficients were high and satisfied psychometric standards. Convergent and discriminant validity was supported by direction, magnitude and pattern of correlations with other health measures. HAQUAMS subscales and its total score distinguished between patient groups of varied disease severity, cognitive impairment, and affective symptomatology. No floor or ceiling effects were found in either of the HAQUAMS subscales. The HAQUAMS is a reliable, valid and appropriate instrument for QoL assessment in multiple sclerosis. Data of responsiveness are currently being obtained.

Adult↗

PubMedDate not supplied

[Validation of a self-efficiency scale for the prevention of AIDS among adolescents].

OBJECTIVES: The objectives are obtain the internal consistency, validity and factorial structure of the Self-Efficacy for AIDS scale, which was developed in American population by Kasen, Vaughan and Walter (1992) and adapted in mexican samples for López and Padilla (1999). INSTRUMENTS: It is employed the Self-efficacy to Prevent the AIDS Scale of 27 items of López and Padilla (1999), together with closed questions Likert type, dicotomics and two opened questions on relevant aspects of the sexual conduct to validate the scale, under a format self-applied test of pencil and paper. MATERIAL AND METHODS: It is a correlacional study with a not experimental design of transverse type. It was accomplished with a simple random sample of 962 adolescents wich were taken of 60 public health centers of Monterrey. None went to consult by motives related to the AIDS. RESULTS: The scale was adjusted to a normal distribution (Zk-s(Normal) = 1.369; p = 0.047). It presents a mean of 95.14 and a standard deviation of 25.80. Its reliability, by the alpha of Cronbach, was 0.89. SEA-27 shows a structure of four independent factors that explain 58.47% of the total variance. CONCLUSIONS: Thus, it is concluded that SEA-27 is a reliable and valid scale.

Acquired Immunodeficiency Syndrome↗

PubMed1995

Validity of three clinical performance assessments of internal medicine clerks.

PURPOSE: To analyze the construct validity of three methods to assess the clinical performances of internal medicine clerks. METHOD: A multitrait-multimethod (MTMM) study was conducted at the Case Western Reserve University School of Medicine to determine the convergent and divergent validity of a clinical evaluation form (CEF) completed by faculty and residents, an objective structured clinical examination (OSCE), and the medicine subject test of the National Board of Medical Examiners. Three traits were involved in the analysis: clinical skills, knowledge, and personal characteristics. A correlation matrix was computed for 410 third-year students who completed the clerkship between August 1988 and July 1991. RESULTS: There was a significant (p < .01) convergence of the four correlations that assessed the same traits by using different methods. However, the four convergent correlations were of moderate magnitude (ranging from .29 to .47). Divergent validity was assessed by comparing the magnitudes of the convergence correlations with the magnitudes of correlations among unrelated assessments (i.e., different traits by different methods). Seven of nine possible coefficients were smaller than the convergent coefficients, suggesting evidence of divergent validity. A significant CEF method effect was identified. CONCLUSION: There was convergent validity and some evidence of divergent validity with a significant method effect. The findings were similar for correlations corrected for attenuation. Four conclusions were reached: (1) the reliability of the OSCE must be improved, (2) the CEF ratings must be redesigned to further discriminate among the specific traits assessed, (3) additional methods to assess personal characteristics must be instituted, and (4) several assessment methods should be used to evaluate individual student performances.

Clinical Clerkship↗

PubMed2002

Family impact of child oral and oro-facial conditions.

OBJECTIVES: The aim of this study was to develop and evaluate the Family Impact Scale, a measure of the family impact of child oral and oro-facial disorders. This formed one component of the Child Oral Health Quality of Life Instrument. METHODS: The scale was developed using a process described by Guyatt et al. (1987) and Juniper et al. (1996). An item pool was developed using a review of existing child health status and family impact questionnaires, interviews with 41 parents-caregivers of children with paedodontic, orthodontic and oro-facial conditions and discussions with dental specialists. The resulting pool of 21 items was used in an item impact study in which 93 parents-caregivers provided data on the frequency and importance of these items. The 14 items identified most frequently or rated the most important were selected for the final questionnaire. The discriminant and construct validity and internal consistency reliability of this 14-item scale were assessed in a study of 266 parents-caregivers from the three clinical groups. Seventy-nine of these participants completed a second copy of the questionnaire to facilitate assessment of test-retest reliability. RESULTS: Family Impact Scale scores ranged from 0 to 33, indicating that the measure was sensitive to variations in family impact. Floor effects were minimal with only 10.2% of subjects having a score of zero and there were no ceiling effects, that is, subjects with maximum scores. Almost three-quarters of parents-caregivers reported some family impact 'sometimes' or 'often/everyday' over the previous 3 months. Impact on parental or family activities of this frequency was reported by 53.0%, impact on parental emotions by 44.0%, conflict in the family by 31.6% and financial difficulties by 31.2%. The measure and its component items were reasonably good at discriminating between the three clinical groups included in the study and showed good construct validity. It had excellent internal consistency reliability with a Cronbach's alpha of 0.83 and was reproducible for parent-caregivers who reported that their child's condition was stable (ICC = 0.80). CONCLUSIONS: The study provides some data to suggest that child oral and oro-facial conditions have a pervasive impact on the family. The Family Impact Scale had good technical properties. Its evaluative properties need to be tested in longitudinal studies.

Adolescent↗

PubMed2005

Aging Males' Symptoms scale: a standardized instrument for the practice.

The Aging Males' Symptoms (AMS) scale was designed and standardized as self-administered scale (a) to assess symptoms of aging (independent from those which are disease-related) among groups of males under different conditions, (b) to evaluate the severity of symptoms over time, and (c) to measure changes pre- and post-androgen replacement therapy. It is a short and easy to apply instrument, it has a very simple evaluation scheme, and was internationally well accepted (translated into over 20 languages). Methodological test characteristics are: a) reliability measures: (internal consistency and test-retest stability) were found to be good across countries, b) validity: the internal structure of the AMS in healthy and androgen deficient males and across countries was sufficiently similar to conclude that the scale really measures the same phenomenon across all age groups. The comparison of the AMS with the two established screening instruments for androgen deficiency showed sufficiently good compatibility. Consequently, a screening tool for hypogonadism was developed, consisting of the AMS scale, body mass index (BMI) and age. The test characteristics of this screening tool (sensitivity and specificity) are promising. Clinicians often consider validity as utility for outcome measurement. The AMS scale showed a convincing ability to measure treatment effects on quality of life across the full range of severity of complaints before therapy. The distribution of complaints of testosterone deficient men before therapy almost returned to normal values after 12 weeks of testosterone treatment.

Adult↗

PubMedDate not supplied

The constipation assessment scale for pregnancy.

OBJECTIVE: To determine the reliability and validity of the Constipation Assessment Scale (CAS) during pregnancy. DESIGN: Survey. SETTING: The assessment tool was administered first to a group of healthy women of childbearing age in a school of nursing and then to pregnant women in their physicians' offices. PARTICIPANTS: A nonrandom sample of 16 nonpregnant women of childbearing age and 30 women pregnant 28 weeks or longer, 15 of whom had low-risk pregnancies and 15 of whom had high-risk pregnancies. MAIN OUTCOME MEASURES: The test-retest reliability, content validity, and internal consistency of the CAS were determined. RESULTS: An expert panel review found a calculated percentage of agreement for content validity of .75 and a Cohen's kappa of .714. Test-retest reliability based on 16 nursing students yielded high positive correlations ranging from rH = .84 to rH = .92. Internal consistency of the CAS for pregnancy based on the 30 surveys indicated an alpha coefficient of .82. CONCLUSIONS: The CAS for pregnancy was found to be reliable and valid within the context of this study. Future studies designed to identify potential therapeutic interventions for constipation during pregnancy could use the CAS for pregnancy as a measurement instrument.

Adult↗

PubMed2002

The development, reliability, and validity of a rating scale of stage-based behavioral counseling for STD/HIV prevention.

This article reports on the development of a scale to evaluate skills for performing Stage-based Behavioral Counseling. This intervention is an adaptation of the Stage of Change/Transtheoretical Model of Behavior Change Theory and is used to promote behavior change for STD and HIV prevention. Eleven essential skill items were identified that combine to characterize the overall skill of performing this method of behavioral counseling. Qualitative and quantitative descriptions were developed, yielding a methodology to evaluate varying levels of performance for each skill item. Correlation coefficients demonstrated high construct validity (.95), internal consistency (.95) and inter-rater reliability (.99) of the scale. This reliable and valid instrument can be used for implementing and maintaining the intervention, program quality assurance, and staff training.

Behavior Therapy↗

PubMed1993

Cognitive performance in senile dementia of the Alzheimer's type: the Kitchen Task Assessment.

The Kitchen Task Assessment (KTA) is a functional measure that records the level of cognitive support required by a person with Senile Dementia of the Alzheimer's Type (SDAT) to complete a cooking task successfully. The results allow the clinician to help caregivers understand the level of support the impaired person needs to perform daily living tasks. This paper presents the validity and internal consistency of the KTA. Data were collected from 106 persons diagnosed with SDAT. Construct validity was established by examining the relationship between subjects' performance on the KTA and standard neuropsychological measures.

Activities of Daily Living↗