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Methodological concerns in evaluating psychiatric nursing care modalities and a proposed standard group protocol format for nurse-led groups.

The importance of detailing therapeutic effort and its outcome cannot be underestimated. The need to document outcomes has been re-emphasized in recent psychiatric mental health literature; however, the methodology for addressing threats to validity is well established. This article identifies the problems and issues related to a systematic evaluation of a therapeutic group intervention in an inpatient setting, specifically threats to validity, and describes the processes used in planning and implementing a standard group protocol format. The findings of this project depicting problems in the clarity and precision of documenting nursing practice are believed to be typical and generalizable. However, problems related to clarity and precision have not been addressed in the nursing literature. For a number of reasons, nursing staff members have not been sensitized to the importance of describing their practices in sufficient detail to allow others to replicate these practices. And yet, adequate evaluations of nursing efforts, particularly programmatic initiatives, require systematic testing with repeated trials. Although no description can describe in absolute terms what occurred, clear and precise descriptions of an intervention provide the foundation for valid conclusions about the effort. A detailed standard group protocol format provides a basis for establishing internal validity in subsequent quasi-experimental research designs as well as program evaluation studies.

Hospitalization↗

Psychometric and cognitive validation of a social capital measurement tool in Peru and Vietnam.

Social capital is a relatively new concept which has attracted significant attention in recent years. No consensus has yet been reached on how to measure social capital, resulting in a large number of different tools available. While psychometric validation methods such as factor analysis have been used by a few studies to assess the internal validity of some tools, these techniques rely on data already collected by the tool and are therefore not capable of eliciting what the questions are actually measuring. The Young Lives (YL) study includes quantitative measures of caregiver's social capital in four countries (Vietnam, Peru, Ethiopia, and India) using a short version of the Adapted Social Capital Assessment Tool (SASCAT). A range of different psychometric methods including factor analysis were used to evaluate the construct validity of SASCAT in Peru and Vietnam. In addition, qualitative cognitive interviews with 20 respondents from Peru and 24 respondents from Vietnam were conducted to explore what each question is actually measuring. We argue that psychometric validation techniques alone are not sufficient to adequately validate multi-faceted social capital tools for use in different cultural settings. Psychometric techniques show SASCAT to be a valid tool reflecting known constructs and displaying postulated links with other variables. However, results from the cognitive interviews present a more mixed picture with some questions being appropriately interpreted by respondents, and others displaying significant differences between what the researchers intended them to measure and what they actually do. Using evidence from a range of methods of assessing validity has enabled the modification of an existing instrument into a valid and low cost tool designed to measure social capital within larger surveys in Peru and Vietnam, with the potential for use in other developing countries following local piloting and cultural adaptation of the tool.

Adult↗

Development of a self-directed learning readiness scale for nursing education.

Self-directed learning is a method of instruction used increasingly in adult education. A scale was developed in response to a need for a valid and reliable instrument to measure self-directed learning readiness. Such a scale will allow nurse educators to diagnose students' attitudes, abilities and personality characteristics, necessary for self-directed learning. This study was undertaken in two stages. In the first, the Delphi technique utilizing a panel of 11 nurse educator experts was used to assess the content and construct validity of a number of items perceived to reflect self-directed learning readiness. Each panel member was asked to independently rate the relevance of each item on a Likert scale. The second stage involved the administration of the questionnaire to a convenience sample of 201 undergraduate nursing students. The questionnaire was analysed using principal components factor analysis with varimax rotation, Chronbach's coefficient alpha, and item-to-total correlations to measure the scale's construct validity, internal consistency (reliability), and unidimensionality, respectively.The resulting self-directed learning readiness scale appears homogeneous and valid. The scale will assist nurse educators in the diagnosis of student learning needs, in order for the educator to implement teaching strategies that will best suit the students. Furthermore the development of this scale will provide valuable data for curriculum development.

Attitude of Health Personnel↗

[Scale of psychological violence against adolescents].

OBJECTIVE: To present strategies and results of a cross-cultural adaptation of a psychological violence scale to be used in Brazilian studies. METHODS: The scale of violence, a translated version in Portuguese of the original in English, was applied to a sample of 266 7th and 8th grade and junior high school students of public and private schools of the municipality of São Gonçalo, Southeastern Brazil. Several types of equivalences were investigated. The semantic equivalence was evaluated in the referential and general meaning of each item. The measurement equivalence was assessed through psychometric properties such as test and retest reliability, construct validity, internal consistency and factorial analysis. Reliability was measured by Kappa and intraclass correlation coefficients and construct validity was evaluated by Pearson's coefficient. RESULTS: The theoretical-conceptual discussions were deemed adequate concerning conceptual and items equivalences. The semantic equivalence was above 60 percentile in the evaluation of the referential and general item meaning. Cronbach's alpha was 0.94, Kappa index agreement was discreet, intraclass correlation coefficient was 0.82 and the factorial analysis with one factor structure had a degree of explanation of 43.5% variance. Construct validity showed significant negative correlation with self-esteem, social support, and a positive correlation with parent violence. CONCLUSIONS: The study results indicate the applicability of the instrument in the Brazilian teenager population.

Adolescent↗

[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↗

Randomized single-subject experimental designs.

Books on single-subject methodology tend to focus on traditional operant research techniques and thus provide little or no discussion of random introduction of treatments and statistical tests based on such randomization, i.e. randomization tests. Those books are the principal references to which researchers must turn for a comprehensive coverage of single-subject methodology, and so many researchers are likely to be unaware of the relevance of randomization (random assignment of treatment times to treatments) and randomization tests to single-subject experimentation. That is unfortunate because randomization is necessary in order to draw valid statistical inferences about treatment effects. The role of randomization in providing control over major threats to internal validity is explained in this article, and a number of randomized single-subject designs and their applications are provided. Appropriate rank tests are specified, and sources of free software for other, more complex, statistical tests are given.

Child, Preschool↗

Threats to the validity of clinical trials employing enrichment strategies for sample selection.

Subject selection and exclusion criteria employed in typical clinical effectiveness trials of investigational new drugs have two fundamental aims: (1) to ensure that patients entering a study are truly suffering from the condition the drug is intended to treat and (2) to maximize the likelihood that the study will detect an effect of the drug if, in fact, one exists. Typical protocol selection criteria not only specify exacting procedures for establishing and documenting the diagnosis of those recruited for a study but also seek to increase, relative to the prevalence in the general population, the proportion of individuals in the sample likely to respond to pharmacological treatment. Because it is ordinarily impossible to learn prior to extensive clinical experience with a new drug which, if any, patient characteristics reliably predict a consistent treatment response, strategies for sample "enrichment" typically operate by excluding patients (for example, those with very advanced and/or complicated illness, those with serious concomitant illness, those at the extremes of age, those with very mild illness, and so forth) in whom a dependable response to treatment seems unlikely on logical and/or generic grounds. Some studies use positive strategies for sample "enrichment." In studies evaluating drugs intended to treat recurrent episodes of psychiatric illnesses, many protocols recommend selective recruitment of patients with a history of meaningful positive responses to antipsychotic treatment during prior episodes. Sample selection procedures of these kinds impose limits on the generalizability of a study's results (i.e., external validity), but the use of nonrandom patient samples is ordinarily held to have no effect on the internal validity of the results. In short, studies employing highly selected patient samples are, despite their limited external validity, regularly accepted as valid sources of evidence bearing on a drug's effectiveness. There are exceptions, however; this paper describes one in which the use of a seemingly innocuous sample enrichment maneuver proved highly damaging to the ultimate credibility of an important multicenter trial. In particular, exposure to an experimental treatment during an open qualification phase may invalidate drug-placebo comparisons made during a later randomized, blinded, controlled phase. Our review of the trial also reveals that the enrichment maneuver employed probably failed to accomplish its intended aims, selecting patients whose improvements on the outcome variable may be as reasonably ascribed to chance as to drug effect. This is all the more surprising because the method of sample enrichment employed has much in common with those long recommended in the clinical trial literature.

Aged↗

Measuring imaging ability in children.

INTRODUCTION: Guided imagery has been suggested as an intervention to help children cope with noxious symptoms associated with medical care. A measure of imaging ability, that is, the ability to generate vivid mental images and to experience those images as if they were real, could be helpful in identifying children most likely to succeed in relieving symptoms with guided imagery. The purpose of this study was to test psychometric properties of a new instrument, the Kids Imaging Ability Questionnaire (KIAQ). METHOD: Three expert clinicians and researchers were asked to review the KIAQ to assess content validity. A convenience sample of 58 children were invited to complete the questionnaire twice to obtain data for tests of reliability and criterion-related validity. RESULTS: Content validity, internal consistency (alpha =.75-.76), and test-retest reliability (r =.73) were acceptable. Criterion-related validity using the Singer Fantasy Proneness Interview as a standard was poor (rho =.31-.46). DISCUSSION: Some psychometric properties were acceptable; however, continued research will be necessary to test validity of the questionnaire and demonstrate a relationship between KIAQ score and success with imagery. With continued research, pediatric nurses may use the KIAQ in practice to identify children most likely to benefit from guided imagery.

Adolescent↗

An evaluation of the oral health quality of life (OHQoL) instrument in a Brazilian population.

OBJECTIVES: To translate and evaluate the performance of a Brazilian Portuguese version of the United Kingdom Oral Health related Quality of Life instrument, OHQoLUK, in assessing the impact of oral health on quality of life among a Brazilian adult population. DESIGN: Following forward-backwards translation the 16-item OHQoLUK measure was administered to adults utilising municipal dental health services in Araraquara, São Paulo, Brazil. The instrument's psychometric properties, validity and reliability, were assessed. RESULTS: The response rate was 72% (323/450). OHQoLUK scores were associated with self-reported oral health status including number of teeth present (p < 0.001), denture status (p < 0.01) and self-reported dental attendance pattern; time (p < 0.05) and reason for last dental visit (p < 0.001), supporting the construct validity of the measure. In addition, OHQoLUK scores were associated with self-ratings of oral health (p < 0.0001) and perceived need for dental treatment (p < 0.001), supporting it's criterion validity. Internal reliability was high: Cronbach's alpha = 0.96, while the agreement for each of the 16 OHQoLUK items (Kappa values) ranged from 0.57 to 0.87. CONCLUSION: The Brazilian Portuguese version of OHQoLUK measure of oral health related quality of life performed well, exhibiting good validity (face, construct and criterion) and reliability (internal and external). This confirms the sound psychometric properties of the OHQoLUK measure and the applicability of the Portuguese version among a Brazilian population.

Adolescent↗

The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions.

OBJECTIVE: To test the feasibility of creating a valid and reliable checklist with the following features: appropriate for assessing both randomised and non-randomised studies; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting, internal validity (bias and confounding) and power, but also for external validity. DESIGN: A pilot version was first developed, based on epidemiological principles, reviews, and existing checklists for randomised studies. Face and content validity were assessed by three experienced reviewers and reliability was determined using two raters assessing 10 randomised and 10 non-randomised studies. Using different raters, the checklist was revised and tested for internal consistency (Kuder-Richardson 20), test-retest and inter-rater reliability (Spearman correlation coefficient and sign rank test; kappa statistics), criterion validity, and respondent burden. MAIN RESULTS: The performance of the checklist improved considerably after revision of a pilot version. The Quality Index had high internal consistency (KR-20: 0.89) as did the subscales apart from external validity (KR-20: 0.54). Test-retest (r 0.88) and inter-rater (r 0.75) reliability of the Quality Index were good. Reliability of the subscales varied from good (bias) to poor (external validity). The Quality Index correlated highly with an existing, established instrument for assessing randomised studies (r 0.90). There was little difference between its performance with non-randomised and with randomised studies. Raters took about 20 minutes to assess each paper (range 10 to 45 minutes). CONCLUSIONS: This study has shown that it is feasible to develop a checklist that can be used to assess the methodological quality not only of randomised controlled trials but also non-randomised studies. It has also shown that it is possible to produce a checklist that provides a profile of the paper, alerting reviewers to its particular methodological strengths and weaknesses. Further work is required to improve the checklist and the training of raters in the assessment of external validity.

Bias↗

Validation study of the TrueAllele automated data review system.

The New York State Convicted Offender DNA Databank is the first U.S. lab to complete an internal validation of the TrueAllele expert data review system. TrueAllele is designed to assess short tandem repeat (STR) DNA data based on several key features such as peak height, shape, area, and position relative to a standard ladder and use this information to make accurate allele calls. The software then prioritizes the allele calls based on several user-defined rules. As a result, the user need only review low-quality data. The validation of this system consisted of an extensive optimization phase and a large concordance phase. During optimization, the rule settings were tailored to minimize the amount of high-quality data viewed by the user. In the concordance phase, a large dataset was typed in parallel with the ABI software Gene Scan and Genotyper (manual review) and TrueAllele (automated review) for comparison of allele calls and sample state assignment. Only one significant difference was discovered out of 2048 samples in the concordance study. In this case, TrueAllele revealed a spike in the profile that was interpreted as a DNA peak by the analyst in Genotyper. TrueAllele was designed to focus the review on poor data and to eliminate the need for complete reanalysis technical review. This validation project proved TrueAllele to be dependable for use at the NYS Convicted Offender DNA Databank.

Alleles↗

Italian validation of the International Consultation on Incontinence Questionnaires.

OBJECTIVE: To validate the Italian version of two questionnaires for lower urinary tract symptoms (LUTS), i.e. the long (LF) and the short form (SF) of the International Consultation on Incontinence Questionnaire (ICIQ). METHODS: Two native Italian speakers and a native English speaker collaborated with clinical investigators through a multistep process to obtain a consensus version of the questionnaires. The resulting Italian versions were then pre-tested during a pilot study on 16 women for the LF and 10 for the SF. The final versions of the ICIQ-LF and ICIQ-SF were administered to two samples of consecutive female patients, aged > or = 18 years, who had been having LUTS for > or = 3 months, with respectively 82 and 50 women. Internal consistency and test-retest reliability were then assessed; to evaluate the latter, a subset of patients (25 for the ICIQ-LF and 42 for ICIQ-SF) was re-rated. To test the capacity of the questionnaires to discriminate women with or without LUTS (respectively cases and controls), a sample of healthy women was also enrolled and assessed. RESULTS: Both scales showed good psychometric properties overall. The correlation coefficient between ratings was > 0.75 in both questionnaires, and the discriminant power between cases and controls was confirmed for both scales. The ICIQ-SF showed good internal consistency for the total score (Cronbach's alpha 0.90). The sections of the ICIQ-LF 'impact of incontinence on everyday life', 'emotional aspects', 'urinary symptoms' and the degree of bother seemed to be internally consistent (Cronbach's alpha > 0.70); there was a weak relationship for items related to 'sexual matters' (Cronbach's alpha 0.38). CONCLUSION: The Italian version of both questionnaires is a valid and robust instrument which can now be used reliably both in daily practice and in clinical research.

Adolescent↗

[Spanish version of a scale for the assessment of mania: validity and reliability of the Young Mania Rating Scale].

BACKGROUND: The Young Mania Rating Scale is the most widely used tool for the assessment of the intensity of manic symptoms. Unfortunately, to date, there was no Spanish validated version available. This study validated the Spanish version of the YMRS. PATIENTS AND METHOD: A sample of 541 DSM-IV manic or hypomanic bipolar patients were recruited in 56 different psychiatric settings in Spain and assessed with the YMRS by 112 clinicians specifically trained in its use on days 1, 7, 14, 30, 45 and at 3 and 6 months. The mania subscale of the Clinical Global Impression for Bipolar Disorders was also performed in order to have a standard measure to compare our results. Feasibility, reliability, validity and sensitivity of the YMRS were analysed. RESULTS: The YMRS Spanish version showed reliability index of 0.88 (internal consistency) and 0.76 (test-retest reliability), and good internal validity and external (p < 0.001) when compared to the mania subscale of the Modified Clinical Global Impression. The results also showed good sensitivity and feasibility. CONCLUSIONS: The YMRS Spanish Version is a useful, valid and reliable tool for the assessment of manic symptoms.

Bipolar Disorder↗

Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group.

BACKGROUND: The paper reports on the development of the WHOQOL-BREF, an abbreyiated version of the WHOQOL-100 quality of life assessment. METHOD: The WHOQOL-BREF was derived from data collected using the WHOQOL-100. It produces scores for four domains related to quality of life: physical health, psychological, social relationships and environment. It also includes one facet on overall quality of life and general health. RESULTS: Domain scores produced by the WHOQOL-BREF correlate highly (0.89 or above) with WHOQOL-100 domain scores (calculated on a four domain structure). WHOQOL-BREF domain scores demonstrated good discriminant validity, content validity, internal consistency and test-retest reliability. CONCLUSION: These data suggest that the WHOQOL-BREF provides a valid and reliable alternative to the assessment of domain profiles using the WHOQOL-100. It is envisaged that the WHOQOL-BREF will be most useful in studies that require a brief assessment of quality of life, for example, in large epidemiological studies and clinical trials where quality of life is of interest. In addition, the WHOQOL-BREF may be of use to health professionals in the assessment and evaluation of treatment efficacy.

Adult↗

Measuring awareness of financial skills: reliability and validity of a new measure.

This paper examines the psychometric properties of a three-part (participant, informant, and performance) Measure for assessing Awareness of Financial Skills (MAFS). The MAFS was administered to 10 seniors with dementia and 25 well-functioning seniors, and their informants. Measures of cognitive functioning, social desirability, neuroticism, and perceived control were administered to each participant to allow for an assessment of validity. Internal consistency estimates for the participant and informant questionnaires were found to be 0.92 and 0.97, respectively. Convergent validity analysis indicated that performance on this measure was related to level of cognitive functioning, with higher level of unawareness associated with decreased cognitive ability. Discriminant validity analysis showed that performance on this measure was not related to social desirability or neuroticism. This study provides evidence that the MAFS is a reliable and valid tool for assessing awareness of financial skills in older adults.

Aged↗

Assessing the appropriateness of physician prescribing for geriatric outpatients. Development and testing of an instrument.

OBJECTIVE: In a randomized, controlled trial evaluating the impact of clinical pharmacists' consultations on physicians' prescribing decisions, a seven-member physician/pharmacist panel developed an instrument to characterize and quantify the full range of drug-prescribing problems. The instrument was tested for validity and reliability. SAMPLE: The instrument was applied in reviewing prescribing for 236 geriatric outpatients. METHODS: To ensure internal validity of the instrument, five panel meetings were devoted to reaching a consensus on procedures, categories, criteria, and scoring. Each case was evaluated independently by two reviewers and each drug in the regimen was evaluated for drug-drug interactions, dosage, schedule, allergic reactions, therapeutic duplication, use of drugs without established diagnoses, and inappropriate drugs for the patient's clinical conditions; discrepancies were adjudicated by the panel chairperson. Self-reported adverse effects of 60 study patients who were interviewed, and hospital readmissions of all study patients were used to test the external validity of the instrument. RESULTS: Inter-rater reliability improved over time, reaching a high of 97.1 percent after six months. A positive association was determined between the prescribing scores and the number of reported adverse effects (rho = 0.28, p = 0.02). Although the number of patients with drug-related hospital readmissions was too few to establish a significant association between the prescribing scores and readmissions, the findings were expected. CONCLUSIONS: Given current requirements for drug utilization reviews in hospitals, health maintenance organizations, and Medicaid programs, this instrument may prove to be very useful.

Aged↗

The proposition: an insight into research.

Propositions form the basis for scientific research. The validity of a research study is, to a large extent, evaluated on the criteria of its propositions. For internal validity, study propositions provide information regarding precision of definitions, measurements, associations, confounding factors etc. that are considered in research. While for external validity, propositions form the premise for the deduction of inferences. The aim of this article is to help readers understand the propositions that are made in research. This article discusses those propositions, which are relevant to medical research.

Causality↗

[Hypothetical model of serotonin deficit in the aged subject. Development and validation of a clinical scale].

Few works exist about specific abnormalities of neurotransmission, therefore noticeable and with important clinical consequences in elderly patients. Specially serotonin, which neurotransmission is lower, seems to have a wide influence. The symptomatology of the serotonin shortage is well known in the young adult (Asberg and Van Praag). The aim of this study is to apply those hypothesis and to look for a particular clinical expression of symptoms usually related to a low level of serotonin in an older population, and this in a transnosographic way. We built up a clinical scale gathering different symptoms supposed to be related to a defect in the serotonin transmission in elderly subjects. From a first factor analysis, a dimensional scale of ten items as been settled and validated in 75 inpatients over 60 years old; each patient has also been assessed by a series of tests (MMS of Folstein, Hamilton Depression Rating Scale, Jouvent mood scale, Widlöcher Retardation Scale). Factor analysis results show an homogeneous factorial structure and highly selective items and had a three factors dispatching (a "main" factor, a "depression" factor, and "sleep" factor). Those subgroups of symptoms have a clinical meaning and fit the litterature. We also find a good specificity: the factor analysis on added items of depressive semiology (Hamilton scale) and serotonin related semiology shows the splitting of the Hamilton items, whenever the 5-HT- Scale items keep a steady factorial repartition. Those preliminary results deserve further studies; and external validation of the scale remains to be done. Nevertheless, the structure of this scale shows a beginning of internal validation and seems to be interesting in the elderly clinical evaluation.

Aged↗