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Reliability and validity: Part II.

Determining measurement reliability and validity involves complex processes. There is usually room for argument about most instruments. It is important that the researcher clearly describes the processes upon which she made the decision to use a particular instrument, and presents the evidence available showing that the instrument is reliable and valid for the current purposes. In some cases, the researcher may need to conduct pilot studies to obtain evidence upon which to decide whether the instrument is valid for a new population or a different setting. In all cases, the researcher must present a clear and complete explanation for the choices, she has made regarding reliability and validity. The consumer must then judge the degree to which the researcher has provided adequate and theoretically sound rationale. Although I have tried to touch on most of the important concepts related to measurement reliability and validity, it is beyond the scope of this column to be exhaustive. There are textbooks devoted entirely to specific measurement issues if readers require more in-depth knowledge.

Humans↗

PubMed2026

Integrated transcriptome analysis and machine learning to construct a homeostatic model of acetylation for bladder cancer and validate the key gene CES1.

BACKGROUND: Bladder cancer (BLCA) is one of the most common malignant tumors of the urinary system. Protein acetylation (PA) plays a critical role in regulating multiple biological processes (BPs), cellular homeostasis, and cancer-related signaling pathways. This study aimed to construct a homeostatic model of acetylation for BLCA using integrated transcriptome analysis and machine learning and to validate the key gene CES1. METHODS: RNA sequencing (RNA-seq) and clinical data were obtained from The Cancer Genome Atlas (TCGA) and Gene Expression Omnibus (GEO) databases. Acetylation-related differentially expressed genes (DEGs) in BLCA were screened using differential expression analysis (DEA). An acetylation homeostatic model was constructed via univariate, machine learning-based least absolute shrinkage and selection operator (LASSO) and multivariate Cox regression analyses, followed by validation in multiple cohorts. Single-cell RNA-seq analysis was used to explore gene expression patterns in diverse cell types. Enrichment analysis (EA), immune infiltration, and drug sensitivity analysis (DSA) were performed to characterize molecular features of different risk groups. Finally, the biological function of CES1 as the key gene was verified by in vitro knockdown experiments. RESULTS: We established a robust acetylation homeostatic model consisting of five genes, which effectively predicted overall survival (OS) and served as an independent prognostic factor in BLCA. High-risk patients showed significantly poorer prognosis, distinct immune infiltration profiles, and differential drug sensitivity. CES1 was identified and validated as the key gene in this model, which was highly expressed in BLCA and associated with poor prognosis. Knockdown of CES1 markedly suppressed cell proliferation, invasion, and migration, and reduced intracellular coenzyme A (CoA) levels, thereby regulating PA homeostasis. CONCLUSIONS: We developed and validated a novel acetylation homeostatic model for survival stratification and personalized treatment guidance in BLCA, based on integrated transcriptome analysis and machine learning. CES1 is closely associated with intracellular CoA levels and the malignant progression of BLCA. Its potential association with PA homeostasis requires further mechanistic validation, and it may act as a candidate therapeutic biomarker for BLCA.

Bladder cancer (BLCA)↗

PubMed1984

Pitfalls in measuring the health status of Mexican Americans: comparative validity of the English and Spanish Sickness Impact Profile.

We tested a Spanish translation of the Sickness Impact Profile (SIP) in a clinical study of low back pain, which included non-Hispanic patients (Group I), Mexican Americans who used the English SIP (Group II), and Mexican Americans who used the Spanish SIP (Group III). The reliability and clinical validity of responses by these three groups were compared. Internal consistency of responses by all three groups was excellent ( Cronbach 's alpha for the overall SIP = .93 - .95). When construct validity was tested by correlating SIP scores with several clinical measures of disease severity, however, important differences emerged. Group I responses appeared to be highly valid, while group III responses did not; Group II responses appeared reasonably valid, but intermediate between the other groups. These differences appear unlikely to be due to clinical differences, interviewing, or translational problems and seem to parallel the groups' levels of "acculturation." It may be that certain aspects of acculturation, including familiarity with questionnaire research, critically affect the validity of responses to this questionnaire.

Adult↗

PubMed1987

The validity of health risk appraisal instruments for assessing coronary heart disease risk.

This study evaluated the validity of the scoring systems employed by 41 health risk assessment instruments (HRAs) with respect to the probability of death due to coronary heart disease. Validity was assessed by comparing predictions of mortality risk produced by each HRA to estimates from the Framingham Heart Study and the Risk Factor Update Project. Correlations with both epidemiologic estimates indicated that instruments employing logistic regression or the Geller/Gesner methodology had the highest validity coefficients, while validity was lowest for self-administered general health status and lifestyle questionnaires. However, most instruments using the Geller/Gesner technique appear to systematically overestimate the probability of CHD mortality. For HRAs based on additive risk scales, validity was often attenuated by the crude categorization of some risk factors and by the omission of the effects of age from the scoring system.

Adult↗

PubMed2001

Reliability and intraoperative validity of preoperative assessment of standardized plain radiographs in predicting bone loss at revision hip surgery.

BACKGROUND: The most challenging aspect of revision hip surgery is the management of bone loss. A reliable and valid measure of bone loss is important since it will aid in future studies of hip revisions and in preoperative planning. We developed a measure of femoral and acetabular bone loss associated with failed total hip arthroplasty. The purpose of the present study was to measure the reliability and the intraoperative validity of this measure and to determine how it may be useful in preoperative planning. METHODS: From July 1997 to December 1998, forty-five consecutive patients with a failed hip prosthesis in need of revision surgery were prospectively followed. Three general orthopaedic surgeons were taught the radiographic classification system, and two of them classified standardized preoperative anteroposterior and lateral hip radiographs with use of the system. Interobserver testing was carried out in a blinded fashion. These results were then compared with the intraoperative findings of the third surgeon, who was blinded to the preoperative ratings. Kappa statistics (unweighted and weighted) were used to assess correlation. Interobserver reliability was assessed by examining the agreement between the two preoperative raters. Prognostic validity was assessed by examining the agreement between the assessment by either Rater 1 or Rater 2 and the intraoperative assessment (reference standard). RESULTS: With regard to the assessments of both the femur and the acetabulum, there was significant agreement (p < 0.0001) between the preoperative raters (reliability), with weighted kappa values of >0.75. There was also significant agreement (p < 0.0001) between each rater's assessment and the intraoperative assessment (validity) of both the femur and the acetabulum, with weighted kappa values of >0.75. CONCLUSIONS: With use of the newly developed classification system, preoperative radiographs are reliable and valid for assessment of the severity of bone loss that will be found intraoperatively.

Acetabulum↗

PubMed2004

Reliability, validity, and responsiveness of the Lysholm knee scale for various chondral disorders of the knee.

BACKGROUND: The Lysholm knee scale is a condition-specific outcome measure that was originally designed to assess ligament injuries of the knee. The purpose of this study was to determine the psychometric properties of the Lysholm knee scale for various chondral disorders of the knee. METHODS: Test-retest reliability, internal consistency, content validity, criterion validity, construct validity, and responsiveness to change were determined for the Lysholm knee scale within subsets of an overall study population of 1657 patients with chondral disorders of the knee. The study population was a heterogeneous group of patients with various types of traumatic and degenerative chondral lesions, including isolated lesions and those associated with meniscal and ligament injuries. RESULTS: The overall Lysholm knee scale and six of the eight domains had acceptable test-retest reliability (intraclass correlation coefficient = 0.91) and internal consistency (Cronbach alpha = 0.65). The overall Lysholm knee scale demonstrated acceptable floor (0%) and ceiling (0.7%) effects; however, the floor effects for the domain of squatting and the ceiling effects for the domains of limp, instability, support, and locking were unacceptable (>30%). There was acceptable criterion validity with significant (p < 0.05) correlations between the overall Lysholm knee scale and the physical functioning, role-physical, and bodily pain domains of the Short Form-12 scale; the pain, stiffness, and function domains of the Western Ontario and McMaster Universities Osteoarthritis Index; and the Tegner activity scale. The overall Lysholm knee scale had acceptable construct validity, with all nine hypotheses demonstrating significance (p < 0.05), and it had acceptable responsiveness to change (effect size, 1.16; standardized response mean, 1.10), with large effects (> or = 0.80) for the domains of pain, limping, swelling, and squatting and a small effect (> or = 0.20) for the domain of instability. CONCLUSIONS: The Lysholm knee scale demonstrated overall acceptable psychometric performance for outcomes assessment of various chondral disorders of the knee, although some domains demonstrated suboptimal performance. Psychometric testing of other condition-specific knee instruments in patients with chondral disorders of the knee would be helpful to allow for comparison of psychometric properties.

Adult↗

PubMed2005

Reliability, validity, and responsiveness of the American Shoulder and Elbow Surgeons subjective shoulder scale in patients with shoulder instability, rotator cuff disease, and glenohumeral arthritis.

BACKGROUND: Outcomes assessment after the treatment of shoulder disorders has involved the use of various condition-specific outcome instruments. The purpose of this study was to determine the psychometric properties of the American Shoulder and Elbow Surgeons subjective shoulder scale in patients with shoulder instability, rotator cuff disease, and glenohumeral arthritis. METHODS: Test-retest reliability, internal consistency, content validity, criterion validity, construct validity, and responsiveness to change were determined for the American Shoulder and Elbow Surgeons shoulder scale within subsets of an overall study population of 455 patients with shoulder instability, 474 patients with rotator cuff disease, and 137 patients with glenohumeral arthritis. RESULTS: There was acceptable test-retest reliability for the overall American Shoulder and Elbow Surgeons shoulder scale (intraclass correlation coefficient = 0.94) and ten of eleven domains. There was acceptable internal consistency for patients with instability (Cronbach alpha = 0.61), rotator cuff disease (0.64), and arthritis (0.62). There were acceptable floor and ceiling effects for patients with instability (0% and 1.3%, respectively), rotator cuff disease (0% for both), and arthritis (0% for both). There was acceptable and appropriate criterion validity, with significant correlations (p < 0.05) between the overall American Shoulder and Elbow Surgeons scale and the physical functioning, role-physical, and bodily pain domains of the Short Form-12 scale, and nonsignificant correlations (p > 0.05) with the role-emotional, mental health, vitality, and social function domains. There was acceptable construct validity, with all twenty-three hypotheses demonstrating significance (p < 0.05), and acceptable responsiveness to change for patients with instability (standardized response mean, 0.93), rotator cuff disease (1.16), and arthritis (1.11). CONCLUSIONS: The use of outcome instruments with psychometric properties that have been vigorously established is essential. The American Shoulder and Elbow Surgeons subjective shoulder scale demonstrated overall acceptable psychometric performance for outcomes assessment in patients with shoulder instability, rotator cuff disease, and glenohumeral arthritis.

Adolescent↗

PubMed2003

Biomarkers, validation and pharmacokinetic-pharmacodynamic modelling.

Four elements are crucial to successful pharmacokinetic-pharmacodynamic (PK/PD) modelling and simulation for efficient and effective rational drug development: (i) mechanism-based biomarker selection and correlation to clinical endpoints; (ii) quantification of drug and/or metabolites in biological fluids under good laboratory practices (GLP); (iii) GLP-like biomarker method validation and measurements and; (iv) mechanism-based PK/PD modelling and validation. Biomarkers can provide great predictive value in early drug development if they reflect the mechanism of action for the intervention even if they do not become surrogate endpoints. PK/PD modelling and simulation can play a critical role in this process. Data from genomic and proteomics differentiating healthy versus disease states lead to biomarker discovery and identification. Multiple genes control complex diseases via hosts of gene products in biometabolic pathways and cell/organ signal transduction. Pilot exploratory studies should be conducted to identify pivotal biomarkers to be used for predictive clinical assessment of disease progression and the effect of drug intervention. Most biomarkers are endogenous macromolecules, which could be measured in biological fluids. Many exist in heterogeneous forms with varying activity and immunoreactivity, posting challenges for bioanalysis. Reliable and selective assays could be validated under a GLP-like environment for quantitative methods. While the need for consistent reference standards and quality control monitoring during sample analysis for biomarker assays are similar to that of drug molecules, many biomarkers have special requirements for sample collection that demand a well coordinated team management. Bioanalytical methods should be validated to meet study objectives at various drug development stages, and possess adequate performance to quantify biochemical responses specific to the target disease progression and drug intervention. Protocol design to produce sufficient data for PK/PD modelling would be more complex than that of PK. Knowledge of mechanism from discovery and preclinical studies are helpful for planning clinical study designs in cascade, sequential, crossover or replicate mode. The appropriate combination of biomarker identification and selection, bioanalytical methods development and validation for drugs and biomarkers, and mechanism-based PK/PD models for fitting data and predicting future clinical endpoints/outcomes provide powerful insights and guidance for effective and efficient rational drug development, toward safe and efficacious medicine for individual patients.

Biomarkers↗

PubMed2002

Utility of pedometers for assessing physical activity: convergent validity.

Valid assessment of physical activity is important to researchers and practitioners interested in surveillance, screening, programme evaluation and intervention. The validity of an assessment instrument is commonly considered its most important attribute. Convergent validity is the extent to which an instrument's output is associated with that of other instruments intended to measure the same exposure of interest. A systematic review of the literature produced 25 articles directly relevant to the question of convergent validity of pedometers against accelerometers, observation, and self-reported measures of physical activity. Reported correlations were pooled and a median r-value was computed. Pedometers correlate strongly (median r = 0.86) with different accelerometers (specifically uniaxial accelerometers) depending on the specific instruments used, monitoring frame and conditions implemented, and the manner in which the outputs are expressed. Pedometers also correlate strongly (median r = 0.82) with time in observed activity. Time in observed inactivity correlated negatively with pedometer outputs (median r = -0.44). The relationship with observed steps taken depended upon monitoring conditions and speed of walking. The highest agreement was apparent during ambulatory activity (running, walking) or during sitting (when both observation and pedometers would register few steps taken). There was consistent evidence of reduced accuracy during slow walking. Pedometers correlate moderately with different measures of energy expenditure (median r = 0.68). The relationship between pedometer outputs and energy expenditure is complicated by the use of many different direct and indirect measures of energy expenditure and population samples. Concordance with self-reported physical activity (median r = 0.33) varied depending upon the self-report instrument used, individuals assessed, and how pedometer outputs are expressed (e.g. steps, distance travelled, energy expenditure). Pedometer output has an inverse relationship with reported time spent sitting (r = -0.38). The accumulated evidence herein provides ample support that the simple and inexpensive pedometer is a valid option for assessing physical activity in research and practice.

Activities of Daily Living↗

PubMed2000

Testing the validity of cost-effectiveness models.

A growing body of recent work has identified several problems with economic evaluations undertaken alongside controlled trials that can have potentially serious impacts on the ability of decision makers to draw valid conclusions. At the same time, the use of cost-effectiveness models has been drawn into question, due to the alleged arbitrary nature of their construction. This has led researchers to try and identify ways of improving the quality of cost-effectiveness models through identifying 'best practice', producing guidelines for peer review and identifying tests of validity. This paper investigates the issue of testing the validity of cost-effectiveness models or, perhaps more appropriately, whether it is possible to objectively measure the quality of a cost-effectiveness model. A review of the literature shows that there is much confusion over the different aspects of modelling that should be assessed in respect to model quality, and how this should be done. We develop a framework for assessing model quality in terms of: (i) the structure of the model; (ii) the inputs of the model; (iii) the results of the model; and (iv) the value of the model to the decision maker. Quality assessment is investigated within this framework, and it is argued that it is doubtful that a set of objective tests of validity will ever be produced, or indeed that such an approach would be desirable. The lack of any clearly definable and objective tests of validity means that the other parts of the evaluation process need to be given greater emphasis. Quality assurance forms a small part of a broader process and is best implemented in the form of good practice guidelines. A set of key guidelines are presented.

Cost-Benefit Analysis↗

PubMed2004

Assessing repeatability and validity of a visual analogue scale questionnaire for use in assessing pain and lameness in dogs.

OBJECTIVE: To develop a visual analogue scale (VAS) questionnaire that is repeatable and valid for use in assessing pain and lameness in dogs. SAMPLE POPULATION: 48 client-owned dogs with mild to moderate lameness. PROCEDURE: The dogs were from 3 studies conducted during a 3-year period. Of the 48 dogs, 19 were used in repeatability assessment, 48 were used in principal component analysis, and 44 were used in model selection procedures and validity testing. A test-retest measure of repeatability was conducted on dogs with a change of < 10% in vertical peak force. A force platform was used as the criterion-referenced standard for detecting lameness. Principal component analysis was used to describe dimensionality of the data. Repeatable questions were used as explanatory variables in multiple regression models to predict force plate measurements. Peak vertical, craniocaudal, and associated impulses were the forces used to quantify lameness. The regression models were used to test the criterion validity of the questionnaire. RESULTS: 19 of 39 questions were found to be repeatable on the basis of a Spearman rank-correlation cut point of > 0.6. Model selection procedures resulted in 3 overlapping subsets of questions that were considered valid representations of the forces measured (vertical peak, vertical impulse, and propulsion peak). Each reduced model fit the data as well as the full model. CONCLUSIONS AND CLINICAL RELEVANCE: The VAS questionnaire was repeatable and valid for use in assessing the degree of mild to moderate lameness in dogs.

Animals↗

PubMed1992

Assessing the likelihood of reliable workplace behavior: further contributions to the validation of the Employee Reliability Inventory.

This paper summarizes a number of studies in which the validity of the Employee Reliability Inventory, a preemployment screening instrument designed to assess the likelihood of reliable and productive workplace behavior, was examined. Criterion-related studies compared the scores of a broadly diverse group of job applicants with those obtained from an array of criterion and comparison groups, for whom there was documented evidence of reliable or unreliable behavior. Criterion-related evidence indicates that the six scales are effective in differentiating a variety of criterion groups with unreliable behavior from a number of different job applicant comparison groups. Construct-related evidence for the validity of an emotional adjustment scale is reported as well. The issue of response distortion in preemployment inventories is discussed, and data are reported which indicate that scores on all six scales appear to be functionally free from the potentially confounding effects of response distortion. These results are consistent with the original validation and cross-validation findings, which supported the validity of the six scales when assessing the likelihood of reliable behavior in a population of job applicants.

Adult↗

PubMed1990

The validity of self-reported abstinence and quality sobriety following chemical dependency treatment.

The validity of self-reports from 171 former patients at a 28-day inpatient treatment program was examined by comparing self-report measures of abstinence and current life functioning with concurrent reports by significant others. Strong convergent validation was found, with 92% of significant others agreeing with the self-reports of the former clients. The "quality of sobriety" measures of familial, occupational, social, and emotional adjustment were studied and validated by the convergent validation technique. Discussed is the value of convergent validation in terms of both follow-up success rates and program evaluation. Methodological concerns and resulting limitations of the data are reviewed.

Adult↗

PubMed2005

Masked priming of number judgments depends on prime validity and task.

The influence of brief masked primes (42 or 50 msec) on number target judgments is shown to be highly sensitive to the list-wide validity of the primes for performing a particular target task. Odd/even judgments were facilitated on parity-valid trials (e.g., 1-7) relative to parity-invalid trials (e.g., 6-7), especially when .8 rather than .2 of the trials were parity valid. The opposite pattern was observed with magnitude judgments relative to 5: Responses were facilitated on magnitude- valid trials (e.g., 6-7) relative to magnitude-invalid trials (e.g., 1-7), especially when .8 of the trials were magnitude valid. These results are consistent with Bodner and Masson's (2001) claim that a processing episode constructed during a masked prime event is more likely to be recruited when there is a high probability that it will facilitate responding to the target.

Humans↗

PubMed1991

Validation of prior nursing knowledge and performance in BSN education by RN students.

This ex post facto study was designed to investigate the use of validation testing of prior nursing knowledge by registered nurse (RN) students for possible correlates usable in baccalaureate nursing education. Record reviews were used with a convenience sample of 182 registered nurses enrolled in a baccalaureate nursing program. Criteria for selection of records included documentation of performance on a standardized validation exam and achievement in two required junior-level clinical courses. The four null hypotheses were rejected with the validation exam as the dependent measure. Significant positive relationships were found with mean scoring on the validation measure and achievement in prerequisite and required upper-division course work. Findings also indicated significantly higher scores on the validation exam after a longer time since graduation from the basic nursing program. Implications of practice experience and academic achievement in the basic nursing program need to be considered in the case of RN students who wish to pursue a baccalaureate in nursing.

Education, Nursing, Associate↗

PubMed2002

Changing conceptions of measurement validity: an update on the new standards.

This article serves as a follow up to a 1997 article in the Journal of Nursing Education, in which the author presented a historical overview of the ways in which views of measurement validity had changed during the past half century. The new American Educational Research Association, American Psychological Association, and National Council on Measurement in Education Standards for Educational and Psychological Testing, released in 1999, includes a revised conceptualization of validity. The key changes, including the elimination of the old "trinity" view of validity and the operationalization of validity as five types of evidence, are described in this article, and specific ways to obtain evidence of each type are provided. The article concludes with a brief discussion of some of the major continuing issues and challenges in validity theory and practice.

Data Interpretation, Statistical↗

PubMed2000

Validation of death certificate diagnosis of out-of-hospital coronary heart disease deaths in Olmsted County, Minnesota.

OBJECTIVE: To evaluate the validity of death certificate diagnosis of out-of-hospital (OOH) coronary heart disease (CHD) and sudden cardiac death (SCD) in Olmsted County, Minnesota, between 1981 and 1994. METHODS: In this review of the medical records, autopsy reports, and coroner's files, OOH deaths with heart disease as the underlying cause of death on the death certificate were classified into CHD (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] codes 410-414) and non-CHD (other ICD-9-CM heart disease codes) deaths. A 10% random sample (n = 174) of these death certificates was reviewed by physicians, and published validation criteria were applied to classify these deaths into validated CHD or non-CHD categories. Sudden cardiac death was defined as validated CHD that occurred at an OOH location with less than 24 hours between symptom onset and death. RESULTS: The death certificate definition of OOH CHD death (ICD-9-CM codes 410-414) had high sensitivity and positive predictive value of 91% and 96%, respectively. The specificity and the negative predictive value were slightly lower at 86% and 72%, respectively. The sensitivity of death certificate diagnosis of CHD for validated SCD was 89%, and the positive predictive value was 77%. Using a more restrictive definition of SCD, that is, less than 1 hour between the onset of symptoms and death, the positive predictive value of CHD codes for SCD was lower at 52%. CONCLUSIONS: In Olmsted County, the positive predictive values of death certificate diagnosis for OOH CHD and SCD are high. Relying on death certificate diagnoses results in about 5% underestimation of the true CHD rates, whereas their use as a surrogate for SCD yields a 16% overestimation of the true SCD rates.

Autopsy↗

PubMed2004

Human Neck Finite Element Model Development and Validation against Original Experimental Data.

This study proposes a detailed FEM of a human volunteer's neck and proceeds to an original model validation against experimental data recorded with this human volunteer. In order to evaluate the new model against existing data a successful temporal validation of the model was obtained under frontal, lateral, oblique and rear impact. New validation parameters are based on an experimental test proceeded in the frequency domain in order to extract the volunteer's Head-Neck system's modal characteristics. In depth validation of the head neck FEM is then performed by superposing the numerical and experimental frequency response function. Model optimisation in the frequency domain permitted after significant properties modification to reproduced accurately both, the neck extension mode at 1.4 Hz and the head retraction mode at 8.8 Hz. Finally the "frequency domain optimised" FEM response was superimposed with the temporal corridors provided in the literature. It must be mentioned that the model's response in the temporal domain remains inside existing corridors after this model optimisation in the frequency domain illustrating that the temporal validation is not accurate enough. This study proposes a neck model with improved geometry description and biofidelity with special attention paid to the retraction mode, a phenomenon which is often masked in the temporal domain.

Journal Article↗