Statistical considerations in the psychometric validation of outcome measures. 2013

Alla Sikorskii, and Philip C Noble
Department of Statistics and Probability, Michigan State University, 619 Red Cedar Road, C423 Wells Hall, East Lansing, MI, 48824, USA, sikorska@stt.msu.edu.

The evaluation of the outcomes of total knee arthroplasty requires measurement tools that are valid, reliable, and responsive to change. However, the accuracy of any outcome measurement is determined by the validity and reliability of the instrument used. To ensure this accuracy, it is imperative that each instrument used in orthopaedics is free of biases leading to inaccurate estimates of treatment effects. WHERE ARE WE NOW?: Many patient-derived outcome instruments have been developed and tested through the application of the standard assessments that form the basis of classical test theory: validity, reliability, and responsiveness. These assessments determine if the instrument reliably measures what it is intended to measure, and if it captures differences among groups of patients or changes over time. WHERE DO WE NEED TO GO?: Thorough evaluation of the outcome instruments used in orthopaedics is a critical prerequisite for the continued improvement of effective patient care. Additional steps of psychometric testing that are sometimes overlooked include testing for differential item functioning (DIF) and the effects of the mode of administration of the outcome instrument. The use of suitable approaches to test for these potential sources of bias would facilitate the development of more robust outcome assessment in research and clinical practice. HOW DO WE GET THERE?: Testing for DIF, including the effects of mode of administration, may be performed using several analytical approaches. This will allow optimal application of each outcome instrument with respect to patient characteristics, time and mode of the administration, and modification, as necessary.

UI MeSH Term Description Entries
D010043 Outcome and Process Assessment, Health Care Evaluation procedures that focus on both the outcome or status (OUTCOMES ASSESSMENT) of the patient at the end of an episode of care - presence of symptoms, level of activity, and mortality; and the process (ASSESSMENT, PROCESS) - what is done for the patient diagnostically and therapeutically. Outcome and Process Assessment (Health Care),Donabedian Model,Donabedian Triad,Outcome and Process Assessment,Structure Process Outcome Triad,Model, Donabedian,Triad, Donabedian
D010147 Pain Measurement Scales, questionnaires, tests, and other methods used to assess pain severity and duration in patients or experimental animals to aid in diagnosis, therapy, and physiological studies. Analgesia Tests,Analogue Pain Scale,Formalin Test,McGill Pain Questionnaire,Nociception Tests,Pain Assessment,Pain Intensity,Pain Severity,Tourniquet Pain Test,Visual Analogue Pain Scale,Analog Pain Scale,Assessment, Pain,McGill Pain Scale,Visual Analog Pain Scale,Analgesia Test,Analog Pain Scales,Analogue Pain Scales,Formalin Tests,Intensity, Pain,Measurement, Pain,Nociception Test,Pain Assessments,Pain Intensities,Pain Measurements,Pain Questionnaire, McGill,Pain Scale, Analog,Pain Scale, Analogue,Pain Scale, McGill,Pain Severities,Pain Test, Tourniquet,Questionnaire, McGill Pain,Scale, Analog Pain,Scale, Analogue Pain,Scale, McGill Pain,Severity, Pain,Test, Analgesia,Test, Formalin,Test, Nociception,Test, Tourniquet Pain,Tests, Nociception,Tourniquet Pain Tests
D011237 Predictive Value of Tests In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test. Negative Predictive Value,Positive Predictive Value,Predictive Value Of Test,Predictive Values Of Tests,Negative Predictive Values,Positive Predictive Values,Predictive Value, Negative,Predictive Value, Positive
D011594 Psychometrics Assessment of psychological variables by the application of mathematical procedures. Psychometric
D011795 Surveys and Questionnaires Collections of data obtained from voluntary subjects. The information usually takes the form of answers to questions, or suggestions. Community Survey,Nonrespondent,Questionnaire,Questionnaires,Respondent,Survey,Survey Method,Survey Methods,Surveys,Baseline Survey,Community Surveys,Methodology, Survey,Nonrespondents,Questionnaire Design,Randomized Response Technique,Repeated Rounds of Survey,Respondents,Survey Methodology,Baseline Surveys,Design, Questionnaire,Designs, Questionnaire,Methods, Survey,Questionnaire Designs,Questionnaires and Surveys,Randomized Response Techniques,Response Technique, Randomized,Response Techniques, Randomized,Survey, Baseline,Survey, Community,Surveys, Baseline,Surveys, Community,Techniques, Randomized Response
D004185 Disability Evaluation Determination of the degree of a physical, mental, or emotional handicap. The diagnosis is applied to legal qualification for benefits and income under disability insurance and to eligibility for Social Security and workmen's compensation benefits. Disability Evaluations,Evaluation, Disability,Evaluations, Disability
D006302 Health Services Research The integration of epidemiologic, sociological, economic, and other analytic sciences in the study of health services. Health services research is usually concerned with relationships between need, demand, supply, use, and outcome of health services. The aim of the research is evaluation, particularly in terms of structure, process, output, and outcome. (From Last, Dictionary of Epidemiology, 2d ed) Health Care Research,Medical Care Research,Research, Health Services,Action Research,Health Services Evaluation,Healthcare Research,Research, Medical Care,Evaluation, Health Services,Evaluations, Health Services,Health Services Evaluations,Research, Action,Research, Health Care,Research, Healthcare
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D015203 Reproducibility of Results The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results. Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes

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