Responsiveness and validity in health status measurement: A clarification

Guyatt, Gordon; Deyo, Richard A.; Charlson, Mary E.; Levine, Mark; Mitchell, Alba

doi:10.1016/0895-4356(89)90128-5

Cited by 411 publications

(228 citation statements)

References 15 publications

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“…The methodological quality of the psychometric validation studies was assessed using criteria adopted from the COSMIN checklist19 20, University of Oxford PROMs development criteria and other studies21, 22, 23, 24, 25, 26, 27, 28. These criteria were compatible with the US Food and Drug Administration PROMs guidelines ( Table 1).…”

Section: Methodsmentioning

confidence: 99%

Systematic review assessing the measurement properties of patient-reported outcomes for venous leg ulcers

et al. 2017

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BackgroundA variety of instruments have been used to assess outcomes for patients with venous leg ulcers. This study sought to identify, evaluate and recommend the most appropriate patient‐reported outcome measures (PROMs) for English‐speaking patients with venous leg ulcers.MethodsThis systematic review used a two‐stage search approach. Electronic searches of major databases including MEDLINE were completed in October 2015, and then updated in July 2016. Additional studies were identified from citation checking. Study selection, data extraction and quality assessment were undertaken independently by at least two reviewers. Evaluation and summary of measurement properties of identified PROMs were done using standard and adapted study‐relevant criteria.ResultsTen studies with data for four generic PROMS and six condition‐specific measures were identified. No generic PROM showed adequate content and criterion validity; however, the EuroQoL Five Dimensions (EQ‐5D™), Nottingham Health Profile (NHP) and 12‐item Short‐Form Health Survey (SF‐12®) had good acceptability. In general, the EQ‐5D™ showed poor responsiveness in patients with venous leg ulcers. Most condition‐specific PROMs demonstrated poor criterion and construct validity. Overall, there was some evidence of internal consistency for the Venous Leg Ulcer Quality of Life (VLU‐QoL) and the Sheffield Preference‐based Venous Ulcer questionnaire (SPVU‐5D). Test–retest reliability was satisfactory for the Venous Leg Ulcer Self‐Efficacy Tool (VeLUSET).ConclusionThe NHP and VLU‐QoL questionnaire seemed the most suitable PROMs for use by clinicians. However, a valid condition‐specific PROM is still required.

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Section: Methodsmentioning

confidence: 99%

Systematic review assessing the measurement properties of patient-reported outcomes for venous leg ulcers

et al. 2017

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“…A person who responds yes at the first administration of the scale would logically answer yes in all subsequent administrations. Therefore, this item is not responsive to changes in emotional function, or suicide risk [17,40].…”

Section: Responsivenessmentioning

confidence: 99%

“…The third factor that influences the accuracy of functional rating scales is their ability to detect clinically important changes over time [31,40]. Responsiveness is also referred to as a measure of longitudinal validity or sensitivity to change.…”

Section: Responsivenessmentioning

confidence: 99%

“…When functional outcome scales are utilized to evaluate differences between 2 groups of subjects at one time point, reliability and validity are sufficient. However, for measures that are designed to evaluate changes over time, responsiveness is also a requirement [34,40]. An example of a nonresponsive item is BI have attempted suicide^from the Sickness Impact Profile, a general measure of health status.…”

Section: Responsivenessmentioning

confidence: 99%

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The Spectrum of Functional Rating Scales in Neurology Clinical Trials

Narayanaswami

2017

Neurotherapeutics

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The selection of an appropriate outcome measure is crucial to the success of a clinical trial, in order to obtain accurate results, which, in turn, influence patient care and future research. Outcomes that can be directly measured are mortality/survival. More frequently, neurology clinical trials evaluate outcomes that cannot be directly measured, such as disability, cognitive function, or change in symptoms of the condition under study. These complex outcomes are abstract ideas or latent constructs and are measured using rating scales. Functional rating scales typically assess the ability of patients to perform tasks and roles for everyday life. Rating scales should be valid (measure what they are supposed to measure), reliable (provide similar results if administered under the same conditions), and responsive (able to detect clinically important changes over time). The clinical relevance of rating scales depends on their ability to detect a minimal clinically important difference, and should be distinguished from statistical significance. Most rating scales are ordinal scales and have limitations. Modern psychometric methods of Rasch analysis and item response theory, termed latent trait theory, are increasingly being utilized to convert ordinal data to interval measurements, both to validate existing scales and to develop new scales. Patient-reported outcomes are being increasingly used in clinical trials and have a role in clinical quality assessment. The PROMIS and NeuroQoL databases are excellent resources for rigorously developed and validated patientreported outcomes.

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“…44 The purpose of a discriminative assessment is to compare 2 or more individuals or groups at a given point in time in the absence of a gold standard measure. 45 For the purpose of this review, discriminative tools were used to identify the presence or 45 Tool Reporting Type…”

Section: Tool Assessment Typementioning

confidence: 99%

Chronic Pain Assessment Tools for Cerebral Palsy: A Systematic Review

et al. 2015

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BACKGROUND AND OBJECTIVE: Chronic pain in children with cerebral palsy (CP) is underrecognized, leading to detriments in their physical, social, and mental well-being. Our objective was to identify, describe, and critique pediatric chronic pain assessment tools and make recommendations for clinical use for children with CP. Secondly, develop an evidenceinformed toolbox to support clinicians in the assessment of chronic pain in children with disabilities.

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Responsiveness and validity in health status measurement: A clarification

Cited by 411 publications

References 15 publications

Systematic review assessing the measurement properties of patient-reported outcomes for venous leg ulcers

Systematic review assessing the measurement properties of patient-reported outcomes for venous leg ulcers

The Spectrum of Functional Rating Scales in Neurology Clinical Trials

Chronic Pain Assessment Tools for Cerebral Palsy: A Systematic Review

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