Methods for assessing responsiveness: a critical review and recommendations
TL;DR: A review of the literature suggests there are two major aspects of responsiveness, which characterizes the ability of a measure to change over a prespecified time frame and which reflects the extent to which change in a measure relates to correspondingchange in a reference measure of clinical or health status.
About: This article is published in Journal of Clinical Epidemiology.The article was published on 2000-05-01. It has received 1310 citations till now.
Citations
More filters
TL;DR: Clinicians can be confident that a 2-point change on the numerical pain rating scale (NPRS) represents clinically meaningful change that exceeds the bounds of measurement error.
Abstract: Study design Cohort study of patients with low back pain (LBP) receiving physical therapy. Objective To examine the responsiveness characteristics of the numerical pain rating scale (NPRS) in patients with LBP using a variety of methods. Summary of background data Although several studies have assessed the reliability and validity of the NPRS, few studies have characterized its responsiveness in patients with LBP. Methods Determination of change on the NPRS during 1 and 4 weeks was examined by calculating mean change, standardized effect size, Guyatt Responsiveness Index, area under a receiver operating characteristic curve, minimum clinically important difference, and minimum detectable change. Change in the NPRS from baseline to the 1 and 4-week follow-up was compared to the average of the patient and therapist's perceived improvement using the 15-point Global Rating of Change scale. Results The majority of patients had clinically meaningful improvement after both 1 and 4 weeks of rehabilitation. The standard error of measure was equal to 1.02, corresponding to a minimum detectable change of 2 points. The area under the curve at the 1 and 4-week follow-up was 0.72 (0.62, 0.81) and 0.92 (0.86, 0.97), respectively. The minimum clinically important difference at the 1 and 4-week follow-up corresponded to a change of 2.2 and 1.5 points, respectively. Conclusions Clinicians can be confident that a 2-point change on the NPRS represents clinically meaningful change that exceeds the bounds of measurement error.
1,132 citations
Cites methods from "Methods for assessing responsivenes..."
..., minimum clinically important difference).(13,15) Several studies assessing the responsiveness of pain intensity in patients with LBP using instruments such as the visual analog scale exist....
[...]
TL;DR: This article reviews current approaches to defining clinically meaningful change in health-related quality of life (HRQOL) and provides guidelines for their use and proposes a new terminology for describing meaningful change derived from anchor-based and distribution-based methods.
1,088 citations
Cites background or methods from "Methods for assessing responsivenes..."
..., Standard error of the None Increases with sample size x1 x0 (di d̄) n(n 1) 2000 [74] mean change...
[...]
...The paired t-statistic (see for example [74]) is used to test the hypothesis that there is no change in a measure over two time points....
[...]
..., sensitive) to change [74,109,110]....
[...]
...[74] Husted JA, Cook RJ, Farewll VT, et al....
[...]
TL;DR: The DASH can detect and differentiate small and large changes of disability over time after surgery in patients with upper-extremity musculoskeletal disorders and show treatment effectiveness after surgery for subacromial impingement and carpal tunnel syndrome.
Abstract: The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The main purpose of this study was to assess the longitudinal construct validity of the DASH among patients undergoing surgery. The second purpose was to quantify self-rated treatment effectiveness after surgery. The longitudinal construct validity of the DASH was evaluated in 109 patients having surgical treatment for a variety of upper-extremity conditions, by assessing preoperative-to-postoperative (6–21 months) change in DASH score and calculating the effect size and standardized response mean. The magnitude of score change was also analyzed in relation to patients' responses to an item regarding self-perceived change in the status of the arm after surgery. Performance of the DASH as a measure of treatment effectiveness was assessed after surgery for subacromial impingement and carpal tunnel syndrome by calculating the effect size and standardized response mean. Among the 109 patients, the mean (SD) DASH score preoperatively was 35 (22) and postoperatively 24 (23) and the mean score change was 15 (13). The effect size was 0.7 and the standardized response mean 1.2. The mean change (95% confidence interval) in DASH score for the patients reporting the status of the arm as "much better" or "much worse" after surgery was 19 (15–23) and for those reporting it as "somewhat better" or "somewhat worse" was 10 (7–14) (p = 0.01). In measuring effectiveness of arthroscopic acromioplasty the effect size was 0.9 and standardized response mean 0.5; for carpal tunnel surgery the effect size was 0.7 and standardized response mean 1.0. The DASH can detect and differentiate small and large changes of disability over time after surgery in patients with upper-extremity musculoskeletal disorders. A 10-point difference in mean DASH score may be considered as a minimal important change. The DASH can show treatment effectiveness after surgery for subacromial impingement and carpal tunnel syndrome. The effect size and standardized response mean may yield substantially differing results.
924 citations
TL;DR: The purpose of this article is to assist appropriate interpretation of the GRC results and to provide evidence-informed advice to guide design and administration of GRC scales.
Abstract: Most clinicians ask their patients to rate whether their health condition has improved or deteriorated over time and then use this information to guide management decisions. Many studies also use patient-rated change as an outcome measure to determine the efficacy of a particular treatment. Global rating of change (GRC) scales provide a method of obtaining this information in a manner that is quick, flexible, and efficient. As with any outcome measure, however, meaningful interpretation of results can only be undertaken with due consideration of the clinimetric properties, strengths, and weaknesses of the instrument. The purpose of this article is to summarize this information to assist appropriate interpretation of the GRC results and to provide evidence-informed advice to guide design and administration of GRC scales. These considerations are relevant and applicable to the use of GRC scales both in the clinic and in research.
907 citations
TL;DR: A lack of clarity exists about the definition and adequate approach for evaluating responsiveness as discussed by the authors, and a lack of distinction between cross-sectional and longitudinal validity arises mostly from the lack of a distinction between treatment effect and responsiveness defined as the correlation of changes in the instrument with changes in other measures.
Abstract: A lack of clarity exists about the definition and adequate approach for evaluating responsiveness. An overview is presented of different categories of definitions and methods used for calculating responsiveness identified through a literature search. Twenty-five definitions and 31 measures were found. When applied to a general and a disease-specific quality of life questionnaire large variation in results was observed, partly explained by different goals of existing methods. Four major issues are considered to claim the usefulness of an evaluative health-related quality of life (HRQL) instrument. Their relation with responsiveness is discussed. The confusion about responsiveness arises mostly from a lack of distinction between cross-sectional and longitudinal validity and from a lack of distinction between responsiveness defined as the effect of treatment and responsiveness defined as the correlation of changes in the instrument with changes in other measures. All measures of what is currently called responsiveness can be looked at as measures of longitudinal validity or as measures of treatment effect. The latter ones tell us little about how well the instrument serves its purpose and are only of use in interpreting score changes. We therefore argue that the concept of responsiveness can be rejected as a separate measurement property of an evaluative instrument.
590 citations
References
More filters
TL;DR: A 36-item short-form survey designed for use in clinical practice and research, health policy evaluations, and general population surveys to survey health status in the Medical Outcomes Study is constructed.
Abstract: A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
33,857 citations
Book•
07 Dec 1989TL;DR: In this article, the authors propose three basic concepts: devising the items, selecting the items and selecting the responses, from items to scales, reliability and validity of the responses.
Abstract: 1. Introduction 2. Basic concepts 3. Devising the items 4. Scaling responses 5. Selecting the items 6. Biases in responding 7. From items to scales 8. Reliability 9. Generalizability theory 10. Validity 11. Measuring change 12. Item response theory 13. Methods of administration 14. Ethical considerations 15. Reporting test results Appendices
9,316 citations
Book•
01 Jan 1983
TL;DR: In this article, a simple linear regression with one predictor variable variable is proposed for time series data, where the predictor variable is a linear regression model with a single predictor variable and the regression model is a combination of linear regression and regression with multiple predictors.
Abstract: Part1 Simple Linear Regression 1Linear Regression with One Predictor Variable 2Inferences in Regression and Correlation Analysis 3Diagnostics and Remedial Measures 4 Simultaneous Inferences and Other Topics in Regression Analysis 5Matrix Approach to Simple Linear Regression Analysis Part 2Multiple Linear Regression 6Multiple Regression I 7 Multiple Regression II 8Building the Regression Model I: Models for Quantitative and Qualitative Predictors 9 Building the Regression Model II: Model Selection and Validation 10Building the Regression Model III: Diagnostics 11Remedial Measures and Alternative Regression Techniques 12Autocorrelation in Time Series Data Part 3Nonlinear Regression 13Introduction to Nonlinear Regression and Neural Networks 14Logistic Regression, Poisson Regression, and Generalized Linear Models
5,099 citations
TL;DR: A structure for representation of patient outcome is presented, together with a method for outcome measurement and validation of the technique in rheumatoid arthritis, and these techniques appear extremely useful for evaluation of long term outcome of patients with rheumatic diseases.
Abstract: A structure for representation of patient outcome is presented, together with a method for outcome measurement and validation of the technique in rheumatoid arthritis. The paradigm represents outcome by five separate dimensions: death, discomfort, disability, drug (therapeutic) toxicity, and dollar cost. Each dimension represents an outcome directly related to patient welfare. Quantitation of these outcome dimensions may be performed at interview or by patient questionnaire. With standardized, validated questions, similar scores are achieved by both methods. The questionnaire technique is preferred since it is inexpensive and does not require interobserver validation. These techniques appear extremely useful for evaluation of long term outcome of patients with rheumatic diseases.
4,253 citations
TL;DR: An approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change is developed, and a plausible range within which the minimal clinically important difference (MCID) falls is established.
4,170 citations