Individual Patient Monitoring in Daily Clinical Practice: a Critical Evaluation of Minimal Important Change

Overview

Journal Qual Life Res

Specialties Pharmacology
Rehabilitation Medicine

Date 2014 Sep 26

PMID 25252608

Citations 5

Authors

Jos Hendrikx

Jaap Fransen

Wietske Kievit

Piet L C M van Riel

Affiliations

Soon will be listed here.

Abstract

Purpose: In daily practice, physicians translate knowledge from clinical trials to practice, to improve health in individual patients. To help interpret meaningful change on disease outcome measures, the concept of minimal important change (MIC) was conceived. The objective of this study was to investigate whether MIC values are suited for individual patient monitoring.

Methods: Three main elements of the MIC concept were evaluated: (1) MIC values for improvement and deterioration were determined, and the amount of misclassification present in quantifying minimal change was analyzed. (2) Discordance between change categories (improved, unchanged, deteriorated), defined by the MIC values, and patients' satisfaction with their health was inspected. (3) Discordance between change categories, defined by MIC values, and patients' willingness to alter therapy was inspected.

Results: MIC value analysis was based on 469 patients with RA seen in daily practice. The chance of falsely classifying health change of an individual patient was high (false-positive range 19-30 % and false-negative range 43-72 %). Of patients classified as improved, 24 % were not satisfied with their health and 69 % were not willing to change therapy. Of patients classified as deteriorated, 54 % were satisfied with their health and 57 % were not willing to change therapy.

Conclusions: The misclassification in the quantification of change and high proportions of discordance between change categories defined by MIC cutoff values and patients' satisfaction and willingness to alter therapy indicate that MIC values as such are not suited for individual patient monitoring.

Citing Articles

Responsiveness and meaningful thresholds of PROMIS pain interference, fatigue, and physical function forms in adults with idiopathic inflammatory myopathies: Report from the OMERACT Myositis Working Group.

Saygin D, DiRenzo D, Raaphorst J, de Groot I, Bingham C, Lundberg I Semin Arthritis Rheum. 2023; 64:152339.

PMID: 38141522 PMC: 11663439. DOI: 10.1016/j.semarthrit.2023.152339.

Transitions in depression: if, how, and when depressive symptoms return during and after discontinuing antidepressants.

Smit A, Snippe E, Bringmann L, Hoenders H, Wichers M Qual Life Res. 2022; 32(5):1295-1306.

PMID: 36418524 PMC: 10123048. DOI: 10.1007/s11136-022-03301-0.

Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures.

Terwee C, Peipert J, Chapman R, Lai J, Terluin B, Cella D Qual Life Res. 2021; 30(10):2729-2754.

PMID: 34247326 PMC: 8481206. DOI: 10.1007/s11136-021-02925-y.

The challenge of measuring intra-individual change in fatigue during cancer treatment.

Moinpour C, Donaldson G, Davis K, Potosky A, Jensen R, Gralow J Qual Life Res. 2016; 26(2):259-271.

PMID: 27469506 PMC: 5274585. DOI: 10.1007/s11136-016-1372-9.

Monitoring rheumatoid arthritis using an algorithm based on patient-reported outcome measures: a first step towards personalised healthcare.

Hendrikx J, Fransen J, van Riel P RMD Open. 2015; 1(1):e000114.

PMID: 26629364 PMC: 4654097. DOI: 10.1136/rmdopen-2015-000114.

References

Ferreira M, Herbert R, Ferreira P, Latimer J, Ostelo R, Nascimento D . A critical review of methods used to determine the smallest worthwhile effect of interventions for low back pain. J Clin Epidemiol. 2011; 65(3):253-61. DOI: 10.1016/j.jclinepi.2011.06.018. View

Terwee C, Roorda L, Dekker J, Bierma-Zeinstra S, Peat G, Jordan K . Mind the MIC: large variation among populations and methods. J Clin Epidemiol. 2009; 63(5):524-34. DOI: 10.1016/j.jclinepi.2009.08.010. View

Fraenkel L, Bogardus S, Concato J, Felson D, Wittink D . Patient preferences for treatment of rheumatoid arthritis. Ann Rheum Dis. 2004; 63(11):1372-8. PMC: 1754807. DOI: 10.1136/ard.2003.019422. View

Khan N, Spencer H, Abda E, Aggarwal A, Alten R, Ancuta C . Determinants of discordance in patients' and physicians' rating of rheumatoid arthritis disease activity. Arthritis Care Res (Hoboken). 2011; 64(2):206-14. PMC: 3703925. DOI: 10.1002/acr.20685. View

Browne J, van der Meulen J, Lewsey J, Lamping D, Black N . Mathematical coupling may account for the association between baseline severity and minimally important difference values. J Clin Epidemiol. 2010; 63(8):865-74. DOI: 10.1016/j.jclinepi.2009.10.004. View

Barton J . Patient preferences and satisfaction in the treatment of rheumatoid arthritis with biologic therapy. Patient Prefer Adherence. 2009; 3:335-44. PMC: 2792871. DOI: 10.2147/ppa.s5835. View

Smolen J, Landewe R, Breedveld F, Buch M, Burmester G, Dougados M . EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2013; 73(3):492-509. PMC: 3933074. DOI: 10.1136/annrheumdis-2013-204573. View

Wells G, Anderson J, Beaton D, Bellamy N, Boers M, Bombardier C . Minimal clinically important difference module: summary, recommendations, and research agenda. J Rheumatol. 2001; 28(2):452-4. View

Strand V, Boers M, Idzerda L, Kirwan J, Kvien T, Tugwell P . It's good to feel better but it's better to feel good and even better to feel good as soon as possible for as long as possible. Response criteria and the importance of change at OMERACT 10. J Rheumatol. 2011; 38(8):1720-7. DOI: 10.3899/jrheum.110392. View

10.

Sanderson T, Morris M, Calnan M, Richards P, Hewlett S . What outcomes from pharmacologic treatments are important to people with rheumatoid arthritis? Creating the basis of a patient core set. Arthritis Care Res (Hoboken). 2010; 62(5):640-6. PMC: 2887082. DOI: 10.1002/acr.20034. View

11.

Ward M, Guthrie L, Alba M . Clinically important changes in individual and composite measures of rheumatoid arthritis activity: thresholds applicable in clinical trials. Ann Rheum Dis. 2014; 74(9):1691-6. PMC: 4216638. DOI: 10.1136/annrheumdis-2013-205079. View

12.

Revicki D, Hays R, Cella D, Sloan J . Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008; 61(2):102-9. DOI: 10.1016/j.jclinepi.2007.03.012. View

13.

Wolfe F, Michaud K . Proposed metrics for the determination of rheumatoid arthritis outcome and treatment success and failure. J Rheumatol. 2008; 36(1):27-33. DOI: 10.3899/jrheum.080591. View

14.

Kievit W, van Hulst L, van Riel P, Fraenkel L . Factors that influence rheumatologists' decisions to escalate care in rheumatoid arthritis: results from a choice-based conjoint analysis. Arthritis Care Res (Hoboken). 2010; 62(6):842-7. PMC: 3682224. DOI: 10.1002/acr.20123. View

15.

Dougados M, Brault Y, Logeart I, van der Heijde D, Gossec L, Kvien T . Defining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the Rheumatoid Arthritis Impact of Disease (RAID). Arthritis Res Ther. 2012; 14(3):R129. PMC: 3446510. DOI: 10.1186/ar3859. View

16.

Beaton D, Boers M, Wells G . Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr Opin Rheumatol. 2002; 14(2):109-14. DOI: 10.1097/00002281-200203000-00006. View

17.

Ferreira M, Ferreira P, Herbert R, Latimer J . People with low back pain typically need to feel 'much better' to consider intervention worthwhile: an observational study. Aust J Physiother. 2009; 55(2):123-7. DOI: 10.1016/s0004-9514(09)70042-x. View

18.

Wolfe F, Michaud K . Resistance of rheumatoid arthritis patients to changing therapy: discordance between disease activity and patients' treatment choices. Arthritis Rheum. 2007; 56(7):2135-42. DOI: 10.1002/art.22719. View

19.

Barrett B . Sufficiently important difference: concepts, caveats, and challenges. Med Decis Making. 2013; 33(6):869-74. DOI: 10.1177/0272989X13476764. View

20.

Kvamme M, Kristiansen I, Lie E, Kvien T . Identification of cutpoints for acceptable health status and important improvement in patient-reported outcomes, in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. J Rheumatol. 2009; 37(1):26-31. DOI: 10.3899/jrheum.090449. View