Individual patient monitoring in daily clinical practice: a critical evaluation of minimal important change
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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.
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.
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.
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.
KeywordsPersonalized care Outcome assessment Psychometrics Clinimetrics Satisfaction Rheumatoid arthritis
The authors thank the following people for their help in recruiting patients and ensuring excellent data management: Joke Alberts-Pijnenborg, Erik Brummelkamp, Thea van Gaalen, Rienke Korver, Marion de Lange-Brandt, Lia Schalkwijk, Diana van Tuijl, Inge Verhagen-Stolk and Carine Vogel.
For this study, patients were required to fill out a one page questionnaire before their outpatient clinic visit. Data of these questionnaires were combined with data from a daily practice registry and were only used for research purposes. This type of study is classified as a non-invasive, observational study with a negligible risk and low respondent burden. According to Dutch legal and medical ethical standards, approval of an ethics committee is not required for this type of study and was therefore not obtained. All patients were informed by a specialized rheumatology nurse about the aim and duration of the study and the requirements for participants prior to their inclusion. All participants were free to revoke their participation in the study at any time and without notice of a reason. All data disclosing the identity of subjects were removed before analysis.
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