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

ABSTRACT: We define the minimal important change (MIC) as a threshold for a minimal within-person change over time above which patients perceive themselves importantly changed. There is a lot of confusion about the concept of MIC, particularly about the concepts of minimal important change and minimal detectable change, which questions the validity of published MIC values. The aims of this study were: (1) to clarify the concept of MIC and how to use it; (2) to provide practical guidance for estimating methodologically sound MIC values; and (3) to improve the applicability of PROMIS by summarizing the available evidence on plausible PROMIS MIC values. We discuss the concept of MIC and how to use it and provide practical guidance for estimating MIC values. In addition, we performed a systematic review in PubMed on MIC values of any PROMIS measure from studies using recommended approaches. A total of 50 studies estimated the MIC of a PROMIS measure, of which 19 studies used less appropriate methods. MIC values of the remaining 31 studies ranged from 0.1 to 12.7 T-score points. We recommend to use the predictive modeling method, possibly supplemented with the vignette-based method, in future MIC studies. We consider a MIC value of 2-6 T-score points for PROMIS measures reasonable to assume at this point. For surgical interventions a higher MIC value might be appropriate. We recommend more high-quality studies estimating MIC values for PROMIS.

SUBMITTER: Terwee CB

PROVIDER: S-EPMC8481206 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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

Terwee Caroline B CB Peipert John Devin JD Chapman Robert R Lai Jin-Shei JS Terluin Berend B Cella David D Griffiths Pip P Mokkink Lidwine B LB

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation 20210710 10

We define the minimal important change (MIC) as a threshold for a minimal within-person change over time above which patients perceive themselves importantly changed. There is a lot of confusion about the concept of MIC, particularly about the concepts of minimal important change and minimal detectable change, which questions the validity of published MIC values. The aims of this study were: (1) to clarify the concept of MIC and how to use it; (2) to provide practical guidance for estimating met ...[more]

PMID: 34247326

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Project description:BackgroundThe minimal important difference is a valuable metric in ascertaining the clinical relevance of a treatment, offering valuable guidance in patient management. There is a lack of available evidence concerning this metric in the context of outcomes related to female urinary incontinence, which might negatively impact clinical decision-making.ObjectivesTo summarize the minimal important difference of patient-reported outcome measures associated with urinary incontinence, calculated according to both distribution- and anchor-based methods.MethodsThis is a systematic review conducted according to the PRISMA guidelines. The search strategy including the main terms for urinary incontinence and minimal important difference were used in five different databases (Medline, Embase, CINAHL, Web of Science, and Scopus) in 09 June 2021 and were updated in January 09, 2024 with no limits for date, language or publication status. Studies that provided minimal important difference (distribution- or anchor-based methods) for patient-reported outcome measures related to female urinary incontinence outcomes were included. The study selection and data extraction were performed independently by two different researchers. Only studies that reported the minimal important difference according to anchor-based methods were assessed by credibility and certainty of the evidence. When possible, absolute minimal important differences were calculated for each study separately according to the mean change of the group of participants that slightly improved.ResultsTwelve studies were included. Thirteen questionnaires with their respective minimal important differences reported according to distribution (effect size, standard error of measurement, standardized response mean) and anchor-based methods were found. Most of the measures for anchor methods did not consider the smallest difference identified by the participants to calculate the minimal important difference. All reports related to anchor-based methods presented low credibility and very low certainty of the evidence. We pooled 20 different estimates of minimal important differences using data from primary studies, considering different anchors and questionnaires.ConclusionsThere is a high variability around the minimal important difference related to patient-reported outcome measures for urinary incontinence outcomes according to the method of analysis, questionnaires, and anchors used, however, the credibility and certainty of the evidence to support these is still limited.

Project description:BackgroundResponsiveness and minimal clinically important difference (MCID) are critical indices to understand whether observed improvement represents a meaningful improvement after intervention. Although simultaneous cognitive-exercise training (SCET; e.g., performing memory tasks while cycling) has been suggested to enhance the cognitive function of older adults, responsiveness and MCID have not been established. Hence, we aimed to estimate responsiveness and MCIDs of two dual task performance involving cognition and hand function in older adults with and without cognitive impairment and to compare the differences in responsiveness and MCIDs of the two dual task performance between older adults with and without cognitive impairment.MethodsA total of 106 older adults completed the Montreal Cognitive Assessment and two dual tasks before and after SCET. One dual task was a combination of Serial Sevens Test and Box and Block Test (BBT), and the other included frequency discrimination and BBT. We used effect size and standardized response mean to indicate responsiveness and used anchor- and distribution-based approaches to estimating MCID ranges. When conducting data analysis, all participants were classified into two cognitive groups, cognitively healthy (Montreal Cognitive Assessment ≥ 26) and cognitively impaired (Montreal Cognitive Assessment < 26) groups, based on the scores of the Montreal Cognitive Assessment before SCET.ResultsIn the cognitively healthy group, Serial Seven Test performance when tasked with BBT and BBT performance when tasked with Serial Seven Test were responsive to SCET (effect size = 0.18-0.29; standardized response mean = 0.25-0.37). MCIDs of Serial Seven Test performance when tasked with BBT ranged 2.09-2.36, and MCIDs of BBT performance when tasked with Serial Seven Test ranged 3.77-5.85. In the cognitively impaired group, only frequency discrimination performance when tasked with BBT was responsive to SCET (effect size = 0.37; standardized response mean = 0.47). MCIDs of frequency discrimination performance when tasked with BBT ranged 1.47-2.18, and MCIDs of BBT performance when tasked with frequency discrimination ranged 1.13-7.62.ConclusionsCurrent findings suggest that a change in Serial Seven Test performance when tasked with BBT between 2.09 and 2.36 corrected number (correct responses - incorrect responses) should be considered a meaningful change for older adults who are cognitively healthy, and a change in frequency discrimination performance when tasked with BBT between 1.47 and 2.18 corrected number (correct responses - incorrect responses) should be considered a meaningful change for older adults who are cognitively impaired. Clinical practitioners may use these established MCIDs of dual tasks involving cognition and hand function to interpret changes following SCET for older adults with and without cognitive impairment.Trial registrationNCT04689776, 30/12/2020.

Project description:ObjectivesTo systematically review and provide estimates of the minimal important change (MIC) and difference (MID) for outcome tools in people with knee osteoarthritis (OA) after non-surgical interventions. Design A systematic review.Data sourcesMEDLINE, CINAHL, Web of Science, Scopus and Cochrane databases were searched up to 21 September 2021.Eligibility criteriaWe included studies that calculated MIC and MID using any calculation method including anchor, consensus and distribution methods, for any knee OA outcome tool after non-surgical interventions.Data extraction and synthesisWe extracted reported MIC, MID and minimum detectable change (MDC) estimates. We used quality assessment tools appropriate to the studies' methods to screen out low-quality studies. Values were combined to produce a median and range, for each method.ResultsForty-eight studies were eligible (anchor-k=12, consensus-k=1 and distribution-k=35). MIC values for 13 outcome tools including Knee injury and Osteoarthritis Outcome Score (KOOS)-pain, activities of daily living (ADL), quality of life (QOL) and Western Ontario and McMaster Universities Arthritis Index (WOMAC)-function were estimated using 5 high-quality anchor studies. MID values for 23 tools including KOOS-pain, ADL, QOL and WOMAC-function, stiffness and total were estimated using 6 high-quality anchor studies. One moderate quality consensus study reported MIC for pain, function and global assessment. MDC values from distribution method estimates for 126 tools including KOOS-QOL and WOMAC-total were estimated using 38 good-to-fair-quality studies.ConclusionMedian MIC, MID and MDC estimates were reported for outcome tools in people with knee OA after non-surgical interventions. The results of this review clarify the current understanding of MIC, MID and MDC in the knee OA population. However, some estimates suggest considerable heterogeneity and require careful interpretation.Prospero registration numberCRD42020215952.

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

Publications

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

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