scholarly journals Minimal important change and responsiveness of the Migraine Disability Assessment Score (MIDAS) questionnaire

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gabriela F. Carvalho ◽  
Kerstin Luedtke ◽  
Tobias Braun

Abstract Background The MIDAS is the most used questionnaire to evaluate migraine-related disability, but its utility to assess treatment response remains unclear. Our aim was to estimate the MIDAS’ minimal important change (MIC) value and its responsiveness. Methods A total of 103 patients were enrolled in a non-pharmacological, preference-based clinical trial. MIDAS and global rating of self-perceived change (GRoC) scores were collected at baseline, after 5 weeks of treatment, 4-weeks and 3-months follow-up after treatment. Anchor-based approaches were used to establish MIC values and responsiveness. Findings In all 3 timepoint comparisons, MIDAS presented a MIC of 4.5 points. A moderate positive correlation was identified between the MIDAS change and GRoC scores. The area under the curve ranged from 0.63 to 0.68. Conclusions This study showed that MIDAS has a limited responsiveness to change. A change of 4.5 points or more represents a clinically important change for patients with high frequent migraine and chronic migraine receiving non-pharmacological treatment.

2020 ◽  
Vol 20 (3) ◽  
pp. 483-490
Author(s):  
Shiva Komesh ◽  
Noureddin Nakhostin Ansari ◽  
Soofia Naghdi ◽  
Parisa Alaei ◽  
Scott Hasson ◽  
...  

AbstractBackground and aimsThe Core Outcome Measures Index (COMI) is a short, self-reported questionnaire for assessing important outcomes in patients with low back pain (LBP). The present study was conducted to explore the responsiveness and longitudinal validity of the Persian COMI (COMI-P) in patients with non-specific chronic LBP.MethodsIn this prospective cohort study of patients with non-specific chronic LBP receiving physiotherapy, patients completed a booklet containing the COMI-P, Persian Functional Rating Index (FRI-P), and a visual analogue scale (VAS) for pain before and after the end of ten-sessions of physiotherapy. Patients also completed a global rating of change scale (GRCS) at the end of the physiotherapy. Responsiveness was examined by means of internal responsiveness methods [t-test, standard effect size (SES); standardized response mean (SRM), and Guyatt responsiveness index (GRI)] and external responsiveness methods [correlation with external criteria and receiver operating characteristics (ROC) curve].ResultsFifty patients with a mean age of 50.62 ± 13.8 years participated. The paired t-test showed significant changes in COMI-P scores (p < 0.001). The effect sizes for COMI-P were large (range 0.96–1.23). The score changes for the COMI-P revealed significant correlations with FRI-P (r = 0.67, p < 0.001), the VAS (r = 0.65, p < 0.001), and the GRCS (r = 0.34, p = 0.02). The COMI-P change scores showed excellent correlation with the dichotomized smallest detectable change (SDC) criterion (r = 0.83, p < 0.001). The ROC area under the curve for the COMI-P based on the dichotomized SDC criterion was perfect. The minimal clinically important change was estimated 2.15 points (sensitivity 94% and specificity 100%).ConclusionsThe COMI-P appears to have responsiveness and longitudinal validity in detecting changes after physiotherapy for non-specific chronic LBP. An improvement of 2.15 points in COMI-P total score is required to be interpreted as minimally clinically important change in individual patients.


2013 ◽  
Vol 93 (2) ◽  
pp. 158-167 ◽  
Author(s):  
Marco Godi ◽  
Franco Franchignoni ◽  
Marco Caligari ◽  
Andrea Giordano ◽  
Anna Maria Turcato ◽  
...  

Background Recently, a new tool for assessing dynamic balance impairments has been presented: the 14-item Mini-BESTest. Objective The aim of this study was to compare the psychometric performance of the Mini-BESTest and the Berg Balance Scale (BBS). Design A prospective, single-group, observational design was used in the study. Methods Ninety-three participants (mean age=66.2 years, SD=13.2; 53 women, 40 men) with balance deficits were recruited. Interrater (3 raters) and test-retest (1–3 days) reliability were calculated using intraclass correlation coefficients (ICCs). Responsiveness and minimal important change were assessed (after 10 sessions of physical therapy) using both distribution-based and anchor-based methods (external criterion: the 15-point Global Rating of Change [GRC] scale). Results At baseline, neither floor effects nor ceiling effects were found in either the Mini-BESTest or the BBS. After treatment, the maximum score was found in 12 participants (12.9%) with BBS and in 2 participants (2.1%) with Mini-BESTest. Test-retest reliability for total scores was significantly higher for the Mini-BESTest (ICC=.96) than for the BBS (ICC=.92), whereas interrater reliability was similar (ICC=.98 versus .97, respectively). The standard error of measurement (SEM) was 1.26 and the minimum detectable change at the 95% confidence level (MDC95) was 3.5 points for Mini-BESTest, whereas the SEM was 2.18 and the MDC95 was 6.2 points for the BBS. In receiver operating characteristic curves, the area under the curve was 0.92 for the Mini-BESTest and 0.91 for the BBS. The best minimal important change (MIC) was 4 points for the Mini-BESTest and 7 points for the BBS. After treatment, 38 participants evaluated with the Mini-BESTest and only 23 participants evaluated with the BBS (out of the 40 participants who had a GRC score of ≥3.5) showed a score change equal to or greater than the MIC values. Limitations The consecutive sampling method drawn from a single rehabilitation facility and the intrinsic weakness of the GRC for calculating MIC values were limitations of the study. Conclusions The 2 scales behave similarly, but the Mini-BESTest appears to have a lower ceiling effect, slightly higher reliability levels, and greater accuracy in classifying individual patients who show significant improvement in balance function.


physioscience ◽  
2017 ◽  
Vol 13 (04) ◽  
pp. 162-169
Author(s):  
M. Bräuer ◽  
T. Schöttker-Königer ◽  
A. Schäfer

Zusammenfassung Hintergrund: Der Straight-Leg-Raise-Test (SLR) dient klinisch häufig zum Wiederbefund. Der kleinste klinisch relevante Unterschied (Minimal clinically important change, MCIC) und die Änderungssensitivität sind unbekannt. Ziel: Diese longitudinale multizentrische Studie untersuchte den MCIC und die Änderungssensitivität für den Straight-Leg-Raise bei Patienten mit subakuten/akuten unteren Rückenschmerzen (LBP) und/oder unilateralen Beinschmerzen. Methode: Bei den eingeschlossenen 10 Probanden mit ausstrahlenden LBP wurden zu 2 Zeitpunkten (t1; t2) der SLR beidseitig mit/ohne Dorsalextension, der LBP sowie die unilateralen Beinschmerzen und die Aktivitätseinschränkung gemessen. Zu t2 wurden die subjektive Veränderung des Gesundheitszustands mittels der Global Rating of Change Scale (GROC) und Korrelationen zwischen den Veränderungen im SLR und der genannten Parameter ermittelt. Mithilfe der Area under the Curve (AUC) und der Korrelationen wurden die Änderungssensitivität und die Schwellenwerte für den SLR berechnet. Ergebnisse: Die Veränderung des LBP zeigte gute bis sehr gute Korrelationen mit dem SLR mit/ohne Dorsalextension. Die AUC mit LBP als Anker erreichte im SLR einen fast akzeptablen Wert. Der dazugehörige Schwellenwert lag bei 17°. Schlussfolgerung: Die zu kleine Stichprobengröße ließ keine präzisen Aussagen zu. Es gibt jedoch Hinweise, dass der SLR als änderungssensitiv für die Konstrukte unilaterale Beinschmerzen und LBP gelten könnte.


2021 ◽  
Author(s):  
Selma Flora Nordqvist ◽  
Victor Brun Boesen ◽  
Åse Krogh Rasmussen ◽  
Ulla Feldt-Rasmussen ◽  
Laszlo Hegedüs ◽  
...  

Objective: ThyPRO is the standard thyroid patient-reported outcome (PRO). The change in scores that patients perceive as important remains to be ascertained. The purpose of this study was to determine values for minimal important change (MIC) for ThyPRO. Methods: A total of 435 patients treated for benign thyroid diseases completed ThyPRO at baseline and 6 weeks following treatment initiation. At 6-weeks follow-up, patients also completed Global Rating of Change items. For each 0-100 scale, two MIC values were identified: an MIC for groups, using the ROC curve method and an MIC for individual patients, using the reliable change Index. Results: ROC analyses provided group-MIC estimates of 6.3 to 14.3 (score range 0-100). Evaluation of area under the curve (AUC) supported the robustness for 9 of 14 scales (AUC > 0.7). Reliable change index estimates of individual-MIC were 8.0 to 21.1. For all scales but two, the individual-MIC values were larger than the group-MIC values. Conclusions: Interpretability of ThyPRO was improved by the establishment of MIC values, which was 6.3 to 14.3 for groups and 8.0 to 21.1 for individuals. Thus, estimates of which changes are clinically relevant, are now available for future studies. We recommend using MIC values found by ROC analyses to evaluate changes in groups of patients, whereas MIC values identified by a dual criterion, including the reliability of changes, should be used for individual patients, e.g. to identify individual responders in clinical studies or practice.


2019 ◽  
Vol 53 (23) ◽  
pp. 1474-1478 ◽  
Author(s):  
Ewa M Roos ◽  
Eleanor Boyle ◽  
Richard B Frobell ◽  
L Stefan Lohmander ◽  
Lina Holm Ingelsrud

IntroductionIn sports physiotherapy, medicine and orthopaedic randomised controlled trials (RCT), the investigators (and readers) focus on the difference between groups in change scores from baseline to follow-up. Mean score changes are difficult to interpret (‘is an improvement of 20 units good?’), and follow-up scores may be more meaningful. We investigated how applying three different responder criteria to change and follow-up scores would affect the ‘outcome’ of RCTs. Responder criteria refers to participants’ perceptions of how the intervention affected them.MethodsWe applied three different criteria—minimal important change (MIC), patient acceptable symptom state (PASS) and treatment failure (TF)—to the aggregate Knee injury and Osteoarthritis Outcome Score (KOOS4) and the five KOOS subscales, the primary and secondary outcomes of the KANON trial (ISRCTN84752559). This trial included young active adults with an acute ACL injury and compared two treatment strategies: exercise therapy plus early reconstructive surgery, and exercise therapy plus delayed reconstructive surgery, if needed.ResultsMIC: At 2 years, more than 90% in the two treatment arms reported themselves to be minimally but importantly improved for the primary outcome KOOS4. PASS: About 50% of participants in both treatment arms reported their KOOS4 follow-up scores to be satisfactory. TF: Almost 10% of participants in both treatment arms found their outcomes so unsatisfactory that they thought their treatment had failed. There were no statistically significant or meaningful differences between treatment arms using these criteria.ConclusionWe applied change criteria as well as cross-sectional follow-up criteria to interpret trial outcomes with more clinical focus. We suggest researchers apply MIC, PASS and TF thresholds to enhance interpretation of KOOS and other patient-reported scores. The findings from this study can improve shared decision-making processes for people with an acute ACL injury.


2019 ◽  
Vol 47 (2) ◽  
pp. 364-371 ◽  
Author(s):  
Julia C.A. Noorduyn ◽  
Victor A. van de Graaf ◽  
Lidwine B. Mokkink ◽  
Nienke W. Willigenburg ◽  
Rudolf W. Poolman ◽  
...  

Background: Responsiveness and the minimal important change (MIC) are important measurement properties to evaluate treatment effects and to interpret clinical trial results. The International Knee Documentation Committee (IKDC) Subjective Knee Form is a reliable and valid instrument for measuring patient-reported knee-specific symptoms, functioning, and sports activities in a population with meniscal tears. However, evidence on responsiveness is of limited methodological quality, and the MIC has not yet been established for patients with symptomatic meniscal tears. Purpose: To evaluate the responsiveness and determine the MIC of the IKDC for patients with meniscal tears. Study Design: Cohort study (design); Level of evidence 2. Methods: This study was part of the ESCAPE trial: a noninferiority multicenter randomized controlled trial comparing arthroscopic partial meniscectomy with physical therapy. Patients aged 45 to 70 years who were treated for a meniscal tear by arthroscopic partial meniscectomy or physical therapy completed the IKDC and 3 other questionnaires (RAND 36-Item Health Survey, EuroQol-5D-5L, and visual analog scales for pain) at baseline and 6-month follow-up. Responsiveness was evaluated by testing predefined hypotheses about the relation of the change in IKDC with regard to the change in the other self-reported outcomes. An external anchor question was used to distinguish patients reporting improvement versus no change in daily functioning. The MIC was determined by the optimal cutoff point in the receiver operating characteristic curve, which quantifies the IKDC score that best discriminated between patients with and without improvement in daily function. Results: Data from all 298 patients who completed baseline and 6-month follow-up questionnaires were analyzed. Responsiveness of the IKDC was confirmed in 7 of 10 predefined hypotheses about the change in IKDC score with regard to other patient-reported outcome measures. One hypothesis differed in the expected direction, while 2 hypotheses failed to meet the expected magnitude by 0.02 and 0.01 points. An MIC of 10.9 points was calculated for the IKDC of middle-aged and older patients with meniscal tears. Conclusion: This study showed that the IKDC is responsive to change among patients aged 45 to 70 years with meniscal tears, with an MIC of 10.9 points. This strengthens the value of the IKDC in quantifying treatment effects in this population.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Tobias Braun ◽  
Christian Thiel ◽  
Ralf-Joachim Schulz ◽  
Christian Grüneberg

Abstract Background In older hospital patients with cognitive spectrum disorders (CSD), mobility should be monitored frequently with standardised and psychometrically sound measurement instruments. This study aimed to examine the responsiveness, minimal important change (MIC), floor effects and ceiling effects of commonly used outcome assessments of mobility capacity in older patients with dementia, delirium or other cognitive impairment. Methods In a cross-sectional study that included acute older hospital patients with CSD (study period: 02/2015–12/2015), the following mobility assessments were applied: de Morton Mobility Index (DEMMI), Hierarchical Assessment of Balance and Mobility (HABAM), Performance Oriented Mobility Assessment, Short Physical Performance Battery, 4-m gait speed test, 5-times chair rise test, 2-min walk test, Timed Up and Go test, Barthel Index mobility subscale, and Functional Ambulation Categories. These assessments were administered shorty after hospital admission (baseline) and repeated prior to discharge (follow-up). Global rating of mobility change scales and a clinical anchor of functional ambulation were used as external criteria to determine the area under the curve (AUC). Construct- and anchor-based approaches determined responsiveness. MIC values for each instrument were established from different anchor- and distribution-based approaches. Results Of the 63 participants (age range: 69–94 years) completing follow-up assessments with mild (Mini Mental State Examination: 19–24 points; 67%) and moderate (10–18 points; 33%) cognitive impairment, 25% were diagnosed with dementia alone, 13% with delirium alone, 11% with delirium superimposed on dementia and 51% with another cognitive impairment. The follow-up assessment was performed 10.8 ± 2.5 (range: 7–17) days on average after the baseline assessment. The DEMMI was the most responsive mobility assessment (all AUC > 0.7). For the other instruments, the data provided conflicting evidence of responsiveness, or evidence of no responsiveness. MIC values for each instrument varied depending on the method used for calculation. The DEMMI and HABAM were the only instruments without floor or ceiling effects. Conclusions Most outcome assessments of mobility capacity seem insufficiently responsive to change in older hospital patients with CSD. The significant floor effects of most instruments further limit the monitoring of mobility alterations over time in this population. The DEMMI was the only instrument that was able to distinguish clinically important changes from measurement error. Trial registration German Clinical Trials Register (DRKS00005591). Registered February 2, 2015.


2014 ◽  
Vol 39 (6) ◽  
pp. 470-476 ◽  
Author(s):  
Paula W Rushton ◽  
William C Miller ◽  
A Barry Deathe

Background:The L Test is a reliable/valid clinical evaluation of mobility that measures walking speed in seconds. It can be used with individuals with lower limb amputation. Responsiveness of the L Test is not yet determined.Objectives:The purpose of this pilot study was to determine how well the L Test identified individuals with a lower limb amputation who have/have not undergone a minimal clinically important difference.Study design:Prospective follow-up study.Methods:In total, 33 individuals with lower limb amputation, deemed to require a major intervention, were recruited consecutively from a follow-up clinic. Participants completed the L Test at baseline and follow-up. A Global Rating Change scale was also completed at follow-up.Results:The participants had a mean age ± standard deviation of 60 ± 13.0 years, and 81.8% had a transtibial amputation. The mean ± standard deviation for the L Test change scores was 6.0 ± 13.9. The area under the curve was 0.67, and the minimal clinically important difference was 4.5 s.Conclusions:The L Test identified individuals as having an important clinical change. Results must be interpreted with caution, as the accuracy, based on the Global Rating Change scale, is low. Further inquiry into the L Test is encouraged.Clinical relevanceThe L Test can guide the clinical management of individuals with lower limb amputation. Results from this pilot study indicate that individuals with a lower limb amputation who improve by at least 4.5 s on the L Test after an intervention have likely undergone an important change. This result must be interpreted with caution given that the ability of the L Test to correctly identify individuals, who have and have not undergone an important change, using the Global Rating Change scale as the gold standard, is limited because this is a pilot study. It is plausible that the precision of the cut-point threshold could increase or decrease given a larger sample or when using a different method of identifying important clinical change.


Author(s):  
Christoffer von Essen ◽  
Riccardo Cristiani ◽  
Lise Lord ◽  
Anders Stålman

Abstract Purpose To analyze minimal important change (MIC), patient-acceptable symptom state (PASS) and treatment failure after reoperation within 2 years of primary ACL reconstruction and compare them with patients without additional surgery. Methods This is a retrospective follow-up study of a cohort from a single-clinic database with all primary ACLRs enrolled between 2005 and 2015. Additional surgery within 2 years of the primary ACLR on the ipsilateral knee was identified using procedural codes and analysis of medical records. Patients who completed the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire preoperatively and at the 2-year follow-up were included in the study. MIC, PASS and treatment failure thresholds were applied using the aggregate KOOS (KOOS4) and the five KOOS subscales. Results The cohort included 6030 primary ACLR and from this 1112 (18.4%) subsequent surgeries were performed on 1018 (16.9%) primary ACLRs. 24 months follow-up for KOOS was obtained on 523 patients (54%) in the reoperation group and 2084 (44%) in the no-reoperation group. MIC; the no-reoperation group had a significantly higher improvement on all KOOS subscales, Pain 70.3 vs 60.2% (p < 0.01), Symptoms 72.1 vs 57.4% (p < 0.01), ADL 56.3 vs 51.2% (p < 0.01), Sport/Rec 67.3 vs 54.4% (p < 0.01), QoL 73.9 vs 56.3% (p < 0.01). PASS; 62% in the non-reoperation group reported their KOOS4 scores to be satisfactory, while only 35% reported satisfactory results in the reoperated cohort (p < 0.05). Treatment failure; 2% in the non-reoperation group and 6% (p < 0.05) in the reoperation group considered their treatment to have failed. Conclusion Patients who underwent subsequent surgeries within 2 years of primary ACLR reported significantly inferior outcomes in MIC, PASS and treatment failure compared to the non-reoperated counterpart at the 2-year follow-up. This study provides clinicians with important information and knowledge about the outcomes after an ACLR with subsequent additional surgery. Level of evidence III.


2018 ◽  
Vol 52 (3) ◽  
pp. 1801384 ◽  
Author(s):  
Stephen M. Humphries ◽  
Jeffrey J. Swigris ◽  
Kevin K. Brown ◽  
Matthew Strand ◽  
Qi Gong ◽  
...  

We evaluated performance characteristics and estimated the minimal clinically important difference (MCID) of data-driven texture analysis (DTA), a high-resolution computed tomography (HRCT)-derived measurement of lung fibrosis, in subjects with idiopathic pulmonary fibrosis (IPF).The study population included 141 subjects with IPF from two interventional clinical trials who had both baseline and nominal 54- or 60-week follow-up HRCT. DTA scores were computed and compared with forced vital capacity (FVC), diffusing capacity of the lung for carbon monoxide, distance covered during a 6-min walk test and St George's Respiratory Questionnaire scores to assess the method's reliability, validity and responsiveness. Anchor- and distribution-based methods were used to estimate its MCID.DTA had acceptable reliability in subjects appearing stable according to anchor variables at follow-up. Correlations between the DTA score and other clinical measurements at baseline were moderate to weak and in the hypothesised directions. Acceptable responsiveness was demonstrated by moderate to weak correlations (in the directions hypothesised) between changes in the DTA score and changes in other parameters. Using FVC as an anchor, MCID was estimated to be 3.4%.Quantification of lung fibrosis extent on HRCT using DTA is reliable, valid and responsive, and an increase of ∼3.4% represents a clinically important change.


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