scholarly journals Determining minimal important change for the thyroid-related quality of life questionnaire ThyPRO

2021 ◽  
Author(s):  
Selma Flora Nordqvist ◽  
Victor Brun Boesen ◽  
Åse Krogh Rasmussen ◽  
Ulla Feldt-Rasmussen ◽  
Laszlo Hegedüs ◽  
...  
Keyword(s):  
Area Under The Curve ◽  
Patient Reported Outcome ◽  
Important Change ◽  
Reliable Change Index ◽  
Global Rating ◽  
Minimal Important Change ◽  
Life Questionnaire ◽  
Reliable Change ◽  
Patient Reported ◽  
The Individual

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.

scholarly journals Assessing baseline dependency of anchor-based minimal important change (MIC): don’t stratify on the baseline score!

2021 ◽  
Author(s):  
Berend Terluin ◽  
Ewa M. Roos ◽  
Caroline B. Terwee ◽  
Jonas B. Thorlund ◽  
Lina H. Ingelsrud
Keyword(s):  
Real Data ◽  
Patient Reported Outcome ◽  
Health Condition ◽  
Important Change ◽  
Alternative Methods ◽  
Minimal Important Change ◽  
Baseline Score ◽  
Patient Reported ◽  
Before And After ◽  
Parallel Tests

Abstract Purpose The minimal important change (MIC) of a patient-reported outcome measure (PROM) is often suspected to be baseline dependent, typically in the sense that patients who are in a poorer baseline health condition need greater improvement to qualify as minimally important. Testing MIC baseline dependency is commonly performed by creating two or more subgroups, stratified on the baseline PROM score. This study’s purpose was to show that this practice produces biased subgroup MIC estimates resulting in spurious MIC baseline dependency, and to develop alternative methods to evaluate MIC baseline dependency. Methods Datasets with PROM baseline and follow-up scores and transition ratings were simulated with and without MIC baseline dependency. Mean change MICs, ROC-based MICs, predictive MICs, and adjusted MICs were estimated before and after stratification on the baseline score. Three alternative methods were developed and evaluated. The methods were applied in a real data example for illustration. Results Baseline stratification resulted in biased subgroup MIC estimates and the false impression of MIC baseline dependency, due to redistribution of measurement error. Two of the alternative methods require a second baseline measurement with the same PROM or another correlated PROM. The third method involves the construction of two parallel tests based on splitting the PROM’s item set. Two methods could be applied to the real data. Conclusion MIC baseline dependency should not be tested in subgroups based on stratification on the baseline PROM score. Instead, one or more of the suggested alternative methods should be used.

scholarly journals Assessing baseline dependency of anchor-based minimal important change (MIC): don’t stratify on the baseline score!

2021 ◽  
Author(s):  
Berend Terluin ◽  
Ewa M Roos ◽  
Caroline B Terwee ◽  
Jonas B Thorlund ◽  
Lina H Ingelsrud
Keyword(s):  
Real Data ◽  
Patient Reported Outcome ◽  
Health Condition ◽  
Important Change ◽  
Alternative Methods ◽  
Minimal Important Change ◽  
Baseline Score ◽  
Patient Reported ◽  
Before And After ◽  
Parallel Tests

Abstract Purpose The minimal important change (MIC) of a patient-reported outcome measure (PROM) is often suspected to be baseline dependent, typically in the sense that patients who are in a poorer baseline health condition need greater improvements to qualify as minimally important. Testing MIC baseline dependency is commonly performed by creating two or more subgroups, stratified on the baseline PROM score. This study’s purpose was to show that this practice produces biased subgroup MIC estimates resulting in spurious MIC baseline dependency, and to develop alternative methods to evaluate MIC baseline dependency. Methods Datasets with PROM baseline and follow-up scores and transition ratings were simulated with and without MIC baseline dependency. Mean change MICs, ROC-based MICs, predictive MICs and adjusted MICs were estimated before and after stratification on the baseline score. Three alternative methods were developed and evaluated. The methods were applied in a real data example for illustration. Results Baseline stratification resulted in biased subgroup MIC estimates and the false impression of MIC baseline dependency, due to redistribution of measurement error. Two of the alternative methods require a second baseline measurement with the same PROM or another correlated PROM. The third method involves the construction of two parallel tests based on splitting the PROM’s item set. Two methods could be applied to the real data. Conclusion MIC baseline dependency should not be tested in subgroups based on stratification on the baseline PROM score. Instead, one or more of the suggested alternative methods should be used.

scholarly journals Comparison of Reliability, Validity, and Responsiveness of the Mini-BESTest and Berg Balance Scale in Patients With Balance Disorders

2013 ◽  
Vol 93 (2) ◽  
pp. 158-167 ◽  
Author(s):  
Marco Godi ◽  
Franco Franchignoni ◽  
Marco Caligari ◽  
Andrea Giordano ◽  
Anna Maria Turcato ◽  
...  
Keyword(s):  
Dynamic Balance ◽  
Intraclass Correlation ◽  
Area Under The Curve ◽  
Correlation Coefficients ◽  
Berg Balance Scale ◽  
Important Change ◽  
Global Rating ◽  
Minimal Important Change ◽  
External Criterion ◽  
Balance Scale

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.

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
Keyword(s):  
Area Under The Curve ◽  
Important Change ◽  
Global Rating ◽  
Minimal Important Change ◽  
Perceived Change ◽  
Midas Questionnaire ◽  
Assess Treatment Response ◽  
Clinically Important Change ◽  
Moderate Positive Correlation

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.

scholarly journals Cross-cultural translation and validation of the Spanish version of the patellofemoral pain and osteoarthritis subscale of the KOOS (KOOS-PF)

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Juan Pablo Martinez-Cano ◽  
Daniel Vernaza-Obando ◽  
Julián Chica ◽  
Andrés Mauricio Castro
Keyword(s):  
Intraclass Correlation ◽  
Patellofemoral Pain ◽  
Spanish Version ◽  
Minimal Detectable Change ◽  
Global Rating ◽  
Minimal Important Change ◽  
Specific Patient ◽  
Retest Reliability ◽  
Patient Reported ◽  
Test Retest Reliability

Abstract Objective The aim of this study was to translate to Spanish the patellofemoral pain and osteoarthritis subscale of the knee injury and osteoarthritis outcome score (KOOS-PF) and validate this Spanish version of a disease-specific patient-reported outcome measure (PROM) for patellofemoral pain. Results The KOOS-PF was translated to Spanish and sixty patients with patellofemoral pain and/or osteoarthritis accepted to complete the questionnaire. 1-week later 58 patients answered the questions again for the test–retest reliability validation and finally 55 patients completed 1-month later for the responsiveness assessment. The Spanish version showed very good internal consistency (Cronbach’s alpha: 0.93) and test–retest reliability (intraclass correlation coefficient: 0.82). Responsiveness was confirmed, showing a strong correlation with the global rating of change (GROC) score (r 0.64). The minimal detectable change was 11.1 points, the minimal important change was 17.2 points, and there were no floor or ceiling effects for the score.

scholarly journals Role of Patient-Reported Outcome Measures on Predicting Outcome of Bunion Surgery

2019 ◽  
Vol 41 (2) ◽  
pp. 133-139 ◽  
Author(s):  
Ashlee MacDonald ◽  
Jeff Houck ◽  
Judith F. Baumhauer
Keyword(s):  
Likelihood Ratio ◽  
Area Under The Curve ◽  
Roc Curves ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Information ◽  
Level Of Evidence ◽  
Meaningful Improvement ◽  
Patient Reported ◽  
Threshold Score

Background: Prior studies have suggested preoperative patient-reported outcome scores could predict patients who would achieve a clinically meaningful improvement with hallux valgus surgery. Our goal was to determine bunionectomy-specific thresholds using Patient-Reported Outcomes Measurement Information System (PROMIS) values to predict patients who would or would not benefit from bunion surgery. Methods: PROMIS physical function (PF), pain interference (PI), and depression assessments were prospectively collected. Forty-two patients were included in the study. Using preoperative and final follow-up visit scores, minimally clinically important differences (MCID), receiver operating characteristic (ROC) curves, and area under the curve (AUC) analyses were performed to determine if preoperative PROMIS scores predicted achieving MCID with 95% specificity or failing to achieve an MCID with 95% sensitivity. Results: PROMIS PF demonstrated a significant AUC and likelihood ratio. The preoperative threshold score for failing to achieve MCID for PF was 49.6 with 95% sensitivity. The likelihood ratio was 0.14 (confidence interval, 0.02-0.94). The posttest probability of failure to achieve an MCID for PF was 94.1%. PI and depression AUCs were not significant, and thus thresholds were not determined. Conclusion: We identified a PF threshold of 49.6, which was nearly 1 standard deviation higher than previously published. If a patient is hoping to improve PF, a patient with a preoperative t score >49.6 may not benefit from surgery. This study also suggests the need for additional research to delineate procedure-specific thresholds. Level of Evidence: Level III, retrospective comparative series.

scholarly journals A systematic review of patient-reported outcome measures (PROMs) in cystic fibrosis

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e033867
Author(s):  
Irushi Ratnayake ◽  
Susannah Ahern ◽  
Rasa Ruseckaite
Keyword(s):  
Quality Of Life ◽  
Cystic Fibrosis ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Cochrane Library ◽  
Life Questionnaire ◽  
Health Measurement ◽  
Patient Reported

BackgroundTo determine patient-reported outcome measures (PROMs) which may be suitable for incorporation into the Australian Cystic Fibrosis Data Registry (ACFDR) by identifying PROMs administered in adult and paediatric cystic fibrosis (CF) populations in the last decade.MethodsWe searched MEDLINE, EMBASE, Scopus, CINAHL, PsycINFO and Cochrane Library databases for studies published between January 2009 and February 2019 describing the use of PROMs to measure health-related quality of life (HRQoL) in adult and paediatric patients with CF. Validation studies, observational studies and qualitative studies were included. The search was conducted on 13 February 2019. The COnsensus-based Standards for the selection of health Measurement INstruments Risk of Bias Checklist was used to assess the methodological quality of included studies.ResultsTwenty-seven different PROMs were identified. The most commonly used PROMs were designed specifically for CF. Equal numbers of studies were conducted on adult (32%, n=31), paediatric (35%, n=34) and both (27%, n=26) populations. No PROMs were used within a clinical registry setting previously. The two most widely used PROMs, the Cystic Fibrosis Questionnaire—Revised (CFQ-R) and the Cystic Fibrosis Quality of Life Questionnaire (CFQoL), demonstrated good psychometric properties and acceptability in English-speaking populations.DiscussionWe found that although PROMs are widely used in CF, there is a lack of reporting on the efficacy of methods and timepoints of administration. We identified the CFQ-R and CFQoL as the most suitable for incorporation in the ACFDR as they captured significant effects of CF on HRQoL and were reliable and valid in CF populations. These PROMs will be used in a further qualitative study assessing patients’ with CF and clinicians’ perspectives toward the acceptability and feasibility of incorporating a PROM in the ACFDR.PROSPERO registration numberCRD42019126931.

Responsiveness and longitudinal validity of the Persian version of COMI to physiotherapy in patients with non-specific chronic low back pain

2020 ◽  
Vol 20 (3) ◽  
pp. 483-490
Author(s):  
Shiva Komesh ◽  
Noureddin Nakhostin Ansari ◽  
Soofia Naghdi ◽  
Parisa Alaei ◽  
Scott Hasson ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Area Under The Curve ◽  
Important Change ◽  
Global Rating ◽  
Low Back ◽  
Operating Characteristics ◽  
Smallest Detectable Change ◽  
Clinically Important Change ◽  
Longitudinal Validity

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.

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