Minimal Clinically Important Difference For Improvement Research Articles

Mental Health Effects on the Minimal Clinically Important Difference in Total Joint Arthroplasty.

The effect of mental health on patient-reported outcome measures is not fully understood in total joint arthroplasty (TJA). Thus, we investigated the relationship between mental health diagnoses (MHDs) and the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W) in primary TJA and revision TJA (rTJA). Retrospective data were collected using relevant Current Procedural Terminology and MHDs International Classification of Diseases, 10th Revision, codes with completed Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form, Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form, Patient-reported Outcomes Measurement Information System (PROMIS)-Physical Function Short Form 10a, PROMIS Global-Mental, or PROMIS Global-Physical questionnaires. Logistic regressions and statistical analyses were used to determine the effect of a MHD on MCID-I/MCID-W rates. Data included 4,562 patients (4,190 primary TJAs/372 rTJAs). In primary total hip arthroplasty (pTHA), MHD-affected outcomes for Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (MCID-I: 81% versus 86%, P = 0.007; MCID-W: 6.0% versus 3.2%, P = 0.008), Physical Function Short Form 10a (MCID-I: 68% versus 77%, P < 0.001), PROMIS Global-Mental (MCID-I: 38% versus 44%, P = 0.009), and PROMIS Global-Physical (MCID-I: 61% versus 73%, P < 0.001; MCID-W: 14% versus 7.9%, P < 0.001) versus pTHA patients without MHD. A MHD led to lower rates of MCID-I for PROMIS Global-Physical (MCID-I: 56% versus 63%, P = 0.003) in primary total knee arthroplasty patients. No effects from a MHD were observed in rTJA patients. The presence of a MHD had a prominent negative influence on pTHA patients. Patients who underwent rTJA had lower MCID-I rates, higher MCID-W rates, and lower patient-reported outcome measure scores despite less influence from a MHD. Level III, retrospective comparative study.

Patients Consistently Report Worse Outcomes Following Revision Total Knee Arthroplasty Compared to Primary Total Knee Arthroplasty

BackgroundDifferences in patient-reported outcome measures (PROMs) between primary TKA (pTKA) and revision TKA (rTKA) have not been well-studied. Therefore, we compared pTKA and rTKA patients by the rates of achieving the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W). MethodsA total of 2,448 patients (2,239 pTKAs/209 rTKAs) were retrospectively studied. Patients who completed the Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a), PROMIS Global-Mental, or PROMIS Global-Physical questionnaires were identified by Current Procedural Terminology (CPT) codes. Patient-reported outcome measures and MCID-I/MCID-W rates were compared. Multivariate logistic regression models measured relationships between surgery type and postoperative outcomes. ResultsPatients who underwent rTKA (all causes) had lower rates of improvement and higher rates of worsening compared to pTKA patients for KOOS-PS (MCID-I: 54 versus 68%, P < .001; MCID-W: 18 versus 8.6%, P < .001), PF10a (MCID-I: 44 versus 65%, P < .001; MCID-W: 22 versus 11%, P < .001), PROMIS Global-Mental (MCID-I: 34 versus 45%, P = .005), and PROMIS Global-Physical (MCID-I: 51 versus 60%, P = .014; MCID-W: 29 versus 14%, P < .001). Undergoing revision was predictive of worsening postoperatively for KOOS-PS, PF10a, and PROMIS Global-Physical compared to pTKA. Postoperative scores were significantly higher for all 4 PROMs following pTKA. ConclusionPatients reported significantly less improvement and higher rates of worsening following rTKA, particularly for PROMs that assessed physical function. Although pTKA patients did better overall, the improvement rates may be considered relatively low and should prompt discussions on improving outcomes following pTKA and rTKA. Level of EvidenceLevel III, retrospective comparative study.

Patient-Reported Outcomes Following Revision Total Hip Arthroplasty Demonstrate Less Improvement and Significantly Higher Rates of Worsening Compared to Primaries

BackgroundPatient-reported outcome measures (PROMs) provide the patient’s perspective following total hip arthroplasty (THA), although differences between primary THA (pTHA) and revision THA (rTHA) remain unclear. Thus, we compared the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W) in pTHA and rTHA patients. MethodsData from 2,159 patients (1,995 pTHAs/164 rTHAs) who had completed Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (HOOS-PS), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a), PROMIS Global-Mental, or PROMIS Global-Physical questionnaires were analyzed. The PROMs and MCID-I/MCID-W rates were compared using statistical tests and multivariate logistic regressions. ResultsCompared to the pTHA group, the rTHA group had lower rates of improvement and higher rates of worsening for almost all PROMs, including HOOS-PS (MCID-I: 54 versus 84%, P < .001; MCID-W: 24 versus 4.4%, P < .001), PF10a (MCID-I: 44 versus 73%, P < .001; MCID-W: 22 versus 5.9%, P < .001), PROMIS Global-Mental (MCID-W: 42 versus 28%, P < .001), and PROMIS Global-Physical (MCID-I: 41 versus 68%, P < .001; MCID-W: 26 versus 11%, P < .001). Odds ratios supported rates of worsening following revision for the HOOS-PS (Odds Ratio (OR): 8.25, 95% Confidence Interval (CI): 5.62 to 12.4, P < .001), PF10a (OR: 8.34, 95% CI: 5.63 to 12.6, P < .001), PROMIS Global-Mental (OR: 2.16, 95% CI: 1.41 to 3.34, P < .001), and PROMIS Global-Physical (OR: 3.69, 95% CI: 2.46 to 5.62, P < .001). ConclusionPatients reported higher rates of worsening and lower rates of improvement following rTHA than pTHA, with significantly less score improvement and lower postoperative scores for all PROMs after revision. Most patients reported improvements following pTHA, with few worsening postoperatively. Level of EvidenceLevel III, retrospective comparative study.

Minimal Clinically Important Differences in 6-Minute Walk Test in Patients With HFrEF and Iron Deficiency

The 6-minute walk test (6MWT) is widely used to measure exercise capacity; however, the magnitude of change that is clinically meaningful for individuals is not well established in heart failure with reduced ejection fraction (HFrEF). To calculate the minimal clinically important difference (MCID) for change in exercise capacity in the 6MWT in iron-deficient populations with HFrEF. In this pooled secondary analysis of the FAIR-HF and CONFIRM-HF trials, mean changes in the 6MWT from baseline to weeks 12 and 24 were calculated and calibrated against the Patient Global Assessment (PGA) tool (clinical anchor) to derive MCIDs in improvement and deterioration. Of 760 patients included in the 2 trials, 6MWT and PGA data were available for 680 (89%) and 656 (86%) patients at weeks 12 and 24, respectively. The mean 6MWT distance at baseline was 281 ± 103 meters. There was a modest correlation between changes in 6MWT and PGA from baseline to week 12 (r = 0.31; P < 0.0001) and week 24 (r = 0.43; P < 0.0001). Respective estimates (95% confidence intervals) of MCID in 6MWT at weeks 12 and 24 were 14 meters (5;23) and 15 meters (3;27) for a "little improvement" (vs no change), 20 meters (10;30) and 24 meters (12;36) for moderate improvement vs a "little improvement,", -11 meters (-32;9.2) and -31 meters (-53;-8) for a "little deterioration" (vs no change), and -84 meters (-144;-24) and -69 meters (-118;-20) for "moderate deterioration" vs a "little deterioration". The MCID for improvement in exercise capacity in the 6MWT was 14 meters-15 meters in patients with HFrEF and iron deficiency. These MCIDs can aid clinical interpretation of study data.

Minimal clinically important differences in average, best, worst and current intensity and unpleasantness of chronic breathlessness.

Chronic breathlessness has devastating consequences. The minimal clinically important difference (MCID) for current intensity has been estimated as 9 mm on a 100-mm visual analogue scale (VAS). We aimed to determine MCIDs for commonly used dimensions and recall periods: the current unpleasantness and current, average, best and worst intensity of the past 24 h for chronic breathlessness. This was a secondary analysis of a randomised controlled trial of morphine versus placebo over 7 days in people with chronic breathlessness from severe disease. The breathlessness scores were self-reported using a diary each evening on 100-mm VAS. The MCID for improvement in each score was estimated using anchor-based and distribution-based methods. 283 participants (mean age 74.2 years; 63% male; 58% COPD; 87.0% modified Medical Research Council (mMRC) score 3-4) were included. Anchor-based MCIDs for breathlessness scores ranged from -13.9 mm to -9.5 mm. The MCIDs were similar when using different anchors and across all participants, and participants with more severe breathlessness (mMRC 3-4). Distribution-based effect sizes were classed as small (-4.7-6.3 mm), moderate (-9.4-12.5 mm) and large (-15.0-20.0 mm) effect. Sample sizes for trials using the different scores were proposed. MCIDs of absolute change were more stable than using relative change from baseline. An improvement of ∼10 mm on a 100-mm VAS is likely to be clinically meaningful across commonly used measures of chronic breathlessness (current intensity, unpleasantness, and average, best and worst intensity over the past 24 h) to evaluate clinical benefit and effects in therapeutic trials.

Responsiveness and minimal clinically important difference of SGRQ-I and K-BILD in idiopathic pulmonary fibrosis

BackgroundIdiopathic pulmonary fibrosis (IPF) specific version of St. George’s Respiratory Questionnaire (SGRQ-I) and King’s Brief Interstitial Lung Disease questionnaire (K-BILD) are validated health-related quality of life (HRQL) instruments, but no or limited data exist on their responsiveness and minimal clinically important difference (MCID). The objectives of this study were to assess responsiveness of SGRQ-I and K-BILD and determine MCID separately for deterioration and improvement in a large, prospective cohort of patients with IPF in a real-world setting.MethodsConsecutive patients with IPF were recruited. SGRQ-I, K-BILD, SGRQ, Shortness of Breath Questionnaire, pulmonary function tests and 6-min walk test measurements were obtained at baseline and at six and 12 months; at six and 12 months, patients also completed Global Rating of Change Scales. Responsiveness was assessed using correlation coefficients and linear regression. Cox regression was used for mortality analyses. MCID was estimated using receiver operating characteristic curves with separate analyses for improvement and deterioration.ResultsA total of 150 IPF patients were included and 124 completed the 12-month follow-up. Based on all HRQL anchors and most physiological anchors, responsiveness analyses supported the evidence pointing towards SGRQ-I and K-BILD as responsive instruments. Multivariate analyses showed an association between SGRQ-I and mortality (HR: 1.18, 95% CI: 1.02 to 1.36, p = 0.03) and a trend was found for K-BILD (HR: 0.82, 95% CI: 0.64 to 1.05, p = 0.12). MCID was estimated for all domains of SGRQ-I and K-BILD. MCID for improvement differed from deterioration for both SGRQ-I Total (3.9 and 4.9) and K-BILD Total (4.7 and 2.7).ConclusionsSGRQ-I and K-BILD were responsive to change concerning both HRQL and most physiological anchors. MCID was determined separately for improvement and deterioration, resulting in different estimates; especially a smaller estimate for deterioration compared to improvement in K-BILD.Trial registrationClinicaltrials.gov, no. NCT02818712. Registered 30 June 2016.

Long-term patient-reported distress in locally advanced cervical cancer patients treated with definitive chemoradiation

Background and purposeTo evaluate longitudinal patient-reported distress in cervical cancer patients treated with definitive chemoradiation (CRT). Materials and methodsBetween 2011 and 2016, consenting cervical cancer patients treated with definitive CRT who completed ≥ 2 revised Edmonton Symptom Assessment System (ESAS-r) questionnaires at clinical visits, including baseline, were included. A linear mixed model was used to assess the longitudinal trend in ESAS-r. A minimal clinically important difference (MCID) for total ESAS-r score was defined as a change of 3-points for improvement and 4-points for deterioration. The proportion of patients with an MCID over time was described using moving averages. To test for changes, mixed effects logistic models were fitted, each of which included patient-specific random intercepts and random slopes. Results67 patients were eligible for analysis (736 ESAS-r assessments). Median (range) follow-up was 24 months (range: 15–45) and compliance at 12 months was 60% (40/67). There was a significant decrease in ESAS-r scores over time. Baseline ESAS-r was strongly predictive of ESAS-r at follow-up (p < 0.001). The proportion of patients with an MCID for improvement from baseline significantly increased over time (p < 0.001) and the proportion with an MCID for deterioration significantly decreased over time (p < 0.001). No predictors for distress were found. ConclusionsLong-term cervical cancer survivors experience distress that significantly improves over time to an extent expected to be clinically meaningful for patients. Implementing cervical cancer specific patient-reported outcome tools into practice could better inform patient needs.

Psychometric properties of the EQ-5D-5L in patients with hip or knee osteoarthritis: reliability, validity and responsiveness.

To study the psychometric properties, including reliability, validity and responsiveness, of the Spanish EQ-5D-5L questionnaire for patients with hip or knee osteoarthritis (OA). We included 758 patients with hip or knee OA who completed the EQ-5D-5L and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, of whom 644 also did 6months later. The EQ-5D-5L contains five questions from which a utility index is derived. The WOMAC covers three dimensions: pain, stiffness and physical function. Floor and ceiling effects were calculated. Reliability was assessed using Cronbach's alpha. Convergent validity was tested using the Spearman correlation coefficient between EQ-5D-5L and WOMAC. We examined known-groups validity by comparing the EQ-5D-5L between subgroups defined by WOMAC scores using ANOVA or the Kruskal-Wallis test. Effect sizes were calculated to assess responsiveness, and minimal clinically important difference (MCID) was estimated. The EQ-5D-5L showed minimal floor and ceiling effects (< 3%). Cronbach's alpha was 0.86. The EQ-5D-5L index was strongly correlated with WOMAC pain and function scores (- 0.688 and - 0.782). Patients with higher WOMAC scores had significantly (p < 0.0001) lower EQ-5D-5L index. The 20.19% had hip or knee replacement during the follow-up. Effect sizes were small among non-surgical patients, but > 0.80 among "improved" surgical patients, being the MCID for improvement 0.32 points. The results support the reliability, validity and responsiveness of the EQ-5D-5L, overcoming the limitations of the EQ-5D-3L in these patients. Therefore, the EQ-5D-5L could be very useful as an outcome measure, at least in patients with hip or knee OA.

Minimal clinically important difference of voice handicap index-10 in vocal fold paralysis.

The Voice Handicap Index-10 (VHI-10) is commonly used to measure patients' perception of vocal handicap. Clinical consensus has previously defined clinically meaningful improvement as a decrease ≥5. This study determines the minimal clinically important difference (MCID) for VHI-10 in patients with unilateral vocal fold paralysis (UVFP) using anchor-based methodology. Prospective cohort questionnaire analysis. Two hundred eighty-one UVFP patients completed the VHI-10 on two consecutive visits (within 3 months). At the follow-up visit, patients answered an 11-point Global Rating of Change Questionnaire (GRCQ) scored from -5 to +5. Relationship between the GRCQ and change in VHI-10 was quantified using analysis of variance, and MCID for the VHI-10 was determined using receiver operating characteristic (ROC) curve analysis. Overall mean VHI-10 change was -3.71 (standard deviation [SD] = 8.89) and mean GRCQ was 1.37 (SD = 2.51). Average interval between measurements was 1.73 months (SD = 0.83). Mean changes in VHI-10 scores were -7.45, -0.53, and +4.40 for patients whose GRCQ scores indicated improvement, no change, and worsening, respectively. Differences between mean scores were statistically significant (P < .001). Area under the ROC curve was 0.80, demonstrating the classification accuracy of VHI-10 change scores. A VHI-10 change of -4 was determined to be the optimal threshold that discriminated between improvement and no improvement (sensitivity and specificity 0.62 and 0.88, respectively). The MCID for improvement in VHI-10 in UVFP patients is a decrease of 4. This information improves understanding of patients' response to treatment and allows comparison between different treatments. Future research should determine MCID for VHI-10 across all voice disorders. 4. Laryngoscope, 128:1419-1424, 2018.

Is there a clinically meaningful difference in patient reported dyspnea in acute heart failure? An analysis from URGENT Dyspnea

BackgroundDyspnea is the most common presenting symptom in patients with acute heart failure (AHF), but is difficult to quantify as a research measure. The URGENT Dyspnea study compared 3 scales: (1) 10 cm VAS, (2) 5-point Likert, and (3) a 7-point Likert (both VAS and 5-point Likert were recorded in the upright and supine positions). However, the minimal clinically important difference (MCID) to patients has not been well established. MethodsWe performed a secondary analysis from URGENT Dyspnea, an observational, multi-center study of AHF patients enrolled within 1 h of first physician assessment in the ED. Using the anchor-based method to determine the MCID, a one-category change in the 7-point Likert was used as the criterion standard (‘minimally improved or worse’). The main outcome measures were the change in visual analog scale (VAS) and 5-point Likert scale from baseline to 6-h assessment relative to a 1-category change response in the 7-point Likert scale (‘minimally worse’, ‘no change’, or ‘minimally better’). ResultsOf the 776 patients enrolled, 491 had a final diagnosis of AHF with responses at both time points. A 10.5 mm (SD 1.6 mm) change in VAS was the MCID for improvement in the upright position, and 14.5 mm (SD 2.0 mm) in the supine position. However, there was no MCID for worsening, as few patients reported worse dyspnea. There was also no significant MCID for the 5-point Likert scale. ConclusionA 10.5 mm change is the MCID for improvement in dyspnea over 6 h in ED patients with AHF.

Definition of Nonresponse to Analgesic Treatment of Arthritic Pain: An Analytical Literature Review of the Smallest Detectable Difference, the Minimal Detectable Change, and the Minimal Clinically Important Difference on the Pain Visual Analog Scale

Our objective was to develop a working definition of nonresponse to analgesic treatment of arthritis, focusing on the measurement of pain on the 0–100 mm pain visual analog scale (VAS). We reviewed the literature to assess the smallest detectable difference (SDD), the minimal detectable change (MDC), and the minimal clinically important difference (MCID). The SDD for improvement reported in three studies of rheumatoid arthritis was 18.6, 19.0, and 20.0. The median MDC was 25.4 for 7 studies of osteoarthritis and 5 studies of rheumatoid arthritis (calculated for a reliability coefficient of 0.85). The MCID increased with increasing baseline pain score. For baseline VAS tertiles defined by scores of 30–49, 50–65, and >65, the MCID for improvement was, respectively, 7–11 units, 19–27 units, and 29–37 units. Nonresponse can thus be defined in terms of the MDC for low baseline pain scores and in terms of the MCID for high baseline scores.