The minimal clinically important difference (MCID) is an important concept with big appeal in a field struggling to interpret quality of life (QOL) and other patient-reported outcomes (PRO), is also a bridge between statistics and clinical medicine. This study uses the ROC curve to formulate the MCID value of the Quality of Life Instruments for Chronic Diseases of Systemic lupus erythematosus (QLICD-SLE V2.0) scale. Using the representative item \"In general, would you say your health is\" of the MOS item short form health survey(SF-36) as an anchor, the questionnaire of QLICD-SLE V2.0 and the anchor item were used to investigate the patients on the first day of hospitalization, and the day before the patient was discharged. 279 patients with lupus erythematosus were participated in this longitudinal follow-up study. The ROC curve was constructed by using the classification based on the anchor item as the gold standard and the difference score of the scale as the test variable. The cut-off point corresponding to the maximum value of the Youden index in the ROC curve is taken as the minimum clinical importance difference (MCID) value of the QLICD-SLE (V2.0) scale. The Results showed that the MCID of physical domain, psychological domain, social domain, general module, specific module and QLICD-SLE (V2.0) total scale are 8.3, 2.3, 2.5, 2.7, 9.2 and 3.2, respectively. Area under the ROC curve of QLICD-SLE (V2.0) is 0.898, P (Area = 0.5) < 0.001, the sensitivity is 100%, the specificity is 66.9%. It concluded that if the total scores after treatments changes at least 3.2 points positively, the treatment intervention can be considered as clinically significant. It is more convincing to use the corresponding cut-off point as the MCID for ROC curve method can visualize the sensitivity and specificity.

OBJECTIVE: To identify independent factors responsible for the poor outcomes after a graft tear after arthroscopic superior capsular reconstruction (ASCR).
METHODS: Patients who underwent ASCR for massive rotator cuff tears between January 2013 and July 2021were reviewed. Based on the achievement of the minimal clinically important differences for clinical outcome measures at the final follow up, patients were divided into the good outcome (GO) and poor outcome (PO) groups. The minimal clinically important differences were calculated as the values equal to one-half of the standard deviation of the changes in outcome scores between the preoperative baseline and the latest follow-up. Pre- and final follow-up variables included demographics, American Shoulder and Elbow Surgeons (ASES) score, Constant score, visual analog scale (VAS) score, range of motion, Preoperative and postoperative 1-year radiological variables were analyzed using MRIs, including anteroposterior (AP) and mediolateral (ML) tear sizes, subscapularis tear, acromiohumeral distance (AHD), and degree of fatty degeneration. Logistic regression analysis was performed to identify the significant predictors of poor outcomes.
RESULTS: A total of 33 patients who underwent ASCR presented with graft tears, which were confirmed by postoperative 1-year magnetic resonance imaging (MRI), and had a minimum follow-up duration of 2 years after surgery were enrolled. The GO group demonstrated significantly greater improvements in functional outcomes compared with the PO group (ASES: 83.5 ± 11.8 vs. 64.0 ± 20.4, P = 0.004; Constant: 67.6 ± 5.7 vs. 57.1 ± 9.8, P <0.001; and VAS: 0.9 ± 1.2 vs. 2.4 ± 2.0, P = 0.026). The postoperative 1-year AHD showed significant improvement in the GO group (3.1 ± 1.2 vs. 6.1 ± 1.4, P <0.001) but no change in the PO group (3.4 ± 1.3 vs. 4.2 ± 0.9, P = 0.074) postoperatively. Multivariate logistic regression analysis indicated that a decreased postoperative 1-year AHD (OR, 0.145; P = 0.019) was associated with a poor outcome after a graft tear.
CONCLUSIONS: A narrow postoperative 1-year AHD was identified as the most importantindependent risk factor indicating poor clinical outcomes after a graft tear post-ASCR, which was related to a larger tear and loss of integrity between the grafts and infraspinatus at 1 year postoperatively.
METHODS: Level IV.

OBJECTIVE: To compare patient-reported outcomes measurements (PROMs) and subsequent surgical interventions in patients treated with anterior cruciate ligament reconstruction (ACLR) using either quadriceps tendon autograft with a patellar bone block (bQT) or soft tissue only (sQT).
METHODS: All ACLRs performed between 01.2010 and 03.2022 were prospectively followed for 24 months and retrospectively evaluated. All primary ACLRs with full 24 months of follow-up data, without any previous surgery or any additional ligamentous interventions, were matched for major ACL risk factors, including gender, age, Tegner activity level (TAL), pivoting sports, and concomitant injuries. PROMs (Lysholm score, Visual Analog Scale (VAS) for pain, and TAL) and subsequent surgical interventions were registered after 6, 12, and 24 months postoperative. Binary logistic regression was used to assess the influence of graft type, age, preinjury TAL, gender, pivoting sports and concomitant interventions on the need to undergo subsequent surgery.
RESULTS: After matching, 246 patients were included in the final analysis. Both groups did not differ regarding any preoperative patient demographics or intraoperative details. At final follow-up, no significant difference in mean Lysholm score (sQT: 90.8±10.6, bQT: 91.8±10.6, p= .46), median TAL (sQT: 6 [1-10], bQT: 6 [1-10], p= .53) and VAS for pain (sQT: 0.7±1.1, bQT: 0.7±1.2, p= .70) was reported between both groups. 70.3% (sQT-A: 70.7%, bQT: 69.9%, p= .89) of patients returned to or exceeded their preinjury activity level. In terms of revision ACLR, there was no statistically significant difference between bQT (3.3%) and sQT (4.1%). Similarly, no difference was observed in contralateral ACLR (bQT: 7.3% sQT: 11.4%). Regression analysis indicated that none of the studied factors, including the use of a patellar bone block, influenced subsequent surgery, revision ACLR, or contralateral ACLR.
CONCLUSIONS: Harvesting an additional patellar bone block in quadriceps tendon ACL reconstruction does not seem to impact postoperative patient-reported outcomes, ACL revision- or contralateral ACL reconstruction rates.
METHODS: Level 3 - Cohort Study.

Objectives: To determine the proportion of people who achieve minimal clinically important differences (MCID) with centre-based or home-based pulmonary rehabilitation and to synthesise data on adverse events.Methods: Cochrane reviews and electronic databases were searched to identify randomised trials comparing centre-based to home-based pulmonary rehabilitation, or either model to usual care, in people with chronic respiratory disease. Primary outcomes were the proportion of participants achieving MCIDs in exercise capacity and disease-specific quality of life. Secondary outcomes were symptoms and adverse events. Cochrane Risk of Bias 1.0 and GRADE were used to assess the risk of bias and certainty of evidence respectively.Results: Forty-nine trials were eligible. Compared to usual care, a higher proportion of pulmonary rehabilitation participants achieved the MCID for exercise capacity (6MWT: 47% vs 20%, p = 0.11), dyspnoea (43% vs 29%, p = 0.0001), fatigue (48% vs 27%, p = 0.0002) and emotional function (37% vs 25%, p = 0.02), with all of these between group differences statistically significant except for exercise capacity. There were no differences between centre-based and home-based pulmonary rehabilitation in the proportion of participants who achieved MCIDs (34%- 58% across studies). Ninety percent of trials reported no adverse events. Certainty of evidence was low-to- moderate with all outcomes except for CRQ-mastery (centre-based vs home-based pulmonary rehabilitation, or pulmonary rehabilitation vs usual care in COPD), ESWT (pulmonary rehabilitation vs usual care in COPD) and 6MWT (pulmonary rehabilitation vs usual care in bronchiectasis) where evidence was very uncertain.Discussion: Clinically meaningful outcomes are achieved by similar proportions of participants in centre-based and home-based pulmonary rehabilitation, with few adverse events. Reporting of trial outcomes according to MCIDs is necessary for informed decision making regarding pulmonary rehabilitation models.

We aimed to determine the minimal clinically important difference (MCID) in pain severity and agreement between the visual analog scale (VAS) and the verbal numeric rating scale (NRS) in people with sickle cell disease (SCD) experiencing an acute vaso-occlusive episode in the emergency department. In the COMPARE-VOE trial (NCT03933397), participants were administered the VAS (0-100), NRS (0-100), and descriptor scale (a lot better, a little better, same, a little worse, much worse) every 30 minutes while in the emergency department. We analyzed data from 100 participants (mean age 30.2 years; 61% female). We calculated the mean differences and 95% confidence intervals (CIs) between current and preceding scores when the participant reported a little worse or a little better pain for each scale (255 VAS and 150 NRS observations) to assess the MCID for the VAS and NRS. Pearson correlation and the Bland-Altman method were used to assess the agreement among 411 paired VAS and NRS observations. Our results indicated that the MCID for the VAS was 8.77 mm (95% CI: 7.43 mm, 10.83 mm) and the NRS was 8.29 (95% CI: 6.47, 11.60). The VAS and NRS scales had a correlation of .88 (P < .001). The Bland-Altman method indicated a mean difference of -4.6 ± 1.96 and the 95% limits of agreement ranged from 20 to -29. Despite high correlation, there was considerable variability of agreement between the VAS and NRS scales, indicating that these scales are not interchangeable to assess pain during a vaso-occlusive event. PERSPECTIVE: The MCID in pain severity for individuals with a SCD vaso-occlusive episode using the VAS (8.77 mm) is lower than previously reported, and the MCID for NRS was 8.29. The agreement between the VAS and NRS was determined and the scales cannot be used interchangeably to measure SCD pain intensity.

UNASSIGNED: To determine the minimal clinically important difference (MCID) for contact lens (CL)-related subjective responses and explore whether MCID values differ between subjective responses and study designs.
UNASSIGNED: This was a retrospective analysis of data from seven one-week bilateral crossover studies and 14 one-day contralateral CL studies. For comfort, dryness, vision, or ease of insertion, participants rated on a 0-100 visual analogue scale (VAS) and indicated lens preference on a five-point Likert scale featuring strong, slight, and no preferences. For each criterion, four MCID estimates were calculated and averaged: mean VAS score difference for \"slight preference,\" lower limit of 95% confidence interval VAS score difference for \"slight preference,\" difference in mean VAS score difference between \"slight\" and \"no preference\" and 0.5 standard deviation of VAS scores.
UNASSIGNED: The four calculation methods generated a small range of MCID values. For bilateral studies, the averaged MCID was 7.2 (range 5.4-8.8) for comfort, 8.1 (5.2-10.6) for dryness, 7.1 (5.5-9.3) for vision and 7.6 (6.0-10.5) for ease of insertion. For contralateral studies, the averaged MCID was 6.9 (6.1-7.6) for comfort at insertion and 7.5 (6.8-8.2) for end-of-day comfort.
UNASSIGNED: This work demonstrated very similar MCID values across subjective responses and study designs, in a population of habitual soft CL wearers. In all cases, MCID values were on average seven units on a 0 to 100 VAS.
UNASSIGNED: This work provides MCID values which are important for interpreting ocular subjective responses and planning clinical studies.

OBJECTIVE: Stroke impairs a patient\'s ability to walk. In patients with acute stroke, a 6-min walking distance (6MWD) is recommended to assess walking function. Minimal clinically important difference (MCID) is used to determine the effectiveness of rehabilitation; however, the MCID for 6MWD has not been adequately validated. This study aimed to estimate the MCID of 6MWD, a measure of walking endurance, in patients with acute stroke using anchor-based methods.
METHODS: Based on the change in 6MWD from baseline to the follow-up measurement 2 weeks later, the MCID was estimated using anchor-based methods (receiver operator operating characteristic curves, predictive and adjustment models) with a patient- and therapist-rated global rating of change scale (p-GRC, t-GRC) as external anchors. The accuracy of \"meaningful change\" was estimated from the area under the curve. Using MCID\'s credibility instruments, the credibility of each anchor was evaluated. Using the credibility instrument, high credibility was defined as satisfying 3/5 of the Core criteria and 6/9 of all criteria.
RESULTS: The analysis included 58 patients. The MCID for each anchor was 78.7-100.0 m for p-GRC, and 95.2-99.5 m for t-GRC. The p-GRC demonstrated excellent accuracy (area under the curve >0.8). With p-GRC as anchors, over 50% of patients showed improvement. The p-GRC satisfied the core criterion of 3/5 and all criteria of 6/9 on the reliability instrument. The t-GRC demonstrated low reliability and satisfied the core criterion of 2/5 and all criteria of 3/9.
CONCLUSIONS: Since the percentage of improved groups exceeded 50%, the adjusted model was useful in the anchor-based method. Therapists may not accurately capture patient fatigue and subjective symptoms, potentially affecting the correlation between the 6MWD change score and the t-GRC and, consequently, the reliability instrument. The p-GRC showed high accuracy and reliability; therefore, the MCID was estimated to be 78.7 m.

OBJECTIVE: Estimates of minimally important differences (MID) can assist interpretation of data collected using patient-reported outcomes (PRO), but variability exists in the emphasis placed on MIDs in health technology assessment (HTA) guidelines. This study aimed to identify to what extent information on the MID of a commonly used PRO, the EQ-5D, is required and utilised by selected HTA agencies.
METHODS: Technology appraisal (TA) documents from HTA agencies in England, France, Germany, and the US between 2019 and 2021 were reviewed to identify documents which discussed MID of EQ-5D data as a clinical outcome assessment (COA) endpoint.
RESULTS: Of 151 TAs utilising EQ-5D as a COA endpoint, 58 (38%) discussed MID of EQ-5D data. Discussion of MID was most frequent in Germany, in 75% (n = 12/16) of Gemeinsamer Bundesausschuss (G-BA) and 44% (n = 34/78) of Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, (IQWiG) TAs. MID was predominantly applied to the EQ-VAS (n = 50), most frequently using a threshold of > 7 or > 10 points (n = 13). G-BA and IQWiG frequently criticised MID analyses, particularly the sources of MID thresholds for the EQ-VAS, as they were perceived as being unsuitable for assessing the validity of MID.
CONCLUSIONS: MID of the EQ-5D was not frequently discussed outside of Germany, and this did not appear to negatively impact decision-making of these HTA agencies. While MID thresholds were often applied to EQ-VAS data in German TAs, analyses were frequently rejected in benefit assessments due to concerns with their validity. Companies should pre-specify analyses of continuous data in statistical analysis plans to be considered for treatment benefit assessment in Germany.

OBJECTIVE: To define the minimal clinically important difference (MCID) for measures of pain and function at 2, 5 and 10 years after osteochondral autograft transplantations (OATs).
METHODS: Patients undergoing OATs of the knee were identified from a prospectively maintained cartilage surgery registry. Baseline demographic, injury and surgical factors were collected. Patient-reported outcome scores (PROMs) were collected at baseline, 2-, 5- and 10-year follow-up, including the International Knee Documentation Committee (IKDC) score, Knee Outcome Survey Activities of Daily Living Scale (KOS-ADLS), Marx activity scale and Visual Analogue Scale (VAS) for pain. The MCIDs were quantified for each metric utilizing a distribution-based method equivalent to one-half the standard deviation of the mean change in outcome score. The percentage of patients achieving MCID as a function of time was assessed.
RESULTS: Of 63 consecutive patients who underwent OATs, 47 (74.6%) patients were eligible for follow-up (surgical date before October 2021) and had fully completed preoperative PROMs. A total of 39 patients (83%) were available for a minimum 2-year follow-up, with a mean (±standard deviation) follow-up of 5.8 ± 3.4 years. The MCIDs were determined to be 9.3 for IKDC, 2.5 for Marx, 7.4 for KOS-ADLS and 12.9 for pain. At 2 years, 78.1% of patients achieved MCID for IKDC, 77.8% for Marx, 75% for KOS-ADLS and 57.9% for pain. These results were generally maintained through 10-year follow-ups, with 75% of patients achieving MCID for IKDC, 80% for Marx, 80% for KOS-ADLS and 69.8% for pain.
CONCLUSIONS: The majority of patients achieved a clinically relevant outcome improvement after OATs of the knee, with results sustained through 10-year follow-up. Patients who experience clinically relevant outcome improvement after OATs in the short term continue to experience sustained benefits at longer-term follow-up. These data provide valuable prognostic information when discussing patient candidacy and the expected trajectory of recovery.
METHODS: Level III.

BACKGROUND: Appropriately defining and using the minimal important change (MIC) and the minimal clinically important difference (MCID) are crucial for determining whether the results are clinically significant. The aim of this study is to survey the status of randomized controlled trials (RCTs) for insomnia interventions to assess the inclusion and interpretation of MIC/MCID values.
METHODS: We conducted a cross-sectional study to survey the status of RCTs for insomnia interventions to assess the inclusion and appropriate interpretation of MIC/MCID values. A literature search was conducted by searching the main sleep medicine journals indexed in PubMed, the Excerpta Medica Database (EMBASE), and the Cochrane Central Register of Controlled Trials (CENTRAL) to identify a broad range of search terms. We included RCTs with no restriction on the intervention. The included studies used the Insomnia Severity Index (ISI) or the Pittsburgh Sleep Quality Index (PSQI) questionnaire as the outcome measures.
RESULTS: 81 eligible studies were identified, and more than one-third of the included studies used MIC/MCID (n = 31, 38.3%). Among them, 21 studies with ISI as the outcome used MIC defined as a relative decrease ranging from 3 to 8 points. The most frequently used MIC value was a 6-point decrease (n = 7), followed by 8-point (n = 6) and 7-point decrease (n = 4), a 4 to 5-points decrease (n = 3), and a 30% reduction from baseline; 6 studies used MCID values, ranging from 2.8 to 4 points. The most frequently used MCID value was a 4-point decrease in the ISI (n = 4). 4 studies with PSQI as the outcome used a 3-point change as the MIC (n = 2) and a 2.5 to 2.7-point difference as MCID (n = 2). 4 non-inferiority design studies considered interval estimation when drawing clinically significant conclusions in their MCID usage.
CONCLUSIONS: The lack of consistent MIC/MCID interpretation and usage in outcome measures for insomnia highlights the urgent need for further efforts to address this issue and improve reporting practices.