The minimal clinically important difference of two multifaceted fatigue evaluation questionnaires in chronic stroke.

PURPOSE: This research sought to ascertain the Minimal Clinically Important Difference (MCID) and Robust Clinically Important Difference (RCID) of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) and Chalder Fatigue Questionnaire-11 (CFQ-11) as two important concepts for the clinical interpretation of the results in chronic post-stroke population. METHODS: A total of 128 subjects with chronic post-stroke completed the MFSI-SF and CFQ-11 before and after six weeks of intervention. The MCIDs were derived using both anchor- and distribution-based methods; however, only anchor-based methods were used to estimate RCIDs. RESULTS: Anchor-based MCIDs for MFSI-SF and CFQ-11 were in the range of -5 to -6.28 and -2 to -4.56, respectively. Distribution-based MCIDs in MFSI-SF and CFQ-11 were calculated in the range of -4.17 to -24.05 and -1.72 to -7.68, respectively. RCID ranges of -10 to -15 were obtained for the MFSI-SF and -6 to -7.33 for the CFQ-11. CONCLUSION: These findings may have implications for clinical experts in the clinical interpretation of fatigue changes observed in MFSI-SF and CFQ-11 in individuals with chronic stroke.

Singing Voice Handicap Index-10 Minimal Clinically Important Difference: A Prospective Determination.

BACKGROUND/OBJECTIVES: The Singing Voice Handicap Index-10 (SVHI-10) is a validated patient-reported outcome measure (PROM) that assesses patients' perception of handicap related to singing voice. A normative value has been established with a score ≥20 being abnormal. However, there is no defined minimal clinically important difference (MCID). This study prospectively determines the MCID of SVHI-10 among a diverse group of singers. METHODS: 103 adult singers with and without voice complaints completed SVHI-10 twice, 30 days apart. MCID for the SVHI-10 was determined using distribution-based receiver-operating characteristic (ROC) curve analysis. RESULTS: Twenty-two men (1 transgender), 75 women (1 transgender), and 6 nonbinary individuals participated. The most frequently reported singing genres were classical (44.7%), musical theater (17.5%), and pop (10.7%). Mean initial SVHI-10 score was 13.05 (standard deviation 7.397), and mean follow-up SVHI-10 was 13.13 (7.994). There was a significant positive correlation between initial and follow-up SVHI-10 scores (r = 0.879, p < 0.001). SVHI-10 scores were significantly higher among participants who reported voice changes in the past year (p < 0.001) or sought voice treatment (p = 0.001) compared with participants who did not. SVHI-10 scores varied significantly based on singing type. The area under the ROC curve for SVHI-10 was 0.700 (p = 0.003). The SVHI-10 MCID was determined to be 9.5. CONCLUSIONS: An SVHI-10 score change ≥10 should be considered clinically meaningful. This definition has been missing from the literature and will improve understanding of patients' responses to treatment, which will help advance clinical care and track research outcomes. LEVEL OF EVIDENCE: 4 Laryngoscope, 2024.

What's in It for Me? Contextualizing the Potential Clinical Impacts of Lecanemab, Donanemab, and Other Anti-ß-amyloid Monoclonal Antibodies in Early Alzheimer's Disease.

A new era of disease-modifying therapy for Alzheimer's disease (AD) arrived in 2021 following the Food and Drug Administration's (FDA) decision to grant accelerated approval for aducanumab, an anti-ß-amyloid (Aß) monoclonal antibody designed to target Aß aggregates, a biological component of AD. More recently, trial outcomes for lecanemab and donanemab, two additional antibodies of this drug class, have shown favorable and significant slowing of metrics for cognitive and functional decline. Lecanemab and donanemab have since received similar FDA approval to aducanumab in January 2023 and July 2024, respectively. Given that these therapies are a clearly emerging tool in the repertoire of clinicians treating AD and related dementias, a critical dialogue has been ongoing regarding the potential impacts and place for these therapies. Here, we seek to contextualize this debate by first considering factors involved in theoretically extrapolating current randomized control trial outcomes to estimate meaningful clinical impacts. In the process of this exercise, we outline a generally useful concept termed Summative Treatment-Associated Benefit measuring Long-term Efficacy/Effectiveness Area as a metric of summative benefits of treatment over the life course of an individual. Second, we consider current real-world factors, such as conditions of FDA approval and other points involved in clinical decision-making that will influence and/or temper the actual impacts of this drug class.

Responsiveness and minimal clinically important difference of the COPD Assessment Test in fibrotic interstitial lung disease.

BACKGROUND AND OBJECTIVE: Patients with fibrotic interstitial lung disease (FILD) have impaired health status. The simple questionnaire in the COPD assessment test (CAT) has been validated for idiopathic pulmonary fibrosis (IPF) and connective tissue disease-related interstitial lung disease (CTD-ILD), but no or limited data exist for patients with FILD as a whole. The aim of this study was to evaluate the reliability, repeatability and responsiveness of the CAT, and estimate the minimal clinically important difference (MCID) in patients with FILD. METHODS: This study was a retrospective chart review of 358 consecutive patients with FILD including 131 with IPF, who underwent clinical assessment over 6-12 month intervals. We assessed the cross-sectional and longitudinal validity of the CAT. MCID was estimated using distribution methods and anchor methods with mean change and regression models. RESULTS: Internal consistency (Cronbach's alpha = 0.898) and repeatability (intraclass correlation coefficient [ICC] = 0.865) for the CAT score was acceptable. A cross-sectional study showed constructive validity. Changes in the CAT over 6-12 months were significantly associated with change in anchors including physiological function, exercise capacity, and dyspnea regardless of IPF diagnosis. The estimated MCIDs of the CAT for the deterioration and improvement directions were at least +5 and at least -3 points, respectively. CONCLUSIONS: The CAT is a reliable, responsive and clinically relevant instrument for assessing health status in patients with FILD.

Predictors of achieving a minimal clinically important difference in lower urinary tract symptoms 3 months after Rezum therapy.

Introduction: Gaining insight into patient characteristics to predict the success of procedures is crucial for improving outcomes and for preoperative counselling. We identified predictors of achieving a minimal clinically important difference (MCID) in lower urinary tract symptoms (LUTS) 3 months after Rezum. Material and methods: A retrospective study was conducted on patients treated with Rezum. Patients with moderate or severe LUTS and a recorded International Prostate Symptom Score (IPSS) at 3 months were included and categorised into 2 cohorts based on experiencing a MCID at 3 months (≥ 25% improvement in IPSS). Predictors were identified through multivariate logistic regression analysis. Results: Out of 174 patients, 134 (77%) achieved a MCID at 3 months, and those who did had a higher median baseline IPSS (20 [16-26] vs 15 [10-21], P <0.001) and were more likely to have severe LUTS at baseline (53.0% vs 35.0%, P = 0.046) when compared to those who did not experience a MCID at 3 months. Higher baseline IPSS (OR: 1.10, 95% CI 1.04-1.17) and larger baseline prostate volumes (OR: 1.03, 95% CI 1.0-1.05) were predictors of achieving a MCID at 3 months. More specifically, a significantly greater proportion of patients with severe LUTS (83.5 vs 70.8%, P = 0.046) and prostate volume ≥60 cc (94.6 vs 71.4%, P = 0.003) achieved MCID at 3 months when compared to patients with moderate LUTS and prostate volumes <60 cc, respectively. Conclusions: More than three-quarters of patients treated with Rezum achieved a MCID at 3 months. Patients with severe LUTS and prostate volumes ≥ 60 cc may be optimal candidates for experiencing early relief in LUTS following Rezum.

Establishing the minimal clinically important difference of the Brief Fatigue Inventory for brain or CNS cancer patients undergoing radiotherapy.

Background: Minimal clinically important differences (MCIDs) quantify the clinical relevance of quality of life results at the individual patient and group level. The aim of this study was to estimate the MCID for the Brief Fatigue Inventory (BFI) and the Worst and Usual Fatigue items in patients with brain or CNS cancer undergoing curative radiotherapy. Methods: Data from a multi-site prospective registry was used. The MCID was calculated using distribution-based and anchor-based approaches. For the anchor-based approach, the fatigue item from the PROMIS-10 served as the anchor to determine if a patient improved, deteriorated, or had no change from baseline to end of treatment (EOT). We compared the unadjusted means on the BFI for the 3 groups to calculate the MCID. For the distribution-based approaches, we calculated the MCID as 0.5 SD of the scores and as 1.96 times the standard error of measurement. Results: Three-hundred and fifty nine patients with brain or CNS tumors undergoing curative radiotherapy filled out the 9-item BFI at baseline and EOT. The MCID for the BFI was 1.33 (ranging from 0.99 to 1.70 across the approaches), 1.51 (ranging from 1.16 to 2.02) and 1.76 (ranging from 1.38 to 2.14) for the usual and worst fatigue items, respectively. Conclusions: This study provides the MCID ranges for the BFI and Worst and Usual fatigue items, which will allow clinically meaningful conclusions to be drawn from BFI scores. These results can be used to select optimal treatments for patients with brain or CNS cancer or to interpret BFI scores from clinical trials.

The gap between statistical and clinical significance: time to pay attention to clinical relevance in patient-reported outcome measures of insomnia.

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.

Special Commentary: Reporting Clinical Endpoints in Studies of Minimally Invasive Glaucoma Surgery.

Minimally invasive glaucoma surgery (MIGS) refers to a group of procedures generally characterized by an ab interno approach, minimal trauma to ocular tissue, moderate efficacy, an excellent safety profile, and rapid recovery. The number of MIGS procedures continues to increase, and their use has become widespread among glaucoma and cataract specialists. Standardization of the methodology and reporting of clinical endpoints in MIGS investigations enhances interpretation and comparison across different studies. The assessment of surgical interventions not only should consider statistical significance, but also whether the outcome is meaningful to patients. Minimal clinically important difference (MCID) is defined as the smallest change in a treatment outcome that is considered beneficial for an individual patient and prompts a change in their clinical management. Expert consensus is an accepted approach to determine the MCID. The American Academy of Ophthalmology's Glaucoma Preferred Practice Pattern® Committee is an expert panel that develops guidelines identifying characteristics and components of quality eye care. The Committee recommends that the cumulative probability of surgical success at 2 years with Kaplan-Meier survival analysis be used as the primary efficacy endpoint in MIGS studies. The Committee suggests that surgical success for standalone MIGS be defined as intraocular pressure (IOP) of 21 mmHg or less and reduced by 20% or more from baseline without an increase in glaucoma medications, additional laser or incisional glaucoma surgery, loss of light perception vision, or hypotony. The proposed MCID for the cumulative probability of success of standalone MIGS at 2 years is 50%. The panel recommends that surgical success for MIGS combined with cataract extraction with intraocular lens implantation (CE-IOL) be defined as a decrease in glaucoma medical therapy of 1 medication or more from baseline without an increase in IOP or IOP of 21 mmHg or less and reduced by 20% or more from baseline without an increase in glaucoma medications, additional laser or incisional glaucoma surgery, loss of light perception vision, or hypotony. The suggested MCID for the cumulative probability of success for MIGS combined with CE-IOL at 2 years is 65%. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

The Knee injury and Osteoarthritis Outcome Score (KOOS) for lateral tibial plateau fractures- relevance, reliability and responsiveness.

BACKGROUND: This study aimed to evaluate the patient-reported relevance, test-retest reliability, and responsiveness for each of the five KOOS subscales in patients with lateral tibial plateau fractures. METHODS: Adult patients with surgically treated lateral tibial plateau fractures (AO 41B) were included. The primary outcome measure was the KOOS subscales: Pain, Symptoms, Activity of Daily Living (ADL), Sport and Recreational Activities (Sport/rec), and kne-related Quality of Life (QOL). The KOOS was repeated at 14 and 15 days, six weeks, and 6 and 12 months. Content validity was partly evaluated by patients ranking the relevance of all the items in the KOOS, test-retest reliability by an interclass correlation coefficient, and responsiveness by effect size and based on 3 pre-defined hypotheses related the the global rating of change. RESULTS: Forty-one patients with a mean age of 54.8 years (ranging from 21 to 81 years) were included. The results showed an acceptable relevance of all the KOOS subscales. The test-retest reliability was moderate to high for all five subscales, with an interclass-correlation coefficient ranging from 0.6 to 0.9. At the 6- and 12-month follow-ups, the responsiveness showed large effect sizes for all the KOOS subscales, ranging from 0.9 to 2.1. Moderate to high correlations (r ≥ 0.4)was observed for the predefine hypotheses. CONCLUSION: The KOOS questionnaire showed acceptable relevance, high test-retest reliability and acceptable responsivness within one year following a lateral tibial plateau fracture. More research is needed for further validation of psychometric properties of KOOS for patients with lateral tibial plateau fractures.

Defining clinically relevant outcome thresholds for pain and function after osteochondral autograft transplantation of the knee.

PURPOSE: 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. LEVEL OF EVIDENCE: Level III.

Estimation of minimal clinically important difference for 6-minute walking distance in patients with acute stroke using anchor-based methods and credibility instruments.

BACKGROUND AND PURPOSE: 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. DISCUSSION: 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.

Comparison of Measures of Pain Intensity During Sickle Cell Disease Vaso-Occlusive Episodes.

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.

No Clinical Advantage of Harvesting a Patellar Bone Block Compared to All Soft Tissue Graft in Primary Quadriceps Tendon Anterior Cruciate Ligament Reconstruction.

PURPOSE: 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. CONCLUSION: 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. LEVEL OF EVIDENCE: Level 3 - Cohort Study.

Optimal dose and type of non-pharmacological treatments to improve cognitive function in people with Alzheimer's disease: a systematic review and network meta-analysis.

OBJECTIVES: To evaluate and rank the effectiveness of specific non-pharmacological treatments (NPTs) in improving the global cognitive function in individuals with Alzheimer's disease (AD) and to examine the dose-response relationship. METHOD: We conducted a systematic search in PubMed, MEDLINE, Embase, PsycINFO, CENTRAL, WOS, and CNKI from their inception to 15 February 2023. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for outcomes using random effects models. RESULTS: We included 68 studies involving 5053 participants in this meta-analysis. The treatments with the highest cumulative probabilities for improving global cognitive function were transcranial direct current stimulation (tDCS), followed by physical exercise (PE), and repetitive transcranial magnetic stimulation (rTMS). Additionally, cognitive stimulation (CS), cognitive training CT), multidisciplinary program (MD), and reminiscence treatment (RT) also significantly improve the global cognitive function of people with AD. A non-linear dose-response association was observed for tDCS, PE, rTMS, CS, and CT with global cognitive improvement. Notably, no minimal threshold was identified for the beneficial effects of PE on cognition. The estimated minimal doses for clinically relevant changes in cognition were 33 min per week for tDCS, 330 MET-min per week for PE, and 8000 pulses per week for rTMS. CONCLUSION: tDCS, PE, and rTMS are the better effective NPTs for enhancing global cognitive function in individuals with AD. Properly dosing these treatments can yield significant clinical benefits. Our findings support the clinical utility of low-dose exercise in improving cognition in people with AD.

Preoperative subjective assessment of disease-specific quality of life significantly influenced the likelihood of achieving the minimal clinically important difference after surgical stabilization for recurrent lateral patellar instability.

PURPOSE: To evaluate which factors exert a predictive value for not reaching the minimal clinically important difference (MCID) in patients who underwent a tailored operative treatment for recurrent lateral patellar dislocation (RLPD). METHODS: A total of 237 patients (male/female 71/166; 22.4 ± 6.8 years) were included. The Banff Patellofemoral Instability Instrument 2.0 (BPII 2.0) and subjective rating of knee function and pain (numeric analogue scale [NAS]; 0-10) were used to evaluate patients' outcomes from pre- to postoperatively. Gender, age at the time of surgery, body mass index (BMI), nicotine abuse, psychiatric diseases, cartilage status and pathoanatomic risk factors were evaluated as potential predictors for achieving the MCID using univariate logistic regression analysis. RESULTS: The MCID for the BPII 2.0 was calculated at 9.5 points. Although the BPII 2.0 and NAS for knee function and pain improved significantly in the total cohort from pre- to postoperatively (all p < 0.001), 29 patients did not reach the MCID at the final follow-up. The analysis yielded that only the preoperative NAS for function and BPII 2.0 score values were significant predictors for reaching the MCID postoperatively. The optimal threshold was calculated at 7 (NAS function) and 65.2 points (BPII 2.0). Age at the time of surgery should be considered for patients with a preoperative BPII 2.0 score >62.5. CONCLUSION: The probability of reaching BPII 2.0 MCID postoperatively depends only on the preoperative BPII 2.0 value and subjective rating of knee function, as well as age at the time of surgery for patients undergoing surgical treatment of RLPD. Here, presented results can assist clinicians in advising and presenting patients with potential outcomes following treatment for this often complex and multifactorial pathology. LEVEL OF EVIDENCE: Level III.

Establishing minimal clinically important differences and patient acceptable symptom state thresholds following birmingham hip resurfacing.

INTRODUCTION: Birmingham Hip Resurfacing (BHR) has emerged as a compelling and innovative alternative to total hip arthroplasty (THA), especially among young, active patients. However, the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptom State (PASS) thresholds have not yet been determined for patients undergoing BHR. Therefore, the current study aimed to (1) determine the MCID and PASS thresholds for both the Hip disability and Osteoarthritis Outcome Score (HOOS)-Pain and HOOS physical function shortform (PS), for patients who underwent BHR; and (2) identify factors influencing the achievement of MCID and PASS for HOOS-Pain and HOOS-PS. METHODS: Prospectively collected data from patients undergoing BHR was analyzed. Patients with osteoarthritis and completed preoperative and 1-year postoperative PROMs were included. Distribution-based and anchored-based approaches were used to estimate MCID and PASS, respectively. The optimal cut-off point for PASS thresholds was calculated using the Youden index. RESULTS: MCID for HOOS-Pain and PS were calculated to be 9.2 and 9.3, respectively. The PASS threshold for HOOS-Pain and PS were ≥ 77.7 and ≥ 87.3, respectively. The current study identified several factors affecting postoperative achievement of thresholds. Baseline Mental Component Summary (MCS) scores were a predictor for achieving MCID for postoperative HOOS-Pain, achieving MCID for postoperative HOOS-PS, achieving PASS for postoperative HOOS-Pain, and achieving PASS for postoperative HOOS-PS. Furthermore, baseline HOOS-Pain was a significant predictor for achieving MCID for postoperative HOOS-PS, achieving PASS for postoperative HOOS-Pain, and achieving PASS for postoperative HOOS-PS. CONCLUSIONS: MCID and PASS thresholds were established for HOOS-Pain and PS domains following BHR with most patients achieving these clinically meaningful benchmarks. Additionally, several factors affecting achievement of MCID and PASS were identified, including modifiable risk factors that may allow clinicians to implement optimization strategies and further improve outcomes.

Estimating minimal clinically important difference (MCID) for gastrointestinal symptoms in cystic fibrosis.

BACKGROUND: Minimal clinically important difference (MCID) is important to establish as a meaningful outcome in research when using patient reported outcome measures (PROMs). We determined the MCID using the distribution-based approach for three measurements used as part of the GALAXY study, which is an observational prospective study on gastrointestinal (GI) symptoms in cystic fibrosis (CF). METHODS: Four hundred and two persons with cystic fibrosis (PwCF) participated in the GALAXY study, all with baseline values available for all questionnaires. Mean age was 20.9 years (2.1- 61.1) with 75 females and 94 males under the age of 18 (42.04 %) and 118 females and 115 males aged 18 or older (57.99 %). MCID was measured for Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Upper Gastrointestinal Symptoms (PAGI-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL) and their subscales. Two distribution-based approaches, defined as multiplications of the standard deviation (SD) or standard error of the mean (SEM), were used to approximate the MCID. RESULTS: The two distribution-based approaches for determining the MCID estimates produced comparable results in trends in MCIDs across the subscales and total scores. In general, MCID estimates of subscales for all three measurements were higher than their total score MCIDs. The one-half SD- and SEM-based MCID estimates for total scores of each questionnaire are as follows: PAC-SYM: 0.26 and 0.14; PAGI-SYM: 0.32 and 0.15; PAC-QOL: 0.27 and 0.18, respectively. CONCLUSION: This paper establishes initial MCIDs estimated by the distribution-based approach for the PAC-SYM, PAGI-SYM and PAC-QOL that can now be used to evaluate interventional studies that may impact gastrointestinal symptoms in PwCF.

The Functioning Assessment Short Test (FAST): Clinically meaningful response threshold in patients with major depressive disorder receiving antidepressant treatment.

BACKGROUND: Functional impairment is common in patients with major depressive disorder (MDD). The Functioning Assessment Short Test (FAST) provides a detailed clinician-rated assessment of functioning across multiple aspects of daily life. This study aimed to establish clinically relevant response thresholds for the FAST in patients with MDD receiving antidepressant treatment. METHODS: Data were derived from three 8-week clinical trials of antidepressant therapy in patients with MDD that included assessment of functioning using the FAST as a pre-specified endpoint. The minimal clinically important difference (MCID) and threshold for response in terms of change in FAST total score were determined using anchor-based methods. RESULTS: After 8 weeks of antidepressant treatment, the mean reduction in FAST total score in patients considered clinically minimally improved (Clinical Global Impression-Improvement [CGI-I] score of 3) was 7-9 points (~20 % reduction). The threshold for functional response (reduction in FAST total score from baseline in patients with a CGI-I score of ≤2 at week 8) was 16-19 points (~50 % reduction). The threshold for functional response was higher in patients with MDD and comorbid generalized anxiety disorder than in those with MDD alone (mean reduction in FAST total score at 8 weeks: 26 points [63 %]). LIMITATIONS: Short-term studies. CONCLUSIONS: These results provide further validation of the FAST for assessing functioning in patients with MDD. In patients with MDD, the suggested MCID for FAST total score is 7-9 points and the proposed threshold for response is a reduction from baseline of approximately 50 %.

Minimal and robust clinically important differences for patient-reported outcome measures of fatigue in chronic stroke survivors after fatigue rehabilitation.

PURPOSE: The minimal and robust clinically important difference (MCID and/or RCID) are essential in assessing the clinical significance of multidimensional fatigue inventory-20 and checklist of individual strength-fatigue subscale questionnaires changes scores. This is the first study to determine the MCID and RCID of these questionnaires in chronic stroke survivors. MATERIALS AND METHODS: A total of 125 participants in an observational cohort study completed MFI-20 and CIS-fs before and after receiving multidisciplinary rehabilitation (cognitive behavioral therapy, graded exercise and adaptive pacing therapy). Anchor-based MCIDs and RCIDs were calculated using the mean change, the mean difference and the receiver operating characteristics methods. To evaluate the accordance between of distribution-based MCIDs (1 SD, ½ SD, SEM, 1.96 SEM and MDC values) with anchored values, the accuracy, sensitivity, specificity and Youden's index were calculated. RESULTS: The anchored MCIDs were between -5 to -7.33 for MFI-20 and -4.87 to -5.40 for CIS-fs. The anchored RCIDs ranged from -5 to -13.88 and -6 to -9.88 for MFI-20 and CIS-fs, respectively. The values of ½ SD and SEM for CIS-fs were consistent with anchored RCIDs. CONCLUSIONS: The estimated MCIDs and RCIDs of MFI-20 and CIS-fs can help researchers and clinicians interpret their chronic stroke patient data.

The Multidimensional Fatigue Inventory-20 (MFI-20) And Checklist Individual Strength-20 (CIS-20) Measures Are Two Important And Valid Instruments For Measuring Fatigue In Patients With Chronic Stroke.The Identified Minimal Clinically Important Differences (MCID) And Robust Clinically Important Difference In The Current Study Can Assist Clinicians In The Clinical Interpretation Of Fatigue Changes Observed In MFI-20 And CIS-20 Scores.The MCID Obtained In This Study Can Be Useful In Determining The Proportion Of Patients Who Benefit From Fatigue Treatment In Stroke Rehabilitation.