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.

Development and preliminary validation of a diagnostic prediction model to optimise outpatient management of patients with urolithiasis using urinary stones and intervention quality of life (USIQoL) measure.

PURPOSE: Patients with urinary calculi undergo resource-intensive follow-up. Application of a PROM, Urinary Stones and Intervention Quality of Life (USIQoL), can potentially optimise current practices if it matches the outcomes of traditional follow-up. Our objective was to develop, and conduct, a preliminary validation of the USIQoL based prediction model to aid triage. METHODS: We performed a two phase prospective cohort study. The 1st phase included development of the USIQoL-based decision model using multicentre data. The 2nd phase involved prospective single-blind external validation for the outpatient application. The aim was to evaluate correlations between the USIQoL scores and key predictors; clinical outcomes and global health ratings (EuroQoL EQ-5D). We used statistical analysis to validate USIQoL cut-off scores to aid triage and the decision to intervene. RESULTS: Of 503 patients invited, 91% (n = 455, Development [305] and Validation [150]; M = 308, F = 147) participated. The relationship between USIQoL domain scores and clinical outcomes was consistently significant (estimated odds: PPH 1.24, p < 0.001, 95% CI 1.13-1.36; PSH 1.22, p < 0.001, 95% CI 1.12-1.33). The ROC values for the model were ≥ 0.75. The optimum domain cut-off scores were derived with rising scores implying increased need to intervene. The model demonstrated satisfactory sensitivity (0.81-0.89) and specificity (0.36-0.47). CONCLUSIONS: The study demonstrates satisfactory correlation between the USIQoL and clinical outcomes making this model a valid aid for triage and optimising outpatient management with the cut-off scores able to identify high risk patients who need active treatment.

Calculation of the minimal clinically important difference in operated patients with adult spine deformity: advantages of the ROC method and significance of prevalence in threshold selection.

PURPOSE: The Minimal Clinically Important Difference (MCID) is crucial to evaluate management outcomes, but different thresholds have been obtained in different works. Part of this variability is due to measurement error and influence of the database, both essential for calculating the MCID. The aim of this study was to introduce the association of the ROC method in the anchor-based MCID calculation for ODI, SRS-22r, and SF-36, to objectively set the threshold for the anchor-based MCID in an adult spine deformity (ASD) population. METHODS: Multicentric study based on a prospective database of consecutively operated ASD patients. An anchor question was used to assess patients' quality of life after surgery. Different approaches were used to calculate the MCID and then compared: SEM (Standard Error of Measurement), MDC (Minimal Detectable Change), and anchor-based MCID with ROC method. RESULTS: 516 patients were included. Those who responded with 6 and 7 to the anchor question were considered improved. The MCID ranges obtained with the ROC method exhibited the lowest variability. Prediction error rates ranged from 31% (SRS-22r) to 41% (SF-36 MCS). The MCID ranges spanned between 12 and 15 for ODI, 0.6 and 0.73 for SRS-22r, 6.62 and 7.41 for SF-36 PCS, and between 2.69 and 5.63 for SF-36 MCS. CONCLUSION: The ROC method proposes an MCID range with error rate, and can objectively determine the threshold for distinguishing improved and non-improved patients. As the MCID correlates with the utilized database and error of measurement, each study should compute its own MCID for each PROM to allow comparison among different publications. LEVEL OF EVIDENCE: II.

Surgical treatment of Roussouly type 1 with realigning Roussouly spinal shape and improving SRS-Schwab modifier: effect on minimal clinically important difference.

PURPOSE: To evaluate outcomes of choosing different Roussouly shapes and improving in Schwab modifiers for surgical Roussouly type 1 patients. METHODS: Baseline (BL) and 2-year (2Y) clinical data of adult spinal deformity (ASD) patients presenting with Roussouly type 1 sagittal spinal alignment were isolated in the single-center spine database. Patients were grouped into Roussouly type 1, 2 and 3 with anteverted pelvis (3a) postoperatively. Schwab modifiers at BL and 2Y were categorized as follows: no deformity (0), moderate deformity (+), and severe deformity (++) for pelvic tilt (PT), sagittal vertical axis (SVA), and pelvic incidence and lumbar lordosis mismatch (PI-LL). Improvement in SRS-Schwab was defined as a decrease in the severity of any modifier at 2Y. RESULTS: A total of 96 patients (69.9 years, 72.9% female, 25.2 kg/m2) were included. At 2Y, there were 34 type 1 backs, 60 type 2 backs and only 2 type 3a. Type 1 and type 2 did not differ in rates of reaching 2Y minimal clinically important difference (MCID) for health-related quality of life (HRQOL) scores (all P > 0.05). Two patients who presented with type 3a had poor HRQOL scores. Analysis of Schwab modifiers showed that 41.7% of patients improved in SVA, 45.8% in PI-LL, and 36.5% in PT. At 2Y, patients who improved in SRS-Schwab PT and SVA had lower Oswestry disability index (ODI) scores and significantly more of them reached MCID for ODI (all P < 0.001). Patients who improved in SRS-Schwab SVA and PI-LL had more changes of VAS Back and Short Form-36 (SF-36) outcomes questionnaire physical component summary (SF-36 PCS), and significantly more reached MCID (all P < 0.001). By 2Y, type 2 patients who improved in SRS-Schwab grades reached MCID for VAS back and ODI at the highest rate (P = 0.003, P = 0.001, respectively), and type 1 patients who improved in SRS-Schwab grades reached MCID for SF-36 PCS at the highest rate (P < 0.001). CONCLUSION: For ASD patients classified as Roussouly type 1, postoperative improvement in SRS-Schwab grades reflected superior patient-reported outcomes while type 1 and type 2 did not differ in clinical outcomes at 2Y. However, development of type 3a should be avoided at the risk of poor functional outcomes. Utilizing both classification systems in surgical decision-making can optimize postoperative outcomes.

High Variability in Standardized Outcome Thresholds of Clinically Important Changes in Shoulder Instability Surgery: A Systematic Review.

PURPOSE: The purpose of this study was to examine reported MCID and PASS values for PROMs following shoulder instability surgery and assess variability in published values depending on the surgery performed. Secondarily, our aims were to describe the methods used to derive MCID and PASS values in the published literature, including anchor-based, distribution-based, or other approaches, and to assess the frequency of MCID and PASS usage in studies on shoulder instability surgery. METHODS: A systematic review of MCID and PASS values following Bankart, Latarjet, and Remplissage procedures was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). The Embase, Pubmed, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were queried from 1985 to 2023. Inclusion criteria included studies written in English, and studies reporting utilization MCID or PASS for patient reported outcome measures (PROMS) following Latarjet, Bankart, Remplissage approaches for shoulder instability surgery. Extracted data included study population characteristics, intervention characteristics, and outcomes of interest. Continuous data were described using median and range. Categorical variables, including PROMs reported and MCID/PASS methods, were described using percentages. As MCID is a patient-level metric and not a group-level metric, the authors validated that all included studies reported proportions (%) of subjects that met or exceeded the MCID. RESULTS: A total of 174 records were screened, and 8 studies were included in this review. MCID was the most widely utilized outcome threshold which was reported in all 8 studies, with only 2 studies reporting both the MCID and the PASS. The most widely studied PROMs were the American Shoulder and Elbow Surgeons (ASES) (range 5.65-9.6 for distribution MCID, 8.5 anchor MCID, 86 anchor PASS); Single Assessment Numeric Evaluation (SANE) (range 11.4-12.4 distribution MCID, 82.5-87.5 anchor PASS); visual analog scale (VAS) (range 1.1-1.7 distribution MCID, 1.5-2.5 PASS); Western Ontario Shoulder Instability Index (WOSI) (range 60.7-254.9 distribution MCID, 126.43 anchor MCID, 571-619.5 anchor PASS); and Rowe scores (range 5.6-8.4 distribution MCID, 9.7 anchor MCID). Notably, no studies reported on substantial clinical benefit (SCB) or maximal outcome improvement (MOI). CONCLUSION: Despite the wide array of available PROMs for assessing shoulder instability surgery outcomes, the availability of clinically significant outcome thresholds such as MCID and PASS remains relatively limited. While MCID has been the most frequently reported metric, there is considerable inter-study variability observed in their values. CLINICAL RELEVANCE: Knowing the outcome thresholds such as MCID and PASS of the PROMs frequently used to evaluate the results of glenohumeral stabilization surgery is fundamental, since they allow us to know what is a clinically significant improvement for the patient.

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.

Several factors predict the achievement of the patient acceptable symptom state and minimal clinically important difference for patient-reported outcome measures following anterior cruciate ligament reconstruction: A systematic review.

PURPOSE: To summarize the predictors of the patient acceptable symptom state (PASS), minimal clinically important difference (MCID) and minimal important change (MIC) for patient-reported outcome measures (PROMs) following anterior cruciate ligament reconstruction (ACLR). METHODS: MEDLINE, PubMed and Embase were searched from inception to 5 January 2024. The authors adhered to PRISMA/R-AMSTAR guidelines, and the Cochrane Handbook for Systematic Reviews of Interventions. Data on statistical associations between predictive factors and PROMs were extracted. Inverse odds ratios (ORs) and confidence intervals (reverse group comparison) were calculated when appropriate to ensure comparative consistency. RESULTS: Thirteen studies comprising 21,235 patients (48.1% female) were included (mean age 29.3 years). Eight studies comprising 3857 patients identified predictors of PASS, including lateral extra-articular tenodesis (LET) (OR = 11.08, p = 0.01), hamstring tendon (HT) autografts (OR range: 2.02-2.63, p ≤ 0.011), age over 30 (OR range: 1.37-2.28, p ≤ 0.02), male sex (OR range: 1.03-1.32, p ≤ 0.01) and higher pre-operative PROMs (OR range: 1.04-1.21). Eight studies comprising 18,069 patients identified negative predictors of MCID or MIC, including female sex (OR = 0.93, p = 0.034), absence of HT autografts (OR = 0.70, p < 0.0001), higher pre-operative PROMs (OR = 0.76-0.84, p ≤ 0.01), meniscectomy (OR = 0.67, p = 0.014) and collision sports (OR = 0.02-0.60, p ≤ 0.05). CONCLUSION: Higher pre-operative PROMs, age over 30, male sex, LETs and HT autografts predicted PASS achievement. Lower pre-operative PROMs, male sex, non-collision sports, and lack of meniscectomies predicted MCID/MIC achievement. This review provides a comprehensive understanding of the predictors of clinically significant post-ACLR outcomes, thus improving clinical decision-making and the management of patient expectations. LEVEL OF EVIDENCE: Level IV.

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.

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.

Stratification of the minimal clinically important difference, substantial clinical benefit, and patient acceptable symptomatic state after total shoulder arthroplasty by implant type, preoperative diagnosis, and sex.

BACKGROUND: Clinical significance, as opposed to statistical significance, has increasingly been utilized to evaluate outcomes after total shoulder arthroplasty (TSA). The purpose of this study was to identify thresholds of the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for TSA outcome metrics and determine if these thresholds are influenced by prosthesis type (anatomic or reverse TSA), sex, or preoperative diagnosis. METHODS: A prospectively collected international multicenter database inclusive of 38 surgeons was queried for patients receiving a primary aTSA or rTSA between 2003 and 2021. Prospectively, outcome metrics including ASES, shoulder function score (SFS), SST, UCLA, Constant, VAS Pain, shoulder arthroplasty smart (SAS) score, forward flexion, abduction, external rotation, and internal rotation was recorded preoperatively and at each follow-up. A patient satisfaction question was administered at each follow-up. Anchor-based MCID, SCB, and PASS were calculated as defined previously overall and according to implant type, preoperative diagnosis, and sex. The percentage of patients achieving thresholds was also quantified. RESULTS: A total of 5851 total shoulder arthroplasties (TSAs) including aTSA (n = 2236) and rTSA (n = 3615) were included in the study cohort. The following were identified as MCID thresholds for the overall (aTSA + rTSA irrespective of diagnosis or sex) cohort: VAS Pain (-1.5), SFS (1.2), SST (2.1), Constant (7.2), ASES (13.9), UCLA (8.2), SPADI (-21.5), and SAS (7.3), Abduction (13°), Forward elevation (16°), External rotation (4°), Internal rotation score (0.2). SCB thresholds for the overall cohort were: VAS Pain (-3.3), SFS (2.9), SST 3.8), Constant (18.9), ASES (33.1), UCLA (12.3), SPADI (-44.7), and SAS (18.2), Abduction (30°), Forward elevation (31°), External rotation (12°), Internal rotation score (0.9). PASS thresholds for the overall cohort were: VAS Pain (0.8), SFS (7.3), SST (9.2), Constant (64.2), ASES (79.5), UCLA (29.5), SPADI (24.7), and SAS (72.5), Abduction (104°), Forward elevation (130°), External rotation (30°), Internal rotation score (3.2). MCID, SCB, and PASS thresholds varied depending on preoperative diagnosis and sex. CONCLUSION: MCID, SCB, and PASS thresholds vary depending on implant type, preoperative diagnosis, and sex. A comprehensive understanding of these differences as well as identification of clinically relevant thresholds for legacy and novel metrics is essential to assist surgeons in evaluating their patient's outcomes, interpreting the literature, and counseling their patients preoperatively regarding expectations for improvement. Given that PASS thresholds are fragile and vary greatly depending on cohort variability, caution should be exercised in conflating them across different studies.

The variability of MCID, SCB, PASS, and MOI thresholds for PROMs in the reverse total shoulder arthroplasty literature: a systematic review.

BACKGROUND: Reverse total shoulder arthroplasty (RTSA) is a common procedure utilized to address degenerative pathologies of the glenohumeral joint and rotator cuff. Increased reliance on patient-reported outcome measures (PROMs) have placed emphasis on the utilization of the minimum clinically important difference (MCID), substantial clinical benefit (SCB), patient acceptable symptom state (PASS), and maximal outcome improvement (MOI) thresholds to assess the clinical efficacy of RTSA. In this study, we systematically reviewed the MCID, SCB, PASS, and MOI thresholds reported for PROMs following RTSA. METHODS: PubMed, Embase, MEDLINE, Cochrane Library, and Google Scholar were queried for articles from January 1, 2000 to August 31, 2023 reporting MCID, SCB, PASS, or MOI values for PROMs following RTSA. Patient demographic data, study characteristics, MCID/SCB/PASS/MOI thresholds, and threshold calculation methods were extracted. RESULTS: One hundred and forty-one articles were screened with 39 ultimately included, comprising 11,984 total patients that underwent RTSA. 34 (87%) studies reported MCID thresholds, 20 (51%) reported SCB, 5 (13%) reported PASS, and 2 (5%) reported MOI. 25/39 (64%) studies referenced a previous study when reporting MCID, SCB, PASS, or MOI values, 11 (28%) used an anchor-based method to calculate threshold values, 1 (3%) used a distribution-based method, and 2 (5%) used both anchor and distribution methods. There were 19 newly calculated MCID (11), SCB (5), PASS (1), and MOI (2) thresholds. For 5 of the 6 most utilized PROMs (ASES, SST, Constant, UCLA, and SPADI), the range of reported MCID values exceeded 50% of the most common threshold. For 3 of 6, the range of SCB values exceeded 25% of the most common threshold. CONCLUSION: There is substantial variability in the MCID and SCB threshold values reported in the RTSA literature. Standardizing the methodologic calculation and utilization of MCID, SCB, PASS, and MOI thresholds for RTSA may allow for improved assessment of PROMs.

Preoperative patient factors that predict achieving the minimal clinically important difference following arthroscopic treatment of snapping scapula syndrome.

BACKGROUND: The aim of this study was to define the minimal clinically important difference (MCID) values for patient-reported outcomes (PROs) after arthroscopic treatment of snapping scapula syndrome (SSS) using a distribution-based method, and to identify demographic, clinical, and intraoperative factors significantly associated with the achievement of MCID. It was hypothesized that subjective satisfaction scores after the procedure would be strongly associated with the achievement of MCID thresholds for the PROs and that pain, preoperative response to injection, and a scapulectomy in addition to bursal resection would be predictive of clinically relevant improvement. METHODS: Patients who underwent arthroscopic treatment of SSS between October 2005 and September 2020 with a minimum of 2-year short-term postoperative follow-up were enrolled in this retrospective single-center study. The MCID was calculated using a distribution-based approach for the following PROs: 12-Item Short Form Health Survey (SF-12), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH), Single Assessment Numeric Evaluation (SANE), and visual analog scale (VAS) pain "today" and "at worst." The association between achievement of the MCID and postoperative subjective satisfaction was investigated, and factors associated with achievement of MCID were determined using bivariate analysis. RESULTS: Of a total of 190 patients assessed for eligibility, 77 patients (38.1 ± 14.3 years; 36 females) were included. Within the study population, statistically significant improvements in postoperative SF-12 physical component summary (PCS) (P < .001) and mental component summary (MCS) (P < 0.034), ASES (P < .001), QuickDASH (P < .001), SANE (P < .001), and VAS pain (P < .001) scores were observed at the minimum 2-year follow-up. The calculated MCID threshold values based on the study population were 5.0 for SF-12 PCS, 5.8 for SF-12 MCS, 11.3 for ASES, -10.5 for QuickDASH, 14.7 for SANE, 1.5 for VAS pain, and 1.7 for VAS pain at worst. Reaching the MCID was strongly associated with postoperative satisfaction (rated on a scale of 1-10). Across the PROs, younger age, favorable preoperative response to injection, partial scapuloplasty or scapulectomy, no prior surgery, and pain and function at baseline were significantly associated with attaining MCID. CONCLUSIONS: Patients who underwent arthroscopic treatment for SSS experienced clinically significant improvements in functional scores, pain, and quality of life. This study demonstrated predictive roles for certain patient-specific factors and diagnostic variables for achieving MCID in PROs, which may help surgeons preoperatively assess the probability of success and manage patient expectations.

Clinically significant outcome thresholds and rates of achievement by shoulder arthroplasty type and preoperative diagnosis.

BACKGROUND: Clinically significant outcome (CSO) benchmarks have been previously established for shoulder arthroplasty by assimilating preoperative diagnoses and arthroplasty types. The purpose of this study was to establish unique CSO thresholds and compare the time-to-achievement of these for reverse shoulder arthroplasty (RSA) for osteoarthritis (GHOA), RSA for rotator cuff arthropathy (RCA), and total shoulder arthroplasty (TSA) for GHOA. MATERIALS AND METHODS: Consecutive patients who underwent elective RSA for GHOA, TSA for GHOA, or RSA for RCA between February 2015 and May 2020, with 2-year minimum follow-up, were retrospectively identified from a prospectively maintained single surgeon registry. The American Shoulder and Elbow Surgeons (ASES) score was administered preoperatively and postoperatively at 2-week, 6-week, 3-month, 6-month, 1-year, and 2-year timepoints. Satisfaction and subjective overall improvement anchor questionnaires were administered at the time of final follow-up. Distribution-based methods were used to calculate the Minimal Clinically Important Difference (MCID), and anchor-based methods were used to calculate the Substantial Clinical Benefit (SCB) and the Patient Acceptable Symptom State (PASS) for each patient group. Median time to achievement, individual incidence of achievement at each time point, and cumulative incidence of achievement calculated using Kaplan-Meier survival curve analysis with interval censoring were compared between groups for each CSO. Cox-regression analyses were also performed to determine which patient factors were significantly associated with early or delayed achievement of CSOs. RESULTS: There were 471 patients eligible for study analysis: 276 RSA for GHOA, 107 TSA for GHOA, and 88 RSA for RCA. The calculated MCID, SCB, and PASS scores differed for each group. There were no significant differences in median time to achievement of any CSO between groups. Log-rank testing revealed that cumulative achievements significantly differed between groups for MCID (P = .014) but not for SCB (P = .053) or PASS (P = .620). On cox regression analysis, TSA patients had earlier achievement of SCB, whereas TSA and RSA for GHOA patients had earlier achievement of MCID. At 2-years, a significantly higher percentage of RSA for GHOA patients achieved MCID and SCB compared to RSA for RCA (MCID:100%, 95.5%, P = .003, SCB:94.6%, 86.4%, P = .036). CONCLUSION: Calculated CSO thresholds differ according to preoperative diagnosis and shoulder arthroplasty type. Patients undergoing TSA and RSA for GHOA achieve CSOs earlier than RSA for RCA patients, and a significantly higher percentage of RSA for GHOA patients achieve CSOs by 2 years compared to RSA for RCA patients.

Minimal important clinical difference values are not uniformly valid in the active duty military population recovering from shoulder surgery.

BACKGROUND: There are multiple methods for calculating the minimal clinically important difference (MCID) threshold, and previous reports highlight heterogeneity and limitations of anchor-based and distribution-based analyses. The Warfighter Readiness Survey assesses the perception of a military population's fitness to deploy and may be used as a functional index in anchor-based MCID calculations. The purpose of the current study in a physically demanding population undergoing shoulder surgery was to compare the yields of 2 different anchor-based methods of calculating MCID for a battery of PROMs, a standard receiver operating characteristic (ROC) curve-based MCIDs and baseline-adjusted ROC curve MCIDs. METHODS: All service members enrolled prospectively in a multicenter database with prior shoulder surgery that completed pre- and postoperative PROMs at a minimum of 12 months were included. The PROM battery included Single Assessment Numeric Evaluation (SANE), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), Patient Reported Outcome Management Information System (PROMIS) physical function (PF), PROMIS pain interference (PI), and the Warfighter Readiness Survey. Standard anchor-based and baseline-adjusted ROC curve MCIDs were employed to determine if the calculated MCIDs were both statistically and theoretically valid (95% confidence interval [CI] either completely negative or positive). RESULTS: A total of 117 patients (136 operations) were identified, comprising 83% males with a mean age of 35.7 ± 10.4 years and 47% arthroscopic labral repair/capsulorrhaphy. Using the standard, anchor-based ROC curve MCID calculation, the area under the curve (AUC) for SANE, ASES, PROMIS PF, and PROMIS PI were greater than 0.5 (statistically valid). For ASES, PROMIS PF, and PROMIS PI, the calculated MCID 95% CI all crossed 0 (theoretically invalid). Using the baseline-adjusted ROC curve MCID calculation, the MCID estimates for SANE, ASES, and PROMIS PI were both statistically and theoretically valid if the baseline score was less than 70.5, 69, and 65.7. CONCLUSION: When MCIDs were calculated and anchored to the results of standard, anchor-based MCID, a standard ROC curve analysis did not yield statistically or theoretically valid results across a battery of PROMs commonly used to assess outcomes after shoulder surgery in the active duty military population. Conversely, a baseline-adjusted ROC curve method was more effective at discerning changes across a battery of PROMs among the same cohort.

Revision Total Knee Arthroplasty Achieves Minimal Clinically Important Difference Faster than Primary Total Knee Arthroplasty.

INTRODUCTION: Revision total knee arthroplasty (rTKA) remains underexplored regarding patient-reported outcome measures (PROMs), particularly in terms of time to reach Minimal Clinically Important Difference (MCID). This study addresses this gap by comparing the time to achieve MCID between primary TKA (pTKA) and rTKA patients, providing valuable insights into their recovery trajectories. METHODS: A total of 8,266 TKAs (7,618 pTKA and 648 rTKA) were retrospectively studied in a multi-institutional arthroplasty registry. Patients who completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical, PROMIS Physical Function Short Form 10a (PF-10a), and Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS) questionnaires were identified by Current Procedural Terminology (CPT) codes. Survival curves with and without interval-censoring were utilized to evaluate the time to achieve MCID. RESULTS: Comparing the time to achieve MCID, rTKAs were significantly faster than pTKA for PROMIS Global Physical (3.5 versus 3.7 months, P = 0.004) and KOOS-PS (3.3 versus 4.2 months, P < 0.001), but similar for PROMIS PF-10a (4.4 versus 4.8 months, P = 0.057). Interval-censoring also showed similar trends with earlier times to achieve MCID for rTKAs for PROMIS Global Physical (0.6 to 0.61 versus 0.97 to 0.97 months, P = 0.009) and KOOS-PS (0.97 to 0.97 versus 1.47 to 1.47 months, P < 0.001), but not for PROMIS PF-10a (2.43 to 2.54 versus 1.90 to 1.91 months, P = 0.92). CONCLUSION: The present study revealed that the time to achieve MCID was faster in patients undergoing rTKA compared to those undergoing pTKA. These findings allow surgeons to reassure preoperative revision TKA patients that their recovery to a minimal clinically important difference postoperatively may be quicker than expected, especially when compared to their initial recovery after primary TKA.

Time to Achieve the Minimal Clinically Important Difference in Primary Total Hip Arthroplasty: Comparison of Anterior and Posterior Surgical Approaches.

BACKGROUND: Controversy remains over outcomes between total hip arthroplasty approaches. This study aimed to compare the time to achieve the minimal clinically important difference (MCID) for the Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (HOOS-PS) and the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-Physical for patients who underwent anterior and posterior surgical approaches in primary total hip arthroplasty. METHODS: Patients from 2018 to 2021 with preoperative and postoperative HOOS-PS or PROMIS Global-Physical questionnaires were grouped by approach. Demographic and MCID achievement rates were compared, and survival curves with and without interval-censoring were used to assess the time to achieve the MCID by approach. Log-rank and weighted log-rank tests were used to compare groups, and Weibull regression analyses were performed to assess potential covariates. RESULTS: A total of 2,725 patients (1,054 anterior and 1,671 posterior) were analyzed. There were no significant differences in median MCID achievement times for either the HOOS-PS (anterior: 5.9 months, 95% confidence interval [CI]: 4.6 to 6.4; posterior: 4.4 months, 95% CI: 4.1 to 5.1, P = .65) or the PROMIS Global-Physical (anterior: 4.2 months, 95% CI: 3.5 to 5.3; posterior: 3.5 months, 95% CI: 3.4 to 3.8, P = .08) between approaches. Interval-censoring revealed earlier times of achieving the MCID for both the HOOS-PS (anterior: 1.509 to 1.511 months; posterior: 1.7 to 2.3 months, P = .87) and the PROMIS Global-Physical (anterior: 3.0 to 3.1 weeks; posterior: 2.7 to 3.3 weeks, P = .18) for both surgical approaches. CONCLUSIONS: The time to achieve the MCID did not differ by surgical approach. Most patients will achieve clinically meaningful improvements in physical function much earlier than previously believed. LEVEL OF EVIDENCE: Level III, Retrospective Comparative Study.

Predicting Outcome of Total Knee Arthroplasty by Cluster Analysis of Patient-Reported Outcome Measures.

BACKGROUND: Total knee arthroplasties (TKAs) exhibit an 8 to 30% risk of suboptimal outcomes, resulting in persistent symptoms, individual morbidity, and revision surgery, prompting a contemporary focus on risk reduction and outcome improvement. This study introduces hierarchical cluster analysis as a way of preoperatively assessing the likelihood of success/failure of TKA based on several patient-reported outcome measures, which have been analyzed both intact and with component questions as individual variables. METHODS: The study utilized data on 1,433 TKAs from The Miriam Hospital's Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) registry. Outcomes are expressed as Knee Injury and Osteoarthritis Outcome Score (KOOS) pain and function scores. Criteria for success/failure were developed with an integrative, anchor-based, minimum clinically important difference. Preoperative and postoperative patient-reported outcome measures (PROMs) were studied by cluster analysis. RESULTS: There were three sequential cluster analyses that revealed clusters of patients, based upon preoperative patient responses, that were predictive of surgical outcomes. Clusters varied most significantly in their responses to individual component questions of preoperative PROMs. Extracting and combining the clinically meaningful patient-reported component questions yielded a new, and clinically relevant, outcome measure that has the potential to preoperatively predict postoperative outcomes of total knee arthroplasty. CONCLUSION: In contrast to a single medical, psychological, or social variable, cluster analysis offers the opportunity to develop a whole-patient profile that reflects the contextual interactions of sociodemographic and clinical variables in predicting outcomes. In the context of determining clinical meaningfulness, cluster analysis has one of its major strengths.

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

BACKGROUND: Differences 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). METHODS: A 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. RESULTS: Patients 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. CONCLUSION: Patients 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 EVIDENCE: Level III, retrospective comparative study.

What Are the Diagnosis-Specific Thresholds of Minimal Clinically Important Difference and Patient Acceptable Symptom State in Hip Disability and Osteoarthritis Outcome Score After Primary Total Hip Arthroplasty?

BACKGROUND: This study aimed to determine the minimal clinically important difference (MCID) and Patient Acceptable Symptom State (PASS) thresholds for Hip Disability and Osteoarthritis Outcome Score (HOOS) pain, physical short form (PS), and joint replacement (JR) 1 year after primary total hip arthroplasty stratified by preoperative diagnosis of osteoarthritis (OA) versus non-OA. METHODS: A prospective institutional cohort of 5,887 patients who underwent primary total hip arthroplasty (January 2016 to December 2018) was included. There were 4,184 patients (77.0%) who completed a one-year follow-up. Demographics, comorbidities, and baseline and one-year HOOS pain, PS, and JR scores were recorded. Patients were stratified by preoperative diagnosis: OA or non-OA. Minimal detectable change (MDC) and MCIDs were estimated using a distribution-based approach. The PASS values were estimated using an anchor-based approach, which corresponded to a response to a satisfaction question at one year post surgery. RESULTS: The MCID thresholds were slightly higher in the non-OA cohort versus OA patients. (HOOS-Pain: OA: 8.35 versus non-OA: 8.85 points; HOOS-PS: OA: 9.47 versus non-OA: 9.90 points; and HOOS-JR: OA: 7.76 versus non-OA: 8.46 points). Similarly, all MDC thresholds were consistently higher in the non-OA cohort compared to OA patients. The OA cohort exhibited similar or higher PASS thresholds compared to the non-OA cohort for HOOS-Pain (OA: ≥80.6 versus non-OA: ≥77.5 points), HOOS-PS (OA: ≥83.6 versus non-OA: ≥83.6 points), and HOOS-JR (OA: ≥76.8 versus non-OA: ≥73.5 points). A similar percentage of patients achieved MCID and PASS thresholds regardless of preoperative diagnosis. CONCLUSIONS: While MCID and MDC thresholds for all HOOS subdomains were slightly higher among non-OA than OA patients, PASS thresholds for HOOS pain and JR were slightly higher in the OA group. The absolute magnitude of the difference in these thresholds may not be sufficient to cause major clinical differences. However, these subtle differences may have a significant impact when used as indicators of operative success in a population setting.

Comparing Rates of Minimal Clinically Important Difference Between Manual and Robotic-Assisted Total Knee Arthroplasty.

BACKGROUND: Differences in patient-reported outcome measures (PROMs) between manual total knee arthroplasty (mTKA) and robotic-assisted TKA (rTKA) have not been adequately assessed. We compared the minimal clinically important difference (MCID) for improvement (MCID-I) and worsening (MCID-W) between mTKA and rTKA patients. METHODS: Patients who underwent primary TKA (874 mTKA and 439 rTKA) with complete preoperative and 1-year postoperative PROMs were retrospectively identified using a multihospital joint arthroplasty registry. Patient-Reported Outcomes Measurement Information System Physical Function Short Form 10a (PROMIS PF-10a), PROMIS Global - Physical, or Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form were collected. The MCID-I, MCID-W, and "no significant change" rates were calculated using distribution-based methods. Propensity score matching was performed to control for confounding. RESULTS: Similar 90-day pulmonary embolism (P = 0.26), deep venous thrombosis (P = 0.67), and emergency department visit (P = 0.35) rates were found. The 90-day readmission rate for mTKA was 1.7 and 3.4% for rTKA (P = 0.08), and the overall revision rates were 2.2% for mTKA and 0.7% for rTKA (P = 0.07). Revision-free survival was 99% at one and 2 years for both groups (P = 0.65 and P = 0.43, respectively). There were no differences in the proportion of patients achieving MCID-I or MCID-W for PROMIS PF-10a, PROMIS Global - Physical, or Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form. The MCID-I for PROMIS PF-10a was achieved in 65.5 and 62.2% of patients who had mTKA and rTKA, respectively (P = 0.32). CONCLUSIONS: Our study demonstrated similar complication rates and MCID-I and MCID-W attainment rates between mTKA and rTKA patients. Future studies should assess MCID attainment rates in the long term and in larger cohorts comparing mTKA and rTKA.