scholarly journals Establishing the Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient Acceptable Symptomatic State following Primary Medial Patellofemoral Ligament Reconstruction

2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0046
Author(s):  
Hailey Huddleston ◽  
Neal Naveen ◽  
Taylor Southworth ◽  
Benedict Nwachukwu ◽  
Brian Cole ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Surgical Procedure ◽  
Predictive Power ◽  
Medial Patellofemoral Ligament ◽  
Minimal Clinically Important Difference ◽  
Mpfl Reconstruction ◽  
Clinically Important Difference ◽  
Substantial Clinical Benefit ◽  
Patient Reported

Objectives: Medial patellofemoral ligament (MPFL) reconstruction is an effective surgical procedure for patients with recurrent lateral dislocations. Outcome measurements can identify the success of a surgical procedure but are shifting away from absolute values or deltas of patient-reported outcomes (PROs) towards the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS), representing the smallest clinical improvement that patients perceive as important, the threshold at which patients notice a considerable improvement, and patient satisfaction with their outcome, respectively. To our knowledge no prior study has defined these thresholds in MPFL reconstruction patients. Methods: An institutional database was reviewed for patients who underwent primary MPFL reconstruction between August 2015 to February 2018 with a minimum 6-month follow-up. IKDC, Kujala and KOOS were administered to all patients pre-operatively and at 6-months and 1-year post-operatively. An anchor-based approach with a receiver-operator curve/area under the curve analysis using the Youden index was performed to calculate the MCID, SCB and PASS. The predictive power was determined to be acceptable with AUC≥70% and excellent with AUC≥80%. Results: From 2015 to 2018, 93 of 162 patients (mean age 23.7±10.1 years; 25 males, 68 females) completed for 6-month follow-up. At 6-months follow-up, SCB and PASS were defined with acceptable predictive power for all scores listed, while MCID achieved this for KOOS pain and sports subscores only (Table 1). At 1-year follow-up, SCB and PASS were each defined with acceptable predictive power for all scores listed, while MCID achieved this mark for KOOS pain and quality of life subscores as well as both Kujala scales. Conclusion: This study establishes MCID, SCB and PASS for IKDC, Kujala, and KOOS subscores at 6-months and 1-year postoperatively with excellent predictive power for 19/23 PROMs investigated at 1-year. These findings represent important benchmarks in patients undergoing primary MPFL reconstruction.

scholarly journals The Minimal Clinically Important Difference and Substantial Clinical Benefit in the Patient-Reported Outcome Measures of Patients Undergoing Osteochondral Allograft Transplantation in the Knee

Cartilage ◽  
2018 ◽  
Vol 12 (1) ◽  
pp. 42-50 ◽  
Author(s):  
Takahiro Ogura ◽  
Jakob Ackermann ◽  
Alexandre Barbieri Mestriner ◽  
Gergo Merkely ◽  
Andreas H. Gomoll
Keyword(s):  
Clinical Benefit ◽  
Minimal Clinically Important Difference ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Curve Analysis ◽  
Osteochondral Allograft ◽  
Roc Curve Analysis ◽  
Clinically Important Difference ◽  
Substantial Clinical Benefit ◽  
Patient Reported

Objective Little is known regarding the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) with regard to the Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Lysholm score, and Short Form 12 (SF-12) score of patients who undergo osteochondral allograft transplantation (OCA). We aimed to determine the MCID and SCB associated with those patient-reported outcome measures (PROMs) after OCA. Design We analyzed the data of 86 consecutive patients who underwent OCA and who completed satisfaction surveys at a minimum of 1 year postoperatively and had at least one repeated PROM. MCID was determined using an anchor-based method: the optimal cutoff point for receiver operative characteristic (ROC) curves. If an anchor-based method was inapplicable, distribution-based methods were employed. SCB was determined using ROC curve analysis. Results Based on the ROC curve analysis, MCID was 16.7 for KOOS pain, 25 for KOOS sports/recreation, and 9.8 for IKDC. SCB was 27.7 for KOOS pain, 10.7 for KOOS symptom, 30 for KOOS sports/recreation, 31.3 for KOOS quality of life, 26.9 for IKDC, 25 for Lysholm, and 12.1 for SF-12 physical component summary. No significant association was noted between SCB achievement and the baseline patient factors and baseline PROMs. Conclusion We demonstrated the MCIDs and SCBs of several PROMs in patients undergoing OCA. These results will aid the interpretation of the effect of treatment and clinical trial settings. Moreover, the SCBs will help surgeons in the counseling of patients, where patients expect optimal results rather than minimal improvement.

Time Required to Achieve Minimal Clinically Important Difference and Substantial Clinical Benefit After Arthroscopic Treatment of Femoroacetabular Impingement

2018 ◽  
Vol 46 (11) ◽  
pp. 2601-2606 ◽  
Author(s):  
Benedict U. Nwachukwu ◽  
Brenda Chang ◽  
Joshua Adjei ◽  
William W. Schairer ◽  
Anil S. Ranawat ◽  
...  
Keyword(s):  
Femoroacetabular Impingement ◽  
Clinical Benefit ◽  
Hip Arthroscopy ◽  
Minimal Clinically Important Difference ◽  
Arthroscopic Treatment ◽  
Clinically Important Difference ◽  
Substantial Clinical Benefit ◽  
Outcome Improvement ◽  
Clinically Significant

Background: Minimal clinically important difference (MCID) defines the minimum degree of quantifiable outcome improvement that a patient perceives as the result of an intervention or in the process of healing. Substantial clinical benefit (SCB) defines the amount of quantifiable outcome improvement that is needed for a patient to feel substantially better. Little is known about when clinically significant outcome improvement is achieved. Purpose: To investigate the time-dependent nature of MCID and SCB after hip arthroscopy for femoroacetabular impingement (FAI). Study Design: Cohort study; Level of evidence, 2. Methods: An institutional hip preservation registry was queried. The modified Harris Hip Score, Hip Outcome Score, and 33-item International Hip Outcome Tool (iHOT-33) were administered to patients undergoing hip arthroscopy for FAI. Follow-up times for outcome measures were classified into 3 periods: 5 to 11 months (6 months), 12 to 23 months (1 year), and 24 to 35 months (2 years). Cumulative probabilities for achieving MCID and SCB were calculated with Kaplan-Meier survival curve analysis and interval censoring. A Weibull parametric regression analysis evaluated the odds of achieving earlier MCID. Results: A total of 719 patients undergoing primary hip arthroscopy were included. The mean ± SD age was 32.5 ± 10.5 years, and the majority were female (n = 380, 52.9%). Across all 4 outcome instruments, patients had the highest probability for achieving MCID and SCB by the 6-month postoperative period. The iHOT-33 demonstrated the highest probability for capturing MCID and SCB improvement at each of the 3 periods, with 76.0%, 84.8%, and 93.6% achieving MCID by 6 months, 1 year, and 2 years, respectively. Similarly, the probabilities of achieving SCB on the iHOT-33 were as follows: 57.1%, 68.0%, and 71.7%. A similar trend was demonstrated across other outcome tools. Older male patients and those with Outerbridge classification 1 to 4 (vs grade 0) had a significantly increased risk for taking a longer time to achieve MCID and SCB. Additionally, patients with higher preoperative outcome scores took a longer time to achieve MCID and SCB. Conclusion: At least half of patients treated with hip arthroscopy for FAI achieve MCID and SCB within the first 6 months after the procedure. However, clinically significant outcome improvement continues to be attained until 2 years postoperatively. Female patients, younger individuals, and those without chondral defects achieve faster clinical outcome improvement. These findings can be helpful for establishing shared decision-making aids and follow-up guidelines for arthroscopic treatment of FAI.

scholarly journals The likelihood of reaching minimum clinically important difference and substantial clinical benefit at 2 years following a 3-column osteotomy: analysis of 140 patients

2015 ◽  
Vol 23 (3) ◽  
pp. 340-348 ◽  
Author(s):  
Shayan Fakurnejad ◽  
Justin K. Scheer ◽  
Virginie Lafage ◽  
Justin S. Smith ◽  
Vedat Deviren ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Minimum Clinically Important Difference ◽  
Thoracic Region ◽  
Self Image ◽  
Clinically Important Difference ◽  
Substantial Clinical Benefit ◽  
Thoracolumbar Region ◽  
Upper Thoracic ◽  
The Impact

OBJECT Three-column osteotomies (3COs) are technically challenging techniques for correcting severe rigid spinal deformities. The impact of these interventions on outcomes reaching minimum clinically important difference (MCID) or substantial clinical benefit (SCB) is unclear. The objective of this study was to determine the rates of MCID and SCB in standard health-related quality of life (HRQOL) measures after 3COs in patients with adult spinal deformity (ASD). The impacts of location of the uppermost instrumented vertebra (UIV) on clinical outcomes and of maintenance on sagittal correction at 2 years postoperatively were also examined. METHODS The authors conducted a retrospective multicenter analysis of the records from adult patients who underwent 3CO with complete 2-year radiographic and clinical follow-ups. Cases were categorized according to established radiographic thresholds for pelvic tilt (> 22°), sagittal vertical axis (> 4.7 cm), and the mismatch between pelvic incidence and lumbar lordosis (> 11°). The cases were also analyzed on the basis of a UIV in the upper thoracic (T1–6) or thoracolumbar (T9–L1) region. Patient-reported outcome measures evaluated preoperatively and 2 years postoperatively included Oswestry Disability Index (ODI) scores, the Physical Component Summary and Mental Component Summary (MCS) scores of the 36-Item Short Form Health Survey, and Scoliosis Research Society-22 questionnaire (SRS-22) scores. The percentages of patients whose outcomes for these measures met MCID and SCB were compared among the groups. RESULTS Data from 140 patients (101 women and 39 men) were included in the analysis; the average patient age was 57.3 ± 12.4 years (range 20–82 years). Of these patients, 94 had undergone only pedicle subtraction osteotomy (PSO) and 42 only vertebral column resection (VCR); 113 patients had a UIV in the upper thoracic (n = 63) orthoracolumbar region (n = 50). On average, 2 years postoperatively the patients had significantly improved in all HRQOL measures except the MCS score. For the entire patient cohort, the improvements ranged from 57.6% for the SRS-22 pain score MCID to 24.4% for the ODI score SCB. For patients undergoing PSO or VCR, the likelihood of their outcomes reaching MCID or SCB ranged from 24.3% to 62.3% and from 16.2% to 47.8%, respectively. The SRS-22 self-image score of patients who had a UIV in the upper thoracic region reached MCID significantly more than that of patients who had a UIV in the thoracolumbar region (70.6% vs 41.9%, p = 0.0281). All other outcomes were similar for UIVs of upper thoracic and thoracolumbar regions. Comparison of patients whose spines were above or below the radiographic thresholds associated with disability indicated similar rates of meeting MCID and SCB for HRQOL at the 2-year follow-up. CONCLUSIONS Outcomes for patients having UIVs in the upper thoracic region were no more likely to meet MCID or SCB than for those having UIVs in the thoracolumbar region, except for the MCID in the SRS-22 self-image measure. The HRQOL outcomes in patients who had optimal sagittal correction according to radiographic thresholds determined preoperatively were not significantly more likely to reach MCID or SCB at the 2-year follow-up. Future work needs to determine whether the Schwab preoperative radiographic thresholds for severe disability apply in postoperative settings.

Establishing the Minimal Clinically Important Difference, Patient Acceptable Symptomatic State, and Substantial Clinical Benefit of the PROMIS Upper Extremity Questionnaire After Rotator Cuff Repair

2020 ◽  
Vol 48 (14) ◽  
pp. 3439-3446
Author(s):  
Eric D. Haunschild ◽  
Ron Gilat ◽  
Michael C. Fu ◽  
Tracy Tauro ◽  
Hailey P. Huddleston ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Upper Extremity ◽  
Clinical Benefit ◽  
Rotator Cuff Repair ◽  
Minimal Clinically Important Difference ◽  
Outcome Measure ◽  
Clinically Important Difference ◽  
Substantial Clinical Benefit ◽  
Clinically Significant ◽  
Cuff Repair

Background: The Patient-Reported Outcome Measurement Information System Upper Extremity (PROMIS UE) questionnaire has been validated as an effective and efficient outcome measure after rotator cuff repair (RCR). However, definitions of clinically significant outcomes used in interpreting this outcome measure have yet to be defined. Purpose: To define clinically significant outcomes of the PROMIS UE questionnaire in patients undergoing arthroscopic RCR. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: We reviewed charts of consecutive patients undergoing RCR in our institution between 2017 and 2018 and included patients who were administered the PROMIS UE before surgery and 12 months after surgery. At 12 months postoperatively, patients were asked domain-specific anchor questions regarding their function and satisfaction after surgery, which were then used to determine the minimal clinically important difference (MCID), Patient Acceptable Symptomatic State (PASS), and substantial clinical benefit (SCB) using receiver operating characteristic and area under the curve (AUC) analysis. Univariate and multivariate logistic regression analysis was utilized to identify patient factors associated with clinically significant outcomes. Results: A total of 105 patients with RCR and minimum 12-month postoperative PROMIS UE were included in the analysis. The defined clinically significant outcomes were 4.87 for the MCID using a distribution-based method, 7.95 for the SCB (sensitivity, 0.708; specificity, 0.833; AUC, 0.760), and 39.00 for the PASS (sensitivity, 0.789; specificity, 0.720; AUC, 0.815). Among respondents, 79.0%, 62.9%, and 64.8% achieved the MCID, SCB, and PASS score thresholds, respectively. Workers’ compensation was negatively associated with achievement of the PASS. Lower preoperative PROMIS UE scores were associated with obtaining the MCID (odds ratio [OR], 0.871; P = .001) and the SCB (OR, 0.900; P = .040), whereas higher preoperative scores were predictive of achieving the PASS (OR, 1.111; P = .020). Conclusion: This study defines the clinically significant outcomes for the PROMIS UE after RCR, of which the majority of patients achieved the MCID, PASS, and SCB at 12 months after surgery. These thresholds should be considered in future study design and interpretation of PROMIS UE in patients with RCR.

Arthroscopic Circumferential Acetabular Labral Reconstruction for Irreparable Labra in the Revision Setting: Patient-Reported Outcome Scores and Rate of Achieving the Minimal Clinically Important Difference at a Minimum 2-Year Follow-up

2021 ◽  
pp. 036354652110057
Author(s):  
Benjamin G. Domb ◽  
Cynthia Kyin ◽  
Cammille C. Go ◽  
Jacob Shapira ◽  
Philip J. Rosinsky ◽  
...  
Keyword(s):  
Health Survey ◽  
Minimal Clinically Important Difference ◽  
Short Form ◽  
Arthroscopic Surgery ◽  
Patient Reported Outcome ◽  
Harris Hip Score ◽  
Clinically Important Difference ◽  
Labral Tears ◽  
Patient Reported

Background: There is a paucity in the literature reporting patient-reported outcome (PRO) scores and the minimal clinically important difference (MCID) after revision hip arthroscopic surgery with circumferential labral reconstruction. Purpose: To report minimum 2-year PRO scores and the rate of achieving the MCID in patients who underwent revision hip arthroscopic surgery with circumferential labral reconstruction in the setting of irreparable labral tears. Study Design: Case series; Level of evidence, 4. Methods: Data were retrospectively reviewed for all patients who underwent revision hip arthroscopic surgery between February 2016 and November 2017. Patients were included if they had undergone circumferential labral reconstruction and had preoperative and postoperative scores for the modified Harris Hip Score (mHHS), Non-Arthritic Hip Score (NAHS), Hip Outcome Score Sport-Specific Subscale (HOS-SSS), International Hip Outcome Tool (iHOT-12), 12-Item Short Form Health Survey physical and mental components (SF-12 P and SF-12 M, respectively), Veterans RAND 12-Item Health Survey physical and mental components (VR-12 P and VR-12 M, respectively), and visual analog scale (VAS) for pain. Exclusion criteria were Tönnis grade >1, Legg-Calve-Perthes disease, slipped capital femoral epiphysis, fractures, hip dysplasia, or revision labral treatment different from circumferential labral reconstruction. The MCID was calculated. Secondary surgical procedures were documented. Results: A total of 26 hips (26 patients; 61.5% female) were included. The mean age and body mass index were 33.2 ± 10.4 years and 25.5 ± 4.9, respectively. Significant improvements were reported for the mHHS (17.0 ± 19.5; P = .0002), NAHS (17.9 ± 16.7; P < .0001), HOS-SSS (21.7 ± 23.1; P = .0005), VAS (–2.2 ± 3.0; P = .006), iHOT-12 (25.8 ± 32.5; P = .0007), SF-12 P (8.5 ± 11.2; P = .001), and VR-12 P (8.9 ± 11.6; P = .001). Rates of meeting the MCID for the mHHS, NAHS, HOS-SSS, iHOT-12, and VAS were 76.9%, 80.0%, 65.0%, 62.5%, and 69.2%, respectively. No case of re-revision arthroscopic surgery was documented, but 1 case of conversion to total hip arthroplasty was documented at 38.6 months. Conclusion: In the setting of revision hip arthroscopic surgery and irreparable labral tears, circumferential labral reconstruction resulted in significant improvements in all PRO and VAS scores at a minimum 2-year follow-up with a high rate of achieving the MCID.

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