Establishing minimal clinically important difference, substantial clinical benefit, and patient acceptable symptomatic state after biceps tenodesis

2019 ◽  
Vol 28 (4) ◽  
pp. 639-647 ◽  
Author(s):  
Richard N. Puzzitiello ◽  
Anirudh K. Gowd ◽  
Joseph N. Liu ◽  
Avinesh Agarwalla ◽  
Nikhil N. Verma ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Minimal Clinically Important Difference ◽  
Biceps Tenodesis ◽  
Clinically Important Difference ◽  
Substantial Clinical Benefit

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.

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.

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