scholarly journals Minimal Clinically Important Difference and Patient Acceptable Symptom State in Patients With Knee Osteoarthritis Treated With PRP Injection

2021 ◽  
Vol 9 (10) ◽  
pp. 232596712110262
Author(s):  
Angelo Boffa ◽  
Luca Andriolo ◽  
Marco Franceschini ◽  
Alessandro Di Martino ◽  
Emanuela Asunis ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Clinical Relevance ◽  
Minimal Clinically Important Difference ◽  
Post Injection ◽  
Threshold Values ◽  
Knee Oa ◽  
Clinically Important Difference ◽  
Psychometric Measures ◽  
Subjective Score ◽  
Patient Acceptable Symptom State

Background: Although several injection-based treatments have been proposed to address knee osteoarthritis (OA), it is often difficult to understand the clinical relevance of the obtained results. The psychometric measures of minimal clinically important difference (MCID) and Patient Acceptable Symptom State (PASS) were developed to better interpret study findings. Purpose: To establish the MCID and the PASS for the International Knee Documentation Committee (IKDC) Subjective score and the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients treated with intra-articular platelet-rich plasma (PRP) injections for knee OA. Study Design: Case series; Level of evidence, 4. Methods: This study included 215 patients with knee OA (68% men, 32% women; age, 53.2 ± 11.3 years; body mass index, 26.8 ± 4.3 kg/m2) who underwent intra-articular PRP injections. Patients were assessed through the IKDC Subjective score and KOOS subscales, and the MCID and the PASS for both measures were independently calculated at 6 and 12 months post-injection. The MCID was calculated using the value equal to half of the standard deviation of the overall cohort improvement. The PASS was assessed using a 2-point scale ( satisfied or not satisfied), with threshold values being detected through a receiver operating characteristic curve analysis and the Youden index to maximize the sensitivity and the specificity of the threshold values. Results: All scores improved significantly from baseline to 6 months and baseline to 12 months ( P < .001 for all scores). All scores were stable from 6 to 12 months except for the KOOS Quality of Life subscale, which improved further ( P = .033). For the IKDC, the MCID values were 8.6 and 8.5 points and the PASS scores were 59.7 and 62.1 at 6 and 12 months, respectively. Overall, the MCID and the PASS for all KOOS subscales remained constant at the 2 follow-up points. The percentage of patients who achieved the MCID and the PASS was higher than 85% at both 6 and 12 months post-injection. Conclusion: This study provided the MCID and PASS thresholds for the IKDC and KOOS scores in patients with knee OA treated with PRP injections. These psychometric measures may allow a better interpretation of the clinical relevance of injection-based treatment outcomes for knee OA.

Defining the Minimal Clinically Important Difference and Patient Acceptable Symptom State for Microfracture of the Knee: A Psychometric Analysis at Short-term Follow-up

2020 ◽  
Vol 48 (4) ◽  
pp. 876-883 ◽  
Author(s):  
Jorge Chahla ◽  
Kyle N. Kunze ◽  
Tracy Tauro ◽  
Joshua Wright-Chisem ◽  
Brady T. Williams ◽  
...  
Keyword(s):  
Minimal Clinically Important Difference ◽  
Lesion Size ◽  
Older Age ◽  
Distribution Method ◽  
Pain Scores ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Patient Acceptable Symptom State ◽  
Male Sex ◽  
Over Time

Background: Several studies have investigated failure rates and magnitude of improvement in patient-reported outcome measures after microfracture surgery for focal chondral defects of the knee; however; what constitutes clinically significant improvement in this patient population is poorly understood. Purpose: To (1) establish the minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds for microfracture surgery including the time-dependent nature of these thresholds and (2) identify predictors of achieving the MCID and PASS in patients specifically undergoing microfracture of the knee. Study Design: Case series; Level of evidence, 4. Methods: A secure institutional cartilage preservation repository was queried for all patients who underwent microfracture between 2004 and 2017. The distribution method was used to calculate MCID thresholds for the International Knee Documentation Committee (IKDC) score and the Knee injury and Osteoarthritis Outcome Score (KOOS), whereas an anchor-based method was used for the PASS. Multivariate logistic regressions were constructed to determine predictors of achieving the MCID and PASS. Results: A total of 206 patients with a mean ± SD age of 33.7 ± 13.2 years and body mass index of 26.9 ± 5.3 kg/m2 were included. All thresholds for the MCID and PASS increased over time except for the MCID thresholds for the KOOS Sports and Symptoms subscales. The proportion of patients who achieved the MCID (6 months, 78.4%; 12 months, 83.9%; 24 months, 88.6%) and PASS (6 months, 67.7%; 12 months, 79.2%; 24 months, 76.1%) generally increased over time. Older age and larger lesion size were negative independent predictors of MCID achievement. Older age was also a negative predictor of the PASS, whereas male sex and higher preoperative KOOS Symptoms and Pain scores were positive independent predictors of the PASS. Conclusion: The MCID and PASS thresholds for the IKDC and KOOS in patients undergoing microfracture of the knee are dynamic, with an increasing number of patients achieving the MCID over time. The percentage achieving the PASS increased between 6 and 12 months and then declined slightly at 24 months. Independent predictors of achieving the MCID were lesion size and age at surgery, whereas predictors of achieving the PASS included lesion size, male sex, and greater preoperative KOOS Symptoms and Pain scores.

scholarly journals Defining the Minimal Clinically Important Difference and Patient-acceptable Symptom State Score for Disability Assessment in Surgical Patients

2020 ◽  
Vol 132 (6) ◽  
pp. 1362-1370 ◽  
Author(s):  
Mark A. Shulman ◽  
Jessica Kasza ◽  
Paul S. Myles
Keyword(s):  
World Health Organization ◽  
Minimal Clinically Important Difference ◽  
World Health ◽  
Disability Assessment ◽  
Clinically Important Difference ◽  
The World ◽  
Significant Disability ◽  
Patient Acceptable Symptom State ◽  
Clinically Significant ◽  
Health Organization

Abstract Background The World Health Organization Disability Assessment Schedule 2.0 has been used to measure postoperative disability in several clinical trials and cohort studies. It is uncertain what the minimal clinically important difference or patient-acceptable symptom state scores are for this scale in patients recovering from surgery. Methods The authors analyzed prospectively collected data from three studies that measured disability 3 and 6 months after surgery. Three distribution-based methods (0.3 multiplied by SD, standard error of the measurement, and 5% range) and two anchor-based methods (anchored to two patient-rated health status questions and separately to unplanned hospital readmission) were averaged to estimate the minimal clinically important difference for the World Health Organization Disability Assessment Schedule 2.0 score converted to a percentage scale. Scores consistent with a patient-acceptable symptom state and clinically significant disability were determined by an anchored 75th centile method. Results Data from 4,361 patients were analyzed. The average minimal clinically important difference estimate for the World Health Organization Disability Assessment Schedule 2.0 was 5%, with similar estimates in patients with or without preoperative disability. The patient-acceptable symptom state score was 16%, and the score consistent with at least moderate clinically significant disability was 35%. Using these estimates, between baseline and 6 months after surgery, 21% of patients had a significant increase in disability, and 73% achieved a patient-acceptable symptom state. Conclusions A change in World Health Organization Disability Assessment Schedule 2.0 score of 5% or more after surgery is consistent with a clinically important change in disability. Patients with a score less than 16% after surgery have an acceptable symptom state and can be considered as disability-free, whereas patients with a score of 35% or more can be considered as having at least moderate clinically significant disability. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Patient Acceptable Symptom State in Knee Osteoarthritis Patients Succeeds Across Different Patient-reported Outcome Measures Assessing Physical Function, But Fails Across Other Dimensions and Rheumatic Diseases

2017 ◽  
Vol 45 (1) ◽  
pp. 122-127 ◽  
Author(s):  
Elien A.M. Mahler ◽  
Nadine Boers ◽  
Johannes W.J. Bijlsma ◽  
Frank H.J. van den Hoogen ◽  
Alfons A. den Broeder ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Physical Function ◽  
Outcome Measures ◽  
Rheumatic Diseases ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Knee Oa ◽  
Cutoff Values ◽  
Patient Reported ◽  
Patient Acceptable Symptom State

Objective.The aims of this study are (1) to establish the Patient Acceptable Symptom State (PASS) cutoff values of different patient-reported outcome measures (PROM) assessing physical function in patients with knee osteoarthritis (OA), and (2) to assess the influence of sex, age, duration of symptoms, and presence of depressive feelings on being in PASS.Methods.Patients fulfilling the clinical American College of Rheumatology knee OA criteria received standardized nonsurgical treatment and completed different questionnaires at baseline and 3 months assessing physical function: Knee Injury and Osteoarthritis Outcome Score, Lequesne Algofunctional Index, Lower Extremity Functional Scale, numerical rating scale, and the physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index. PASS values were defined as the 75th percentile of the score of questionnaires for those patients who consider their state acceptable.Results.Of the 161 included patients, 62% were women with a mean age of 59 years (SD 9) and body mass index of 30 kg/m2 (SD 5). Standardized PASS values (95% CI) for different questionnaires for physical function varied between 48 (44–54) and 54 (50–56). Female patients and patients feeling depressed were found to have a lower probability to be in PASS for physical function, with OR (95% CI) varying from 0.45 (0.23–0.91) to 0.50 (0.26–0.97) and from 0.27 (0.14–0.55) to 0.38 (0.19–0.77), respectively.Conclusion.PASS cutoff values for physical function are robust across different PROM in patients with knee OA. Our results indicate that PASS values are not consistent across dimensions and rheumatic diseases, and that the use of a generic PASS value for patients with OA or even patients with other rheumatic diseases might not be justifiable.

The Minimal Clinically Important Difference (MCID) for the WOMAC and Factors Related to Achievement of the MCID After Medial Opening Wedge High Tibial Osteotomy for Knee Osteoarthritis

2021 ◽  
pp. 036354652110168
Author(s):  
Man Soo Kim ◽  
In Jun Koh ◽  
Keun Young Choi ◽  
Yong Gyu Sung ◽  
Dong Chul Park ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
High Tibial Osteotomy ◽  
Minimal Clinically Important Difference ◽  
Multivariate Logistic Regression Analysis ◽  
Medial Compartment ◽  
Tibial Osteotomy ◽  
Opening Wedge ◽  
Clinically Important Difference ◽  
Pain Subscale ◽  
Wedge High Tibial Osteotomy

Background: Many approaches have been used to determine the minimal clinically important difference (MCID) in patients undergoing total knee arthroplasty, but the MCID for outcome measures after medial opening wedge high tibial osteotomy (MOWHTO) for the treatment of medial compartment knee osteoarthritis (OA) has not been reported. Purpose: To define the MCID for the Western Ontario and McMaster Universities Arthritis Index (WOMAC) after MOWHTO and to identify risk factors for not achieving the MCID. Study Design: Case-control study; Level of evidence, 3. Methods: Among patients with medial compartment knee OA who underwent MOWHTO, 174 patients who were followed for 2 years were included in the study. The MCID and substantial clinical benefit (SCB) for the WOMAC were determined using the anchor-based method with a 15-item questionnaire. Preoperative OA severity was measured by the Kellgren-Lawrence (K-L) grading system, and the acceptable range of the postoperative weightbearing line ratio was 50% to 70%. Patients were divided into 2 groups based on whether the MCID and SCB were achieved, and then factors related to failure to achieve the MCID and SCB were analyzed using multivariate logistic regression analysis. Results: The MCID for the WOMAC was 4.2 points for the pain subscale, 1.9 points for the stiffness subscale, 10.1 points for the function subscale, and 16.1 points for the total. Additionally, the SCB for the WOMAC was 6.4 for pain, 2.6 for stiffness, 16.4 for function, and 25.3 for the total. Overall, 116 (66.7%), 99 (56.9%), 127 (73.0%), and 128 (73.6%) patients achieved the MCID for the WOMAC pain, stiffness, function, and total, respectively, after MOWHTO. The odds of not achieving the MCID for the WOMAC total were 1.09 times greater (95% CI, 1.05-1.13; P < .001) in patients with a low preoperative WOMAC total score (cutoff values: 10.5 for pain, 3.5 for stiffness, 34.5 for function, and 51.0 for the total), 11.77 times greater (95% CI, 3.68-37.70; P < .001) in patients with K-L grade 4 OA compared with K-L grades 2 or 3 OA, and 8.39 times greater (95% CI, 2.98-23.63; P < .001) in patients with undercorrection or overcorrection. A low preoperative WOMAC score, K-L grade 4 OA, and undercorrection or overcorrection were also associated with not achieving the SCB for the WOMAC total (all P < .05). Conclusion: Patients treated with a MOWHTO require a 16.1-point improvement in the WOMAC total score to achieve a MCID from the procedure. Low preoperative WOMAC scores, severe OA, and undercorrection or overcorrection were related to failure to achieve the MCID.

scholarly journals Efficacy and safety of a single intra-articular injection of 6 ml Hylan G-F 20 compared to placebo in Chinese patients with symptomatic knee osteoarthritis

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan Ke ◽  
Wenxue Jiang ◽  
Yongsheng Xu ◽  
Yajun Chen ◽  
Qingsong Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Clinical Efficacy ◽  
Post Injection ◽  
Efficacy And Safety ◽  
Treatment Groups ◽  
Knee Oa ◽  
Link Type ◽  
Symptomatic Knee Osteoarthritis ◽  
The Mean

Abstract Background Single 6 ml Hylan G-F 20 injection, is indicated for knee osteoarthritis patients who have failed to respond to non-pharmacologic therapy and/or simple analgesics. To obtain more thorough understanding of the clinical efficacy and safety, a randomized clinical trial was conducted comparing intra-articular (IA) administration of single 6 ml Hylan G-F 20 injection versus placebo in knee OA patients of Chinese ethnicity. Methods This was a randomized, multi-center, double-blind, placebo-controlled clinical trial conducted in 21 centers across China. Four hundred forty adults with knee OA received a single 6 ml Hylan G-F 20 or placebo injection and were evaluated for clinical efficacy and safety outcomes over 26 weeks. Western Ontario and McMaster Universities OA (WOMAC) A1 index, treatment-emergent adverse events (TEAEs) and standard safety parameters were measured at pre-injection, and at weeks 1, 4, 8, 12, 16, 20 and 26 post-injection. Results Four hundred forty patients (male: 98 [22.3%]; female: 342 [77.7%]) were randomized. The mean age [standard deviation (SD)] was 61.5 (7.9) years. All patients were of East Asian ethnicity. Mean WOMAC A1 score at baseline was 5.3 (1.2) and 5.2 (1.3) in single 6 ml Hylan G-F 20 injection and placebo groups, respectively. Significant reductions of WOMAC A1 score were observed in both treatment groups when compared to baseline at 26 weeks post-injection, with the mean reduction of [standard error (SE)/percentage] -2.146 (0.108)/− 40.5% and − 2.271 (0.110) /− 43.7% in the single 6 ml Hylan G-F 20 injection and the placebo groups, respectively. Additionally, clinically important reductions in pain at 26 weeks was reported in 67.0 and 68.2% in single 6 ml Hylan G-F 20 injection and placebo groups (p = 0.36). Regarding safety, TEAEs were similar between the two treatment groups (hylan G-F 20 single: 61.5%; placebo: 64.5%). Conclusions While the magnitude of the effect of a single 6 ml Hylan G-F 20 injection in this study is consistent with previously published literature with respect to the efficacy and safety of the drug, the current study shows a strong IA placebo effect and did not established superiority of single 6 ml Hylan G-F 20 injection over IA placebo in Chinese knee OA patients. Trial registration Prospectively registered Jun 16, 2017 at www.clinicaltrials.gov (NCT03190369).

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