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.

scholarly journals Minimal Clinically Important Difference of Patient Reported Outcome Measures of Lower Extremity Injuries in Orthopedics

2017 ◽  
Vol 5 (2_suppl2) ◽  
pp. 2325967117S0007 ◽  
Author(s):  
Derya Çelik ◽  
Özge Çoban ◽  
Önder Kılıçoğlu
Keyword(s):  
Lower Extremity ◽  
Outcome Measures ◽  
Minimal Clinically Important Difference ◽  
Rating Scale ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Foot And Ankle ◽  
Clinically Important Difference ◽  
Outcome Score ◽  
Patient Reported

Purpose: MCID scores for outcome measures are frequently used evidence-based guides to gage meaningful changes. To conduct a systematic review of the quality and content of the the minimal clinically important difference (MCID) relating to 16 patient-rated outcome measures (PROM) used in lower extremity. Methods: We conducted a systematic literature review on articles reporting MCID in lower extremity outcome measures and orthopedics from January 1, 1980, to May 10, 2016. We evaluated MCID of the 16 patient reported outcome measures (PROM) which were Harris Hip Score (HHS), Oxford Hip Score (OHS), Hip Outcome Score (HOS), Hip Disability and Osteoarthritis Outcome Score (HOOS), The International Knee Documentation Committee Subjective Knee Form (IKDC), The Lysholm Scale, The Western Ontario Meniscal Evaluation Tool (WOMET), The Anterior Cruciate Ligament Quality of Life Questionnaire (ACL-QOL), The Lower Extremity Functional Scale (LEFS), The Western Ontario and Mcmaster Universities Index (WOMAC), Knee İnjury And Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS), Kujala Anterior Knee Pain Scale, The Victorian Institute of Sports Assessment Patellar Tendinosis (Jumper’s Knee) (VİSA-P), Tegner Activity Rating Scale, Marx Activity Rating Scale, Foot And Ankle Outcome Score (FAOS), The Foot Function Index (FFI), Foot And Ankle Ability Measure (FAAM), The Foot And Ankle Disability Index Score and Sports Module, Achill Tendon Total Rupture Score(ATRS), The Victorian İnstitute Of Sports Assesment Achilles Questionnaire(VİSA-A), American Orthopaedic Foot and Ankle Society (AOFAS). A search of the PubMed/MEDLINE, PEDro and Cochrane Cen¬tral Register of Controlled Trials and Web of Science databases from the date of inception to May 1, 2016 was conducted. The terms “minimal clinically important difference,” “minimal clinically important change”, “minimal clinically important improvement” “were combined with one of the PROM as mentioned above. Results: A total of 223 abstracts were reviewed and 119 articles chosen for full text review. Thirty articles were included in the final evaluation. The MCID was mostly calculated for WOMAC and frequently reported in knee and hip osteoartritis, knee and hip atrhroplasties, femoraasetabular impingement syndrome and focal cartilage degeneration. In addition, Receiver Operating Characteristic (ROC) analysis was the most used method to report MCID. Conclusions: MCID is an important concept used to determine whether a medical intervention improves perceived outcomes in patients. Despite an abundance of methods reported in the literature, little work in MCID estimation has been done in the PRAM related to lower extremity. There is a need for future studies in this regard.

Understanding the Minimal Clinically Important Difference (MCID) of Patient-Reported Outcome Measures

2019 ◽  
Vol 161 (4) ◽  
pp. 551-560 ◽  
Author(s):  
Ahmad R. Sedaghat
Keyword(s):  
Minimal Clinically Important Difference ◽  
Threshold Value ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Clinically Important Difference ◽  
Consensus Statements ◽  
Patient Reported ◽  
Clinically Significant ◽  
The Many

ObjectiveThe minimal clinically important difference (MCID) of a patient-reported outcome measure (PROM) represents a threshold value of change in PROM score deemed to have an implication in clinical management. The MCID is frequently used to interpret the significance of results from clinical studies that use PROMs. However, an understanding of the many caveats of the MCID, as well as its strengths and limitations, is necessary. The objective of this article is to provide a review of the calculation, interpretation, and caveats of MCID.Data SourcesMEDLINE and PubMed Central.Review MethodsLiterature search—including primary studies, review articles, and consensus statements—pertinent to the objectives of this review using PubMed.ConclusionsThe MCID of a PROM may vary depending on the patients and clinical context in which the PROM is given. The primary approaches for calculating MCID are distribution-based and anchor-based methods. Each methodology has strengths and limitations, and the ideal determination of a PROM MCID includes synthesis of results from both approaches. The MCID of a PROM is also not perfect in detecting patients experiencing a clinically important improvement, and this is reflected in its accuracy (eg, sensitivity and specificity).Implications for PracticeInterpretation or application of MCID requires consideration of all caveats underlying the MCID, including the patients in whom it was derived, the limitations of the methodologies used to calculate it, and its accuracy for identifying patients who have experienced clinically significant improvement.

Minimal Clinically Important Difference as Applied in Rheumatology: An OMERACT Rasch Working Group Systematic Review and Critique

2015 ◽  
Vol 43 (1) ◽  
pp. 194-202 ◽  
Author(s):  
Beyza Doganay Erdogan ◽  
Ying Ying Leung ◽  
Christoph Pohl ◽  
Alan Tennant ◽  
Philip G. Conaghan
Keyword(s):  
Ordinal Data ◽  
Minimal Clinically Important Difference ◽  
Health Assessment ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
The Past ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Full Text Review ◽  
Assessment Questionnaire

Objective.We aimed to evaluate how minimal (clinically) important differences (MCID/MID) were calculated in rheumatology in the past 2 decades and demonstrate how the calculation is compromised by the lack of interval scaling.Methods.We conducted a systematic literature review on articles reporting MCID calculation in osteoarthritis (OA) and rheumatoid arthritis (RA) from January 1, 1989, to May 9, 2014. We evaluated the methods of MCID calculation and recorded the ranges of MCID for common patient-reported outcome measures (PROM). Taking data from the Health Assessment Questionnaire (HAQ), we showed the effects of performing mathematical calculations on ordinal data.Results.A total of 330 abstracts were reviewed and 123 articles chosen for full text review. Thirty-six (19 OA, 16 RA and 1 OA-RA) articles were included in the final evaluation. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was the most frequently reported PROM with relevant calculations in OA, and the HAQ in RA. Sixteen articles used anchor-based methods alone for calculation of MCID, and 1 article used distribution-based methods alone. Nineteen articles used both anchor and distribution-based methods. Only 1 article calculated MCID using an interval scale. Wide ranges in MCID for the WOMAC in OA and HAQ in RA were noted. Ordinal-based derivations of MCID are shown to understate true change at the margins, and overstate change in the mid-range of a scale.Conclusion.The anchor-based method is commonly used in the calculation of MCID. However, the lack of interval scaling is shown to compromise validity of MCID calculation.

scholarly journals Substantial clinical benefit and patient acceptable symptom states of the Forgotten Joint Score 12 after primary knee arthroplasty

2021 ◽  
Author(s):  
Siri Heijbel ◽  
Annette W-Dahl ◽  
Kjell G Nilsson ◽  
Margareta Hedström
Keyword(s):  
Clinical Benefit ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
University Hospital ◽  
Operating Characteristics ◽  
Forgotten Joint Score ◽  
Substantial Clinical Benefit ◽  
Receiver Operating Characteristics Curve ◽  
Patient Reported ◽  
Patient Acceptable Symptom State

Background and purpose — Knowing how to interpret values obtained with patient reported outcome measures (PROMs) is essential. We estimated the substantial clinical benefit (SCB) and patient acceptable symptom state (PASS) for Forgotten Joint Score 12 (FJS) and explored differences depending on methods used for the estimates. Patients and methods — The study was based on 195 knee arthroplasties (KA) performed at a university hospital. We used 1 item from the Knee injury and Osteoarthritis Outcome Score domain quality of life and satisfaction with surgery, obtained 1-year postoperatively, to assess SCB and PASS thresholds of the FJS with anchor-based methods. We used different combinations of anchor questions for SCB and PASS (satisfied, satisfied with no or mild knee difficulties, and satisfied with no knee difficulties). A novel predictive approach and receiver-operating characteristics curve were applied for the estimates. Results — 70 and 113 KAs were available for the SCB and PASS estimates, respectively. Depending on method, SCB of the FJS (range 0–100) was 28 (95% CI 21–35) and 22 (12–45) respectively. PASS was 31 (2–39) and 20 (10–29) for satisfied patients, 40 (31–47) and 38 (32–43) for satisfied patients with no/mild difficulties, and 76 (39–80) and 64 (55–74) for satisfied patients with no difficulties. The areas under the curve ranged from 0.82 to 0.88. Interpretation — Both the SCB and PASS thresholds varied depending on methodology. This may indicate a problem using meaningful values from other studies defining outcomes after KA. This study supports the premise of the FJS as a PROM with good discriminatory ability in patients undergoing KA.

scholarly journals Minimal Clinically Important Differences and Substantial Clinical Benefit in Patient-Reported Outcome Measures after Autologous Chondrocyte Implantation

Cartilage ◽  
2018 ◽  
Vol 11 (4) ◽  
pp. 412-422 ◽  
Author(s):  
Takahiro Ogura ◽  
Jakob Ackermann ◽  
Alexandre Barbieri Mestriner ◽  
Gergo Merkely ◽  
Andreas H. Gomoll
Keyword(s):  
Clinical Benefit ◽  
Autologous Chondrocyte Implantation ◽  
Short Form ◽  
International Knee Documentation Committee ◽  
Patient Reported Outcome ◽  
Roc Curve Analysis ◽  
Substantial Clinical Benefit ◽  
Patient Reported ◽  
Chondrocyte Implantation ◽  
Autologous Chondrocyte

Objective We sought to determine the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) associated with the Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Lysholm, and Short Form–12 (SF-12) after autologous chondrocyte implantation (ACI). Design Ninety-two patients with satisfaction surveys at a minimum of 2 years postoperatively and at least 1 repeated patient-reported outcome measure (PROM) were analysed. The MCID was determined using 4 anchor-based methods: average change, mean change, minimally detectable change, and the optimal cutoff point for receiver operating characteristic (ROC) curves. If an anchor-based method was not applicable, standard deviation–based and effect size–based estimates were used. SCB was determined using ROC curve analysis. Results The 4 anchor-based methods provided a range of MCID values for each PROM (11-18.8 for the KOOS pain, 9.2-17.3 for the KOOS activities of daily living, 12.5-18.6 for the KOOS sport/recreation, 12.8-19.6 for the KOOS quality of life, 10.8-16.4 for the IKDC, and 6.2-8.2 for the SF-12 physical component summary). Using the 2 distribution-based methods, the following MCID value ranges were obtained: KOOS symptom, 3.6 to 8.4; the Lysholm, 4.2 to 10.5; and the SF-12 mental component summary, 1.9 to 4.6. SCB was 30 for the KOOS sport/recreation and 34.4 for the IKDC, which most accurately predict substantial improvement. No significant association was noted between SCB achievement and the baseline PROMs. Conclusion The MCID and SCB determined in our study will allow interpretation of the effects of treatment in clinical practice and trials. Given the varied MCID values in this study, standardisation of the most appropriate calculation methods is warranted.

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.

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