The Minimal Clinically Important Difference: A Review of Clinical Significance

2021 ◽  
pp. 036354652110538
Author(s):  
David A. Bloom ◽  
Daniel J. Kaplan ◽  
Edward Mojica ◽  
Eric J. Strauss ◽  
Guillem Gonzalez-Lomas ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Study Design ◽  
Minimal Clinically Important Difference ◽  
Clinical Status ◽  
Patient Reported Outcome ◽  
Universal Method ◽  
Status Change ◽  
Clinically Important Difference ◽  
Orthopaedic Literature ◽  
Patient Reported

Background: The minimal clinically important difference (MCID) is a term synonymous with orthopaedic clinical research over the past decade. The term represents the smallest change in a patient-reported outcome measure that is of genuine clinical value to patients. It has been derived in a myriad of ways in existing orthopaedic literature. Purpose: To describe the various modalities for deriving the MCID. Study Design: Narrative review; Level of evidence, 4. Methods: The definitions of common MCID determinations were first identified. These were then evaluated by their clinical and statistical merits and limitations. Results: There are 3 primary ways for determining the MCID: anchor-based analysis, distribution-based analysis, and sensitivity- and specificity-based analysis. Each has unique strengths and weaknesses with respect to its ability to evaluate the patient’s clinical status change from baseline to posttreatment. Anchor-based analyses are inherently tied to clinical status yet lack standardization. Distribution-based analyses are the opposite, with strong foundations in statistics, yet they fail to adequately address the clinical status change. Sensitivity and specificity analyses offer a compromise of the other methodologies but still rely on a somewhat arbitrarily defined global transition question. Conclusion: This current concepts review demonstrates the need for (1) better standardization in the establishment of MCIDs for orthopaedic patient-reported outcome measures and (2) better study design—namely, until a universally accepted MCID derivation exists, studies attempting to derive the MCID should utilize the anchor-based within-cohort design based on Food and Drug Administration recommendations. Ideally, large studies reporting the MCID as an outcome will also derive the value for their populations. It is important to consider that there may be reasonable replacements for current derivations of the MCID. As such, future research should consider an alternative threshold score with a more universal method of derivation.

scholarly journals The ENDOPAIN 4D Questionnaire: A New Validated Tool for Assessing Pain in Endometriosis

2021 ◽  
Vol 10 (15) ◽  
pp. 3216
Author(s):  
Anne Puchar ◽  
Pierre Panel ◽  
Anne Oppenheimer ◽  
Joseph Du Cheyron ◽  
Xavier Fritel ◽  
...  
Keyword(s):  
Minimal Clinically Important Difference ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
Dimensional Structure ◽  
Clinically Important Difference ◽  
Urinary Tract Symptoms ◽  
New Instrument ◽  
Patient Reported ◽  
Good Internal Consistency ◽  
Pain Symptoms

Objectives: To study the measurement properties, the responsiveness and the minimal clinically important difference of the ENDOPAIN-4D: a new questionnaire for assessing pain in endometriosis. Methods: A prospective, observational, multicentre study was conducted including all women ≥18 years consulting for symptomatic proven endometriosis between 1 January 2017 and 30 June 2018 and volunteering to participate. Each patient had to answer a new self-administered patient-reported outcome (PRO) questionnaires (the ENDOPAIN-4D) at inclusion (T0) and 12 months after medical or surgical treatment (T1). Criteria defined by COSMIN were used to validate the questionnaire's measurement properties. The minimal clinically important difference was estimated by the anchor-based method. Results: The study included 199 women. The ENDOPAIN-4D score had a four dimensional structure with good internal consistency (measured by Cronbach α): I) pain-related disability (α = 0.79), II) painful bowel symptoms (α = 0.80), III) dyspareunia (α = 0.83), and IV) painful urinary tract symptoms (α = 0.77). They produced four subscores that can be summed to obtain a single score (α = 0.61). The ENDOPAIN-4D total score ranged from 0 to 94.00 (mean ± SD: 46.7 ± 22). The total score was significantly correlated with the PROs used in endometriosis. Sensitivity to change was good with large effect sizes (ES) (mean of the differences: 36.3 p = 1.8 10−7, ES 0.76). The minimal clinically important difference of the global score was determined to be 10.9. Conclusions: The ENDOPAIN-4D questionnaire is easy to use, valid, and effective in assessing patient reported pain symptoms in women treated for endometriosis. This new instrument can be used as the primary outcome for future clinical trials and as a tool for routine patient follow-up.

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.

Defining the Minimal Clinically Important Difference for Patients With Vestibular Schwannoma: Are all Quality-of-Life Scores Significant?

Neurosurgery ◽  
2018 ◽  
Vol 85 (6) ◽  
pp. 779-785 ◽  
Author(s):  
Panagiotis Kerezoudis ◽  
Kathleen J Yost ◽  
Nicole M Tombers ◽  
Maria Peris Celda ◽  
Matthew L Carlson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Acoustic Neuroma ◽  
Minimal Clinically Important Difference ◽  
Patient Reported Outcome ◽  
Cross Sectional ◽  
Prospective Data ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Spearman’S Correlation

Abstract BACKGROUND The diagnosis of vestibular schwannomas (VS) is associated with reduced patient quality of life (QOL). Minimal clinically important difference (MCID) was introduced as the lowest improvement in a patient-reported outcome (PRO) score discerned as significant by the patient. We formerly presented an MCID for the Penn Acoustic Neuroma QOL (PANQOL) battery based on cross-sectional data from 2 tertiary referral centers. OBJECTIVE To validate the PANQOL MCID values using prospective data. METHODS A prospective registry capturing QOL was queried, comprising patients treated at the authors’ institution and Acoustic Neuroma Association members. Anchor- and distribution-based techniques were utilized to determine the MCID for domain and total scores. We only included anchors with Spearman's correlation coefficient larger than 0.3 in the MCID threshold calculations. Most domains had multiple anchors with which to estimate the MCID. RESULTS A total of 1254 patients (mean age: 57.4 yr, 65% females) were analyzed. Anchor-based methods produced a span of MCID values (median, 25th-75th percentile) for each PANQOL domain and the total score: hearing (13.1, 13-16 points), balance (14, 14-19 points), pain (21, 20-28 points), face (25, 16-36 points), energy (16, 15-18 points), anxiety (16 [1 estimate]), general (13 [1 estimate]), and total (12.5, 10-15 points). CONCLUSION Current findings corroborate our formerly shared experience using multi-institutional, cross-sectional information. These MCID thresholds can serve as a pertinent outcome when deciphering the clinical magnitude of VS QOL endpoints in cross-sectional and longitudinal studies.

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.

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.

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.

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