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 ◽  
...  

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.

2019 ◽  
Vol 161 (4) ◽  
pp. 551-560 ◽  
Author(s):  
Ahmad R. Sedaghat

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.


2017 ◽  
Vol 5 (2_suppl2) ◽  
pp. 2325967117S0007 ◽  
Author(s):  
Derya Çelik ◽  
Özge Çoban ◽  
Önder Kılıçoğlu

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.


2021 ◽  
pp. 036354652110057
Author(s):  
Benjamin G. Domb ◽  
Cynthia Kyin ◽  
Cammille C. Go ◽  
Jacob Shapira ◽  
Philip J. Rosinsky ◽  
...  

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.


2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Krisztina Horváth ◽  
Zsuzsanna Aschermann ◽  
Péter Ács ◽  
Gabriella Deli ◽  
József Janszky ◽  
...  

Background and Aims. The aim of the present study was to determine the estimates of minimal clinically important difference for Parkinson’s Disease Sleep Scale 2nd version (PDSS-2) total score and dimensions.Methods. The subject population consisted of 413 PD patients. At baseline, MDS-UPDRS, Hoehn-Yahr Scale, Mattis Dementia Rating Scale, and PDSS-2 were assessed. Nine months later the PDSS-2 was reevaluated with the Patient-Reported Global Impression Improvement Scale. Both anchor-based techniques (within patients’ score change method and sensitivity- and specificity-based method by receiver operating characteristic analysis) and distribution-based approaches (effect size calculations) were utilized to determine the magnitude of minimal clinically important difference.Results. According to our results, any improvements larger than −3.44 points or worsening larger than 2.07 points can represent clinically important changes for the patients. These thresholds have the effect size of 0.21 and −0.21, respectively.Conclusions. Minimal clinically important differences are the smallest change of scores that are subjectively meaningful to patients. Studies using the PDSS-2 as outcome measure should utilize the threshold of −3.44 points for detecting improvement or the threshold of 2.07 points for observing worsening.


Neurosurgery ◽  
2018 ◽  
Vol 85 (6) ◽  
pp. 779-785 ◽  
Author(s):  
Panagiotis Kerezoudis ◽  
Kathleen J Yost ◽  
Nicole M Tombers ◽  
Maria Peris Celda ◽  
Matthew L Carlson ◽  
...  

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.


2019 ◽  
Vol 161 (5) ◽  
pp. 890-896 ◽  
Author(s):  
Katie M. Phillips ◽  
Eric Barbarite ◽  
Lloyd P. Hoehle ◽  
David S. Caradonna ◽  
Stacey T. Gray ◽  
...  

Objective Acute exacerbation of chronic rhinosinusitis (AECRS) is associated with significant quality-of-life decreases. We sought to determine characteristics associated with an exacerbation-prone phenotype in chronic rhinosinusitis (CRS). Study Design Cross-sectional. Setting Tertiary care rhinology clinic. Subjects Patients with CRS (N = 209). Methods Patient-reported number of sinus infections, CRS-related antibiotics, and CRS-related oral corticosteroids taken in the last 12 months were used as metrics for AECRS frequency. Sinonasal symptom burden was assessed with the 22-item Sinonasal Outcome Test (SNOT-22). Ninety patients reporting 0 for all AECRS metrics were considered to have had no AECRS in the prior 12 months. A total of 119 patients reported >3 on at least 1 AECRS metric and were considered as having an exacerbation-prone phenotype. Characteristics associated with patients with an exacerbation-prone phenotype were identified with exploratory regression analysis. Results An exacerbation-prone phenotype was positively associated with comorbid asthma (adjusted odds ratio [ORadj] = 3.68, 95% CI: 1.42-9.50, P = .007) and SNOT-22 (ORadj = 1.06, 95% CI: 1.04-1.09, P < .001). Polyps were negatively associated (ORadj = 0.27, 95% CI: 0.11-0.68, P = .005) with an exacerbation-prone phenotype. SNOT-22 score ≥24 identified patients with an exacerbation-prone phenotype with a sensitivity of 93.3% and a specificity of 57.8%. Having either a SNOT-22 score ≥24 with a nasal subdomain score ≥12 or a SNOT-22 score ≥24 with an ear/facial discomfort subdomain score ≥3 provided >80% sensitivity and specificity for detecting patients prone to exacerbation. Conclusions In total, these results point to a CRS exacerbation-prone phenotype characterized by high sinonasal disease burden with comorbid asthma but interestingly without polyps.


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