Discordance Abounds in Minimum Clinically Important Differences in THA: A Systematic Review.
The minimum clinically important difference (MCID) is intended to detect a change in a patient-reported outcome measure (PROM) large enough for a patient to appreciate. Their growing use in orthopaedic research stems from the necessity to identify a metric, other than the p value, to better assess the effect size of an outcome. Yet, given that MCIDs are population-specific and that there are multiple calculation methods, there is concern about inconsistencies. Given the increasing use of MCIDs in total hip arthroplasty (THA) research, a systematic review of calculated MCID values and their respective ranges, as well as an assessment of their applications, is important to guide and encourage their use as a critical measure of effect size in THA outcomes research.
We systematically reviewed MCID calculations and reporting in current THA research to answer the following: (1) What are the most-reported PROM MCIDs in THA, and what is their range of values? (2) What proportion of studies report anchor-based versus distribution-based MCID values? (3) What are the most common methods by which anchor-based MCID values are derived? (4) What are the most common derivation methods for distribution-based MCID values? (5) How do the reported medians and corresponding ranges compare between calculation methods for each PROM?
The EMBASE, MEDLINE, and PubMed databases were systematically reviewed from inception through March 2022 for THA studies reporting an MCID value for any PROMs. Two independent authors reviewed articles for inclusion. All articles calculating new PROM MCID scores after primary THA were included for data extraction and analysis. MCID values for each PROM, MCID calculation method, number of patients, and study demographics were extracted from each article. In total, 30 articles were included. There were 45 unique PROMs for which 242 MCIDs were reported. These studies had a total of 1,000,874 patients with a median age of 64 years and median BMI of 28.7 kg/m 2 . Women made up 55% of patients in the total study population, and the median follow-up period was 12 months (range 0 to 77 months). The overall risk of bias was assessed as moderate using the modified Methodological Index for Nonrandomized Studies criteria for comparative studies (the mean score for comparative papers in this review was 18 of 24, with higher scores representing better study quality) and noncomparative studies (for these, the mean score was 10 of a possible 16 points, with higher scores representing higher study quality). Calculated values were classified as anchor-based, distribution-based, or not reported. MCID values for each PROM, MCID calculation method, number of patients, and study demographics were extracted from each study. Anchor-based and distribution-based MCIDs were compared for each unique PROM using a Wilcoxon rank sum test, given the non-normal distribution of values.
The Oxford Hip Score (OHS) and the Hip Injury and Osteoarthritis Score (HOOS) Pain and Quality of Life subscore MCIDs were the most frequently reported, comprising 12% (29 of 242), 8% (20 of 242), and 8% (20 of 242), respectively. The EuroQol VAS (EQ-VAS) was the next-most frequently reported (7% [17 of 242]) followed by the EuroQol 5D (EQ-5D) (7% [16 of 242]). The median anchor-based value for the OHS was 9 (IQR 8 to 11), while the median distribution-based value was 6 (IQR 5 to 6). The median anchor-based MCID values for HOOS Pain and Quality of Life were 33 (IQR 28 to 35) and 25 (14 to 27), respectively; the median distribution-based values were 10 (IQR 9 to 10) and 13 (IQR 10 to 14), respectively. Thirty percent (nine of 30) of studies used an anchor-based method to calculate a new MCID, while 40% (12 of 30) used a distribution-based technique. Thirty percent of studies (nine of 30) calculated MCID values using both methods. For studies reporting an anchor-based calculation method, a question assessing pain relief, satisfaction, or quality of life on a five-point Likert scale was the most commonly used anchor (30% [eight of 27]), followed by a receiver operating characteristic curve estimation (22% [six of 27]). For studies using distribution-based calculations, the most common method was one-half the standard deviation of the difference between preoperative and postoperative PROM scores (46% [12 of 26]). Most reported median MCID values (nine of 14) did not differ by calculation method for each unique PROM (p > 0.05). The OHS, HOOS JR, and HOOS Function, Symptoms, and Activities of Daily Living subscores all varied by calculation method, because each anchor-based value was larger than its respective distribution-based value.
We found that MCIDs do not vary very much by calculation method across most outcome measurement tools. Additionally, there are consistencies in MCID calculation methods, because most authors used an anchor question with a Likert scale for the anchor-based approach or used one-half the standard deviation of preoperative and postoperative PROM score differences for the distribution-based approach. For some of the most frequently reported MCIDs, however, anchor-based values tend to be larger than distribution-based values for their respective PROMs.
We recommend using a 9-point increase as the MCID for the OHS, consistent with the median reported anchor-based value derived from several high-quality studies with large patient groups that used anchor-based approaches for MCID calculations, which we believe are most appropriate for most applications in clinical research. Likewise, we recommend using the anchor-based 33-point and 25-point MCIDs for the HOOS Pain and Quality of Life subscores, respectively. We encourage using anchor-based MCID values of WOMAC Pain, Function, and Stiffness subscores, which were 29, 26, and 30, respectively.
Deckey DG
，Verhey JT
，Christopher ZK
，Gerhart CRB
，Clarke HD
，Spangehl MJ
，Bingham JS
... -
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Defining Patient-relevant Thresholds and Change Scores for the HOOS JR and KOOS JR Anchored on the Patient-acceptable Symptom State Question.
When evaluating the results of clinical research studies, readers need to know that patients perceive effect sizes, not p values. Knowing the minimum clinically important difference (MCID) and the patient-acceptable symptom state (PASS) threshold for patient-reported outcome measures helps us to ascertain whether our interventions result in improvements that are large enough for patients to care about, and whether our treatments alleviate patient symptoms sufficiently. Prior studies have developed the MCID and PASS threshold for the Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) and Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) anchored on satisfaction with surgery, but to our knowledge, neither the MCID nor the PASS thresholds for these instruments anchored on a single-item PASS question have been described.
(1) What are the MCID (defined here as the HOOS/KOOS JR change score associated with achieving PASS) and PASS threshold for the HOOS JR and KOOS JR anchored on patient responses to the single-item PASS instrument? (2) How do patient demographic factors such as age, gender, and BMI correlate with MCID and PASS thresholds using the single-item PASS instrument?
Between July 2020 and September 2021, a total of 10,970 patients underwent one primary unilateral THA or TKA and completed at least one of the three surveys (preoperative HOOS or KOOS JR, 1-year postoperative HOOS or KOOS JR, and 1-year postoperative single-item anchor) at one large, academic medical center. Of those, only patients with data for all three surveys were eligible, leaving 13% (1465 total; 783 THAs and 682 TKAs) for analysis. Despite this low percentage, the overall sample size was large, and there was little difference between completers and noncompleters in terms of demographics or baseline patient-reported outcome measure scores. Patients undergoing bilateral total joint arthroplasty or revision total joint arthroplasty and those without all three surveys at 1 year of follow-up were excluded. A receiver operating characteristic curve analysis, leveraging a 1-year, single-item PASS (that is, "Do you consider that your current state is satisfactory?" with possible answers of "yes" or "no") as the anchor was then used to establish the MCID and PASS thresholds among the 783 included patients who underwent primary unilateral THA and 682 patients who underwent primary unilateral TKA. We also explored the associations of age at the time of surgery (younger than 65 years or 65 years and older), gender (men or women), BMI (< 30 or ≥ 30 kg/m 2 ), and baseline Patient-Reported Outcome Measure Information System-10 physical and mental component scores (< 50 or ≥ 50) for each of the MCID and PASS thresholds through stratified analyses.
For the HOOS JR, the MCID associated with the PASS was 23 (95% CI 18 to 31), with an area under the receiver operating characteristic curve of 0.75, and the PASS threshold was 81 (95% CI 77 to 85), with an area under the receiver operating characteristic curve of 0.81. For the KOOS JR, the MCID was 16 (95% CI 14 to 18), with an area under the receiver operating characteristic curve of 0.75, and the PASS threshold was 71 (95% CI 66 to 73) with an area under the receiver operating characteristic curve of 0.84. Stratified analyses indicated higher change scores and PASS threshold for younger men undergoing THA and higher PASS thresholds for older women undergoing TKA.
Here, we demonstrated the utility of a single patient-centered anchor question, raising the question as to whether simply collecting a postoperative PASS is an easier way to measure success than collecting preoperative and postoperative patient-reported outcome measures and then calculating MCIDs and the substantial clinical benefit.
Level III, therapeutic study.
Dekhne MS
，Fontana MA
，Pandey S
，Driscoll DA
，Lyman S
，McLawhorn AS
，MacLean CH
... -
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Who Benefits From Hip Arthroplasty or Knee Arthroplasty? Preoperative Patient-reported Outcome Thresholds Predict Meaningful Improvement.
Hip arthroplasty (HA) and knee arthroplasty (KA) are high-volume procedures. However, there is a debate about the quality of indication; that is, whether surgery is truly indicated in all patients. Patient-reported outcome measures (PROMs) may be used to determine preoperative thresholds to differentiate patients who will likely benefit from surgery from those who will not.
(1) What were the minimum clinically important differences (MCIDs) for three commonly used PROMs in a large population of patients undergoing HA or KA treated in a general orthopaedic practice? (2) Do patients who reach the MCID differ in important ways from those who do not? (3) What preoperative PROM score thresholds best distinguish patients who achieve a meaningful improvement 12 months postsurgery from those who do not? (4) Do patients with preoperative PROM scores below thresholds still experience gains after surgery?
Between October 1, 2019, and December 31, 2020, 4182 patients undergoing HA and 3645 patients undergoing KA agreed to be part of the PROMoting Quality study and were hence included by study nurses in one of nine participating German hospitals. From a selected group of 1843 patients with HA and 1546 with KA, we derived MCIDs using the anchor-based change difference method to determine meaningful improvements. Second, we estimated which preoperative PROM score thresholds best distinguish patients who achieve an MCID from those who do not, using the preoperative PROM scores that maximized the Youden index. PROMs were Hip Disability and Osteoarthritis Outcome Score-Physical Function short form (HOOS-PS) (scored 0 to 100 points; lower indicates better health), Knee Injury and Osteoarthritis Outcome Score-Physical Function short form (KOOS-PS) (scored 0 to 100 points; lower indicates better health), EuroQol 5-Dimension 5-level (EQ-5D-5L) (scored -0.661 to 1 points; higher indicates better health), and a 10-point VAS for pain (perceived pain in the joint under consideration for surgery within the past 7 days) (scored 0 to 10 points; lower indicates better health). The performance of derived thresholds is reported using the Youden index, sensitivity, specificity, F1 score, geometric mean as a measure of central tendency, and area under the receiver operating characteristic curve.
MCIDs for the EQ-5D-5L were 0.2 for HA and 0.2 for KA, with a maximum of 1 point, where higher values represented better health-related quality of life. For the pain scale, they were -0.9 for HA and -0.7 for KA, of 10 points (maximum), where lower scores represent lower pain. For the HOOS-PS, the MCID was -10, and for the KOOS-PS it was -5 of 100 points, where lower scores represent better functioning. Patients who reached the MCID differed from patients who did not reach the MCID with respect to baseline PROM scores across the evaluated PROMs and for both HA and KA. Patients who reached an MCID versus those who did not also differed regarding other aspects including education and comorbidities, but this was not consistent across PROMs and arthroplasty type. Preoperative PROM score thresholds for HA were 0.7 for EQ-5D-5L (Youden index: 0.55), 42 for HOOS-PS (Youden index: 0.27), and 3.5 for the pain scale (Youden index: 0.47). For KA, the thresholds were 0.6 for EQ-5D-5L (Youden index: 0.57), 39 for KOOS-PS (Youden index: 0.25), and 6.5 for the pain scale (Youden index: 0.40). A higher Youden index for EQ-5D-5L than for the other PROMs indicates that the thresholds for EQ-5D-5L were better for distinguishing patients who reached a meaningful improvement from those who did not. Patients who did not reach the thresholds could still achieve MCIDs, especially for functionality and the pain scale.
We found that patients who experienced meaningful improvements (MCIDs) mainly differed from those who did not regarding their preoperative PROM scores. We further identified that patients undergoing HA or KA with a score above 0.7 or 0.6, respectively, on the EQ-5D-5L, below 42 or 39 on the HOOS-PS or KOOS-PS, or below 3.5 or 6.5 on a 10-point joint-specific pain scale presurgery had no meaningful benefit from surgery. The thresholds can support clinical decision-making. For example, when thresholds indicate that a meaningful improvement is not likely to be achieved after surgery, other treatment options may be prioritized. Although the thresholds can be used as support, patient preferences and medical expertise must supplement the decision. Future studies might evaluate the utility of using these thresholds in practice, examine how different thresholds can be combined as a multidimensional decision tool, and derive presurgery thresholds based on additional PROMs used in practice.
Preoperative PROM score thresholds in this study will support clinicians in decision-making through objective measures that can improve the quality of the recommendation for surgery.
Langenberger B
，Steinbeck V
，Busse R
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ResearchGate
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钛学术
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