Advertisement

Substantial Clinical Benefit Values Demonstrate a High Degree of Variability When Stratified by Time and Geographic Region

Open AccessPublished:November 01, 2022DOI:https://doi.org/10.1016/j.jseint.2022.10.003

      Abstract

      Background

      A Substantial Clinical Benefit (SCB) value is the amount of change in a patient reported outcome measure required for a patient to feel they significantly improved from an intervention. Previously published SCB values are often cited by researchers when publishing outcomes data. Where these SCB values are set can have a large impact on the conclusions drawn from a study citing them. As such, the goal of this study was to determine the generalizability of SCB values for a procedure when stratified by time from surgery and geographic region.

      Methods

      A nationwide outcomes database was utilized to obtain preoperative, one-year, and two-year postoperative outcome measurements for patients who underwent anatomic (aTSA) or reverse total shoulder arthroplasty (rTSA). The data was divided into three geographic regions: South, Midwest, and West. An East region was not included due to its limited number of patients. SCB values were calculated for four outcomes measures: Single Assessment Numeric Evaluation score, American Shoulder Elbow Surgeons score, Visual Analogue Scale, and Western Ontario Osteoarthritis of the Shoulder score. SCB values were calculated for each region, for each procedure, and at both one and two years postoperatively. To determine the variability of potential SCBs within each region, simulated datasets were created to determine a distribution of possible calculated SCBs.

      Results

      A total of 380 aTSA patients and 543 rTSA patients were included for analysis. There was a high degree of variability of SCB values when stratified by procedure, time, and region. While some simulated datasets did produce homogenous SCB distributions amongst regions, some outcome measures demonstrated a large heterogeneity in distribution amongst regions, with concomitant large distributions of values within individual regions.

      Conclusions

      There is notable heterogeneity of SCB values when stratified by region or time. The current method of citing previously published SCB values for determining the efficacy of an intervention may be inappropriate. It is likely that this variability holds true in other areas of orthopedics.

      Keywords

      Patient reported outcome measures (PROMs) have become a mainstay of orthopedic research, providing quantitative measurements of patients’ function and perceptions of their health. However, the wide variety of PROMs with different scoring systems can be difficult to interpret, and statistically significant results do not always correlate with clinically meaningful differences.
      • Harris J.D.
      • Brand J.C.
      • Cote M.P.
      • Faucett S.C.
      • Dhawan A.
      Research pearls: The significance of statistics and perils of pooling. Part 1: Clinical versus statistical significance.
      The minimal clinically important difference (MCID), which defines the change in PROM score that represents a clinically meaningful difference, was proposed to address this problem.
      • Jaeschke R.
      • Singer J.
      • Guyatt G.H.
      Measurement of health status: ascertaining the minimal clinically important difference. Control.
      MCID has since became a common value to reference when publishing on the efficacy of a procedure. The substantial clinical benefit (SCB) was subsequently developed to provide a more thorough framework for interpreting PROMs, with the MCID acting as a threshold for change that patients can perceive and the SCB acting as a target for defining clinical success.
      • Glassman S.D.
      • Copay A.G.
      • Berven S.H.
      • Polly D.W.
      • Subach B.R.
      • Carreon L.Y.
      Defining substantial clinical benefit following lumbar spine arthrodesis.
      These values have become increasingly prevalent in orthopedic literature in recent years, especially with regards to shoulder conditions.
      • Su F.
      • Allahabadi S.
      • Bongbong D.N.
      • Feeley B.T.
      • Lansdown D.A.
      Minimal clinically important difference, substantial clinical benefit, and patient acceptable symptom state of outcome measures relating to shoulder pathology and surgery: A systematic review.
      An SCB value is the amount of change after an intervention for a particular outcome measure that is needed to predict a patient reporting that they substantially benefited from the intervention. For example, if an SCB for an outcome measure, such as Single Assessment Numeric Evaluation (SANE), after reverse shoulder arthroplasty is determined to be 50, a patient who had an increase in that outcome measure of 50 or greater is likely to report that they substantially improved from the arthroplasty. Subsequently, if a patient had an improvement of less than 50, they are likely to report that they did not improve substantially.
      The SCB value is determined for one PROM for a specific pathology and/or procedure via a concomitantly administered anchor question.
      • Glassman S.D.
      • Copay A.G.
      • Berven S.H.
      • Polly D.W.
      • Subach B.R.
      • Carreon L.Y.
      Defining substantial clinical benefit following lumbar spine arthrodesis.
      ,
      • Jaeschke R.
      • Singer J.
      • Guyatt G.H.
      Measurement of health status: ascertaining the minimal clinically important difference. Control.
      This anchor question seeks to provide a patient reported, clear response regarding the efficacy of the intervention. Researchers then use these values to determine the efficacy of an intervention. Often, investigators will determine the percentage of patients who crossed these previously published SCB thresholds and report this as a measurement of surgical success.
      • Berthold D.P.
      • Muench L.N.
      • Kia C.
      • Ziegler C.G.
      • Laurencin S.J.
      • Witmer D.
      • et al.
      Surgeon and Patient Upper Extremity Dominance Does Not Influence Clinical Outcomes After Total Shoulder Arthroplasty.
      ,
      • Cusano A.
      • Kanski G.
      • Uyeki C.
      • Adams K.
      • Cote M.P.
      • Muench L.N.
      • et al.
      Outcomes of Reverse Shoulder Arthroplasty Following Failed Superior Capsular Reconstruction.
      ,
      • Muench L.N.
      • Kia C.
      • Jerliu A.
      • Williams A.A.
      • Berthold D.P.
      • Cote M.P.
      • et al.
      Clinical outcomes following biologically enhanced patch augmentation repair as a salvage procedure for revision massive rotator cuff tears. Arthrosc.
      Utilization of SCBs in this manner relies on an assumption of high degrees of homogeneity between patient populations, and any variation in the SCB value can have a drastic effect on the outcomes of the study.
      The SCB is likely influenced by factors beyond symptomatic state alone, as indicated by the high variability between SCB values for different procedures.
      • Su F.
      • Allahabadi S.
      • Bongbong D.N.
      • Feeley B.T.
      • Lansdown D.A.
      Minimal clinically important difference, substantial clinical benefit, and patient acceptable symptom state of outcome measures relating to shoulder pathology and surgery: A systematic review.
      Despite this, the SCB is frequently determined in a population receiving care at one institution, often from one surgeon.
      • Su F.
      • Allahabadi S.
      • Bongbong D.N.
      • Feeley B.T.
      • Lansdown D.A.
      Minimal clinically important difference, substantial clinical benefit, and patient acceptable symptom state of outcome measures relating to shoulder pathology and surgery: A systematic review.
      SCBs are calculated using both the change in outcome measure and, more importantly, their expectations for symptomatic improvement. As such, any factor impacting patients’ expectations, whether they be cultural/societal influences or the expectations set by a surgeon preoperatively, would significantly affect an SCB value. There may be significant heterogeneity between populations presenting to different institutions, which limits the utility of broadly applying the SCB determined in one patient population as a threshold for clinical success. For example, an SCB value published by an institution in the West may not apply to a patient from the South.
      Understanding the consistency of these values is critical, as the current state of outcomes research relies on the assumption that they are highly homogenous. If there were significant differences in SCB values based on time or location, it would call into question the current methods by which SCB values are employed in outcomes research. The purpose of the present study was to determine the SCB values for four outcome measures for patients undergoing either anatomic (aTSA) or reverse total shoulder arthroplasty (rTSA) stratified by both time from surgery and region within the United States, and to see if there is significant heterogeneity between these values. We hypothesized that a high degree of variability will exist for SCBs when separated out by region and time.

      Methods

      This study uses data collected under IRB number 16-042-1 Total Shoulder Multi-Center Registry provided by an industry sponsor (Arthrex Total Shoulder Registry). Patients were consented before surgery to be followed for 10 years. A database of outcome measures collected for aTSA and rTSA comprised of patients from 12 states across the United States was utilized for this study. Four PROMs were used: SANE score, American Shoulder Elbow Surgeons (ASES) score, Visual Analogue Scale (VAS), and Western Ontario Osteoarthritis of the Shoulder (WOOS) score. To be included in the SCB calculation for each of these scores, patients required preoperative scores, both one- and two-year postoperative scores, and an answer to the anchor question: “How well did the treatment meet your expectations with regard to reducing your pain level?”. Patients who responded to this question that they either “exceeded” or “met” surgical expectations were classified as having a substantial clinical benefit and those that responded “did not meet” were classified as having not substantially benefitted. This methodology was based on prior studies calculating SCBs.
      • Cohn M.R.
      • Kunze K.N.
      • Polce E.M.
      • Nemsick M.
      • Garrigues G.E.
      • Forsythe B.
      • et al.
      Establishing clinically significant outcome thresholds for the Single Assessment Numeric Evaluation 2 years following total shoulder arthroplasty.
      ,
      • Glassman S.D.
      • Copay A.G.
      • Berven S.H.
      • Polly D.W.
      • Subach B.R.
      • Carreon L.Y.
      Defining substantial clinical benefit following lumbar spine arthrodesis.
      ,
      • Lyman S.
      • Lee Y.-Y.
      • McLawhorn A.S.
      • Islam W.
      • MacLean C.H.
      What are the minimal and substantial improvements in the HOOS and KOOS and JR versions after total joint replacement?.
      ,
      • Martin R.L.
      • Kivlan B.R.
      • Christoforetti J.J.
      • Wolff A.B.
      • Nho S.J.
      • Salvo Jr., J.P.
      • et al.
      Minimal clinically important difference and substantial clinical benefit values for the 12-item international hip outcome tool.
      While some studies use Likert based anchor questions and exclude those that report a “slight improvement” of their symptoms,
      • Simovitch R.
      • Flurin P.H.
      • Wright T.
      • Zuckerman J.D.
      • Roche C.P.
      Quantifying success after total shoulder arthroplasty: the substantial clinical benefit.
      we elected to include those that “met” surgical expectations for pain relief in the substantial improvement group as patients likely expect a significant improvement in their symptomatic pain after a procedure. Thus, those that “met expectations” for surgical pain relief likely experienced a significant improvement in their symptoms.
      The states in the dataset were divided into three regions for analysis: Southeast (Kentucky, North Carolina, South Carolina, Texas, Virginia), Midwest (Ohio, Illinois, Michigan, Missouri), and West (Arizona, Colorado, Oregon). Analyzing based on region allowed for larger sample sizes to be used for calculations, as well as allowed for the incorporation of states which had too few patients to conduct an SCB analysis on their own. Initially, a East region was to be included however there were too few patients in this region to perform complete statistical analyses. SCBs for each of the outcome measures were then calculated at 1- and 2-years from the index procedure.

      Statistical Analysis

      Patients were grouped according to their response to the anchor question. Patients indicating that treatment met or exceed expectations were considered to have experienced a substantial clinical benefit and those who responded that the treatment did not meet expectations were considered to have failed to experience substantial benefit. For each of the four PROMs evaluated, the difference in score was calculated by subtracting the postoperative score at each time interval from the preoperative score. Receiver-operating characteristics (ROC) type analysis was conducted to determine the difference in score that most accurately separated the two groups. The optimal SCB value was defined as difference in score that maximized Youden index, which is the sum of sensitivity and specificity. For example, in a group of 30 hypothetical patients of which half noted significant improvement after surgery and half did not, ROC-analysis plots each subject’s change in an outcome measure of choice and aims to find a cutoff that most accurately separates out those who did or did not significantly improve. This value is deemed the SCB.
      ROC-analysis does not address potential variability in SCB values determined from a single patient population. To determine variation in potential SCB scores calculated from an identical dataset, data was simulated using the sample size, mean, and standard deviation of the difference scores for each procedure, timepoint, and region. From each simulated dataset the optimal SCB values were determined as described above. This process was repeated 1,000 times resulting in 1,000 SCB values for each of the groupings. The mean and standard deviation of these simulated values were calculated as a measure of variation in SCB values. Analyses were performed using the cutpointr package for the R programming language.

      Results

      A total of 380 patients were included for analysis in the aTSA group, while 543 were included in the rTSA group. For aTSA there were 51 were in the South group, 70 in the Midwest group, and 259 in the West group. For rTSA there were 92 in the South group, 141 in the Midwest group, and 310 in the West group. Table 1 demonstrates the SCB values calculated for SANE, ASES, VAS, and raw WOOS scores at one and two years postoperatively for each region and all data combined (Table 1).
      Table 1SCB Values at 1 and 2 years Postoperatively Stratified by Region
      Post-Operative TimeaTSA
      South (n=51)Midwest (n=70)West (n=259)Combined (n=380)
      SANE1 Year30464040
      SANE2 Year31405033
      ASES1 Year33303838
      ASES2 Year30403333
      VAS1 Year-4.00-4.90-3.69-3.63
      VAS2 Year-1.76-4.00-3.36-3.50
      WOOS1 Year-813-6.73-671-674
      WOOS2 Year-977-532-1035-1002
      rTSA
      South (n=92)Midwest (n=141)West (n=310)Combined (n=543)
      SANE1 Year1263338
      SANE2 Year59513131
      ASES1 Year32212831
      ASES2 Year24242727
      VAS1 Year-3.12-3.02-3.88-3.68
      VAS2 Year-2.08-3.73-3.40-3.73
      WOOS1 Year-541-627-763-706
      WOOS2 Year-528-797-753-814
      The mean SCBs were then calculated for 1000 simulated datasets from each region to determine the potential variability of SCB values within region. The distribution of these values was then plotted (Figure 1). These values were grouped by time from surgery, region, procedure, and PROM. While some of these distributions were consistent between regions, other outcome measures had a high degree of variability. Some regional distributions of SCBs did not overlap at all, such as the VAS and SCB distributions at 1 year for rTSA between the Midwest and West groups. Additionally, there was a significant amount of heterogeneity of distribution sizes amongst regions. For example, the WOOS SCB distribution at 1 year for rTSA had a large distribution in the Midwest group, while there was a small distribution seen in the South group.
      Figure thumbnail gr1
      Figure 1Mean SCB values for VAS Pain, SANE, ASES, and WOOS scores calculated at one- and two-years postoperatively from 1000 simulated datasets. The error lines indicate the range of potential SCB values calculated from these datasets.

      Discussion

      Our study found notable differences in the observed SCB values for both reverse and anatomic total shoulder arthroplasties based on time from index procedure as well as geographical region. When these differences were explored further with data simulation, there was considerable variation in the SCB suggesting that a wide range of potential values are possible for a given outcome measure and patient population. These findings illustrate the inherent heterogeneity of SCB values for each outcome measure and demonstrate the lack of generalizability when using a single SCB value for outcome measures across varying patient populations.
      These results are important as the use of a previously reported SCB values as a surrogate for identifying patients who have experienced substantial benefit has become more prevalent in shoulder arthroplasty research,
      • Berthold D.P.
      • Muench L.N.
      • Kia C.
      • Ziegler C.G.
      • Laurencin S.J.
      • Witmer D.
      • et al.
      Surgeon and Patient Upper Extremity Dominance Does Not Influence Clinical Outcomes After Total Shoulder Arthroplasty.
      ,
      • Cusano A.
      • Kanski G.
      • Uyeki C.
      • Adams K.
      • Cote M.P.
      • Muench L.N.
      • et al.
      Outcomes of Reverse Shoulder Arthroplasty Following Failed Superior Capsular Reconstruction.
      ,
      • Drager J.
      • Polce E.M.
      • Fu M.
      • Nemsick M.
      • Huddleston H.P.
      • Forsythe B.
      • et al.
      Patients undergoing anatomic total shoulder arthroplasty achieve clinically significant outcomes faster than those undergoing reverse shoulder arthroplasty.
      ,
      • Routman H.D.
      • Simovitch R.W.
      • Wright T.W.
      • Flurin P.H.
      • Zuckerman J.D.
      • Roche C.P.
      Acromial and Scapular Fractures After Reverse Total Shoulder Arthroplasty with a Medialized Glenoid and Lateralized Humeral Implant: An Analysis of Outcomes and Risk Factors.
      and the orthopedic literature in general.
      • Beletsky A.
      • Gowd A.K.
      • Liu J.N.
      • Manderle B.J.
      • Yanke A.B.
      • Forsythe B.
      • et al.
      Time to Achievement of Clinically Significant Outcomes After Isolated Arthroscopic Partial Meniscectomy: A Multivariate Analysis.
      ,
      • Campbell A.
      • Emara A.K.
      • Klika A.
      • Piuzzi N.S.
      Does Implant Selection Affect Patient-Reported Outcome Measures After Primary Total Hip Arthroplasty?.
      ,
      • Djurasovic M.
      • Glassman S.D.
      • Dimar J.R.
      • Howard J.M.
      • Bratcher K.R.
      • Carreon L.Y.
      Does fusion status correlate with patient outcomes in lumbar spinal fusion?.
      ,
      • Jung J myung
      • Chung C.K.
      • Kim C.H.
      • Yang S.H.
      • Won Y.I.
      • Choi Y.
      Effects of Total Psoas Area Index on Surgical Outcomes of Single-Level Lateral Lumbar Interbody Fusion.
      While this well-intended approach allows the results to be viewed from the perspective of clinical significance, it is reliant upon the stability of the SCB as it relates to the outcome measure and patient population of interest. If the SCB being utilized is considerably different than the true SCB of the patient group under study, the interpretation of these results could be misleading. For instance, an SCB that’s too large would result in an intervention appearing less efficacious, while an SCB that’s too small would make it appear more effective than it truly is. Interestingly, a systematic review by Kolin et al found similar heterogeneity previously reported MCID values for shoulder arthroplasty outcome measurements.
      • Kolin D.A.
      • Moverman M.A.
      • Pagani N.R.
      • Puzzitiello R.N.
      • Dubin J.
      • Menendez M.E.
      • et al.
      Substantial Inconsistency and Variability Exists Among Minimum Clinically Important Differences for Shoulder Arthroplasty Outcomes: A Systematic Review.
      Table 1 demonstrates the large disparities in SCB values between regions. While certain values were consistent, such as those for rTSA ASES scores at 1 year (range: 24-38), other values like aTSA WOOS scores at 2 years (range: -373 - -1035) were highly variable. Figure 1 shows that some regions had no overlap in potential SCB values. For example, the Midwest and West regions had no overlap in their potential SCB values for VAS and ASES pain scores for rTSA at 1 year. This suggests that if a researcher in the Midwest published an SCB value for ASES for rTSA at 1 year, it would have no applicability to a researcher in the West using this value. While some potential SCB values were similar amongst regions, such as the WOOS for rTSA at 2 years, this was not consistently the case for other outcome measures at other timepoints.
      Figure 1 demonstrated that some SCB ranges had large standard deviations, such as rTSA WOOS at 1 year in the Midwest, which suggests that even when drawn from the same patient population there is a high degree of variability in SCB values. The simulated dataset for rTSA in the Midwest at 1 year produced a mean WOOS SCB value of -498 with a standard deviation of 238. This suggests that a researcher looking to establish an SCB for WOOS in this region at 2 years might report a value between -736 and -260 . This almost 476-point disparity between potential reported values would have a large impact on the results of future outcomes research quoting this value, even if the future research was conducted with the same patient pool.
      It is important to note that the use of regions as a comparator in this study was arbitrary. The dataset could have just as well been divided into East coast versus West coast, North versus South, or even states with an “A” in their name versus those without. The goal of the study was not to establish regional or temporal SCBs for rTSA and TSA, but rather to show the high degree of lability that is associated with these values.
      The SCB values for each region in this study were not consistently homogenous. There are many potential explanations for this heterogeneity, such as differences in culture, socioeconomic status, or even simply the preoperative expectations set by the treating surgeons. Additionally, our study showed that SCB values fluctuated with time. While reported SCB values may specify the follow-up time at which they were calculated, this is not always the case.
      • Cohn M.R.
      • Kunze K.N.
      • Polce E.M.
      • Nemsick M.
      • Garrigues G.E.
      • Forsythe B.
      • et al.
      Establishing clinically significant outcome thresholds for the Single Assessment Numeric Evaluation 2 years following total shoulder arthroplasty.
      Even if an SCB value is reported at a particular follow-up interval, researchers using previously established SCB values may apply a value calculated at 2 years postoperatively for a study evaluating clinical efficacy at 1 year. Our results suggest that this usage of SCBs in this manner may be suboptimal given the variations seen at one and two-year postoperatively.
      While the results of this study call into question a foundational methodology of modern clinical outcomes research, there are simple ways for future outcomes research projects to avoid this issue of heterogeneity among SCB values. One option would be to calculate SCB values on an individual study basis. This can be accomplished by incorporating an anchor question into patient questionnaires from which an SCB can be calculated. Even more simply, SCBs can be done away with entirely. Instead, studies can report the percentage of patients who respond with a significant improvement to an anchor question. This would allow researchers to report the percentage of patients who substantially benefitted from an intervention calculating an SCB in the first place (i.e. 94% of patients reported significant improvement of their symptoms postoperatively).
      While this study was successful in its aims, it is not without limitations. Firstly, this study did not investigate the level of heterogeneity of other outcomes thresholds such as MCID or the Patient Acceptable Symptomatic State (PASS) values. These were not addressed in this study as they require different anchor questions for their calculation which were not available in the utilized dataset. MCID values have been shown to be highly variable between previously publications.
      • Kolin D.A.
      • Moverman M.A.
      • Pagani N.R.
      • Puzzitiello R.N.
      • Dubin J.
      • Menendez M.E.
      • et al.
      Substantial Inconsistency and Variability Exists Among Minimum Clinically Important Differences for Shoulder Arthroplasty Outcomes: A Systematic Review.
      It is likely that PASS values are variable as well, however further study is warranted to make this conclusion. This study included those that “met” surgical expectations for pain relief in the substantially improved group with the assumption that patients’ surgical expectations are likely a significant improvement in their preoperative pain. While this would not accurately characterize patients that expected only mild symptomatic improvements from surgery, we believe this would be a minority of patients. Additionally, this study was only conducted using data from anatomic and reverse total shoulder arthroplasty. It was limited to these procedures due to the availability of data suitable for this kind of analysis, however, future research is needed to validate if this trend is seen in other orthopedic procedures. Finally, as these are patient reported outcome measures, there is always an influence of human error such as patients misunderstanding of outcome measure questions and responses or errors in recording of these responses.

      Conclusions

      SCB values for anatomic and reverse total shoulder arthroplasty were inconsistent when stratified by time and region. This suggests that the practice of applying previously established SCB values to new datasets may be suboptimal.

      References

        • Beletsky A.
        • Gowd A.K.
        • Liu J.N.
        • Manderle B.J.
        • Yanke A.B.
        • Forsythe B.
        • et al.
        Time to Achievement of Clinically Significant Outcomes After Isolated Arthroscopic Partial Meniscectomy: A Multivariate Analysis.
        Arthrosc. Sport. Med. Rehabil. 2020 Dec 1; 2: e723-e733https://doi.org/10.1016/J.ASMR.2020.06.002
        • Berthold D.P.
        • Muench L.N.
        • Kia C.
        • Ziegler C.G.
        • Laurencin S.J.
        • Witmer D.
        • et al.
        Surgeon and Patient Upper Extremity Dominance Does Not Influence Clinical Outcomes After Total Shoulder Arthroplasty.
        Orthop. J. Sport. Med. 2020; 82325967120932106https://doi.org/10.1177/2325967120932106
        • Campbell A.
        • Emara A.K.
        • Klika A.
        • Piuzzi N.S.
        Does Implant Selection Affect Patient-Reported Outcome Measures After Primary Total Hip Arthroplasty?.
        J. Bone Joint Surg. Am. 2021 Dec 15; 103: 2306-2317https://doi.org/10.2106/JBJS.20.01931
        • Cohn M.R.
        • Kunze K.N.
        • Polce E.M.
        • Nemsick M.
        • Garrigues G.E.
        • Forsythe B.
        • et al.
        Establishing clinically significant outcome thresholds for the Single Assessment Numeric Evaluation 2 years following total shoulder arthroplasty.
        J Shoulder Elbow Surg. 2021 Apr 1; 30: e137-e146https://doi.org/10.1016/J.JSE.2020.07.011
        • Cusano A.
        • Kanski G.
        • Uyeki C.
        • Adams K.
        • Cote M.P.
        • Muench L.N.
        • et al.
        Outcomes of Reverse Shoulder Arthroplasty Following Failed Superior Capsular Reconstruction.
        J Shoulder Elbow Surg. 2022 Jul; 31: 1426-1435https://doi.org/10.1016/j.jse.2021.12.044
        • Djurasovic M.
        • Glassman S.D.
        • Dimar J.R.
        • Howard J.M.
        • Bratcher K.R.
        • Carreon L.Y.
        Does fusion status correlate with patient outcomes in lumbar spinal fusion?.
        Spine (Phila. Pa. 1976). 2011 Mar 1; 36: 404-409https://doi.org/10.1097/BRS.0B013E3181FDE2C4
        • Drager J.
        • Polce E.M.
        • Fu M.
        • Nemsick M.
        • Huddleston H.P.
        • Forsythe B.
        • et al.
        Patients undergoing anatomic total shoulder arthroplasty achieve clinically significant outcomes faster than those undergoing reverse shoulder arthroplasty.
        J Shoulder Elbow Surg. 2021 Nov 1; 30: 2523-2532https://doi.org/10.1016/J.JSE.2021.02.015
        • Glassman S.D.
        • Copay A.G.
        • Berven S.H.
        • Polly D.W.
        • Subach B.R.
        • Carreon L.Y.
        Defining substantial clinical benefit following lumbar spine arthrodesis.
        JBJS. 2008; 90: 1839-1847https://doi.org/10.2106/JBJS.G.01095
        • Harris J.D.
        • Brand J.C.
        • Cote M.P.
        • Faucett S.C.
        • Dhawan A.
        Research pearls: The significance of statistics and perils of pooling. Part 1: Clinical versus statistical significance.
        Arthrosc. J. Arthrosc. Relat. Surg. 2017; 33: 1102-1112https://doi.org/10.1016/j.arthro.2017.01.053
        • Jaeschke R.
        • Singer J.
        • Guyatt G.H.
        Measurement of health status: ascertaining the minimal clinically important difference. Control.
        Clin. Trials. 1989; 10: 407-415
        • Jung J myung
        • Chung C.K.
        • Kim C.H.
        • Yang S.H.
        • Won Y.I.
        • Choi Y.
        Effects of Total Psoas Area Index on Surgical Outcomes of Single-Level Lateral Lumbar Interbody Fusion.
        World Neurosurg. 2021 Oct 1; 154: e838-e845https://doi.org/10.1016/J.WNEU.2021.08.031
        • Kolin D.A.
        • Moverman M.A.
        • Pagani N.R.
        • Puzzitiello R.N.
        • Dubin J.
        • Menendez M.E.
        • et al.
        Substantial Inconsistency and Variability Exists Among Minimum Clinically Important Differences for Shoulder Arthroplasty Outcomes: A Systematic Review.
        Clin. Orthop. Relat. Res. 2022; : 10-1097https://doi.org/10.1097/CORR.0000000000002164
        • Lyman S.
        • Lee Y.-Y.
        • McLawhorn A.S.
        • Islam W.
        • MacLean C.H.
        What are the minimal and substantial improvements in the HOOS and KOOS and JR versions after total joint replacement?.
        Clin. Orthop. Relat. Res. 2018; 476: 2432https://doi.org/10.1097/CORR.0000000000000456
        • Martin R.L.
        • Kivlan B.R.
        • Christoforetti J.J.
        • Wolff A.B.
        • Nho S.J.
        • Salvo Jr., J.P.
        • et al.
        Minimal clinically important difference and substantial clinical benefit values for the 12-item international hip outcome tool.
        Arthrosc. J. Arthrosc. Relat. Surg. 2019; 35: 411-416https://doi.org/10.1016/j.arthro.2018.09.028
        • Muench L.N.
        • Kia C.
        • Jerliu A.
        • Williams A.A.
        • Berthold D.P.
        • Cote M.P.
        • et al.
        Clinical outcomes following biologically enhanced patch augmentation repair as a salvage procedure for revision massive rotator cuff tears. Arthrosc.
        J. Arthrosc. Relat. Surg. 2020; 36: 1542-1551https://doi.org/10.1016/j.arthro.2020.02.006
        • Routman H.D.
        • Simovitch R.W.
        • Wright T.W.
        • Flurin P.H.
        • Zuckerman J.D.
        • Roche C.P.
        Acromial and Scapular Fractures After Reverse Total Shoulder Arthroplasty with a Medialized Glenoid and Lateralized Humeral Implant: An Analysis of Outcomes and Risk Factors.
        J. Bone Joint Surg. Am. 2020 Oct 7; 102: 1724-1733https://doi.org/10.2106/JBJS.19.00724
        • Simovitch R.
        • Flurin P.H.
        • Wright T.
        • Zuckerman J.D.
        • Roche C.P.
        Quantifying success after total shoulder arthroplasty: the substantial clinical benefit.
        J Shoulder Elbow Surg. 2018 May 1; 27: 903-911https://doi.org/10.1016/j.jse.2017.12.014
        • Su F.
        • Allahabadi S.
        • Bongbong D.N.
        • Feeley B.T.
        • Lansdown D.A.
        Minimal clinically important difference, substantial clinical benefit, and patient acceptable symptom state of outcome measures relating to shoulder pathology and surgery: A systematic review.
        Curr. Rev. Musculoskelet. Med. 2021; 14: 27-46https://doi.org/10.1007/s12178-020-09684-2