TY - JOUR
T1 - Minimal important clinical difference values are not uniformly valid in the active duty military population recovering from shoulder surgery
AU - MOTION Collaborative
AU - Sheean, Andrew J.
AU - Tenan, Matthew S.
AU - DeFoor, Mikalyn T.
AU - Cognetti, Daniel J.
AU - Bedi, Asheesh
AU - Lin, Albert
AU - Dekker, Travis J.
AU - Antosh, Ivan J.
AU - Bailey, James
AU - Barlow, Brian T.
AU - Bottoni, Craig R.
AU - Bradley, Matthew W.
AU - Cameron, Kenneth L.
AU - Daner, William E.
AU - Dekker, Travis
AU - Dickens, Jonathan F.
AU - Donohue, Michael A.
AU - Galvin, Joseph W.
AU - Garcia, Estephan J.
AU - Gee, Shawn
AU - Haley, Chad A.
AU - Hurvitz, Andrew P.
AU - Kilcoyne, Kelly
AU - Lanzi, Joseph T.
AU - LeClere, Lance
AU - Lee, Ian E.
AU - McDonald, Lucas S.
AU - Min, Kyong S.
AU - Owens, Brett D.
AU - Pallis, Mark
AU - Patzkowski, Jeanne C.
AU - Posner, Matthew
AU - Potter, Benjamin K.
AU - Provencher, Matthew T.
AU - Rhon, Daniel
AU - Roach, Christopher J.
AU - Robins, Richard Judd
AU - Rodriguez, Marina J.
AU - Schmitz, Matthew R.
AU - Slabaugh, Mark
AU - Smith, Jennifer L.
AU - Song, Daniel J.
AU - Streets, David T.
AU - Tennent, David
AU - Tokish, John M.
AU - Tucker, Christopher J.
AU - Wagner, Scott C.
AU - Waltz, Robert
AU - Volk, William R.
N1 - Publisher Copyright:
© 2024
PY - 2024
Y1 - 2024
N2 - Background: There are multiple methods for calculating the minimal clinically important difference (MCID) threshold, and previous reports highlight heterogeneity and limitations of anchor-based and distribution-based analyses. The Warfighter Readiness Survey assesses the perception of a military population's fitness to deploy and may be used as a functional index in anchor-based MCID calculations. The purpose of the current study in a physically demanding population undergoing shoulder surgery was to compare the yields of 2 different anchor-based methods of calculating MCID for a battery of PROMs, a standard receiver operating characteristic (ROC) curve–based MCIDs and baseline-adjusted ROC curve MCIDs. Methods: All service members enrolled prospectively in a multicenter database with prior shoulder surgery that completed pre- and postoperative PROMs at a minimum of 12 months were included. The PROM battery included Single Assessment Numeric Evaluation (SANE), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), Patient Reported Outcome Management Information System (PROMIS) physical function (PF), PROMIS pain interference (PI), and the Warfighter Readiness Survey. Standard anchor-based and baseline-adjusted ROC curve MCIDs were employed to determine if the calculated MCIDs were both statistically and theoretically valid (95% confidence interval [CI] either completely negative or positive). Results: A total of 117 patients (136 operations) were identified, comprising 83% males with a mean age of 35.7 ± 10.4 years and 47% arthroscopic labral repair/capsulorrhaphy. Using the standard, anchor-based ROC curve MCID calculation, the area under the curve (AUC) for SANE, ASES, PROMIS PF, and PROMIS PI were greater than 0.5 (statistically valid). For ASES, PROMIS PF, and PROMIS PI, the calculated MCID 95% CI all crossed 0 (theoretically invalid). Using the baseline-adjusted ROC curve MCID calculation, the MCID estimates for SANE, ASES, and PROMIS PI were both statistically and theoretically valid if the baseline score was less than 70.5, 69, and 65.7. Conclusion: When MCIDs were calculated and anchored to the results of standard, anchor-based MCID, a standard ROC curve analysis did not yield statistically or theoretically valid results across a battery of PROMs commonly used to assess outcomes after shoulder surgery in the active duty military population. Conversely, a baseline-adjusted ROC curve method was more effective at discerning changes across a battery of PROMs among the same cohort.
AB - Background: There are multiple methods for calculating the minimal clinically important difference (MCID) threshold, and previous reports highlight heterogeneity and limitations of anchor-based and distribution-based analyses. The Warfighter Readiness Survey assesses the perception of a military population's fitness to deploy and may be used as a functional index in anchor-based MCID calculations. The purpose of the current study in a physically demanding population undergoing shoulder surgery was to compare the yields of 2 different anchor-based methods of calculating MCID for a battery of PROMs, a standard receiver operating characteristic (ROC) curve–based MCIDs and baseline-adjusted ROC curve MCIDs. Methods: All service members enrolled prospectively in a multicenter database with prior shoulder surgery that completed pre- and postoperative PROMs at a minimum of 12 months were included. The PROM battery included Single Assessment Numeric Evaluation (SANE), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), Patient Reported Outcome Management Information System (PROMIS) physical function (PF), PROMIS pain interference (PI), and the Warfighter Readiness Survey. Standard anchor-based and baseline-adjusted ROC curve MCIDs were employed to determine if the calculated MCIDs were both statistically and theoretically valid (95% confidence interval [CI] either completely negative or positive). Results: A total of 117 patients (136 operations) were identified, comprising 83% males with a mean age of 35.7 ± 10.4 years and 47% arthroscopic labral repair/capsulorrhaphy. Using the standard, anchor-based ROC curve MCID calculation, the area under the curve (AUC) for SANE, ASES, PROMIS PF, and PROMIS PI were greater than 0.5 (statistically valid). For ASES, PROMIS PF, and PROMIS PI, the calculated MCID 95% CI all crossed 0 (theoretically invalid). Using the baseline-adjusted ROC curve MCID calculation, the MCID estimates for SANE, ASES, and PROMIS PI were both statistically and theoretically valid if the baseline score was less than 70.5, 69, and 65.7. Conclusion: When MCIDs were calculated and anchored to the results of standard, anchor-based MCID, a standard ROC curve analysis did not yield statistically or theoretically valid results across a battery of PROMs commonly used to assess outcomes after shoulder surgery in the active duty military population. Conversely, a baseline-adjusted ROC curve method was more effective at discerning changes across a battery of PROMs among the same cohort.
KW - Basic Science Study
KW - Minimal clinically important difference (MCID)
KW - Validation of Outcome Measures
KW - anchor-based method
KW - military readiness
KW - patient reported outcome measures (PROM)
KW - receiver operator curve (ROC)
KW - shoulder
UR - http://www.scopus.com/inward/record.url?scp=85201117714&partnerID=8YFLogxK
U2 - 10.1016/j.jse.2024.02.044
DO - 10.1016/j.jse.2024.02.044
M3 - Article
AN - SCOPUS:85201117714
SN - 1058-2746
JO - Journal of Shoulder and Elbow Surgery
JF - Journal of Shoulder and Elbow Surgery
ER -