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PROM Thresholds & Interpretation
How to interpret PROM score severity — classified as poor, moderate, mild, or satisfactory. Outcome score bands, MCIDs, and severity classification for ASES, QuickDASH, DASH, Oxford Shoulder, Constant-Murley, PRWE, WOSI, WORC, CTS-6.

Overview¶
Interpreting patient-reported outcome measures (PROMs) in orthopaedic surgery requires distinguishing between individual clinical significance and group-level trial effects. Applying patient-level thresholds for clinically meaningful differences to interpret group-level differences leads to an underestimation of treatment effects [1]. To address this, Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) provide surgeons with threshold values to determine which scores are clinically meaningful to patients [6]. These metrics assist with therapeutic decision-making and expectation setting [6]. However, the availability of clinically significant outcome thresholds for specific procedures, such as shoulder instability surgery, remains relatively limited [3]. Standardizing the methodologic calculation and utilization of MCID, SCB, PASS, and MOI thresholds may allow for improved assessment of PROMs [17], while comprehensive methodologies for identifying recommended values in reverse total shoulder arthroplasty aim to standardize the assessment of clinically significant improvement [8].
The utility of these thresholds is constrained by the psychometric properties of the instruments used. Outcome instruments ought not to be altered [4], and it is important to understand the fundamentals of reliability, validity, and responsiveness when evaluating studies reporting health-related quality of life [23]. Reported values for internal consistency and test-retest reliability of generic health-related quality of life measures are acceptable for group comparisons but insufficient for individual clinical use [12]. Comparisons across these generic measures reveal minimal differences in internal consistency and test-retest reliability [12]. Most total knee arthroplasty PROMs have limited evidence for their psychometric properties [15], whereas PROMIS measures are less burdensome and demonstrate no floor or ceiling effects, making them a potential alternative to legacy patient-reported outcome measures for the hip [11]. The M-SANE, a single-question, joint-specific PROM, performed similarly across multiple psychometric properties to more burdensome PROMs in assessing patient-reported outcomes after total hip arthroplasty [5].
Adoption of these tools faces practical and systemic barriers. Reasons for limited use of PROMs by orthopaedic surgeons include a lack of knowledge on how to use them and the perception that it is too time-consuming to add to regular clinical routine [7]. There is evidence of limited familiarity with knee and hip PROMs among orthopaedic surgeons [30]. CMS's mandatory PROM-based performance measures face significant challenges regarding compliance, financial burden, and potential exacerbation of health disparities [24]. Furthermore, PROM scores often plateau by six months to one year, making extended data collection inefficient [24]. To accurately interpret PRO data in clinical trials, an anchor question should be included so that the MCID can be determined for the specific patient population [22]. Data from long-term test-retest reliability studies help establish the effects of longer, clinically pragmatic testing intervals on test-retest reliability [10]. Ultimately, outcome questionnaires are a means to move from common language to common understanding and add to the ability to understand what is happening to patients without replacing existing tools [14].
Anatomy & Pathophysiology¶
Hallux rigidus is a common disorder characterized by restriction of motion at the first metatarsophalangeal joint [56]. This condition is often associated with mechanical block from periarticular osteophytes [56]. Pain is a complex, multi-dimensional experience that is usually associated with local tissue damage or may be referred from a distant site [81].
Classification¶
Threshold Hierarchy: Patient-level thresholds for clinically meaningful differences are typically larger than relevant group-level differences [1]. Reported values for internal consistency and test-retest reliability are acceptable for group comparisons but insufficient for individual clinical use [12]. Comparisons of internal consistency and test-retest reliability across measures reveal minimal differences between instruments [12].
MCID Calculation: The MCID was calculated using a distribution-based method wherein threshold values were derived based on one-half of the standard deviation of the mean change in outcome score [20]. The threshold value for each respective outcome metric was quantitatively established and applied to determine the proportion of patients achieving the MCID at various follow-up time points [20]. A clinically significant improvement between time points was established if an improvement in an outcome score significantly exceeded the previously established MCID for the specific outcome measure [16]. If multiple MCIDs were previously reported for an individual PROM, the smallest MCID was used for analysis to remain consistent with the definition of MCID [16]. An anchor question should be included so that the MCID can be determined for the specific patient population included in the study [22].
MDC Calculation: The minimal detectable change (MDC) needed to discern a true health change from measurement error-induced variability was calculated based on score distribution by implementing a correction factor to the standard error of measurement (SEM) [35]. The specific formula for MDC was MDC = Z-score x SEM x √2, where SEM = SD x √(1-eICC) [35]. SD and intra-class correlation coefficient (ICC) reflect the SD of baseline PROMs and ICC representing the intraclass correlation coefficient utilized in previous analyses at a median reliability of 0.90 across all HOOS subdomains [35]. Z-scores of 1.28, 1.64, and 1.96 were applied to MDC 80, MDC 90, and MDC 95, respectively [35]. 80% (MDC 80), 90% (MDC 90), and 95% (MDC 95) confidence intervals were evaluated, which roughly correspond to one-in-five, one-in-ten, and one-in-twenty likelihoods of the patients’ true PROMs lying outside of the reported score [35].
Other Considerations: Standardizing the methodologic calculation and utilization of MCID, SCB, PASS, and MOI thresholds for RTSA may allow for improved assessment of PROMs [17]. A comprehensive methodology was used to identify recommended MCID and SCB values for common rTSA PROMs [8]. These thresholds should be calculated for common rTSA PROMs moving forward to standardize assessment of clinically significant improvement [8]. This study reports MCID thresholds that can be used when assessing the effectiveness for each of the common types of shoulder arthroplasty [33]. Subgroup analyses stratified patients in the cohort according to the time from injury to surgery [36]. The MOI thresholds were recalculated for patients with chronicity of >6 and ≤6 months, respectively [36].
Using PASS thresholds for PROs can aid clinicians when considering when patients can safely return to activities after ACLR [9]. Patient expectations for function evolved based on PASS and SCB thresholds [13]. Lower expectations at long-term follow-ups resulted in a higher percentage of patients meeting certain thresholds [13]. It is important to compare a patient's outcome scores with the age-normalized scores to establish an accurate reference frame with which to interpret outcomes [25].
The M-SANE, a single-question, joint-specific PROM, performed similarly across multiple psychometric properties to more burdensome PROMs in assessing patient-reported outcomes after THA [5]. PROMIS measures are less burdensome and demonstrate no floor or ceiling effects [11]. PROMIS measures are a potential alternative to legacy patient-reported outcome measures for the hip [11]. Most TKA PROMs have limited evidence for their psychometric properties [15].
Content validity is defined as “the degree to which the content of an instrument is an adequate reflection of the construct to be measured” [27]. The final set of trauma outcomes measures includes measures on clinical outcomes, functional status, psychological well-being, mental health and patient reported health status [28]. The scales for the measurement of severity of symptoms and functional status in carpal tunnel syndrome are reproducible, internally consistent, and responsive to clinical change [29]. The scales for the measurement of severity of symptoms and functional status in carpal tunnel syndrome measure dimensions of outcomes not captured by traditional measurements of impairment of the median nerve [29]. AIS 2005 is the culmination of collaborative efforts to provide a viable research tool [32]. AIS 2005 is expected to remain the gold standard for injury severity determination for years to come [32].
Outcome questionnaires are a means to move from common language to common understanding [14]. Outcome questionnaires do not replace existing tools but add to the ability to understand what is happening to patients [14]. Reasons for not using PROMs include a lack of knowledge on how to use them and the perception that it is too time-consuming to add to regular clinical routine [7].
The orthopaedic community has shifted toward the inclusion of patient-based measures in outcome assessments [18]. There was a notable increase in the use of patient-based measures in randomized controlled trials between 1991 and 2001 [18]. The shift toward value-based health care has underscored the critical role of PROMs in evaluating the quality and effect of care delivered [26]. For TJA, PROMs offer a unique opportunity to capture patients' perspectives on their pain, functional status, and quality of life throughout the care continuum [26]. By integrating PROMs into clinical workflows and decision-making processes, healthcare organizations can align their objectives with the core tenets of value-based care [26]. If the standards and procedures as outlined are used, the use of PROs will contribute to improved patient care and clinical research [21].
The Cleveland Clinic's Orthopaedic Minimal Data Set Episode of Care (OME) cohort serves as an exemplary model of a comprehensive PROMs data collection platform tailored specifically for TJA [26]. By integrating PROMs collection into the routine clinical workflow, the OME system achieves high baseline completion rates (>97%) without requiring major additional personnel or resources [26]. OME employs a combination of passive methods, such as automated reminders, and active methods, including telephone calls and personalized letters, to ensure strong response rates at the 1-year follow-up [26]. Determining the optimal timing for PROMs collection is crucial for ensuring the validity and cost-effectiveness of outcomes assessment in TJA [26].
Clinical Presentation¶
The orthopaedic community has shifted toward the inclusion of patient-based measures in outcome assessments, with a notable increase in the use of these measures in randomized controlled trials between 1991 and 2001 [18]. Integrating PROMs into clinical workflows and decision-making processes allows healthcare organizations to align their objectives with the core tenets of value-based care [26]. Determining the optimal timing for PROMs collection is crucial for ensuring the validity and cost-effectiveness of outcomes assessment in total joint arthroplasty [26]. The Cleveland Clinic's Orthopaedic Minimal Data Set Episode of Care (OME) cohort achieves high baseline completion rates (>97%) without requiring major additional personnel or resources [26].
Interpretation Frameworks: Clinical relevance in the context of PROMs is defined as a feature of patient-reported clinical changes with respect to the health of their knee throughout the course of their treatment [20]. A clinically significant improvement between time points in shoulder arthroplasty outcomes is established if an improvement in an outcome score significantly exceeds the previously established MCID for the specific outcome measure [16]. When multiple MCIDs are previously reported for an individual PROM, the smallest MCID is used for analysis to remain consistent with the definition of the smallest difference patients perceive as beneficial [16]. To accurately interpret PRO data in clinical trials, an anchor question should be included so that the MCID can be determined for the specific patient population included in the study [22].
Threshold Specificity: A comprehensive understanding of differences in MCID, SCB, and PASS thresholds stratified by implant type, preoperative diagnosis, and sex is essential to assist surgeons in evaluating outcomes and counseling patients [31]. Caution should be exercised in conflating PASS thresholds across different studies [31]. PASS thresholds can be used to define treatment success in future outcome studies following unicompartmental knee arthroplasty [19]. Patient expectations for function evolve over long-term follow-up, with lower expectations at long-term follow-ups resulting in a higher percentage of patients meeting certain thresholds based on PASS and SCB [13].
Validity and Measurement: According to the COSMIN group, no gold standard exists for health-related, patient reported outcomes [42]. Simply using another comparative instrument as a "gold standard" to establish criterion validity is incorrect [42]. When both instruments have continuous scores, the preferred method for estimating criterion validity is by presenting the correlation coefficient, which should preferably be above 0.70 [42]. When the outcome instrument has a continuous score and the gold standard has a dichotomous score, the area under the receiver operated characteristic (ROC) is the preferred method, with a criterion of 0.70 suggested [42]. When both scores are dichotomous, specificity and sensitivity are the preferred methods to use for estimating criterion validity [42].
Specific Instrument Metrics: The minimal clinically important difference of SF36 PCS/MCS scores ranges from 2 to 7 for different diseases, with 5 selected as a commonly used threshold [39]. A cut-off score of 44 is recommended for overall diagnostic efficiency for PTSD in people injured in a motor vehicle crash [39]. Evidence suggests 5 points is the minimum threshold to report clinical change for the PTSD Checklist Civilian Version [39]. Scales for the measurement of severity of symptoms and functional status in carpal tunnel syndrome are reproducible, internally consistent, and responsive to clinical change [29]. Cutoff scores were not established for the instrument in the systematic review of clinical diagnosis of carpal tunnel syndrome because the relative importance of items varies within and across studies [40].
Demographic and Methodological Considerations: Preoperative sex-based differences in PROMIS scores are underappreciated in the shoulder arthroplasty literature [52]. Females undergoing reverse total shoulder arthroplasty show significantly lower baseline PROMIS physical function scores than males, with differences exceeding the minimal clinically important difference [52]. Data on longer, clinically pragmatic testing intervals help establish the effects on test-retest reliability of baseline cognitive assessments using ImPACT [10]. Telephone surveys demonstrate higher patient-reported outcome scores and greater improvement compared to in-person or online surveys [53]. There is evidence of limited familiarity with knee and hip PROMs among orthopaedic surgeons in mainland China [30].
Scope and Core Outcomes: The final set of internationally agreed trauma outcome measures includes measures on clinical outcomes, functional status, psychological well-being, mental health, and patient reported health status [28]. Four constructs on the relationship expected between outcome measures, determined prior to data collection, were observed as anticipated, supporting the validity of outcome questionnaires for elbow pathology [34]. Core outcome sets developed for paediatric conditions need to further incorporate the perspectives of children, alongside parents and other adults [41].
Investigations¶
Threshold Definitions and Calculation Methods¶
The Minimal Clinically Important Difference (MCID) is defined as the smallest difference in score which patients perceive as beneficial [16]. A clinically significant improvement between time points is established if an improvement in an outcome score significantly exceeds the previously established MCID for the specific outcome measure [16]. When multiple MCIDs are reported for an individual PROM, the smallest MCID is used for analysis to err on the side of more frequent visits owing to increased sensitivity of detecting change [16]. The Minimal Detectable Change (MDC) is calculated using the formula MDC = Z-score × SEM × √2, where SEM = SD × √(1−ICC) [35]. Z-scores of 1.28, 1.64, and 1.96 correspond to MDC 80, MDC 90, and MDC 95 confidence intervals, respectively [35]. A distribution-based method for calculating MCID derives threshold values based on one-half of the standard deviation of the mean change in outcome score [20]. The MCID and PASS provide surgeons with threshold values to help determine PROMIS scores that are clinically meaningful to patients [6]. The MCID and SCB values identified through a comprehensive methodology suggest how these thresholds should be calculated for common rTSA PROMs to standardize assessment of clinically significant improvement [8]. Future orthopaedic research should employ the MCID with transparency and caution and continue to develop patient-centered metrics that have greater reproducibility and that bridge statistical results with real clinical meaning [58].
Threshold Variability and Standardization¶
There is high variability in standardized outcome thresholds of clinically important changes in shoulder instability surgery [3]. The variability of MCID, SCB, PASS, and MOI thresholds exists in the reverse total shoulder arthroplasty literature [17]. A comprehensive understanding of differences in MCID, SCB, and PASS thresholds by implant type, preoperative diagnosis, and sex is essential to assist surgeons in evaluating outcomes and counseling patients [31]. Patient expectations for function evolved based on PASS and SCB thresholds, with lower expectations at long-term follow-ups resulting in a higher percentage of patients meeting certain thresholds [13]. Preoperative sex-based differences in PROMIS scores are underappreciated in the shoulder arthroplasty literature, with females undergoing rTSA showing significantly lower baseline scores than males exceeding the minimal clinically important difference [52].
Measurement Properties and Instrument Validity¶
For the purpose of evaluating studies reporting health-related quality of life, it is important to understand the fundamentals of reliability, validity, and responsiveness of the outcome measure being used [23]. Comparisons of internal consistency and test-retest reliability across generic measures of health-related quality of life reveal minimal differences between instruments, with reported values acceptable for group comparisons but insufficient for individual clinical use [12]. Long-term test-retest reliability data help establish the effects of longer, clinically pragmatic testing intervals on test-retest reliability [10]. Four of five frequently used orthopedic PROMs (mHHS, HAGOS, IKDC-SKF, KOOS, and KNEES-ACL) possess inadequate content validity according to a COSMIN evaluation [27]. These scales measure dimensions of outcomes not captured by traditional measurements of impairment of the median nerve [29].
Clinical Application and Interpretation¶
The MCID and PASS can assist with therapeutic decision making as well as expectation setting [6]. Following primary THA for hip osteoarthritis, percentage thresholds for achieving the MOI for the FJS, HHS, and VAS for pain were 54.2%, 65%, and 67.1%, respectively [98]. The ASES standardized shoulder assessment form is offered as a baseline measure of shoulder function applicable to all patients regardless of diagnosis [48]. The adoption of the ASES form is intended to facilitate communication between investigators, stimulate multicenter studies, and encourage validity testing [48]. If the standards and procedures for PROs are used, the use of PROs will contribute to improved patient care and clinical research [21].
Barriers to Implementation¶
Reasons for limited use of PROMs by orthopedic surgeons include a lack of knowledge on how to use PROMs and the perception that it is too time-consuming to add to regular clinical routine [7].
Treatment¶
Non-Operative¶
The evidence base provided does not detail specific conservative management protocols such as weight loss, physical therapy, NSAIDs, or injections. However, the orthopaedic community has shifted toward the inclusion of patient-based measures in outcome assessments to expand understanding of intervention effects, with a notable increase in the use of these measures in randomized controlled trials between 1991 and 2001 [18]. Outcome questionnaires serve as a means to move from common language to common understanding, adding to the ability to understand what is happening to patients without replacing existing tools [14].
Operative¶
Indications: Patient-level thresholds for clinically significant improvement are typically larger than relevant group-level differences [1]. To standardize the assessment of clinically significant improvement for common reverse total shoulder arthroplasty (rTSA) PROMs, recommended MCID and SCB values identified through a comprehensive methodology suggest how these thresholds should be calculated [8]. For shoulder instability surgery, the availability of clinically significant outcome thresholds such as MCID and PASS remains relatively limited [3].
Surgical Approach / Technique: The Cleveland Clinic's Orthopaedic Minimal Data Set Episode of Care (OME) cohort serves as a model of a comprehensive PROMs data collection platform tailored specifically for total joint arthroplasty (TJA) [26]. This system achieves high baseline completion rates (>97%) without requiring major additional personnel or resources [26].
Implant Selection: No specific evidence regarding prosthesis design choices is provided in this section.
Alignment / Balancing Strategy: No specific evidence regarding alignment strategies is provided in this section.
Pain Management: No specific evidence regarding analgesia regimens is provided in this section.
Adjuncts: No specific evidence regarding operative adjuncts is provided in this section.
Setting of Care: No specific evidence regarding outpatient versus inpatient settings is provided in this section.
Revision: No specific evidence regarding revision-procedure principles is provided in this section.
Other Considerations: Surgeons have cited a lack of knowledge on how to use PROMs and the perception that it is too time-consuming to add to regular clinical routine as reasons for limited use of these tools [7]. When evaluating studies reporting health-related quality of life, it is important to understand the fundamentals of reliability, validity, and responsiveness of the outcome measure being used in addition to appraising the validity of the study [23]. Comparisons of internal consistency and test-retest reliability across generic measures reveal minimal differences between instruments; reported values are acceptable for group comparisons but insufficient for individual clinical use [12]. The SMFA-NL is a valid, reliable, and moderately responsive method for the assessment of functional status of patients who have a broad range of musculoskeletal disorders [46]. There is a need to establish normative data by the application of the available outcome measurement techniques in large centres [2].
Complications¶
Other Considerations: The MCID and PASS provide surgeons with threshold values to help determine PROMIS scores that are clinically meaningful to patients, assisting with therapeutic decision making and expectation setting [6]. Comparisons of internal consistency and test-retest reliability across generic health-related quality of life measures reveal minimal differences between instruments, with values acceptable for group comparisons but insufficient for individual clinical use [12]. It is important to compare a patient's outcome scores with age-normalized scores to establish an accurate reference frame for interpreting outcomes [25].
Predictive Value of Early MCID Failure: Failure to achieve a distribution-based MCID within the first postoperative month following total hip arthroplasty is associated with an almost three-fold increased odds of failing to reach anchor-based MCID at three months to a year [50]. Ceiling effects did not materially affect the conclusion that early distribution-based MCID failure predicts late anchor-based MCID failure in total hip arthroplasty patients [50].
Methodological Limitations & Future Directions: Distribution-based MCID thresholds have historically been criticized for relying solely on statistical variability rather than incorporating the patient's subjective perspective [50]. Future orthopaedic research should employ the MCID with transparency and caution and continue to develop patient-centered metrics that have greater reproducibility and bridge statistical results with real clinical meaning [58].
Ceiling Effects & Instrument Selection: The Forgotten Joint Score (FJS) has been proposed to reduce observed ceiling effects in PROMs after total hip and total knee arthroplasty [76]. Ceiling and floor effects for the Forgotten Joint Score were very low, showing promising discriminatory power between patients with a good outcome and patients with an excellent outcome [76].
Recovery¶
Functional milestones: A clinically significant improvement in total shoulder arthroplasty is established when an outcome score improvement significantly exceeds the previously established minimal clinically important difference (MCID) for that specific measure [16]. When multiple MCIDs are reported for an individual patient-reported outcome measure (PROM), the smallest MCID is used for analysis to remain consistent with the definition of the smallest difference patients perceive as beneficial [16]. In osteochondral autograft transplantation of the knee, clinical relevance is defined as patient-reported clinical changes regarding knee health throughout treatment, captured by PROMs [20]. The MCID for this procedure was calculated using a distribution-based method, with threshold values derived from one-half of the standard deviation of the mean change in the outcome score [20].
Other Considerations: Patient expectations for function evolve based on PASS and SCB thresholds, with lower expectations at long-term follow-ups resulting in a higher percentage of patients meeting certain thresholds [13]. In total hip arthroplasty, failure to achieve a distribution-based MCID in the early postoperative period is associated with failure to attain a patient-perceived (anchor-based) MCID at subsequent scheduled clinic visits up to one year [50]. Patients who fail to achieve the distribution-based MCID within the first postoperative month demonstrate an almost three-fold increased odds of failing to reach the anchor-based MCID at three months to a year [50]. Ceiling effects did not materially affect the conclusion that early distribution-based MCID failure predicts late anchor-based MCID failure in total hip arthroplasty [50].
Key Evidence¶
- [L5] Applying patient-level thresholds for clinically meaningful differences to interpret group-level differences in orthopaedic trials leads to an underestimation of treatment effects, as patient-level thresholds are typically larger than relevant group-level differences. [1] (10.1002/ksa.12805)
- [L5] There is a need to establish normative data by the application of the available outcome measurement techniques in large centres. [2] (10.1016/s0266-7681(03)00108-6)
- [L1] Despite the wide array of available PROMs for assessing shoulder instability surgery outcomes, the availability of clinically significant outcome thresholds such as MCID and PASS remains relatively limited. [3] (10.1016/j.arthro.2024.07.039)
- [L5] The authors agree that outcome instruments ought not to be altered. [4] (10.1016/j.jhsa.2004.08.002)
- [L3] The M-SANE, a single-question, joint-specific PROM, performed similarly across multiple psychometric properties to more burdensome PROMs in assessing patient-reported outcomes after THA. [5] (10.1016/j.arth.2020.01.015)
- [L3] The MCID and PASS provide surgeons with threshold values to help determine PROMIS scores that are clinically meaningful to patients, and they can assist with therapeutic decision making as well as expectation setting. [6] (10.1177/0363546520960461)
- [L4] The reasons provided included a lack of knowledge on how to use PROMs and the perception that it is too time-consuming to add to regular clinical routine. [7] (10.1186/s13018-020-02135-1)
- [L2] The study presents recommended MCID and SCB values identified through a comprehensive methodology and suggests how these thresholds should be calculated for common rTSA PROMs moving forward to standardize assessment of clinically significant improvement. [8] (10.1016/j.jse.2025.02.018)
- [L3] Using PASS thresholds for PROs can aid clinicians when considering when patients can safely return to activities after ACLR. [9] (10.1177/03635465241298917)
- [L4] These data help establish the effects of longer, clinically pragmatic testing intervals on test-retest reliability. [10] (10.1177/0363546509343805)
- [L3] PROMIS measures are less burdensome and demonstrate no floor or ceiling effects, making them a potential alternative to legacy patient-reported outcome measures for the hip. [11] (10.1177/0363546518825252)
- [L5] Comparisons of internal consistency and test-retest reliability across measures reveal minimal differences between instruments, and reported values are acceptable for group comparisons but insufficient for individual clinical use. [12] (10.1016/j.injury.2010.11.044)
- [L4] Based on the PASS and SCB thresholds, patient expectations for function evolved, with lower expectations at long-term follow-ups resulting in a higher percentage of patients meeting certain thresholds. [13] (10.1177/03635465251345823)
- [Paper] Outcome questionnaires are a means to move from common language to common understanding and do not replace existing tools but add to the ability to understand what is happening to patients. [14] (10.1016/s0894-1130(01)80035-1)
- [L1] Most TKA PROMs have limited evidence for their psychometric properties. [15] (10.1016/j.arth.2016.12.052)
- [L4] [16] (10.1016/j.jse.2018.03.007)
- [L2] Standardizing the methodologic calculation and utilization of MCID, SCB, PASS, and MOI thresholds for RTSA may allow for improved assessment of PROMs. [17] (10.1016/j.jse.2024.03.051)
- [L4] The orthopaedic community has shifted toward the inclusion of patient-based measures in outcome assessments, expanding its understanding of the effects of intervention, with a notable increase in the use of these measures in randomized controlled trials between 1991 and 2001. [18] (10.1097/01.blo.0000079772.06654.c8)
- [L3] PASS thresholds can be used to define treatment success in future outcome studies. [19] (10.1007/s00167-021-06592-x)
- [L3] [20] (10.1002/ksa.12422)
- [Paper] If the standards and procedures as outlined above are used, the use of PROs will contribute to improved patient care and clinical research. [21] (10.1016/j.injury.2019.10.073)
- [L3] These results suggest that to accurately interpret PRO data in clinical trials, an anchor question should be included so that the MCID can be determined for the specific patient population included in the study. [22] (10.1177/1558944718812180)
- [Paper] For the purpose of evaluating studies reporting health-related quality of life it is important to understand the fundamentals of reliability, validity, and responsiveness of the outcome measure being used in addition to appraising the validity of the study. [23] (10.1097/01.blo.0000079771.06654.13)
- [L5] The paper concludes that CMS's mandatory PROM-based performance measures face significant challenges regarding compliance, financial burden, and potential exacerbation of health disparities, while noting that PROM scores often plateau by six months to one year, making extended data collection inefficient. [24] (10.1016/j.arth.2025.12.002)
- [L3] It is important to compare a patient's outcome scores with the age-normalized scores to establish an accurate reference frame with which to interpret outcomes. [25] (10.1177/03635465211056666)
- [L5] [26] (10.5435/jaaos-d-25-00977)
- [L3] [27] (10.1007/s00167-021-06761-y)
- [L5] The final set includes measures on clinical outcomes, functional status, psychological well-being, mental health and patient reported health status. [28] (10.1016/j.injury.2025.112582)
- [L4] The scales for the measurement of severity of symptoms and functional status are reproducible, internally consistent, and responsive to clinical change, and that they measure dimensions of outcomes not captured by traditional measurements of impairment of the median nerve. [29] (10.2106/00004623-199311000-00002)
- [L4] There is evidence of limited familiarity with knee and hip PROMs among orthopaedic surgeons. [30] (10.1186/s12891-021-04459-3)
- [L3] A comprehensive understanding of these differences is essential to assist surgeons in evaluating outcomes and counseling patients, though caution should be exercised in conflating PASS thresholds across different studies. [31] (10.1016/j.jse.2024.01.040)
- [Paper] AIS 2005 is the culmination of collaborative efforts to provide a viable research tool and is expected to remain the gold standard for injury severity determination for years to come. [32] (10.1016/j.injury.2006.07.009)
- [L3] This study reports MCID thresholds that can be used when assessing the effectiveness for each of the common types of shoulder arthroplasty. [33] (10.1016/j.jse.2022.02.010)
- [L4] Four constructs on the relationship expected between outcome measures, determined prior to data collection, were observed as anticipated, supporting the validity of outcome questionnaires. [34] (10.1016/s0894-1130(01)80040-5)
- [L3] [35] (10.1016/j.arth.2024.01.051)
- [L4] [36] (10.2106/jbjs.23.01330)
- [L2] [39] (10.1186/s12891-016-1152-2)
- [L1] [40] (10.1197/j.jht.2004.02.015)
- [L2] Core outcome sets developed for paediatric conditions need to further incorporate the perspectives of children, alongside parents and other adults, and adopt research methods fit for this purpose. [41] (10.1371/journal.pone.0244878)
- [Paper] [42] (10.1016/j.injury.2010.11.042)
- [L4] This study shows that the SMFA-NL is a valid, reliable and moderately responsive method for the assessment of functional status of patients who have a broad range of musculoskeletal disorders. [46] (10.1016/j.injury.2011.07.013)
- [L5] The ASES standardized shoulder assessment form is offered as a baseline measure of shoulder function applicable to all patients regardless of diagnosis, with the hope that its adoption will facilitate communication between investigators, stimulate multicenter studies, and encourage validity testing. [48] (10.1016/s1058-2746(09)80019-0)
- [L3] [50] (10.1016/j.arth.2026.04.043)
- [L3] Preoperative sex-based differences in PROMIS scores are underappreciated in the shoulder arthroplasty literature, with females undergoing rTSA showing significantly lower baseline scores than males exceeding the minimal clinically important difference. [52] (10.1016/j.jseint.2023.07.012)
- [L4] This study demonstrates higher patient-reported outcome scores and greater improvement by telephone surveys compared to in-person or online. [53] (10.1007/s00167-015-3802-6)
- [L5] Hallux rigidus is a common disorder characterized by restriction of motion at the first metatarsophalangeal joint, often associated with mechanical block from periarticular osteophytes. [56] (10.2106/00004623-199806000-00015)
- [L5] Future orthopaedic research should employ the MCID with transparency and caution and continue to develop patient-centered metrics that have greater reproducibility and that bridge statistical results with real clinical meaning. [58] (10.2106/jbjs.25.00868)
- [L1] [76] (10.1016/j.arth.2019.10.058)
- [Paper] Pain is a complex, multi-dimensional experience that is usually associated with local tissue damage or may be referred from a distant site. [81] (10.1016/s0894-1130(01)80038-7)
- [L3] Following primary THA for hip osteoarthritis, percentage thresholds for achieving the MOI for the FJS, HHS, and VAS for pain were 54.2, 65, and 67.1%, respectively. [98] (10.1016/j.arth.2024.10.119)
References¶
[1] Treatment effects in orthopaedic trials are underestimated by applying patient‐level PRO thresholds for meaningful differences at the group level. Knee Surgery, Sports Traumatology, Arthroscopy. 2025. DOI: 10.1002/ksa.12805
[2] Assessing Outcome after Hand Surgery: the Current State. Journal of Hand Surgery. 2003. DOI: 10.1016/s0266-7681(03)00108-6
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