Abstract
Background:
Although clinically relevant thresholds such as minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) have been widely described across orthopaedics, their application in hallux valgus surgery remains scarce. The purpose of this study was to determine the MCID and PASS thresholds for the visual analog scale (VAS) and Foot and Ankle Ability Measure (FAAM) scores after hallux valgus surgery.
Methods:
A retrospective review was performed in patients undergoing hallux valgus surgery at a single institution from January 2021 through December 2022. Patient-reported outcome measures (PROMs) were collected preoperatively and 1 year postoperatively. The specific PROMs used were the FAAM–activities of daily living (FAAM-ADL), Single Assessment Numeric Evaluation (SANE), and VAS scale. Two methods were used to calculate MCID and PASS thresholds: a distribution-based approach for MCID and an anchor-based approach using responses to a 1-year postoperative satisfaction question for PASS. The analysis identified optimal cutoff points that maximized sensitivity and specificity based on the Youden index. Overall, 86% (136/158) completed baseline PROMs, and 73% (99/136) completed 1-year PROMs.
Results:
The distribution-based MCID for FAAM-ADL, SANE, and VAS were calculated to be 10.8, 14.1, and 1.2, respectively. The percentage of patients who achieved MCID thresholds was 54% for FAAM-ADL, 42% for SANE, and 96% for VAS. The PASS threshold for FAAM-ADL, SANE, and VAS were ≥78.5, ≥85, and ≤ 2, respectively. The percentage of patients who achieved PASS thresholds was 78% for FAAM-ADL, 72% for SANE, and 69% for VAS.
Conclusion:
This study identified useful values for the MCID and PASS thresholds of FAAM-ADL, SANE, and VAS scores at 1-year follow-up for patients undergoing hallux valgus surgery. Overall, despite not meeting the MCID thresholds, patients undergoing hallux valgus surgery were still likely to be satisfied with their surgery.
Keywords
Introduction
Hallux valgus is a prevalent forefoot deformity, affecting approximately 23% of adults. 23 As this condition progresses, joint subluxation and inflammation can lead to great toe and plantar discomfort, often requiring modifications to shoe wear, activities, and lifestyle. For cases that do not respond to conservative treatments, surgery is often required to realign the first metatarsophalangeal joint and alleviate symptoms. 8 However, a lack of consensus exists regarding the optimal surgical technique to achieve the best outcomes. More than 100 different osteotomies have been described, and there remains much dispute over the best way to gain consistent correction.
Patient-reported outcome measures (PROMs) play a pivotal role in assessing the effectiveness of interventions. Various PROMs, such as the Manchester-Oxford Foot Questionnaire (MOXFQ) and American Orthopaedic Foot & Ankle Society (AOFAS) scale, Foot and Ankle Ability Measure (FAAM), and Patient-Reported Outcomes Measurement Information System (PROMIS) have been used to evaluate the results of hallux valgus surgery.15,16,19,29,33,35,36 Although the use of these scores has been increasing, a significant limitation for them remains that statistical significance in score changes may not necessarily correlate with clinical significance.6,7,17 To address this issue and enhance the clinical relevance of these scores, the concept of the minimal clinically important difference (MCID) and the patient acceptable symptom state (PASS) have been introduced. MCID reflects the minimum perceived change for patients, while PASS represents the postoperative score associated with patient satisfaction.6,7,27 Understanding and applying these measures enables clinicians to better evaluate the real-world effectiveness of interventions and set appropriate expectations when counseling patients and improving shared decision making.6,7,27
Although clinically relevant thresholds such as MCID and PASS have been widely described across orthopaedics, specifically following spine, hip, and knee surgery, their application in hallux valgus surgery remains scarce, especially regarding the FAAM.6,7 Previous studies have defined MCID values for the PROMIS, FAAM-ADL, MOXFQ, and AOFAS after hallux valgus surgery.5,9,15,16,37 Of note, however, PASS thresholds have been infrequently defined for PROMs in the context of hallux valgus treatment outcomes. 12 Furthermore, certain PROMs such as AOFAS are actually starting to fall out of favor when compared to newer measures such as PROMIS. 17 Defining these parameters provides clinically meaningful indicators of surgical effectiveness and patient expectations.
This study aimed to determine MCID and establish PASS thresholds for FAAM-ADL and visual analog scale (VAS) scores after hallux valgus surgery to allow for further and improved interpretation of these scores. Establishing these values will better delineate clinically significant improvements that could further help guide surgical decision making and evaluation.
Methods
Study Design and Data Sources
A retrospective review of collected data was performed in patients undergoing hallux valgus surgery at a single institution from January 2021 through December 2022. The study adhered to institutional review board approval and followed the guidelines set forth by Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) to ensure rigorous and transparent reporting of observational studies. Patients who did not complete baseline or 1-year patient-reported outcome measures (PROMs) were excluded from the analysis (Figure 1). The data were collected using our institutional database, a comprehensive and validated systemwide prospective data collection system that captures all elective orthopaedic procedures within the health care system.4,26,32

STROBE diagram representing the flow of patients within the study.
All patients who underwent hallux valgus surgery were screened for inclusion (n=158), of which 22 (14%) did not complete baseline PROMs and 27 (27%) did not complete 1-year follow-up. Therefore, a total of 99 patients (67%) completed 1-year follow-up and were subsequently analyzed (Figure 1).
Cohort Stratification and Outcome Measures
Patient-reported outcome measures (PROMs) were collected both preoperatively (within 90 days) and 1 year postoperatively (with patients having up to 6 months past the 1-year mark to complete these measures). The primary outcome of this study was the extent of change in measured PROMs (FAAM-ADL, Single Assessment Numeric Evaluation [SANE], and VAS) at 1 year post hallux valgus surgery compared with the preoperative baseline. The FAAM is a patient-reported tool used to evaluate outcomes across various foot and ankle conditions. This scale includes 2 sections: activities of daily living (ADL) with 21 items, and an 8-item sports subscale. Each item is rated on a 5-point scale, ranging from 0 for no difficulty to 4 for inability to perform the activity. Responses in each subsection are converted to scores between 0 and 100, with higher scores representing less disability and better function.21,35 The SANE consisted of the following question: “How would you rate your current level of function during your usual activities of daily living or sports-related activities from 0 to 100?” Responses were reported on a scale from 0% to 100%, with 100% being completely normal. 2 PASS values represented thresholds that indicated optimal patient satisfaction and were estimated using an anchor-based approach, which corresponds to a response to the following question at 1 year: “Taking into account all the activities you have during your daily life, your level of pain, and also your activity limitations and participation restrictions, do you consider the current state of your foot satisfactory?”3,11,18,20 The VAS is a validated, subjective measure used to assess pain. Patients mark their level of pain on a 10-cm line, with scores ranging from 0 to 10. The far left of the scale represents “no pain” and the far right represents the “worst possible pain” imaginable.
Statistical Analysis
Continuous variables are presented as means ± SDs or medians and interquartile ranges (IQRs) according to distribution, whereas categorical variables are presented as absolute and relative frequencies.
Based on the extent of change in PROMs, thresholds for MCID in the aforementioned PROMs were determined. Furthermore, PASS thresholds and corresponding percentages of patients achieving those thresholds at 1 year postoperatively for each PROM were calculated.
The MCID was estimated to reflect the minimum PROM improvement that translates into a patient-perceived change in their health status. MCID was calculated through distribution-based methods.3,11,30 MCID was calculated through specifically the 0.5 SD methodology, which is widely used in the literature and recommended by experts as a standard approach for distribution-based MCID calculation.25,39 Specifically, we calculated the mean difference between postoperative and preoperative scores for each PROM, and then used half of the SD of this difference to determine the MCID.
The percentage of patients who achieved PASS and MCID thresholds were also calculated. To determine cutoff values for each PROM, the Youden index was calculated with its respective sensitivity, specificity, and area under the curve (AUC) using receiver operating characteristic (ROC) curve analysis to best discriminate patient satisfaction. 40 The statistical analysis was performed using Stata, version 17 (Stata Corp). P values <.05 were considered statistically significant.
Results
Patient Characteristics
Patient demographics and baseline determinants were extracted (Table 1). There were no revision or bilateral surgeries in the study population. Postoperative functional outcomes were significantly improved compared to baseline in FAAM-ADL (70.1 ± 22 vs 85.1 ± 18.5, P < .001) SANE (68.7 ± 25.4 vs 84.2 ± 21.2, P < .001), and VAS ( 5.1 ± 2.3 vs 2 ± 2.3, P < .001) (Table 2).
Baseline Characteristics of Study Population (N = 136).
Abbreviations: ADL, activities daily living subscale; FAAM, Foot and Ankle Ability Measure; IM, intermetatarsal; PASS, patient acceptable symptom state; SANE, Single Assessment Numeric Evaluation; VAS, visual analog scale.
Clinical Outcomes Hallux Valgus Surgery.
Abbreviations: ADL, activities daily living subscale; FAAM, Foot and Ankle Ability Measure; SANE, Single Assessment Numeric Evaluation; VAS, visual analog scale.
MCID and PASS
The MCID for FAAM-ADL was 10.8, with 54% of patients achieving this MCID (Tables 3 and 4). For FAAM-ADL, the PASS threshold was ≥78.5, which was reached by 78% of the cohort (Figure 2). Sensitivity and specificity for the calculated threshold were 90% and 81%, respectively. The AUC was 0.91 (95% CI 0.81-0.96) based on the ROC curve for FAAM-ADL (Figure 3).
MCID and PASS Thresholds Following Hallux Valgus Surgery.
Abbreviations: ADL, activities of daily living subscale; FAAM, Foot and Ankle Ability Measure; MCID, minimal clinically important difference; PASS, patient acceptable symptom state; SANE, Single Assessment Numeric Evaluation; VAS, visual analog scale.
Achievement of MCID and PASS Thresholds Following Hallux Valgus Surgery.
Abbreviations: ADL, activities of daily living subscale; FAAM, Foot and Ankle Ability Measure; MCID, minimal clinically important difference; PASS, patient acceptable symptom state; SANE, Single Assessment Numeric Evaluation; VAS, visual analog scale.

Receiver operating characteristic curve analysis for Foot and Ankle Ability Measure–activities of daily living (FAAM-ADL) score threshold value for 1-year patient acceptable symptom state (PASS).

Receiver operating characteristic curve analysis for Foot and Ankle Ability Measure- Activities daily living (FAAM-ADL) score threshold value for 1-year Patient acceptable symptom state (PASS).
The MCID for SANE was 14.1, with 41.8% of patients achieving this MCID (Tables 3 and 4). For SANE, the PASS threshold was ≥85, which was reached by 71% of the cohort (Figure 2). Sensitivity and specificity for the calculated threshold were 81% and 75%, respectively. The AUC was 0.86 (95% CI 0.76-0.92) based on the ROC curve for SANE (Figure 4).

Receiver operating characteristic curve analysis for Single Assessment Numeric Evaluation (SANE) score threshold value for 1-year patient acceptable symptom state (PASS).
The MCID for VAS was 1.2, with 95.8% of patients achieving this MCID (Tables 3 and 4). For VAS, the PASS threshold was ≤2, which was reached by 69% of the cohort (Figure 2). Sensitivity and specificity for the calculated threshold were 79% and 81%, respectively. The AUC was 0.88 (95% CI 0.76-0.94) based on the ROC curve for VAS (Figure 5).

Receiver operating characteristic curve analysis for pain intensity, interference with enjoyment of life, and interference with general activity (VAS) score threshold value for 1-year patient acceptable symptom state (PASS).
Discussion
This study established clinically significant thresholds for patient-reported outcome measures in hallux valgus surgery patients using both distribution-based and anchor-based approaches. We defined values for MCID reflecting statistical meaningful change, as well as PASS representing satisfaction thresholds across 3 measurement tools. Although many patients exceeded the MCID thresholds for the various metrics, an even greater proportion achieved the PASS benchmarks. This suggests that some patients, even without detecting the minimum level of meaningful improvement, still considered their outcome acceptable and were satisfied. Additionally, when examining dimensions of health status, a larger percentage demonstrated clinically significant reductions in pain compared with gains in physical function. Overall, these findings provide robust, standardized indicators of treatment effectiveness that can be used to assess and compare outcomes in this population. Moving forward, applying these parameters in research and clinical practice can better delineate the patient perspective on surgical success.
Although PROMs have been increasingly aligned with patient-centered metrics in fields like spine, hip, and knee surgery, there has been comparatively less focus on establishing clinically meaningful thresholds for foot and ankle procedures.6,7 Prior works have established MCID thresholds for outcomes such as the AOFAS score and MOXFQ after hallux valgus. Dawson et al 8 focused on establishing MCID values for the MOXFQ and AOFAS scales in patients undergoing hallux valgus surgery. Using both anchor- and distribution-based methods, they found MCIDs ranging from 12 to 25 points for the MOXFQ and 8 to 30 points for the AOFAS. The MOXFQ demonstrated excellent responsiveness and performance comparable to the AOFAS. Chan et al 5 also examined MCID thresholds for the AOFAS score, specifically in hallux valgus patients. Their analysis produced a range of MCID values from 8 to 30 points, further validating the AOFAS as a responsive measure. Sutton et al 36 retrospectively analyzed data from 170 patients who underwent hallux valgus correction, with an average of 2 years’ follow-up. As outcome measures, they used the VAS pain scale, FAAM-ADL scale, and a 6-point Likert scale of pain satisfaction. Using 1 distribution-based (SD method) and 2 anchor-based approaches, they calculated a range of MCID values from 1.8 to 5.2 points for VAS pain and 11.1 to 22.7 points for FAAM-ADL. The distribution method resulted in 73.5% of patients achieving MCID for VAS pain but only 38.6% achieving MCID for FAAM-ADL, suggesting that pain improvement is more clinically meaningful than functional improvement for this surgery. Similarly, our study found that 95.4% of patients achieved the MCID threshold for the VAS pain score, whereas only 42% to 54% achieved the MCID for the various FAAM functional scores. Collectively, these results suggest that although most patients experience clinically meaningful reductions in pain after hallux valgus correction, gains in function tend to be more modest. Our study adds further evidence that pain improvement may be more clinically impactful than functional gains for many patients undergoing this surgery. Defining MCID thresholds for both pain and functional PROMs provides a nuanced perspective on the aspects of health status that are most responsive to treatment.
Reflecting rising attention to patient-centered medical treatment, the PASS score aims to evaluate if patients feel genuinely “well,” not just somewhat “better” (MCID concept, after an operation. This focuses on the patient’s overall quality of life rather than just technical surgical outcomes. Using such PROMs could prove an additional helpful metric for assessing health care quality.12,38 Goh et al 13 analyzed data from 548 patients who underwent hallux valgus surgery to define PASS threshold for the AOFAS hallux score. Using anchor-based methods with a satisfaction question, they identified a PASS threshold of 88.5 at 2 years postsurgery. The AOFAS demonstrated good ability to discriminate between acceptable and unacceptable symptom states (AUC 0.78), and approximately 78% of patients achieved the PASS threshold at 2 years. Similarly, in our study, 68.7% of patients achieved the PASS threshold for pain, whereas 71% to 75% reached PASS thresholds for function. Defining overall rates of acceptable symptom states further aids in delineating patient-centered surgical targets. Notably, our analysis revealed higher rates of achieving PASS thresholds compared with MCID thresholds across the PROMs. For example, 77% reached the PASS threshold for FAAM-ADL vs only 54% achieving MCID. This suggests that although some patients may not perceive the minimum level of meaningful improvement, they still consider their outcome acceptable and are satisfied. The phenomenon of patients reporting satisfaction without meeting MCID thresholds could be attributed to several factors. A crucial explanation for the discrepancy between MCID achievement and patient satisfaction lies in our methodology for calculating MCID and the baseline characteristics of our patient population. We used a distribution-based method to calculate MCID, specifically the 0.5-SD approach, which relies on the change in PROM scores from pre- to postoperation. This method, although statistically robust, may not fully capture clinical significance in populations with high baseline scores. In our study, we observed relatively high baseline PROM scores. For instance, the mean preoperative FAAM-ADL score was 70.1 ± 22, and the mean preoperative SANE score was 68.7 ± 25.4. These high baseline scores leave limited room for improvement, creating a potential “ceiling effect.” The calculated MCID values were 10.8 for FAAM-ADL and 14.1 for SANE. However, the actual mean improvements were 15 points for FAAM-ADL (from 70.1 to 85.1) and 15.5 points for SANE (from 68.7 to 84.2). Although these improvements are statistically significant (P < .001 for both), they are close to the MCID thresholds. This scenario creates a situation where patients may experience meaningful improvement and be satisfied with their outcomes, yet not meet the calculated MCID threshold. Conversely, VAS pain scores showed more dramatic improvement, decreasing from 5.1 ± 2.3 to 2.0 ± 2.3 (P < .001). This change easily surpassed the MCID of 1.2, which aligns with the high percentage of patients (95.8%) achieving MCID for VAS. Another potential explanation lies in the nature of patient expectations. Patients who are well-informed about realistic outcomes may report satisfaction even with modest functional improvements, as long as their primary concerns (eg, pain relief or shoe wear) are addressed. This underscores the importance of thorough preoperative counseling and shared decision making. From a clinical perspective, this finding challenges the notion that MCID should be the sole benchmark for surgical success. Although MCID represents a statistically significant change, PASS may better reflect patient-centered outcomes. Surgeons should consider both metrics when evaluating surgical outcomes and counseling patients. The policy and alternative payment model implications of these findings are substantial. As health care systems increasingly move toward value-based care, the selection of appropriate outcome measures becomes crucial. Our results suggest that satisfaction-based measures like PASS may be more aligned with patient-centered care than change-based measures like MCID. Policy makers and insurers should consider incorporating both types of measures in quality metrics and reimbursement models to provide a more comprehensive assessment of surgical value.
This study is not without limitations. It is known that MCID and PASS thresholds vary significantly based on method of estimation and the nature of anchor questions in the case of anchor-based estimations.20,30 In this study, we only used a distribution-based method for calculating MCID without implementing an anchor-based comparison.7,18,20 The method that we chose to use was the 0.5-SD estimation, the most commonly accepted and recognized in the literature for MCID.24,25,28 Although this approach limits the generalizability of MCID to populations that are roughly similar to ours, the calculation of MCID regarding using one method for multiple procedure (ie, calculating MCID in multiple procedures using 0.5 SD) has proven to be remarkably consistent.10,16 Notably, the literature indicates that anchor-based MCID calculation may lead to higher MCID thresholds, which may not align with the conceptual definition of MCID as the minimal improvement appreciated by patients. 18 Although anchor-based MCID calculations have their advantages as well, they have also been suggested to have recall bias as well as patient reporting reflective of their current health status.22,31,34 Another potential limitation of this study is the possibility of a ceiling effect with the FAAM instrument when applied specifically to hallux valgus patients. The FAAM may lack sensitivity to detect meaningful changes in high-functioning patients after hallux valgus surgery. This could partially explain why some patients report satisfaction (achieving PASS) without meeting MCID thresholds. Another limitation of our study is the inability to calculate substantial clinical benefit (SCB) estimates. SCB represents a higher threshold of improvement compared with MCID, indicating a more pronounced clinical benefit that patients consider important. 15 Our study design and data collection methods, particularly our use of a binary satisfaction anchor question, do not allow for the differentiation between minimal and substantial improvement. Future studies should consider incorporating multilevel anchor questions or other methodologies that would enable SCB calculation. Including SCB alongside MCID and PASS would provide a more comprehensive picture of clinically meaningful outcomes after hallux valgus surgery, offering additional valuable data points for clinical interpretation and decision making. Additionally, one-third of patients did not complete 1-year outcomes, which could introduce bias in the results. With only 73% 1-year-follow-up rate, there is potential for attrition bias if patients lost to follow-up differed systematically from those who completed assessments. Our study would be strengthened by strategies to improve participant retention. Our patients also did not report their length of symptoms or severity, which could make comparison challenging across different populations. A final limitation to our study comes from the PROM itself. Although FAAM is a reliable and valid measure of patient physical ability regarding foot and ankle disorders, the overall trend in both orthopaedics in general and foot and ankle surgery in particular has been toward the use of the PROMIS.14,15,17 Furthermore, our study did not include mental health measures such as PROMIS depression or anxiety, which have been widely validated and used in orthopaedic research.14,15,17 Given the well-established link between mental health and physical/pain outcomes, the omission of these measures may have biased our MCID and PASS estimates. Future studies should incorporate mental health assessments to provide a more comprehensive understanding of patient outcomes following hallux valgus surgery.1,37 Finally, an important area for future research, which was not addressed in our current study, is the assessment of factors associated with achieving PASS, MCID, and SCB thresholds. Identifying these factors could provide valuable insights for patient selection and preoperative counseling. Additionally, future work should focus on determining preoperative PROMs cutoffs that might predict postoperative outcomes. Even with the aforementioned limitations, our study still expands on the use of FAAM in hallux valgus surgery and patient-reported outcome measures, because through our robust methodology we believe we were able to compensate. Further investigation should also apply both anchor and distribution methods to confirm the robustness of these MCID thresholds.
Conclusion
This study identified useful values for the MCID and PASS thresholds of FAAM-ADL, SANE, and VAS scores at 1-year follow-up after hallux valgus surgery. Although a sizable proportion surpassed MCID thresholds across the metrics, rates of achieving PASS benchmarks were uniformly higher. This indicates that some patients, despite not perceiving the same threshold clinical gains experienced by the general population, still considered their outcome satisfactory. Moreover, a greater percentage reached clinically significant improvement in pain vs function. Collectively, these results provide insight into nuances around patient expectations and perceptions of success following hallux valgus correction but also suggest that further research in patient satisfaction compared with MCID is needed.
Supplemental Material
sj-pdf-1-fai-10.1177_10711007241298675 – Supplemental material for Establishment of Minimum Clinically Important Difference and Patient Acceptable Symptom State Thresholds for Foot and Ankle Ability Measure and Visual Analog Scale Scores After Hallux Valgus Surgery
Supplemental material, sj-pdf-1-fai-10.1177_10711007241298675 for Establishment of Minimum Clinically Important Difference and Patient Acceptable Symptom State Thresholds for Foot and Ankle Ability Measure and Visual Analog Scale Scores After Hallux Valgus Surgery by Ignacio Pasqualini, Jason R. Teplensky, Oguz Turan, Sarah E. Poirier, William A. Cantrell, James Mueller, Sagar Chawla and Sara Lyn Miniaci-Coxhead in Foot & Ankle International
Footnotes
Ethical Approval
Ethical approval for this study was obtained from Cleveland Clinic Institutional Review Board (06-196).
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Sara Lyn Miniaci-Coxhead, MD, reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Exactech, Inc, and Avitus. Disclosure forms for all authors are available online.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
References
Supplementary Material
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