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. Author manuscript; available in PMC: 2025 Mar 1.
Published in final edited form as: J Orthop Trauma. 2024 Mar 1;38(3):121–128. doi: 10.1097/BOT.0000000000002750

Establishing the Patient Acceptable Symptom State Thresholds for Patient Reported Outcomes After Operatively Treated Tibial Plateau Fractures

Eleanor H Sato 1, Emily A Treu 1, Devin L Froerer 1, Chong Zhang 1, Dillon C O’Neill 1, Amy M Cizik 1, Justin M Haller 1
PMCID: PMC11330326  NIHMSID: NIHMS2012613  PMID: 38117573

Abstract

OBJECTIVES:

Define patient acceptable symptom state (PASS) thresholds and factors impacting PASS thresholds for Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Knee Injury and Osteoarthritis Outcome Score (KOOS) following operatively treated tibial plateau fractures.

METHODS:

Design:

Retrospective cohort.

Setting:

Single Level I academic trauma center.

Patient Selection Criteria:

All patients (n=159) who underwent fixation of a tibial plateau fracture from 2016–2021 and completed patient reported outcome measurements (PROMs) at minimum one-year follow-up.

Outcome Measures and Comparisons:

PASS thresholds for global outcome (PASS-Global), pain (PASS-Pain), and function (PASS-Function) were determined using anchor-based questions and calculated using three methods: 1) 80% specificity, 2) 75th percentile, and 3) Youden Index.

RESULTS:

60% of patients were satisfied with their global outcome and 53% with function. Using 80% specificity, 75th percentile, and Youden Index, PASS-Global thresholds were 48.5, 44.5, and 47.9 for PROMIS-PF and 56.3, 56.2, and 56.3 for KOOS-QOL, respectively. PASS-Pain threshold for KOOS-Pain was 84.4, 80.6, and 80.6. PASS-Function thresholds were 48.9, 46.8, and 48 for PROMIS-PF and 94.1, 90.2, and 86.8 for KOOS-ADL, respectively. Younger patients, bicondylar fractures, and infections were associated with significantly lower PASS-Pain thresholds. Schatzker II fractures, lateral column involvement, or isolated lateral approach resulted in significantly higher PASS-global and -function thresholds.

CONCLUSIONS:

This study defines global, functional, and pain PASS thresholds for tibial plateau fractures. Patients with bicondylar fractures, infections, and medial column involvement were more often unsatisfied. These thresholds are valuable references to identify patients who have attained acceptable outcomes and to counsel patients with risk factors for unacceptable outcomes following tibial plateau fractures.

Keywords: Tibial plateau fractures, patient reported outcome measurements, patient acceptable symptom state, minimal clinically important difference (MCID), PROMIS

Introduction

Patient reported outcome measures (PROMs) have become ubiquitous in orthopaedics as healthcare systems continue to emphasize value-based and patient-centered care (1). However, despite increasing utilization of PROMs in orthopaedic literature and clinical practice, interpreting the clinical value of PROMs remains a challenge (2, 3). Several measures of clinical relevance, including the minimal clinically important difference (MCID) and the patient acceptable symptom state (PASS), have been proposed to add clinical utility to the interpretation of PROMs (1).

In many orthopaedic subspecialities, the MCID is one of the most frequently used markers of clinical relevance (4, 5). MCID is defined as the smallest detectable difference between two PROMs that patients consider a significant improvement (or worsening) of symptoms (3, 6, 7). For an individual patient, a minimum of two scores at different timepoints, most commonly pre- and post-operatively, are required to calculate the MCID (3). Thus, calculating the MCID is especially difficult for orthopaedic interventions in the trauma population, as it is oftentimes impractical to collect pre-operative PROMs given the high-acuity of injuries, lack of in-hospital research infrastructure, and frequent need for transfer to tertiary care centers.

In contrast, the PASS establishes a threshold score for a PROM, a cutoff beyond which patients consider their outcome satisfactory (3, 8). For a given PROM, patients who score equal to or higher than the PASS threshold are labeled PASS positive (PASS+), while patients who score below the threshold are PASS negative (PASS-). Although initially used in rheumatology research, PASS thresholds have been quickly gaining popularity in orthopaedics given the ease of application and robustness of thresholds over time and across patient demographics (3, 8, 9). Previous studies have defined PASS thresholds following hip, knee, and shoulder arthroplasty and arthroscopy, as well as spine surgery (8–13). However, no prior research exists regarding PASS thresholds in the orthopaedic trauma population despite the obvious utility of PASS as a marker of clinical relevance in the setting of limited pre-operative PROM data in the trauma population.

Two frequently used PROMs to evaluate outcomes after tibial plateau fractures are the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Knee Injury and Osteoarthritis Outcome Score (KOOS) (14–16). Given potential benefits associated with developing PASS thresholds in the orthopaedic trauma population, the goal of this study was to define PASS thresholds for PROMIS-PF Computer Adaptive Tests (CATs) and KOOS following operative fixation of tibial plateau fractures. Secondarily, this study also sought to determine risk factors, fracture characteristics, and operative techniques associated with PASS status.

Materials and Methods

Patient Selection

Institutional Review Board (IRB) approval was obtained prior to the initiation of this study. All patients with a tibial plateau fracture at an academic Level-1 trauma center from 2016–2021 were identified using Current Procedural Terminology (CPT) codes 27535 and 27536, corresponding to operative fixation of unicondylar and bicondylar proximal tibial fractures, respectively. All patients underwent operative fixation by one of four orthopaedic trauma fellowship-trained surgeons. Retrospective review of electronic medical records was performed to verify diagnosis and record demographic information including gender, age, body mass index (BMI), Charlson Comorbidity Index (CCI), diabetes, and smoking status. Injury characteristics including laterality, open fracture, bicondylar or unicondylar fracture pattern, Schatzker classification, primary column involvement, surgical approach(es), intraoperative meniscus repair were collected. Primary column involvement was determined based on the degree of comminution and classified as primarily medial, lateral, posterior, or equal medial and lateral column involvement. Post-operative outcomes and complications including post-operative infection were also collected. Exclusion criteria included: inaccurate CPT code, bilateral tibial plateau fractures, ipsilateral lower extremity compartment syndrome, failure to complete questionnaires, and follow-up less than one year. Patients provided written, informed consent and those who met criteria were contacted via telephone or email to complete three pre-determined electronic questionnaires: PROMIS-PF CAT, KOOS, and anchor questions. Patients completed surveys electronically via Research Electronic Data Capture (REDCap) or were entered by research coordinators over the phone (17).

Patient Reported Outcome Scores

PROMIS was created by the National Institutes of Health (NIH) to develop standardized outcome measures applicable to clinical practice, research, and quality measurement. PROMIS uses a domain-specific approach, with item banks for each domain, including Physical Function, Fatigue, Pain, Emotional Distress, and Social Role Participation (16). PROMIS-PF CAT is a computer-based questionnaire with a 165-item bank. Participant responses to each question guide subsequent items proposed. Each question proposes a function task, and the patient scores themselves on a scale of ability from 0 (unable to perform the task) to 5 (perform without any difficulty) or limitations from 0 (cannot do) to 5 (not at all limited). At least four items must be answered to receive a score.

The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific questionnaire designed to assess symptoms and function in patients with knee injuries or osteoarthritis. Five subscales are evaluated, including: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Subscales are scored from 0 (extreme problems) to 100 (no problems) (15).

Anchor Questions for PASS

An anchor-based method was utilized to determine PASS thresholds, where an external indicator (anchor question) is compared to a PROM to reveal the significance of change (18). PASS thresholds were determined using three anchor-based questions to more accurately evaluate three independent PROM domains: global outcome (PASS-global), pain (PASS-pain), and function (PASS-function) (18–20). Anchor questions using Likert scales were adapted from previous anchor questions evaluating the patient’s opinion about their current symptom state (9, 19, 21–25). A global anchor question was used for PROMIS-PF and KOOS QOL and asked, “How satisfied are you today with your injured lower extremity?” (21, 23, 26). Answer choices included: very satisfied, satisfied, neutral, unsatisfied, and very unsatisfied. A pain anchor was used for KOOS Pain and asked, “If you had to spend the rest of your life with the pain in your injured lower extremity that you have now, how would you feel about it?” (19, 22, 25). A function anchor was used for PROMIS-PF CAT and KOOS ADL and asked, “If you had to spend the rest of your life with the function in your lower extremity that you have now, how would you feel about it?”(19, 22, 25). Answer choices for pain and function anchors included: satisfied, unsure/neutral, or unsatisfied. PASS positive (PASS+) was defined as answering “very satisfied” or “satisfied.” PASS negative (PASS-) was defined as answering “neutral,” “unsatisfied,” or “very unsatisfied.”

Statistical Analysis

Patient characteristics were summarized descriptively and compared between PASS status. Continuous variables were summarized as mean and standard deviation (SD) and compared using t-test if the distribution was approximately normal, otherwise, as median and interquartile range (IQR) and compared using Wilcoxon rank-sum tests. Categorical variables were summarized as frequency (%) and compared using Fisher’s exact test. Wilcoxon rank sum tests were used to compare scores between PASS+ and PASS-. The validity of each anchor question was determined with a Spearman Rank correlation between the anchor and respective PROM (20).

Three previously validated anchor-based methods were used to determine the optimal PASS threshold for each PROM: 1) 80% specificity, 2) 75th percentile, 3) Youden Index (3, 8). The primary method utilized was the 80% specificity method and the 75th percentile and Youden Index methods were used as a sensitivity analysis in order to evaluate variability of the thresholds between methods (8, 11, 27). The 80% specificity method is the threshold below which 80% of patients answered “unsatisfied” to the anchor and are correctly identified to have a score lower than the PASS threshold (8, 11). The 75th percentile method is the threshold at which 75% of patients who answered ‘satisfied’ to the anchor will report a score equal or higher to (8, 11). The Youden index method is the threshold at which the sum of sensitivity and specificity are maximized (8, 11, 28). Area under the receiver operating characteristic curve (AUROC or AUC) was used to compare the ability of different PASS thresholds to differentiate between patients who are PASS+ and those who are PASS- over a wide range of thresholds. AUCOR were reported with 95% confidence intervals (CIs). Statistical analyses were conducted in R Core Team (Vienna, Austria). Significance was defined as p<0.05 and all tests were two-sided.

Results

Study Inclusion

Overall, 366 patients were identified via CPT code. Of those, 46 patients were excluded for having fractures other than a tibial plateau fracture due to incorrect CPT coding. Six patients were excluded for ipsilateral lower extremity compartment syndrome and three patients were excluded for bilateral tibial plateau fractures. Of the 311 patients who met inclusion criteria, 199 had minimum one-year follow-up and of those, 40 patients failed to complete PROM and anchor question surveys. Thus, 159 patients were included in the final analysis (Figure 1). Average age was 50.0 years old (range 18.7 – 83.8, SD 15.0) and 53.5% were female.

Figure 1.

Figure 1.

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Flowchart of final patient cohort.

Overall Patient Reported Outcome Scores

Average time to completion of PROMs post-operatively was 36.03 months (range 12 – 64.9). Overall, 60% of patients considered their global outcome acceptable (very satisfied or satisfied); 58% of patients were satisfied their pain level and 52% were satisfied with their function (Figure 2).

Figure 2.

Figure 2.

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Box plot with patient reported outcome measurements between patient acceptable symptom state positive (PASS+) and PASS negative (PASS-) status, grouped by PASS anchor question. The box indicates the interquartile range (IQR) and the line within the box reflects the median score. Error bars indicate the range of scores and circles demonstrate outliers. All p-values are < 0.001 by Wilcoxon rank sum test.

For PASS-Global, the overall mean PROMIS-PF score was 47.0. The mean PROMIS-PF score was 50.5 for PASS+ patients and 41.9 for PASS- patients (p<0.001). KOOS QOL mean score was 57.9 overall and was 71.4 for PASS+ patients and 37.9 for PASS- patients (p<0.001). For PASS-Pain, the KOOS Pain mean score was 78.6 overall and was 87.5 for PASS+ patients and 66.3 for PASS- patients (p<0.001). For PASS-Function, the PROMIS-PF mean score was 47.0 overall, while it was 51.1 for PASS+ patients and 42.6 for PASS- patients (p<0.001). The KOOS ADL mean score was 83.4 overall and was 92.2 for PASS+ patients and 73.4 for PASS- patients (p<0.001).

PASS Thresholds

Each anchor question demonstrated moderate to high correlation with the PROM scores (Spearman Rank correlation coefficient > 0.5) (20). Using 80% specificity, 75th percentile, and Youden Index, PASS-Global thresholds were 48.5, 44.5, and 47.9 for PROMIS-PF and 56.3, 56.2, and 56.3 for KOOS QOL, respectively. Similarly, the PASS-pain thresholds for KOOS Pain were 84.4, 80.6, and 80.6, respectively. PASS-Function thresholds were 48.9, 46.8, and 48.0 for PROMIS-PF and 94.1, 90.2, and 86.8 for KOOS ADL, respectively. All PASS thresholds performed very well in distinguishing between PASS+ and PASS- (AUC values > 0.7). The AUC value for KOOS QOL was highest at 0.88. (Table 1)

Table 1.

PASS Threshold Values According to Three Different Methods.

Anchor PROM 80% Specificity 75th Percentile Youden Index AUC (95% CI) Spearman Rank
Global PROMIS-PF 48.5 44.5 47.9 0.79 (0.73,0.86) 0.53
KOOS QOL 56.3 56.2 56.3 0.88 (0.83,0.94) 0.74
Pain KOOS Pain 84.4 80.6 80.6 0.84 (0.78,0.90) 0.61
Function PROMIS-PF 48.9 46.8 48.0 0.80 (0.73,0.87) 0.54
KOOS ADL 94.1 90.2 86.8 0.83 (0.76,0.89) 0.59
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Factors Affecting PASS Status

The influence of demographics, fracture characteristics, surgical approach, and complications on PASS status was evaluated (Table 2). Demographics between PASS+ and PASS- groups were similar with respect to body mass index (BMI), Charlson Comorbidity Index (CCI), diabetes, smoking status, laterality of fracture, and intraoperative meniscus repair. Patients that did not achieve the PASS pain and function thresholds were significantly younger than patients who did (p=0.001, p=0.017, respectively). Patients with bicondylar fractures were significantly more PASS- with their pain (p=0.016) and function (p-=0.01). Patients with Schatzker II fractures were more commonly PASS+ in their pain and function outcome (p=0.029, p=0.009, respectively). Similarly, patients who primarily had lateral column involvement or an isolated lateral approach were significantly more PASS+ in their global outcome (p=0.045, p=0.024, respectively) and function (p=0.017, p=0.007, respectively). Patients with isolated lateral surgical approach were also more PASS+ with their pain (p=0.023). Patients with post-operative infections were more PASS- with their global outcome (p=0.035) and pain (p=0.042). (Table 2)

Table 2.

Descriptive Statistics by PASS Status Reported as Mean (SD) or n (%).

All
 Global
 Pain
 Function
Variable (N=159) PASS+ (N=95) PASS- (N=64) P-value PASS+ (N=93) PASS- (N=66) P-value PASS+ (N=83) PASS- (N=75) P-value
Age 50 (15) 52 (16) 48 (13) 0.12t 53 (15) 46 (14) 0.001 t 53 (16) 47 (14) 0.017 t
Bicondylar 73 (46%) 39 (41%) 34 (53%) 0.15f 35 (38%) 38 (58%) 0.016 f 30 (36%) 43 (57%) 0.01 f
Schatzker Classification
I 8 (5.1%) 4 (4%) 4 (6%) 0.06f 5 (5%) 3 (5%) 0.029 f 4 (5%) 4 (5%) 0.009 f
II 58 (37%) 41 (44%) 17 (27%) - 42 (46%) 16 (24%) - 39 (48%) 18 (24%) -
III 11 (7%) 9 (10%) 2 (3%) - 7 (8%) 4 (6%) - 7 (9%) 4 (5%) -
IV 21 (13%) 12 (13%) 9 (14%) - 12 (13%) 9 (14%) - 11 (14%) 10 (13%) -
V 8 (5.1%) 3 (3%) 5 (8%) - 2 (2%) 6 (9%) - 2 (2%) 6 (8%) -
VI 51 (32%) 24 (26%) 27 (42%) - 23 (25%) 28 (42%) - 18 (22%) 33 (44%) -
Primary Column
 Lateral 98 (62%) 67 (71%) 31 (48%) 0.045 f 64 (69%) 34 (52%) 0.07f 60 (72%) 37 (49%) 0.017 f
 Medial 22 (14%) 10 (11%) 12 (19%) - 12 (13%) 10 (15%) - 9 (11%) 13 (17%) -
 Posterior 10 (6%) 5 (5%) 5 (8%) - 6 (6%) 4 (6%) - 5 (6%) 5 (7%) -
 Medial + Lateral 29 (18%) 13 (14%) 16 (25%) - 11 (12%) 18 (27%) - 9 (11%) 20 (27%) -
Surgical Approach
 Lateral 81 (51%) 57 (60%) 24 (38%) 0.024 f 57 (61%) 24 (36%) 0.023 f 53 (64%) 27 (36%) 0.007 f
 Medial 15 (9%) 5 (5%) 10 (16%) - 8 (9%) 7 (11%) - 6 (7%) 9 (12%) -
 Medial + Lateral 52 (33%) 27 (28%) 25 (39%) - 24 (26%) 28 (42%) - 19 (23%) 33 (44%) -
 Posterior 8 (5%) 5 (5%) 3 (5%) - 3 (3%) 5 (8%) - 4 (5%) 4 (5%) -
 Other 3 (2%) 1 (1%) 2 (3%) - 1 (1%) 2 (3%) - 1 (1%) 2 (3%) -
Post-op Infection 13 (9%) 4 (4%) 9 (15%) 0.035 f 4 (4%) 9 (14%) 0.042 f 4 (5%) 9 (12%) 0.15f
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t

T-test

f

Fisher’s exact test

w

Wilcoxon rank sum test.

Discussion

The main goal of this study was to establish PASS thresholds to help interpret PROMs after operative fixation of tibial plateau fractures. Nearly 50–60% reported their symptoms as acceptable regarding global outcome, pain, and function post-operatively.

Based on the primary method of PASS threshold determination utilizing the 80% specificity method, the PASS-global threshold for PROMIS-PF of 48.5 is consistent with raw PROMIS-PF scores in cohort studies evaluating long-term outcomes following operative fixation of tibial plateau fractures (29, 30). In addition, it is within a MCID of the reference population score of 50 for PROMIS-PF scores, suggesting a satisfied patients’ overall outcome is comparable to the general population functional status. The PASS-global threshold of 56.3 for KOOS QOL is slightly higher than previous literature evaluating KOOS QOL outcome scores following tibial plateau fractures, which may reflect improvements in surgical techniques over time or patient demographic differences (2, 14). However, the threshold remains below the 95% CI compared to same-age reference healthy populations and is nearly 10 points lower than PASS thresholds for KOOS QOL one year following total knee arthroplasty (2, 8, 14, 31, 32). These PASS thresholds after TKA are similarly slightly lower than population norms (8). Overall, this demonstrates that the knee-related QOL symptom state that patients with tibial plateau fractures deem acceptable is lower when compared to an average healthy adult.

Similarly, the PASS-pain threshold for KOOS Pain of 84.4 falls within the lower end or below the 95% CI for same-age healthy reference populations (31, 32). The PASS-function threshold for PROMIS-PF score of 48.9 is within a MCID of the reference population score for PROMIS-PF (29, 30). However, the PASS-function threshold for KOOS ADL score of 94.1 was at the lower limit or below the 95% CI of a same-age healthy population in a single-center U.S. study (32). This suggests that the pain and functional symptom state that patients deem acceptable following operative fixation of a tibial plateau fracture may be below the average healthy adults.

A secondary analysis was performed to determine which patient- and treatment-related factors influenced PROMs and affected PASS thresholds. Younger patients (< 50 years old) were more often unsatisfied with their pain and function. Increasing age has not been associated with increased complications following operative fixation of tibial plateau fractures (33–35). However, the PASS- of younger patients may also be partially explained by younger patients having higher-energy mechanisms of injury, resulting in increased soft tissue damage and fracture complexity (36, 37). Younger patients may also have a lower baseline pain and higher activity level pre-injury, higher energy injuries, and increased functional demands post-operatively compared to their elder counterparts and may thus be more likely to be unsatisfied with inferior outcomes. These results also suggest that bicondylar tibial plateau fractures and post-operative infections are associated with a less satisfactory symptom state, which is consistent with prior literature as both have been shown to have lower PROMs and worse overall outcomes (35, 38, 39). Patients with Schatzker II fractures, primarily lateral column involvement, or an isolated lateral approach were more likely to be PASS+ with their global outcome and function. Medial column involvement in tibial plateau fractures is far less common due to the stronger bone of the medial column, which requires more force to fracture. They have historically been associated with worse functional outcomes, consistent with a below-average acceptable symptom state (40). Additionally, there has been mounting evidence that mental health may play a role in PROM outcomes, and this is an area for further investigation to evaluate the impact of mental health on PASS thresholds (41, 42).

PASS thresholds help shift the focus to patient acceptability as measured by satisfaction rather than exaggerating the importance of clinically irrelevant improvement in PROMs. The current data provides clinical utility to PROMs, as providers collecting either PROMIS-PF CAT or KOOS can compare individual scores to the thresholds established in this study. In addition, use of PASS thresholds are especially advantageous within the orthopaedic trauma population, given that many patients do not have baseline pre-operative PROMs to calculate a MCID or other similar marker of clinical relevance.

There are several limitations of this study. First, there is no gold standard statistical analysis for determining PASS thresholds. In this study, PASS thresholds determined with the primary method of 80% specificity should be referenced in clinical use. However, thresholds varied slightly between the two secondary anchor-based methods used to determine optimal cut-off points. This variability may be explained by a range of PASS threshold values that could reasonably determine patient satisfaction rather than a single cut-off value and requires further external validation studies. In addition, PASS thresholds are inherently limited by the rigor and interpretation of satisfaction used in anchor questions and the lack of standardized, validated anchor questions across the literature (8, 19, 22, 23).

Second, defining PASS thresholds at a single time point does not account for the fact that PROMs may vary over time post-operatively. PASS thresholds have previously demonstrated stability over time one- and three-years following total knee arthroplasty, and in the lower extremity fracture setting, minimum follow-up of one-year may be sufficient to evaluate the symptom state of fracture union as little improvement is expected after 30 months (8, 43, 44). However, this introduces a potential risk of bias if patients have not recovered maximally when they completed final PROMs, regardless of time post-operatively. Additionally, follow-up in this study was higher than average in the trauma population, with rates of 35% at one-year being reported in the literature (44). Thus, these PASS thresholds for tibial plateau fractures determined with minimum one-year follow-up are likely sufficient to determine the symptom state of tibial plateau fracture union, while remaining clinically applicable in the trauma population where limited follow-up is the norm. However, further external validation applying the PASS thresholds for tibial plateau fractures to a larger patient cohort is required (11).

Third, an internal validation analysis with a validation question was not performed. However, AUCs were all > 0.78, suggesting that the PASS thresholds were able to discriminate between satisfactory and unsatisfactory outcomes well. Additionally, each anchor showed good correlation with the PROM during the validation analysis. Lastly, specific patient, fracture, and treatment related factors that may influence PASS threshold estimates were selected from available retrospectively collected data. There may be other variables that influence PASS thresholds that were not analyzed.

Conclusion

This study defines global, functional, and pain PASS thresholds for tibial plateau fractures. Patients with bicondylar fractures, infections, and medial column involvement were more often unsatisfied. These PASS thresholds are valuable clinical references to identify patients who have attained acceptable outcomes and to counsel patients with risk factors for unacceptable outcomes following operatively treated tibial plateau fractures.

Acknowledgments

Chong Zhang receives grant funding from National Center for Research Resources and the National Center for Advancing Translational Sciences and National Institutes of Health through Grant UL1TR002538. Amy Cizik receives grant funding through Orthopaedic Research and Education Foundation grant, receives consulting fees for Balmoral, LLC and University of Washington. Justin Haller receives grant funding through the Arthritis Foundation, consulting fees from Stryker, Orthogrid, Osteocentric, Newclip Technics, is a participant on NIAMS Safety Officer for PA-20-206 advisory board, and has leadership roles for Orthopaedic Trauma Association, Western Orthopaedic Association, and AO Foundation.

Footnotes

Disclosures:

Eleanor Sato, Emily Boes, Devin Froerer, and Dillon O’Neill have no disclosures or conflicts of interest.

LEVEL OF EVIDENCE: Level III

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