Abstract
Introduction:
Understanding minimal clinically important differences (MCID) in patient reported outcome measurement are important in improving patient care. The purpose of this study was to determine the MCID of Patient-Reported Outcome Measurement System (PROMIS) Physical Function (PF) domain for patients who underwent operative fixation of a tibial plateau fracture.
Methods:
All patients with tibial plateau fractures that underwent operative fixation at a single level 1 trauma center were identified by Current Procedural Terminology codes. Patients without PROMIS PF scores or an anchor question at two-time points postoperatively were excluded. Anchor-based and distribution-based MCIDs were calculated.
Results:
The MCID for PROMIS PF scores was 4.85 in the distribution-based method and 3.93 (SD 14.01) in the anchor-based method. There was significantly more improvement in the score from the first postoperative score (<7 weeks) to the second postoperative time (<78 weeks) in the improvement group 10.95 (SD 9.95) compared to the no improvement group 7.02 (SD 9.87) in the anchor-based method (P<0.001). The percentage of patients achieving MCID at 7 weeks, 3 months, 6 months, and 1 year were 37–42%, 57–62%, 80–84%, and 95–87%, respectively.
Discussion:
This study identified MCID values for PROMIS PF scores in the tibial plateau fracture population. Both MCID scores were similar, resulting in a reliable value for future studies and clinical decision-making. An MCID of 3.93 to 4.85 can be used as a clinical and investigative standard for patients with operative tibial plateau fractures.
Keywords: MCID, Tibial plateau fracture, PROMIS, Physical function, Functional outcome, Psychometric analysis
Introduction
Tibial plateau fractures comprise 1% of all fractures and 8% of fractures in the elderly[1]. This injury can represent a life-changing event for patients, with devastating short-term complications such as a 5.9–12% infection rate or long-term issues like post-traumatic osteoarthritis and chronic pain[2–7]. Given the prevalence and risk for complications there has been an increased interest in patient-reported outcomes (PROs) in patients with operative tibial plateau fractures[2,8,9].
Due to the importance of PRO measurement (PROM) in improving patient outcomes, the National Institute of Health developed the Patient Reported Outcomes Measurement Information System (PROMIS), a set of instruments that measures PROs, including the ability to collect these measures using computerized adaptive testing (CAT) to decrease administrative burden while retaining strong psychometric qualities[10]. The PROMIS physical function (PF) instrument has been validated by multiple studies in orthopedic populations showing similar results to legacy measures but demonstrating less ceiling effect and less administrative burden[10–13]. PROMIS shows great potential in accurate assessment of patient outcomes after lower extremity trauma including tibial plateau fractures.
However, utility in PROs requires a meaningful interpretation of the scores from the patient perspective. The minimal clinically important difference (MCID) reflects the smallest amount of change that is deemed meaningful to a patient[14–17]. There are ongoing methodological discussions about the most reliable way to calculate MCIDs but the two most widely accepted techniques are a distribution-based approach and an anchor-based approach[14,15,17]. To date, a PROMIS PF based MCID for operative treatment of tibial plateau fractures has not been evaluated14. The purpose of this study was to define the MCID of PROMIS PF for patients who underwent open reduction and internal fixation (ORIF) of a tibial plateau fracture and provide trajectory data on the percentage of patients achieving MCID over different time points. We used a distribution-based and anchor-based method to define meaningful change from the patient perspective.
Methods
There were 635 patients with tibial plateau fractures treated at a single tertiary level 1 trauma center between January 2014 and April 2022. Patients were identified using Current Procedural Terminology (CPT) codes for tibial plateau fractures (27535, 27536). Patients completed the PROMIS PF v1.2 or V2 Computerized Adaptive Testing (CATs). Data was collected as part of routine clinical follow-up at a post-operative baseline within 7 weeks (mean= 2.75 weeks, SD=1.56), 3 months (mean = 2.87 months, SD = 0.35), 6 months (mean 5.88 months, SD = 0.9), and 12 months (mean = 12.41 months, SD = 2.59). PROMIS PF and anchor-based questionnaires were collected at each timepoint (Fig 1).
Figure 1. Timeline of PROMIS PF and Anchor-Based Questionnaire Collection.
There were 141 patients that failed to complete the PROMIS v1.2 or v2 CAT PF scores and were categorized into a non-responder group leaving 494 patients in the responder group who were available for the distribution-based analysis (Fig. 2). This was a 78% PROMs survey response rate. To be included in the anchor-based analysis, patients needed a score at a second-time point and a recorded response to the anchor question, leaving 302 patients. Patient demographics were collected including age on admission, sex, BMI, smoking status and alcohol use. American Society of Anesthesiologists (ASA) class and Charleston Comorbidity Index (CCI) were collected to assess comorbidity status. The Schatzker Classification was used to categorize injury patterns[18].
Figure 2.
Consort Diagram
Diagram showing the inclusion and exclusion of patients. CPT=Current Procedural Terminology, PROMIS PF=Patient Reported Outcomes Measurement Information System Physical Function.
Statistical Analysis
Distribution-based MCID.
The distribution-based MCID was calculated using a half SD of the change in the PROMIS PF score from the initial score to follow-up scores at a later time point, or MCID = 0.5 × SDΔPF score [19,20].
Anchor-based MCID.
Patients included in the anchor-based analysis were asked the following questions: “Compared to your first evaluation, how would you describe your physical function level now?”[21–24] The responses were separated into two groups, the improvement group and no improvement group. Responses included in the improvement group were “slightly improved,” “improved,” and “much improved.” Responses included in the no improvement group were “no change,” “slightly worse,” “worse,” and “much worse.” The anchor-based MCID was defined as the difference of the average score change between the improvement and no improvement group, [20].
The study cohort’s demographics were analyzed using descriptive statistics. All statistical analyses were performed using statistical software R 4.1.0 (R Development Core Team, Vienna, Austria)
Results
For the distribution-based MCID 494 patients met inclusion criteria and 302 met inclusion criteria for the anchor-based MCID (Fig. 2). The average initial time point was 2.75 (SD 1.56, range 2–6.86 weeks) weeks and the average second follow up was 37.41 (SD 23.34, range 8–72 weeks) weeks. The overall Schatzker Classification break down of the cohort was as follows, I (8.2%), II (36.5%), III (3.8%), IV (11.3%), V (8.3%), and VI (31.8%).
Patient Characteristics
When comparing patients who completed a PROMIS PF score (N=494) to those who did not (N=141), responders had a higher BMI (responders 29.1 (SD 7.2), non-responders 26.9 (SD 6.6), P<0.001), fewer ASA class 1 (responder 23.5%, non-responder 29.8%, P=0.003), higher CCI score (responder 0.7 (SD 1.4), non-responder 0.4 (1.3), P=0.002), lower alcohol use (responder 39.3%, non-responder 44%, P<0.001), and lower smoking rates (responder 60.3%, 52.5%, P=0.003) (Table 1). There were no differences between responders and non-responders in terms of Schatzker Classifications. Comparing patient demographics in those included in the anchor-based method, patients in the improvement group had more categorized as ASA Class 1 (improvement group 27.5%, no improvement group 6.9%) (Table 2.) There were no differences between responders and non-responders in terms of Schatzker Classifications
Table 1.
Demographic Comparison between Tibial Plateau Fracture Patients with and without PROMIS Physical Function Scores
| Demographic Variable | Responder | Non-Responder | P Value |
|---|---|---|---|
| Number of Patients | 494 | 141 | |
| Age, mean (SD) | 46 (16) | 47.4 (16.6) | 0.304 |
| Female, % | 44.9 | 40.4 | 0.387 |
| BMI, mean (SD) | 29.1 (7.4) | 26.9 (6.6) | <0.001 |
| ASA Class 1, % | 23.5 | 29.8 | 0.003 |
| CCI Score, mean (SD) | 0.7 (1.4) | 0.4 (1.3) | 0.002 |
| Alcohol Use, % | 39.3 | 44 | <0.001 |
| Never Smoker, % | 60.3 | 52.5 | 0.003 |
| Schatzker Classification, % | 0.742 | ||
| - I | 8.5 | 7.1 | |
| - II | 36.2 | 37.6 | |
| - III | 3.8 | 3.5 | |
| - IV | 10.3 | 14.9 | |
| - V | 8.7 | 7.1 | |
| - VI | 32.4 | 29.8 |
Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index; CCI, Charlson Comorbidity Index. All P values were calculated using the Wilcoxon rank sum test for continuous variables and Fisher exact test for categorical variables. Boldface indicates significance
Table 2.
Demographic of Anchor Based-Cohort
| Demographic Variable | Overall | Improvement | No Improvement | P Value |
|---|---|---|---|---|
| Number of Patients | 302 | 273 | 29 | |
| Age, mean (SD) | 45.6 (15) | 45.2 (15.1) | 49.2 (14.4) | 0.189 |
| Female, % | 45 | 45.4 | 41.4 | 0.7 |
| BMI, mean (SD) | 29.6 (7.1) | 19.4 (7.1) | 30.9 (7.6) | 0.212 |
| ASA Class 1, % | 25.5 | 27.5 | 6.9 | 0.008 |
| ASA Class 3 & 4, % | 22.2 | 20.2 | 41.4 | 0.008 |
| CCI Score, mean (SD) | 0.5 (1.2) | 0.5 (1.1) | 0.8 (1.4) | 0.195 |
| Alcohol Use, % | 45.4 | 46.9 | 31 | 0.206 |
| Never Smoker, % | 59.9 | 61.2 | 48.3 | 0.105 |
| Schatzker Classification, % | 0.873 | |||
| - I | 9.6 | 9.9 | 6.9 | |
| - II | 36.8 | 37 | 34.5 | |
| - III | 3.6 | 4 | 0 | |
| - IV | 9.3 | 8.8 | 13.8 | |
| - V | 9.6 | 9.5 | 10.3 | |
| - VI | 31.1 | 30.8 | 34.5 |
Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index; CCI, Charlson Comorbidity Index. All P values were calculated using the Wilcoxon rank sum test for continuous variables and Fisher exact test for categorical variables. Boldface indicates significance.
Distribution-Based MCID
There were 494 patients included in the distribution-based analysis. Using the formula MCID = 0.5 × SD, the distribution-based MCID was 4.85.
Anchor-Based MCID
Of the 302 patients included in anchor-based MCID analysis, 273 (90%) improved and 29 (10%) had no improvement or worsened. Overall, the cohort’s PROMIS PF scores improved from the first postoperative score of 26.63 (SD 6.73) to a second postoperative score of 37.11 (9.16) at an average time point of 31 weeks (SD, range) Comparing the first postoperative PROMIS PF score there was no difference between the improvement group (26.62 (SD 6.76) and no improvement group (26.68(SD 6.55)(P=0.727) (Table 3). However, the improvement group had significantly higher second score (improvement group 37.57 (SD 9.06), no improvement group 33.7 (SD 9.19), P<0.001) and total score change (improvement group 10.95 (SD 9.95), no improvement group 7.02 (SD 9.87), P<0.001) (Table 3). An anchor-based MCID of 3.93 was calculated with an SD of 14.01.
Table 3.
Comparison in Scores by 1st Postoperative Score and 2nd Postoperative Score in Anchor Group
| Overall | Improvement | No Improvement | P Value | |
|---|---|---|---|---|
| 1st Postoperative Score, mean (SD) | 26.63 (6.73) | 26.62(6.76) | 26.68(6.55) | 0.727 |
| 2nd Postoperative Score, mean (SD) | 37.11 (9.16) | 37.57(9.06) | 33.7(9.19) | <0.001 |
| Score Change, mean (SD) | 10.48 | 10.95(9.95) | 7.02(9.87) | <0.001 |
P values were calculated based on the Wilcoxon signed-rank test. Boldface indicates significance.
Trajectory Data
The average post-operative baseline score was 25.59 (SD 6.64), this progressively improved in the cohort till 1 year with an average score of 40.75 (SD 9.33) (Table 4). The average score changes at 3 months, 6 months and 1 year were 6.79 (SD 8.59), 12.82 (SD 9.20), and 15.20 (SD 9.33), respectively.
Table 4.
Summary of mean PROMIS Physical Function scores over post-operative period between groups
| Post-operative time | Scores (SD) | Mean Score Change (SD) |
|---|---|---|
| Post-operative baseline | 26.59 (6.64) | - |
| 3 months | 34.03 (7.50) | 6.79 (8.59) |
| 6 months | 39.74 (8.65) | 12.82 (9.20) |
| 1 year | 40.75 (9.33) | 15.20 (9.33) |
The percentage of patients achieving MCID at 7 weeks, 3 months, 6 months, and 1 year were 37–42%, 57–62%, 80–84%, and 95–87%, respectively (Table 5).
Table 5.
Percentage of patients reaching MCID over post-operative period across groups
| Distribution-based MCID | N (%) | Anchor-based MCID | N (%) |
|---|---|---|---|
| Physical Function- 4.85 | Physical Function-3.94 | ||
| 7 weeks | 46 (37.7%) | 7 weeks | 52 (42.6%) |
| 3 months | 306 (57.3%) | 3 months | 331 (62%) |
| 6 months | 401 (80.8%) | 6 months | 418 (84.3%) |
| 1 year | 408 (85.5%) | 1 year | 415 (87%) |
Discussion
Patient-reported outcomes are increasingly becoming a part of orthopedic evaluation and practice[25]. As healthcare shifts toward value-based care, we will need to continue to focus on patient outcomes in an objective way[14]. The ability to translate PROM scores is essential to deriving real meaning and clinical utility from these values. We determined the MCID for PROMIS PF scores in patients following ORIF of their tibial plateau fracture. A MCID of 4.85 was found utilizing the distribution method while the anchor-based method calculated a MCID of 3.93. The proximity of the results using the distribution and anchor-based approach gives validity to the findings. This is the first study to calculate an PROMIS PF MCID in ORIF tibial plateau fractures[9,14].
While no other studies have defined a PROMIS PF based MCID, Dattani et al identified an MCID of 5.5 for the Short Form 36 (SF-36), 4.4 for the Short Musculoskeletal Function Assessment (SMFA), and 6.7 for the Western Ontario McMaster Osteoarthritis (WOMAC) questionnaires in the tibial plateau fracture population[9]. Having MCIDs across different assessments allows us to compare improvement across these instruments. However, PROMIS is the only one of these instruments to be designed using item response theory with rigorous psychometric methods, which reduces ceiling and floor effects found in classically designed measures and allows for generalizability to other orthopedic trauma populations and broader operative treatments to demonstrate value-based care[12].
Additionally, Dattani et al. only calculated MCID via the distribution-based method. Utilizing two MCID calculations, such as distribution-based and anchor-based, improves reliability and validity of the estimates, allows for an evaluation of an MCID range, and reduces the risk of error[20]. Additionally, the MCIDs calculated by Dattani et al are limited by a small sample size. They calculated their SF-36 MCID with 30 patients, SMFA with only 16 patients, and WOMAC with 18 patients. This is likely due to their narrow inclusion criteria of only tibial plateaus with split depression type fractures, however this limits the generalizability of their MCIDs outside of this particular classification. The current studies sample size was much larger, with a distribution-based population of 494 and an anchor-based population of 302, and included all tibial plateau fractures treated with ORIF. This large sample and broad inclusions of tibial plateau fracture types increases the current study’s MCID score generalizability. Finally, Dattani et al, and other PROM studies in this population continue to use the SF-36. While validated, the SF-36 takes participants 4 minutes longer to fill out than the PROMIS PF, and may include inherent bias as minorities and elderly take longer to complete it[26]. Clinicians and researchers need to select tests that balance performance, time burden, and health equity. Many recent studies indicate that PROMIS PF outperforms the SF-36, and SMFA in orthopedic trauma populations[12,26,27].
Several MCIDs have been recently reported utilizing PROMIS PF. Including a cohort of ankle fractures that reported a distribution-based MCID of 5.05 and an anchor-based MCID of 5.43 [23]. Within the trauma literature another study identified a distribution-based MCID of 5.19 and an anchor-based MCID of 7.18 in pelvic ring and acetabular fractures[24]. When focusing on tibial plateau fractures, a recent study utilizing PROMIS PF found a distribution-based MCID of 5.7 and anchor-based MCID of 7.84[22]. The current studies MCIDs (4.85, 3.94) are in line with past trauma MCID PROMIS PF and MCID reported in carpometacarpal arthritis (3.5, 3.9), distal radius fractures (3.6, 4.6), and upper extremity trauma (4.6, 4.8)[28–30].
Additionally, this study defined the trajectory of the PROMIS PF scores during the post-operative course. After only 3 months, more than half of patients achieved MCID, and by 6 months >80% of patients had achieved MCID. However, these results plateaued after 6 months. Our results are similar to another study which examined recovery curves in tibial plateau fractures utilizing SF-36[31]. They found that at 76%−95% achieved MCID at 6 months, which was followed by a subsequent plateauing of the recovery curve. Interestingly, they followed patients for 5 years and found that patients continued to modestly improve up to 5 years after surgery.
Another finding of this study is that within the anchor-based method, the improvement group had a significantly lower ASA score than the no improvement group. This is not surprising, as healthier patients are likely to have less complications or chronic health issues that may compromise physical function. This trend has been seen in other orthopedic PROMIS PF MCID scores, Myhre et al found that 40.6% of the no improvement group had severe systemic disease compared to 20.2% of the improvement group in ankle fractures[23]. In the current study, 41.4% of the no improvement group had severe systemic disease compared to 20.2% of the improvement group, mirroring the past findings. This continues to demonstrate the value in collecting PROMs to counsel patients and engage in clinical decision-making especially for patients who are at higher risk to not improve or improve as much as expected following operative treatment.
This study has several limitations. All patients were treated at a single level 1 referral center, with set treatment protocols and thus the patient population that might not be generalizable to tibial plateau fractures treated outside of this type of setting. However, in the current study Schatzker type II fractures were the most common, followed by type IV, which mirrors past literature and helps support the generalizability of the current study[18,32]. Additionally, the current study’s protocol included all tibial plateau fractures captured by the CPT codes (27535, 27536). While this increases generalizability across all populations, the MCID scores are likely higher than in populations that exclude open fractures or more severe fracture patterns. These factors increase the risk for complications and poor outcomes, thus the MCID may be elevated to account for their poor physical function. Less severe fractures will likely achieve MCID even though they may not of had the complex cases been excluded. However, a strength of this study is reporting the number of patients achieving MCID at different points in the post-operative recovery curve, this can be used as a reference for surgeons and researchers. This recovery curve tracking can help overcome limitations of a broad inclusion net by allowing a closer analysis of patients’ improvement. Additionally, in the anchor-based MCID method, there is an intrinsic recall bias that impact patients perceived outcomes[33]. This bias increases MCID as patients feel that they are clinically worse than they were at their first post-operative evaluation. Finally, given the unpredictability of trauma, there are no preinjury scores, thus no true baseline to compare outcome scores. Despite these limitations, there seemed to be strong agreement between the distribution and anchor-based MCIDs, indicating that these issues had minimal impact.
Conclusion
MCIDs are a standard to compare patient’s clinical progress to or investigate differences in treatment options. With the increasing importance of PROMs and the need to demonstrate clinical improvement following operative treatment, it is critical to define MCID for different injury and surgical treatment populations. For operatively treated tibial plateau fractures, the current study found a distribution-based MCID of 4.85 and an anchor-based MCID of 3.93. Use discretion if drawing clinical or investigative conclusions on PROMIS PF scores with a difference less than 3.93 in operatively treated tibial plateau fractures.
Highlights:
The distribution-based MCID for PROMIS PF was 4.85 for operatively fixed tibial plateau fractures
The anchor-based MCID for PROMIS PF was 3.93 for operatively fixed tibial plateau fractures
An MCID of 3.93 to 4.85 can be used as a clinical and investigative standard for patients with operative tibial plateau fractures
Funding:
This investigation was supported by the University of Utah Study Design and Biostatistics Center, with funding in part from the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through grant UL1TR002538 (formerly 5UL1TR001067- 05, 8UL1TR000105, and UL1RR025764). Dr. Cizik receives Extramural Loan Repayment Program for Clinical Researchers through NIAMS 1 L30 AR077934-01. Justin Haller is a paid consultant for NewClip Technics, Osteocentric, and Stryker. He is a board/committee member of the Orthopaedic Trauma Association, and Western Orthopedic Association. Thomas Higgins is a paid consultant for DePuy Synthes, Osteocentric, and Globus Medical. He has stock or stock options in Imagen, NT nPhase, Orthogrid, and Osteocentric. He receives IP royalties from DePuy, A Johnson & Johnson Company. He is a board or committee member of the Orthopaedic Trauma Association. No other authors had funding disclosures or conflicts of interest relevant to the current study.
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