The importance of evaluating outcomes in total hip arthroplasty (THA) is well recognized, and the resources to do so continue to expand and evolve. Twenty-eight tools for measuring outcomes have been described, and the most commonly referenced include the modified Harris Hip Score (mHHS), the Hip Disability and Osteoarthritis Outcome Score, and the Western Ontario and Mc-Master Universities Osteoarthritis Index.1–4 Despite their lengthy history of use, legacy measures have limitations, including the potential introduction of surgeon bias in outcome assessment.5
The current paradigm of surgical outcome assessment acutely focuses on patient perspectives, attempts to eliminate bias, and is broadly termed patient-reported outcomes (PROs).6,7 The Patient-Reported Outcomes Measurement Information System (PROMIS) is a psychometrically robust outcomes assessment research tool to assess self-reported symptoms for a multitude of chronic conditions.8 The PROMIS leverages computer adaptive testing (CAT) methodology that uses a large pool of questions and an iterative algorithm that results in decreased assessment time, immediate scoring, good accuracy, improved precision, and low floor and high ceiling effects compared with static legacy measures of assessment.8–13
Although PROMIS has been psychometrically and statistically validated in many settings, including osteoarthritis, it is a global health assessment tool and has not been validated specifically in THA populations.14–18 In comparison, the mHHS is a disease-specific instrument and has been shown to have high validity and reliability for assessing outcomes after THA.1,4 However, the mHHS has observer bias and high floor and low ceiling effects.19–21
In this study, the authors sought to assess the global health (nonarthroplasty-specific) PROMIS Pain Interference and Physical Function CATs and the hip arthroplasty–specific mHHS for statistical correlation in patients undergoing primary THA for osteoarthritis.
Materials and Methods
Following institutional review board approval, patients were prospectively enrolled in the study. Patients 18 to 90 years old undergoing primary THA for the diagnosis of osteoarthritis at a single institution were included. Criteria for exclusion included at-risk populations, prior fracture, active infection, or revision surgery.
Prior to surgery, informed consent was obtained and demographic and medical comorbidity information recorded. Patients completed a preoperative assessment including PROMIS CATs (Pain Interference and Physical Function) and mHHS to serve as a baseline. These assessments were collected on an iPad using the Assessment Center ( www.assessmentcenter. net) online software application. All patients underwent anterior THA performed by 1 of 2 fellowship-trained arthroplasty surgeons.
Patients also completed the above noted assessments at their 3-, 6-, 12-, and 52-week follow-up visits. If the assessments could not be completed in clinic, they were completed over the phone or by email at those same time points. All pre- and postoperative assessments were identical in content but in random order so that individual questions could not be clearly linked by patients or assessors to a specific scoring system.
The PROMIS Physical Function CAT version 1.2 and Pain Interference CAT version 1.0 were used. These 2 PROMIS CATs were selected for comparison because the mHHS has both a physical function component and a pain interference component. After the completion of each individual assessment item, the CAT algorithm selects a subsequent item based on prior responses. The score is based on a population norm of 50, with a standard deviation of 10. For the Physical Function CAT, higher scores represent better function; for the Pain Interference CAT, lower scores represent less pain.
Of the 3 scoring systems used, only the Pain Interference score numerically decreases with increasing patient improvement. This makes a direct comparison to the mHHS difficult because the mHHS is a composite of both pain and physical functional components. Therefore, the authors inverted the PROMIS Pain Interference score such that it increases with increasing patient improvement without altering the scale or item response. To facilitate direct comparison with the mHHS, the authors summed the PROMIS Physical Function and Pain Interference scores to create a composite score (combined PROMIS score). This creates a comprehensive PROMIS assessment that increases with less pain and better function, just as the mHHS does. The combined PROMIS score was then directly compared with the mHHS. In addition, each PROMIS CAT score was directly compared with its corresponding mHHS subcategory of pain and function/gait.
Modified Harris Hip Score
The mHHS includes 8 questions divided into Pain, Function-Gait, and Functional Activities subsections. A score of 44 on the Pain subsection, 33 on the Function-Gait subsection, and 14 on the Functional Activities subsection yields a maximum point total of 91. Based on standard convention, this maximum score is then linearly scaled up using a multiplier to yield a total maximum score of 100. Higher scores represent less pain and better function.
Descriptive statistics, including mean and standard deviation, were calculated for each assessment score, at each time point. Pearson correlation coefficients were determined to compare the combined PROMIS score with the mHHS preoperatively and at 3, 6, 12, and 52 weeks postoperatively and to assess for convergent validity between them. Identical statistical methods were used to directly compare individual PROMIS CATs and the corresponding mHHS subcategory. A Pearson r value of 0.40 to 0.59 is regarded as a moderate correlation, 0.60 to 0.79 as a strong correlation, and 0.80 to 1.0 as a very strong correlation. To evaluate for responsiveness, change from baseline to each follow-up was assessed using a Student's paired t test. Significance was set at a P value greater than .05. Power analysis was conducted, with beta being 0.20, alpha being 0.05, and difference to detect of 5 points on a 0 to 100 scale, which yielded a minimum sample size of 17 patients.
PROMIS and mHHS: Preoperative Outcomes
A total of 48 patients were included in the study, 46 (96%) of whom completed all assessments at all time points; 64% were women, and 36% were men. Mean PROMIS Physical Function and Pain Interference scores at each time point are summarized in Table 1. Preoperatively, both measures were greater than 1 standard deviation worse than the healthy population norm (37.3 for Physical Function, 36.9 for Pain Interference). Mean PROMIS total score was worse than the population norm of 100 (74.2). Mean mHHS was significantly worse than the population norm score preoperatively (50.8).
PROMIS and Modified Harris Hip Scores Preoperatively and at 3, 6, 12, and 52 Weeks Postoperatively
Using Pearson correlation coefficients, the preoperative PROMIS Pain Interference CAT (Table 2) was found to have a moderate, statistically significant correlation with the preoperative mHHS Pain subsection (r=−0.49, P=.0008). The preoperative PROMIS Physical Function CAT was found to have a moderate, statistically significant correlation with the preoperative mHHS combined Function-Gait plus Functional Activities subsections (r=0.53; P=.0002). The total PROMIS score preoperatively (combined Pain Interference and Physical Function CAT) was found to have a moderate, statistically significant correlation with the total mHHS (r=0.56; P<.0001; Table 3).
PROMIS and Modified Harris Hip Scores Subcomponent Components Correlations
Correlation Coefficient Between Total PROMIS and Modified Harris Hip Scores
PROMIS and mHHS: 3-week Postoperative Outcomes
At 3 weeks postoperatively, PROMIS Physical Function scores did not change significantly (37.2; P=.95), but Pain Interference scores did improve significantly (45.2; P<.01). Total PROMIS score improved significantly (82.4; P<.01), and mHHS also improved significantly (68.2; P<.01). Total PROMIS score (combined Pain Interference and Physical Function CAT) had a strong correlation with the mHHS (r=0.74; P<.0001; Table 3).
PROMIS and mHHS: 6-week Postoperative Outcomes
At 6 weeks postoperatively, both PROMIS Physical Function and Pain Interference scores improved significantly (43.7 and 50.6, respectively; both P<.01). Total PROMIS score improved significantly (94.3; P<.01), and mHHS also improved significantly (81.1; P<.01). Total PROMIS score (combined Pain Interference and Physical Function CAT) had a strong correlation with the mHHS (r=0.74; P<.0001; Table 3).
PROMIS and mHHS: 12-week Postoperative Outcomes
By 12 weeks postoperatively, both PROMIS Physical Function and Pain Interference scores had improved to nearly population mean levels (47.6 for Physical Function, 52.4 for Pain Interference; both P<.01). Total PROMIS score improved significantly (100, P<.01), and mHHS also improved significantly (85.9; P<.01). Total PROMIS score (combined Pain Interference and Physical Function CAT) had a strong correlation with the mHHS (r=0.73; P<.0001; Table 3).
PROMIS and mHHS: 52-week Postoperative Outcomes
By 52 weeks postoperatively, all scores had stabilized (Figure 1). The PROMIS Physical Function and Pain improved significantly (46.8 and 53.2, respectively; both P<.01). Total PROMIS score improved significantly (100; P<.01), and mHHS also improved significantly (88.6; P<.01). Total PROMIS score (combined Pain Interference and Physical Function CAT) had a very strong correlation with the mHHS (r=0.80; P<.0001; Table 3).
Line graph showing the total modified Harris Hip Score and total Patient-Reported Outcomes Measurement Information System (PROMIS) score vs time.
PROMIS and mHHS Subcategory Correlations
Preoperatively, the PROMIS Pain Interference CAT was found to have a moderate correlation with the mHHS Pain sub-category (r=−0.49; P=.0008; Table 2). Preoperatively, the PROMIS Physical Function CAT was found to have a moderate correlation with the mHHS Function-Gait subcategory (r=0.53; P=.0002).
At 3, 6, 12, and 52 weeks postoperatively, the PROMIS Pain Interference CAT was found to have a moderate or strong correlation with the mHHS Pain subcategory (r=−0.59, −0.69, −0.60, and −0.57, respectively; all P<.0001). At 3, 6, 12, and 52 weeks postoperatively, the PROMIS Physical Function CAT was found to have a strong to very strong correlation with the mHHS Function-Gait subcategory (r=0.80, 0.67, 0.74, and 0.68, respectively; all P<.0001; Table 2).
The PROMIS is a valid and psychometrically sound PRO assessment tool that uses CAT methodology and has been shown to be efficient, accurate, and precise in determining patient outcome in several medical disciplines.8–10,13,22 The functional basis of CAT, and therefore PROMIS, is item response theory, in which questions are selected and administered from a larger bank of questions.12,23 In item response theory, each question is automatically selected based on the patient's response to the previous question. Thus, each assessment may comprise a completely different group of questions and may be considered tailored testing. This allows the assessment to accurately and precisely hone in on a respondent's true pain or functional level with fewer questions than a traditional assessment and fewer ceiling and floor effects.11,13,18
After completing the assessment, a probability-based score is calculated and plotted against healthy population norms, often in fewer than 5 questions with reliability similar to lengthy static legacy measures.1–3,6,14 Efficient collection of outcome data reduces patient effort, increases compliance, and allows for more frequent sampling.11 In addition, the ease of use of PROMIS is optimized because it can be delivered on multiple platforms, including iPads, smartphones, web-based interfaces sent by email, and EPIC Care Ambulatory Core EMR.24 A study by Bjorner et al25 showed that PROMIS questionnaires can be delivered across a multitude of platforms with equal efficacy.
For the efficient capture of accurate, precise, electronic outcome data following THA, the PROMIS is attractive because it can be easily administered within the context of the clinical environment and serve to meet the demands of quality reporting and total joint registry level IV data contribution.15,26 However, PROMIS is unfamiliar to many orthopedic practitioners and little data are available that directly compare it with familiar, static legacy measures, such as the mHHS.15,26,27 In addition, although PROMIS has been used to evaluate arthritis, it has not been used to validate mHHS in THA outcomes.10,14–18
The authors found that PROMIS Pain Interference and Physical Function, such as the mHHS, improved significantly (P<.01) at each time point from preoperative baseline through 52 weeks postoperative, indicating responsiveness to change. When comparing the preoperative PROMIS Pain Interference score with the mHHS pain subcategory, the authors found a moderate correlation. Similarly, when comparing the pre-operative PROMIS Physical Function score and the mHHS function subcategory, the authors found a moderate correlation. At 3, 6, 12, and 52 weeks postoperatively, PROMIS Pain Interference and Physical Function had moderate or strong correlation with mHHS pain and functional components, respectively, indicating convergent validity in addition to responsiveness to change.
The authors also compared the total PROMIS score with the total mHHS. Preoperatively, they found a moderate correlation between the 2 scoring systems. A strong correlation was found at 3, 6, and 12 weeks postoperatively and a very strong correlation at 52 weeks between total PROMIS and total mHHS, indicating convergent validity and the ability of PROMIS to accurately assess early clinical outcome following THA. The authors interpret the weaker preoperative correlation to be reasonably ascribed to differences in floor effects between PROMIS CATs and the static mHHS.11,13,18 They hypothesize that at maximal improvement, differences in ceiling effects may potentially lead to a lesser correlation but this remains to be investigated in a longer follow-up to this study. To that end, it may be useful to develop a THA disease-specific PROMIS CAT.
A total of 5 time points and 52-weeks' study duration were selected to optimize this study. In contrast to studies evaluating patient clinical outcomes where long-term clinical follow-ups are needed, PRO measurement tools can be validated at just a single time point using statistical tools. A single time point was used to validate multiple orthopedic and nonorthopedic PROMIS studies, including the following: PROMIS vs QuickDASH; PROMIS vs DASH; PROMIS vs FFAM and FFI; PRIMIS vs GAITRite; and multiple others.11,13,28–36 Thus, a single preoperative and postoperative data set would have been sufficient. However, the authors elected to use 4 postoperative data sets up to 52 weeks postoperatively.
Pain Interference and Physical Function PROMIS CATs were selected for comparison with the mHHS because the mHHS has both a pain and a function component.1,37,38 Other PROMIS CATs are available and have been investigated in total joint replacement. However, for the purposes of validating the mHHS, the 2 PROMIS CATs were thought to be most appropriate for direct comparison.18,27,37
This study had limitations. First, multiple other PROMIS CATs are available for use, but this study only examined 2 of the available CATs. However, as noted above, PROMIS Pain Interference and Physical Function are most suitable for direct comparison of PROMIS with the mHHS because the mHHS has both a pain and a physical function component and lacks any social or mental health assessment (eg, anxiety, depression, social support, and so on).
In addition, this investigation was limited to primary, anterior THA performed for the diagnosis of osteoarthritis. Different hip-specific diagnoses or surgical approaches could have different time-based responses to surgical intervention. Finally, this study was limited to a target of 50 patients. This was deemed an appropriate number based on the authors' a priori power analysis. Although their findings reached statistical significance, a larger study could be beneficial in future work particularly in developing an arthroplasty-specific PROMIS CAT module.
The PROMIS Pain Interference and Physical Function for patients undergoing THA are significantly worse than the population norm preoperatively, and nearly normal at 12 and 52 weeks postoperatively. Preoperatively, the total PROMIS score has a moderate correlation with total mHHS. At all time points postoperatively up to 52 weeks, total PROMIS demonstrated a consistently strong or very strong correlation with total mHHS. Postoperatively, PROMIS Pain Interference and Physical Function subcomponent scores exhibited strong correlation with mHHS Pain and Physical Function subcomponents at all time points. The combined PROMIS Pain Interference and Physical Function assessments are comparable with mHHS when assessing outcome following THA for osteoarthritis.
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PROMIS and Modified Harris Hip Scores Preoperatively and at 3, 6, 12, and 52 Weeks Postoperativelya
|Score||Preoperative||3 weeks||6 weeks||12 weeks||52 weeks|
|PROMIS Pain Interference||36.9||6.7||45.2||9.0||<.01||50.6||8.4||<.01||52.4||8.5||<.01||53.2||8.8||<.0001|
|PROMIS Physical Function||37.3||6.8||37.2||7.0||.95||43.7||7.2||<.01||47.6||7.6||<.01||46.8||7||<.0001|
|mHHS Functional Activities||7.9||2.1||9.1||3.0||.019||11.1||2.3||<.01||11.4||2.9||<.01||12.3||2.2||<.0001|
PROMIS and Modified Harris Hip Scores Subcomponent Components Correlations
|Pearson correlation coefficient||Preoperative PROMIS||3 weeks||6 weeks||12 weeks||52 weeks|
Correlation Coefficient Between Total PROMIS and Modified Harris Hip Scores
|Statistical value||Pearson correlations between combined PROMIS and mHHS|
|3 weeks||6 weeks||12 weeks||52 weeks|