Abstract
Background
To assess disability more efficiently with less burden on the patient, the National Institutes of Health has developed the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function—an instrument based on item response theory and using computer adaptive testing (CAT). Initially, upper and lower extremity disabilities were not separated and we were curious if the PROMIS Physical Function CAT could measure upper extremity disability and the Quick Disability of Arm, Shoulder and Hand (QuickDASH).
Questions/purposes
We aimed to find correlation between the PROMIS Physical Function and the QuickDASH questionnaires in patients with upper extremity illness. Secondarily, we addressed whether the PROMIS Physical Function and QuickDASH correlate with the PROMIS Depression CAT and PROMIS Pain Interference CAT instruments. Finally, we assessed factors associated with QuickDASH and PROMIS Physical Function in multivariable analysis.
Methods
A cohort of 93 outpatients with upper extremity illnesses completed the QuickDASH and three PROMIS CAT questionnaires: Physical Function, Pain Interference, and Depression. Pain intensity was measured with an 11-point ordinal measure (0–10 numeric rating scale). Correlation between PROMIS Physical Function and the QuickDASH was assessed. Factors that correlated with the PROMIS Physical Function and QuickDASH were assessed in multivariable regression analysis after initial bivariate analysis.
Results
There was a moderate correlation between the PROMIS Physical Function and the QuickDASH questionnaire (r = −0.55, p < 0.001). Greater disability as measured with the PROMIS and QuickDASH correlated most strongly with PROMIS Depression (r = −0.35, p < 0.001 and r = 0.34, p < 0.001 respectively) and Pain Interference (r = −0.51, p < 0.001 and r = 0.74, p < 0.001 respectively). The factors accounting for the variability in PROMIS scores are comparable to those for the QuickDASH except that the PROMIS Physical Function is influenced by other pain conditions while the QuickDASH is not.
Conclusions
The PROMIS Physical Function instrument may be used as an upper extremity disability measure, as it correlates with the QuickDASH questionnaire, and both instruments are influenced most strongly by the degree to which pain interferes with achieving goals.
Level of Evidence
Level III, diagnostic study. See the Instructions for Authors for a complete description of levels of evidence.
Introduction
With standard outcome questionnaires such as the DASH, the patient addresses 30 questions (11 for the QuickDASH) [18, 20]. Combined with other similar questionnaires and forms for baseline demographics, patients in research studies may spend 15 to 30 minutes completing questionnaires. If patients lose focus or energy completing lengthy questionnaires, they may alter their responses, skip questions, or stop completing questionnaires altogether [24, 36]. An approach that may limit patient burden, avoid missed questions, and may be less prone to floor and ceiling effects is computer adaptive testing (CAT) [19, 25, 26]. CAT uses item response theory to optimize questionnaire administration by administering only relevant items based on the estimated level of function [9, 11]. For instance, if a patient says they can walk a mile, it will not ask if they can walk a block. CAT and full-length questionnaires are highly correlated and measure patient disability with comparable precision [9]. CAT can be completed more quickly and has lower floor and ceiling effects [13, 19, 22]. The National Institutes of Health has developed several questionnaires based on this approach: the Patient Reported Outcomes Measurement Information System (PROMIS) [10, 14].
Initially, upper and lower extremity function was assessed together under PROMIS Physical Function because there was little distinction between upper and lower extremity conditions in initial field testing and validation [7, 15, 16]; an upper extremity-specific disability measure recently was released for PROMIS. We were surprised that the developers of the PROMIS Physical Function CAT found little difference when they separated upper and lower extremity questions. The finding that it does not matter much if you ask patients questions regarding legs or arms—if confirmed—would suggest that measures of musculoskeletal disability may be measuring something other than pathophysiology or impairment. In other words, if patients with upper extremity illness report equal trouble with upper and lower extremity activities, then the instrument may not be measuring the upper extremity. Given the evidence that measure of symptoms and disability correlate most strongly with psychosocial factors, perhaps these instruments are measures of mindset and circumstances more than physical disease and impairment [37, 39].
The aims of our study were to confirm that a general disability measure (PROMIS Physical Function) correlates with a measure of upper extremity disability (QuickDASH), and to determine the factors influencing the variation in both scores to see if they are similar [2, 8, 12, 18, 20, 28–30, 32, 41, 42].
We hypothesized that there would be no correlation between the PROMIS Physical Function CAT and the QuickDASH. Secondary study questions addressed whether the PROMIS Physical Function and QuickDASH correlate with the PROMIS Depression CAT and PROMIS Pain Interference CAT instruments. Finally, we assessed the differences among the demographic, diagnostic, and psychologic factors associated with QuickDASH and PROMIS Physical Function in multivariable analysis.
Patients and Methods
Study Design
Between May 2013 and July 2013 we invited new and followup outpatients presenting to the hand surgery outpatient clinic of three orthopaedic hand surgeons to participate in this institutional review board-approved observational cross-sectional study. We excluded pregnant women, patients younger than 18 years, subjects with a mental health condition, and patients unable to communicate in English. Informed consent was obtained. Except for patients missed while the researcher was occupied, these were consecutive patients and represented the average patient seen in the office.
From the 105 patients who fulfilled our eligibility criteria, 11 declined participation, and one was unable to complete the study questionnaires because of lack of time. This resulted in a final sample of 93 patients from which data were used for analysis. There were 41 men and 52 women with an average age of 50 ± 18 years (range, 21−94 years) (Table 1).
Table 1.
Demographics of the 93 patients
| Demographic | Mean | SD | Range |
|---|---|---|---|
| Age (years) | 50 | 18 | 21−94 |
| Education (years) | 15 | 2.3 | 12−20 |
| Sex | Number | Percent | |
|---|---|---|---|
| Women | 52 | 56 | |
| Men | 41 | 44 | |
| Work status | |||
| Working full-time | 41 | 44 | |
| Working part-time | 11 | 12 | |
| Homemaker | 1 | 1.1 | |
| Retired | 21 | 23 | |
| Unemployed, able to work | 6 | 6.5 | |
| Unemployed, unable to work | 11 | 12 | |
| Workers compensation | 1 | 1.1 | |
| Currently on sick leave | 1 | 1.1 | |
| Marital status | |||
| Single | 35 | 38 | |
| Living with partner | 2 | 2.2 | |
| Married | 41 | 44 | |
| Separated/divorced | 12 | 13 | |
| Widowed | 3 | 3.2 | |
| Prior surgery | |||
| Yes | 10 | 11 | |
| No | 83 | 89 | |
| Sought treatment before | |||
| Yes | 37 | 40 | |
| No | 56 | 60 | |
| Other pain conditions | |||
| Yes | 27 | 29 | |
| No | 66 | 71 | |
| Health-related outcomes | Mean | SD | Range |
|---|---|---|---|
| QuickDASH | 34 | 23 | 0−95 |
| PROMIS Physical Function | 46 | 9.5 | 20−66 |
| PROMIS Pain Interference | 57 | 7.5 | 39−75 |
| PROMIS Depression | 47 | 9.1 | 34−65 |
| Numeric rating scale | 3.9 | 2.8 | 0−10 |
QuickDASH = Quick Disability of Arm, Shoulder and Hand; PROMIS = Patient Reported Outcomes.
Measurement Information System.
Outcome Measures
Patients completed the PROMIS Physical Function CAT and the QuickDASH to assess physical function and upper extremity disability, respectively. In addition, the PROMIS Pain Interference CAT and PROMIS Depression CAT were completed. Pain intensity at the time of enrollment was measured with an 11-point ordinal measure (0−10 numeric rating scale).
The overall score of each PROMIS instrument can range from 0 to 100 with a score of 50 points being the mean score for the general population in the United States. Higher scores of instruments assessing negatively worded items (eg, depression, pain interference) reflect higher levels of depression or pain interference. For positively worded questionnaires such as the PROMIS Physical Function, total scores are positively correlated with the level of physical function. All PROMIS items use a 5-point Likert scale: 1 = not at all; 2 = a little bit; 3 = somewhat; 4 = quite a bit; or 5 = very much [33].
The PROMIS Physical Function (Version 1.0) questionnaire assesses one’s ability to accomplish physical activities ranging from low-impact tasks (eg, bathing and dressing) to vigorous physical activities (eg, running, strenuous sports). The questions do not refer to a particular recall period, but involve the participant’s status at the time of completion [7, 21, 35].
In the PROMIS Depression (Version 1.0) questionnaire, patients are asked to state the severity of their symptoms during the past 7 days. The PROMIS Depression CAT uses a 28-item question bank [17, 30].
The PROMIS Pain Interference (Version 1.0) assesses the consequences of pain on common aspects of daily life. This incorporates social, cognitive, emotional, physical, and recreational aspects. The PROMIS Pain Interference CAT uses the full 41-item question bank [1].
The QuickDASH is an 11-item questionnaire that measures upper extremity-specific disability [18]. Items are answered on 5-point Likert scales. The overall score is scaled to range from 0 (no disability) to 100 (most severe disability) with a score of 11 points reflecting the mean score for the general US population [3, 18, 29].
The numeric rating scale for pain is an 11-point ordinal pain intensity scale anchored at each end by opposite statements, which are “no pain” (0) versus “worst possible pain” (10) [23, 40].
Statistical Analysis
An a priori power analysis was conducted with respect to the primary null hypothesis. This indicated that a minimum sample size of 84 patients was needed to detect a 0.3 (moderate) correlation between the QuickDASH and the PROMIS Physical Function with 80% power (alpha 0.05). Taking a potential 10% incomplete data into account, a total of 93 patients was required.
Bivariate and multivariable analyses were conducted to test our hypotheses. A Pearson correlation was conducted to assess normally distributed variables. Spearman’s rank correlation method was conducted for nonparametric data. The association between dichotomous variables and continuous variables was analyzed using the Student’s t-test in case of normally distributed data and the Wilcoxon rank-sum test in case of nonnormally distributed data. The association between categorical variables (eg, marital status, work status) and continuous variables were analyzed by use of the one-way ANOVA test in case of normally distributed data and the Kruskal-Wallis test for nonnormally distributed data.
To determine the factors that are independently and most strongly associated with PROMIS Physical Function and QuickDASH score, a backward, stepwise, multivariable linear regression analysis was performed. Explanatory variables that met p less than 0.10 significance criteria in bivariate factor analysis were entered in the multivariable linear regression. An adjusted R-squared was calculated to assess the collective influence of the factors in the final multivariable regression model on the variability in PROMIS Physical Function and QuickDASH scores.
Mean imputation was used for one missing pain intensity score and the marital status of one patient was retrieved from the medical records.
Results
There was moderate correlation between the PROMIS Physical Function and the QuickDASH questionnaire (r = −0.55; p < 0.001) (Table 2).
Table 2.
Bivariate analyses
| Health-related outcomes | PROMIS Physical Function | QuickDASH | ||
|---|---|---|---|---|
| Coefficient | p value | Coefficient | p value | |
| QuickDASH | −0.55 | < 0.001 | N/A | N/A |
| PROMIS Physical Function | N/A | N/A | −0.55 | < 0.001 |
| PROMIS Pain Interference | −0.51 | < 0.001 | 0.74 | < 0.001 |
| PROMIS Depression | −0.35 | < 0.001 | 0.34 | < 0.001 |
| Age | −0.27 | 0.0084 | 0.23 | 0.026 |
| Years of education | 0.17 | 0.10 | −0.19 | 0.074 |
| Pain | −0.20 | 0.055 | 0.38 | < 0.001 |
PROMIS = Patient Reported Outcomes Measurement Information System; QuickDASH = Quick Disability of Arm, Shoulder and Hand; N/A = not applicable.
Higher PROMIS Physical Function correlated with lower PROMIS Depression (r = −0.35; p < 0.001) and PROMIS Pain Interference (r = −0.51; p < 0.001). Similarly, higher disability on the QuickDASH correlated with PROMIS Depression (r = 0.34; p < 0.001) and PROMIS Pain Interference (r = 0.74; p < 0.001) (Table 2).
Other correlates of greater disability in bivariate analysis included older age and work status (Table 3).
Table 3.
Bivariate analyses
| Patient demographics (n = 93) | PROMIS Physical Function | QuickDASH | ||
|---|---|---|---|---|
| Mean (SD) | p value | Mean (SD) | p value | |
| Sex | ||||
| Men | 48 (9.4) | 0.034 | 31 (21) | 0.21 |
| Women | 44 (9.2) | 37 (24) | ||
| Marital status | ||||
| Single | 46 (9.3) | 0.26 | 33 (23) | 0.44 |
| Living with partner | 40 (7.1) | 28 (11) | ||
| Married | 47 (9.3) | 33 (22) | ||
| Separated/divorced | 42 (11) | 38 (27) | ||
| Widowed | 37 (9.1) | 58 (19) | ||
| Work status | ||||
| Working full-time | 49 (8.1) | 0.0014 | 28 (18) | 0.0018 |
| Working part-time | 50 (5.2) | 18 (12) | ||
| Homemaker | 50 (0) | 75 (0) | ||
| Retired | 42 (8.7) | 39 (22) | ||
| Unemployed, able to work | 43 (13) | 41 (21) | ||
| Unemployed, unable to work | 37 (10) | 58 (26) | ||
| Workers compensation | 37 (0) | 39 (0) | ||
| Currently on sick leave | 45 (0) | 36 (0) | ||
| Other pain condition | ||||
| Yes | 41 (8.3) | < 0.001 | 38 (22) | 0.20 |
| No | 47 (9.3) | 33 (23) | ||
| Sought treatment before | ||||
| Yes | 44 (9.2) | 0.12 | 36 (24) | 0.67 |
| No | 47 (9.6) | 33 (22) | ||
| Prior surgery | ||||
| Yes | 39 (10) | 0.014 | 47 (24) | 0.080 |
| No | 46 (9.2) | 33 (22) | ||
PROMIS = Patient Reported Outcomes Measurement Information System; QuickDASH = Quick Disability of Arm, Shoulder and Hand.
After controlling for likely confounding variables in multivariable analysis, pain interference had the strongest influence on physical function (ß = −0.57, partial R-squared = 0.25; p < 0.001). Together with male sex; presence of other pain conditions; prior surgery; retired patients; unemployed patients who are able to work; and patients on workers compensation, the full model accounted for 49% of the variance in PROMIS Physical Function scores (Table 4).
Table 4.
Multivariable analysis of predictive factors for disability
| PROMIS Physical Function | Coefficient | Partial R2 | SE | p value | Adjusted R2 | 95% CI | |
|---|---|---|---|---|---|---|---|
| PROMIS Pain Interference | −0.57 | 0.25 | 0.11 | < 0.001 | 0.49 | −0.7 | −0.36 |
| Sex | 3.2 | 0.054 | 1.5 | 0.030 | 0.31 | 6.1 | |
| Other pain conditions | −3.8 | 0.059 | 1.6 | 0.023 | −7.0 | −0.53 | |
| Prior surgery | −4.3 | 0.039 | 2.3 | 0.066 | −8.9 | 0.29 | |
| Work status retired | −4.7 | 0.080 | 1.7 | 0.0080 | −8.2 | −1.3 | |
| Work status unemployed, unable to work | −6.5 | 0.076 | 2.4 | 0.010 | −11 | −1.6 | |
| Work status on workers compensation | −19 | 0.083 | 6.9 | 0.0070 | −33 | −5.5 | |
| QuickDASH | Coefficient | Partial R2 | SE | p value | Adjusted R2 | 95% CI | |
|---|---|---|---|---|---|---|---|
| PROMIS Pain Interference | 1.9 | 0.48 | 0.22 | < 0.001 | 0.61 | 1.5 | 2.4 |
| Age | 0.24 | 0.081 | 0.086 | 0.0070 | 0.065 | 0.41 | |
| Work status homemaker | 43 | 0.094 | 14 | 0.0040 | 14 | 71 | |
| Work status unemployed, able to work | 14 | 0.056 | 6.0 | 0.027 | 1.6 | 26 | |
| Work status unemployed, unable to work | 13 | 0.072 | 5.0 | 0.011 | 3.0 | 23 | |
| Work status on workers compensation | 31 | 0.050 | 14 | 0.036 | 2.0 | 59 | |
PROMIS = Patient Reported Outcomes Measurement Information System; QuickDASH = Quick Disability of Arm, Shoulder and Hand; SE = standard error.
Again, after controlling for likely confounding variables, PROMIS Pain Interference had the strongest influence on QuickDASH scores (ß =1.9, partial R-squared = 0.48; p < 0.001). Together with older age; homemakers; unemployed patients who are able to work; unemployed patients who are unable to work; and patients on workers compensation, the full model accounted for 61% of the variance in QuickDASH scores (Table 4).
Discussion
To assess disability more efficiently with less burden on the patient, the NIH developed the PROMIS Physical Function instrument based on item response theory and using CAT. We were curious if the PROMIS Physical Function CAT could measure upper extremity disability as well as the QuickDASH—a standard upper extremity-specific disability measure. We found that the PROMIS Physical Function instrument may be used to measure disability in patients with upper extremity illness as it correlates with the QuickDASH questionnaire. We also found that both instruments are influenced most strongly by the degree to which pain interferes with achieving goals (pain interference).
This study should be considered in light of its shortcomings. Participants filled out four questionnaires, which might have affected the quality of the data. Lengthy questionnaires cause respondents to become tired, distracted, and even bored [24, 36]. However, most of our questionnaires use CAT and therefore are relatively short. Furthermore, our study addressed the general mix of patients in a hand and upper extremity office and the findings might be different among patients with specific injuries or illnesses, patients from certain backgrounds or locales, studies of problems at a particular anatomic site, studies at a specific point of recovery from injury or surgery, among patients with different levels of psychologic distress, and among patients with different types of coping strategies in response to pain.
Our findings suggest that the PROMIS Physical Function instrument can be used to study patients with upper extremity illness because it correlates with the QuickDASH questionnaire. Prior studies have shown good correlation of general and more specific measures of disability; however, general measures are somewhat less responsive to specific conditions and more prone to floor and ceiling effects owing to measurement of domains that are not relevant to the condition being studied [4–6, 27, 38]. There are several possible explanations for why a general physical function measure correlates well with an upper extremity specific instrument. First, it is possible that the strong correlation of disability (general and anatomic-specific) with psychosocial factors indicates that disability measures are assessing these aspects of illness more than pathophysiology or impairment (ie, that disability is not specific to a given anatomy or pathophysiology). Second, it is possible that general disability correlates with anatomy-specific disability because both are influenced by general health and activity level. Finally, there may be enough upper extremity-specific questions in general disability measures that a high correlation can be expected.
Regarding our secondary study questions, both disability measures correlated with symptoms of depression and ineffective coping strategies (pain interference), which is consistent with prior research [34, 35]. Ineffective coping strategies had the stronger influence in this study although coping skills and depression tend to correlate. Also consistent with prior work, secondary gain (eg, workers compensation)—a strong sociological influence on illness—correlated with both instruments [37]. The finding that PROMIS Physical Function was influenced more by other pain conditions than the QuickDASH is not surprising given that it is a general measure. Because the relative influence of other pain conditions was quite low emphasizes the much stronger influence of psychosocial factors on symptoms and disability.
The observation that a general measure of disability (the PROMIS Physical Function instrument) correlates with an upper-extremity-specific measure (the QuickDASH) in patients with upper extremity illness is interesting and may be because both measures are most strongly affected by psychosocial factors. Future studies will address the recently released PROMIS Upper Extremity questionnaire to determine the advantage it provides over the general physical function measure. Studies of the responsiveness of each measure and the reasons for such high correlations might contribute to better assessment and amelioration of disability.
Footnotes
Anna Foundation|NOREF provided one of the authors (CLO) with financial support for her internship, which was not of influence on this research project.
All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.
Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.
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