Abstract
Purpose
The minimal clinically important difference (MCID) is used in research and clinical settings as a benchmark to gauge response to treatment. The purpose of this study was to provide anchor-based MCID estimates for PROMIS and legacy instruments in a non-shoulder hand and upper extremity population.
Methods
Adult patients (≥ 18 years) seeking care at a tertiary academic outpatient hand surgery clinic completed patient-reported outcome measures on tablet computers between January 2015 and August 2017. Data were collected at baseline and at six ± two weeks of follow-up. The PROMIS Upper Extremity (UE), Physical Function (PF), and Pain Interference (PI) Computer Adaptive Test (CAT) instruments were administered, along with the qDASH. A mean-change anchor-based method was used to estimate MCIDs by comparing scores between anchor groups reporting ‘no change’ versus ‘slightly improved’ in terms of function and pain.
Results
Scores for each instrument significantly improved over the study period. With significant differences in scores between groups reporting ‘no change’ and ‘slightly improved’ function, anchor-based MCID estimates were calculated as follows: 2.1 for the PROMIS UE CAT, 1.7 for the PROMIS PF CAT, and 6.8 for the qDASH. There was no significant difference in PROMIS PI CAT scores between anchor groups when queried for level of pain improvement, precluding estimation of the MCID.
Conclusions
We have provided anchor-based MCID estimates for the PROMIS UE CAT, PROMIS PF CAT, and the qDASH for a general non-shoulder hand and upper extremity population. These values may be useful in future research for informing power calculations and when interpreting whether the magnitude of change on these instruments are clinically-significant at a population level.
Statement of Clinical Relevance
This study provides clinicians with a reference for values that may reflect clinically meaningful changes in scores for patient-reported outcome instruments commonly utilized in the current literature.
Keywords: Hand surgery, Minimal clinically important difference (MCID), PROMIS, Upper extremity (UE) CAT, Physical Function (PF) CAT, QuickDASH/qDASH
INTRODUCTION
In recent decades, there has been an effort to include the patient perspective into the assessment of treatment outcomes, and the development of patient-reported outcome (PRO) instruments has become an important adjunct to physical and radiologic evaluations. PRO instruments are useful for measuring patient improvement while offering reliability, validity, and interpretability of scores.1 Advancements in test development using item-response theory have created instruments with individually calibrated items that can be administered electronically, reduce redundancy, shorten test administration time, and reduce respondent burden. Recently, there has been an increased focus upon tools developed with the National Institutes of Health, specifically the Patient-Reported Outcomes Measurement Information System (PROMIS). By using computer adaptive testing (CAT), responder burden, or the number of questions asked, may be lower than for traditional legacy scales.2 However, floor and ceiling effects have been described which may be negative trade-offs resulting from scale brevity.3,4
Useful PROs allow meaningful interpretations of scores.5 In clinical research, determining statistical significance is relatively straightforward, whereas understanding the clinical significance of differing or changing outcome scores may be less clear. One measure intended to help clarify clinical significance in score interpretation is the minimal clinically important difference (MCID), which reflects the minimal amount of change in an outcome score that may be meaningful to the patient.6 There are two primary ways to determine MCID scores. The first method is the distribution-based approach, which relies on statistical methods and probability sampling. This method can detect change that falls beyond what might be considered random variation for the specific patient population, but it does not factor in patient input regarding their perceived change in their condition.5 Distribution methods focus on how scores vary between patients, and involve calculating a magnitude of change that is beyond random fluctuation.7 Anchor-based methods, by contrast, tie scores to another measure of improvement that is supplied directly by the patient.7 The anchor could be a clinical evaluation of change, a score change on another PRO that is considered a reference standard in clinical care, or a question that asks the patient about their level of change.
Although the development of PROMIS began in 2004,2 there remains a paucity of studies reporting the responsiveness, ability to detect meaningful change, or MCID in orthopaedic populations. Additionally, elucidation of MCID values in the hand and upper extremity population for PROMIS instruments is also limited, with recent published reports that are specific to carpal tunnel release or distal radius fracture10 patient populations. Therefore, the purpose of our study was to establish the MCID values of three PROMIS instruments (UE CAT, PF CAT, and PI CAT) and one legacy instrument (qDASH) using a mean-change anchor-based approach for an orthopaedic non-shoulder hand and upper extremity patient population.
METHODS
Data Collection
Institutional Review Board approval was obtained prior to the start of data collection. Patients seeking care at a university orthopaedic clinic for non-shoulder hand and upper extremity conditions were prospectively asked to complete demographic and physical function questionnaires on handheld tablet computers prior to seeing one of four fellowship-trained orthopaedic hand surgeons. All patients were aged 18 years or older, and sought care for their baseline visit between January 2015 and August 2017. Follow-up outcomes data was again collected at return clinic visits 6 ± 2 weeks following the baseline visit. Participants completed PRO assessments as part of standard and customary clinic care and were not required to complete informed consent documentation.
Patient-Reported Outcome Instruments
Four PRO instruments were administered, including the PROMIS Upper Extremity (UE) CAT v1.2, the PROMIS Physical Function (PF) CAT v1.2, the PROMIS Pain Interference (PI) CAT v1.1, and the qDASH. The PROMIS UE v1.2 has a 16-item test bank (Appendix I). The PROMIS PF v1.2 draws from a 121-item test bank and contains both upper extremity and lower extremity items (Appendix II). The PROMIS PI v1.1 has a 40-item bank (Appendix III). The qDASH is an 11-item shorted version of the 30-item DASH (Appendix IV).11 Each item of the qDASH was administered to every patient. The PROMIS instruments were administered with computer adaptive testing (CAT) formats made available through the Assessment Center, a web-based portal established by PROMIS developers.12 The CAT administration minimizes patient burden by structuring question selection from the item bank that adjusts based on prior patient answers. For example, patients would not be asked, ‘Are you able to run or jog for two miles (3 km)?’ if they had previously answered ‘Unable to Do’ to the question, ‘Are you able to stand for one hour?’. Therefore, different questions were administered to different patients.
PROMIS instruments are calculated as standardized T-scores and calibrated in the general population to a mean of 50 and a standard deviation (SD) of 10.13 Higher scores on the PROMIS PF and UE indicate better patient function, whereas higher scores on the PROMS PI indicate greater levels of pain interference. Scores on the qDASH range from 0 to 100, in which higher scores represent greater levels of self-reported disability. The four instruments were administered at the baseline clinic visit, and again in follow-up within 6 ± 2 weeks of the baseline visit. Patients were included if at least one instrument assessing function (UE CAT, PF CAT, or qDASH) was collected at both baseline and follow-up, and if the anchor questions for function was answered at the follow-up visit.
Statistical Analysis
Statistical analysis included descriptive information regarding patient characteristics and demographics. Scores for each instrument were measured at follow-up, then compared individually to their respective baseline scores. Changes in scores were calculated as the absolute value difference between the baseline score and the follow-up scores for all four PROs. Differences in scores were assessed using the Wilcoxon rank sum test or Student’s t-test, as indicated. Categorical data were compared using the Fisher exact or Chi-square tests, as indicted.
The anchor question assessing change in function was a global rating of change: ‘Compared to your FIRST EVALUATION at the xxx: how would you describe your physical function now?’(much worse, worse, slightly worse, no change, slightly improved, improved, much improved). Another anchor question assessed a global rating of change in pain (‘Compared to your FIRST EVALUATION at the xxx: how would you describe your episodes of PAIN now?’) using the same responses. For each instrument, the anchor-based MCID was determined through a calculation of mean change in scores between groups of patients reporting ‘no change’ and ‘slightly improved’ on the anchor question. The change in PF, UE and qDASH scores were anchored against the anchor question for physical function. The PROMIS PI score change was anchored against the anchor question for pain. For both function and pain instruments, the anchor-based MCID was calculated as the mean difference between the ‘no change’ group and ‘slightly improved’ group. The MCID estimations were anchored to patient responses to the questions above, which provided a global rating of change (GRC), between baseline and a follow-up encounters. As a patient-reported anchor, the GRC is related to the patient perceptions, thus can be interpreted as a meaningful level of change.6 GRC’s are the most common approach to anchoring change scores in MCID studies14,15, though they have also been criticized for relying on recall which introduces variability.5,14
Spearman correlation coefficients were calculated to evaluate the following associations: 1) to compare the Likert scale anchor question responses to the follow-up scores, and 2) to compare the Likert scale anchor question responses to the change in scores for each instrument. Absolute values of resulting r-values were interpreted as follows in terms of strength of the association: negligible (r < 0.3), low (0.3 ≤ r < 0.5), moderate (0.5 ≤ r < 0.7), high (0.7 ≤ r < 0.9), and very high (≥0.9).16,17 All pertinent tests were 2-sided, and a significance level of 0.05 was used throughout.
RESULTS
A total of 847 patients were included in the study with an average age of 45.4 ± 18 years, in which 420 (50%) were male and 427 (50%) were female. For patients that completed at least one of the three instruments assessing function (UE CAT, PF CAT, QuickDASH), comparisons in baseline patient characteristics between groups reporting ‘no change’ and ‘slightly improved’ are depicted in Table 1. There were no significant differences in basic demographic factors between groups reporting ‘no change’ and ‘slightly improved’ on the function anchor question with the exception of provider (p < 0.05).
Table 1 –
Baseline patient characteristics
| Variable | Levels/Statistics | All | 2.Slightly improved (N=377) | 1.No change (N=348) | P-value | Test |
|---|---|---|---|---|---|---|
| Age at Admission | Mean (SD) | 45.5 (18.1) | 44.3 (18.4) | 46.8 (17.7) | - | - |
| Median (IQR) | 46 (31, 59) | 45 (28, 58) | 46 (33, 60.2) | 0.09 | Wilcox | |
| Range | (1, 92) | (1, 92) | (8, 88) | - | - | |
| Gender | Female | 375 (52%) | 194 (51.5%) | 181 (52%) | 0.88 | Chi-square |
| Male | 350 (48%) | 183 (48.5%) | 167 (48%) | - | - | |
| Ethnicity | Hispanic | 63 (9%) | 36 (9.5%) | 27 (7.8%) | 0.88 | Fisher |
| Non-Hispanic | 652 (90%) | 336 (89.1%) | 316 (90.8%) | - | - | |
| Patient Opts Ou | 6 (1%) | 3 (0.8%) | 3 (0.9%) | - | - | |
| Unknown/Missing | 4 (1%) | 2 (0.5%) | 2 (0.6%) | - | - | |
| Race | White or Caucasian | 608 (84%) | 310 (82.2%) | 298 (85.6%) | 0.80 | Fisher |
| Asian | 15 (2%) | 9 (2.4%) | 6 (1.7%) | - | - | |
| American Indian/Alaska Native | 7 (1%) | 3 (0.8%) | 4 (1.1%) | - | - | |
| Black/African American | 11 (2%) | 6 (1.6%) | 5 (1.4%) | - | - | |
| Native Hawaiian/Other Pacific Islander | 7 (1%) | 4 (1.1%) | 3 (0.9%) | - | - | |
| Other | 70 (10%) | 42 (11.1%) | 28 (8%) | - | - | |
| Unknown/Patient Refused | 7 (1%) | 3 (0.8%) | 4 (1.1%) | - | - | |
| Provider | Provider A | 190 (26%) | 107 (28.4%) | 83 (23.9%) | < 0.05 | Chi-square |
| Provider B | 186 (26%) | 111 (29.4%) | 75 (21.6%) | - | - | |
| Provider C | 221 (30%) | 98 (26%) | 123 (35.3%) | - | - | |
| Provider D | 93 (13%) | 45 (11.9%) | 48 (13.8%) | - | - | |
| Provider E | 35 (5%) | 16 (4.2%) | 19 (5.5%) | - | - | |
| Marital Status | Married/Life Partner/Domestic Partner | 404 (56%) | 201 (53.3%) | 203 (58.3%) | 0.32 | Fisher |
| Single | 228 (31%) | 129 (34.2%) | 99 (28.4%) | - | - | |
| Divorced/WidowedLegally Separated | 79 (11%) | 39 (10.3%) | 40 (11.5%) | - | - | |
| Other | 1 (0%) | 0 (0%) | 1 (0.3%) | - | - | |
| Unknown/Missing | 13 (2%) | 8 (2.1%) | 5 (1.4%) | - | - | |
| Alcohol Use | Yes | 227 (31%) | 119 (31.6%) | 108 (31%) | 0.25 | Chi-square |
| No | 322 (44%) | 158 (41.9%) | 164 (47.1%) | - | - | |
| Unknown/Missing | 176 (24%) | 100 (26.5%) | 76 (21.8%) | - | - | |
| Tobacco Use | Yes | 90 (12%) | 49 (13%) | 41 (11.8%) | 0.78 | Chi-square |
| No | 601 (83%) | 309 (82%) | 292 (83.9%) | - | - | |
| Unknown/Missing | 34 (5%) | 19 (5%) | 15 (4.3%) | - | - |
The majority of the cohort was recovering from a surgical intervention (n = 429, 50.6%): 323 (38.1%) of patients had surgery between the baseline and the follow-up visit, and 106 (12.5%) had surgery within 1 year prior to the baseline visit. Most patients were recovering from one surgery, whereas 39 (4.6%) patients had more than one procedure performed during their surgery. The most common surgical procedures included carpal tunnel release (13.3%), mass excision (6.4%) and distal radius fracture open reduction internal fixation (3.9%). Additional procedures performed on the study cohort are illustrated in Table 2. Of the non-operative patients, 81 (9.5%) received an injection and 302 (35.7%) were treated by hand therapy at the baseline visit.
Table 2:
Summary of surgeries performed on the study cohort.
| Procedure | n | Percent |
|---|---|---|
| Carpal Tunnel Release | 113 | 13.3 |
| Mass Excision | 54 | 6.4 |
| Distal Radius Fracture Open Reduction Internal Fixation | 33 | 3.9 |
| Ligament Reconstruction Tendon Interposition | 20 | 2.4 |
| Scaphoid Open Reduction Internal Fixation | 18 | 2.1 |
| Tendon Repair | 18 | 2.1 |
| Trigger Finger Release | 18 | 2.1 |
| Cubital Tunnel Release | 17 | 2.0 |
| Phalanx Open Reduction Internal Fixation | 14 | 1.7 |
| Intercarpal Open Reduction Internal Fixation | 13 | 1.5 |
| Ligament Repair | 13 | 1.5 |
| Amputation Revision | 9 | 1.1 |
| Incision and Debridement | 9 | 1.1 |
| Distal Interphalangeal Fusion | 7 | 0.8 |
| Intercarpal Fusion | 7 | 0.8 |
| Dupuytren’s Release | 6 | 0.7 |
| Phalanx Pinning | 6 | 0.7 |
| Dequervain’s release | 5 | 0.6 |
| Extensor Tendon Centralization | 5 | 0.6 |
| Nerve Repair | 5 | 0.6 |
| Biceps Tendon Repair | 4 | 0.5 |
| Hardware Removal | 4 | 0.5 |
| Intercarpal Pinning | 4 | 0.5 |
| Radius Open Reduction Internal Fixation | 4 | 0.5 |
| Ulnar Nerve Transposition | 4 | 0.5 |
| Darrach | 3 | 0.4 |
| Radial Head Open Reduction Internal Fixation | 3 | 0.4 |
| Reimplantation | 3 | 0.4 |
| Ulnar Open Reduction Internal Fixation | 3 | 0.4 |
| Wrist Fusion | 3 | 0.4 |
| Biopsy | 2 | 0.2 |
| Thumb Carpal Metacarpal Pinning | 2 | 0.2 |
| Fasciotomy | 2 | 0.2 |
| Elbow Arthroplasty | 2 | 0.2 |
| Extensor Indicis Proprius Transfer | 2 | 0.2 |
| Distal Radius Fracture External Fixation Placement | 2 | 0.2 |
| Finger Arthroplasty | 2 | 0.2 |
| Humeral Shaft Open Reduction Internal Fixation | 2 | 0.2 |
| Lateral Epicondyle Debridement | 2 | 0.2 |
| Nerve Exploration | 2 | 0.2 |
| Pronator Release | 2 | 0.2 |
| Radial Head Excision | 2 | 0.2 |
| Scaphoid Excision | 2 | 0.2 |
| Vascular Re-anastamosis | 2 | 0.2 |
| Proximal Row Carpectomy | 2 | 0.2 |
| Closed Reduction | 1 | 0.1 |
| Closed Wedge Dorsal Osteotomy | 1 | 0.1 |
| Distal Radius Fracture Pinning | 1 | 0.1 |
| Elbow Manipulation | 1 | 0.1 |
| Finger Avulsion Repair | 1 | 0.1 |
| Hemi-hamate Reconstruction of Proximal Interphalangeal | 1 | 0.1 |
| Mallet Pinning | 1 | 0.1 |
| Olecranon Bursate Excision | 1 | 0.1 |
| Olecranon Open Reduction Internal Fixation | 1 | 0.1 |
| Neurectomy | 1 | 0.1 |
| Phalanx External Fixation | 1 | 0.1 |
| Pisiform Excision | 1 | 0.1 |
| Radial Head Replacement | 1 | 0.1 |
| Radial Shortening | 1 | 0.1 |
| Radial Tunnel Release | 1 | 0.1 |
| Synovectomy | 1 | 0.1 |
| Tenosynovitis Debridement | 1 | 0.1 |
| Triangular Fibrocartilage Complex Debridement | 1 | 0.1 |
| Total Shoulder | 1 | 0.1 |
| Ulnar Debridement | 1 | 0.1 |
| Blood Vessel Repair | 1 | 0.1 |
| Radial Styloidectomy | 1 | 0.1 |
| None/ Non-operative | 418 | 49.3 |
Scores for each instrument significantly improved over the study period (p < 0.05 for each instrument; Table 3).
Table 3 -.
Change in scores over the study period
| Instrument | Baseline | Follow-Up | p-value | ||
|---|---|---|---|---|---|
| Mean Score (SD) | Median Baseline Score (IQR) | Mean Score (SD) | Median Baseline Score (IQR) | ||
| PROMIS UE CAT | 33.9 (10) | 32.9 (27.1, 38.4) | 34.7 (9.5) | 34.8 (28.2, 38.9) | < 0.05 |
| PROMIS PF CAT | 43.1 (10.4) | 44 (35.6, 50.0) | 45.3 (10.2) | 46.1 (37.4, 51.3) | < 0.05 |
| qDASH | 47.2 (22.8) | 47.7 (29.5, 65.9) | 39.9 (22.7) | 38.6 (22.7, 59.1) | < 0.05 |
| PROMIS PI CAT | 59.1 (8.1) | 59.0 (52.8, 64.4) | 56.3 (8.8) | 56.1 (52.6, 61.6) | < 0.05 |
IQR - interquartile range
p-values per Wilcoxon signed-rank test comparing median scores.
For the anchor question addressing physical function, correlation with the follow-up score and anchor response level was low (coefficient 0.37; p < 0.05) for the PROMIS UE CAT, low (0.33; p < 0.05) for the PROMIS PF CAT, and low (−0.45; p < 0.05) for the qDASH. For the pain anchor question, correlation with the follow-up PI CAT score and anchor response level was also low (−0.48; p < 0.05).
For the anchor question addressing physical function, correlation with the change in score (follow-up minus baseline) and anchor response level was low (0.48; p < 0.05) for the PROMIS UE CAT, low (0.36; p < 0.05) for the PROMIS PF CAT, and moderate (−0.51; p < 0.05) for the qDASH. For the pain anchor question, correlation with the change in the PI CAT score and anchor response level was low (−0.48; p < 0.05).
Based upon differences in scores between patient groups reporting ‘no change’ and those reporting ‘slightly improved’ to the anchor questions, the following anchor-based MCID values were determined for each instrument: 2.1 for the PROMIS UE CAT, 1.7 for the PROMIS PF CAT, and 6.8 for the qDASH (Table 4). Sample sizes for ‘no change’ and ‘slightly improved’ groups were 306 and 343 for the PROMIS UE CAT, 258 and 309 for the PROMIS PF CAT, and 340 and 370 for the qDASH, respectively. There was no significant difference in PROMIS PI CAT scores between ‘no change’ (n = 265) and ‘slightly improved’ (n =275) groups for the PROMIS PI CAT (p = 0.74). This precluded the calculation of a meaningful anchor-based MCID estimate for this instrument (estimate −0.2). Note that the difference in mean scores between the ‘no change’ and ‘slightly improved’ groups for the qDASH is a negative value, but that by convention MCID is reported as the magnitude of difference between these two groups.
Table 4 –
Anchor-based MCID Calculation Summary.
| Instrument | Baseline Score: Mean (SD) | Follow-Up Score: Mean (SD) | Change in Scores: Mean (SD) | MCID Value | p-value | |||
|---|---|---|---|---|---|---|---|---|
| Slight Improvement Group | No Change Group | Slight Improvement Group | No Change Group | Slight Improvement Group | No Change Group | |||
| PROMIS UE CAT | 32.22 (9.6) | 35.78 (10.14) | 33.99 (8.46) | 35.44 (10.55) | 1.77 (8.07) | −0.34 (7.67) | 2.1 | < 0.05 |
| PROMIS PF CAT | 42.30 (10.67) | 44.06 (10.07) | 45.29 (9.98) | 45.38 (10.55) | 2.98 (9.18) | 1.32 (7.66) | 1.7 | < 0.05 |
| qDASH | 50.40 (22.79) | 43.70 (22.4) | 39.84 (21.87) | 39.97 (23.51) | −10.56 (20.92) | −3.73 (18.38) | 6.8 | < 0.05 |
| PROMIS PI CAT | 60.81 (7.04) | 57.31 (8.73) | 57.90 (7.14) | 54.61 (10.06) | −2.90 (6.8) | −2.70 (7.57) | N/A (−0.2) | 0.74 |
SD - standard deviation
p-values per Student’s t-test comparing change in scores between ‘no change’ and ‘slight change’ groups
DISCUSSION
As patient-reported outcome measures are increasingly integrated into clinical care,18 the interpretability of scores becomes increasingly important. The use of PROMIS instruments can make important contributions to clinical practice,19 but it is important to understand how patients perceive changes in scores. The present study expands the evaluation of MCIDs for the PROMIS UE CAT and PROMIS PF CAT to a non-shoulder hand and upper extremity patient population.
Our MCID estimate for the PROMIS UE CAT was 2.1. Compared to an MCID estimate of 5.0 as a rough estimate for the MCID of PROMIS instruments, which can be calculated using the 1/2 standard deviation method given their standard deviation is designed to be 10 in a normative population,20 we note that our anchor-based value is subjectively smaller. For a carpal tunnel release patient population, Bernstein et al calculated anchor-based MCID values for the PROMIS UE CAT of 6.3 and 8.0 based upon Michigan Hand Questionnaire and Boston Carpal Tunnel Questionnaire anchors, respectively.8 The authors derived a value of 4.2 using the 1/2 SD method, and Kazmers et al derived a value of 3.6 in a similar patient population using the same calculation method.8,9 These values are also subjectively larger than that in the current study. We speculate this could relate to the paucity of nerve-specific questions in the UE CAT question bank, which in turn could reduce the responsiveness of this instrument for carpal tunnel release, and therefore lead to a given patient noting clinical improvement only with relatively larger score changes. Based on our findings, it is possible that treatments that afford improvements as low as 2.1 points on the PROMIS UE CAT may be clinically beneficial at a population level.
Our MCID value of 1.7 for the PROMIS PF CAT is subjectively smaller than the anchor-based values derived by Sandvall et al for a distal radius fracture population (3.6 to 4.6), but similar to the value of 2.3 obtained using the minimal detectable change method.10 As in the current study, the authors used the most stringent MCID definition by compared groups experiencing no improvement to those with only mild improvement for their anchor-based calculations. It is possible that differences in the anchor question wording or responses, follow-up duration, or diagnosis of included patients contributed to subjectively differing estimates. Our calculated value is also subjectively similar to the 2–3 point MCID range reported in a pediatric population for the mobility subscale,21 but is subjectively lower than the values identified in a cancer population for the PROMIS PF CAT (range 4 to 6, depending on the method of calculation)22 and the value of 4.6 calculated by Kazmers et al for a carpal tunnel release population using the 1/2 SD method.9 Using the ½ SD method, Ho et al calculated an MCID value of 4.2 in an orthopaedic foot and ankle population, which is also subjectively greater than our estimate.23 Despite these differences, it is notable that the 1/2 SD method does not incorporate patient input into the calculations, and perhaps the smaller MCID estimates derived from stringent anchor-based calculations may be more clinically relevant.
Although the MCID of the qDASH has been previously reported, we provided an estimate in the current investigation to serve as a reference point when interpreting the MCID values obtained for PROMIS instruments. Our estimate of the qDASH MCID of 6.8 falls slightly below the range reported in prior studies on upper extremity patients (8 to 19).24–27 Specifically, two studies on a physical therapy population calculated qDASH MCID estimates of 8 points26 and 11 points,27 and an estimate of 14 was determined by Sorensen et al in a hand surgery population.24 These differences between our results and prior reports are likely due to our use of a stringent anchor-based calculation: Sorensen et al included patients with more than minimal change in their calculation,24 Mintken et al used a receiver operating curve method and did not confine the calculation to a comparison of ‘no change’ and ‘minimal change’ groups,26 and Polson et al compared groups reporting ‘no change’ to the group reporting that they had ‘much improved’.27 Therefore, we conclude that our value of 6.8 truly represents minimal change for a hand surgery population.
Limitations of the study deserve mention. We were unable to calculate an anchor-based MCID value for the PROMIS PI CAT, although prior reports range from 3.4 to 9.7 among carpal tunnel release patients, and 2–6 in other populations.21,22,28–30 Perhaps use of a different anchor question, inclusion of patients that improved beyond a minimal amount, or a different follow-up time frame would change our findings. Also, the study sample was comprised of individuals with upper extremity hand conditions, but there was not a sufficient sample size to stratify the analysis by procedure codes or diagnosis so we were unable to determine if variability related to diagnosis or treatment exists or not. In addition, there have been updates to wordings of the questions and responses of the PROMIS PF and UE CAT instruments, thus the MCID values determined in this study may not reflect MCIDs for the updated versions of these instruments. However, it is likely that the MCIDs for the updated instruments are the same or similar to what we have established in this study as the general methodologies for developing, refining, scaling and scoring the PROMIS instruments has not changed. There is not yet a standardized or generally agreed upon method for establishing the most clinically useful MCID,14 and other studies have shown only moderate agreement between MCID methods.31 However, use of an anchor-based MCID calculation approach may be favored from the clinical perspective, given that patient input is factored into the calculation. Although prior research suggests that MCID determination is not overly dependent on disease severity,32,33 our study was limited in that we did not attempt to evaluate for this possibility in a hand surgery population.
In summary, we have calculated the MCID for the PROMIS Upper Extremity CAT (2.1), PROMIS Physical Function CAT (1.7), and the qDASH (6.8) in a general non-shoulder hand and upper extremity population using a stringent anchor-based approach. These values may be useful when determining whether changes in outcomes scores are clinically significant at a population level, and for powering prospective clinical studies.
Acknowledgements
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.
Appendix I.
PROMIS v1.2 Upper Extremity item bank.
| Item | ID | Question |
|---|---|---|
| 1 | PFA16r1 | Are you able to dress yourself, including tying shoelaces and buttoning your clothes? |
| 2 | PFA17 | Are you able to reach into a high cupboard? |
| 3 | PFA18 | Are you able to use a hammer to pound a nail? |
| 4 | PFA20 | Are you able to cut your food using eating utensils? |
| 5 | PFA28 | Are you able to open a can with a hand can opener? |
| 6 | PFA29r1 | Are you able to pull heavy objects (10 pounds/5 kg) towards yourself? |
| 7 | PFA35 | Are you able to open and close a zipper? |
| 8 | PFA38 | Are you able to dry your back with a towel? |
| 9 | PFA44 | Are you able to put on a shirt or blouse? |
| 10 | PFA48 | Are you able to peel fruit? |
| 11 | PFA54 | Are you able to button your shirt? |
| 12 | PFB21 | Are you able to pick up coins from a table top? |
| 13 | PFB22 | Are you able to hold a plate full of food? |
| 14 | PFB30 | Are you able to open a new milk carton? |
| 15 | PFB33 | Are you able to remove something from your back pocket? |
| 16 | PFB36 | Are you able to put on a pullover sweater? |
Note: Response options for questions 1–16 are 1 = Unable to do; 2 = With much difficulty; 3 = With some difficulty; 4 = With a little difficulty; or 5 = Without any difficulty.
Appendix II.
PROMIS v1.2 Physical Function item bank.
| Item | ID | Questions |
|---|---|---|
| 1 | PFA10 | Are you able to stand for one hour?* |
| 2 | PFA11 | Are you able to do chores such as vacuuming or yard work? |
| 3 | PFA12 | Are you able to push open a heavy door? |
| 4 | PFA13 | Are you able to exercise for an hour? |
| 5 | PFA14r1 | Are you able to carry a heavy object (over 10 pounds/ 5kg)? |
| 6 | PFA15 | Are you able to stand up from an armless straight chair? |
| 7 | PFA16r1 | Are you able to dress yourself, including tying shoelaces and buttoning up your clothes? |
| 8 | PFA17 | Are you able to reach into a high cupboard? |
| 9 | PFA18 | Are you able to use a hammer to pound a nail? |
| 10 | PFA19r1 | Are you able to run or jog for two miles (3 km)? |
| 11 | PFA20 | Are you able to cut your food using eating utensils? |
| 12 | PFA21 | Are you able to go up and down stairs at a normal pace? |
| 13 | PFA22 | Are you able to open previously opened jars? |
| 14 | PFA23 | Are you able to go for a walk of at least 15 minutes? |
| 15 | PFA25 | Are you able to do yard work like raking leaves, weeding, or pushing a lawn mower? |
| 16 | PFA28 | Are you able to open a can with a hand can opener? |
| 17 | PFA29r1 | Are you able to pull heavy objects (10 pounds/5kg) towards yourself? |
| 18 | PFA30 | Are you able to step up and down curbs? |
| 19 | PFA31r1 | Are you able to get up from the floor from lying on your back without help? |
| 20 | PFA32 | Are you able to stand with your knees straight? |
| 21 | PFA33 | Are you able to exercise hard for half an hour? |
| 22 | PFA34 | Are you able to wash your back? |
| 23 | PFA35 | Are you able to open and close a zipper? |
| 24 | PFA36 | Are you able to put on and take off a coat or jacket? |
| 25 | PFA37 | Are you able to stand for short periods of time? |
| 26 | PFA38 | Are you able to dry your back with a towel? |
| 27 | PFA39r1 | Are you able to run at a fast pace for two miles (3 km)? |
| 28 | PFA40 | Are you able to turn a key in a lock? |
| 29 | PFA41 | Are you able to squat and get up? |
| 30 | PFA42 | Are you able to carry a laundry basket up a flight of stairs? |
| 31 | PFA43 | Are you able to write with a pen or pencil? |
| 32 | PFA44 | Are you able to put on a shirt or blouse? |
| 33 | PFA45 | Are you able to get out of bed into a chair? |
| 34 | PFA47 | Are you able to pull on trousers? |
| 35 | PFA48 | Are you able to peel fruit? |
| 36 | PFA49 | Are you able to bend or twist your back? |
| 37 | PFA50 | Are you able to brush your teeth? |
| 38 | PFA51 | Are you able to sit on the edge of a bed? |
| 39 | PFA52 | Are you able to tie your shoelaces? |
| 40 | PFA53 | Are you able to run errands and shop? |
| 41 | PFA54 | Are you able to button your shirt? |
| 42 | PFA55 | Are you able to wash and dry your body? |
| 43 | PFA56 | Are you able to get in and out of a car? |
| 44 | PFA8 | Are you able to move a chair from one room to another? |
| 45 | PFA9 | Are you able to bend down and pick up clothing from the floor? |
| 46 | PFB10 | Are you able to climb up five steps? |
| 47 | PFB11 | Are you able to wash dishes, pots, and utensils by hand while standing at a sink? |
| 48 | PFB12 | Are you able to make a bed, including spreading and tucking in bed sheets? |
| 49 | PFB13 | Are you able to carry a shopping bag or briefcase? |
| 50 | PFB14 | Are you able to take a tub bath? |
| 51 | PFB15 | Are you able to change the bulb in a table lamp? |
| 52 | PFB16 | Are you able to press with your index finger (for example ringing a doorbell)? |
| 53 | PFB17 | Are you able to put on and take off your socks? |
| 54 | PFB18 | Are you able to shave your face or apply makeup? |
| 55 | PFB19 | Are you able to squeeze a new tube of toothpaste? |
| 56 | PFB20 | Are you able to cut a piece of paper with scissors? |
| 57 | PFB21 | Are you able to pick up coins from a table top? |
| 58 | PFB22 | Are you able to hold a plate full of food? |
| 59 | PFB23 | Are you able to pour liquid from a bottle into a glass? |
| 60 | PFB24 | Are you able to run a short distance, such as to catch a bus? |
| 61 | PFB25 | Are you able to push open a door after turning the knob? |
| 62 | PFB26 | Are you able to shampoo your hair? |
| 63 | PFB27 | Are you able to tie a knot or a bow? |
| 64 | PFB28r1 | Are you able to lift 10 pounds (5 kg) above your shoulder? |
| 65 | PFB29 | Are you able to lift a full cup or glass to your mouth? |
| 66 | PFB30 | Are you able to open a new milk carton? |
| 67 | PFB31 | Are you able to open car doors? |
| 68 | PFB32 | Are you able to stand unsupported for 10 minutes? |
| 69 | PFB33 | Are you able to remove something from your back pocket? |
| 70 | PFB34 | Are you able to change a light bulb overhead? |
| 71 | PFB36 | Are you able to put on a pullover sweater? |
| 72 | PFB37 | Are you able to turn faucets on and off? |
| 73 | PFB39r1 | Are you able to reach and get down a 5 pound (2 kg) object from above your head? |
| 74 | PFB40 | Are you able to stand up on tiptoes? |
| 75 | PFB41 | Are you able to trim your fingernails? |
| 76 | PFB42 | Are you able to stand unsupported for 30 minutes? |
| 77 | PFB56r1 | Are you able to lift one pound (0.5 kg) to shoulder level without bending your elbow? |
| 78 | PFB8r1 | Are you able to carry two bags filled with groceries 100 yards (100 m)? |
| 79 | PFB9 | Are you able to jump up and down? |
| 80 | PFC13r1 | Are you able to run 100 yards (100 m)? |
| 81 | PFC29 | Are you able to walk up and down two steps? |
| 82 | PFC31 | Are you able to reach into a low cupboard? |
| 83 | PFC32 | Are you able to climb up 5 flights of stairs? |
| 84 | PFC33r1 | Are you able to run ten miles (16 km)? |
| 85 | PFC38 | Are you able to walk at a normal speed? |
| 86 | PFC39 | Are you able to stand without losing your balance for several minutes? |
| 87 | PFC40 | Are you able to kneel on the floor? |
| 88 | PFC41 | Are you able to sit down in and stand up from a low, soft couch? |
| 89 | PFC43 | Are you able to use your hands, such as for turning faucets, using kitchen gadgets, or sewing? |
| 90 | PFC45r1 | Are you able to sit on and get up from the toilet? |
| 91 | PFC46 | Are you able to transfer from a bed to a chair and back? |
| 92 | PFC47 | Are you able to be out of bed most of the day? |
| 93 | PFC49 | Are you able to water a house plant? |
| 94 | PFC51 | Are you able to wipe yourself after using the toilet? |
| 95 | PFC52 | Are you able to turn from side to side in bed? |
| 96 | PFC53 | Are you able to get in and out of bed? |
| 97 | PFC6r1 | Are you able to walk a block (100 m) on flat ground? |
| 98 | PFC7r1 | Are you able to run five miles (8 km)? |
| 99 | PFA1 | Does your health now limit you in doing vigorous activities, such as running, lifting heavy objects, participating in strenuous sports?** |
| 100 | PFA3 | Does your health now limit you in bending, kneeling, or stooping? |
| 101 | PFA4 | Does your health now limit you in doing heavy work around the house like scrubbing floors, or lifting or moving heavy furniture? |
| 102 | PFA5 | Does your health now limit you in lifting or carrying groceries? |
| 103 | PFA6 | Does your health now limit you in bathing or dressing yourself? |
| 104 | PFB1 | Does your health now limit you in doing moderate work around the house like vacuuming, sweeping floors or carrying in groceries? |
| 105 | PFB3 | Does your health now limit you in putting a trash bag outside? |
| 106 | PFB43 | Does your health now limit you in taking care of your personal needs (dress, comb hair, toilet, eat, bathe)? |
| 107 | PFB44 | Does your health now limit you in doing moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf? |
| 108 | PFB48 | Does your health now limit you in taking a shower? |
| 109 | PFB49 | Does your health now limit you in going for a short walk (less than 15 minutes)? |
| 110 | PFB5r1 | Does your health now limit you in hiking a couple of miles (3 km) on uneven surfaces, including hills? |
| 111 | PFB51 | Does your health now limit you in participating in active sports such as swimming, tennis, or basketball? |
| 112 | PFB54 | Does your health now limit you in going OUTSIDE the home, for example to shop or visit a doctor’s office? |
| 113 | PFB7 | Does your health now limit you in doing strenuous activities such as backpacking, skiing, playing tennis, bicycling or jogging? |
| 114 | PFC10 | Does your health now limit you in climbing several flights of stairs? |
| 115 | PFC12 | Does your health now limit you in doing two hours of physical labor? |
| 116 | PFC35 | Does your health now limit you in doing eight hours of physical labor? |
| 117 | PFC36r1 | Does your health now limit you in walking more than a mile (1.6 km)? |
| 118 | PFC37 | Does your health now limit you in climbing one flight of stairs? |
| 119 | PFC54 | Does your health now limit you in getting in and out of the bathtub? |
| 120 | PFC56 | Does your health now limit you in walking about the house? |
| 121 | PFB50 | How much difficulty do you have doing your daily physical activities, because of your health?*** |
Note:
Response options for questions 1–98 are 1=Unable to do; 2=With much difficulty; 3=With some difficulty; 4=With a little difficulty; 5=Without any difficulty.
Response options for questions 99–123 are 1=Cannot do; 2=Quite a lot; 3=Somewhat; 4=Very little; 5=Not at all
Response options for question 121 are 1=Can’t do because of health, 2=A lot of difficulty; 3=Some difficulty; 4=A little bit of difficulty; 5=No difficulty at all
Appendix III.
PROMIS v1.1 Pain Interference item bank
| Item | ID | Question |
|---|---|---|
| 1 | PAININ1 | In the past 7 days, how difficult was it for you to take in new information because of pain?* |
| 2 | PAININ3 | In the past 7 days, how much did pain interfere with your enjoyment of life?* |
| 3 | PAININ5 | In the past 7 days, how much did pain interfere with your ability to participate in leisure activities?* |
| 4 | PAININ6 | In the past 7 days, how much did pain interfere with your close personal relationships?* |
| 5 | PAININ8 | In the past 7 days, how much did pain interfere with your ability to concentrate?* |
| 6 | PAININ9 | In the past 7 days, how much did pain interfere with your day to day activities?* |
| 7 | PAININ10 | In the past 7 days, how much did pain interfere with your enjoyment of recreational activities?* |
| 8 | PAININ11 | In the past 7 days, how often did you feel emotionally tense because of your pain?* |
| 9 | PAININ12 | In the past 7 days, how much did pain interfere with the things you usually do for fun?* |
| 10 | PAININ13 | In the past 7 days, how much did pain interfere with your family life?* |
| 11 | PAININ17 | In the past 7 days, how much did pain interfere with your relationships with other people?* |
| 12 | PAININ18 | In the past 7 days, how much did pain interfere with your ability to work (included work at home)?* |
| 13 | PAININ19 | In the past 7 days, how much did pain make it difficult to fall asleep?* |
| 14 | PAININ20 | In the past 7 days, how much did pain feel like a burden to you?* |
| 15 | PAININ22 | In the past 7 days, how much did pain interfere with work around the home?* |
| 16 | PAININ31 | In the past 7 days, how much did pain interfere with your ability to participate in social activities? * |
| 17 | PAININ34 | In the past 7 days, how much did pain interfere with your household chores? * |
| 18 | PAININ35 | In the past 7 days, how much did pain interfere with your ability to make trips from home that kept you gone for more than 2 hours? * |
| 19 | PAININ36 | In the past 7 days, how much did pain interfere with your enjoyment of social activities? * |
| 20 | PAININ48 | In the past 7 days, how much did pain interfere with your ability to do household chores? * |
| 21 | PAININ49 | In the past 7 days, how much did pain interfere with your ability to remember things? * |
| 22 | PAININ56 | In the past 7 days, how irritable did you feel because of pain? * |
| 23 | PAININ14 | In the past 7 days, how much did pain interfere with doing your tasks away from home (e.g., getting groceries, running errands)? * |
| 24 | PAININ16 | In the past 7 days, how often did pain make you feel depressed?** |
| 25 | PAININ24 | In the past 7 days, how often was pain distressing to you? ** |
| 26 | PAININ26 | In the past 7 days, how often did pain keep you from socializing with others?** |
| 27 | PAININ29 | In the past 7 days, how often was your pain so severe you could think of nothing else? ** |
| 28 | PAININ32 | In the past 7 days, how often did pain make you feel discouraged?** |
| 29 | PAININ37 | In the past 7 days, how often did pain make you feel anxious?** |
| 30 | PAININ38 | In the past 7 days, how often did you avoid social activities because it might make you hurt more?** |
| 31 | PAININ40 | In the past 7 days, how often did pain prevent you from walking more than 1 mile? |
| 32 | PAININ42 | In the past 7 days, how often did pain prevent you from standing for more than one hour?** |
| 33 | PAININ46 | In the past 7 days, how often did pain make it difficult for you to plan social activities?** |
| 34 | PAININ47 | In the past 7 days, how often did pain prevent you from standing for more than 30 minutes?** |
| 35 | PAININ50 | In the past 7 days, how often did pain prevent you from sitting for more than 30 minutes?** |
| 36 | PAININ51 | In the past 7 days, how often did pain prevent you from sitting for more than 10 minutes?** |
| 37 | PAININ52 | In the past 7 days, how often was it hard to plan social activities because you didn’t know if you would be in pain?** |
| 38 | PAININ53 | In the past 7 days, how often did pain restrict your social life to your home?** |
| 39 | PAININ55 | In the past 7 days, how often did pain prevent you from sitting for more than one hour?** |
| 40 | PAININ54 | In the past 7 days, how often did pain keep you from getting into a standing position?** |
Note:
Response options for questions 1–23 are 1=Not at all; 2 = A little bit; 3 = Somewhat; 4 = Quite a bit; 5 = Very Much
Response options for questions 24–40 are 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; 5 = Always
Appendix IV.
qDASH item bank.
| Item | Question |
|---|---|
| Please rate your ability to do the following activities in the last week. | |
| 1 | Open a tight or new jar.* |
| 2 | Do heavy household chores (e.g., wash walls, floors).* |
| 3 | Carry a shopping bag or briefcase.* |
| 4 | Wash your back.* |
| 5 | Use a knife to cut food.* |
| 6 | Recreational activities in which you take some force or impact through your arm, shoulder or hand (e.g., golf, hammering, tennis, etc.).* |
| 7 | During the past week, to what extent has your arm, shoulder or hand problem interfered with your normal social activities with family, friends, neighbors or groups?** |
| 8 | During the past week, were you limited in your work or other regular daily activities as a result of your arm, shoulder or hand problem?*** |
| Please rate the severity of the following symptoms in the last week. | |
| 9 | Arm, shoulder or hand pain.**** |
| 10 | Tingling (pins and needles) in your arm, shoulder or hand.**** |
| 11 | During the past week, how much difficulty have you had sleeping because of the pain in your arm, shoulder or hand?* |
Note:
Response options for questions 1–6, 11 are 1 = No difficulty; 2 = Mild difficulty; 3 = Moderate difficulty; 4 = Severe difficulty; 5 = So much difficulty that I can’t sleep
Response options for question 7 are 1 = Not at all; 2 = Slightly; 3 = Moderately; 4 = Quite a bit; 5 = Extremely
Response options for question 8 are 1 = Not limited at all; 2 = Slightly limited; 3 = Moderately limited; 4 = Very limited; 5 = Unable
Response options for questions 9–10 are 1 = None; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Extreme
Footnotes
Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
REFERENCES
- 1.Deutsch L, Smith L, Gage B, Kelleher C, Garfinkel D, editors. Patient-reported outcomes in performance measurement: Commissioned paper on pro-based performance measures for healthcare accountable entities. Washington, DC: National Quality Forum; 2012. [Google Scholar]
- 2.Cella D, Yount S, Rothrock N, et al. The patient-reported outcomes measurement information system (promis): Progress of an nih roadmap cooperative group during its first two years. Medical care. 2007;45(5 Suppl 1):S3. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Beckmann JT, Hung M, Voss MW, Crum AB, Bounsanga J, Tyser AR. Evaluation of the patient-reported outcomes measurement information system upper extremity computer adaptive test. The Journal of hand surgery. 2016;41(7):739–744 e734. [DOI] [PubMed] [Google Scholar]
- 4.Beleckas CM, Padovano A, Guattery J, Chamberlain AM, Keener JD, Calfee RP. Performance of patient-reported outcomes measurement information system (promis) upper extremity (ue) versus physical function (pf) computer adaptive tests (cats) in upper extremity clinics. J Hand Surg Am. 2017;42(11):867–874. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Wright A, Hannon J, Hegedus EJ, Kavchak AE. Clinimetrics corner: A closer look at the minimal clinically important difference (mcid). J Man Manip Ther. 2012;20(3):160–166. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10(4):407–415. [DOI] [PubMed] [Google Scholar]
- 7.McGlothlin AE, Lewis RJ. Minimal clinically important difference: Defining what really matters to patients. JAMA. 2014;312(13):1342–1343. [DOI] [PubMed] [Google Scholar]
- 8.Bernstein DN, Houck JR, Mahmood B, Hammert WC. Minimal clinically important differences for promis physical function, upper extremity, and pain interference in carpal tunnel release using region- and condition-specific prom tools. J Hand Surg Am. 2019;44(8):635–640. [DOI] [PubMed] [Google Scholar]
- 9.Kazmers NH, Hung M, Bounsanga J, Voss MW, Howenstein A, Tyser AR. Minimal clinically important difference after carpal tunnel release using the promis platform. J Hand Surg Am. 2019; [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Sandvall B, Okoroafor UC, Gerull W, Guattery J, Calfee RP. Minimal clinically important difference for promis physical function in patients with distal radius fractures. J Hand Surg Am. 2019;44(6):454–459 e451. [DOI] [PubMed] [Google Scholar]
- 11.Beaton DE, Wright JG, Katz JN. Development of the quickdash: Comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005;87(5):1038–1046. [DOI] [PubMed] [Google Scholar]
- 12.Gershon RC, Rothrock N, Hanrahan R, Bass M, Cella D. The use of promis and assessment center to deliver patient-reported outcome measures in clinical research. Journal of applied measurement. 2010;11(3):304–314. [PMC free article] [PubMed] [Google Scholar]
- 13.Rose M, Bjorner JB, Gandek B, Bruce B, Fries JF, Ware JE. The promis physical function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. J Clin Epidemiol. 2014;67(5):516–526. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Cook CE. Clinimetrics corner: The minimal clinically important change score (mcid): A necessary pretense. J Man Manip Ther. 2008;16(4):E82–83. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61(2):102–109. [DOI] [PubMed] [Google Scholar]
- 16.Mukaka MM. Statistics corner: A guide to appropriate use of correlation coefficient in medical research. Malawi Med J. 2012;24(3):69–71. [PMC free article] [PubMed] [Google Scholar]
- 17.Hinkle D, Wiersma W, Jurs S. Applied statistics for the behavioral sciences. Boston, MA: Houghton Mifflin; 2003. [Google Scholar]
- 18.Hossain FS, Konan S, Patel S, Rodriguez-Merchan EC, Haddad FS. The assessment of outcome after total knee arthroplasty: Are we there yet? The bone & joint journal. 2015;97-b(1):3–9. [DOI] [PubMed] [Google Scholar]
- 19.Cella D, Riley W, Stone A, et al. The patient-reported outcomes measurement information system (promis) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol. 2010;63(11):1179–1194. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Healthmeasures - interpret scores: Promis. Northwestern University; 2019. [2/22/2019]; Available from: http://www.healthmeasures.net/score-and-interpret/interpret-scores/promis.
- 21.Thissen D, Liu Y, Magnus B, et al. Estimating minimally important difference (mid) in promis pediatric measures using the scale-judgment method. Qual Life Res. 2016;25(1):13–23. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Yost KJ, Eton DT, Garcia SF, Cella D. Minimally important differences were estimated for six patient-reported outcomes measurement information system-cancer scales in advanced-stage cancer patients. J Clin Epidemiol. 2011;64(5):507–516. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Ho B, Houck JR, Flemister AS, et al. Preoperative promis scores predict postoperative success in foot and ankle patients. Foot Ankle Int. 2016;37(9):911–918. [DOI] [PubMed] [Google Scholar]
- 24.Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-rated outcomes instruments. J Hand Surg Am. 2013;38(4):641–649. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25.Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. Minimal clinically important difference of the disabilities of the arm, shoulder and hand outcome measure (dash) and its shortened version (quickdash). J Orthop Sports Phys Ther. 2014;44(1):30–39. [DOI] [PubMed] [Google Scholar]
- 26.Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the arm, shoulder, and hand questionnaire (quickdash) and numeric pain rating scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009;18(6):920–926. [DOI] [PubMed] [Google Scholar]
- 27.Polson K, Reid D, McNair PJ, Larmer P. Responsiveness, minimal importance difference and minimal detectable change scores of the shortened disability arm shoulder hand (quickdash) questionnaire. Man Ther. 2010;15(4):404–407. [DOI] [PubMed] [Google Scholar]
- 28.Eton DT, Cella D, Yost KJ, et al. A combination of distribution- and anchor-based approaches determined minimally important differences (mids) for four endpoints in a breast cancer scale. J Clin Epidemiol. 2004;57(9):898–910. [DOI] [PubMed] [Google Scholar]
- 29.Amtmann D, Kim J, Chung H, Askew RL, Park R, Cook KF. Minimally important differences for patient reported outcomes measurement information system pain interference for individuals with back pain. J Pain Res. 2016;9(251–255. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 30.Chen CX, Kroenke K, Stump TE, et al. Estimating minimally important differences for the promis pain interference scales: Results from 3 randomized clinical trials. Pain. 2017; [DOI] [PMC free article] [PubMed] [Google Scholar]
- 31.Beaton DE, van Eerd D, Smith P, et al. Minimal change is sensitive, less specific to recovery: A diagnostic testing approach to interpretability. J Clin Epidemiol. 2011;64(5):487–496. [DOI] [PubMed] [Google Scholar]
- 32.Terwee CB, Roorda LD, Dekker J, et al. Mind the mic: Large variation among populations and methods. J Clin Epidemiol. 2010;63(5):524–534. [DOI] [PubMed] [Google Scholar]
- 33.Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and functional status in low back pain: Towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008;33(1):90–94. [DOI] [PubMed] [Google Scholar]