scholarly journals Performance of PROMIS Global-10 Compared With Legacy Instruments for Rotator Cuff Disease

2018 ◽  
Vol 47 (1) ◽  
pp. 181-188 ◽  
Author(s):  
Allen D. Nicholson ◽  
Hafiz F. Kassam ◽  
Steven D. Pan ◽  
Jacob E. Berman ◽  
Theodore A. Blaine ◽  
...  

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 was recently developed to assess physical and mental health and provide an estimated EuroQol-5 Dimension (EQ-5D) score. This instrument needs to be validated for specific patient cohorts such as those with rotator cuff pathology. Hypothesis: There is moderate to high correlation between the PROMIS Global-10 and legacy patient-reported outcome measures; PROMIS Global-10 will not show ceiling effects; and estimated EQ-5D scores will show good correlation and low variance with actual EQ-5D scores. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: A total of 323 patients with rotator cuff disease were prospectively enrolled before treatment. Each patient completed the PROMIS Global-10, EQ-5D, American Shoulder and Elbow Surgeons (ASES) shoulder assessment form, and Single Assessment Numeric Evaluation (SANE), and those with known rotator cuff tears completed the Western Ontario Rotator Cuff Index (WORC). Spearman correlations were calculated. Bland-Altman agreement tests were conducted between estimated EQ-5D scores from the PROMIS and actual EQ-5D scores. Ceiling and floor effects were assessed, defined as ≥15% respondents with highest or lowest possible score. Results: Correlation between the PROMIS Global-10 and EQ-5D was excellent (0.70, P < .0001). Correlation of the PROMIS physical scores was excellent-good with the ASES (0.62, P < .0001), good with the WORC (0.47, P < .0001), and good with the SANE (0.41, P < .0005). Correlation between the PROMIS mental scores was poor with the ASES (0.34, P < .0001), the WORC (0.32, P = .0016), and the SANE (0.24, P < .0001). No floor or ceiling effects were found. Agreement analysis showed substantial variance in individual scores, despite the overall similarity in mean scores between the estimated and actual EQ-5D scores, indicating poor agreement. Bland-Altman 95% limits of agreement for estimated EQ-5D scores ranged from 34% below to 31% above actual EQ-5D scores. Conclusion: Physical function scores of the PROMIS Global-10 show high correlation with legacy patient-reported outcome instruments, suggesting that it is a reliable tool for outcome assessment in a population with rotator cuff pathology. The large variability in 95% limit of agreement suggested that the estimated EQ-5D scores from the PROMIS Global-10 cannot replace traditional EQ-5D scores.

2020 ◽  
pp. 175857322094702
Author(s):  
Eric Gibson ◽  
Justin LeBlanc ◽  
Marlis T Sabo

Background Surgery for rotator cuff syndrome does not always produce symptom improvement. Biological factors may explain some symptoms, but mood disorder symptoms may also contribute. The purpose of this study is to examine the interaction between disease severity, prevalence of mood disorder diagnoses, and current mood disorder symptoms in preoperative rotator cuff patients. Methods A prospective cohort of patients aged 35–75 years with unilateral rotator cuff disease awaiting surgery participated. Demographics, psychiatric history, the Hospital Anxiety & Depression Scale, and the Western Ontario Rotator Cuff index were collected. Descriptive and univariate statistical testing was performed. Results Of 140 participants (75M:65W) aged 55 ± 8 years, 34 reported a prior diagnosis of a mood disorder. There was a moderate positive relationship between disease severity and current depression and anxiety scores. Women were more likely to carry a diagnosis of a mood disorder, but there were no differences in current symptom levels between genders. No differences were found in patient-reported outcome measure scores between patients with and without a mood disorder diagnosis. Discussion Current mood disorder symptoms were associated with greater disease severity, whereas the presence of a past mood disorder diagnosis was not. Awareness of this relationship may reduce bias about past mood disorder diagnoses during decision-making.


2020 ◽  
Vol 8 (4) ◽  
pp. 232596712091554 ◽  
Author(s):  
Christina J. Hajewski ◽  
Jacqueline E. Baron ◽  
Natalie A. Glass ◽  
Kyle R. Duchman ◽  
Matthew Bollier ◽  
...  

Background: The Patient-Reported Outcome Measurement Information System (PROMIS) was developed to improve patient-reported outcome measures (PROMs) and administration through a computer adaptive test (CAT). The PROMIS physical function-CAT (PF-CAT) has not been investigated in patients with patellofemoral instability (PFI). Purpose/Hypothesis: The purpose of this study was to evaluate the construct validity of the PROMIS PF-CAT with previously validated tools for measuring PROMs in patients with a diagnosis of PFI. We hypothesized that the PF-CAT will have the strongest correlations with other PROMs that evaluated PF as well as moderate correlations with PROMs that measured other health domains. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Patients enrolled in this study who underwent operative intervention for PFI completed the following evaluations preoperatively: PROMIS PF-CAT, 36-Item Short Form Health Survey (SF-36), Knee injury and Osteoarthritis Outcome Score (KOOS), EuroQol-5 dimensions (EQ-5D), and Kujala Anterior Knee Pain Scale (AKPS). Correlation coefficients and the percentage of patients achieving the highest and lowest possible outcome score of each instrument were calculated to assess floor and ceiling effects. Statistical significance was defined as P < .05. Results: In total, 91 participants (63.7% females; mean age, 20.1 ± 7.2 years) completed the questionnaires. PF-CAT had the lowest number of questions (4.3 ± 1.1). The strongest correlations were between the PF-CAT and SF-36 PF subscale ( r = 0.78; P < .01), AKPS ( r = 0.68; P < .01), and KOOS Activities of Daily Living subscale ( r = 0.68; P < .01). Correlation was moderate between the PF-CAT and the KOOS subscales of Sports/Recreation ( r = 0.58; P < .01), Quality of Life ( r = 0.53; P < .01), and Symptoms ( r = 0.47; P < .01). The PROMIS PF-CAT demonstrated no floor or ceiling effects. Conclusion: In patients with PFI, construct validity of the PROMIS PF-CAT was supported by strong correlations demonstrated between the PF-CAT and PROMs evaluating PF and moderate correlations with those assessing other health domains. Our results demonstrated a low respondent burden and no floor or ceiling effects associated with the PROMIS PF-CAT. The PROMIS PF-CAT may be considered a beneficial alternative to previously established PF PROMs for preoperative evaluation of patients with PFI.


2011 ◽  
Vol 38 (8) ◽  
pp. 1759-1764 ◽  
Author(s):  
JAMES FRIES ◽  
MATTHIAS ROSE ◽  
ESWAR KRISHNAN

Objective.Use of item response theory (IRT) and, subsequently, computerized adaptive testing (CAT), under the umbrella of the NIH-PROMIS initiative (National Institutes of Health – Patient-Reported Outcomes Measurement Information System), to bring strong new assets to the development of more sensitive, more widely applicable, and more efficiently administered patient-reported outcome (PRO) instruments. We present data on current progress in 3 crucial areas: floor and ceiling effects, responsiveness to change, and interactive computer-based administration over the Internet.Methods.We examined nearly 1000 patients with rheumatoid arthritis and related diseases in a series of studies including a one-year longitudinal examination of detection of change; compared responsiveness of the Legacy SF-36 and HAQ-DI instruments with IRT-based instruments; performed a randomized head-to-head trial of 4 modes of item administration; and simulated the effect of lack of floor and ceiling items upon statistical power and sample sizes.Results.IRT-based PROMIS instruments are more sensitive to change, resulting in the potential to reduce sample size requirements substantially by up to a factor of 4. The modes of administration tested did not differ from each other in any instance by more than one-tenth of a standard deviation. Floor and ceiling effects greatly reduce the number of available subjects, particularly at the ceiling.Conclusion.Failure to adequately address floor and ceiling effects, which determine the range of an instrument, can result in suboptimal assessment of many patients. Improved items, improved instruments, and computer-based administration improve PRO assessment and represent a fundamental advance in clinical outcomes research.


2021 ◽  
Vol 9 (10_suppl5) ◽  
pp. 2325967121S0026
Author(s):  
Amar Vadhera ◽  
Alexander Beletsky ◽  
Harsh Singh ◽  
Jorge Chahla ◽  
Brian Cole ◽  
...  

Objectives: To examine the preoperative and postoperative performance of PROMIS Upper Extremity 2.0 across various orthopedic procedures for the upper extremity. Secondarily, to define susceptibility to pre- and post-operative floor and ceiling effects. Methods: Retrospective analysis of prospectively collected patient-reported outcome (PRO) data was conducted utilizing an electronic outcome registry for procedures between May 2017 and August 2018. Current procedural terminology (CPT) codes were utilized to examine cohorts for various upper extremity orthopedic procedures including Bankart repair and arthroscopic rotator cuff repair (ARCR). Shapiro-Wilks normality testing was used to assess score distributions for normalcy; given non-normal score distributions, Spearman correlation coefficients were calculated for preoperative patient-reported outcome (PRO) scores. Absolute floor and ceiling effects were calculated for each time point based on CPT code. Results: A total of 488 patients were included across Bankart repair (n=109, 29.3 + 12.5 years) and ARCR (n=379, 57.5 + 9.5 years) cohorts. In the Bankart repair cohort, PROMIS PI demonstrate strong correlations with ASES (r=-0.63), Constant (r=-0.75), PROMIS UE (r=-0.75), and the VR6D (r=-0.61). PROMIS Depression (r=0.23 vs. 0.17), SF12 MCS (r=0.34 vs. 0.11), and VR12 MCS (r=0.44 vs. 0.15) exhibited poor correlations with PROMIS PI and UE, respectively. In the ARCR cohort, PROMIS PI scores demonstrated a good correlation with PROMIS UE (r=0.61). Constant (r=0.58 vs. 0.67), VR12 PCS (r=0.58 vs. 0.47), and VR6D (r=0.67 vs. 0.53) exhibited good correlations with both PROMIS PI and UE measures, respectively. No significant absolute floor or ceiling effects were observed for the PROMIS instruments except PROMIS Depression; an absolute floor was noted for both Bankart (n=12, 30%) and ARCR (n=38, 14.7%) groups. Conclusions: PROMIS PI and UE instruments perform comparably to legacy outcome instruments in patients receiving Bankart repair, as well as those receiving ARCR. Furthermore, in both populations, the PROMIS Depression instrument exhibits absolute floor effects, whereas PROMIS PI and UE instruments fail to demonstrate any absolute floor or ceiling effects.


2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0038
Author(s):  
Purnachandra Tejaswi ◽  
Ivan H. Wong

Objectives: To determine the healing rate of rotator cuff reconstruction with an acellular human dermal allograft compared with the current gold standard arthroscopic maximal rotator cuff repair of large, chronic tears of the rotator cuff. Methods: Thirty patients with a two-tendon chronic retracted rotator cuff tear were enrolled in the study and were randomly allocated (15) to each group. All the patients were evaluated for structural integrity of repair using a 1.5 T MRI at an average of 15 months after surgery. Rotator cuff arthropathy (RCA) and acromio-humeral distance (AHD) were graded using X-rays. WORC, DASH, MARX scores, range of motion (ROM) of shoulder were also analyzed. Results: The re-tear rate in reconstruction group was 13% (2 of 15 patients) compared to 67%(10/15) in repair group (p=0.008). Progression of RCA was seen in 7.14%(1/14) and 35.71%(4/14) of patients in reconstruction and repair group; respectively (p=0.006). The change in AHD (preop-postop) was significantly higher in repair (reduced by 2.27 mm) than the reconstruction group (increased by 0.1 mm) (P=0.006). Both groups had significant improvements in patient reported outcome scores. Reconstruction group had statistically significant better forward flexion (p= 0.01) and scapular plane abduction (p=0.03) compared to repair. Conclusion: Rotator cuff reconstruction with a dermal allograft demonstrated favourable structural healing rates and improved range of motion compared to maximal repair in the short term. Moreover, those in the maximal repair group were more likely to develop RCA compared to reconstruction.


2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0033
Author(s):  
Jian Xu ◽  
Anjaneyulu Purnachandra Tejasw Ravipati ◽  
John-Paul King ◽  
Catherine Coady ◽  
Ivan Wong

Objectives: To determine healing rate of rotator cuff reconstruction with an acellular human dermal allograft compared with the gold standard arthroscopic maximal rotator cuff repair of large, chronic tears of the rotator cuff. Methods: Thirty patients with a two-tendon chronic retracted rotator cuff tear were enrolled in the study and were randomly allocated (15) to each group. All the patients were evaluated for structural integrity of repair using a 1.5T MRI at an average of 15 months after surgery. Rotator cuff arthropathy (RCA) and acromio-humeral distance (AHD) were graded using X-rays. Western Ontario Rotator Cuff (WORC), Disabilities of the Arm, Shoulder, and Hand (DASH), Marx Activity Rating Scale (MARX) scores, range of motion (ROM) of shoulder were analyzed. Results: The re-tear rate in the reconstruction group was 13% (2 of 15 patients) compared to 73% (11/15) in the repair group (p=0.008). Progression of RCA was seen in 7% (1/15) and 35.71% (5/15) of patients in the reconstruction and repair group, respectively (p=0.006). The change in AHD (preop-postop) was significantly higher in the repair (reduced by 2.27 mm) than the reconstruction group (increased by 0.1 mm) (P=0.006). Both groups had significant improvements in patient reported outcome scores. The reconstruction group had statistically significant better forward flexion (p= 0.01) and scapular plane abduction (p=0.03) compared to the repair group. Conclusions: Rotator cuff reconstruction with a dermal allograft demonstrated favorable structural healing rates and improved range of motion compared to maximal repair in the short term. Moreover, the maximal repair group were more likely to develop RCA than reconstruction. [Table: see text]


2021 ◽  
Vol 9 (2) ◽  
pp. 232596712098426
Author(s):  
Stefan Greiner ◽  
Max Kaeaeb ◽  
Andreas Voss ◽  
Robert Lawton ◽  
Pushkar Bhide ◽  
...  

Background: Superior capsular reconstruction (SCR) represents a new option for the treatment of irreparable rotator cuff tears. Purpose/Hypothesis: This study aimed to evaluate the clinical and radiologic outcomes of SCR and compare them with the outcomes of partial repair (PR) of the infraspinatus tendon. The hypothesis was that there would be no significant differences between the clinical and radiologic outcome parameters of SCR and PR after a minimum follow-up of 2 years. Study Design: Cohort study; Level of evidence, 3. Methods: Of 21 patients who underwent SCR, 20 patients were matched in a 1:1 ratio according to sex, age, and tear configuration with 20 of 60 patients who had undergone PR; all patients were prospectively evaluated for a minimum follow-up of 2 years. The investigated outcome measures included the Constant score; Western Ontario Rotator Cuff (WORC) index; Disabilities of the Arm, Shoulder and Hand (DASH) score; and radiologic analysis of acromiohumeral distance (AHD) and humeral head centralization (HHC). Results: There were no differences in the demographic data between the SCR and PR groups. The mean age of both groups was 62.3 years (range, 47-79 years), the mean tear configuration was Bateman 3.0 and Patte 2.8, and the mean follow-up period was 29.4 months (range, 24-53 months). At final follow-up, no significant differences were seen between the SCR and PR groups with regard to Constant score (77.1 vs 82.7), age- and sex-adapted Constant score (85.5% vs 91.4%), DASH score (15.6 vs 7.8), or WORC index (81.1 vs 90.4). No significant differences in the AHD or HHC were seen between the groups. The reoperation rate was 4.8% (1/21) in the SCR cohort and 15% (9/60) in the PR cohort. Conclusion: Both SCR and PR resulted in significant improvements in patient-reported outcomes at 2-year follow-up, with no significant differences in clinical outcomes between the 2 techniques. Further follow-up is needed to determine whether there are long-term differences in HHC and development of cuff tear arthropathy. Further investigations should also focus on the cost-effectiveness of the respective procedures.


2021 ◽  
pp. 155633162199312
Author(s):  
Chintanpreet Singh ◽  
Patrick H. Lam ◽  
George A. C. Murrell

Background: The surgical treatment of rotator cuff tears traditionally involves rotator cuff repair (RCR) with concomitant acromioplasty. However, there is some doubt as to whether acromioplasty is of value to this procedure. Questions/Purpose: We sought to evaluate whether RCR with acromioplasty provided better outcomes than RCR without acromioplasty in a cohort of more than 1000 patients. Methods: This retrospective cohort study involved 1320 patients with rotator cuff tears who subsequently received a primary arthroscopic RCR, with acromioplasty (n = 160) or without acromioplasty (n = 1160), performed by a single surgeon. Acromioplasty was performed if there was significant mechanical impingement on the rotator cuff. To assess outcomes, all patients completed a standardized, modified L’Insalata questionnaire in which they reported the level and severity of pain at rest and during activities. An examiner assessed shoulder strength and range of motion before and 1 week, 6 weeks, 12 weeks, and 6 months after surgery. Results: Patients who had RCR with concurrent acromioplasty had a greater level of pain and more frequent pain 1 week after surgery. However, at 6 months there were no differences between patients who underwent RCR with or without acromioplasty in any patient-reported outcome (level of pain with overhead activity, at rest and during sleep; frequency of pain with activity, sleep and extreme pain, difficulty of activity overhead and behind back, level of shoulder stiffness; and overall shoulder satisfaction). The postoperative re-tear rate in both groups was 13%. Conclusion: This study showed no additional benefit to acromioplasty in patients undergoing RCR.


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