scholarly journals PROMIS and FAAM Minimal Clinically Important Differences in Foot and Ankle Orthopedics

2018 ◽  
Vol 40 (1) ◽  
pp. 65-73 ◽  
Author(s):  
Man Hung ◽  
Judith F. Baumhauer ◽  
Frank W. Licari ◽  
Maren W. Voss ◽  
Jerry Bounsanga ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Minimum Clinically Important Difference ◽  
Measurement Information ◽  
Diagnostic Study ◽  
Foot And Ankle ◽  
Meaningful Change ◽  
Level Of Evidence ◽  
Patient Reported ◽  
Level I

Background: Establishing score points that reflect meaningful change from the patient perspective is important for interpreting patient-reported outcomes. This study estimated the minimum clinically important difference (MCID) values of 2 Patient-Reported Outcomes Measurement Information System (PROMIS) instruments and the Foot and Ankle Ability Measure (FAAM) Sports subscale within a foot and ankle orthopedic population. Methods: Patients seen for foot and ankle conditions at an orthopedic clinic were administered the PROMIS Physical Function (PF) v1.2, the PROMIS Pain Interference (PI) v1.1, and the FAAM Sports at baseline and all follow-up visits. MCID estimation was conducted using anchor-based and distribution-based methods. Results: A total of 3069 patients, mean age of 51 years (range = 18-94), were included. The MCIDs for the PROMIS PF ranged from approximately 3 to 30 points (median = 11.3) depending on the methods being used. The MCIDs ranged from 3 to 25 points (median = 8.9) for the PROMIS PI, and from 9 to 77 points (median = 32.5) for the FAAM Sports. Conclusions: This study established a range of MCIDs in the PROMIS PF, PROMIS PI, and FAAM Sports indicating meaningful change in patient condition. MCID values were consistent across follow-up periods, but were different across methods. Values below the 25th percentile of MCIDs may be useful for low-risk clinical decisions. Midrange values (eg, near the median) should be used for high stakes decisions in clinical practice (ie, surgery referrals). The MCID values within the interquartile range should be utilized for most decision making. Level of Evidence: Level I, diagnostic study, testing of previously developed diagnostic measure on consecutive patients with reference standard applied.

scholarly journals Responsiveness of the PROMIS and FAAM Instruments in Foot and Ankle Orthopedic Population

2018 ◽  
Vol 40 (1) ◽  
pp. 56-64 ◽  
Author(s):  
Man Hung ◽  
Judith F. Baumhauer ◽  
Frank W. Licari ◽  
Jerry Bounsanga ◽  
Maren W. Voss ◽  
...  
Keyword(s):  
T Test ◽  
Measurement Information ◽  
Foot And Ankle ◽  
Level Of Evidence ◽  
Paired Samples ◽  
Level Ii ◽  
Patient Reported ◽  
Prospective Comparative Study ◽  
Ability Measure

Background: Investigating the responsiveness of an instrument is important in order to provide meaningful interpretation of clinical outcomes. This study examined the responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), the PROMIS Pain Interference (PI), and the Foot and Ankle Ability Measure (FAAM) Sports subscale in an orthopedic sample with foot and ankle ailments. Methods: Patients presenting to an orthopedic foot and ankle clinic during the years 2014–2017 responded to the PROMIS and FAAM instruments prior to their clinical appointments. The responsiveness of the PROMIS PF v1.2, PROMIS PI v1.1, and FAAM Sports were assessed using paired samples t test, effect size (ES), and standardized response mean (SRM) at 4 different follow-up points. A total of 785 patients with an average age of 52 years (SD = 17) were included. Results: The PROMIS PF had ESs of 0.95 to 1.22 across the 4 time points (3, >3, 6, and <6 months) and SRMs of 1.04 to 1.43. The PROMIS PI had ESs of 1.04 to 1.63 and SRMs of 1.17 to 1.23. For the FAAM Sports, the ESs were 1.25 to 1.31 and SRMs were 1.07 to 1.20. The ability to detect changes via paired samples t test provided mixed results. But in general, the patients with improvement had statistically significant improved scores, and the worsening patients had statistically significant worse scores. Conclusion: The PROMIS PF, PROMIS PI, and FAAM Sports were sensitive and responsive to changes in patient-reported health. Level of Evidence: Level II, prospective comparative study.

Comparison Between Polyvinyl Alcohol Implant and Cheilectomy With Moberg Osteotomy for Hallux Rigidus

2020 ◽  
Vol 41 (9) ◽  
pp. 1031-1040 ◽  
Author(s):  
Bopha Chrea ◽  
Stephanie K. Eble ◽  
Jonathan Day ◽  
Scott J. Ellis ◽  
Mark C. Drakos ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Polyvinyl Alcohol ◽  
Pain Intensity ◽  
Physical Function ◽  
Patient Reported Outcomes ◽  
Hallux Rigidus ◽  
Measurement Information ◽  
Level Of Evidence ◽  
Patient Reported

Background: In 2016, the US Food and Drug Administration (FDA) approved the use of a polyvinyl alcohol (PVA) hydrogel implant for the surgical management of hallux rigidus. Though recent studies have evaluated the safety and efficacy of the implant, no study has compared outcomes following PVA implantation with those following traditional joint-preserving procedures for hallux rigidus, such as cheilectomy with Moberg osteotomy. The purpose of this study was to compare clinical and patient-reported outcomes for patients undergoing cheilectomy and Moberg osteotomy, with or without PVA implant, at a single multisurgeon academic center. Our hypothesis was that the addition of the PVA implant would result in superior clinical and patient-reported outcomes. Methods: In total, 166 patients were identified who underwent cheilectomy and Moberg osteotomy with (PVACM; n = 72) or without (CM; n = 94) a PVA implant between January 2016 and December 2018 by 1 of 8 foot and ankle fellowship-trained orthopedic surgeons at our institution. Of these patients, 60 PVACM and 73 CM patients had both baseline and minimum 1-year postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores. The average time to survey follow-up was 14.5 months for PVACM patients and 15.6 months for CM patients. Retrospective chart review was performed to assess the incidence of postoperative complications and reoperations, with an average clinical follow-up of 27.7 (range, 16.0-46.4) months for PVACM patients and 36.6 (range, 18.6-47.8) months for CM patients. Results: Both PVACM and CM cohorts demonstrated significant improvement in the PROMIS Physical Function, Pain Interference, Pain Intensity, and Global Physical Health domains when comparing preoperative and postoperative scores within each group ( P < .01). When comparing scores between the PVACM and CM cohorts, preoperative scores were similar, while CM patients demonstrated significantly higher postoperative Physical Function (51.8 ± 8.7 vs 48.8 ± 8.0; P = .04) and significantly lower Pain Intensity (39.9 ± 8.3 vs 43.4 ± 8.7; P = .02) scores. The pre- to postoperative change in Physical Function was also significantly greater for CM patients (7.1 ± 8.5 vs 3.6 ± 6.2; P = .011). In the PVACM group, there were 3 revisions (5%), 1 reimplantation, 1 conversion to arthrodesis, and 1 revision to correct hyperdorsiflexion. In the CM group, there was 1 revision (1.4%), a conversion to arthrodesis ( P = .21). Other postoperative complications included persistent pain (7 out of 60 PVACM patients [11.7%] and 8 out of 73 CM patients [11.0%]; P = .90) and infection in 3 PVACM patients (5%) and no CM patients ( P = .05). Conclusion: Though our results generally support the safety and utility of the PVA implant as previously established by the clinical trial, at 1 to 2 years of follow-up, CM without a PVA implant may provide equivalent or better relief compared with a PVACM procedure, while avoiding potential risks associated with the implant. Level of Evidence: Level III, retrospective comparative study.

Patient-Reported Outcomes After Structural Autograft for Large or Cystic Talar Dome Osteochondral Lesions

2020 ◽  
Vol 41 (5) ◽  
pp. 549-555
Author(s):  
Todd Kim ◽  
Andrew Haskell
Keyword(s):  
Patient Reported Outcomes ◽  
Distal Tibia ◽  
Case Series ◽  
Osteochondral Lesions ◽  
Measurement Information ◽  
Talar Dome ◽  
Level Of Evidence ◽  
Structural Bone Graft ◽  
Patient Reported

Background: While smaller talar dome osteochondral lesions (OCLs) are successfully treated with bone marrow stimulation techniques, the optimal treatment for large or cystic OCLs remains controversial. This study tested the hypothesis that transferring structural autograft bone from the distal tibia to the talus for large or cystic OCLs improves pain and function. Methods: Thirty-two patients with large or cystic OCLs underwent structural bone grafting from the ipsilateral distal tibia to the talar dome. Patients were assessed with subjective patient-centered tools and objective clinical outcomes. Average age was 48.6 ± 14.9 years, and average follow-up was 19.5 ± 13.3 months. Average lesion area was 86.2 ± 23.5 mm2, and average depth was 8.4 ± 3.0mm. Results: At final follow-up, improvement compared to preoperative scores was seen in American Orthopaedic Foot & Ankle Society (65.4 ± 21.2 to 86.9 ± 15.0, P < .05), Foot Function Index (48.9 ± 20.8 to 21.1 ± 18.9, P < .05), visual analog scale for pain (4.7 ± 3.0 to 1.4 ± 1.5, P < .05), and Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (40.4 ± 5.4 to 45.5 ± 7.4, P < .05) scores. There was no improvement in PROMIS pain interference (54.7 ± 18.1 to 52.4 ± 7.3, P > .05). Satisfaction with surgery was 8.4 ± 1.3/10, and 96% of patients would have the procedure again. Ninety-four percent of patients returned to work and/or play. One patient had a deep vein thrombosis 6 weeks postoperatively, and 1 patient underwent ankle fusion at 18 months postoperatively. Conclusion: This study demonstrates that structural bone graft harvested from the distal tibia transferred to the talus was a safe and effective treatment for large and cystic OCLs. Outcomes compare favorably to other described techniques for treatment of these injuries. Level of Evidence: Level IV, case series.

scholarly journals Patient-Reported Outcomes and Early Complications After Synthetic Cartilage Device Implantation

2020 ◽  
Vol 5 (3) ◽  
pp. 247301142093069
Author(s):  
William M. Engasser ◽  
J. Chris Coetzee ◽  
Patrick B. Ebeling ◽  
Bryan D. Den Hartog ◽  
Jeffrey D. Seybold ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Case Series ◽  
Retrospective Chart Review ◽  
Hallux Rigidus ◽  
Early Complications ◽  
Level Of Evidence ◽  
Device Implantation ◽  
Patient Reported ◽  
Level I

Background: Previous Level I studies show promising results for the use of a hydrogel synthetic cartilage implant (SCI) for the treatment of hallux rigidus. A recent independent retrospective review has put those results into question, however. The purpose of this article is to report patient-reported outcomes and early complications using this implant so as to add to the paucity of data in the literature regarding this implant. Methods: This was a retrospective chart review of patients undergoing hydrogel synthetic cartilage implant for the treatment of hallux rigidus from July 2017 to November 2018. Data collected included patient demographics, radiographic grading, and outcomes: Veterans Rand 12 Item Health Survey (VR-12), Foot and Ankle Ability Measure (FAAM), visual analog scale (VAS), patient satisfaction, and complications. Fifty-four patients (59 feet) with an average age of 57.6 (range, 39-78) years were analyzed. The average latest follow-up was 18.9 (range, 3-31.3) months. Body mass index was 26.7 (range, 18.7-35.2). None were diabetic and 5 were smokers. Results: The mean outcome improvements were 6.5 points (VR-12 Physical), 17.2 points (FAAM ADL), 27.4 points (FAAM Sport), and 18.4 points (VAS) ( P < .01 for each). Scores were significantly improved from preoperatively to most recent follow-up for FAAM ADL (71.0 vs 88.2 points), FAAM Sports (44.6 vs 72.0 points), and VAS (49.4 vs 31.0) ( P < .01). Overall, 72.5% patients would definitely or probably have the operation again. Ten patients (18.5%) went on to have revision surgery. Of these, 7 patients were revised to an arthrodesis, and 1 metal hemiarthroplasty and 2 implants were removed because of infection. Conclusion: Synthetic cartilage implantation for the treatment of hallux rigidus demonstrated improved pain and outcome scores at short-term follow-up. Reoperation and conversion to fusion rates were comparable to prior studies. Level of Evidence: Level IV, case series.

scholarly journals Comparison of Patient-Reported Outcomes for Major Pathologies of the Forefoot, Midfoot, Hindfoot, and Achilles Using PROMIS

2020 ◽  
Vol 5 (4) ◽  
pp. 247301142095905
Author(s):  
Daniel A. Hu ◽  
Rusheel Nayak ◽  
Elijah O. Ogunkoya ◽  
Milap S. Patel ◽  
Anish R. Kadakia
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Medical Center ◽  
Postoperative Outcomes ◽  
Measurement Information ◽  
Anatomical Location ◽  
Foot And Ankle ◽  
Level Of Evidence ◽  
Patient Reported ◽  
Pain Outcomes

Background: Patient-Reported Outcomes Measurement Information System (PROMIS) is a newly developed patient-reported outcome that has been validated for the general foot and ankle population and has been applied to a variety of specific foot and ankle procedures. However, there is little data regarding clinical outcomes of patients at a more intermediate subgroup level. Thus, our study utilized PROMIS to provide normative data on pathologic conditions of the foot and ankle and assess postoperative outcomes based on anatomical location. Methods: Preoperative and 1-year postoperative PROMIS Physical Function (PF) and Pain Interference (PI) surveys were prospectively collected from a cohort of patients undergoing a foot and ankle procedure at a tertiary medical center. The cohort was split into forefoot (n = 136), midfoot (n = 44), hindfoot (n = 109), and Achilles (n = 62) procedure groups. Paired-t tests were used to compare preoperative versus postoperative outcomes within operative groups, while a 1-way analysis of variance (ANOVA) was used to detect differences in PROMIS scores between anatomic subgroups. Results: Paired t tests indicated that all 4 operative groups had significantly improved PROMIS PF and PI scores preoperatively versus 1 year postoperatively (all P < .001). One-way ANOVA demonstrated that there were no differences in postoperative PROMIS PF and PI scores between anatomic subgroups. A majority of patients achieved the minimal clinically important difference level of improvement in PROMIS PF and PI scores following surgery. Conclusions: All 4 operative groups had improvement in physical function and pain outcomes. Additionally, there were no differences in physical function and pain outcomes between operative groups. Level of Evidence: Level III, retrospective cohort study.

scholarly journals Sex differences in outcomes after arthroscopic bankart repair

2020 ◽  
Vol 6 (1) ◽  
pp. e000965
Author(s):  
Natalie A Lowenstein ◽  
Peter J Ostergaard ◽  
Daniel B Haber ◽  
Kirsten D Garvey ◽  
Elizabeth G Matzkin
Keyword(s):  
Mental Health ◽  
Sex Differences ◽  
Patient Reported Outcomes ◽  
Strength Function ◽  
Bankart Repair ◽  
Level Of Evidence ◽  
Arthroscopic Bankart Repair ◽  
Patient Reported ◽  
Males And Females

ObjectivesRisk factors for anterior shoulder dislocation include young age, contact activities and male sex. The influence of sex on patient-reported outcomes of arthroscopic Bankart repair (ABR) is unclear, with few studies reporting potential differences. This study’s purpose was to compare patient-reported outcomes of males and females following ABR.MethodsProspectively collected data was analysed for 281 patients (males: 206, females: 75) after ABR with preoperative, 1-year and 2-year follow-up responses. The Wilcoxon signed-rank and χ2 tests, preoperative, 1 year and 2 year follow-up results were examined to determine differences of scores in males versus females.ResultsNo statistically significant sex differences were observed in Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons (ASES), Visual Analogue Scale (VAS) or Single Assessment Numerical Evaluation (SANE) Scores at 1-year or 2-year follow-up. Females had lower Veterans RAND 12-item health survey (VR-12) mental health subscores at 2-year follow-up (females: 52.3±9.0, males: 55.8±7.6, p=0.0016). Females were more likely to report that treatment had ‘exceeded expectations’ at 2-year follow-up regarding motion, strength, function and normal sports activities.ConclusionResults of study demonstrate that ABR has similar outcomes for both males and females. There were no statistically significant sex-related differences in SST, ASES, VAS or SANE scores following ABR. VR-12 mental health subscores showed a minimal difference at 2-year follow-up, with lower scores in females.Level of evidenceRetrospective cohort study; level II.

The association of patient education level with outcomes after elective lumbar surgery: a Michigan Spine Surgery Improvement Collaborative study

2021 ◽  
pp. 1-9
Author(s):  
Travis Hamilton ◽  
Mohamed Macki ◽  
Seok Yoon Oh ◽  
Michael Bazydlo ◽  
Lonni Schultz ◽  
...  
Keyword(s):  
Spine Surgery ◽  
Patient Reported Outcomes ◽  
Minimum Clinically Important Difference ◽  
Estimating Equation ◽  
Generalized Estimating Equation ◽  
Measurement Information ◽  
Patient Reported ◽  
Physical Function Score ◽  
Measurement Information System ◽  
College Educated

OBJECTIVE Socioeconomic factors have been shown to impact a host of healthcare-related outcomes. Level of education is a marker of socioeconomic status. This study aimed to investigate the relationship between patient education level and outcomes after elective lumbar surgery and to characterize any education-related disparities. METHODS The Michigan Spine Surgery Improvement Collaborative registry was queried for all lumbar spine operations. Primary outcomes included patient satisfaction determined by the North American Spine Society patient satisfaction index, and reaching the minimum clinically important difference of Patient-Reported Outcomes Measurement Information System Physical Function score and return to work up to 2 years after surgery. Multivariate Poisson generalized estimating equation models reported adjusted risk ratios. RESULTS A total of 26,229 lumbar spine patients had data available for inclusion in this study. On multivariate generalized estimating equation analysis all comparisons were done versus the high school (HS)/general equivalency development (GED)–level cohort. For North American Spine Society satisfaction scores after surgery the authors observed the following: at 90 days the likelihood of satisfaction significantly decreased by 11% (p < 0.001) among < HS, but increased by 1% (p = 0.52) among college-educated and 3% (p = 0.011) among postcollege-educated cohorts compared to the HS/GED cohort; at 1 year there was a decrease of 9% (p = 0.02) among < HS and increases of 3% (p = 0.02) among college-educated and 9% (p < 0.001) among postcollege-educated patients; and at 2 years, there was an increase of 5% (p = 0.001) among postcollege-educated patients compared to the < HS group. The likelihood of reaching a minimum clinically important difference of Patient-Reported Outcomes Measurement Information System Physical Function score at 90 days increased by 5% (p = 0.005) among college-educated and 9% (p < 0.001) among postcollege-educated cohorts; at 1 year, all comparison cohorts demonstrated significance, with a decrease of 12% (p = 0.007) among < HS, but an increase by 6% (p < 0.001) among college-educated patients and 14% (p < 0.001) among postcollege-educated compared to the HS/GED cohort; at 2 years, there was a significant decrease by 19% (p = 0.003) among the < HS cohort, an increase by 8% (p = 0.001) among the college-educated group, and an increase by 16% (p < 0.001) among the postcollege-educated group. For return to work, a significant increase was demonstrated at 90 days and 1 year when comparing the HS or less group with college or postcollege cohorts. CONCLUSIONS This study demonstrated negative associations on all primary outcomes with lower levels of education. This finding suggests a potential disparity linked to education in elective spine surgery.

Arthroscopic ligament-specific repair for triangular fibrocartilage complex foveal avulsions: a minimum 2-year follow-up study

2020 ◽  
pp. 175319342095790
Author(s):  
Bo Liu ◽  
Margareta Arianni ◽  
Feiran Wu
Keyword(s):  
Patient Reported Outcomes ◽  
Triangular Fibrocartilage Complex ◽  
Wrist Flexion ◽  
Level Of Evidence ◽  
Flexion Extension ◽  
Patient Reported ◽  
Triangular Fibrocartilage ◽  
The Mean ◽  
Viable Method

This study reports the arthroscopic ligament-specific repair of the triangular fibrocartilage complex (TFCC) that anatomically restores both the volar and dorsal radioulnar ligaments into their individual foveal footprints. Twenty-five patients underwent arthroscopic ligament-specific repair with clinical and radiological diagnoses of TFCC foveal avulsions. The mean age was 28 years (range 14–47) and the mean follow-up was 31 months (range 24–47). Following arthroscopic assessment, 20 patients underwent double limb radioulnar ligament repairs and five had single limb repairs. At final follow-up, there were significant improvements in wrist flexion–extension, forearm pronation–supination and grip strength. There were also significant improvements in pain and patient-reported outcomes as assessed by the patient-rated wrist evaluation, Disabilities of the Arm, Shoulder and Hand score and modified Mayo wrist scores. Arthroscopic ligament-specific repair of the TFCC does not require specialist dedicated equipment or consumables and offers a viable method of treating these injuries. Level of evidence: IV

Sign in / Sign up

Export Citation Format

Share Document