scholarly journals A multicentre prospective randomized equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilization for torus fractures of the distal radius in children

2020 ◽  
Vol 1 (6) ◽  
pp. 214-221 ◽  
Author(s):  
Juul Achten ◽  
Ruth Knight ◽  
Susan J. Dutton ◽  
Matthew L. Costa ◽  
James Mason ◽  
...  

Aims Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures . Methods Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre. Results At day one, three, and seven, data on pain, function, QoL, immobilization, and analgesia will be collected. Three and six weeks after injury, the main outcomes plus data on complications, resource use, and school absence will be collected. The primary outcome is the Wong-Baker FACES pain scale at three days post-randomization. All data will be obtained through electronic questionnaires completed by the participants and/or parents/guardian. Cite this article: Bone Joint Open 2020;1-6:214–221.

2020 ◽  
Vol 1 (6) ◽  
pp. 214-221 ◽  
Author(s):  
Juul Achten ◽  
Ruth Knight ◽  
Susan J. Dutton ◽  
Matthew L. Costa ◽  
James Mason ◽  
...  

Aims Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures . Methods Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre. Results At day one, three, and seven, data on pain, function, QoL, immobilization, and analgesia will be collected. Three and six weeks after injury, the main outcomes plus data on complications, resource use, and school absence will be collected. The primary outcome is the Wong-Baker FACES pain scale at three days post-randomization. All data will be obtained through electronic questionnaires completed by the participants and/or parents/guardian. Cite this article: Bone Joint Open 2020;1-6:214–221.


Hand ◽  
2021 ◽  
pp. 155894472097412
Author(s):  
Ali Aneizi ◽  
Dominique Gelmann ◽  
Dominic J. Ventimiglia ◽  
Patrick M. J. Sajak ◽  
Vidushan Nadarajah ◽  
...  

Background: The objectives of this study were to determine the baseline patient characteristics associated with preoperative opioid use and to establish whether preoperative opioid use is associated with baseline patient-reported outcome measures in patients undergoing common hand surgeries. Methods: Patients undergoing common hand surgeries from 2015 to 2018 were retrospectively reviewed from a prospective orthopedic registry at a single academic institution. Medical records were reviewed to determine whether patients were opioid users versus nonusers. On enrollment in the registry, patients completed 6 Patient-Reported Outcomes Measurement Information System (PROMIS) domains (Physical Function, Pain Interference, Fatigue, Social Satisfaction, Anxiety, and Depression), the Brief Michigan Hand Questionnaire (BMHQ), a surgical expectations questionnaire, and Numeric Pain Scale (NPS). Statistical analysis included multivariable regression to determine whether preoperative opioid use was associated with patient characteristics and preoperative scores on patient-reported outcome measures. Results: After controlling for covariates, an analysis of 353 patients (opioid users, n = 122; nonusers, n = 231) showed that preoperative opioid use was associated with higher American Society of Anesthesiologists class (odds ratio [OR], 2.88), current smoking (OR, 1.91), and lower body mass index (OR, 0.95). Preoperative opioid use was also associated with significantly worse baseline PROMIS scores across 6 domains, lower BMHQ scores, and NPS hand scores. Conclusions: Preoperative opioid use is common in hand surgery patients with a rate of 35%. Preoperative opioid use is associated with multiple baseline patient characteristics and is predictive of worse baseline scores on patient-reported outcome measures. Future studies should determine whether such associations persist in the postoperative setting between opioid users and nonusers.


2018 ◽  
Vol 40 (1) ◽  
pp. 65-73 ◽  
Author(s):  
Man Hung ◽  
Judith F. Baumhauer ◽  
Frank W. Licari ◽  
Maren W. Voss ◽  
Jerry Bounsanga ◽  
...  

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.


2018 ◽  
Vol 40 (1) ◽  
pp. 56-64 ◽  
Author(s):  
Man Hung ◽  
Judith F. Baumhauer ◽  
Frank W. Licari ◽  
Jerry Bounsanga ◽  
Maren W. Voss ◽  
...  

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.


2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0018
Author(s):  
Jonathan Day ◽  
Matthew S. Conti ◽  
Nicholas Williams ◽  
Scott J. Ellis ◽  
Jonathan T. Deland ◽  
...  

Category: Midfoot/Forefoot; Other Introduction/Purpose: Severe adult-acquired flatfoot deformity (AAFD) is often associated with painful medial column collapse at the naviculocuneiform (NC) joint. The purpose of this study was to examine the role of first tarsometatarsal (1st TMT) fusion combined with subtalar fusion in correcting deformity at this joint. Methods: We retrospectively analyzed 40 patients (41 feet) who underwent 1st TMT and subtalar (ST) fusion as part of a flatfoot reconstructive procedure. We assessed six radiographic parameters both preoperatively and at a minimum of 6 months postoperatively, including talonavicular (TN) coverage angle, lateral talo-first metatarsal angle, lateral talocalcaneal angle, calcaneal pitch, hindfoot moment arm, and a newly defined navicular-cuneiform incongruency angle (NCIA). Patient-Reported Outcomes Measurement Information System (PROMIS) clinical outcomes were assessed preoperatively and at a minimum 1 year follow-up. Results: The NCIA demonstrated excellent interobserver reliability, with no significant change between pre- and postoperative measurements. All other radiographic parameters, except calcaneal pitch, demonstrated statistically significant improvement postoperatively (p <0.01). Overall, patients had statistically significant improvement in all PROMIS domains (p <0.01), except for depression. Worsening NC deformity was not associated with worse patient-reported outcomes. Conclusion: Our data suggests that when addressing collapse of the medial arch in patients with AAFD, fusion of the 1st TMT joint in combination with other procedures leads to acceptable radiographic and clinical outcomes. There was no change in deformity at the NC joint at short-term follow-up, and patients achieved significant improvement in multiple PROMIS domains. Based on our findings, deformity through the NC joint does not significantly impact clinical outcomes. In addition, the NCIA was established as a reliable radiographic parameter that can be used to assess NC deformity in the presence of talonavicular and/or 1st TMT fusion. [Table: see text]


Hand ◽  
2017 ◽  
Vol 13 (5) ◽  
pp. 572-580 ◽  
Author(s):  
Johanna Rundgren ◽  
Anders Enocson ◽  
Cecilia Mellstrand Navarro ◽  
Gunnar Bergström

Background: The EuroQol Group 5-Dimension (EQ-5D) questionnaire is frequently used as an outcome measure of general patient-reported health-related quality of life (HRQoL). We evaluated the internal and external responsiveness of EQ-5D (specifically EQ-5Dindex score) in patients with a surgically treated distal radius fracture. Methods: Within the context of a randomized controlled trial (RCT), 132 patients with a surgically treated distal radius fracture filled out EQ-5D and Patient-Rated Wrist Evaluation (PRWE-Swe) at baseline (preinjury state), and at 3 and 12 months. Internal responsiveness was evaluated by calculating mean change score and standardized response mean (SRM) of the EQ-5Dindex scores. External responsiveness was evaluated with PRWE-Swe as the external criterion. PRWE-Swe was used to define 4 subgroups of patients with different clinical outcomes. The ability of EQ-5Dindex change score to discriminate between these subgroups was analyzed with logistic regression, receiver operating characteristic (ROC) curves, and area under the ROC curves (AUROCs). Correlation analysis was made with Spearman’s ρ test. Results: The mean change in EQ-5Dindex score from baseline to the 3-month follow-up was −16.1 and from the 3- to the 12-month follow-up was 7.6. The corresponding SRMs were large (0.93) and small to moderate (0.47). Analysis of external responsiveness displayed odds ratios >1 and AUROCs between 0.70 and 0.76 in all 4 subgroups. The proportion of patients correctly classified into the 4 subgroups by the EQ-5Dindex change scores was 78% to 94%. Spearman’s ρ was 0.35. Conclusion: EQ-5D displayed an overall acceptable to good responsiveness in patients with a distal radius fracture. It may thus be used as a measure of HRQoL in this patient group.


2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 203-203
Author(s):  
Grace K Ellis ◽  
Bryce B Reeve ◽  
Salama Itimu ◽  
Ande Salima ◽  
Grace Banda ◽  
...  

203 Background: Health-related quality of life (HRQoL) is an important outcome in cancer care and research, but such data from sub-Saharan Africa are scant. We translated and validated the Pediatric Patient-Reported Outcome Measurement Information System (PROMIS)-25 questionnaire for use in Malawi. Methods: We administered the Pediatric PROMIS-25 at baseline, mid-treatment, treatment completion, and follow-up to pediatric lymphoma patients receiving care in Lilongwe. Domain scores were transformed into PROMIS T-scores. Differences in follow-up and baseline values were calculated and compared to published minimally important difference (MID) estimates of 3 points. Results: Eighty-one questionnaires were completed at diagnosis, 41 at mid-treatment, 24 at treatment completion, and 25 at follow-up [Table]. At baseline, 57 (70%) were male, median age was 11 (IQR 9-13), and 50 (62%) reported Pain Intensity ≥8. Mobility, Anxiety, Depressive Symptoms, and Pain Interference improved during treatment, but seemed to worsen at treatment completion. At follow-up, substantial improvements in HRQoL were reported [Table]. Conclusions: Despite poor HRQoL at baseline, improvements in all measured domains exceeded accepted MID thresholds. This suggests treatment led to meaningful improvements in HRQoL, but high mortality in data may reflect a survivor effect. Incorporating serial HRQoL assessments in emerging cancer programs in sub-Saharan Africa should be a regional priority. HRQoL T-scores during care, median (IQR). Lower Mobility and Peer Relationship scores reflect worse functioning; higher symptom scores reflect worse symptom burden. [Table: see text]


Hand ◽  
2022 ◽  
pp. 155894472110643
Author(s):  
Pragna N. Shetty ◽  
Kavya K. Sanghavi ◽  
Mihriye Mete ◽  
Aviram M. Giladi

Background: Amount of opioid use correlates poorly with procedure-related pain; however, prescription limits raise concerns about inadequate pain control and impacts on patient-reported quality indicators. There remain no consistent guidelines for postoperative pain management after carpal tunnel release (CTR). We sought to understand how postoperative opioid use impacts patient-reported outcomes after CTR. Methods: This is a pragmatic cohort study using prospectively collected data from all adult patients undergoing uncomplicated primary CTR over 17 months at our center. Patients were categorized as having received or not received a postoperative opioid prescription, and then as remaining on a prescription opioid at 2-week follow-up or not. Questionnaires were completed before surgery and at 2-week follow-up. We collected brief Michigan Hand questionnaire (bMHQ) score, Patient-Reported Outcomes Measurement Information System Global Health score, satisfaction, and pain score. Results: Of 505 included patients, 405 received a postoperative prescription and 67 continued use at 2-weeks. These 67 patients reported lower bMHQ, lower satisfaction, and higher postoperative pain compared to those that discontinued. Multivariable regressions showed that receiving postoperative prescriptions did not significantly influence outcomes or satisfaction. However, remaining on the prescription at 2 weeks was associated with significantly lower bMHQ scores, particularly in patients reporting less pain. Conclusions: Patients remaining on a prescription after CTR reported worse outcomes compared to those who discontinued. Unexpectedly, the widest bMHQ score gap was seen across patients reporting lowest pain scores. Further research into this high-risk subgroup is needed to guide policy around using pain and patient-reported outcomes as quality measures. Level of Evidence: Level III.


2018 ◽  
Vol 43 (9) ◽  
pp. 925-930 ◽  
Author(s):  
Brianna Fram ◽  
Lindley B. Wall ◽  
Richard H. Gelberman ◽  
Charles A. Goldfarb

Painful extensor carpi ulnaris tendon instability has various treatments with limited available outcome data. We treated 12 wrists of 11 patients (including eight collegiate or professional athletes) with dorsal transposition of the extensor carpi ulnaris tendon to lie over the 5th compartment, stabilized with a retinacular sling from 2010–2015. All patients had symptom resolution and returned to sport at the pre-injury level by 3 months after surgery. Mean post-surgical Patient Reported Outcomes Measurement Information System (PROMIS) upper extremity score was 56, and PROMIS pain interference score was 42. Patient overall satisfaction averaged 9.8 points on a 10-point scale for the procedure and pain decreased by 6 points on a 10-point scale from before surgery to final follow-up. We conclude that surgical treatment of the extensor carpi ulnaris tendon instability via dorsal transposition of the extensor carpi ulnaris tendon is an effective surgical option for all patients including the high level athlete. Level of evidence: IV


2018 ◽  
Vol 25 (7) ◽  
pp. 1248-1254 ◽  
Author(s):  
Edward L Barnes ◽  
Millie D Long ◽  
Michael D Kappelman ◽  
Christopher F Martin ◽  
Robert S Sandler

Abstract Background High levels of patient activation (having the knowledge, skills, and confidence to effectively manage one’s care), have been associated with improved outcomes in many chronic conditions. There have been few studies of the effects of activation in patients with inflammatory bowel disease (IBD). We performed a large, prospective Internet-based study to assess the relationship between patient activation level and clinical remission in patients with Crohn’s disease or ulcerative colitis. Methods We administered the Patient Activation Measure (Insignia Health) to 1486 cohort participants. Patients completed a follow-up survey within 13 months (median, 189 days). We collected demographic and clinical data; anxiety and depression were assessed using Patient-Reported Outcomes Measurement Information System instruments. We used bivariate analyses and multivariable logistic regression to identify characteristics associated with low or high patient activation and to evaluate the association between levels of patient activation and subsequent disease activity. Results Higher anxiety (adjusted odds ratio [aOR], 0.32; 95% confidence interval [CI], 0.29–0.36) and depression (aOR, 0.33; 95% CI, 0.29–0.37) scores were associated with a decreased odds of high patient activation. After we adjusted for education status, smoking, medication use, and other confounders, we found that patients with high activation at baseline were more likely to be in clinical remission during the follow-up period (aOR, 1.71; 95% CI, 1.20–2.45). Conclusions In a large, prospective Internet-based cohort of patients with IBD, we found a strong association between patient activation and clinical remission. These findings suggest that patient activation affects disease outcomes.


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