Reported Outcomes Measurement Information System Research Articles

ODP108 Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva: Methodology of the Phase III Open-Label PIVOINE Rollover Trial

Abstract Objectives Fibrodysplasia ossificans progressiva (FOP) is an ultra-rare genetic disorder characterized byheterotopic ossification (HO) and progressive restriction of mobility. To date, no approved disease-modifying treatments for FOP exist, but interim phaseIII MOVE trial (NCT03312634) results suggest marked efficacy for palovarotene (PVO). 1 The PIVOINE rollover trial (NCT05027802) has been designed to allow treatment continuity and further evaluation of PVO safety and efficacy; the methodology is given here. Methods Patients will receive 5 mg PVO daily, or the parent study completion dose, for a maximum of 3 years; during flare-ups, patients will receive 20 mg daily for 4 weeks, then 10 mg daily for 8 weeks. Enrollment criteria: completion of a parent study (end of study/treatment visit of NCT03312634 or NCT02279095/NCT02979769), ≥14 years of age, full skeletal maturity if aged <18 or deemed to be final adult height. PIVOINE aims to enroll 61 patients; recruitment has not begun. The primary outcome will be the incidence and description of all treatment-emergent adverse events, collected continuously over the study period. Secondary outcomes (collected every 6 months; reported as raw values and change from the inclusion visit for outcomes specified by *) include: range of motion* (using Cumulative Analogue Joint Involvement Scale total score), the use of aids, assistive devices and adaptations*, physical function* (using adult form of the FOP-Physical Function Questionnaire; total score and upper extremities and mobility sub-scores), the frequency of healthcare utilization, and physical and mental health* (using Patient Reported Outcomes Measurement Information System Global Health Scale). Lung function will be assessed via observed and percentage predicted (PP) forced vital capacity (FVC)*, forced expiratory volume in 1 second (FEV 1)*, diffusion capacity of the lung for carbon monoxide*, and the absolute and PP FEV 1 /FVC ratio*. The number of investigator-reported flare-ups*, including duration and outcomes, will be reported along with the percentage of patients with new bone growth. Summary Results from PIVOINE, estimated to end in November 2024, will allow further evaluation of PVO in FOP.

Life after COVID-19: the road from intensive care back to living – a prospective cohort study

ObjectivesThe aim of the study was to evaluate recovery of participation in post-COVID-19 patients during the first year after intensive care unit (ICU) discharge. The secondary aim was to identify...

Outcomes of arthroscopic tuberoplasty for symptomatic irreparable rotator cuff tendon tear without pseudoparalysis.

The purpose of this study is to report the outcomes in patients undergoing arthroscopic tuberoplasty for symptomatic irreparable rotator cuff tear (RCT). This is a retrospective cohort study comparing preoperative and postoperative data of patients undergoing arthroscopic tuberoplasty for symptomatic irreparable RCT. Exclusion criteria included open tuberoplasty, concomitant partial RCT repair, glenohumeral arthritis, concomitant ipsilateral extremity fractures, <12 months follow-up, or pseudoparalysis. Demographics, shoulder range of motion (ROM), RCT morphology, re-operation rates, satisfaction and outcome scores were collected from medical records and questionnaires. Outcome scores included Patient Reported Outcome Measurement Information System Upper Extremity (PROMIS), American Shoulder and Elbow Surgeons score (ASES), Subjective Shoulder Value (SSV), and pain Visual Analog Score (VAS). Out of 28 patients identified between 2012 and 2019, 20 (21 shoulders) were available for follow-up at a mean of 43.3 ± 20.9 months. Mean age was 64.6 ± 8.8 years. Mean PROMIS was 37.7 ± 7.3, ASES was 82.9 ± 13.8, and SVV was 67.1 ± 19.4. VAS with activity decreased from 5.0 ± 2.9 preoperatively to 2.3 ± 2.6 (P = .0029). Pre- and post-operative ROM were unchanged. There were 4 failures requiring revision. The remaining 17 patients reported high satisfaction scores (3.4 ± 0.7) and 15 (88.2%) answered "yes" to getting the procedure again, with 3/4 failures stating they would also undergo arthroscopic tuberoplasty again. Arthroscopic tuberoplasty demonstrates high levels of satisfaction and pain reduction in symptomatic irreparable RCT. In appropriately indicated patients, this treatment should be considered prior to other salvage options.

Increased insula response to interoceptive attention following mindfulness training is associated with increased body trusting among patients with depression

Interoceptive dysfunction is often present in anxiety and depression. We investigated the effects of an 8-week intervention, Mindfulness Training for Primary Care (MTPC), on brain mechanisms of interoceptive attention among patients with anxiety and/or depression. We hypothesized that fMRI brain response to interoception in the insula, a region known for interoceptive processing, would increase following the MTPC intervention, and that such increases would be associated with post-intervention changes in self-reported measures of interoceptive awareness. Adults (n = 28) with anxiety and/or depression completed baseline and post-intervention fMRI visits, including a task in which they alternated between focusing on their heartbeat (interoception (INT)) and a control visual attention task (exteroception (EXT)). Following MTPC, we observed increased evoked fMRI response (relative to baseline) in left anterior insula during the INT-EXT task contrast (z > 3.1, p < 0.001 corrected). In patients with moderate-to-severe depression as defined by the Patient Reported Outcomes Measurement Information System (PROMIS), increased post-intervention insula response was associated with increased Body Trusting, a subscale of the Multidimensional Assessment of Interoceptive Awareness (z > 3.1, p = 0.007 corrected). This study demonstrates that patients with mood disorders may respond differentially to mindfulness-based treatment depending on depression severity, and that among those who are more depressed, increased trusting in one's own body sensations and experiencing the body as a safe place to attend to may be necessary components of positive responses to mindfulness-based interventions.

Implementation of a Patient-Tailored Opioid Prescribing Guideline in Ventral Hernia Surgery

IntroductionOpioids are commonly prescribed beyond what is necessary to adequately manage postoperative pain, increasing the likelihood of chronic opioid use, pill diversion, and misuse. We sought to assess opioid utilization and patient-reported outcomes (PROs) in patients undergoing ventral hernia repair (VHR) following the implementation of a patient-tailored opioid prescribing guideline. MethodsA patient-tailored opioid prescribing guideline was implemented in March of 2018 for patients undergoing inpatient VHR in a large regional healthcare system. We retrospectively assessed opioid utilization and patient-reported outcomes among patients who did (n = 42) and did not receive guideline-based care (n = 121) between March 2018 and December 2019. PROs, operative details, and patient characteristics were extracted from the Abdominal Core Health Quality Collaborative (ACHQC) registry data, and length-of-stay and prescription information were extracted from the electronic health record system at the healthcare institution. ResultsThe milligram morphine equivalents (MME) prescribed at discharge was lower for patients receiving guideline-based care (Median = 65, interquartile range [IQR] = 50-75) than patients receiving standard care (Median = 100, IQR = 60-150). After adjusting for patient characteristics, the odds of receiving an opioid refill after discharge did not significantly differ between patient groups (P = 0.43). Patient Reported Outcomes Measurement Information System (PROMIS) pain scores and hernia-specific quality-of-life (HerQLes) scores at follow-up also did not differ between patients receiving guideline-based care (Mean PROMIS = 57.3; Mean HerQLes = 53.1) versus those that did not (Mean PROMIS = 56.7; Mean HerQLes = 46.6). ConclusionsPatients who received tailored, guideline-based opioid prescriptions were discharged with lower opioid dosages and did not require more opioid refills than patients receiving standard opioid prescriptions. Additionally, we found no differences in pain or quality-of-life scores after discharge, indicating the opioids prescribed under the guideline were sufficient for patients.

Remote assessment of cognitive dysfunction in hematologic malignancies using web-based neuropsychological testing.

Cognitive impairment is a frequent adverse effect of cancer and its therapies. As neuropsychological assessment is not often standard of care for patients with non-CNS disease, efficient, practical assessment tools are required to track cognition across the disease course. We examined cognitive functioning using a web-based cognitive testing battery to determine if it could detect differences between patients with cancer and controls. We enrolled 22 patients with multiple myeloma (MM) or non-Hodgkin lymphoma (NHL) and 40 healthy controls (mean age=56 ± 11 years, 52% male). Participants completed the BrainCheck cognitive testing battery and online versions of select measures from the Patient Reported Outcome Measures Information System (PROMIS) during a video conference. MANOVA was used to compare BrainCheck and PROMIS scores between groups controlling for age and sex. An exploratory linear regression analysis was conducted within the cancer group to determine potential contributors to cognitive functioning. All participants except for one control completed the online assessment measures without difficulty. Compared to controls, the cancer group demonstrated significantly lower scores in objective and subjective cognitive function, physical functioning, and social role performance and elevated fatigue scores. Corticosteroid treatment, immunotherapy, lower physical functioning, lower income, and older age significantly contributed to lower cognitive function (adjusted R2 = 0.925, F= 19.63, p= 0.002). Remote assessment of cognitive and psychosocial functioning is feasible with patients with cancer following treatments. The BrainCheck cognitive testing battery has the potential to detect differences in cognition between patients with cancer and controls.

Adolescent athletes return to sports rapidly after posterior spine fusion for idiopathic scoliosis: a prospective cohort study.

No consensus exists regarding the timing for return to sports after PSF for patients with AIS. Return-to-play protocols are based on expert opinion and vary widely. The purpose of this study was to determine how rapidly athletes return to baseline sports activity following posterior spinal fusion for adolescent idiopathic scoliosis. Athletes were consecutively enrolled. Inclusion criteria included competition at a junior varsity level or greater for ≥ 3months yearly, major Cobb angle of 40-75°, age 10-18years, and one year of follow-up. Athletes completed preoperative sports performance and Patient Reported Outcomes Measurement Information System (PROMIS) physical activity, pain interference, and depressive symptoms questionnaires. Self-assessments were repeated monthly until one year after PSF. Twenty-six athletes were enrolled. The median time to return to sport was 2.7months [range: 0.6-13months]. At twelve months, 24 of 26 [90.1%; 95% CI 36.9-74.9%] athletes reported they had returned to the sport at their presurgical level of play. Participation in contact sports was associated with a longer return to sport relative to participation in non-contact/limited contact sports [Hazard Ratio: 0.37, 95% 95% CI 0.14-0.97, p = 0.0427]. Conditioning and flexibility were the most common barriers to return to sport. When released to unrestricted activity at 4-8weeks, athletes rapidly return to baseline levels of sports performance, with over half achieving this metric by 3months.

Factors Affecting Patient Reported Outcomes after Surgical Fixation for a Lisfranc Injury

Category: Bunion; Other Introduction/Purpose: Hallux valgus is a common deformity the foot and ankle surgeon will encounter that tends to have a progressive nature with a predilection for females. There are many operative techniques to appropriately treat HV however, there is limited literature focused on patient-reported outcomes for these procedures. In particular, we intend to compare patient- reported outcomes for those who had early (2 weeks postoperatively) vs standard weight-bearing (SWB) (6 weeks postoperatively) postoperative protocols after hallux valgus correction via the Lapidus procedure. Methods: A retrospective analysis of patients that underwent hallux valgus correction at our facility from 2010-2021 was conducted. Patients were selected if they underwent this correction via the Lapidus procedure. Basic patient demographics, preoperative and post-operative hallux valgus angles and intermetatarsal angles were recorded, type of hardware used for fixation, postoperative weight bearing protocol, complication rate, deformity recurrence, duration of symptoms, and any adjunctive procedures were all recorded utilizing the electronic medical record. Early weight-bearing (EWB) was defined as beginning a protected weight-bearing protocol at the two week visit. To evaluate outcomes, we utilized the Foot and Ankle Ability Measure (FAAM) survey as well as the Patient Reported Outcomes Measurement Information System (PROMIS) survey. Results: A total of 77 patients met criteria for this study with 20 patients having completed both the FAAM and PROMIS score surveys. The average time point at which the outcomes were collected was 5.65 years postoperatively ranging from 2.43 to 11.5 years. There were 35 patients in the EWB cohort and 42 in the SWB protocol. The average PROMIS physical function, pain interference, and depression scores for the EWB population was 45.96, 54.66, and 47.48 respectively vs 47.10, 48.34, and 50.21 in the SWB group. Patients in the EWB group reported their average activities of daily living (ADLs) via the FAAM subscale to be at 57% vs 62% in the SWB group. For the FAAM Sports Subscale, both groups reported fairly low numbers at 44% and 36% respectively. In this study, 1 patient experienced wound infection, 3 patients experienced nonunion (2 EWB, 1 SWB), and 1 patient experienced deformity recurrence. Conclusion: Preliminary results suggest equivalent results for EWB and SWB postoperative protocol for patients undering the Lapidus procedure. We plan to increase the power of our study for a more thorough investigation as well as conduct a more intensive statistical analysis to gain more insight on patient related factors and their effect on outcomes. We expect a higher number of patients to complete the PROMIS and FAAM surveys as we continue to reach out to these patients.

Early Radiographic and Clinical Outcomes of the Cadence Total Ankle Replacement System

Category: Ankle Arthritis; Ankle; Other Introduction/Purpose: The Cadence Total Ankle System (Smith and Nephew, Memphis, TN) is a two-component, fixed-bearing fourth generation total ankle arthroplasty (TAA) system that was introduced for clinical use in 2016. Few studies have investigated short-term outcomes of this new TAA system, and no outcomes have yet been reported by independent authors. The purpose of this study was to report non-inventor, non-industry funded survivorship, radiographic and clinical outcomes, and early complications following use of the new fourth generation TAA system at a minimum of 2 years. Methods: This is a single-center retrospective study of patients who underwent TAA by two surgeons with the Cadence between January 2017 and September 2018. There were 50 ankles in 50 patients, and 48 (96%; mean age of 66.1 years) patients were evaluated at a minimum 2-year follow-up. Two patients were lost due to death and refusal to participate in the study. Patients had an average follow-up of 33.6 (range, 24-50) months. Radiographic outcomes included preoperative and postoperative tibiotalar alignment (TTA) on anteroposterior radiographs of the ankle, sagittal tibial alignment (STA) on lateral radiographs of the ankle, and periprosthetic cyst formation (greater than 5mm in size) and cyst location. Data regarding reoperations and revisions were also collected. Patient-reported outcomes were assessed using Patient Reported Outcomes Measurement Information System (PROMIS). Subgroup analysis was performed to assess for associations between preoperative deformity, postoperative implant alignment, PROMIS scores, and periprosthetic cyst formation. Results: Survivorship of implant was 93.7%, with 3 revisions, 1 due to infection and 2 due to loosening of the implant (one tibial and one talar component). Three patients had reoperations (6.3%): 2 for irrigation and debridement for cellulitis, and 1 for gutter debridement due to medial gutter impingement. Preoperatively, 9 ankles had varus alignment (mean TTA 77.9 degrees), 20 had neutral alignment (mean TTA 90.2 degrees), and 13 had valgus alignment (mean TTA 102.9 degrees). Postoperatively, TTA and STA significantly improved, and all patients demonstrated neutral coronal alignment (TTA between 85 and 95 degrees). Fifteen patients (35.8%) developed periprosthetic cysts, all on the tibial side. PROMIS scores improved after surgery in all domains except Depression (Table 1). Patients with postoperative periprosthetic cysts had a smaller preoperative STA and a worse postoperative PROMIS Physical function and Pain interference domain than patients without periprosthetic cysts (p&lt;0.05). Conclusion: This study demonstrated excellent minimum 2-year clinical and radiographic outcomes, along with low revision and reoperation rates, of this new fourth generation TAA system. Future studies with longer follow-up, especially on patients with periprosthetic cysts, are necessary to investigate the long-term complications and understand the long-term functional and radiographic outcomes of this implant.

VP.07 Lived experience of functioning of patients with nemaline myopathy and related disorders in Finland

Nemaline myopathy (NM) and related disorders (NMr) are ultrarare congenital myopathies with severity varying from mild muscle- or muscle group-specific weakness to a neonatally lethal disorder. Medical and biomedical studies of NM and NMr have dominated the research field, whereas little is known about coping in everyday life among persons with NM. To study the lived experience of physical, psychological and social functioning of adult NM and NMr patients in Finland, we conducted a survey using items primarily from PROMIS® (Patient Reported Outcomes Measurement Information System) questionnaires. The impact of the COVID-19 pandemic on functioning was also assessed. The items were linked to the International Classification of Functioning, Disability and Health (ICF) categories. In total, 20 persons aged 19-75 years and resident in Finland participated in the study; 12 had NM and eight NMr; 15 were women and five men. Sixteen were ambulatory and four used wheelchairs. Non-ambulatory patients reported more problems in all areas of functionality. However, there was a large variability in the functioning of the participants. The differences were smaller in the psychological and social functioning. In addition, the COVID-19 pandemic had affected the functioning of non-ambulatory patients more than that of ambulatory patients. The results indicate that patients using wheelchairs and patients dependent on the help of others might be more vulnerable and prone to impairments in general and social functioning especially during pandemics. Possible explanations include further restriction of their participation in social life and restricted access to physical rehabilitation services due to the pandemics. To our knowledge, this pilot study is the first study on self-experienced functioning of persons with rare congenital muscle disorders, and the results indicate on the need for expanding this study nationally and internationally.

Factors Affecting Patient Reported Outcomes after Surgical Fixation of Lisfranc Injury

Category: Midfoot/Forefoot; Trauma Introduction/Purpose: The Lisfranc joint accounts for a small percentage of all fractures and is typically caused by trauma, high falls, or from athletic injuries. The treatment can be divided into operative and non-operative management based on the extent of the injury. Currently, as to the best of our knowledge, there is no literature that assesses patient reported outcomes after surgical intervention for Lisfranc injuries. This study provides an overview of the relationship between PROMIS scores and overall outcomes of patients who underwent surgical management for Lisfranc injury. Methods: A retrospective analysis was conducted for patients that underwent Lisfranc surgical repair at our facility from 2010- 2020. Using the electronic medical record (EMR), basic patient demographics, mechanism of injury, presence of rheumatoid arthritis, osteopenia/osteoporosis, time from injury to surgery, type of intervention utilized (ORIF, pinning, arthrodesis), use of bone grafting, and surgical complications were recorded. To evaluate outcomes, we used the Patient Reported Outcomes Measurement Information System (PROMIS) survey and Foot Function Index (FFI) scores. Results: A total of 248 patients met the criteria for our study with 80 participants completing both the PROMIS and FFI surveys. The average PROMIS physical function, pain interference, and depression scores were reported as 43.2, 55.4, and 45.4, respectively. The average FFI scores in this population are as follows: FFI pain- 37.1, FFI disability- 34.2, FFI activity limitation- 12.35, and the average FFI total score was 30.95. There was a significant decrease in postoperative pain scores when compared to preoperative pain from 5.23 to 1.85 (p=0.046). Complications were fairly low in this population with 4 patients experiencing surgical site infection, 36 patients described problematic hardware, and 45 patients underwent revisional surgery. Conclusion: Preliminary results suggest surgical intervention for Lisfranc injuries may be viewed as satisfactory amongst patients. Further analysis to compare patient reported outcomes based on the type of surgical intervention, hardware used for fixation, and whether any patient demographic factors have any influence on these outcomes are being conducted. Our fairly large patient population has a time from surgery date ranging from 1.5 years to 11.2 years. We believe further analysis will also provide quality information on the long-term outcomes regarding Lisfranc injuries

Patient Reported Outcomes Following Hindfoot Fusion Utilizing the Triple Arthrodesis Procedure

Category: Hindfoot; Ankle Arthritis Introduction/Purpose: Fusions are used as a salvage procedure to improve stability and return patient to regular functions of daily activities. Triple Arthrodesis is a fusion of three joints, talonavicular, subtalar, calcaneocuboid. There is limited literature on the patient-reported long-term outcomes for this procedure. The aim of this study is to quantify the patient-reported outcomes for the Triple Arthrodesis procedure. Methods: A retrospective analysis was conducted for patients that underwent Triple Arthrodesis at our facility from 2014-2021. Using the electronic medical record (EMR), basic patient demographics, time since surgery, presence of osteoarthritis or rheumatoid arthritis, development of infection, nonunion, hardware failure, and history of previous foot and ankle procedures were all noted. Additionally, we recorded the hardware used during the operation and whether concomitant procedures were performed during the time of surgery. To evaluate outcomes, we used the Patient Reported Outcomes Measurement Information System (PROMIS) survey and Foot Function Index (FFI) scores. Results: A total of 132 patients were included in this study with 50 participants completing the PROMIS and FFI surveys. The average time point at which the outcomes were collected was 5.50 years postoperatively. Postoperative PROMIS scores for physical function, pain interference, and depression were all within one standard deviation of the reference population. The average PROMIS physical function was 38.35, pain interference was 61.52, and depression was 49.82 for this population. The mean FFI scores were 58.56 for pain, 60.06 for disability, 48.06 for activity limitation. There was a significant decrease in postoperative pain scores when compared to preoperative pain of 5.4 to 2.55 (p=0.023). Four patients experienced wound infection, four patients experienced nonunion, six patients required revisional surgery, and three patients experienced hardware failure. Conclusion: Preliminary results Triple Arthrodesis may be beneficial in decreasing pain and lead variable long-term patient satisfaction. We plan to include further statistical analysis comparing the various types of fixation techniques used and the resultant PROMIS and FFI scores. Additionally, we are currently continuing patient calls to collect more completed PROMIS and FFI reports.

Five-Year Minimum Patient-Reported Outcomes Following Isolated Gastrocnemius Recession for Plantar Fasciitis and Achilles Tendinopathy

Category: Hindfoot; Other Introduction/Purpose: Plantar fasciitis and Achilles tendinopathy are common foot and ankle overuse conditions encountered in clinical practice. Treatment modalities for these diagnoses vary however, isolated gastrocnemius recession may be a viable treatment option for these conditions when conservative management has failed. There is little published on the long-term outcomes of this procedure with very few studies able to report on the five-year reported outcomes in these patients. Here, we assess patient-reported outcome in those with a minimum of five-year follow up that underwent isolated gastrocnemius resection for the above indications. Methods: A retrospective analysis of patients that underwent gastrocnemius recession at our facility from 2011 to 2018 was conducted. Patients were selected if they underwent an isolated gastrocnemius recession specifically due to Achilles tendinopathy or plantar fasciitis. Patients were excluded if they had a history of musculoskeletal disorders of a history of previous recession. Basic patient demographics, chronic use of fluoroquinolones and NSAIDs, duration of symptoms, presence of rheumatoid arthritis, history of previous foot and ankle operations, and surgical complications were all recorded. To evaluate outcomes, we utilized Foot Function Index (FFI) scores as well as the Patient Reported Outcomes Measurement Information System (PROMIS) survey. Results: A total of 141 patients met inclusion criteria with all individuals completing both the PROMIS survey and 115 completing the FFI survey. The average time point at which outcomes were collected was 6.6 years postoperatively. Postoperative PROMIS scores for physical function, pain interference, and depression were all within one standard deviation of the reference population. The average PROMIS physical function, pain interference, and depression scores for this population was 45.67, 50.87, and 41.20, respectively. The mean FFI scores were 28.58 for pain, 36.11 for disability, 21.11 for activity limitation with an average total FFI of 31.40. Six patients developed surgical site infection, 36 patients reported postoperative symptoms of sural neuropathy with 12 reporting complete resolution of the neuropathy, and four patients required revisional surgery. Conclusion: With the limited data regarding the long-term outcomes of gastrocnemius recession, we sought to explore patient- reported outcomes in terms of pain, disability, physical function, depression, and pain interference. Our results prove that gastrocnemius recessions for Achilles tendinopathy and plantar fasciitis can lead to long term satisfaction for patients and can expect relatively low complication rates during the process. Additionally, the high retention rate of patients answering all required patient surveys further strengthens the findings reported here.

The OFAR Experiment: Barriers, Lessons, and Findings From an Orthopedic Patient Outcomes Database

Category: Other; Ankle; Hindfoot; Midfoot/Forefoot Introduction/Purpose: As digital healthcare systems advance, patient reported outcomes (PRO) platforms offer an effective strategy for clinicians to evaluate patient relevant treatment outcomes. Initiated by AOFAS in 2018, the Orthopaedic Foot and Ankle Outcomes Research (OFAR) Network was a multi-center surgical outcomes registry platform established to collect, aggregate, and report PRO data. OFAR included surgical information, patient demographics, and PRO instruments developed by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS). Due to high costs and competing technologies, OFAR data collection ended in 2020. Although OFAR did not achieve widespread and sustained use, a large number of patients were enrolled over the 2-year period. We hypothesized that each aggregated PRO metric improved at all post-operative time points compared to preoperative values. Methods: From 2018-2020, four sites and 10 orthopedic surgeons were approved and able to contribute patient data to the OFAR database. Enrolled patients completed a pre-operative survey and then post-operative surveys at 3-months, 6-months, and 12-months. Five PROMIS metrics were collected at each survey point, including Physical Function CAT (PF), Pain Intensity Short Form (PI), Pain Interference CAT, Global Health Short Form and Depression CAT. Descriptive statistics were used to summarize the demographics and clinical characteristics of all individuals. Linear mixed models were used to test for differences in patient reported outcomes (PROs) across the study visits. The unstructured covariance structure was used to account for the repeated measures. After the OFAR closed to enrollment, all investigators of the OFAR consortium, including those who were not able to participate as a site, were surveyed to investigate the barriers they faced when launching OFAR at their site. Results: The final OFAR database includes 1,675 procedures performed at four institutions, with 1,126 having complete data for analysis. Ankle impingement (12%), ankle fracture/syndesmosis (11%), ankle arthritis (10%), and hallux valgus (9%) were the most common conditions among 28 unique conditions. The cumulative incidence of post-operative complications was 6.2% and the re- operation rate was 1.5%. Relative to the pre-operative visit, there was significant improvement in all metrics across post-operative time points (Table 1). The majority of OFAR consortium member sites (15 of 19) were unable to enroll patients in OFAR. The most common barriers noted included resistance from institutional EMR/IT or compliance teams, and institutional requirements to collect PROs through another platform. The majority of OFAR members (55%) indicated they would participate in a future low-cost, low-effort multi-center outcomes database. Conclusion: The OFAR database successfully collected patient outcomes data from multiple institutions. The resulting database also provided a comprehensive resource to answer targeted clinical questions about outcome predictors for common interventions. Barriers to participation in a multi-center registry more frequently emanated from the technologic or compliance constraints of hospital systems rather than individual providers. Increasing demand for PROs in practice, combined with the evolving technical landscape of greater automation and EHR interoperability will lead to more sustainable, affordable, and collaborative outcomes platforms. Institutional EMR and compliance barriers remain an important factor in advancing these important initiatives.

Results of an Interim Analysis of a Prospective Multicenter Study Assessing Radiographic and Patient Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing

Category: Bunion; Midfoot/Forefoot Introduction/Purpose: The majority of hallux valgus corrections are performed via a two dimensional approach with 1st metatarsal osteotomy and translation in the transverse plane. This approach has demonstrated high long-term recurrence rates. Recent research demonstrates that 87% of hallux valgus deformities are three-dimensional with abnormal frontal-plane rotation of the metatarsal, which cannot be completely addressed with a two dimensional metatarsal osteotomy alone. While correction at the 1st tarsometatarsal (TMT) joint may provide the optimal surgical approach for 3D anatomic restoration at the apex of the deformity, 1st TMT fusion historically entails an extended period of non-weightbearing. This study evaluated the clinical, radiographic, and patient-reported outcomes in patients undergoing instrumented triplanar 1st TMT arthrodesis (TMTA) with a biplanar plating system and protected near-immediate weightbearing. Methods: This is a prospective multicenter study that will continue for 60 months post-operatively. Patients between 14-58 years old with symptomatic hallux valgus (intermetatarsal and hallux valgus angles between 10.0-22.0° and 16.0-40.0°, respectively) and no prior hallux valgus surgery on the operative foot were eligible for this study. Patients were treated with an instrumented TMTA procedure using a biplanar plating system with protected near-immediate weightbearing. Several outcomes (radiographic, return to weightbearing and activities, pain measured by visual analog scale (VAS), Manchester-Oxford Foot Questionnaire (MOxFQ), and Patient Reported Outcomes Measurement Information System (PROMIS)) were evaluated post-operatively. Two independent fellowship trained musculoskeletal radiologists reviewed all radiographic data. These interim results are limited to patients completing at least 6 months of follow-up. Results: 165 patients underwent TMTA with at least 6 months follow-up (mean (SD): 17.8 (7.7); min, max: 5.8, 37.3). Mean age was 41.0 (range:14-58) years; 91.5% of patients were female. Mean (SD) days to protected weightbearing in CAM boot and return to full work were 8.4 (7.7) and 56.8 (45.6), respectively. Significant improvements from baseline in HVA, IMA, and TSP (Table 1), VAS score, MOxFQ and PROMIS domains were observed as early as 6 weeks post-procedure. At 12 months, mean (95% CI) change in VAS was -3.7(-4.0, -3.3); Walking/Standing (MOxFQ) change was -35.2 (-39.6, -30.8); and Physical Function (PROMIS) change was 8.7 (7.1, 10.3). Fifteen (9.1%) patients experienced hardware complications, yet maintained radiographic correction to date. No patients (0/58) with 24 months follow-up have experienced recurrence. Conclusion: These interim findings support that TMTA with biplanar plating is successful in correcting the 3D hallux valgus deformity with early return to weightbearing while demonstrating favorable clinical and patient-reported outcomes. Patients exhibited meaningful pain reduction after surgery and were able to return to full, unrestricted work and activities in less than two months, on average. Statistically significant improvements in patients' health-related quality of life were observed at 6 and 12 months, post-operatively. Patients will continue to be followed for up to 60 months with additional evaluations for complications, 24-month recurrence, and patient satisfaction.

Exploring pain interference and self-perceived health status in children with osteogenesis imperfecta - a cross-sectional study

BackgroundChronic pain may affect and interfere in children’s everyday life and can be present in children with Osteogenesis Imperfecta (OI). However, the knowledge is still sparse to what extent pain is present, how pain interfere in children’s everyday life and affect their self-perceived health status. The purpose of the study was therefore to explore presence of chronic pain, pain interference in daily life, and self-perceived health status in children with OI.MethodsChildren with OI, aged 6–18 years, were recruited consecutively to this cross-sectional study. Participants answered a standardised interview including five pre-structured questions, and the Numeric Pain Rating Scale (NPRS), the Pain Interference Index, and a questionnaire concerning self-perceived health status the Patient Reported Outcomes Measurement Information System Pediatric-25 Profile v1.1 (PROMIS-25).ResultsTwenty-eight children (median: 11 years, IQR 6) with OI type I, III, or IV participated. Pain was present in 27 of 28 children and interfered in their everyday life regardless of OI-type, sex, and age. The median NPRS for average pain intensity was 4 (IQR 2), the median for pain frequency was 2–3 times/week, and the median frequency of school absence due to pain was 2–3 times per month. The most common pain locations were back and feet. Pain in the feet was more frequently reported in children with type I (p = 0.032), and pain in the hip was more often reported in children ≥13 years (p = 0.011). The children were asked what they thought to be the cause of pain and the most frequent response was “walking long distances”. Self-perceived health status for mobility was lower than the general population, and lowest for children with type III (p = 0.016). Pain interference was associated with children’s self-perceived health status (rs = 0.84, p < 0.001).ConclusionAlmost all children experienced pain, which interfered in children’s everyday lives, affected participation in various activities and was associated with reduced self-perceived health status. If children avoid physical activities because of pain, it might cause a vicious circle of inactivity, which further decreases bone density and increase the risk of fractures. The results emphasize the importance to offer adequate pain reducing interventions.

Screening and Assessment of Cancer-Related Fatigue: A Clinical Practice Guideline for Health Care Providers.

Cancer-related fatigue (CRF) is the most common side effect of cancer treatment. Regular surveillance is recommended, but few clinical practice guidelines transparently assess study bias, quality, and clinical utility in deriving recommendations of screening and assessment methods. The purpose of this clinical practice guideline (CPG) is to provide recommendations for the screening and assessment of CRF for health care professions treating individuals with cancer. Following best practices for development of a CPG using the Appraisal of Guidelines for Research and Evaluation (AGREE) Statement and Emergency Care Research Institute (ECRI) Guidelines Trust Scorecard, this CPG included a systematic search of the literature, quality assessment of included evidence, and stakeholder input from diverse health care fields to derive the final CPG. Ten screening and 15 assessment tools supported by 114 articles were reviewed. One screen (European Organisation for Research and Treatment of Cancer–Quality of Life Questionnaire–30 Core Questionnaire) and 3 assessments (Piper Fatigue Scale–Revised, Functional Assessment of Chronic Illness Therapy–Fatigue, and Patient Reported Outcome Measurement Information System [PROMIS] Fatigue-SF) received an A recommendation (“should be used in clinical practice”), and 1 screen and 5 assessments received a B recommendation (“may be used in clinical practice”). Health care providers have choice in determining appropriate screening and assessment tools to be used across the survivorship care continuum. The large number of tools available to screen for or assess CRF may result in a lack of comprehensive research evidence, leaving gaps in the body of evidence for measurement tools. More research into the responsiveness of these tools is needed in order to adopt their use as outcome measures.ImpactHealth care providers should screen for and assess CRF using one of the tools recommended by this CPG.

The relationships of kinesiophobia and physical function and physical activity level in juvenile idiopathic arthritis

BackgroundKinesiophobia may hinder physical performance measures and functional quality of life in children with juvenile idiopathic arthritis (JIA). This study aims to quantify differences in physical function in patients with JIA compared to healthy controls, and determine the effects of kinesiophobia on physical function and physical activity.MethodsThis was a comparative study of participants with JIA and healthy controls (JIA n = 26, control n = 17). All children with JIA had lower extremity joint involvement. Performance-based measures included gait speed, chair and stair navigation performance. Self-reported measures included Patient Reported Outcome Measurement Information System (PROMIS®) Physical Function Mobility, and Pain Interference and the Pediatric Functional Activity Brief Scale (Pedi-FABS). The Tampa Scale of Kinesiophobia (TSK-11) assessed patient fear of movement due to pain. Linear regression models were used to determine the contribution of TSK-11 scores on performance test and Pedi-FABS scores.ResultsGait speeds were 11–15% slower, chair rise repetitions were 28% fewer, and stair ascent and descent times were 26–31% slower in JIA than controls (p < .05). PROMIS® Physical Function Mobility scores were 10% lower and Pain Interference scores were 2.6 times higher in JIA than healthy controls (p = .003). TSK-11 scores were higher in JIA than controls (p < .0001). After controlling for covariates, TSK-11 scores explained 11.7–26.5% of the variance of regression models for stair climb time, chair rise performance and Pedi-FABS scores (p < .05).ConclusionsChildren with JIA experience difficulty with tasks related to body transfers. Kinesiophobia is a significant contributor to the functional task performance and may impact clinical outcomes.

Effects Of A Tai Chi App On Mental Health Among Breast Cancer Survivors

PURPOSE: To our best knowledge, few studies have integrated Tai Chi (TC) and social media apps to facilitate disease prevention and management in breast cancer survivors (BCS). In response, this study investigated the effects of a mobile TC app and Facebook (FB) program on stress and quality of life (QoL) among BCS. METHODS: This study was a remote, 12-week 2-arm parallel randomized controlled trial (RCT). Participants were randomly assigned into either the intervention condition (practicing TC app exercise three times a day, at least five days/week and receiving FB health tips) or the comparison condition (receiving FB health tips). The final sample comprised 35 female BCS ( = 56.17). The Perceived Stress Scale was used to measure stress and the Patient Reported Outcome Measurement Information System was used to assess QoL - mental health (anxiety and depression) and physical health. RESULTS: There were no significant time*group interaction effects for stress and mental health (Wilk’s lambda =0.96, F (2, 32) = 0.74, p = 0.48, η2 = 0.04) and physical health (Wilk’s lambda =1.00, F (1,33) = 0.14, p = 0.71, η2 = 0.00). However, a significant time effect was observed for mental health, F (1,33) = 5.51, p = 0.02, η2 = 0.14; and physical health, F (1,33) = 5.59, p = 0.05, η2 = 0.14; but not for stress, F (1,33) = 1.70, p = 0.20, η2 = 0.05. Specifically, participants’ physical health (1.57 vs. 1.42) and mental health (1.80 vs. 1.63) significantly improved over time across both groups. Also, a group effect for mental health approached the significant level, F (1,33) = 4.06, p = 0.05, η2 = 0.11. In detail, the intervention participants had significantly better mental health at post-test (1.43 vs. 1.90) compared to the comparison participants (p 0.05, 95%CI: -0.91 to -0.40). CONCLUSION: The study findings suggested that the implementation of the Tai Chi app combined FB health tips program had positive effects on BCS’s mental health. Also, offering a health education program could be beneficial to BCS’s physical health as well. The present findings are meaningful given that physical activity plays an important role in promoting health and reducing cancer-related death and breast cancer events (e.g., recurrence, new breast cancer primaries) in BCS.

Adaptation of the Patient Reported Outcome Measurement Information System (PROMIS) tool for childhood cancer in India: A qualitative study.

To fill the gap in patient-reported outcome (PRO) assessment in children with cancer in India, we planned to adapt domains from the HealthMeasures Patient Reported Outcomes Measurement Information System (PROMIS) tool. This study attempted to identify and pool outcomes relevant to children with cancer and their caregivers in Northern India. The study was qualitative and conducted through focussed group discussions (FGDs) and in-depth interviews of children with cancer and their caregivers. Content analysis of transcripts from the sessions was done. The collected themes were collated with existing item banks of the PROMIS tool and new concepts unique to our population were compiled. A set of three FGDs and 14 interviews each for children and their caregivers were conducted. Following content analysis, 121 themes were identified including 10 new concepts. Themes pertaining to the physical domain were cited most. The theme distribution across the three domains was similar among children and caregivers. In the survivor cohort, the relative frequency of mention of psychological and social themes was higher compared to the whole cohort. Themes pertaining to mobility, cognitive dysfunction and peer relationships were more common among survivors. This qualitative study in children with cancer and their caregivers in India has facilitated a better understanding of the issues pertaining to cancer care that are of most importance to its stake holders. The themes collected may be used to formulate a PRO tool uniquely tailored for use in this population.