Global Physical Health Research Articles

Ridge Regression for Functional Form Identification of Continuous Predictors of Clinical Outcomes in Glomerular Disease

Introduction: Penalized regression models can be used to identify and rank risk factors for poor quality of life or other outcomes. They often assume linear covariate associations, but the true associations may be nonlinear. There is no standard, automated method for determining optimal functional forms (shapes of relationships) between predictors and the outcome in high-dimensional data settings. Methods: We propose a novel algorithm, ridge regression for functional form identification of continuous predictors (RIPR) that models each continuous covariate with linear, quadratic, quartile, and cubic spline basis components in a ridge regression model to capture potential nonlinear relationships between continuous predictors and outcomes. We used a simulation study to test the performance of RIPR compared to standard and spline ridge regression models. Then, we applied RIPR to identify top predictors of Patient-Reported Outcomes Measurement Information System (PROMIS) adult global mental and physical health scores using demographic and clinical characteristics among N = 107 glomerular disease patients enrolled in the Nephrotic Syndrome Study Network (NEPTUNE). Results: RIPR resulted in better predictive accuracy than the standard and spline ridge regression methods in 56–80% of simulation repetitions under a variety of data characteristics. When applied to PROMIS scores in NEPTUNE, RIPR resulted in the lowest error for predicting physical scores, and the second-lowest error for mental scores. Further, RIPR identified hemoglobin quartiles as an important predictor of physical health that was missed by the other models. Conclusion: The RIPR algorithm can capture nonlinear functional forms of predictors that are missed by standard ridge regression models. The top predictors of PROMIS scores vary greatly across methods. RIPR should be considered alongside other machine learning models in the prediction of patient-reported outcomes and other continuous outcomes.

A Multicenter Prospective Investigation on Patient Physical and Mental Health After Girdlestone Resection Arthroplasty

BackgroundGirdlestone resection arthroplasty is a salvage procedure for hip periprosthetic joint infection (PJI) that controls infection and reduces chronic pain, but may result in limited postoperative joint function. The aim of this study was to assess physical function and mental health after Girdlestone. MethodsThis was a multicenter, prospective study evaluating patients with Girdlestone. The Prosthesis Evaluation Questionnaire (PEQ) and patient-reported outcomes measurement information system (PROMIS) global physical health and mental health surveys were administered postoperatively via telephone. The PEQ consists of four scales (ie, ambulation, frustration, perceived response, and social burden) with scores ranging from 0 to 10. The PROMIS measures generated T-scores (mean: 50, standard deviation: 10) that enable comparison to the general population. ResultsThirty-five patients completed all surveys. The average time from procedure to survey completion was 6 years (range, 1 to 20). The median scores for the ambulation, frustration, perceived response, and social burden scales of the PEQ were 0.0 [interquartile range: 0-4.1], 6.0 [3.0-9.3], 9.0 [7.2-10.0], and 7.5 [4.3-9.5]. The median raw scores of the PROMIS global physical health and mental health were 11.91 [interquartile range: 9-14] and 14.0 [10.0-16.0]. These corresponded to average T scores of 39.7 (standard error : 4.3) for physical health and 46.1 (standard error: 3.8) for mental health, which were 10.3 points and 3.9 points below the average score in the United States general population, respectively. ConclusionGirdlestone can have a substantial negative impact on physical functions; however, mental health and social interaction may be only moderately affected. These outcomes can be used to guide patient expectations, as this procedure may be necessary in certain salvage scenarios.

Patient Reported Outcomes after Ferric Carboxymaltose Treatment for Iron Deficiency Anemia: A Prospective Observational Study

Objective: Fatigue is a common symptom reported by iron deficiency anemia (IDA) patients. Iron deficiency has also been shown to reduce physical function independent of anemia. Parenteral iron therapy is indicated for the treatment of iron deficiency anemia (IDA) in patients who are intolerant or nonresponsive to oral iron. This study assessed fatigue symptoms and patient-reported functioning in IDA patients for up to 6 months after treatment with ferric carboxymaltose (FCM). Methods: This prospective, single arm, longitudinal observational study included adult patients diagnosed with IDA who were prescribed FCM under routine clinical care across 7 clinical practice sites in US. Eligible patients had baseline serum hemoglobin of >7 g/dL and <13 for males or <12 for females, no potential contraindications to FCM, and no parenteral iron therapy within 3 months before study enrollment. Patients completed patient-reported outcome (PRO) questionnaires prior to receiving FCM treatment, and at 3 months and 6 months after the first course of FCM. PROs included the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale, the Patient Reported Outcomes Measurement and Information System (PROMIS) Physical Function v2.0 Short Form, and the PROMIS Global Health v1.2 Short Form (physical and mental health). A higher FACIT-Fatigue or a lower PROMIS Physical Function, PROMIS Global Physical Health or Mental Health score indicate more health problems. For each measure, a mean change from baseline of ≥5 points was considered clinically meaningful. Associations between baseline serum hemoglobin and each PRO score were assessed using Spearman's rank correlation coefficient. Results: 152 patients with median IDA history of 2.0 years were included in the intent-to-treat population (mean age=47.4 ± 16.0 years, 82.2% females, 17.1% with inflammatory bowel disease, 13.8% with abnormal uterine bleeding, 9.2% with cancer, mean baseline serum Hgb =10.19±1.35 g/dL). About one-third of patients (34.9%) had oral iron treatment and 2.6% had a blood transfusion within 3 months prior to FCM treatment. A small proportion of patients (6.6%) had parenteral iron treatment in the 12 months before study enrollment. Most patients (83.6%) were prescribed 2 doses of FCM (total dose of 1500mg) at baseline. Within 6 months after the first course of FCM, no patient received treatment with erythropoietin stimulating agents, 1 patient received a blood transfusion, and 14 (9.7%) patients required additional IV iron treatment after the initial course of FCM treatment prescribed at baseline. Median time from baseline to additional IV treatment was 86.5 days. Fatigue symptoms were improved after FCM treatment, as indicated by significantly lower mean FACIT-Fatigue scores at 3 months (50.19 ± 9.51) and at 6 months (52.42 ± 9.31) compared to baseline (61.01 ± 8.96), with p<0.0001 each. A majority of patients had a reduction of at least 5 points in FACIT-Fatigue score from baseline to 3 months (72.7%) and 6 months (67.3%), respectively. Physical function also improved, as indicated by significantly higher mean PROMIS Physical Function score at 3 months (46.08 ± 8.52) and 6 months (45.15±8.85) compared to baseline (41.31±8.63), with p<0.0001 each. Improvements in PROMIS Global Physical Health (p<0.0001) and the PROMIS Global Mental Health score (p=0.0027) were also observed at 3 months and 6 months compared to baseline. Correlations between baseline serum hemogloblin levels and PRO scores were borderline to highly significant, with correlation coefficients of 0.151 (p=0.0647) with PROMIS Global Mental Health, 0.276 (p=0.0006) with Global Physical Health, 0.286 (p=0.0004) with PROMIS Physician Function and -0.294 (p=0.0002) with FACIT-Fatigue. Conclusions: IDA patients treated with FCM reported significant reduction in fatigue symptoms and improvements in physical function, physical health and mental health at 3 months after treatment. These benefits were sustained at 6 months after treatment, with only a small proportion of patients requiring re-treatment with additional IV iron beyond the initial course of FCM treatment. Significant correlations between serum Hgb and PRO scores observed in this study suggest that data collected directly from patients in a real-world setting can provide a valuable supplement to traditional clinical outcomes for evaluating treatment effectiveness. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Higher comorbidity burden is associated with lower self-reported quality of life after stroke.

This study assesses the association of comorbidity burden and polypharmacy with self-reported quality of life after stroke. We performed a post-hoc analysis of a prospective, single-center, observational study of outcome evaluation by patient-reported outcome measures in stroke clinical practice. Consecutive patients with acute ischemic stroke (AIS) were enrolled and self-reported health-related quality of life (HrQoL) was assessed 90 days after acute stroke using the Patient-reported Outcomes Measurement Information System 10-Question Short-Form (PROMIS-10). Comorbidities at baseline were assessed by the Charlson Comorbidity Index (CCI). Polypharmacy was defined as medication intake of ≥5 at baseline. We used linear regression analysis to study the association of CCI, polypharmacy and other clinical covariates with HrQoL after stroke. Of 781 patients (median age 76 years, 48.4% female) enrolled, 30.2% had a CCI Score ≥2, and 31.5% presented with polypharmacy. At follow up, 71 (9.1%) had died. In 409 (52.4%) reached for outcome evaluation, Global Physical Health T-Score was 43.8 ± 10 and Global Mental Health T-Score was 43.5 ± 8.76, indicating lower HrQoL than the average population. A CCI Score ≥2, higher NIHSS Score, female sex, dependency on others for dressing, toileting and mobility before index stroke, atrial fibrillation and hypertension were independent predictors of worse physical and mental health outcomes, while polypharmacy was not. In patients with AIS, high comorbidity burden and polypharmacy are frequent. Comorbidity burden at admission is independently associated with worse self-reported physical and mental health three months after stroke.

Patient-Reported Outcomes for Fully Vaccinated COVID-19 Patients Over 6Weeks: The Experiences of Clinical Breakthrough Cases.

While coronavirus disease 2019 (COVID-19) vaccines have high rates of efficacy, fully vaccinated individuals can become infected with COVID-19. Among this population, symptoms tend to be less severe and shorter lasting. Less is known about how vaccinated individuals who contract COVID-19 experience the disease through patient-reported outcomes (PROs) and how this changes over time. The aim of this study was to describe the physical, mental, and social health PROs for fully vaccinated individuals who contracted COVID-19 over a 6-week period. Prospective design using the Patient-Reported Outcomes Measurement Information System short-form (PROMIS-10) collected through a mobile application-based platform. 1114 fully vaccinated patients who tested positive for COVID-19 at a large US health system and engaged with the study on or after 1 March 2021 and reported onset of illness prior to 1 November 2021. Global physical and mental health PROMIS-10 T-scores for the 6-week period, component PROMIS-10 questions for the 6-week period, and component PROMIS-10 questions restricted to a subset of participants for the first month to measure individual recovery were analyzed. Mean global physical and mental health T-scores increased over time and remained within one standard deviation of the population mean. At baseline, at least 40% of participants reported good health for all component questions except Fatigue (25%), and the proportion reporting good health increased over time for all questions, with the largest improvements in Fatigue (25.5 to 67.5%), Pain (59.1 to 82.8%), and Emotional Problems (42.3 to 62.5%). Over the first month, the greatest positive changes in individual recovery were observed for Fatigue (65.0%), Pain (53.0%), and Emotional Problems (41.1%); at least 30% of respondents reported no change in at least one category, and the greatest decreases were for Usual Social Activities (23.9%), Social Satisfaction (23.2%), and Mental Health (21.8%). This study provides an important step towards better understanding the impact of 'breakthrough' COVID-19 infections on clinically engaged, fully vaccinated patients' physical and mental health to improve support for their treatment and recovery.

The impact of TK2 deficiency syndrome and its treatment by nucleoside therapy on quality of life

TK2d is an ultrarare autosomal recessive mitochondrial DNA depletion syndrome. Nucleoside therapy improves or stabilizes disease across key outcomes including survival, ambulation, and requirement for mechanical ventilation. However, little is known about the effects of nucleoside therapy treatment of TK2d from the patient's perspective. This study sought to address this knowledge gap. Participants with TK2d and/or their parents/caregivers completed online surveys with standardized health measures and interviews. During interviews, participants rated and described TK2d’s impact on 13 quality of life domains, changes since starting nucleoside therapy, and if they would recommend nucleoside therapy. Twenty-five individuals participated (17 adults with TK2d, 4 parent-participant pairs, 4 parents of children with TK2d). Adult participants with TK2d had clinically meaningfully worse scores than the general population on global physical and mental health, physical function, pain interference, fatigue, anxiety, and social function. Children’s mobility and pain interference were significantly worse than the general pediatric population. Physical domains most affected by TK2d were: mobility (84%), fatigue (60%), respiratory function (56%), and hospitalizations (55%). Psychosocial domains most affected were: impact on family members (39%), mood (36%), and social life (28%). Most (77%) treated patients reported improvement; whereas, 67% in the untreated group reported worsening. All participants would recommend nucleoside therapy. In summary, TK2d has significant negative impacts on most areas of life and function. Measures of fatigue, sleep, swallowing/eating, speaking, and mood, should be considered as outcomes in clinical trials and research studies. Nucleoside therapy appears to provide meaningful improvements across many health domains affected by TK2d. SynopsisThe consequences of having TK2d are devastating for both those with the disorder and their families; however, nucleoside therapy appears to provide meaningful improvements across many health domains affected by TK2d.

Patient-Reported Quality of Life in Adolescents and Young Adults with Cancer before, during, and after Radiation Therapy

<h3>Purpose/Objective(s)</h3> Adolescents and young adults (AYAs, 15-39 yo) with cancer have unique vulnerabilities that affect quality-of-life (QOL) during treatment and in survivorship. Yet, few studies have assessed QOL in AYAs with cancer who received radiation therapy (RT). Therefore, we performed a cross-sectional study in AYAs with cancer who completed patient-reported outcomes (PROs) assessing QOL before, during, or after RT. <h3>Materials/Methods</h3> We identified 265 AYAs with cancer who were treated with RT and completed an AYA PRO survey from 2019-2022. The survey containing ten validated PRO instruments from the PROMIS inventory: Global Physical and Mental Health, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Roles, Pain Interference, and Cognitive Function (score of 50 represents the mean from the reference U.S. general population; higher score represents more of the concept being measured). Patients were stratified into 3 cohorts based on the date of PRO completion: before RT, peri-RT (during RT or within 6 months of RT completion), or after RT (6+ months following RT completion). Mean (standard deviation [SD]) PRO scores were calculated. Patient characteristics were extracted from the medical record. Kruskal-Wallis analysis was used to compare scores between cohorts. ANOVA and t-test analyses were used to compare scores between co-variates. <h3>Results</h3> 87 (33%) patients completed PROs before RT, 84 (32%) peri-RT, and 94 (35%) after RT; median [IQR] age was 28 [21-33], 26 [20-32], and 22 [17-27], respectively. Cancer types varied; most had sarcoma (26%) or CNS cancer (23%). Compared to the before RT cohort, the peri-RT cohort had worse Global Physical and Mental Health PRO scores [SD] (48.7 [8.9] vs. 44.9 [9.8] (p=0.03) and 50.9 [8.6] vs. 46.2 [10.3] (p<0.01), respectively). These PRO scores were similar between the peri- and after RT cohorts (44.9 [9.8] vs. 45.5 [9.8] (p=0.68) and 46.2 [10.3] vs. 47.9 [9.6] (p=0.26), respectively). Compared to the before RT cohort, the peri- and after RT cohorts had better Anxiety PRO scores [SD] (55.2 [9] vs. 52.6 [10.4] and 51 [10], respectively, p=0.02). Remaining PRO scores were similar between cohorts (p>0.05). In the peri-RT cohort, patients with any acute RT toxicity had worse Pain Interference PRO scores [SD] vs. patients with none (50.8 [8.9] vs. 44.7 [5.7], p=0.03). In the after RT cohort, adolescents (15-18 yo) and young adults (26-39 yo) had worse Global Mental Health PRO scores [SD] vs. emerging adults (19-25 yo) (46.9 [9.1] and 47.9 [11.2], respectively, vs. 53.8 [9.2], p=0.04); patients with any late RT toxicity had worse Sleep Disturbance PRO scores [SD] vs. patients with none (58.4 [8] vs. 52.4 [9.2], p<0.001). <h3>Conclusion</h3> AYAs with cancer reported lower general physical and mental health QOL scores during RT, which persisted into survivorship. Developmental age, stage, and presence of RT toxicities may contribute to differing scores. Future longitudinal analyses are needed to improve QOL for AYAs receiving RT.

Long-Term Patient-Reported Outcomes of Ultrasound-Guided Carpal Tunnel Release

INTRODUCTION: The use of ultrasound-guided carpal tunnel release (US-Guided CTR) is a cost-effective, less invasive solution for carpal tunnel syndrome but lacks comprehensive previously reported outcomes. This report adds to existing literature of one-year outcomes following US-Guided CTR by a single surgeon. METHODS: This retrospective chart review included patients having undergone US-Guided CTR between September 2017 and October 2020. As part of the standard of care, patients were mailed surveys at one-year postsurgery, with 183 of 300 (61%) surveys returned and included in data analysis. Incomplete postoperative clinic notes were present in seven patients, but the surveys were included in data analysis. Pre- and two-week post-operative clinical outcomes were collected and one-year patient-reported outcomes included Boston Carpal Tunnel Questionnaire Function (BCTQ-F) and Symptom (BCTQ-S) scores, PROMIS Global Physical Health (GPH) and Global Mental Health (GMH) scores, and satisfaction ratings (1 = very unsatisfied, 5 = very satisfied). RESULTS: Overall, the average age was 65.1 ± 12.7 years and 82 (44.8%) patients were male. Prior to operations, clinical symptoms included pain (100%), numbness (99.5%), and night pain (98.4%). At two weeks postoperation, 173/175 (98.9%) patients had full range of motion and 168/176 (95.5%) had no residual sensory deficits. No complications, reoperations, or pillar pain occurrences were noted. One-year postoperative outcomes included: BCTQ-S = 1.7 ± 0.8, BCTQ-F = 1.6 ± 0.8, GPH = 49.5 ± 8.8, GMH = 51.4 ± 8.5, and 85% of patients reported “satisfied” or “very satisfied.” CONCLUSION: With proper surgical training, US-Guided CTR is a feasible option for carpal tunnel syndrome and provides early recovery and good patient outcomes.

Profiles of executive functioning and neuroticism in emerging adulthood: Concurrent associations with psychopathology and health-related quality of life

Objective: We employed latent profile analysis (LPA) to discern configurations of executive functioning (EF) and neuroticism (NE) and tested their concurrent validity with respect to internalizing and externalizing problems and physical health. Participants: A total of 125 college students completed the study. Methods: Participants self-reported NE and EF on separate normed rating scales and completed computerized tests of EF. Self-reported internalizing problems, externalizing problems, and global physical health were collected. Results: LPA revealed four profiles: (1) Lower EF + Higher NE, (2) Higher EF + Lower NE, (3) Inconsistent EF + Higher NE, and (4) Inconsistent EF + Lower NE. Adjusting for covariates, profiles were differentially associated with internalizing problems, externalizing problems, and physical health. Conclusions: Screening EF and NE in college students may identify those at risk for psychopathology and physical health concerns. Tailored prevention and intervention efforts on college campuses targeting EF and NE may enhance well-being.

Are Detailed, Patient-level Social Determinant of Health Factors Associated With Physical Function and Mental Health at Presentation Among New Patients With Orthopaedic Conditions?

Are Detailed, Patient-level Social Determinant of Health Factors Associated With Physical Function and Mental Health at Presentation Among New Patients With Orthopaedic Conditions?

Orthopaedic Foot and Ankle Post-Operative Outcomes: The University of Colorado Orthopaedic Surgery Monitoring of Outcomes System (U-COSMOS)

Category: Other; Ankle; Hindfoot; Lesser Toes; Midfoot/Forefoot Introduction/Purpose: The automation and integration of patient reported outcomes (PROs) into standard of care practice and electronic health systems is becoming increasingly viable. While often collected as a quality assurance measure for a practice and surgical decision-making, PROs are also valuable to assess the relative treatment outcomes. In order for physicians to gain the most insight from PROs, more baseline outcomes are needed to serve as a benchmark of anticipated patient improvement following surgical interventions. The goal of this study is to evaluate differences in patient improvement among validated physical and mental health PROs in a foot and ankle surgery practice. Methods: Consecutive patients undergoing foot and ankle surgery were enrolled into the U-COSMOS pathway. All PROs are automatically distributed and tracked through a secure, HIPAA-compliant, online PRO data capture tool. All patients are invited to complete the PROMIS Physical Function (PF) Computer Adaptive Test (CAT), PROMIS Pain Interference CAT (PI), Foot and Ankle Single Assessment Numeric Evaluation (SANE), PROMIS Global Physical Health (GPH), PROMIS Global Mental Health (GMH), PROMIS Depression, and a brief resiliency scale (BRS). PROs are collected pre-operatively, and post-operatively at 3- months, 6-months, 12-months, and 24-months. In this study, differences between pre- and post-operative scores for each PRO are evaluated using an unpaired Mann-Whitney U Test. Results: To date, 3154 patients have been enrolled into the U-COSMOS foot and ankle surgery pathway. Overall survey compliance was 77%. A significant improvement was seen in PF, PI, SANE, and GPH at 6-months, 12-months, and 24-months (p &lt; 0.0001, see Table 1). There was no significant improvement in PF or GPH at the 3-month mark, supporting reduction of pain interference may be observed before return of physical function. All PROs measuring changes in mental health or resilience (Depression, GMH, BRS) did not significantly change at any post-operative visit relative to baseline. We found a mild positive correlation between BRS and improved 12-month PF and PI outcomes and a mild inverse correlation between pre-operative depression and 12-month PI and PF scores. Conclusion: Our data suggests that foot and ankle surgery leads to significant improvement in physical outcomes such as function or pain interference, but mental health and resilience outcomes remain somewhat unchanged throughout treatment on average. Within physical outcomes, we also find significant improvement in pain interference precedes functional and general measures. Early findings from the U-COSMOS outcomes pathway demonstrates greater overall improvement in physical health PROs, and a sustained improvement up to 24 months post-op. Future investigation of outcomes specific to procedures and conditions within the U-COSMOS pathway will help elucidate anticipated variation from general trends.

A Patient-Reported Outcome Based Comparison of Cheilectomy with and without Proximal Phalangeal Dorsiflexion Osteotomy for Hallux Rigidus

Category: Midfoot/Forefoot Introduction/Purpose: Cheilectomy with and without Moberg osteotomy is used to improve function and remove pain in early- moderate stage hallux rigidus. The rise of patient-reported outcome measurements allows greater precision in comparing treatments as value-driven paradigms become increasingly important in clinical decision-making. This study provides the first comparison of patient-reported outcomes between isolated cheilectomy (C) and cheilectomy with Moberg (CM) osteotomy for hallux rigidus. We compared one and two-year PROM scores between patients who underwent C and CM for hallux rigidus using PROMIS, a validated patient-reported outcomes measurement system, and compared rates of complications and subsequent operations between the two groups. We hypothesized that patients who underwent CM would experience better clinical outcomes and fewer returns to the operating room than patients undergoing cheilectomy alone. Methods: A single-center, retrospective registry search identified all patients with preoperative PROMIS scores who underwent cheilectomy, with and without concomitant proximal phalangeal dorsiflexion osteotomy, for hallux rigidus between January 2016 and December 2020. An a priori power analysis determined that 24 patients per cohort were needed to detect a previously published minimum clinically important difference of 5.8 points on the PROMIS Physical Function scale with alpha = .05 and 80% power. However, all C patients were included. Because there were far fewer isolated cheilectomies (62), all C patients were compared with a commensurate number of consecutive CM cases (67) using preoperative, one-year, and two-year PROMIS scores for Physical Function, Pain Interference, Pain Intensity, Global Physical Health, Global Mental Health, and Depression, as well as complication and revision data from chart review. Age, sex, BMI, preoperative radiographic hallux rigidus grade, and preoperative range of motion were compared between the two cohorts. Results: PROMIS outcome data is given in Table 1. Both groups demonstrated statistically significant improvements in PROMIS Physical Function, Pain Interference, Pain Intensity, and Global Physical Health (P &lt;.001 for all, both preoperative to one-year and preoperative to two-year), but not Global Mental Health or Depression. There were no differences between groups among the demographic and preoperative variables compared. The CM cohort reported worse Pain Interference scores preoperatively (58.1+- 5.9 vs. 52.4 +- 7.01, P &lt; .001) and at one year (50.0 +- 9.3 vs. 45.1 +- 9.8, P = .01), while the C cohort reported worse Pain Intensity scores preoperatively (55.6 +- 7.3 vs. 49.6 +- 6.8, P &lt; .001) and at one year (45.9 +- 8.0 vs. 39.9 +- 8.2, P &lt; .001). These differences were no longer significant at two years postoperatively. There were no statistically significant differences between cohorts for additional PROMIS scores or complications data. Conclusion: The addition of a Moberg osteotomy does not appear to significantly change short-medium term outcomes of cheilectomy for hallux rigidus treatment. Our data contradicts the notion that addition of a Moberg osteotomy increases the likelihood of postoperative complications. The overall good results found for both procedures, as well as the general similarity between outcomes between them, suggest that external considerations like recovery time, comfort level with a more invasive osteotomy, and overall goals with surgery may be of greater importance than short-term clinical outcomes when deciding on the appropriate course of treatment for a given patient.

Lateral Trans-Fibular Total Ankle Replacement Capability in Correcting Ankle Osteoarthritis Deformities and Improving Clinical Outcomes

Category: Ankle; Ankle Arthritis; Hindfoot; Other Introduction/Purpose: Total ankle replacement (TAR) has been shown as a viable surgical option to reduce pain, improve function, and preserve ankle joint range of motion in patients with Ankle osteoarthritis (AO). Standard anterior approach TAR capability in correcting deformities is already established by several studies. However, there is a paucity of literature evaluating patient outcomes as well as the potential to correct alignment using a lateral approach TAR. Therefore, the primary objective of this study was to assess the capability of lateral trans-fibular approach TAR in correcting coronal and sagittal plane deformity and secondarily to report the ability to improve patient-reported outcomes (PROs) following lateral TAR. Methods: This IRB-approved, retrospective comparative study included 14 consecutive patients that underwent lateral trans- fibular approach TAR for end-stage AO. Average age and BMI were 63.9 years (range 43-83) and 32.7 kg/m2 (SD 7.5). All patients had received pre- and post-operative weight-bearing CT imaging on the affected foot and ankle. Foot and Ankle Offset (FAO), Talar Tilt Angle (TTA), Hindfoot Moment Arm (HMA), and Lateral Talar Station (LTS) were performed. PROs were collected pre- and post-operatively at the latest clinical follow-up including: PROMIS Global Physical Health score, the Tampa Scale of Kinesiophobia (TSK), the European Foot and Ankle Society (EFAS) score, the Pain Catastrophizing Scale (PCS) and the Foot and Ankle Ability Measure (FAAM) Daily Living Score. One-way ANOVA and Wilcoxon tests were used for comparison at each interval time period. A multivariate regression analysis was then performed to evaluate the association between change in alignment and improvements of PROs. Results: Three of 14 patients (21.4%) underwent a concomitant osseous re-alignment procedure. At an average of 16.1 months (range 11 to 24), all patients demonstrated a significant deformity correction in measurements performed: FAO (7.73% - 3.63%, p=0.031), HMA (10.93mm - 5.10mm, p=0.037), TTA (7.9o - 1.5o, p=0.003), and LTS (5.25mm - 2.83mm, p=0.018). Four of the PROs demonstrated significant improvement postoperatively: TSK (42.7-34.5, p=0.012), PROMIS Global Physical Health (46.1- 54.5, p=0.011), EFAS (5-10.3, p=0.004), and FAAM (60.5-79.7, p=0.04). PROMIS was associated (p=0.0015) with optimization of FAO (p=0.00065) and LTS (p=0.00436), R2 of 0.98). Improvements in TSK were associated with changes in the HMA (p=0.0074), R2 of 0.66. Improvements in FAAM correlated (p=0.048) with improvements in FAO (p=0.023) and TTA (p=0.029), and an R2 of 0.78. Conclusion: In this retrospective comparative cohort study, the results suggest that the lateral trans-fibular TAR can correct different aspects of AO deformity. Clinical benefit was also demonstrated by the impacted PROs, particularly TSK, PROMIS Global Physical Health, EFAS, and FAAM Daily Living. Direct and strong correlations between deformity correction measurements and the significantly improved PROs were found. The obtained data might help surgeons when planning treatment and may serve as the basis for future comparative prospective studies.

A Prospective Evaluation of a 4th Generation Total Ankle Prosthesis with 2-Year Follow-Up

Category: Ankle Arthritis; Ankle Introduction/Purpose: The availability of fourth-generation ankle replacements has burgeoned over the past several years. These ankle replacements benefit from improved surgical technique, respect for bony preservation, and increased surgeon awareness of operative indications. Documentation of implant survivability and comparison studies of the latest generation implants are limited. The purpose of this study is report on prospectively collected patient reported outcome measures (PROMs) in a multi-institutional study of a fourth-generation total ankle. Methods: Patients presenting for a total ankle replacement at 9 institutions were prospectively enrolled and implanted in both academic and private settings. Each patient received an INFINITY ankle prothesis (Stryker, Memphis, TN, USA) Patients had demographics and PROMs recorded pre-operatively and at 6 month, 12 months, and 24- month intervals. The following PROMs were collected: Ankle Osteoarthritis Score (AOS), PROMIS Global Physical Health, Foot and Ankle Outcome Score (FAOS), and satisfaction scores. The preoperative and latest follow-up scores for patients with two years of follow-up were analyzed. Results: A total of 147 patients were enrolled :(54.7% male) average age of 64.2 +- 9.4 years old, average BMI of 31.0 +- 5.2. pre- operative diagnosis for arthritis type was degenerative arthritis (48.7%), rheumatoid arthritis (2.7), post-traumatic arthritis (47.9%), and other (0.70%). Thirty-seven percent of patients had previously undergone surgery at the index joint. Eighty-eight patients had at least two years of follow-up. There were 3 (1.3%) clinical failures:(2 with aseptic tibial component loosening: at months 17 and 21, and 1 tibial subsidence at month 14). The patients improved in all PROMs domains at two years including: Mean Total AOS (17.2 +- 18.3, p&lt;.0001); PROMIS Global Physical Health (47.6 +- 7.4, p&lt;.0001); Total FAOS (76.3 +- 18.7, p&lt;.0001). 97.5% of patients were satisfied with their surgery. Conclusion: At two-year post-implantation follow-up, the INFINITY total ankle replacement had a low revision rate and proved to be safe and effective compared to historical ankle replacement outcomes. Patients were overwhelmingly satisfied and had statistically significant clinical improvements in each domain of their PROMs.

Impact of Asymptomatic Flatfoot on Clinical and Radiographic Outcomes of the Modified Lapidus Procedure in Patients with Hallux Valgus

Category: Midfoot/Forefoot; Bunion Introduction/Purpose: Patients presenting for hallux valgus frequently have an associated flatfoot deformity; however, many are not symptomatic. It is unclear if an asymptomatic flatfoot adversely affects outcomes of hallux valgus correction and should be simultaneously addressed. Prior studies have demonstrated that flatfoot alignment may not affect clinical outcomes after osteotomy procedures, yet no studies have investigated whether this also affects outcomes of the modified Lapidus procedure. The modified Lapidus achieves multiplanar correction through the tarsometatarsal (TMT) joint and stabilizes the medial column, which may be advantageous for flatfoot pathology. We aimed to investigate the relationship between asymptomatic flatfoot and patient-reported and radiographic outcomes after modified Lapidus for hallux valgus. We hypothesized that clinical and radiographic outcomes would be minimally affected by the presence of asymptomatic flatfoot. Methods: This was a retrospective cohort study including 142 patients who underwent the modified Lapidus procedure for hallux valgus at a single institution by 1 of 10 fellowship-trained foot and ankle surgeons. Sixty-one patients met radiographic criteria for asymptomatic flatfoot, which were 1) Meary's angle &gt; 4 degrees, 2) calcaneal pitch &lt; 18 degrees, and talonavicular coverage angle (TNCA) &gt; 7 degrees. Patients with cavus deformity were excluded. Preoperative and minimum 1-year postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores between asymptomatic flatfoot and control groups were compared. Radiographic assessment involved comparisons of hallux valgus angle (HVA), intermetatarsal angle (IMA), Meary's angle, talonavicular coverage angle (TNCA), and calcaneal pitch (CP). Preoperative and postoperative radiographic measures were compared to assess improvement in hallux valgus and flatfoot parameters. Results: Preoperatively, the flatfoot group had higher BMI (24.6 vs 22.6, P &lt; .01). Both groups demonstrated preoperative to postoperative improvement in PROMIS physical function (P &lt; .01), pain interference (P &lt; .001), pain intensity (P &lt; .001), and global physical health (P &lt; .001). There were no preoperative or postoperative differences in PROMIS scores between groups (Table 1). Preoperatively, the flatfoot group had a higher IMA (15.2 vs 14.0 degrees, P = .02). Postoperatively, there were no differences in HVA or IMA between groups; however, the flatfoot group exhibited greater deformity in Meary's angle (8.3 vs -0.1 degrees), TNCA (19.2 vs 14.3 degrees), and CP (15.1 vs 19.6 degrees) (all P &lt; .001). Both cohorts demonstrated significant preoperative to postoperative improvement in all radiographic parameters except for CP in the control group (P = .95). Conclusion: There were no significant postoperative differences in patient-reported outcomes of the modified Lapidus procedure between patients with and without asymptomatic flatfoot. Both groups achieved similar excellent radiographic correction of their hallux valgus deformity. Although radiographic flatfoot parameters did not improve to the level of control patients, patients experienced clinical improvement, without adverse outcomes or new flatfoot symptomatology. The modified Lapidus effectively corrects forefoot deformity and concurrently addresses instability at the first TMT joint, making it a valuable option for hallux valgus correction in patients with asymptomatic flatfoot.

Correlation of the Modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score with Patient-Reported Outcome Scores for Postoperative Assessment of Ankle Osteochondral Lesions

Category: Ankle; Arthroscopy; Trauma Introduction/Purpose: The MOCART scoring system is commonly used in both the knee and ankle literature to quantitatively assess cartilage repairs on MRI. For both the knee and ankle, MOCART scores have demonstrated little ability to correlate with clinical outcomes such as survey scores. The system also suffers from issues with repeatability and reproducibility of individual scores. This study seeks to analyze the correlation between MOCART scores and PRMOIS scores obtained from the same time period from patients undergoing surgical management of an osteochondral lesion of the talus. It also seeks to determine MOCART's intra-rater reliability by analyzing multiple independent scoring attempts by the same radiologist. We hypothesized that MOCART scores would correlate with PROMIS outcomes and be repeatable for a given rater. Methods: Patients treated for an osteochondral lesion of the talus by a single surgeon in our department were screened for the existence of preoperative and postoperative MRI and survey scores completed within five months of one another. Each MRI was scored using the MOCART system by one radiologist fellowship-trained in musculoskeletal radiology on two separate occasions, with at least one week between scoring attempts. Each MOCART category and the overall score was compared to each PROMIS category. We also compared the presence of cysts and edema, as noted by the raters, to each PROMIS category. Results: MOCART scores were found to be repeatable between scoring attempts for individual categories and especially for the overall score. Preoperative MOCART scores correlated positively to preoperative PROMIS scores for the Physical Function (r= 0.0173), Pain Interference (r=0.1093), and Depression (r=0.0812) domains. Postoperative MOCART scores correlated positively with postoperative PROMIS scores for the Physical Function (r=0.1639) and Global Physical Health (r= 0.2152) domains. Postoperative MOCART scores did not correlate positively to change in PROMIS scores nor did change in MOCART scores correlate positively to change in PROMIS scores as we had expected. One significant correlation existed between postoperative MOCART score and pre to postoperative change in PROMIS Global Mental Health, but the correlation was negative (r= -0.527; p= 0.044). The presence of cyst and edema likewise did not demonstrate any consistent pattern. Conclusion: While the MOCART score may be repeatable for a given reader, it faces significant issues with correlation to PROMIS outcomes. This has been noted before for certain surgical techniques and other outcomes measurements. We find that this pattern holds true more broadly when looking at a range of methods for the treatment of osteochondral lesions. While quantitative evaluation of MRI is important for better understanding cartilage repair techniques, problems with the MOCART system should be acknowledged and solutions considered.

Rotator cuff tendinopathy: magnitude of incapability is associated with greater symptoms of depression rather than pathology severity

Population-based studies have established that rotator cuff tendinopathy develops in most persons during their lifetimes, it is often accommodated, and there is limited correspondence between symptom intensity and pathology severity. To test the relationship between effective accommodation and mental health on its continuum, we studied the relative association of magnitude of capability with symptoms of anxiety or depression compared with quantifications of rotator cuff pathology such as defect size, degree of retraction, and muscle atrophy among patients presenting for specialty care. We analyzed a retrospective cohort of 71 adults seeking specialty care for symptoms of rotator cuff tendinopathy who underwent a recent magnetic resonance imaging scan of the shoulder and completed the following questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire (a measure of symptom intensity and magnitude of capability, consisting of mental and physical health subscores), Generalized Anxiety Disorder questionnaire (measuring symptoms of anxiety), and Patient Health Questionnaire (measuring symptoms of depression). Two independent reviewers measured the sagittal length of the rotator cuff defect and tendon retraction in millimeters on magnetic resonance imaging scans (excellent reliability) and rated rotator cuff muscle atrophy and fatty infiltration (more limited reliability), and we used the average measurement or rating for each patient. Multivariable statistical models were used to identify factors associated with the PROMIS Global Health score and mental and physical health subscores. Accounting for potential confounding in multivariable analysis, lower PROMIS Global Health total scores and physical health subscale scores were independently associated with greater symptoms of depression but not with measures of pathology. Lower PROMIS mental health subscale scores were independently associated with greater symptoms of anxiety and greater muscle atrophy. The observation that magnitude of incapability among patients seeking care for symptoms of rotator cuff pathology is associated with symptoms of depression but not with measures of the severity of the rotator cuff pathology suggests that treatment strategies for patients who seek care for symptoms of rotator cuff tendinopathy may be incomplete if they do not anticipate and address mental health.

Association of Chronic Pancreatitis Pain Features With Physical, Mental, and Social Health

Pain is a cardinal symptom of chronic pancreatitis (CP). Using Patient-Reported Outcomes Measurement Information System (PROMIS) measures, we characterized physical and mental health and symptom profiles of a well-defined cohort of individuals with CP and compared them with control subjects. Among patients with CP, we also examined associations between pain (intensity, temporal nature) and PROMIS symptom profiles and the prevalence of clinically significant psychological comorbidities. We analyzed baseline data in 488 CP patients and 254 control subjects enrolled in PROCEED (Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies), an ongoing longitudinal cohort study. Participants completed the PROMIS-Global Health, which captures global physical and mental health, and the PROMIS-29 profile, which captures 7 symptom domains. Self-reported pain was categorized by severity (none, mild-moderate, severe) and temporal nature (none, intermittent, constant). Demographic and clinical data were obtained from the PROCEED database. Pain was significantly associated with impairments in physical and mental health. Compared with participants with no pain, CP participants with severe pain (but not mild-moderate pain) had more decrements in each PROMIS domain in multivariable models (effect sizes, 2.54-7.03) and had a higher prevalence of clinically significant depression, anxiety, sleep disturbance, and physical disability (odds ratios, 2.11-4.74). Similar results were noted for constant pain (but not intermittent pain) for PROMIS domains (effect sizes, 4.08-10.37) and clinically significant depression, anxiety, sleep disturbance and physical disability (odds ratios, 2.80-5.38). Severe and constant pain are major drivers for poor psychological and physical health in CP. Systematic evaluation and management of psychiatric comorbidities and sleep disturbance should be incorporated into routine management of patients with CP. (ClinicalTrials.gov, Number: NCT03099850).

Do COFAS Scores Effect the Outcomes of a 4th Generation Total Ankle Prosthesis? A 2-Year Follow- Up

Category: Ankle Arthritis; Ankle Introduction/Purpose: Fourth generation ankle replacements benefit from improved surgical technique, respect for bony preservation, and increased surgeon awareness of operative indications. In order to better compare and stratify pre-operative ankle arthritis patients, the Canadian Orthopaedic Foot and Ankle (COFAS) pre-operative classification for end-stage ankle arthritis score was developed. The purpose of this study is report on how the COFAS scores effects prospectively collected patient reported outcome measures(PROMs) in a multi-institutional study of a fourth-generation total ankle replacement. Methods: Patients presenting for a total ankle replacement at 9 institutions were prospectively enrolled and implanted in both academic and private settings. Each patient received an INFINITY ankle prosthesis (Stryker, Memphis, TN, USA). Patients had their COFAS pre-operative classification for end-stage ankle arthritis scores, and PROMs recorded pre-operatively and at 6 months,12 months, and 24-month intervals. The following PROMs were collected: Ankle Osteoarthritis Score (AOS), PROMIS Global Physical Health, and Foot and Ankle Outcome Score (FAOS). The preoperative and latest follow-up scores for patients with two years of follow-up were analyzed. Results: A total of 147 patients were prospectively enrolled. for study participation. COFAS types; were delineated as Type 1 (42.6%, isolated ankle arthritis), Type 2 (27.0%, ankle arthritis with varus or valgus deformity, tight Achilles, ankle instability), Type 3(4.7%, ankle arthritis with hindfoot deformity, tibial malunion), and Type 4 (25.8%, Types 1-3, plus hindfoot arthritis). Eighty-eight (88) patients had at least 24 months of follow-up. COFAS Types 1, 2, 3, and 4 patients had significant improvements in all domains of the AOS, PROMIS, and FAOS Scores (p&lt;0001). The type and severity of deformity or amount of hindfoot arthritis, hindfoot deformity, or ankle instability significantly effected the PROMs in those patients with at least 2-year follow-up. Implant revision rates were not affected by COFAS type, and there were three revisions (One Type 4 and two Type 2). Conclusion: At two-year follow-up, all study participants had significant improvements in PROMs, regardless of COFAS Type. These results suggest that COFAS type has little impact on patient outcomes using current generation total ankle replacements. Longer term follow-up may serve to further confirm these promising early results.

Does Severe Ankle Deformity Affect the Outcomes of a 4th Generation Total Ankle Prosthesis? A 2- Year Follow-Up

Category: Ankle Arthritis Introduction/Purpose: Fourth generation ankle replacements benefit from improved surgical technique, respect for bony preservation, and increased surgeon awareness of operative indications. In some studies, pre-operative degree of deformity has been reported to influence survivorship, pain, and functional outcomes. The purpose of this multi-institutional study was to evaluate whether pre- operative deformity affects prospectively collected patient reported outcome measures (PROMs) of a fourth-generation total ankle replacement. Methods: Patients presenting for a total ankle replacement at 9 institutions were prospectively enrolled and implanted in a variety of academic and private settings. Each patient received an INFINITY ankle prosthesis. (Styker, Memphis, TN, USA). The degree of deformity was radiographically classified pre-operatively as severe if ankle varus or valgus was greater than 10° in the coronal plane. PROMs were recorded pre-operatively and at 6 months, 12 months, and 24-month intervals. The following PROMs were collected: Ankle Osteoarthritis Score (AOS), PROMIS Global Physical Health, and Foot and Ankle Outcome Score (FAOS). The preoperative and latest follow-up scores for patients with two years of follow-up were analyzed. Results: A total of 147 patients were enrolled in the study. Fifty-two patients exhibited a pre-operative ankle deformity of greater than 10° varus or valgus. Eighty-eight patients had 24 months of follow-up. All patients with severe deformity had significant improvements in all domains of the AOS, PROMIS, and FAOS Scores (p&lt;0001). The degree of deformity, ankle instability, or hindfoot arthritis did not impact the PROMs (AOA p=.2661, PROMIS p=.543, FAOS p=.684) in those with 2-year follow-up.There were three revisions with varying degrees of deformity. Two patients had revisions for aseptic loosening (6o valgus and 10o varus). One patient had a revision for tibial subsidence (11o varus). Conclusion: Severe pre-operative deformity did not impact PROMs in patients undergoing implantation with a 4th generation total ankle replacement. In carefully selected patients, greater deformity did not necessarily correlate with an increased need for revision surgery.