Prospective Patient-reported Outcomes Research Articles

RANDOMIZED PROSPECTIVE TRIAL COMPARING THE SALTO TALARIS FIXED-BEARING AND SALTO MOBILE-BEARING TOTAL ANKLE ARTHROPLASTY

IntroductionComparative studies examining Fixed-Bearing (FB) and Mobile-Bearing (MB) Total Ankle Replacement (TAR) designs have demonstrated similar results and successful long-term outcomes for both. To date there has been no study directly comparing FB and MB designs of the same prosthesis. We present the first prospective randomised trial comparing patient satisfaction, functional outcomes and radiographic results of the Salto Talaris Fixed-Bearing and the Salto Mobile-Bearing Total Ankle Replacement in the treatment of end-stage ankle arthritis.MethodsA total of 108 adult patients with end-stage ankle arthritis were enrolled in the study between November 2014 and October 2021 with similar demographic comparison. Prospective patient-reported outcomes and standardised weightbearing ankle radiographs were performed preoperatively, at 6 weeks, 6 months and 12 months post-operatively, followed by yearly intervals. All surgeries were performed by a single non-design orthopaedic foot and ankle specialist with experience in over 200 Salto and Salto Talaris TAR prior to the study. Radiographs were examined independently by two clinicians. Complete patient data and radiographs were available for 103 patients with an average follow up of 2 years.ResultsBoth groups demonstrated statistically significant improvement from preoperative evaluation to most recent follow up with no statistically significant difference between the two groups in all outcome measures. Radiographic incidence of subchondral cyst formation was 8.9% and 38.2% for FB and MB, respectively. Talar subsidence occurred in 2.2% and 5.5% of FB and MB, respectively.DiscussionOur study demonstrates a higher than previously reported rate of cyst formation in the MB TAR and comparatively higher talar subsidence in the MB TAR vs FB however this did not correlate with clinical outcome measures which were favourable for both groups.ConclusionFixed-Bearing and Mobile-Bearing Total Ankle Replacement demonstrate comparable favourable

Follow-up for human papillomavirus-related oropharynx cancer concentrated on unequal symptom change (FOCUS): Prospective patient-reported outcome collection.

Post-treatment surveillance recommendations for oropharyngeal cancer do not vary with p16 status despite the differences in outcomes. The optimal algorithm personalizing follow-up for these patients remains undefined. Here, we evaluate the feasibility and utility of incorporating electronic patient-reported outcomes (ePROs) and circulating tumor DNA (ctDNA) into routine surveillance for patients treated for p16+ oropharynx cancer. A prospective registry was developed in which ePROs and ctDNA were incorporated into routine surveillance among patients with oropharynx cancer. ePROs were emailed monthly for 1 year and blood HPV ctDNA testing was performed every 3-6 months. The primary objective was to assess patient compliance with ePRO-based surveillance with adequate compliance defined as ≥85% of patients completing monthly ePROs. Sensitivity, specificity, and positive/negative predictive values to detect recurrence were calculated for ePROs, HPV ctDNA, or the combination. Of 122 patients who initially expressed interest, 76 completed the electronic consent process and 44/76 (58%) were compliant with monthly surveys over 1 year; thus adequate compliance was not achieved. Technical difficulties associated with ePRO receipt through email largely limited participation. Provider feedback was significantly associated with heightened ePRO compliance. One hundred and six patients had ctDNA testing with a mean number of three tests per patient. Sensitivity to detect recurrence was 75% for the combination of ePROs and ctDNA. Despite lower than anticipated compliance with ePROs, our findings show promise for incorporation of HPV ctDNA into surveillance paradigms for HPV-related oropharynx cancer with suggestions of methods to optimize ePRO formats for personalized surveillance.

Clinical Depression and Anxiety Are Relieved by Microvascular Decompression in Patients with Trigeminal Neuralgia-A Prospective Patient-Reported Outcome Study.

Objective: Patients with idiopathic trigeminal neuralgia (TN) live in constant fear of triggering shock-like pain episodes, which may cause symptoms of depression and a reduction in quality of life. Microvascular decompressive surgery has been demonstrated to achieve satisfactory and stable results. With this study, we wanted to investigate prevalence and risk factors for depression and perceived stress in correlation with symptom relief after surgical treatment. Methods: In this prospective study, patients undergoing microvascular decompression (MVD) for TN were included. The Barrow Neurological Institute Pain Score (BNI), Beck Depression Inventory (BDI), Chronic Pain Acceptance Questionnaire (CPAQ), Perceived Stress Questionnaire (PSQ) and McGill questionnaire were used to evaluate depression, stress and anxiety disorders before and 3 months after MVD. Results: A total of 35 patients (16 male (46%)) with a mean age of 55.4 (SD 15) years were included in this study. The BDI revealed that 24 (68.8%) patients harbored mild-to-extreme depression preoperatively (2.4 ± 1.4), which improved to 1.2 (±0.6, p < 0.0001). Pain acceptance also changed from 64 (±11.3) to 67.7 (±9.3, p = 0.006). Perceived stress decreased from 46.9 (±21.9) to 19.6 (±18.6) (p < 0.0001) postoperatively, and pain decreased from 31.0 (±11.7) to 9.4 (±12.9, p < 0.0001). Microvascular decompression reduced the mean BNI pain score significantly from 4.6 to 1.8 postoperatively (p < 0.00001). Conclusions: Depression and perceived stress are prevalent in patients with idiopathic TN. Adequate treatment not only provides a high rate of satisfaction through pain relief, but also leads to immediate and significant improvements in depression and stress. Thus, in patients with TN who do not reach an adequate and timely pain reduction through medical management and develop signs of depression, early treatment with microvascular decompression should be considered.

Bridging the clinical-research gap: Harnessing an electronic data capture, integration, and visualization platform to systematically assess prospective patient-reported outcomes in mitochondrial medicine

PurposeOptimizing individualized clinical care in heterogeneous rare disorders, such as primary mitochondrial disease (PMD), will require gaining more comprehensive and objective understanding of the patient experience by longitudinally tracking quantifiable patient-specific outcomes and integrating subjective data with clinical data to monitor disease progression and targeted therapeutic effects. MethodsElectronic surveys of patient (and caregiver) reported outcome (PRO) measures were administered in REDCap within clinical domains commonly impaired in patients with PMD in the context of their ongoing routine care, including quality of life, fatigue, and functional performance. Descriptive statistics, group comparisons, and inter-measure correlations were used to evaluate system feasibility, utility of PRO results, and consistency across outcome measure domains. Real-time tracking and visualization of longitudinal individual-level and cohort-level data were facilitated by a customized data integration and visualization system, MMFP-Tableau. ResultsAn efficient PRO electronic capture and analysis system was successfully implemented within a clinically and genetically heterogeneous rare disease clinical population spanning all ages. Preliminary data analyses demonstrated the flexibility of this approach for a range of PROs, as well as the value of selected PRO scales to objectively capture qualitative functional impairment in four key clinical domains. High inter-measure reliability and correlation were observed. Between-group analyses revealed that adults with PMD reported significantly worse quality of life and greater fatigue than did affected children, while PMD patients with nuclear gene disorders reported lower functioning relative to those with an mtDNA gene disorder in several clinical domains. ConclusionIncorporation of routine electronic data collection, integration, visualization, and analysis of relevant PROs for rare disease patients seen in the clinical setting was demonstrated to be feasible, providing prospective and quantitative data on key clinical domains relevant to the patient experience. Further work is needed to validate specific PROs in diverse PMD patients and cohorts, and to formally evaluate the clinical impact and utility of harnessing integrated data systems to objectively track and integrate quantifiable PROs in the context of rare disease patient clinical care.

Older Adults with Acute Myeloid Leukemia (AML) Experience Improvement in Health-Related Quality of Life (HRQoL) Scores with Intensive Therapy: Prospective Study from ECOG-ACRIN (EA) E2906 Phase 3 Trial

Background There is limited prospective or comparative data evaluating the HRQoL impact of intensive chemotherapy (IC) in older adults (age ≥60 years) with AML. In the recent EA E2906 phase 3 study of '7&amp;3' (daunorubicin &amp; cytarabine) vs. clofarabine (CLO), a putative lower intensity therapy, we incorporated a prospective patient-reported outcomes (PRO) assessment of HRQoL and fatigue to understand treatment impact from the patients' (pts) perspective. Methods E2906 study design and results have been presented previously [n=727, med. age 68 years (range 60-86), randomized 1:1 to ‘standard’ ‘7&amp;3‘ &amp; high dose cytarabine (Arm A) vs. single agent CLO (Arm B), as remission induction (Step 1) and consolidation (Step 2), respectively]. There was no difference in composite complete remission (CCR, 50%) or 30-day mortality rates (8.5%), and in primary analysis CLO was inferior for Overall Survival. HRQoL was a key secondary protocol endpoint. PROs assessed HRQoL and leukemia-specific symptoms and concerns using Functional Assessment of Cancer Therapy-Leukemia scale (FACT-Leu), &amp; Fatigue using FACT-Fatigue subscale. PROs were administered at prespecified time points: (1) Baseline; (2) Cycle 1 at nadir (approx. Day 15); (3) End of Step 1 restaging (approx. D 40); (4) Beginning of Step 2 (1 st consolidation, approx. D 45); and (5) 2 nd cycle consolidation/End Step 2 (approx. D 60). The FACT-Leu Trial Outcome Index ( TOI) was calculated by summing physical well-being, functional well-being, and leukemia-specific concerns subscales to create a single composite score. Higher TOI scores correspond to better HRQoL. The primary endpoint was to evaluate TOI difference from randomization to day 30 after induction therapy between arms, evaluated using Wilcoxon rank sum test. We also compared Clinically Meaningful differences (CMiD) in TOI (defined as patient change ≥½ standard deviation from baseline TOI) between arms, using the X2 test. Pts not completing at least 2 assessment forms (including baseline) were excluded. Testing of constructs of Physical Well-being (PWB), Functional, Leukemia &amp; Fatigue scales demonstrated high Cronbach's a values (a &amp;gt;0.7) except for PWB (a=0.672) at a single time point (End of Step 2). Results Baseline TOI was available for n=489, and 364 pts (n=182 each Arm) were evaluable in this planned analysis. Evaluating CMiD during Cycle 1 induction, pts in Arm B were less likely to experience ‘Worse’ TOI score (32% vs. 40.7%, Arm A), more likely to maintain stable TOI scores (49.1% vs. 39%, Arm A), and had a similar proportion of ‘Better’ TOI scores (20.3%, A vs. 18.9%, B) although differences were not significant (p=0.1389). Conversely in cycle 1 consolidation, more patients in Arm A experienced Better TOI (45.1% vs. 29.2%, Arm B), fewer had stable TOI (45.1% vs. 58.3%, Arm B), and rates of ‘Worse’ TOI were similar (9.8%, A vs 12.5%, Arm B), again differences were not significant (p=0.2616). There was no difference in Fatigue scores between Arms (p=0.49). We evaluated whether TOI and Fatigue scores could predict the ability to complete protocol therapy. In univariate analysis baseline TOI (p=0.0059) and Fatigue (p=0.0057) were associated with Step 1 completion, however on multivariate analysis (adjusting for age, sex, and Arm) were no longer significant [TOI, Odds Ratio (OR) 1.03 (0.98-1.08, p=0.27); Fatigue, OR 1.03 (0.96-1.11, p=0.42)]. There was a borderline association of TOI with Step 2 completion [TOI OR 1.10 (1.00-1.23, p=0.06)]. Using a multivariable linear mixed effects model, we observed similar and significant changes in TOI scores in both Arms, demonstrating the effect of IC &amp; CLO on HRQoL (Figure). Comparing to baseline, TOI scores decreased significantly at C1 induction nadir (-4.0873, p&amp;lt;0.0001), and increased by 5.0762 (p=0.0004) at end Step 1, by 6.9047 at cycle 1 consolidation (p&amp;lt;0.0001), and by 11.4601 (p&amp;lt;0.0001) at end Step 2. Differences were mainly apparent in those who achieved CCR, and there was significant attrition in PRO responses in non-CCR pts. Conclusions Older adults experienced significant improvement in HRQoL after nadir regardless of therapy, and those achieving CCR report significantly higher scores. We did not observe differences in leukemia specific HRQoL or fatigue between treatment Arms (7&amp;3 vs. CLO). Patient-reported HRQoL &amp; Fatigue was not predictive of completion of protocol therapy. These results serve as a benchmark for expectations with IC in older adults.

Implementing routine use of self-removed ureteric stents on extraction strings: prospective patient-reported outcome measures and complications

PurposeUreteric stents placed after ureteroscopy typically require cystoscopy for removal. Stent extraction strings allow the option of patient self-removal. This facilitates shorter stent dwell time, and cost-savings. Concerns regarding safety and limited evidence regarding patient acceptability are speculated reasons for infrequent clinical use of extraction strings. This study investigates our recent experience using routine self-removal of stents on extraction strings to provide evidence to address these concerns.MethodsIn February 2020, our hospital adopted a policy for self-removal of stents on extraction strings to be routine following ureteroscopy. This was influenced by motivation to improve service capacity for diagnostic flexible cystoscopy, hospital avoidance during the pandemic, perceived improvement for the patient experience, and cost-saving. Prospective clinical and patient-reported outcome data were collected and evaluated.ResultsThere were 168 patients who had stents on extraction strings. Mean stent dwell time was 5.2 ± 1.8 days. Primary ureteroscopy was performed in 40.5%, and 59.5% had procedures using an access sheath. Self-removal at home was successful for 79% of patients. Stent dislodgement rate was 3.0% (5/168) and retained stents due to string detachment occurred in 1.8% (3/168). Almost all indicated they “would remove the stent on string again” (90%, 128/142) and the majority reported stent removal as “very easy” (61%, 87/142). Cost modelling estimates a total saving of AUD $148,869 per annum for routine use of extraction strings at our hospital.ConclusionOur experience reflects that stent extraction strings may be used routinely with acceptable low complication rates, favourable patient experiences and associated cost savings.

Patient-reported persistent symptoms after radiotherapy and association with quality of life for prostate cancer survivors

Purpose To evaluate the persistence of symptoms after radiotherapy (RT) for localised prostate cancer (PCa) and the association with quality of life (QOL). Materials and methods Prospective patient-reported outcome (PRO) from a multi-institutional study on PCa treated with radical RT (2010–2014) was analysed. Data was collected at baseline (BL) and follow-ups (FUPs) up to 5 years. Patients with BL and ≥3 late FUPs (≥6 months) were analysed. PRO was scored by means of the IPSS and ICIQ-SF (urinary), LENT-SOMA (gastrointestinal [GI]), and EORTC-C30 (pain, insomnia, fatigue, and QOL) questionnaires. Symptoms were defined ‘persistent’ if the median score over FUPs was ≥3 (urinary) or ≥2 (GI, pain, insomnia, and fatigue), and worse than BL. Different thresholds were chosen to have enough events for each symptom. QOL was linearly transformed on a continuous scale (0–100). Linear-mixed models were used to identify significant differences between groups with and without persistent symptoms including age, smoking status, previous abdominal surgery, and diabetes as confounders. Mean QOL differences between groups were evaluated longitudinally over FUPs. Results The analysis included 293 patients. Persistent urinary symptoms ranged from 2% (straining) to 12% (weak stream, and nocturia). Gastrointestinal symptoms ranged from 7% (rectal pain, and incontinence) to 30% (urgency). Proportions of pain, insomnia, and fatigue were 6, 13, and 18%. Significant QOL differences of small-to-medium clinical relevance were found for urinary incontinence, frequency, urgency, and nocturia. Among GI symptoms, rectal pain and incontinence showed small-to-medium differences. Fatigue was associated with the largest differences. Conclusions The analysis showed that symptoms after RT for PCa occur with different persistence and their association with QOL varies in magnitude. A number of persistent urinary and GI symptoms showed differences in a comparable range. Urinary incontinence and frequency, rectal pain, and faecal incontinence more often had significant associations. Fatigue was also prevalent and associated with largely deteriorated QOL.

210. Patient-reported and clinical outcomes after lumbar laminectomy and fusion versus laminectomy alone in patients with lumbar spondylolisthesis and harmonious sagittal spinopelvic alignment

<h3>BACKGROUND CONTEXT</h3> The treatment of degenerative spondylolisthesis with decompression alone remains controversial. However, it is well known that all degenerative spondylolistheses are not created equally. As such, one must compare equivalent pathology to better assess treatment options. <h3>PURPOSE</h3> This study assessed 2-year clinical outcomes following laminectomy plus fusion versus laminectomy alone for management of Grade I degenerative spondylolisthesis and comorbid spinal canal stenosis among patients with sagittal spinopelvic alignment (pelvic incidence - lumbar lordosis <10°). <h3>STUDY DESIGN/SETTING</h3> Subgroup analysis of observational prospective cohort study. <h3>PATIENT SAMPLE</h3> A total of 679 patients treated with laminectomy with fusion or laminectomy alone for Grade I degenerative spondylolisthesis and comorbid spinal stenosis at a tertiary care center. <h3>OUTCOME MEASURES</h3> Outcome measures comprised estimated blood loss, operative time, length of hospital stay, discharge to skilled nursing facility, prospective patient-reported outcomes (PROs) and reoperation. <h3>METHODS</h3> Cohorts were matched based on degree of lumbar spondylolisthesis, flexion-extension listhesis and intervertebral disc height. Two alternative matching methods were employed to minimize treatment selection bias when estimating treatment effects: (1) propensity score matching (PSM) and (2) coarsened exact matching (CEM). Binary outcomes between cohorts were evaluated using McNemar test; continuous outcomes used the Wilcoxon rank-sum test. <h3>RESULTS</h3> A total of 327 (48.1%) study patients had low PILL mismatches (< 10°), indicating good sagittal spinopelvic alignment. After PSM and CEM matching to control treatment choice bias, patients undergoing fusion experienced greater operative blood loss (203 vs 125 mL, p=0.0006), operative time (216 vs 128 min, p=0.0006), and length of stay (3.50 vs 2.83 days, p < 0.0001) than patients receiving decompression alone; in turn, these patients were more likely to be discharged to rehabilitation facilities (6.86% vs 0.98%, p=0.0412) and receive longer durations of physical therapy postoperatively (2.47 vs 1.34 months, p<0.0001). Finally, fusion-treated patients had a greater likelihood of reoperation at 2 years (25.49% vs 14.71%, p=0.0152). CEM matching generally did not alter the pattern, significance or direction of findings. <h3>CONCLUSIONS</h3> Lumbar laminectomy was superior to fusion in health-related quality of life and reoperation rate at 2 years postoperatively for patients without PILL mismatch. Patients with low-grade spondylolisthesis, spinal stenosis, and spinopelvic harmony may benefit from less invasive decompression alone. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

A novel duodenal-release formulation of caraway oil and L-menthol is a safe, effective and well tolerated therapy for functional dyspepsia

BackgroundA randomized, placebo-controlled clinical trial (FDREST) of a novel formulation of caraway oil and L-menthol (COLM-SST) demonstrated symptom relief in patients with functional dyspepsia (FD). Two follow-up studies were conducted to evaluate patient satisfaction, self-regulated dosing, and long-term safety data: FDACT, Functional Dyspepsia Adherence and Compliance Trial, and FDSU36, Functional Dyspepsia Safety Update at 36 months.MethodsA patient reported outcomes (PRO) questionnaire was designed and distributed online to assess real-world satisfaction and dosing frequency of open-label COLM-SST in patients with FD. A separate study analyzing voluntary safety surveillance data evaluated the frequency and severity of reported adverse events (AEs).ResultsA total of 600 FD patients were enrolled in the PRO study. Ninety five percent of respondents reported a major or moderate improvement in their FD symptoms and 91.7% indicated a major or moderate improvement in quality of life (QOL) using COLM-SST. Between 1 and 4 capsules were consumed daily by 91.2% of respondents, with 56.2% taking them before meals. Symptom relief was rapid, with 86.4% of respondents indicating relief within 2 h of taking COLM-SST. Few adverse events (AEs) were reported (0.0187%) by patients using COLM-SST. No serious AEs were identified.ConclusionCOLM-SST is safe, well tolerated, and provides rapid relief of FD symptoms. These findings, demonstrated in the FDREST trial, were further supported by a large prospective PRO study evaluating self-regulated dosing frequency, symptom improvement, and QOL. COLM-SST was well-tolerated based on review of AE data at 36 months.

Patient-reported outcomes and chemotherapy-related cognitive impairment in gynecologic malignancy

ObjectiveChemotherapy has multiple adverse effects, including chemotherapy-related cognitive impairment, the phenomenon colloquially referred to as ‘chemobrain’. The objective of this study was to understand patient-reported experiences of this phenomenon in...

Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer

BackgroundLong-term prospective patient-reported outcomes (PRO) after breast cancer adjuvant radiotherapy is scarce. TomoBreast compared conventional radiotherapy (CR) with tomotherapy (TT), on the hypothesis that TT might reduce lung-heart toxicity.MethodsAmong 123 women consenting to participate, 64 were randomized to CR, 59 to TT. CR delivered 50 Gy in 25 fractions/5 weeks to breast/chest wall and regional nodes if node-positive, with a sequential boost (16 Gy/8 fractions/1.6 weeks) after lumpectomy. TT delivered 42 Gy/15 fractions/3 weeks to breast/chest wall and regional nodes if node-positive, 51 Gy simultaneous-integrated-boost in patients with lumpectomy. PRO were assessed using the European Organization for Research and Treatment of Cancer questionnaire QLQ-C30. PRO scores were converted into a symptom-free scale, 100 indicating a fully symptom-free score, 0 indicating total loss of freedom from symptom. Changes of PRO over time were analyzed using the linear mixed-effect model. Survival analysis computed time to > 10% PRO-deterioration. A post-hoc cardiorespiratory outcome was defined as deterioration in any of dyspnea, fatigue, physical functioning, or pain.ResultsAt 10.4 years median follow-up, patients returned on average 9 questionnaires/patient, providing a total of 1139 PRO records. Item completeness was 96.6%. Missingness did not differ between the randomization arms. The PRO at baseline were below the nominal 100% symptom-free score, notably the mean fatigue-free score was 64.8% vs. 69.6%, pain-free was 75.4% vs. 75.3%, and dyspnea-free was 84.8% vs. 88.5%, in the TT vs. CR arm, respectively, although the differences were not significant. By mixed-effect modeling on early ≤2 years assessment, all three scores deteriorated, significantly for fatigue, P ≤ 0.01, without effect of randomization arm. By modeling on late assessment beyond 2 years, TT versus CR was not significantly associated with changes of fatigue-free or pain-free scores but was associated with a significant 8.9% improvement of freedom from dyspnea, P = 0.035. By survival analysis of the time to PRO deterioration, TT improved 10-year survival free of cardiorespiratory deterioration from 66.9% with CR to 84.5% with TT, P = 0.029.ConclusionModern radiation therapy can significantly improve long-term PRO.Trial registrationTrial registration number ClinicalTrials.govNCT00459628, April 12, 2007 prospectively.

Prospective Patient-reported Psychosocial Outcomes of Facial Feminization Surgery

PURPOSE: Gender affirming surgery is an essential component in the treatment of gender dysphoria. While health insurance plans have deemed several gender-affirming surgeries as medically necessary, facial reconstructive procedures continue to be debated due to a deficiency of high-level evidence for quality-of-life improvements. As face perception neural networks allow for immediate gender identification, facial gender-affirming surgery is frequently the first and most important surgery for many patients with gender dysphoria, particularly in the transfeminine population. In this work, we administer a battery of validated, quantitative patient-reported outcomes measures examining the psychosocial functioning of a cross-section of transgender patients who have or have not received facial feminization surgery (FFS). METHODS: In total, 96 patients (age 33.07 ± 10.60 years) receiving an FFS consultation at the University of California, Los Angeles were prospectively enrolled from 2019 to 2021 and administered 11 adult Patient-Reported Outcomes Measurement Information System item banks, including version 1.0 anxiety short form 8a, version 1.1 anger short form 5a, version 1.0 depression short form 8b, version 1.2 global health form, version 2.0 satisfaction with sex life form, version 1.0 positive affect short form 15a, version 1.0 meaning and purpose short form 4a, version 2.0 emotional support short form 4a, version 2.0 companionship short form 4a, and version 2.0 social isolation short form 4a. Descriptive statistics and linear regression analyses were performed. RESULTS: Patients who received FFS (assessed 236.35 ± 143.30 days postoperatively) demonstrated improvements in anxiety, anger, depressive symptoms, sex life, positive affect, emotional support, and meaning and purpose instrument scores. Because psychosocial functioning is likely to be influenced by multiple factors, we developed a linear regression model to understand whether FFS would be an independent predictor of psychosocial scores. Other predictors included were the presence or absence of other gender affirming surgery, binary or non-binary gender identity, duration of hormone treatment, age at the time of assessment, and global health scores as a measure of baseline health. For anxiety scores, this model accounted for 36.6% of the variance [F(6,78) = 7.512, P < 0.001], and for anger scores, this model accounted for 23.2% of the variance [F(6,78) = 3.919, P = 0.02]. The completion of FFS independently predicted lower anxiety scores (beta = −0.197, P = 0.04) and lower anger scores (beta = −0.219, P = 0.04). With the exception of global health, no other variables were significantly predictive of either anxiety or anger scores. CONCLUSIONS: Our prospective, cross-sectional assessment of psychosocial outcomes demonstrated a global improvement in psychosocial functioning in patients who have received FFS. The linear regression model that includes other potential predictors of variance in scores such as other gender affirming surgery, age, and duration of hormone therapy demonstrated that completion of FFS was an independent predictor of lower anxiety and anger scores. This work is the first Level II evidence study in quality of life of outcomes for patients who have undergone FFS and it is also the first study utilizing robust, validated instruments for assessment. Future directions of this work include longitudinal analyses of patient outcomes after FFS.

Evaluating Prospective Patient-Reported Pain and Function Outcomes After Ankle and Hindfoot Arthrodesis.

Background:Hindfoot and ankle fusions are mechanically limiting procedures for patients. However, patient-reported outcomes of these procedures have not been well studied. This study assessed outcomes of hindfoot and ankle fusions by using Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) Computer Adaptive Tests (CATs).Methods:Between 2014 and 2018, 102 patients were prospectively enrolled after presenting to a tertiary care facility for ankle and hindfoot fusions, including tibiotalar, tibiotalocalcaneal, subtalar, and triple arthrodeses. Study participants completed preoperative and 12-month postoperative PF and PI CATs. The differences between mean 12-month postoperative and preoperative PROMIS PF and PI T scores were analyzed with paired t tests. The relationship between the 12-month PF and PI differences for the overall sample and patient factors was examined using multiple regression modeling.Results:The sample had mean age of 57.69 years; 48% were male, and 55% were obese. Patients who underwent ankle and hindfoot arthrodesis had statistically significant improvements from preoperative to 12 months postoperative in mean PF (36.26±7.85 vs 39.38±6.46, P = .03) and PI (61.07±7.75 vs 56.62±9.81, P = .02). Triple arthrodesis saw the greatest increases in physical function (▵PF = 7.22±7.31, P = .01) and reductions in pain (▵PI = –9.17±8.31, P = .01), achieving minimal clinically important difference (MCID). Patients who underwent tibiotalar fusion had significant improvement in physical function (▵PF = 4.18±5.68, P = .04) and pain reduction that approached statistical significance (▵PI = –6.24±8.50, P = .09), achieving MCID. Older age (≥60 years ) was associated with greater improvements in PF (β = 0.20, P = .07) and PI (β = –0.29, P = .04). Preoperative PF and PI T scores were significantly associated with the 12-month change in PF and PI T scores, respectively (β = –0.74, P < .01; β = –0.61, P < .01).Conclusion:Hindfoot and ankle fusions are procedures with favorable patient outcomes leading to increased physical function and decreased pain at 12 months postoperation relative to preoperation.Level of Evidence:Level II, prospective comparative study.

Development of a Financial Toxicity Screening Tool for Radiation Oncology: A Secondary Analysis of a Pilot Prospective Patient-Reported Outcomes Study

PurposeFinancial toxicity is highly prevalent in oncology. Early identification of at-risk patients is essential because financial toxicity is associated with inferior outcomes. Validated general oncology screening tools are cumbersome and not specific to challenges related to radiation therapy, such as daily treatments. In the population of radiation oncology patients, no standardized, validated, rapid screening tool exists. We sought to develop a rapid, no-cost, and reliable financial-toxicity screening tool for clinical radiation oncology. Methods and MaterialsWe retrospectively analyzed data from a prospective survey study conducted at a large referral center with a heterogeneous population. Before treatment, a 25-item modified comprehensive survey for financial toxicity incorporating subjective and objective patient-reported measures was administered to identify factors linked to the risk of developing financial toxicity, which was defined as radiation therapy resulting in any of the following: loss of income, job, or spouse or difficulty paying for meals, housing, or transportation. We applied a logistic regression model with a stepwise, backward model selection procedure. Estimated probabilities of experiencing financial toxicity were computed using the inverse-logit transformation of the sum of patient-specific predictor values multiplied by the coefficients of the selected logistic regression model. The Youden index was used to determine a reasonable risk threshold. ResultsA total of 157 patients completed the questionnaire, and 34 (22%) were assessed as experiencing financial toxicity. The model retained 3 factors: age, money owed, and copayment-related worries. It resulted in a concordance statistic of 0.85, developed with a risk threshold of 18% (Youden index, 0.59). This model conferred a sensitivity of 89%, specificity of 70%, positive predictive value of 44%, and negative predictive value of 96%. ConclusionsOur proposed financial-toxicity screen is rapid, free, sensitive, and specific, and in this study, it identified early-onset, patient-reported financial toxicity after radiation therapy with just 3 simple variables: age, money owed, and copayment-related concerns. Future research steps should include a validation cohort and identification of interventions to mitigate financial toxicity.

Total Joint Replacement of Ankle, Knee, and Hip: How Do Patients Perceive Their Operative Outcomes at 10 Years?

Background:Patient-reported outcomes (PROMs) are an integral part of national joint registers in measuring outcomes of operative procedures and improving quality of care. There is lack of literature comparing outcomes of total ankle replacement (TAR) to total knee replacement (TKR) and total hip replacement (THR). The aim of this study was to compare PROMs between TAR, TKR, and THR patient groups at 1, 5, and 10 years.Methods:Prospective PROMs from patients who underwent a TAR, TKR, or THR procedure between 2003 and 2010 were studied. Patients were divided into 3 groups based on their index joint replacement (hip, knee, or ankle). Patient demographics (age, gender, body mass index), patient-reported outcome scores (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC], 36-Item Short Form Health Survey [SF-36]) and patient satisfaction scores (4-point Likert scale) at follow-up were compared between the 3 groups.Results:Data was available on 1797 THR, 2475 TKR, and 146 TAR patients. TAR patients were younger and reported fewer number of comorbidities. All 3 groups improved significantly from preoperative to 10 years for WOMAC scores (P < .001). For SF-36 scores at 10 years, the THR group (32.2% follow-up) scored the highest for 3 domains (P = .031) when compared to the TKR group (29.1% follow-up). All 3 groups had similar outcomes for 5 of 8 domains; P < .05). For patient satisfaction, the THR group reported overall 95.1% satisfaction followed by 89.8% for the TKR group and 83.9% in the TAR group (42.4% follow-up).Conclusion:In this cohort with diminishing numbers over the decade of time the patients were followed up we found that patients are equally happy with functional and general health outcomes from total ankle replacement vs other major lower extremity joint replacement. TAR surgery should be considered as a viable treatment option in this patient group.Level of Evidence:Level III, retrospective case series.

Open vs Minimally Invasive Scarf Osteotomy for Hallux Valgus Correction: A Randomized Controlled Trial.

Minimally invasive (MI) surgery is becoming increasingly popular in the treatment of hallux valgus (HV). The scarf osteotomy is an effective procedure with a track record in open HV surgery. We adapted this effective osteotomy to MI surgery as a novel technique never reported before. The aim of this study was to compare the clinical and radiologic outcomes of patients who underwent open or MI scarf. Between 2017 and 2018, 58 patients were randomized to either open or MI scarf to treat HV deformity. Prospective patient-reported outcome measures and weightbearing radiographs were obtained. Data included the AOFAS score, radiologic angular correction, operative time, fluoroscopy radiation dose, and postoperative pain on visual analog scale (VAS). The mean follow-up was of 21 (range, 12-38) months. Radiologic measurements (postoperative hallux valgus angle, first-to-second intermetatarsal angle, and distal metaphyseal articular angle) were similar in both groups and showed statistically significant improvement from preoperative measures. The mean operative time for the MI group was 16.7 vs 26.1 minutes in the open group, a statistically significant difference. Radiation exposure was 14 times higher in the MI group when compared to the open group (mean: 34 vs 2.4 mGy/cm2, P < .001). There were no major complications in either group. The MI scarf provides a clinically and radiologically equivalent outcome to open scarf for the treatment of HV with reduced operative time and immediate postoperative VAS for pain but is associated with a small increase in radiation exposure. Level I, randomized controlled trial.

The Impact of AC and AC-T Chemotherapy's Toxicities on Quality of Life Among Women with Breast Cancer in Ethiopia: A Prospective Patient-Reported Outcomes Study.

PurposeThe study aimed to evaluate the quality of life patterns and the effects of AC and AC-T chemotherapy’s toxicities on QoL among Ethiopian women with breast cancer.MethodsQoL was measured at baseline and at every end of two cycles, for the median of 8 cycles among 146 breast cancer women on AC and AC-T chemotherapy, using EORTC QLQ-C30 and BR23 instruments. The effect of QoL score, socio-demographic, and clinical variables at baseline were adjusted for the effect of chemotherapy’s toxicities on QoL.ResultsOverall QoL, all functional scales (except cognitive functioning, body image, future perspectives, and sexual functioning) and symptom scales (except dyspnea, insomnia, pain score, arm, and breast symptoms) of EORTC QLQ-C30 and BR23 deteriorated significantly both clinically and statistically, in particular, during the first two cycles of chemotherapy. After the end of cycle 2 or 4, except for cognitive, social functioning, and financial difficulties of the patients, almost all other QoL dimensions were improved towards pretreatment score by the end of cycle 8. In addition to age, educational status, and tumor stage, the Global Health Status (−10.55≤B≤−7.71, P≤0.013), and the functional scales (−25.320≤B≤−6.351, P≤0.033) of EORTC QLQ-C30 and BR23 were significantly affected at least by one of the AC and AC-T chemotherapy’s toxicity such as grade≥2 fatigue, dysgeusia, constipation, dry mouth, vomiting, oral mucositis, skin hyperpigmentation and/or peripheral neuropathy than their lower grade. Grade≥2 fatigue, dysgeusia, oral mucositis, constipation, peripheral neuropathy, anemia arthralgia/myalgia, dry mouth, diarrhea, constipation, and/or skin hyperpigmentation were positively predicted for the deterioration of symptoms scale of EORTC QLQ-C30 and BR23 (4.819≤B≤26.451, P≤0.043).ConclusionQuality of life among Ethiopian breast cancer patients on AC and AC-T regimens significantly deteriorated particularly during the first two cycles of chemotherapy. In addition to the age, tumor stage and educational status of the patients, grade≥2 fatigue, dysgeusia, constipation, oral mucositis, dry mouth, peripheral neuropathy, and skin hyperpigmentation due to AC and AC-T chemotherapy were frequently associated with deterioration of different scales/items QoL. Hence, devising different strategies to improve the deteriorated QoL due to chemotherapy’s toxicities particularly during the first two cycles has paramount importance.

Evaluating Prospective Patient-Reported Pain and Function Outcomes after Ankle and Hindfoot Arthrodesis

Category:Hindfoot; AnkleIntroduction/Purpose:Hindfoot and ankle arthritis and deformity constitute a significant disease burden upon affected patients. Surgical hindfoot and ankle arthrodesis procedures are indicated for pain and instability in such patients and include ankle arthrodesis, tibitalocalcaneal (TTC) fusion, subtalar arthrodesis, and triple arthrodesis. Long-term patient-reported outcomes, including postoperative pain, function, and overall satisfaction, of these procedures have not yet been well-studied. The purpose of this study was to assess the outcomes and prognosis of various hindfoot fusion subtypes along with ankle fusion by using two validated patient-reported outcome measures: The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) Computer Adaptive Tests (CATs).Methods:The sample consisted of 68 patients presenting to a tertiary care facility for ankle and hindfoot fusion surgeries, including ankle arthrodesis (n= 16), TTC fusion (n= 9), subtalar arthrodesis (n= 25), and triple fusion (n= 18), who had completed preoperative, 12-month postoperative, and 24-month postoperative PROMIS PF and PI CATs. Differences in CAT T-scores were calculated for each patient to create a prognostic estimation of pain and physical function at one and two years postoperative. Mean absolute T-scores for each procedure were also calculated and compared to PROMIS reference population mean (SD) T- scores of 50 (10). The distribution of PROMIS PF and PI T-scores were assessed via a Shapiro-Wilk test, and then paired t-tests were used to compare mean differences in T-scores.Results:Importantly, no statistically significant difference was found between 12-month mean PI scores for patients undergoing any fusion procedure and PROMIS reference population mean. Moreover, triple fusion patients had significantly decreased pain at 12 (delta-T-score= -11.10, p= 0.02) and 24 months (delta-T-score= -12.72, p= 0.01) relative to preoperative T-scores along with increased physical function at 12 (delta-T-score= 6.67, p= 0.04) and 24 months (delta-T-score= 8.70, p= 0.04). PF differences after 12 months were not statistically significant for ankle (delta-T-score= -1.67, p= 0.73), TTC (delta-T-score= 0.04, p= 0.99), or subtalar arthrodesis (delta-T-score= 0.37, p= 0.72). PI decreased after 12 months for ankle (delta-T-score= -14.57, p= 0.16), TTC (delta-T-score =-4.08, p= 0.21), and subtalar arthrodesis (delta-T-score= -0.64, p= 0.53); however, these differences did not achieve statistical significance.Conclusion:Overall, at 12 months after an ankle or hindfoot arthrodesis, patients experienced a similar level of pain to the reference population mean. Following a triple fusion procedure, patients can be provided with an accurate prognosis that they can expect reduced pain and increased physical function that will progressively improve from 12 to 24 months postoperative. No statistically significant difference in pain or physical function at 12 or 24 months for ankle, TTC, or subtalar arthrodesis was found.

Black women disproportionately suffer throughout cancer treatment: Results from a prospective patient-reported outcomes program in gynecologic malignancy

Objective: The collection of patient-reported outcomes (PROs) is associated with improved outcomes in patients with malignancy. To date, little research has examined the PROs of black women undergoing treatment for gynecologic malignancy. This study describes the results of black women with gynecologic malignancy participating in a large, prospective PRO program.

Prospective Patient-Reported Outcomes, Physician-Assessed Toxicities, and Treatment Outcomes in Sinonasal Malignancies Following Proton Beam Therapy

Historically, sinonasal cancer outcomes have had minimal improvement in the photon radiotherapy (XRT) treatment eras, with 3-year overall survival (OS) of 40-70% and grade 3+ (G3) physician-assessed toxicities (PATs) of 15-35%. Proton beam therapy (PBT) has the potential to improve outcomes but prospective data is scarce, particularly PATs and patient-reported outcomes (PROs). To report on the outcomes and toxicities for a prospective patient cohort with sinonasal malignancies treated using PBT. From 2011-2019, PBT treated patients with a sinonasal malignancy were enrolled with a primary endpoint of toxicity assessment. PATs and PROs were assessed at baseline, acute (during PBT), subacute (90 days after PBT), and chronic time-points. PATs were graded using CTCAE. PROs were assessed using the Xerostomia-Related Quality of Life Scale (XeQoLS), MD Anderson Dysphagia Inventory (MDADI), and Functional Assessment of Cancer Therapy (FACT). PATs and PROs were analyzed with a paired t-test. Kaplan-Meier and log-rank tests were used to analyze local control (LC), local-regional control (LRC), disease-free survival (DFS), and OS. Sixty-four patients had a median follow-up of 33 months (range: 2-129). The most common histologies included olfactory neuroblastoma (28%), sinonasal undifferentiated carcinoma (22%), squamous cell carcinoma (20%), and adenoid cystic carcinoma (15.6%). The majority of patients had T3-T4 (52%) disease and were treated with surgery followed by adjuvant chemo-PBT (33%) or PBT (23%). The most common acute G3 PATs were radiation dermatitis (20%), oral mucositis (11%), and pain (6%); there were no acute G4-5 toxicities. The only acute G3 neurologic PAT was blurred vision (2%) which resolved. There were no G3-4 late PATs. Feeding tube placement occurred in 6% (4/64; 1 permanent in re-irradiation case, 1 lost to follow-up, 1 death with tube, 1 removed after 4 months). On XeQoLS, physical function was significantly worse from baseline (median score of 0; range: 0-3.5) to the acute (delta of +0.75; P<0.01), subacute (delta of +0.5; P<0.01), and chronic (delta of +0.25; P=0.01) follow-up. Similarly, MDADI physical was significantly worse from baseline (median score: 90.6; range: 37.5-100) to the acute (delta of -11.4; P<0.01), subacute (delta of -10.1; P<0.01), and chronic (delta of -3.2; P=0.02) follow-up. Unlike MDADI, there was significant improvement in the FACT-HN global from baseline (median of 2.1; range: 1.6-2.5) to chronic follow-up (delta of +0.2; P=0.001). The 3-year LC, LRC, DFS, and OS was 88%, 82%, 76%, and 82%, respectively. In a predominantly locally advanced, recurrent, or heavily pre-treated patient cohort with sinonasal cancer, we demonstrate some of the most encouraging LC, DFS, and OS rates following PBT. PATs favor PBT compared to historically reported XRT data. PROs suggest significant changes in the acute/subacute period with gradual recovery to baseline.