Changes In Patient-reported Outcomes Research Articles

Effects of Elective Revision After Breast Reconstruction On Patient-Reported Outcomes.

There has been increasing emphasis on patient-reported satisfaction as a measure of surgical outcomes. While previous research has investigated factors influencing patient satisfaction following breast reconstruction, there are few studies on how patient satisfaction is impacted by revision procedures. The purpose of this study was to investigate whether elective revisions following breast reconstruction are significantly associated with changes in patient-reported outcomes and quality of life. A retrospective review was conducted of patients who underwent immediate autologous or alloplastic breast reconstruction at a single institution from 2015-2021. Patients were included if they had completed BREAST-Q pre-operatively, post-initial reconstruction, and post-revision procedures. Patients were excluded if they received adjuvant radiation or if they had previously undergone breast reconstruction procedures. The primary outcome measures were BREAST-Q domains. Demographic, clinical, and surgical variables were also analyzed. Of the 123 patients included for analysis, 61 underwent autologous breast reconstruction and 62 underwent alloplastic reconstruction. Mean age was 49.31 ± 11.58 years and BMI was 29.55 ± 5.63 kg/m2. 48 patients underwent no revision procedures and 75 patients underwent at least one revision. Between these two groups, there were no differences in age, BMI, complication rates, socioeconomic status, or pre-operative BREAST-Q scores. Patients reported significantly higher satisfaction with outcome after their first revision compared to after initial reconstruction alone (p=0.04). Autologous reconstruction patients who had at least one revision had significantly higher Satisfaction with Outcome (p=0.02) and Satisfaction with Surgeon (p=0.05) in the 2-year follow-up period compared to patients who had no revisions. Revision procedures following autologous breast reconstruction are associated with higher patient satisfaction with outcome. Further research should explore specific factors influencing patient decision-making regarding whether to undergo revisions.

Abstract PO3-01-10: Changes in Patient-Reported Outcomes with 3 Months of Pre-operative Endocrine Therapy in the POWER Trial

Abstract Background: The Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions Trial (POWER, NCT04272801) aims to determine whether 3 months of pre-operative endocrine therapy (pre-ET) affects decision-making regarding adjuvant radiation therapy (RT) among older women with early-stage, estrogen receptor (ER) positive breast cancer. The goal of the present study is to evaluate changes in patient-reported outcomes (PROs) during the course of pre-ET. We hypothesize that PROs will change over the course of pre-ET and that those changes can be used to identify patients who are at-risk for long-term noncompliance to adjuvant ET and who may benefit from RT. Methods: Participants in the POWER Trial receive 3 months of pre-ET prior to breast-conserving surgery and final treatment decisions regarding adjuvant RT. Health-related quality of life (HRQOL) (EORTC QLQ-C30 and QLQ-BR23), depression (Center for Epidemiologic Studies Depression Scale Revised), and general symptom burden (Breast Cancer Prevention Trial Symptom Checklist (BCPT-SCL)) are assessed at baseline and at day 90 after pre-ET. Perceived sensitivity to medicine (Perceived Sensitivity to Medicine (PSM) survey) is assessed at baseline. The BCPT-SCL was used to examine common ET side effects, including hot flashes, musculoskeletal symptoms, cognitive problems, weight gain, and bladder control. Graphical methods are used to display results. Results: The first 46 participants who completed pre-ET in the POWER trial were included in this preliminary assessment. From baseline to day 90, there was notable variability in HRQOL and no definitive shift towards worsening HRQOL with a median change (IQR) of 0 (-8.33, 8.33). Similarly, the median change in symptom profiles for the whole cohort was 0 over the 90 days of pre-ET. However, a subset of patients experienced changes in symptom burden throughout the 90-day period. Approximately one-fourth of participants reported an increase in hot flashes and musculoskeletal symptoms from baseline to day 90. There does not appear to be worsening fatigue, depression scores, cognitive problems, or weight gain. After stratifying by self-perceived sensitivity to medicine, patients with high PSM scores have a greater median change (0.5 and 0.33) in symptoms compared to those with low PSM scores (0 and 0) for hot flashes and musculoskeletal symptoms, respectively (Figure 1). Conclusions: When looking at this cohort, there was no change in symptoms or quality of life after the 3-month course of pre-ET. Evaluation of the changes in PROs identified a subset of participants with worsening symptoms after pre-ET. Future analyses, when trial accrual is complete, will examine the relationship between PROs and long-term adherence to adjuvant ET and will elucidate if the patients who experience worsening BCPT-SCL symptoms during the 90-day period are more likely to opt for RT. Figure 1 Change in symptoms after pre-ET Change in hot flash burden and musculoskeletal symptom burden is greater in patients with high perceived sensitivity to medicine. Citation Format: Trish Millard, Lena Turkheimer, Christiana Brenin, David Brenin, Patrick Dillon, Einsley Janowski, Anneke Schroen, Gina Petroni, Shayna Showalter. Changes in Patient-Reported Outcomes with 3 Months of Pre-operative Endocrine Therapy in the POWER Trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-01-10.

Single-Center Pilot Study of Remote Therapeutic Monitoring in Patients with Operative Spinal Pathologies

ObjectivesSpine pathology affects a significant portion of the population, leading to neck and back pain, impacting quality of life, and potentially requiring surgical intervention. Current pre- and postoperative monitoring methods rely on patient reported outcome (PRO) measures and lack continuous objective data on patients' recoveries. Remote therapeutic monitoring (RTM) using wearable devices offers a promising solution to bridge this gap, providing real-time physical function data. This study aims to assess the feasibility and correlation between changes in physical function and daily activity levels using RTM for individuals with operative spinal pathologies. MethodsA single-center pilot study involving 21 participants with operative spinal pathologies was conducted at an academic hospital. Participants were provided Bluetooth-enabled Fitbit Inspire 2 activity trackers and asked to wear them daily for 100 days. The Healthcare Recovery Solutions (HRS) mobile application facilitated remote administration of the PROMIS - Physical Function Short Form 6b PROs questionnaire at days 1, 30, and 90. Linear regression, Students' paired T tests, and one-way ANOVA were used to analyze collected data. ResultsAverage compliance with RTM was found to be 82.4% compared to only 48% for PROMs. Changes in daily steps were moderately positively correlated with changes in PROs at both 30 and 90 days. Participant satisfaction with RTM was high, and responses indicated greater satisfaction with RTM compared to PROMs. ConclusionsRTM offers continuous and objective data collection, presenting a potential solution to the limitations of intermittent clinical assessments and self-reported outcomes. The study demonstrated a moderate correlation between changes in activity levels and changes in PROs, suggesting that RTM data could serve as a surrogate for PROs. Participants' high compliance and satisfaction with RTM underscore its feasibility and potential clinical utility. This study lays the groundwork for larger future investigations into the clinical benefits and broader application of RTM in spine care.

RESULTS OF THE ECHO-R TRIAL – A PRAGMATIC, TELEHEALTH-DELIVERED EXERCISE INTERVENTION FOR WOMEN WITH RECURRENT OVARIAN CANCER

INTRODUCTION & AIMS Wide-spread and equitable uptake of exercise into standard cancer care will require evidence of safety and efficacy across all cancer and treatment types. People with rarer cancers, lower survival prospects, and higher morbidity have been under-represented in exercise oncology trials. The ECHO-R trial for women with recurrent ovarian cancer aimed to address this research gap, evaluating the efficacy of a 6-month telephone-delivered, exercise intervention consistent with ESSA exercise oncology prescription guidelines. METHODS 50 women scheduled to receive chemotherapy for recurrent ovarian cancer were recruited to the pre-post exercise trial with assessments at baseline and post-intervention (6 months post-baseline). The intervention was delivered via 12 telephone sessions, with the option of five additional study-funded, in-person sessions with a community-based AEP. The intervention had a global target of 150 minutes of moderate-intensity multimodal exercise per week, with actual volume and prescription individualised at each session, dependent on functional capacity, goals, and barriers. Outcomes included feasibility (volume of exercise completed) and harms profile (occurrence of adverse outcomes) of the intervention, changes in patient-reported outcomes (quality of life [QoL; FACT-O], fatigue [FACT-Fatigue] and neurotoxicity [FACT-GOG-NTX]), and objective assessment of aerobic function (6-minute-walk test), muscular endurance (30-second sit-to-stand) and strength (hand grip). RESULTS The average volume of exercise completed did not meet the target (median 100 min/week, min: 0; max 527). QoL, fatigue, neurotoxicity, aerobic function, muscular endurance, and strength remained stable between the pre and post-intervention assessments. There were no serious adverse events. CONCLUSION Recurrent ovarian cancer is an incurable disease, characterised by declining QoL and physical capacity. Findings from this study suggest that maintenance of QoL and physical function is possible through participation in an exercise intervention, even if exercise targets are not met. Physical activity guidelines may need to reflect this.

Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial

Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction - General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

Defining predictors of responsiveness to advanced therapies in Crohn’s disease and ulcerative colitis: protocol for the IBD-RESPONSE and nested CD-metaRESPONSE prospective, multicentre, observational cohort study in precision medicine

IntroductionCharacterised by chronic inflammation of the gastrointestinal tract, inflammatory bowel disease (IBD) symptoms including diarrhoea, abdominal pain and fatigue can significantly impact patient’s quality of life. Therapeutic developments in the...

Early response to benralizumab in Canadian patients with severe eosinophilic asthma: Interim results from a prospective observational cohort

RATIONALE: There is a need to characterize the real-world impact of benralizumab, an anti-interleukin-5 receptor alpha antibody, for add-on maintenance therapy of patients with severe eosinophilic asthma. OBJECTIVES The objective of this study was to assess change in patient-reported outcomes following initiation of benralizumab, focusing on asthma control, quality of life (QoL), and work and activity impairment. METHODS This is an interim analysis of the prospective, single-arm, multi-center, observational POWER study. Eligible patients were recruited from 20 clinics across Canada from 2019 to 2022, had an Asthma Control Questionnaire, 6 Item (ACQ-6) score ≥1.5 and were benralizumab-naïve. MEASUREMENTS AND MAIN RESULTS: A total of 131 patients had baseline assessments at the 24-week interim analysis. Asthma control was assessed with ACQ-6 (minimum clinically important difference: change of 0.5 units), and stratified into well-controlled (<0.75), partial control (0.75–1.5) and poor control (>1.5). Improvements in asthma control were observed as early as one week following benralizumab initiation. At 24 weeks, mean change in ACQ-6 was −1.46 (95% confidence interval: −1.71, −1.21), and 47% achieved well-controlled or partial control. Mean EuroQol 5 Dimension, 5 Level (EQ-5D-5L) utility score increased nearly 10% from baseline (0.09; standard deviation 0.2). Absenteeism and presenteeism decreased from baseline (20% and 39%, respectively) to 24 weeks (2% and 21%, respectively). CONCLUSION Patients reported meaningful improvements in asthma control, quality of life (QoL) and work and activity impairment 24 weeks after initiating benralizumab, highlighting its positive impact in patients with severe asthma. One- and two-year follow-up are planned to assess exacerbations, healthcare resource use and sustainability of observed benefits.

Prospective Trial of Functional Lung Avoidance Radiation Therapy for Lung Cancer: Quality of Life Report

PurposeA novel form of lung function imaging has been developed that uses 4DCT data to generate lung ventilation images (4DCT-ventilation). Functional avoidance uses 4DCT-ventilation to reduce doses to functional lung with the aim of reducing pulmonary side-effects. A 4DCT-ventilation functional avoidance, phase II, multi-center clinical trial was completed. The purpose of this work is to quantify patient reported outcomes (PRO) changes for patients treated with functional avoidance and to determine which metrics are predictive of PRO changes. Materials and MethodsPatients with locally advanced lung cancer receiving curative intent radiotherapy were accrued. Each patient had a 4DCT-ventilation image generated using 4DCT data and image processing. PRO instruments included the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, administered pre-treatment, 3, 6, and 12 months post-treatment. FACT-TOI (Trial Outcome Index) and the FACT-LCS (Lung Cancer Subscale) percentage of clinically meaningful declines (CMD) were determined. A linear mixed-effects model was used to determine which patient, clinical, dose, and dose-function metrics were predictive of PRO decline. Results59 patients completed baseline PRO surveys. 83% of patients had non-small-cell lung cancer, with 75% having stage III disease. The median dose was 60 Gy in 30 fractions. CMD FACT-TOI decline was 46.3%, 38.5%, and 26.8%, at 3, 6, and 12 months, respectively. CMD FACT-LCS decline was 33.3%, 33.3%, and 29.3%, at 3, 6, and 12 months, respectively. While an increase in most dose and dose-function parameters was associated with a modest decline in PROs, none of the results were significant (all p>0.053). ConclusionThe current work provides an innovative combination of functional avoidance and PROs and is the first report of PROs for patients treated with prospective 4DCT-ventilation functional avoidance. Approximately 30% of patients had clinically significant decline in PROs at 12 months. The study provides additional data on outcomes with 4DCT-ventilation functional avoidance.

Effects of COVID-19 vaccines on patient-reported outcomes in patients with inflammatory bowel disease: a multicenter survey study in Korea.

The impact of vaccination on inflammatory bowel disease (IBD) patients is still unknown, and no studies have assessed the changes in patient-reported outcomes (PROs) after vaccination in patients with IBD. Therefore, in this study, we investigated the impact of vaccines on the PROs of patients with IBD. We conducted a questionnaire survey of patients with IBD who visited outpatient clinics at 4 specialized IBD clinics of referral university hospitals from April 2022 to June 2022. A total of 309 IBD patients were included in the study. Patient information was collected from a questionnaire and their medical records, including laboratory findings, were reviewed retrospectively. Risk factors associated with an increase in PROs after COVID-19 vaccination were analyzed using logistic regression analyses. In addition, we assessed whether there were differences in variables by vaccine order using the linear mixed model. In multivariate analysis, young age ( < 40 years) and ulcerative colitis (UC) were found to be independent risk factors for aggravation of PROs in patients with IBD. In all patients, platelet count significantly increased with continued vaccination in multiple pairwise comparisons. In UC patients, PROs such as the short health scale, UC-abdominal signs and symptoms, and UC-bowel signs and symptoms were aggravated significantly with continued vaccination. There was no significant increase in the variables of patients with Crohn's disease. Therefore, there may be a need to counsel patients with IBD younger than 40 years of age, and patients with UC before they receive COVID-19 vaccinations.

Frailty is not an independent risk factor for worse clinical outcomes in lumbar spinal surgery: a prospective cohort study.

Recently, many studies revealed that frailty affects unfavorably on postoperative outcomes in lumbar spinal diseases. This study aimed to investigate the relationship between frailty and clinical outcomes while identifying risk factors associated with worse clinical outcomes following lumbar spinal surgery. From March 2019 to February 2021, we prospectively enrolled eligible patients with degenerative lumbar spinal diseases requiring surgery. Frailty was assessed preoperatively. To identify the impact of frailty on lumbar spinal diseases, clinical outcomes, which were measured with patient-reported outcomes (PROs) and postoperative complications, were compared according to the frailty. PROs were assessed preoperatively and one year postoperatively. In addition, risk factors for preoperative and postoperative worse clinical outcomes were investigated. PROs were constantly lower in the frail group than in the non-frail group before and after surgery, and the change of PROs between before and after surgery and postoperative complications were not different between the groups. In addition, frailty was a persistent risk factor for postoperative worse clinical outcome before and after surgery in lumbar spinal surgery. Frailty persistently affects the clinical outcome negatively before and after surgery in lumbar spinal surgery. However, as the change of the clinical outcome is not different between the frail group and the non-frail group, it is difficult to interpret whether the frail patients are vulnerable to the surgery. In conclusion, frailty is not an independent risk factor for worse clinical outcome in lumbar spinal surgery.

Are changes in patient-reported outcomes prognostic for diffuse large B-Cell lymphoma survival? Results from the GOYA trial.

In this hypothesis-generating analysis, we examined whether longitudinal changes in patient-reported outcomes (PROs), such as symptoms, over time would be prognostic for progression-free survival (PFS) and overall survival (OS) in patients with diffuse large B-cell lymphoma (DLBCL) who were newly treated with obinutuzumab (G) in combination with CHOP (G-CHOP) or rituximab (R) with CHOP (R-CHOP), in the GOYA Phase 3 trial (NCT01287741). Our results show that from the study baseline to cycle 3day 1, every 1-point increase (worsening) in fever symptoms was associated with a 41% higher risk of death (hazard ratio [HR], 1.41; P = 0.01). Every 1-point increase (worsening) in lumps or swelling symptoms was associated with a 27% higher risk of disease progression or death (PFS events) (HR, 1.27; P = 0.01) and a 29% higher risk of death (OS events) (HR, 1.29; P = 0.02). No significant associations were observed between survival and changes in other symptoms, such as itching. Our study suggests that changes in some PROs are related to survival in DLBCL patients.

Obese patients with CEAP (clinical, etiology, anatomy, pathophysiology) C2 and C3 disease show enhanced symptom improvement after endovenous thermal ablation

ObjectiveEndovenous thermal ablation (EVTA) is a prevalent treatment option for patients with severe venous disease. However, the decision to intervene for patients with less severe disease (CEAP [clinical, etiology, anatomy, pathophysiology] C2 and C3) is less clear and becomes further complicated for patients with obesity, a pathology known to increase venous disease symptom severity. Therefore, the objective of this study was to use the Society for Vascular Surgery Vascular Quality Initiative database to evaluate outcomes after EVTA in obese patients with CEAP C2 and C3 venous insufficiency. MethodsUsing the Society for Vascular Surgery Vascular Quality Initiative database, we retrospectively analyzed the initial procedure of all patients with a CEAP clinical class of C2 or C3 who underwent EVTA from January 2015 to December 2021. Patients were grouped by obesity, defined as a body mass index of ≥30 kg/m2. The primary outcome was the change in venous clinical severity score (VCSS) from the procedure to the patient's initial follow-up. The secondary outcomes included the change in patient-reported outcomes at follow-up via the HASTI (heaviness, achiness, swelling, throbbing, itching) score, incidence of follow-up complications, and recanalization of treated veins. The change in the VCSS and HASTI score were analyzed using Student t tests, and complications and recanalization were assessed using the Fisher exact test. Significant outcomes were confirmed by multiple variable logistic regression. The remaining significant variables were then analyzed, with obesity categorized using the World Health Organization classification system to analyze how increasing obesity levels affect outcomes. ResultsThere were 8146 limbs that met the inclusion criteria, of which 5183 (63.6%) were classified as nonobese and 2963 (36.4%) as obese. Obesity showed no impact on improvement in the VCSS (−3.29 vs −3.35; P = .408). Obesity was found to be associated with a larger improvement in overall symptoms, as evidence by a greater improvement in the HASTI score (−7.24 vs −6.62; P < .001). Obese limbs showed a higher incidence of superficial phlebitis (1.5% vs 0.7%; P = .001), but no difference was found in recanalization or any other complication. ConclusionsThese data suggest that obese patients with CEAP clinical class C2 or C3 experience greater improvement in their perceived symptoms after EVTA with little difference in clinical improvement and complications compared with nonobese patients. Although obesity has been associated with increased severity of venous disease symptoms, obese patients are able to derive significant relief after treatment during the short term and may experience greater relief of symptoms than nonobese patients when treated at more mild disease presentations.

Association of 5-Year Hip Arthroscopy Outcomes with Hip Morphology and Cartilage Status at Time of Surgery: A National Registry Study With HAGOS Outcomes in 281 Patients With Femoroacetabular Impingement Syndrome.

The effects of specific bony hip morphologies, cam and dysplasia, and cartilage damage on mid- and long-term (≥5 years) patient-reported outcomes (PROs) are understudied. To investigate if changes in PROs from preoperatively to 5 years after hip arthroscopy are associated with preoperative bony hip morphology and cartilage status in patients with femoroacetabular impingement syndrome. Cohort study; Level of evidence, 3. Patients were identified in the Danish Hip Arthroscopy Registry. Hip and groin function was assessed from preoperatively to 5 years postoperatively with the Copenhagen Hip and Groin Outcome Score (HAGOS) Activities of Daily Living (ADL) and Sports and Recreation (Sport) subscales. Morphology was defined using the anterior alpha angle (AA) and lateral center-edge angle (LCEA) as follows: mild to moderate cam (55°≤ AA < 78°), severe cam (AA ≥ 78°), pincer (LCEA > 39°), and borderline dysplasia (20°≤ LCEA < 25°). Joint space width (JSW) was defined as slightly reduced (3.1 mm ≤ JSW ≤ 4 mm) or severely reduced (2.1 mm ≤ JSW ≤ 3 mm). Acetabular cartilage status was defined by modified Beck grades 0 to 4 and femoral head cartilage status by International Cartilage Regeneration & Joint Preservation Society grades 0 to 4. Acetabular and femoral cartilage injury areas were categorized as <1, 1 to 2, or >2 cm2. Multiple regression analyses assessed adjusted associations between hip morphology and cartilage injuries with improvement in HAGOS-ADL and HAGOS-Sport. The study included 281 patients (age, 35 ± 10 years; 52.3% female). No cam and mild-to-moderate cam were associated with greater improvement in HAGOS-ADL (16 points [P = .002] and 7 points [P = .038], respectively) compared with severe cam. Normal JSW was associated with greater improvement in HAGOS-ADL (21 points; P = .026) compared with severely reduced JSW. Femoral head cartilage injury area <1 cm2 was associated with greater improvements in HAGOS-ADL (17 points; P = .03) and HAGOS-Sport (21 points; P = .035) compared with femoral cartilage injury area >2 cm2. Patients having no-to-moderate cam morphology, normal JSW, or femoral head cartilage injury area <1 cm2 had greater improvement in PROs 5 years after hip arthroscopy compared with patients having severe cam morphology, severely reduced JSW, or femoral cartilage injury area >2 cm2.

Real-world outcomes of Omnipod DASH system use in people with type 1 diabetes: Evidence from the Association of British Clinical Diabetologists (ABCD) study

AimsTo evaluate real-world outcomes in people with Type 1 Diabetes (PwT1D) initiated on Omnipod DASH® Insulin Management System. MethodsAnonymized clinical data were submitted to a secure web-based tool within the National Health Service network. Hemoglobin A1c (HbA1c), sensor-derived glucometrics, total daily dose of insulin (TDD), and patient-reported outcome changes between baseline and follow-up were assessed. Individuals were classified to “new-to-pump” (switched from multiple daily injections) and “established-on-pump” (switched from a tethered insulin pump) groups. Results276 individuals from 11 centers [66.7 % female; 92 % White British; median age 41 years (IQR 20–50); diabetes duration 20 years (IQR 11–31); 49.3 % within “new-to-pump” group] were included. Baseline HbA1c was 8.0 ± 1.3 % (64 ± 14 mmol/mol). At follow-up [3 years (IQR 1.5–3.2)], HbA1c reduced by 0.3 % [(3 mmol/mol); p = 0.002] across the total population, 0.4 % [(5 mmol/mol); p = 0.001] in those “new-to-pump” and remained unchanged in those “established-on-pump”. TDD decreased in the “new-to-pump” cohort (baseline:44.9 ± 21.0units vs follow-up:38.1 ± 15.4units, p = 0.002). Of those asked, 141/143 (98.6 %) stated Omnipod DASH had a positive impact on quality of life. ConclusionsOmnipod DASH was associated with improvements in HbA1c in PwT1D “new-to-pump” and maintained previous HbA1c levels in those “established-on-pump”. User satisfaction in all groups and TDD reduction in those “new-to-pump” were reported.

Continuous Glucose Monitoring Profiles and Health Outcomes after Dapagliflozin Plus Saxagliptin vs Insulin Glargine.

Glycemic variability and hypoglycemia during diabetes treatment may impact therapeutic effectiveness and safety, even when glycated hemoglobin (HbA1c) reduction is comparable between therapies. We employed masked continuous glucose monitoring (CGM) during a randomized trial of dapagliflozin plus saxagliptin (DAPA+SAXA) vs insulin glargine (INS) to compare glucose variability and patient-reported outcomes (PROs). 24-week sub-study of a randomized, open-label, two-arm, parallel-group, phase 3b study. Multicenter study (112 centers in 11 countries). 283 adults with type 2 diabetes (T2D) inadequately controlled with metformin ± sulfonylurea. DAPA+SAXA vs INS. Changes in CGM profiles, HbA1c, and PROs. Changes from baseline in HbA1c with DAPA+SAXA were similar to those observed with INS, with mean difference [95% CI] between decreases of -0.12% [-0.37 to 0.12%], P = .33. CGM analytics were more favorable for DAPA+SAXA, including greater percent time in range (> 3.9 and ≤ 10 mmol/L; 34.3 ± 1.9 vs 28.5 ± 1.9%, P = .033), lower percent time with nocturnal hypoglycemia (area under the curve ≤ 3.9 mmol/L; 0.6 ± 0.5 vs 2.7 ± 0.5%, P = .007), and smaller mean amplitude of glycemic excursions (-0.7 ± 0.1 vs -0.3 ± 0.1 mmol/L, P = .017). Improvements in CGM were associated with greater satisfaction, better body weight image, less weight interference, and improved mental and emotional well-being. DAPA+SAXA and INS were equally effective in reducing HbA1c at 24 weeks, but people with T2D treated with DAPA+SAXA achieved greater time in range, greater reductions in glycemic excursions and variability, less time with hypoglycemia, and improved patient-reported health outcomes.

Exercise and behaviour change support for individuals living with and beyond cancer: Interim results and program satisfaction of the EXCEL study

PurposeExamine the impact of the EXercise for Cancer to Enhance Living Well's (EXCEL) 10–12-week exercise and behaviour change support intervention on secondary effectiveness outcomes, including patient-reported outcomes, physical function, and program satisfaction. MethodsIndividuals with cancer up to 3 years post treatment with any tumour type were eligible. Outcomes were measured at baseline and immediately following the 10–12-week intervention. Patient-reported outcomes included participant characteristics, overall well-being, cognition, fatigue, symptom severity, exercise barrier self-efficacy, and program satisfaction. Physical function included shoulder flexion, 30-s sit to stand, sit and reach, 2-min step test or 6-min walk test (in-person only), and single leg balance. Wilcoxon signed-rank tests were used to assess changes in patient-reported outcomes and physical function assessments from baseline to 12-weeks. ResultsA total of 804 participants enrolled in the study in the first 2.5-years, with 699 completing the intervention. Wilcoxon signed rank tests and Rosenthal coefficients (r) showed significant (p ​< ​0.05) small improvements in well-being (r ​= ​0.10), fatigue (r ​= ​0.25), symptom severity (r ​= ​0.17), and self-efficacy (r ​= ​0.11). Significant (p ​< ​0.01) moderate to large improvements were observed for the 30-s sit to stand (r ​= ​0.54), sit and reach (left: r ​= ​0.46; right: r ​= ​0.41), 2-min step test (r ​= ​0.66), 6-min walk test (r ​= ​0.52), and single leg balance (left: r ​= ​0.32; right: r ​= ​0.34) assessments. Participants reported high satisfaction with program staff (average ​= ​4.5/5) and that the program was beneficial and enjoyable (average ​= ​4.6/5). ConclusionEXCEL's group-based exercise program with behaviour change support, delivered in an online supervised setting to individuals living with cancer, may improve patient-reported outcomes and physical function and is associated with high participant satisfaction.

Increased risk for early revision with quadriceps graft compared with patellar tendon graft in primary ACL reconstructions.

Bone patella-tendon bone (BPTB) and hamstring tendon (HT) autografts are the most used grafts in primary anterior cruciate ligament (ACL) reconstructions (ACLR) in Norway. Quadriceps tendon (QT) autograft has gained more popularity during the past years. The purpose of this study is to compare revision rates and patient-reported outcomes of primary QT with BPTB and HT autograft ACL reconstructions in Norway at 2-year follow-up. It was hypothesized that there would be no difference in 2-year revision rates between all three autografts. Data included primary ACLR without concomitant ligament surgeries, registered in the Norwegian Knee Ligament Register from 2004 through 2021. Revision rates at 2 years were calculated using Kaplan-Meier analysis. Hazard ratios (HR) for revision were estimated using multivariable Cox regression analysis with revision within 2 years as endpoint. Mean change in patient-reported outcome was recordedpreoperatively and at 2 years through the Knee Injury and Osteoarthritis Outcome Score (KOOS) subcategories 'Sport' and 'Quality of Life' was measured for patients that were not revised and analysed with multiple linear regression. A total of 24,790 primary ACLRs were identified, 10,924 with BPTB, 13,263 with HT and 603 with a QT graft. Patients in the QT group were younger (23.5 years), more of them were women (58.2%) and over 50% had surgery <3 months after injury. The QT group had the highest prevalence of meniscal injuries (61.9%). Revision estimates at 2-years were 3.6%, 2.5% and 1.2% for QT, HT and BPTB, respectively (p < 0.001). In a Cox regression analysis with QT as reference, BPTB had a lower risk of revision (HR 0.4, 95% Cl 0.2-0.7, p < 0.001). No significant difference was observed in the revision risk between QT and HT (HR 1.1, 95% Cl 0.7-1.8, n.s.). The two most common reported reasons for revision were: traumatic graft rupture and nontraumatic graft failure. There were no differences between the groups in change of KOOS in subcategories 'Sport' and 'Quality of Life' at 2-years follow-up. The 2-year risk of revision after ACLR with QT was higher than BPTB and similar to HT. No difference was found between the groups in patient-reported outcomes. This study provides valuable insights for both surgeons and patients when making decisions about the choice of autografts in primary ACL reconstructions. Level II.

Mature results of a phase 2 pilot study of radium-223 and radiotherapy in untreated hormone-naïve men with oligometastatic prostate cancer to bone.

160 Background: We hypothesized that treatment with Radium-223 (Ra223) and to ≤5 sites of bony metastases could safely delay the time to start androgen deprivation therapy (ADT) and maintain quality of life (QoL). Methods: 20 men previously treated with surgery, radiation, or both for M0 PCa later developed ≤5 bone-only mets were eligible for this prospective trial. Inclusion: testosterone ≥ 100 ng/dL and mets on conventional bone scan, validated by a CT, MRI, or PET/CT. Exclusion: LHRH therapies after initial treatment or N1 disease at diagnosis of bone mets. Therapy was 6 cycles of Ra223 and SBRT (30 Gy in 5 fractions between cycles 1-2). Bone scan was performed at baseline and q3 months. PSA was evaluated monthly during the Ra223 course and q3 months after. Therapeutic effectiveness was defined as ≥20% of patients meeting the primary endpoint of freedom from ADT (FFAdt) use at 15 months. Discontinuation of study therapy occurred if: PSA rise &gt; 10% if baseline PSA &gt;20ng/ml, PSA&gt;20 if baseline PSA &lt;20 ng/ml, radiographic progression or a skeletal-related event (SRE). All endpoints were timed from the Cycle 1 radium date. Patients were followed for 2 years. Clinically significant changes in patient-reported outcome (PRO) measures were defined as &gt;1/2 standard deviation from the mean baseline value and were censored after the time of ADT use. Continuous and categorical covariates were compared using the Wilcoxon rank sum and Pearson’s Chi2 tests and univariate Cox regression. Statistical significance was considered at P&lt;0.05. Results: The median number of Ra223 cycles was 6. 6 patients had &lt;6 cycles (range 2-5) due to progression. FFAdt at 15 and 24 months was 50.0% and 40.0%, respectively (p&lt;0.001). Median time to ADT was 15 months. 11 (55%) and 5 (25%) patients had a PSA decline exceeding 50% and 90%, respectively. Two patients had undetectable (PSA&lt;0.01) at 2 years. There were no significant changes from baseline in any PRO QoL domain (physical functioning, anxiety, depression, fatigue, satisfaction with participation in social roles, sleep disturbance, and pain interference). There were 2 patients with Grade 3 SREs (bone fracture, pain). Grade 2+ events attributed as possible or likely to Ra-223 were seen in 4 patients (bone pain, fatigue, fracture, decreased WBC count, and other). Grade 2+ events attributed as possible or likely to EBRT were seen in 2 patients, including fatigue and other pain. No differences were noted for age, baseline PSA, days from primary treatment, NCCN risk group, TNM stage, ISUP grade group, BMI, or # of lesions in those who met or failed the primary endpoint (all p&gt;0.05). Conclusions: In this prospective pilot study, the first-line use of Ra223 and SBRT to conventionally imaged oligomets in hormone-naïve men resulted in a significant delay in ADT use compared to historical control. The therapy is well tolerated, maintains QoL, and may result in undetectable PSA. Clinical trial information: NCT03304418 .

Outcomes After Total Ankle Arthroplasty in Patients Aged ≤50 Years at Midterm Follow-up.

Ankle arthritis differs from arthritis of the hip and knee in that 80% is posttraumatic and thus often occurs in a younger patient population. The literature supporting total ankle arthroplasty (TAA) in younger patients has increased over recent years and has bolstered the argument that in the short term, TAA in younger patients has successful outcomes that are comparable to older, lower-demand patients.The purpose of our study was to evaluate patient-reported outcomes (PROs) and implant survivorship at midterm after primary TAA in patients ≤ 50 years of age at the time of surgery. A retrospective chart review was conducted of patients ≤ 50 years of age who underwent primary TAA at a single institution from 2000 to 2017. Patient demographics, outcome measures, and complications were recorded. All patients had a minimum clinical follow-up of 5 years. PRO measures were evaluated at preoperative, 1-year postoperative, and final follow-up visits. Paired t tests were performed to compare individual patient changes in PROs from preoperative. Implant survivorship was evaluated based on need for revision of either the tibial or talar component. The need for additional surgery related to the TAA was also evaluated. A total of 58 patients were included. The average age at the time of the index surgery was 43.3 years (range 22-50 years). All patients had a minimum follow-up of 5 years with a mean follow-up of 8.8 years. A total of 11 patients required additional surgery related to their TAA. Six patients (10.3%) required bone grafting of peri-implant cysts, 3 patients (5.2 %) required gutter debridement, and 1 patient underwent complete revision of metal components. Mean visual analog scale, 36-item Short Form Health Survey, Short Musculoskeletal Function Assessment, and American Orthopaedic Foot & Ankle Society hindfoot scores significantly improved from preoperative to 1-year postoperative and final postoperative follow-up. The patients aged ≤50 years treated with a TAA whom we have been able to observe for a minimum of 5 years showed generally maintained improvement in functional scores and thus far have had a relatively low rate of secondary surgeries.Level of Evidence:Level III, retrospective cohort study.

Incorporation of emergent symptoms and genetic covariates improves prediction of aromatase inhibitor therapy discontinuation.

Early discontinuation is common among breast cancer patients taking aromatase inhibitors (AIs). Although several predictors have been identified, it is unclear how to simultaneously consider multiple risk factors for an individual. We sought to develop a tool for prediction of AI discontinuation and to explore how predictive value of risk factors changes with time. Survival machine learning was used to predict time-to-discontinuation of AIs in 181 women who enrolled in a prospective cohort. Models were evaluated via time-dependent area under the curve (AUC), c-index, and integrated Brier score. Feature importance was analysis was conducted via Shapley Additive Explanations (SHAP) and time-dependence of their predictive value was analyzed by time-dependent AUC. Personalized survival curves were constructed for risk communication. The best-performing model incorporated genetic risk factors and changes in patient-reported outcomes, achieving mean time-dependent AUC of 0.66, and AUC of 0.72 and 0.67 at 6- and 12-month cutoffs, respectively. The most significant features included variants in ESR1 and emergent symptoms. Predictive value of genetic risk factors was highest in the first year of treatment. Decrease in physical function was the strongest independent predictor at follow-up. Incorporation of genomic and 3-month follow-up data improved the ability of the models to identify the individuals at risk of AI discontinuation. Genetic risk factors were particularly important for predicting early discontinuers. This study provides insight into the complex nature of AI discontinuation and highlights the importance of incorporating genetic risk factors and emergent symptoms into prediction models.