EPIC Score Research Articles

Patient-Reported Outcome Measures and Decision Regret After Salvage Radical Prostatectomy for Recurrent Prostate Cancer Following Radiotherapy or Focal Therapy

Background/Objectives: Radical prostatectomy (RP) may be considered for recurrent prostate cancer (PCa) following primary curative-intended local therapy. The effect of different prior therapies on patient-reported outcome measures (PROMs) after RP is not well defined. Methods: Validated PROMs (SF-12, EPIC-26, Decision Regret Scale) were used to compare health-related quality of life (HRQOL) and functional status changes following salvage RP after radiotherapy (RT-sRP) or focal therapy (FT-sRP), relative to primary RP. Results: Among 26,515 RP patients who underwent RP between 2014 and 2024, 107 (0.4%) previously received radiotherapy (RT-sRP) and 98 (0.4%) previously received focal therapy (FT-sRP). Compared with primary patients before RP, only the sexual function of RT-sRP patients was lower (EPIC score, 51 vs. 75, p < 0.001). One year after RP, RT-sRP patients exhibited lower functional status in all EPIC-26 domains compared to primary RP patients, whereas FT-sRP patients did not differ significantly. For instance, the median 1 yr EPIC-26 urinary incontinence scores were 46 (RT-sRP), 86 (FT-sRP), and 92 (primary RP). In adjusted mixed model analyses, the detrimental effects of RT-sRP vs. primary RP were further validated. In contrast, no such association was observed for FT-sRP. Decision regret and severe complications were low. Conclusions: Prior FT had only a marginal effect on HRQOL and functional status following RP, while urinary continence and sexual function were lower for RT-sRP patients as compared to primary RP patients. However, from an overall PROM perspective, prior therapies did not exert a prohibitive effect that would preclude RP as a treatment option in those patients.

Pembuatan Media Promosi Menggunakan Desain Feed Instagram Berbasis Aplikasi Canva Pada UMKM Tropic.1996, Mojokerto

Promotional media through the Instagram platform provides a space for companies to share information about their products with the aim of influencing consumers and increasing sales. UMKM Tropic.1996 has been promoting through Instagram but has not managed it effectively, resulting in unstructured product photos and an unappealing and uninformative Instagram feed. This research aims to create a feed design using the Canva application that can be used as promotional media on the Instagram account of UMKM Tropic.1996. This research adopted the action research method. Data collection methods included interviews, observations, questionnaires, and documentation. The effectiveness of the design was measured using the EPIC Rate method, which included four indicators: empathy, persuasion, impact, and communication. The research was conducted in two cycles. Based on the data obtained from the questionnaires, the average EPIC score in the first cycle indicates an effectiveness value of 4.3, while in the second cycle, the effectiveness value increased by 0.4 to 4.7 fell into the category of highly effective. In conclusion, the created Instagram feed design is deemed suitable for publication and highly effective as a promotional medium. Therefore, it is recommended that the company maintains consistency in promoting through the Instagram feed by regularly uploading content and paying attention to the day, time, caption, and hashtags when posting content to optimize the promotion.

Differential Effect of Patient- and Provider-Level Factors on Patient Satisfaction Scores in Academic General Internal Medicine Clinics.

Determine whether patient-level or provider-level factors have greater influence on patient satisfaction scores in an academic general internal medicine clinic. Two years of data (2017-2019) from the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CGCAHPS) surveys from ambulatory internal medicine clinic visits in an academic health center located in the Midwest United States were used. Patient satisfaction was measured using the overall provider satisfaction score (0-10), dichotomized with 9-10 defined as satisfactory and 0-8 as unsatisfactory. Provider-level independent variables included age, sex, race/ethnicity, provider type, service type, clinical effort, academic rank, and years since graduation. Patient-level factors included age, sex, race/ethnicity, education, and Epic Risk Score. Generalized mixed-effects logistic regression models were used to investigate associations between top-box satisfaction score and patient- and provider-level factors, accounting for the nesting of patients within providers. Thirty-three providers and 4597 patients were included in the analysis. Male providers (OR, 1.57; 95% CI, 1.00, 2.47), minority group 2 (OR, 3.54; 95% CI, 1.24, 10.07) and minority group 3 (OR, 6.04; 95% CI, 1.45, 25.12), faculty (OR, 3.83; 95% CI, 1.56, 9.36), and primary care providers (OR, 5.60; 95% CI, 1.62, 19.34) had increased odds of having a top-box rating compared with females, minority group 1, advanced practice providers, and perioperative providers respectively. Age was the only patient independent correlate of top-box rating with a 3% increased odds of top-box rating for every year increase in age (OR, 1.03; 95% CI 1.02, 1.03). In this academic general internal medicine clinic, top-box satisfaction scores were more strongly associated with provider-level factors, including provider race/ethnicity, provider type, and service type, as opposed to patient-level factors. Further research is needed to confirm these findings and identify potential system-level interventions.

Prostate Advanced Radiation Technologies Investigating Quality of Life (PARTIQoL): A Phase III Randomized Clinical Trial of Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer.

Prostate cancer is the most common non-cutaneous cancer diagnosed among men in the United States, and the majority of patients are diagnosed with localized disease. Men with localized prostate cancer have several treatment options including external beam radiotherapy with either photons or protons. Proton beam therapy (PBT) has certain dosimetric advantages and the potential to reduce treatment-associated morbidity and improve oncologic outcomes, but current PBT is significantly more costly than intensity-modulated radiotherapy (IMRT). The PARTIQoL trial (NCT01617161) is the first multicenter phase 3 randomized trial comparing protons to photons in the treatment of localized prostate cancer. Patients with low or intermediate risk prostate cancer (Stage T1c-T2c, PSA < 20, Gleason score ≤ 7) are randomized to receive either PBT or IMRT, with targeted recruitment efforts for minority populations. A companion registry study has concurrently enrolled patients who declined randomization or whose insurance denied coverage for PBT. Patients are stratified by clinical site, age, use of rectal spacer, and fractionation schedule (conventional fractionation: 79.2 Gy in 44 fractions vs moderate hypofractionation: 70.0 Gy in 28 fractions). Participants are followed longitudinally to assess patient-reported outcomes (PROs) of bowel, urinary, and erectile function for 60 months after completion of radiotherapy (with an option for additional follow up through 10 years). Participants may also participate in correlative studies, including serial CT imaging during treatment and analyses of biopsy tissue, blood and urine specimens. The primary objective is to compare PROs of bowel function using the EPIC score at 24 months following completion of radiation. Secondary objectives are to assess treatment-related differences in urinary and erectile functions, adverse events, efficacy endpoints (biochemical control, metastasis-free survival, disease-specific survival, and overall survival), health state utilities, perceptions of care, late effects, cost-effectiveness, association between radiotherapy dose distribution and PROs, and to identify biomarkers of radiation response and toxicity. The randomized trial has completed accrual, with 450 patients enrolled at 27 sites between June 2012 and November 2021. 20.3% of patients enrolled are non-white. Accrual on the companion registry is active, with 354 patients enrolled as of February 2023. Follow-up for the primary endpoint on the randomized trial will be reached in 2024. The PARTIQoL randomized clinical trial will rigorously assess the clinical benefits of PBT relative to IMRT and results will inform decision making by patients, providers, policymakers, and payers.

Electronic health record-based readmission risk model performance for patients undergoing outpatient parenteral antibiotic therapy (OPAT).

Outpatient Parenteral Antibiotic Therapy (OPAT) provides coordinated services to deliver parenteral antibiotics outside of the acute care setting. However, the reduction in monitoring and supervision may impact the risks of readmission to the hospital. While identifying those at greatest risk of hospital readmission through use of computer decision support systems could aid in its prevention, validation of such tools in this patient population is lacking. The primary aim of this study is to determine the ability of the electronic health record-embedded EPIC Unplanned Readmission Model 1 to predict all-cause 30-day hospital unplanned readmissions in discharged patients receiving OPAT through the Duke University Heath System (DUHS) OPAT program. We then explored the impact of OPAT-specific variables on model performance. This retrospective cohort study included patients ≥ 18 years of age discharged to home or skilled nursing facility between July 1, 2019 -February 1, 2020 with OPAT care initiated inpatient and coordinated by the DUHS OPAT program and with at least one Epic readmission score during the index hospitalization. Those with a planned duration of OPAT < 7 days, receiving OPAT administered in a long-term acute care facility (LTAC), or ongoing renal replacement therapy were excluded. The relationship between the primary outcome (unplanned readmission during 30-day post-index discharge) and Epic readmission scores during the index admission (discharge and maximum) was examined using multivariable logistic regression models adjusted for additional predictors. The performance of the models was assessed with the scaled Brier score for overall model performance, the area under the receiver operating characteristics curve (C-index) for discrimination ability, calibration plot for calibration, and Hosmer-Lemeshow goodness-of-fit test for model fit. The models incorporating maximum or discharge Epic readmission scores showed poor discrimination ability (C-index 0.51, 95% CI 0.45 to 0.58 for both models) in predicting 30-day unplanned readmission in the Duke OPAT cohort. Incorporating additional OPAT-specific variables did not improve the discrimination ability (C-index 0.55, 95% CI 0.49 to 0.62 for the max score; 0.56, 95% CI 0.49 to 0.62 for the discharge score). Although models for predicting 30-day unplanned OPAT-related readmission performed slightly better, discrimination ability was still poor (C-index 0.54, 95% CI 0.45 to 0.62 for both models). EPIC Unplanned Readmission Model 1 scores were not useful in predicting either all-cause or OPAT-related 30-day unplanned readmission in the DUHS OPAT cohort. Further research is required to assess other predictors that can distinguish patients with higher risks of 30-day unplanned readmission in the DUHS OPAT patients.

Two-fraction stereotactic MRI-guided ablative radiotherapy with simultaneous boost to dominant intraprostatic lesion: Results from the 2SMART phase 2 trial.

349 Background: Prostate stereotactic ablative radiotherapy (SABR) for localised prostate cancer is commonly delivered over 5 fractions. Focal boost to the dominant intraprostatic lesion (DIL) seen on multiparametric magnetic resonance imaging (mpMRI) is an approach for dose-escalation in prostate SABR. This is the first report of the outcomes of the 2SMART trial, a phase 2 single-arm study using 2-fraction prostate SABR with DIL boost. Methods: Men with low to intermediate risk prostate cancer were enrolled in the study. Three gold fiducial markers were inserted for image guidance. The clinical target volume (CTV) included the prostate gland, and the planning target volume (PTV) was a 2mm expansion antero-posterior and laterally, and 2.5mm supero-inferiorly. The DIL was contoured on fused mpMRI. The prescribed dose was 26Gy in 2 fractions (EQD2 110Gy, α/β of 1.4) to the CTV, and up to 32Gy in 2 fractions (EQD2 164Gy) to the DIL as long as the dose constraints for the organs at risks were not exceeded. Each fraction was delivered 1 week apart. Daily image guidance with cone-beam computed tomography was used pre- and post-treatment. The primary endpoint was acute (≤3 months) changes in quality of life (QOL), assessed using the EPIC questionnaire. Minimal clinically important change (MCIC) in QOL was defined as an EPIC score decrease of &gt;0.5 standard deviation of the baseline EPIC score for each domain. Secondary endpoints were acute and late toxicities (assessed using CTCAEv4), and biochemical failure (based on Phoenix criteria). Results: 30 men were enrolled in the study, of which 2 (7%) had low risk and 28 (93%) had intermediate risk prostate cancer. The median follow-up was 44 months (range: 39-49 months). The median PSA nadir was 0.2ng/mL, with median time to nadir of 37 months. One patient (3%) had biochemical failure at 44 months post-treatment. 1 (3%) and 17 (57%) had acute Grade 2 GU and GI toxicities, while 3 (10%) and 15 (50%) had late (&gt;6 months) Grade 2 GU and GI toxicities. No acute or late Grade ≥3 GU or GI was reported. 10 (33%), 6 (20%), and 3 (10%) men had acute MCIC in urinary, bowel and sexual domains respectively. 15 (50%), 9 (30%) and 13 (43%) had late MCIC in urinary, bowel and sexual domain respectively. Conclusions: Two-fraction prostate SABR with DIL boost is a safe approach for dose-escalation for localised prostate cancer, with minimal impact on acute QOL, and no grade 3-4 toxicities. Clinical trial information: NCT03588819 .

PACE-A: An international phase 3 randomised controlled trial (RCT) comparing stereotactic body radiotherapy (SBRT) to surgery for localised prostate cancer (LPCa)—Primary endpoint analysis.

298 Background: People presenting with early-stage LPCa have several treatment options. There is therapeutic equipoise with lack of randomised evidence for superiority of radiotherapy or surgery. PACE-A aimed to determine if there is improved quality of life (QoL) following SBRT compared to surgery. Methods: PACE (NCT01584258) is a phase 3 open-label multiple-cohort RCT. In PACE-A, people with LPCa, T1-T2, Gleason≤3+4, PSA≤20ng/mL &amp; suitable for surgery were randomised (1:1) to SBRT or surgery. SBRT dose was 36.25Gy/5 fractions in 1-2 weeks; surgery was laparoscopic or robotically assisted prostatectomy. Androgen deprivation was not permitted. Co-primary endpoints were patient reported outcomes (PROs) of Expanded Prostate Index Composite (EPIC-26) questionnaire number of absorbent pads per day &amp; EPIC bowel subdomain score at 2 years. Target sample size was 234 participants (pts) to detect 9% difference in urinary incontinence (80% power, 5% 2-sided alpha) &amp; 5-point difference in mean bowel subdomain score (90% power, 5% 2-sided alpha) with higher EPIC score (range 0-100) indicating better QoL. Secondary endpoints included clinician reported toxicity and additional PROs (1% significance level). Analysis is by treatment received. Results: From Aug 2012 to Feb 2022, 123 men from 10 UK centres were randomised. The IDMC advised stopping recruitment after a 2-year gap in during COVID. Pts had median age 66years (IQR: 61, 69), median PSA 8ng/ml (6, 11) with 52% tumours ≥T2b and 79% Gleason 3+4; 93% pts were of white race. 58/63 pts received SBRT as allocated (2 received surgery, 2 unknown, 1 withdrawn); 48/60 received surgery as allocated (1 received SBRT, 3 received CRT, 2 unknown, 6 withdrawn). 8 laparoscopic and 42 robotic assisted operations were performed. Median follow-up is 50 months (IQR 41, 74). At 2 years, fewer SBRT pts reported use of urinary pads: 2/43 (4.5%) vs 15/32 (46.9%), p&lt;0.001. SBRT pts had significantly worse bowel subdomain score (mean (SD) 88.4 (12.7) vs 97.3 (5.5), p&lt;0.001). 7/45 (15.6%) SBRT and 0/31 (0%) surgery pts reported moderate/big problem with bowel symptoms (p=0.04). SBRT pts reported less EPIC sexual subdomain score (58.0 (31.9) vs 29.3 (20.5), p&lt;0.001); there was no evidence of a difference in urinary subdomain score (85.5 (19.8) vs 80.5 (20.8), p=0.29). At 2 years, CTCAE genitourinary grade 2 or higher(G2+) toxicity was seen in 5/54 (9.3%) SBRT vs 4/42 (9.5%) surgery pts (p=0.97); there was no G2+ gastrointestinal (GI) events seen in either group. Conclusions: PACE-A contributes the first randomised data to the comparison of SBRT with surgery in LPCa providing PRO data relevant to informed decision making. Compared to surgery, pts receiving SBRT had better urinary continence &amp; sexual bother score; clinician reported GI toxicity was low but SBRT pts reported more bowel bother at 2 years. Clinical trial information: NCT01584258 .

Improved early and late continence following robot-assisted radical prostatectomy with concurrent bladder neck fascial sling (RoboSling).

To describe a novel RoboSling technique performed at the time of robot-assisted radical prostatectomy (RARP) and its utility for enhancing urinary function recovery postoperatively. The surgical technique involves harvesting a vascularised, fascial flap from the peritoneum on the posterior aspect of the bladder. Following completion of prostatectomy, the autologous flap is tunnelled underneath the bladder and incorporated into the rectourethralis and vertical longitudinal detrusor fibres at the posterior bladder neck with a modified Rocco suture. After urethra-vesical anastomosis is completed, the corners of the flap are hitched up to Cooper's ligament bilaterally with V-Loc sutures, tensioned and secured creating a bladder neck sling. A prospective, longitudinal cohort study was performed of 193 consecutive patients undergoing RARP between December 2016 and September 2019. The first 163 patients underwent standard RARP, and the last 30 patients had the RoboSling technique performed concurrently. Continence outcomes were the primary outcomes assessed using pad number and Expanded Prostate Cancer Composite (EPIC)-urinary domain questionnaire. Operative time (OT), estimated blood loss (EBL), complications and oncological outcomes were secondary outcomes. The two groups were comparable for demographics and clinicopathological variables. At 3 months, zero pad usage (p= 0.005) and continence rates, defined as EPIC score ≥ 85 (p= 0.007), were both higher in the RoboSling group. EBL, complication rate and positive surgical margin rate did not differ between the two groups. Superior zero pad usage was observed at 1 year in the RoboSling group (p= 0.029). The RoboSling technique added on average 16 min to OT. The RoboSling procedure at the time of RARP was associated with earlier return to continence without negatively impacting other postoperative outcomes. This improvement in continence outcomes was maintained long term.

Why U.S. Patients Declined Hospital-at-Home during the COVID-19 Public Health Emergency: An Exploratory Mixed Methods Study.

To understand why US patients refused participation in hospital-at-home (H@H) during the coronavirus disease 2019 Public Health Emergency, eligible adult patients seen at 2 Mayo Clinic sites, Mayo Clinic Health System-Northwest Wisconsin region (NWWI) and Mayo Clinic Florida (MCF), from August 2021 through March 2022, were invited to participate in a convergent-parallel study. Quantitative associations between H@H participation status and patient baseline data at hospital admission were investigated. H@H patients were more likely to have a Mayo Clinic patient portal at baseline (P-value: .014), indicating a familiarity with telehealth. Patients who refused were more likely to be from NWWI (P-value < .001) and have a higher Epic Deterioration Index score (P-value: .004). The groups also had different quarters (in terms of fiscal calendar) of admission (P-value: .040). Analyzing qualitative interviews (n = 13) about refusal reasons, 2 themes portraying the quantitative associations emerged: lack of clarity about H@H and perceived domestic challenges. To improve access to H@H and increase patient recruitment, improved education about the dynamics of H@H, for both hospital staff and patients, and inclusive strategies for navigating domestic barriers and diagnostic challenges are needed.

Patient Reported Quality of Life after Moderately Hypofractionated Proton Beam Therapy or Intensity Modulated Radiation Therapy for Prostate Cancer

<h3>Purpose/Objective(s)</h3> We aim to quantify and compare changes in patient reported quality of life (PRQOL) after moderately hypofractionated (MHF) Proton Beam Therapy (PBT) or Intensity Modulated Radiation Therapy (IMRT) for prostate cancer (PC). <h3>Materials/Methods</h3> This multi-institutional analysis included patients with NCCN low or intermediate risk PC treated at 4 tertiary cancer centers with MHF PBT or IMRT with prospective PRQOL collection. Patients completed International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) pre-treatment and at 3-to-6-month intervals starting at the end of treatment. EPIC is a questionnaire measuring health related quality of life (HRQOL) domains of genitourinary (GU), gastrointestinal (GI), sexual, and hormonal function. Questions are scored from 0 (no problem) to 4 (big problem). EPIC score of 3 or more was considered a meaningful QOL decrement. IPSS measures GU HRQOL; each question is measured from a score of 0 to 5 with a maximum score of 35. Baseline characteristics were compared with Chi squared and t test for IPSS. Models were limited to long term data, at 12 and 36 months. Generalized linear regression models testing effects of time, treatment, and their interaction were fit via Generalized Estimating Equations, controlling for age, race, and NCCN risk group. <h3>Results</h3> 287 IMRT and 485 PBT patients were included. Intermediate NCCN risk group (81.2 vs. 68.2%; p < 0.001), median age at diagnosis (70 vs 66.9 years; p < 0.001) were higher in the IMRT group. Mean IPSS was slightly worse at baseline in the PBT arm (+0.22; CI, -1.54 – 1.10; p=0.74) and slightly better at 3 years (-0.09; CI, -1.48 – 1.65; p=0.91). On Poisson regression controlling for age, race, and NCCN risk group, PBT IPSS trended worse at 12 months (OR, 1.19; CI, 0.98 - 1.44; p=0.077) without any difference at 36 months (OR, 1.08; CI, 0.80 - 1.26; p=0.94). Similarly, EPIC questionnaire for overall GI function trended worse with PBT at 12 months (CI, 0.83 - 16.27; p=0.085) without difference at 36 months (CI, 0.49 - 12.27, p=0.27). 4.9% and 4.8% patients in the PBT and IMRT arms, respectively, rated their overall GI function at 12 months as a severe problem. Among PBT and IMRT patients combined, severe GU concerns were unlikely at 12 months (GU frequency: 17.5; GU pain: 3.6; stream problem: 11.2%). <h3>Conclusion</h3> PRQOL showed a non-significant trend toward worse 1-year overall GI function and IPSS for PBT; this effect was not present at 3 years. In this multi-institutional, prospective study of PC, long-term GU and GI function was not significantly different between PBT or IMRT arms.

Mina #Ecosmartphone Films 2021

MINA - Mobile Innovation Network and Association is the longest-running film festival in the Southern Hemisphere dedicated to mobile &amp; smartphone filmmaking with a focus on moving-image arts, documentary, community-engaged film productions, experimental films and emerging film production forms and formats, such as MoJo, drone videos, AR and Mobile Cinematic VR. The tenth edition of MINA is presenting a special program titled #EcoSmartphoneFilms, a showcase of contemporary mobile film production about environmental protection and ecology in all its aspects. It is an eclectic collection of short international environmentally themed films from all over the world made on smartphones, pocket cameras, laptops and Instagram. The films show the planet’s beauty as well as the various local, regional and global environmental challenges we are facing. By using a variety of creative solutions that illustrate the power of mobile film, they help to raise awareness about environmental topics from around the globe and make us aware of the role mobile media can play in this. In the spirit of Margaret Mead’s statement that we should “never doubt that a small group of thoughtful, committed citizens can change the world” with this special #EcoSmartphoneFilms program we hope to inspire a deeper critical understanding of ecological issues and strengthen our commitment as both filmmakers and curators to inspire future generations to go mobile and stay sustainable. Save Me (UK) Michael CoppolaShot on iPhone 11 Pro Max SAVE ME is an experimental sci-fi drama short film about the fragmentation of the human psyche, manmade planetary destruction and the possible end of the subjective and objective world, told through the experiences of a lost girl stranded on a deserted beach, accompanied by an epic orchestral score and futuristic sound design with the use of CGI. Iumbar Project - The First One (Australia) Martin K. Koszolko Shot on iPad Pro This music video documents human intervention into environment. The footage shows the fate of trees and other plants disposed of by human inhabitants of the land. This short film raises questions about our relationship with the natural environment and highlights the beauty of the shapes and forms of trees. This beauty is evident even if the plants have been cut down and are no longer alive. The Almeda Fire (USA) David Scott LeibowitzShot on iPhone 11 Pro My Mobile movies took a swift turn from art to ENG when the Almeda fire swept through this part of the Rogue Valley. After The Flood (USA) Alexandra GuillossouShot on iPhone XR An observational piece on two seemingly dissimilar St. Louis events that took place in June 2019. Man and nature can be equally explosive and yet only one has the option of choice. Tree Time (USA) Alexandra Lerman Shot on iPhone 7 &amp; iPhone X Tree Time imagines a relationship between nature and technology unmediated by human presence. The video was shot in the Amazon rainforest with a drone enacting a disembodied point of view that floats through the densely compressed forest canopy, taking off, hovering above the ground, and occasionally returning to it. Kaminda (NL) David van DeldenShot on iPhone X &amp; iPhone 11 Pro A visual poem of a 3-year-old boy's journey of self-discovery. Kaminda revisits David’s childhood adventures narrated by a young voice in spoken words written by Juan- Carlos Goilo. From the dry northern plains to the atmospheric damp caves, Kaminda takes you through the rustic landscapes of Curaçao with stunningly captured scenes. Hear the primitive sounds of Curaçao's "Muzik di Zumbi" accompanied by scenes shot underwater, on land and in the air. Little Beings (Mexico) DiAminda Ordaz Shot on iPhone 8 I tended my senses and they were there,I stopped to contemplate and they were there, I opened my eyes and they were there,I woke up and they were there,I paid attention and they were there.So I wanted to take off my sandals,as not to hurt them with my walk.

Experience Measures after Radical Prostatectomy: A Register-Based Study Evaluating the Association between Patient-Reported Symptoms and Quality of Information.

Patient-reported data are important for quality assurance and improvement. Our main aim was to investigate the association between patient-reported symptoms among patients undergoing radical prostatectomy and their perceived quality of information before treatment. In this single-centre study, 235 men treated with robotic-assisted radical prostatectomy (RARP) between August 2017 and June 2019, responded to a follow-up questionnaire 20–42 months after surgery. A logistic regression analysis was performed to assess the association between patient-reported symptoms, measured with Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), and the perceived quality of information. Adverse effects were defined as a higher EPIC score at follow-up than at baseline. The majority (77%) rated the general information as good. Higher EPIC-CP at follow-up was significantly associated with lower perceived quality of information, also after adjustment for age and level of education (bivariate model OR 1.12, 95% CI 1.07; 1.16, p < 0.001 and multiple model OR 1.12 95% CI 1.08; 1.17, p < 0.001). The share who rated information as good was almost identical among those who reported more symptoms after treatment and those who reported less symptoms (78.3% and 79.2%). Consequently, adverse effects could not explain the results. Our findings suggest a need for improvement of preoperative communication.

Radiation technique and outcomes following moderately hypofractionated treatment of low risk prostate cancer: A secondary analysis of the NRG oncology RTOG 0415 randomized clinical trial.

243 Background: While intensity-modulated radiotherapy (IMRT) is commonly used to deliver moderately hypofractionated radiotherapy (MHRT) for prostate cancer (PC), IMRT has not been prospectively compared to three-dimensional conformal radiotherapy (3D-CRT) in the context of MHRT. This secondary analysis of the phase III RTOG 0415 trial compares survival outcomes and toxicity across RT technique between IMRT and 3D-CRT for low-risk PC. Methods: The phase III, non-inferiority trial RTOG 0415 randomized patients with low risk PC to either MHRT (70Gy at 2.5Gy/fraction) or conventionally fractionated radiation (CFRT; 73.8Gy at 1.8Gy/fraction) with stratification by RT technique. A secondary analysis for differences in overall (OS), biochemical recurrence free survival (BRFS), or toxicity by EPIC scores and Common Terminology Criteria for Adverse Events (CTCAE) was performed. For patient and tumor characteristics, continuous data were compared with Wilcoxon rank sum test and categorical data with Chi-squared test, as appropriate. Rates of BRFS and overall survival (OS) were calculated using the Kaplan-Meier method. Results: 1079 patients received the allocated intervention with a median follow up of 5.8 years. RT technique was balanced between treatment arms, with 79.1% of patients receiving IMRT. RT protocol compliance was &gt; 95% for both IMRT and 3D-CRT. There were no significant differences in BRFS between patients treated with 3D-CRT versus IMRT for all patients (p = 0.33), those randomized to CFRT (p = 0.78), or those randomized to MHRT (p = 0.24). Overall survival did not differ by RT technique as well. For all patients, there was no difference in acute and late GI and GU toxicity rates across RT technique. For patients treated with MHRT, late grade 2 GU toxicity was more common with IMRT than 3D-CRT (31.3% vs 23.4%; p = 0.004). On logistic regression analysis, only poor baseline urinary function, defined as an EPIC score of 90 or below, correlated with acute (p &lt; 0.001) or late (p &lt; 0.001) GU toxicity. Baseline bowel function did not correlate to GI toxicity. Conclusions: RT technique did not impact survival outcomes or toxicity rates following MHRT for low risk PC. Higher rates of late CTCAE grade 2+ GU and GI toxicity observed within the RTOG 0415 MHRT arm were not disproportionally observed following 3D-CRT than IMRT. These data highlight the need for careful consideration of target delineation and normal tissue constraints in the selection and delivery of appropriate RT technique.

Pengukuran Efekivitas Iklan Gojek Menggunakan Metode Epic Model di Kalangan Mahasiswa

This research is a descriptive quantitative study that aims to find out how effective Gojek's online advertising is for students living in Jakarta using the EPIC Model method. The sample in this study used 100 active students residing in Jakarta as respondents. Sample selection was done by purposive sampling method with non-probability sampling technique. In this study, measurements will be carried out on the 4 dimensions of EPIC by looking for the average score of each dimension, the results of the study show the empathy dimension makes advertising able to attract customers' attention, the dimension of persuasion that advertising can affect customers, the impact dimension makes the advertisement give a deep impression to the customer, and the communication dimension can be stated that Gojek advertising can be well remembered and understood. From the results of the EPIC Rate of the four dimensions, the average EPIC score indicates the effective category.

Comparison of multi-omics results between patients with acute myeloid leukemia with long-term survival and healthy controls.

BackgroundAcute myeloid leukemia (AML) is a group of highly heterogeneous diseases, for which approximately 35–40% of patients younger than 60 years old can be cured. However, the multi-omics characteristics and immune cell infiltration (ICI) status of adult long-term survival patients with AML patients compared with healthy controls are still relatively under-explored.MethodsA total of 10 healthy transplant donors (control group) and 11 long-term survival patients with AML with de novo sampling from 2019 to 2020 at the Institute of Hematology in the Hospital of Blood Diseases were enrolled. We simultaneously performed 850 K methylation and bulk RNA-seq on these 21 patients for comparing the differential gene methylation and expression levels between the two groups. The analysis of immune cell gene expression was based on 4 algorithms single sample gene set enrichment analysis (ssGSEA), EPIC, ESTIMATE and immunophenotype score (IPS) on the bulk RNA-seq data.ResultsThe differential methylation positions (DMPs) of the control group was significantly higher than that of the long-term survival group (P<0.01). The hypomethylated probes for Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment is summarized as follows: the significant pathway was related to NK-cell-mediated cytotoxicity and amino acid metabolism. We also found the Differential expression genes (DEGs) of long-term survival AML were roughly similar, and the DEGs were highly relevant to the cellular amino acid metabolic process pathway by gene set enrichment analysis (GSEA). Based on the further univariate and multivariate Cox survival analyses in GSE37642, genes crosslinked of DEGs and DMPs: LOXL1 and PDZRN4, which characterized as hypomethylated and upregulated, may become an AML prognostic marker (P<0.05). Besides, compared with the long-term-survival AML patients who discontinued chemotherapy after >3 years and the healthy donors, T cell-, natural killer cell-, MHC- and effector cell (EC)-related genes were downregulated; suppressor cells (SC) and checkpoint (CP) cells were significantly upregulated in the long-term-survival AML patients who discontinued chemotherapy after <3 years.ConclusionsIn terms of DNA methylation, RNA expression and ICI, AML patients with long-term survival were slightly different than that of healthy people. The profile of long-term AML survivors, especially those who discontinued chemotherapy less than 3 years, still differed from that of healthy people.

Comparison of radiological scoring systems, clinical scores, neutrophil-lymphocyte ratio and serum C-reactive protein level for severity and mortality in acute pancreatitis.

Comparison of radiological scoring systems, clinical scores, neutrophil-lymphocyte ratio and serum C-reactive protein level for severity and mortality in acute pancreatitis BACKGROUND/AIMS To compare radiological scoring systems, clinical scores, serum C-reactive protein (CRP) levels and the neutrophil-lymphocyte ratio (NLR) for predicting the severity and mortality of acute pancreatitis (AP). MATERIALS AND METHODS Demographic, clinical, and radiographic data from 80 patients with AP were retrospectively evaluated. The harmless acute pancreatitis score (HAPS), systemic inflammatory response syndrome (SIRS), bedside index for severity in acute pancreatitis (BISAP), Ranson score, Balthazar score, modified computed tomography severity index (CTSI), extrapancreatic inflammation on computed tomography (EPIC) score and renal rim grade were recorded. The prognostic performance of radiological and clinical scoring systems, NLR at admission, and serum CRP levels at 48 hours were compared for severity and mortality according to the revised Atlanta Criteria. The data were evaluated by calculating the receiver operator characteristic (ROC) curves and area under the ROC (AUROC). RESULTS Out of 80 patients, 19 (23.8%) had severe AP, and 9 (11.3%) died. The AUROC for the BISAP score was 0.836 (95%CI: 0.735-0.937), with the highest value for severity. With a cut-off of BISAP ≥2, sensitivity and specificity were 68.4% and 78.7%, respectively. The AUROC for NLR was 0.915 (95%CI: 0.790-1), with the highest value for mortality. With a cut-off of NLR >11.91, sensitivity and specificity were 76.5% and 94.1%, respectively. Of all the radiological scoring systems, the EPIC score had the highest AUROC, i.e., 0.773 (95%CI: 0.645-0.900) for severity and 0.851 (95%CI: 0.718-0.983) for mortality, with a cut-off value ≥6. CONCLUSION The BISAP score and NLR might be preferred as early determinants of severity and mortality in AP. The EPIC score might be suggested from the current radiological scoring systems.

An analysis of inpatient and ED admissions within 30 days of chemotherapy: An OP-35 review.

e19302 Background: To evaluate patients who were within 30 days of outpatient chemotherapy infusion for an admission or ED visit associated with a primary or secondary diagnosis of anemia, dehydration, diarrhea, emesis, fever, nausea, neutropenia, pain, pneumonia or sepsis. Methods: A review of Epic was performed on all Mercy patients with cancer who received at least one outpatient chemotherapy between 1/1/16-12/31/18. Non leukemia patients ≥ 18 years of age with an inpatient admission(IPA) or ED visit (EDV) were further evaluated for either the primary or secondary diagnosis for referral with at least one of the following diagnoses: anemia, dehydration, diarrhea, emesis, fever, nausea, neutropenia, pain, pneumonia, or sepsis. Univariate and multivariable analyses were performed to identify significant clinical variables associated with the risk of referral. Adjusted Odds Ratios were calculated for the significant variables with a p value &lt; 0.05 being significant. Results: Of the 9,590 cancer patients who presented to an outpatient infusion center during the study interval, there were 8,319 eligible patients excluding those with leukemia or age &lt; 18 (n = 503) or for a presentation in which a chemotherapy agent was not infused. There were 90,030 eligible chemotherapy encounters of which 16.8% of patients (n = 1400) had an IPA and 11.8% (n = 980) had an EDV within 30 days of infusion. Age, social deprivation status, NCI comorbidity index, Epic readmission score, ECOG performance score, smoking, and malnutrition were significantly associated with either an IPA or EDV in both settings. Sepsis, pneumonia, and anemia were the most common OP35 related diagnoses for an IPA at 47.2%, 26.9%, and 23.2%, respectively. Similarly, pain, dehydration and nausea were the most common OP35 related diagnosis for an EDV at 48.1%, 14.2%, and 14.1% respectively. Factors having the strongest association with an IPA were malnutrition (OR: 2.34 2.08-2.65; p &lt; 0.00001) and an antibiotic type of chemotherapy (OR: 2.16 1.72-2.72; p &lt; 0.0001). Factors having strongest association with an EDV were severe pain score (OR: 2.56 2.21-2.97; p &lt; 0.0001) and moderate to most deprived social deprivation status (OR: 2.10 1.62-2.72; p &lt; 0.0001). ER referrals for pain, dehydration, and anemia most commonly occurred during clinic hours. Conclusions: Many clinical variables were found to be significantly associated with an IPV or EDV. These variables are opportunities for outpatient interventional algorithms to enhance patient care.

Prostate oncologic therapy while ensuring neurovascular conservation (POTEN-C): A phase II randomized controlled trial of stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing for erectile function preservation in localized prostate cancer.

TPS381 Background: Radiotherapy (RT) associated sexual dysfunction occurs in half of men following treatment for localized prostate cancer. Proposed mechanisms include vascular injury of adjacent internal pudendal arteries (IPA), penile bulb (PB), corpora cavernosa (CC) or neurovascular bundles (NVB). Ability to spare these structures has been limited by a presumed need to treat the entire prostate gland, while also preventing rectal injury. Recent innovations have challenged this issue: a) precise dose delivery with stereotactic ablative RT (SAbR), b) improved spatial mapping of clinically significant disease with mpMRI, c) rectal avoidance with rectal spacer use. Methods: POTEN-C is a multi-center phase II randomized control trial, which includes men with a) low-intermediate risk prostate cancer eligible for SAbR without ADT, b) potent by sexual composite score ≥60 on EPIC patient-reported quality of life instrument, c) mpMRI delineated disease (PIRADS v2 score 3-5) ≥5mm to at least one ‘spared’ NVB. After placement of rectal spacer gel and CT/MRI simulation, men are randomized to standard SAbR to 40-45Gy/5fx or neurovascular-sparing SAbR. In the sparing experimental arm, the prostate PTV is given 30Gy/5fx excluding unilateral ‘spared’ NVB, while a 40-45Gy PTV further excludes a 5mm protective shell on the unilateral ‘spared’ NVB+IPA+PB+CC. Centralized rapid review of initial contours/plans and online training materials are integrated. The primary endpoint is 2-year patient-reported potency, measured by EPIC sexual composite score. We hypothesize that neurovascular sparing SAbR will reduce 2-year EPIC score decline from a control of 20 to 10 (corresponding to a MCID). Assuming standard deviation 20, two-sided significance level 0.10 with two-sample t-testing, and 15% attrition, we intend to enroll 120 patients to provide 80% power to detect this difference. Secondary endpoints include sexual medication/aid use, relapse rates, GU/GI toxicity. Enrollment is ongoing. Details: http://www.poten-c.org . Clinical trial information: 03525262.

Toxicity and Quality of Life Outcomes from a Randomized Phase II Trial of HDR Monotherapy for Low and Intermediate-Risk Prostate Cancer

To report health-related quality of life (HRQOL) and toxicity outcomes at 4-years in prostate cancer patients treated with high-dose rate (HDR) brachytherapy as monotherapy using single-fraction of 19 Gy or 2 fractions of 13.5 Gy (27 Gy/2 fractions one week apart). Patients with low or intermediate-risk prostate cancer (NCCN definition) were accrued to a randomized phase II clinical trial of HDR brachytherapy as monotherapy, randomized to either 19 Gy/1 or 27 Gy/2. HRQOL (Expanded Prostate Cancer Index Composite [EPIC]), urinary symptoms (International Prostate Symptom Score [IPSS]), and toxicity (Common Terminology Criteria for Adverse Events [CTCAE], v4.0) were assessed prospectively. Comparison between the two arms was analyzed using Fisher exact test. Univariate linear and logistic regression analysis was used to investigate association between HRQOL/toxicity and baseline covariates. Median follow-up is 51 months. 170 patients were treated (87 with single 19 Gy, 83 with 27 Gy/2). Late (>6 months) GI toxicity was minimal in both arms, with G-2 toxicity <1%, and no difference between the arms. Late G-2 urinary toxicity was low and <2%, except for urinary frequency and incontinence. G-2 urinary frequency was similar between arms (19% for 19Gy/1 and 10% 27Gy/2; p=0.27). There was a significantly later G-2 urinary incontinence with 19 Gy/1, and none with 27 Gy/2 (6% vs 0%, p=0.0318). G 2-3 urinary tract obstruction was only observed in 4 patients, all of whom were treated with 19 Gy/1. No change in the median EPIC scores at 4 years (follow-up - baseline score) was observed with 27 Gy/2 for urinary, bowel or hormonal domains, but a decline in sexual domain by 16 points. In the single fraction arm, there was no change in the bowel or hormonal domains too, but a drop in sexual domain by 9 points, comparable to 27 Gy/2 (p=0.53). There was a significantly greater drop in urinary domain, function, and bother with 19 Gy/1 (-3.5 vs 0.0, p=0.003; -5.0 vs 0.0, p=0.004; and -3.57 vs 0.0, p=0.006, respectively). Urinary QOL was slightly worse with 19 Gy/1 compared to 27 Gy/2, with greater clinically significant decrement (defined as a decrease in EPIC score >0.5 SD) in urinary domain (46.15% vs 16.67%, p=0.007), function (52.5% vs 15.38%, p=0.0008) and bother (43.59% vs 16.67%, p=0.0136). Treatment with 19 Gy/1 (OR 4.286, p=0.0082) and higher PTV V100 (OR 1.6, p=0.02) were the only factors predictive of clinically significant decrement in urinary QOL. There was no difference in clinically significant decrement between arms in other QOL domains (bowel, sexual, or hormonal). Both single 19 Gy and 13.5 Gy x 2 are well tolerated with low toxicity and good HRQOL at 4 years. Single fraction 19 Gy is associated with higher rates of G-2 urinary toxicity, worse urinary function and bother, and greater decline in urinary QOL at 4 years. Treatment with 19 Gy/1 and having higher PTV V100 are predictive of decrement in urinary QOL.

The PACE trial: International randomised study of laparoscopic prostatectomy vs. stereotactic body radiotherapy (SBRT) and standard radiotherapy vs. SBRT for early stage organ-confined prostate cancer.

TPS153 Background: The development of Stereotactic Body Radiotherapy (SBRT) has provided a further treatment option for early stage prostate cancer. In addition to the benefits of an overall treatment time reduction, profound hypofractionation could result in therapeutic gain given the radiobiology of prostate cancer. Evidence suggests SBRT to be safe and effective; however randomised data is lacking comparing outcomes with standard treatment options. Aim: To assess whether SBRT offers therapeutic benefit in comparison to prostatectomy or standard radiotherapy. Methods: The PACE trial is an international multicentre phase III trial, comprising two parallel randomisation processes. Within PACE A, potential surgical candidates are randomised between radical prostatectomy and SBRT (36.25 Gy in 5 fractions). In PACE B, randomisation is between standard radiotherapy (78Gy in 39 fractions or 62Gy in 20 fractions) and SBRT (36.35Gy in 5 fractions). SBRT can be delivered using Cyberknife or gantry based techniques. Patients with low or intermediate risk prostate cancer are eligible for the trial, and are treated without the use androgen deprivation therapy. Follow up is for a period of 10 years. The aim is to recruit 234 patients to PACE A (117 in each arm) and 858 patients to PACE B (429 patients in each arm). Primary Objectives: PACE A: To determine whether there is improved quality of life after SBRT compared with surgery at 2 years post treatment, using EPIC score to measure urinary incontinence and bowel bother. PACE B: to determine whether SBRT is non-inferior to surgery in terms of freedom from biochemical/clinical failure at 5 years from randomisation. Progress: PACE A has been slower to recruit than anticipated due to the difficulties of a surgery versus radiotherapy randomisation. However, it is expected to reach target accrual, having recruited 57 patients from 3 centres. In contrast, PACE B is recruiting exceptionally well, open in 40 centres, and as of October 2017 recruited 762 patients. Accrual target is expected to be reached by the end of 2017. Clinical trial information: NCT01584258.