Changes In QoL Research Articles

Changes in quality of life and health across the first two years of the COVID-19 pandemic: A mixed methods, longitudinal study of older adults

The objective of this study was to identify shifts in older adults’ well-being over the first two years of the COVID-19 pandemic. Between March 2020 and April 2022, 76 adults aged 65+ from the upper Midwest participated in telephone interviews across five timepoints. Quantitative and qualitative questions focused on perceptions of QOL, physical health and mental health, as well as changes over the two years of interviews. Repeated measures ANOVAs indicated significant changes in self-reported QOL over time, but no significant changes to self-reported physical or mental health. Thematic content analysis revealed relevant themes for each content area. Findings provided a longitudinal view of changes in perceived QOL and health among older adults during the COVID-19 pandemic. Despite quantitative improvements in QOL and stability in health, qualitative themes indicated nuances impacts including challenges to physical activity and fluctuations in mental health and QOL.

Characteristics and Impact of Long COVID at a Neurology Clinic

Introduction: Long COVID can also lead to neurological sequelae that affect existing diseases. This study explored how COVID-19 infection affects neurological patients and the relationship between long COVID and exacerbating factors. Methods: This retrospective study was conducted on 85 patients with neurological diseases after COVID-19 at the Neurology Department, Inje University Busan Paik Hospital, Korea. The data were collected between August and October 2022. The patients had a medical history, including COVID-19 infection, and completed symptom questionnaires. A long COVID questionnaire consisting of 35 inquiries in 10 categories was completed. Anxiety, depression, fatigue, functional difficulties, QOL, and health status changes were assessed. Results: The analysis comprised 85 participants (age: 56.4 ± 15.2 years; 63.5% women). Of the categories, neurological symptoms (68.2%) were the most prevalent, followed by systemic symptoms (64.7%) and cardiopulmonary symptoms (56.5%). Anxiety, depression, and fatigue symptoms were reported by 36.5%, 34.1%, and 42.4% of the participants. Subjective neurological deterioration after COVID-19 was reported in 28 participants (28/81, 34.6%). Anxiety, depression, and fatigue were influenced by long COVID symptoms and the subjective deterioration of neurological conditions. Conclusion: This study analyzed the long COVID symptoms in patients with preexisting neurological conditions and their impact on mental health and quality of life. One-third of the participants reported a subjective worsening of their preexisting neurological conditions. This study highlights the need for comprehensive follow-ups and a multidisciplinary approach for patients with neurological conditions and prolonged COVID-19 symptoms.

Transperineal laser ablation (TPLA) of the prostate for benign prostatic obstruction: the first 100 patients cohort of a prospective, single-center study

PurposeTransperineal laser ablation (TPLA) is a new minimally-invasive surgical treatment for patients with benign prostatic obstruction (BPO). We report the perioperative and mid-term functional results of the first 100 consecutively patients undergoing TPLA at our institution.MethodsClinical data from consecutive patients undergoing TPLA at our institution from April 2021 to July 2023 were prospectively collected. Primary endpoints were the postoperative changes in IPSS, QoL and MSHQ 3-item questionnaires and in Qmax and post-void residual volume (PVR).ResultsOverall, 100 consecutive patients underwent the procedure. Median age and prostate volume were 66 (IQR 60–75) years and 50 (IQR 40–70) ml, respectively. In the cohort, 14 (14%) patients had an indwelling catheter and 81 (81%) were under oral BPO therapy at the time of TPLA. Baseline median Qmax (ml/s) and PVR (ml) were 9.1 (IQR 6.9–12) and 90 (IQR 50–150), respectively, while median IPSS and QoL were 18 (IQR 15–23) and 4 (IQR 3–4). At all the follow-up timepoints, the evaluated outcomes on both symptoms and functional parameters showed a statistically significant improvement (p < 0.001). Antegrade ejaculation was preserved in all sexually active patients. No postoperative Clavien-Dindo > 2 complications were recorded.ConclusionsTPLA represents a safe option for selected well-informed patients swith LUTS due to BPO. Our prospective study confirms the feasibility and favorable perioperative and functional outcomes in a real-world cohort with heterogenous prostate volumes and patient characteristics.

Early Changes in Nutritional Status of Elderly Patients with Lung Cancer Undergoing Chemotherapy Are Positively Related with Symptoms of Depression: A Prospective Follow-Up Study

This study aims to assess early effects of chemotherapy on symptom alleviation, nutritional status, and mental health in elderly patients with advanced non-small-cell lung cancer (NSCLC). This prospective study included 45 NSCLC patients (32 males, 13 females) aged 65–82 years (mean age 70.0 ± 4.5 years) with good performance status. Assessments were conducted immediately after diagnosis and after two chemotherapy cycles, focusing on nutritional status (assessed with MNA questionnaire), quality of life (QoL, based on FACT-L and FACT-TOI questionnaires), lung cancer-related symptoms (based on LCSS), and mental health (based on PHQ-9 questionnaire). Despite significant alleviation of symptoms like cough, dyspnea, and body weight loss, there was no significant correlation between changes in symptoms burden and changes in nutritional status (r 2 = 0.122, P = 0.427), and change of patients’ mental condition (r 2 = –0.141, P = 0.255). No significant QoL changes were noted, but a decrease in severe depression frequency was observed. The improvement of patients’ mental condition was related strictly to the improvement of nutritional status (r 2 = -0.589, P < 0.001). The study highlights the vital link between nutritional status and mental health in elderly NSCLC patients, emphasizing the need for integrated care approaches that address both aspects to enhance treatment effectiveness and patient well-being.

Post–COVID-19 Condition in Children 6 and 12 Months After Infection

There is a need to understand the long-term outcomes among children infected with SARS-CoV-2. To quantify the prevalence of post-COVID-19 condition (PCC) among children tested for SARS-CoV-2 infection in pediatric emergency departments (EDs). Multicenter, prospective cohort study at 14 Canadian tertiary pediatric EDs that are members of the Pediatric Emergency Research Canada network with 90-day, 6-month, and 12-month follow-up. Participants were children younger than 18 years who were tested for SARS-CoV-2 infection between August 2020 and February 2022. Data were analyzed from May to November 2023. The presence of SARS-CoV-2 infection at or within 14 days of the index ED visit. Presence of symptoms and QoL reductions that meet the PCC definition. This includes any symptom with onset within 3 months of infection that is ongoing at the time of follow-up and affects everyday functioning. The outcome was quantified at 6 and 12 months following the index ED visit. Among the 5147 children at 6 months (1152 with SARS-CoV-2 positive tests and 3995 with negative tests) and 5563 children at 12 months (1192 with SARS-CoV-2 positive tests and 4371 with negative tests) who had sufficient data regarding the primary outcome to enable PCC classification, the median (IQR) age was 2.0 (0.9-5.0) years, and 2956 of 5563 (53.1%) were male. At 6-month follow-up, symptoms and QoL changes consistent with the PCC definition were present in 6 of 1152 children with positive SARS-CoV-2 tests (0.52%) and 4 of 3995 children with negative SARS-CoV-2 tests (0.10%; absolute risk difference, 0.42%; 95% CI, 0.02% to 0.94%). The PCC definition was met at 12 months by 8 of 1192 children with positive SARS-CoV-2 tests (0.67%) and 7 of 4371 children with negative SARS-CoV-2 tests (0.16%; absolute risk difference, 0.51%; 95% CI, 0.06 to 1.08%). At 12 months, the median (IQR) PedsQL Generic Core Scale scores were 98.4 (90.0-100) among children with positive SARS-CoV-2 tests and 98.8 (91.7-100) among children with negative SARS-CoV-2 tests (difference, -0.3; 95% CI, -1.5 to 0.8; P = .56). Among the 8 children with SARS-CoV-2 positive tests and PCC at 12-month follow-up, children reported respiratory (7 of 8 patients [88%]), systemic (3 of 8 patients [38%]), and neurologic (1 of 8 patients [13%]) symptoms. In this cohort study of children tested for SARS-CoV-2 infection in Canadian pediatric EDs, although children infected with SARS-CoV-2 reported increased chronic symptoms, few of these children developed PCC, and overall QoL did not differ from children with negative SARS-CoV-2 tests.

Health-related quality of life is improved after coronary artery bypass graft surgery: a 1-year follow-up study

Objectives: The purpose of this study was to detect changes in QoL after coronary artery bypass grafting surgeries (CABG) in one year, and to identify the possible predictive factors associated with the change. Design: A single-center prospective study of 501 patients was conducted between 2013 and 2018 using the EQ-5D VAS questionnaire for estimating the QoL. The patients filled in a questionnaire preoperatively, at 6 and at 12 months postoperatively. Univariate and multivariable logistic regression analyses were used to find out if certain pre-selected factors or EQ5D dimensions had independent effects on the observed EQ VAS scores. Results: QoL improved in all EQ-5D dimensions and in EQ VAS scores at 6 and at 12 months: the greatest changes in the number of reported problems were in the dimensions “mobility” (–34.2%, p<.001), “self-care” (–36.7%, p=.001) and “pain or discomfort” (–31.0%, p<.001). With the multivariable regression model, we could show that normal left ventricle ejection fraction (LVEF) and improvement in mobility and pain/discomfort dimensions were in association with improvement of EQ VAS score at 6 months. At 12 months this association was no longer detectable. Conclusions: CABG procedure can improve patient’s QoL when judged with EQ5D dimensions and related overall self-rated health (VAS). This improvement was seen both at 6 and at 12 months postoperatively. Except for LVEF, the other patient-specific risk factors we examined did not seem to affect QoL in the long term.

Impact of Treviamet® & Treviamet XR® on quality of life besides glycemic control in type 2 DM patients

BackgroundMaintaining the quality of life is the main objective of managing type 2 diabetes (T2DM) (QoL). Since it is a key factor in patient motivation and adherence, treatment-related QoL has always been considered when choosing glucose-lowering medicines. The objective of the study was to evaluate the quality of life besides glycemic control among type 2 diabetes mellitus patients receiving Treviamet® & Treviamet XR® (Sitagliptin with Metformin) in routine care.MethodsIt was a prospective, open-label, non-randomized clinical trial including T2DM patients uncontrolled on Metformin therapy. All patients received Treviamet® & Treviamet XR® for six months. Sequential changes in QoL, fasting plasma glucose, HbA1c, body weight, and blood pressure were monitored from baseline to 3 consecutive follow-up visits. The frequency of adverse events (AEs) was also noted throughout the study.ResultsA total of 504 patients were screened; 188 completed all three follow-ups. The mean QoL score significantly declined from 57.09% at baseline to 33.64% at the 3rd follow-up visit (p < 0.01). Moreover, a significant decline in mean HbA1c and FPG levels was observed from baseline to 3rd follow-up visit (p < 0.01). Minor adverse events were observed, including abdominal discomfort, nausea, flatulence, and indigestion. Gender, HbA1c, diarrhea, and abdominal discomfort were significant predictors of a patient’s QoL, as revealed by the Linear Regression Model (R2 = 0.265, F(16, 99) = 2.231).ConclusionTreviamet® & Treviamet XR® significantly improved glycemic control (HbA1c levels) and QoL in T2DM patients without serious adverse events.Trial registrationClinicalTrials.gov identifier (NCT05167513), Date of registration: December 22, 2021.

Top-down holmium laser enucleation of the prostate (HoLEP) versus traditional HoLEP for the treatment of benign prostatic hyperplasia (BPH): 1-year outcomes of a randomized controlled trial.

The top-down holmium laser enucleation of the prostate (HoLEP) technique recently emerged as a safe and effective modification of traditional HoLEP. In our randomized controlled trial, we compared intraoperative and postoperative outcomes of traditional and top-down HoLEP for the treatment of benign prostatic hyperplasia (BPH) in patients with a prostate size ≥80 g. One-hundred patients with BPH and a prostate volume ≥80 cc participated in this prospective randomized controlled trial. Outcome measures were collected and compared, including IPSS, QoL, flow rate, PVR, IIEF-15, PSA, and TRUS prostate volume changes. Perioperative complications were also recorded. All patients were followed up at 1, 3, 6, and 12 months. There were no significant differences in preoperative baseline characteristics between the two surgical groups. The median prostate volume for the traditional and top-down HoLEP groups was 107 and 102 cc, respectively. The operative parameters and postoperative outcomes were comparable for both cohorts. The median enucleation time for traditional HoLEP was 60 min, which was not significantly longer than that of top-down HoLEP (52 min) (p = 0.07). At 3 months follow-up, there was no statistically significant difference in transient stress urinary incontinence (SUI) in the traditional HoLEP (4.1%) versus the top-down HoLEP group (2.2%), (p = 0.61). There were no significant differences in functional and sexual outcomes between the two groups at 12 months. The HoLEP procedure significantly improves patients' urinary functional outcomes and has comparable postoperative outcomes regardless of the technique utilized.

2069P QoL changes of caregivers during first-line palliative chemotherapy for patients with incurable cancer

2069P QoL changes of caregivers during first-line palliative chemotherapy for patients with incurable cancer

Long Term Results of Prostate Cancer Patients Treated with Cs131 LDR Brachytherapy Compared with Recently Published SBRT Data.

The use of LDR prostate brachytherapy (PB) as monotherapy has been established as a definitive treatment for prostate cancer patients with low and favorable intermediate risk. Patients choose PB in part due to it being minimally invasive with a quick return to full activity. Recently, there has been more interest in using shorter courses of radiotherapy, citing the same rationale. We present patient-reported outcomes from a cohort of patients treated at our institution treated with PB using Cs131to compare our outcomes with the 5-year data from the published RTOG 0938 MATERIALS/METHODS: We analyzed data from patients treated at our institution with Cs131 PB monotherapy who completed the EPIC questionnaire at baseline and at 1, 2, and 5 years after treatment. Urinary and bowel functions were evaluated based on the EPIC questionnaire the same way they were evaluated in the recently published RTOG 0938, assessing the proportion of patients with deterioration from baseline of >5 for urinary function and >2 for bowel function. We also report the 5- and 10-year bDFS calculated using the Kaplan Meier method RESULTS: A total of 138 patients were included in this analysis with a median age of 66 and median follow-up of 121.5 months. Change in urinary score of >2 at 1, 2, and 5 years was 62%, 53%, and 43% respectively (compared with 44.3, 51.7, and 41.3 respectively for RTOG 0938). Change in bowel score of >5 at 1, 2, and 5 years was 27%, 23%, and 25% (compared with 29.3, 28.7, and 30.6 respectively for RTOG 0938). Interestingly, there were a number of patients who reported improvement in their urinary score at 1, 2, and 5 years (26%, 36%, and 46%, respectively), The same held for patients who reported improvement in their bowel score at 1, 2 and 5 years (37%, 38% and 41%, respectively). Hence, the median urinary score was 6.25 lower at year 1, but only 2.08 lower at year 2 with no difference by year 5. The median bowel score showed zero difference at every time point. The 5-year bDFS in our cohort was 97.8% (compared to 91.3% in RTOG 0938). Our 10-year bDFS was 96%. Single modality PB with Cs131 provides excellent long-term bDFS, especially when compared to recently published RTOG 0938 as 47% of our patients had intermediate-risk disease (RTOG 0938 had low-risk disease only and only 5-year data). Our patients had modest changes in urinary and bowel QOL compared to baseline, also comparable to published SBRT data. At 5 years in our cohort, 46% and 41% reported improvement in their urinary and bowel EPIC scores. The reason for this needs to be explored.

O.1.1-7 As we were and as we should be, concurrent exercise training in adults with schizophrenia: CORTEX-SP study

Abstract Purpose People with schizophrenia (SP) in addition to presenting an unhealthy lifestyle, psychosocial determinants, such as decreased self-esteem and social stigma, and the presence of psychiatric symptoms, have a profound impact on the health-related quality of life (HRQoL). Thus, people with SP have reported greater disability than those healthy control (HC) in HRQoL, assessed by the 36-Item Short-Form Health Survey questionnaire (SF-36). Therefore, the promotion of a healthy lifestyle and interventions aiming to increase physical activity (i.e., aerobic and resistance training) should be a priority given the health benefits. It is well known that regular physical activity improves HRQoL contributing to perceived well-being, with greater improvements in interventions supervised by exercise specialists. Methods This research was carried out to analyze the HRQoL measurements in an SP population (n = 112, 20.4% women, 41.3±10.4 yr old) in comparison to an HC sample (n = 30), and to determine in the SP sample the changes in QoL following 20-week supervised concurrent exercise training program (EX) compared to a Treatment-As-Usual (TAU). The SF-36 questionnaire was used to assess HRQoL. Results At baseline, the SP population showed lower scores (P &amp;lt; 0.05) in physical function, role-physical, bodily pain, general health, vitality, social functioning, mental health, and physical and mental component summaries compared to HC. After 20-week intervention, physical functioning (↑12.9%), general health (↑15.3%), mental health (↑8.3%), and physical component summary (↑5.1%), increased (P &amp;lt; 0.05) in EX group. In contrast, no significant changes were seen in the TAU for any of the domains studied. Following the Bonferroni correction, there were between-group significant differences. Thus, the EX group showed significant (P &amp;lt; 0.05) improvements (i.e., higher values) compared with the TAU group in physical functioning (difference = 14.3; 95% CI, 5.8-22.8), general health (difference = 11.7; 95% CI, 5.0-18.5) and physical component summary (difference = 4.6; 95% CI, 1.1-8.2), and no significant between-group differences were found in any other domains. Conclusions These results highlight the important role of supervised exercise in improving physical and psychological health.

Self at Risk: Self-Esteem and Quality of Life in Cancer Patients Undergoing Surgical Treatment and Experiencing Bodily Deformities.

Self-esteem is an important factor determining QoL after surgical procedures leading to bodily deformities associated with cancer treatment. However, there are few data on which components of self-esteem are most closely related to QoL. The article presents two studies that aim to fill this gap. Study 1 concerns changes in global self-esteem and QoL in patients treated surgically for oral cancer (n = 35); Study 2 concerns changes in explicit and implicit self-esteem and QoL in women with breast cancer undergoing mastectomy (n = 96). The study was longitudinal with two measurements: before and after surgery. Both studies used the EORTC QLQ-C30 and Rosenberg's SES questionnaires. In Study 2, the Implicit Association Test (IAT) was additionally performed. The patients' global QoL and self-esteem deteriorated after surgery. In Study 1, patients with higher initial self-esteem showed a greater range of decreased self-esteem and QoL than patients with initially low self-esteem. In Study 2, the largest decreases in various dimensions of QoL and explicit self-esteem were observed in women with fragile self-esteem. A group of women with high explicit and implicit self-esteem showed the best QoL after mastectomy. Cancer patients with high, fragile self-esteem are at risk of the greatest deterioration in QoL and self-image after cancer surgery. These people should be given special psycho-oncological care.

Italian version of the Brief Questionnaire of Olfactory Disorders (Brief-IT-QOD).

To evaluate the reliability and validity of the Italian version of the Brief Questionnaire of Olfactory Disorders (Brief-IT-QOD). The study consisted of six phases: item generation, reliability analysis (112 dysosmic patients for internal consistency analysis and 61 for test-retest reliability analysis), normative data generation (303 normosmic subjects), validity analysis (comparison of Brief-IT-QOD scores of healthy and dysosmic subjects and scores correlation with psychophysical olfactory testing TDI and SNOT-22 scores), responsiveness analysis (10 dysosmic chronic rhinosinusitis with nasal polyps patients before and after biologic therapy), and cut-off value determination (ROC curve analysis of Brief-IT-QOD sensitivity and specificity). All subjects completed the Brief-IT-QOD. Internal consistency (α > 0.70) and test-retest reliability (ICC > 0.7) were acceptable and satisfactory for both questionnaire subscales. A significant difference between dysosmic and control subjects was found in both subscales (p < 0.05). Significant correlations between subscales scores and TDI and SNOT-22 scores were observed. Brief-IT-QOD scores before treatment were significantly higher than after biological therapy. Brief-IT-QOD is reliable, valid, responsive to changes in QoL, and recommended for clinical practice and outcome research.

Wellbeing in Addiction Recovery: Does It Differ across Addictions?

Limited research has been conducted on the experiences of individuals in long-term recovery from addiction, and addictions are usually studied in isolation. However, no theories of addiction differentiate between addictions or assume that individuals will experience only one addiction. This study aimed to compare affect between individuals with addictions to drugs and alcohol and to explore how QoL changes in long-term recovery from addiction. Individuals in recovery from addiction (n = 115; 52.2% male) were recruited via snowball sampling on social media signposted by an addiction rehabilitation charity. Participants completed questionnaires about QoL (WHOQOL-Bref) and positive and negative affect (PANAS-X). The main primary addictions were drugs (76.5%) and alcohol (21.7%), with 69.7% reporting multiple addictions including food, sex, internet, and gambling. Affect and coping strategies did not differ by addiction. QoL appeared to improve with time in recovery. The high percentage of multiple addictions and greater similarities than differences between individuals with drug and alcohol addictions suggest that addictions should not be studied in isolation when studying psychological health during long-term recovery.

Celiac plexus radiosurgery for pain management in advanced cancer: An international phase II trial, health-related quality of life (HRQOL) outcomes.

e16293 Background: Upper abdominal / lower back pain characterizes celiac plexus involvement from pancreatic and other cancers which may impair HRQOL; its satisfactory treatment is an unmet clinical need. We hypothesized that ablative radiation delivered to the celiac plexus would decrease pain and improve HRQOL. Methods: An international single arm Phase II study included patients with an average pain level ≥ 5/11 on the brief pain inventory (BPI), ECOG 0-2, and anatomical involvement of the celiac axis. The intervention was a single fraction of 25Gy delivered to the celiac plexus. The primary endpoint was ‘complete or partial (≥2 points) pain response’ based upon the BPI ‘average pain’ 11-point scale. Changes in Health-related QOL at 3 &amp; 6 weeks compared to baseline were secondary endpoints as measured by FACT-Hep, &gt; 8 point change being the minimal clinically important difference (MCID). Evaluable patients included eligible irradiated subjects, who had stable pain levels pre-treatment, and were alive 3 weeks’ post-treatment. The sample size was 90 evaluable patients, giving 90% power to show response rate ≥ 40%. Opioid usage was assessed using intravenous morphine equivalent dose. Sensitivity HRQOL analyses imputed worsened outcomes (-9 for total FACT-Hep) for missing data. Results: Between 2018 and 2022, 149 patients were enrolled, 90/125 who received treatment were evaluable. Median age was 65.5 years (range 28-88), 65% were female, 92% had pancreatic cancer, and 86% had metastatic disease. Median Zubrod PS was 1, median number of systemic treatment lines was 1 (range 0-5), and median baseline opioid use 31 mg/d. At 3 weeks, 48 (53.3%, 95% CI 42.5-63.9) had at least a partial pain, the BPI ‘average pain’ score decreased by a mean of 2.5 points at 3 weeks (86/90 reported) and 3.2 points at 6 weeks (67/90 reported), both p&lt;0.001. Opioid usage decreased by 0.6 mg/d at 3 weeks (NS) and 16.9 mg/d at 6 weeks (p=0.005). The FACT-Hep total score increased by 7.8 points at 3 weeks (54/90 reported, NS diff. from 8) and 16.6 points at 6 weeks (45/90 reported, sig. &gt; 8, p = 0.01), showing an improvement in patients’ HRQOL. Changes in FACT-Hep were especially noted in the Physical Well Being subscale. The Trial Outcome Index (sum of physical, functional &amp; disease-specific concerns) increased markedly at 3 weeks (6.6 points, p=0.005) after treatment and even more after 6 weeks (14.5 points, p&lt;0.). Sensitivity analyses demonstrated improvements in HRQOL at 3 and 6 weeks (1.1, 3.8), but these were less than MCID. Conclusions: Celiac plexus SBRT decreases pain and opioid use amongst patients with pancreatic cancer and other tumors invading the celiac axis. The treatment appears to improve HRQOL. Clinical trial information: NCT03323489 .

A phase 2 study to determine the pathological (path) response to neoadjuvant nivolumab (nivo) and relatlimab (rela) in high-risk stage II cutaneous melanoma: NeoReNi II.

TPS9610 Background: Patients diagnosed with stage II melanoma account for ~50% of those who develop metastatic disease and die (Poklepovic et al., 2020). Neoadjuvant therapy (NAT) is a powerful treatment platform to rapidly assess drug activity in resectable cancers using the International Neoadjuvant Melanoma Consortium (INMC) path response criteria (Tetzlaff et al., 2018), wherein a major path response (≤10% viable tumor) correlates with low risk of recurrence in resectable stage III melanoma (Menzies et al., 2021). Other benefits include early insight into response, feedback to pts regarding their individual response and prognosis, ability to tailor subsequent management, and collection of translational specimens to explore mechanisms of response and resistance (Amaria et al., 2019). NAT for stage II melanoma is an opportunity to improve survival rates beyond the gains achieved with adjuvant therapy, as illustrated by the phase II SWOG 1801 trial (Patel et al., 2022) for pts with stage III melanoma. The NeoReNi II trial will examine whether combination PD-1 blockade plus lymphocyte-activation 3 (LAG3) checkpoint inhibition will achieve a high rate of path response with manageable toxicity. Methods: Pts with histologically confirmed AJCC (8th ed.) clinical stage IIA (T2b, T3A), IIB (T3b, T4a), or IIC (T4b) primary cutaneous melanoma from a partial biopsy, with residual macroscopic disease at study entry, are eligible (N = 20). Pts with IIA disease must have an estimated ≥20% risk of recurrence at 5 years, according to the Melanoma Institute Australia stage II risk calculator (melanomarisk.org.au). All pts undergo wide excision and sentinel lymph node resection (RES) at wk 6 following NAT with 2 doses of nivo (480 mg, IV) plus rela (160 mg, IV). Pts with no ( &gt; 50% viable tumor) or partial path response ( &gt; 10% - ≤50% viable tumor) receive a further 11 cycles (Q4W) of adjuvant nivo (480 mg) plus rela (160 mg), and radiological and clinical surveillance. Pts with complete (pCR; 0% viable tumor) or near-complete (≤10% viable tumor) path response will undergo radiological and clinical surveillance after RES. All pts will be followed for recurrence (6 monthly CT) and survival for 10 years. Lymphatic mapping, dermoscopy, in vivo confocal microscopy, CT, and FDG PET/CT will be performed at baseline (BL) and prior to RES to measure response to NAT. Tumour and fecal samples are collected at BL, RES, and recurrence. Blood samples are collected at BL, wk 4, RES, and recurrence. The primary endpoint is the rate of pCR at RES after 6 wks of NAT using INMC response criteria (Tetzlaff et al., 2018). Secondary endpoints include assessing the feasibility of NAT in a stage II pt population, RFS, OS, safety/tolerability, surgical outcomes, changes in confocal microscopy and dermoscopy, rate of sentinel node positivity and changes in lymphatic mapping, QOL, and biomarker analyses. Clinical trial information: NCT05418972 .

Prospective cohort study investigating quality of life outcomes following multi-speciality robotic-assisted surgery.

Despite recent evidence on the surgical outcomes of robotic-assisted surgery (RAS), other patient centre outcomes, including quality of life (QOL), are lacking. This study aims to examine changes in QoL trajectories following RAS across different surgical specialities. A prospective cohort study was conducted for patients undergoing urologic, cardiothoracic, colorectal or benign gynaecological RAS, between June 2016 and January 2020 at a tertiary referral hospital in Australia. QoL was measured using the 36-item Short-Form Health Survey at pre-operative, 6 weeks and 6 months postoperatively. Physical and mental summary scores and utility index were primary outcomes, and sub-domains were secondary outcomes. Mixed-effects linear regressions were used to determine changes in QoL trajectories. Of the 254 patients undergoing RAS, 154 underwent urologic, 36 cardiothoracic, 24 colorectal and 40 benign gynaecological surgery. Overall, the average age was 58.8 years and most patients were male (75.1%). Physical summary scores significantly decreased from pre-operative to 6 weeks' post-operative in urologic and colorectal RAS; with all surgical specialities at least returning to pre-operative levels within 6 months postoperatively. Mental summary scores consistently increased from pre-operative to 6 months postoperatively for colorectal and gynaecological RAS. RAS contributed to positive changes in QoL, with physical health returning to the pre-operative level and mental health improvements across specialities, in the short term. While degrees of post-operative changes varied amongst specialities, significant improvements demonstrate benefits in RAS.

MP13-07 AQUABLATION THERAPY ® VS TRANSURETHRAL RESECTION OF THE PROSTATE: 5-YEAR OUTCOMES OF THE WATER RANDOMIZED CLINICAL TRIAL FOR MEDIUM-SIZED PROSTATES

You have accessJournal of UrologyCME1 Apr 2023MP13-07 AQUABLATION THERAPY® VS TRANSURETHRAL RESECTION OF THE PROSTATE: 5-YEAR OUTCOMES OF THE WATER RANDOMIZED CLINICAL TRIAL FOR MEDIUM-SIZED PROSTATES Kussil Oumedjbeur, Ahmed Ibrahim, Imad Matta, David-Dan Nguyen, Adel Arezki, Iman Sadri, David Bouhadana, Tawfik Elsherbini, Peter Gilling, Neil Barber, Mihir Desai, Alexis E. Te, Claus G. Roehrborn, and Kevin C. Zorn Kussil OumedjbeurKussil Oumedjbeur More articles by this author , Ahmed IbrahimAhmed Ibrahim More articles by this author , Imad MattaImad Matta More articles by this author , David-Dan NguyenDavid-Dan Nguyen More articles by this author , Adel ArezkiAdel Arezki More articles by this author , Iman SadriIman Sadri More articles by this author , David BouhadanaDavid Bouhadana More articles by this author , Tawfik ElsherbiniTawfik Elsherbini More articles by this author , Peter GillingPeter Gilling More articles by this author , Neil BarberNeil Barber More articles by this author , Mihir DesaiMihir Desai More articles by this author , Alexis E. TeAlexis E. Te More articles by this author , Claus G. RoehrbornClaus G. Roehrborn More articles by this author , and Kevin C. ZornKevin C. Zorn More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003233.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The WATER trial previously introduced Aquablation® as a safe and effective TURP alternative in the management of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) for prostates <80 mL. To date, no long-term superiority endpoints have been reported for medium-sized prostates. In this subset analysis of the WATER cohort, we aim to compare the 5-year efficacy and safety of Aquablation® vs. TURP for the management of 50-80 mL prostates. METHODS: WATER is a double-blinded, multicenter and prospective randomized-controlled clinical trial for prostates 30-80 mL. 96 men with prostates 50-80 mL randomized to either Aquablation Therapy® or TURP from the initial cohort were retained for the subset analysis. Men received follow-up at 1, 3, 6 and 12 months, then annually up to 5 years. The primary efficacy endpoint was reduction of IPSS at 5-year follow-up. The primary safety endpoint was the occurrence of Clavien-Dindo postoperative complications grade 1 persistent (CD1P) and grade 2 (CD2) or higher at 6 months. Other measures included QoL, Qmax, PVR and MSHQ-EjD. RESULTS: Both study groups had comparable baseline voiding parameters and clinical demographics. Overall reduction in IPSS score was significantly higher in the Aquablation group across 5 years of follow-up (-14.1 vs. -10.8, p=0.02). Changes in QoL, Qmax and PVR were similar across groups (p>0.05). The Aquablation group displayed no changes in MSHQ-EjD score, while TURP yielded poorer questionnaire scores across all follow-ups (0.6 vs -2.1, p=0.01). The Aquablation group achieved a significantly lower rate of CD1P and CD2 or higher events at 6 months (RD=-23.1%; 95% CI [-29.9, -15.5], p=0.018). Among complications, post-operative ejaculatory dysfunction was notably lower in Aquablation® (RD=-21.9%; 95% CI [-32.5, -10.7], p=0.0005), while risk of bleeding was similar. The surgical and medical retreatment rate was also lower in Aquablation® (RD=-14.4%, 95% CI [-2.29, -30.4], p=0.015). CONCLUSIONS: Aquablation Therapy® yields better long-term efficacy and safety outcomes than TURP in the management of LUTS for prostate volumes of 50-80 mL within the WATER trial. This further supports adoption of Aquablation Therapy® over TURP for men with medium-sized prostates. Source of Funding: The trial is funded by PROCEPT BioRobotics. No funding was provided for the abstract creation © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e175 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kussil Oumedjbeur More articles by this author Ahmed Ibrahim More articles by this author Imad Matta More articles by this author David-Dan Nguyen More articles by this author Adel Arezki More articles by this author Iman Sadri More articles by this author David Bouhadana More articles by this author Tawfik Elsherbini More articles by this author Peter Gilling More articles by this author Neil Barber More articles by this author Mihir Desai More articles by this author Alexis E. Te More articles by this author Claus G. Roehrborn More articles by this author Kevin C. Zorn More articles by this author Expand All Advertisement PDF downloadLoading ...

502 The Prospective Geriatric Patient Reported Outcomes (GERI-PRO) Study: Understanding Post- Traumatic Injury Recovery from the Patient’s Perspective

OBJECTIVES/GOALS: Patient reported outcomes (PROs) provide unique insight to the patients experience with their healthcare related quality of life QoL. This study aims to 1. Characterize geriatric trauma patients’(GTPs) perceived QoL, at time of injury vs. 3- and 6-months post-injury. 2. Introduce and validate a PROs tool, known as the Five Favorite Activities. METHODS/STUDY POPULATION: This is a prospective cohort study of older adults (≥65) presenting to our trauma center with mild traumatic brain injury and/or mild spine, thoracic or extremity fractures. Participants will be asked to complete the NIH-validated Patient-Reported Outcome Measure Information System (PROMIS)-29, PROMIS Cognitive and Functional Abilities, Life-Space Levels and Five Favorite Activities assessment (a list of the five favorite overall and daily activities) tools. Cognitive function will be measured using Montreal Cognitive Assessment tool. Physical function will be evaluated using the Activity Measure for Post-Acute Care 6-click tool. Patients will be contacted at 3- and 6- months post discharge and asked to complete the assessment tools listed above to evaluate changes in QoL during the recovery process. RESULTS/ANTICIPATED RESULTS: We hypothesize that geriatric trauma patients will experience a decline in QoL, physical and cognitive function post-injury. This decline will be associated with a decrease in return to the ability to participate in their pre-injury Five Favorite Activities . DISCUSSION/SIGNIFICANCE: First, this study is one of the first to evaluate PROMs in GTPs. Second, the Five Favorite Activities PROM, will provide a unique, direct and individualized characterization of what GTPs find important to their recovery post injury compared to the current generic PROMs. This information can be utilized in the future to align goal of care with expectations

MP12-07 PROSPECTIVE HEALTH RELATED QUALITY OF LIFE IN WOMEN UNDERGOING RADICAL CYSTECTOMY AND URINARY DIVERSION

You have accessJournal of UrologyCME1 Apr 2023MP12-07 PROSPECTIVE HEALTH RELATED QUALITY OF LIFE IN WOMEN UNDERGOING RADICAL CYSTECTOMY AND URINARY DIVERSION Kelly R. Pekala, Daniel Sjoberg, Matthew B. Clements, Benjamin Beech, Thomas Atkinson, Yuelin Li, Andrew Vickers, Harry Herr, S. Machele Donat, Amy Tin, Guido Dalbagni, and Bernard H. Bochner Kelly R. PekalaKelly R. Pekala More articles by this author , Daniel SjobergDaniel Sjoberg More articles by this author , Matthew B. ClementsMatthew B. Clements More articles by this author , Benjamin BeechBenjamin Beech More articles by this author , Thomas AtkinsonThomas Atkinson More articles by this author , Yuelin LiYuelin Li More articles by this author , Andrew VickersAndrew Vickers More articles by this author , Harry HerrHarry Herr More articles by this author , S. Machele DonatS. Machele Donat More articles by this author , Amy TinAmy Tin More articles by this author , Guido DalbagniGuido Dalbagni More articles by this author , and Bernard H. BochnerBernard H. Bochner More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003227.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: There is a paucity of detailed health related quality of life (HRQoL) outcomes available for women undergoing radical cystectomy (RC). Our primary objective was to evaluate HRQoL after RC using patient reported outcome measures (PROMs) in women to identify patterns of recovery and whether any gender specific differences exist. METHODS: We conducted a prospective HRQoL study of patients undergoing RC using 14 different PROMs over a 2 year follow up period to evaluate the pattern of QoL changes from baseline. Using the Wald test, we simultaneously tested whether the sex and sex-urinary diversion interaction coefficients were non-zero to assess whether post-RC QoL was different between males and females. To assess whether post-RC QoL differed by sex, we fit one general estimating equation regression model for each QoL domain. This model estimates the mean QoL over the follow-up period. For each QoL domain, we build a regression model with QoL as the outcome and time point, urinary diversion type, and a time point-diversion type interaction as covariates. RESULTS: We observed statistically significant differences in post-RC QoL between men and women. Domains demonstrating female/male differences included global QoL, physical functioning, social functioning, body image, sexual functioning, mental health, and satisfaction with life. Women reported worse global QoL, physical function, social function, mental health and body image symptoms, including women who received continent diversions. (Figure 1a-c) Most of the observed differences were numerically small and correlate with a minimal clinically significant change. Women reported slightly higher sexual functioning (Figure 1d) and satisfaction with life scores compared to men. Over the recovery period, there were no female/male related differences found for bowel function, fear of recurrence, or decisional conflict. CONCLUSIONS: We identified several female specific differences in reported HRQoL after RC compared to men. Most differences were small and of questionable clinical significance; however, much work is needed to better understand the HRQoL specific to women undergoing RC. Characterization of sex-related differences is an essential step to improve preoperative counseling and make meaningful improvements in female patients’ QoL following RC. Source of Funding: Sidney Kimmel Center for Prostate and Urologic Cancers, the National Cancer Institute Cancer Center Core grant number P30-CA008748, Ruth L. Kirschstein National Research Service Award T32CA082088, and the Pin Down Bladder Cancer Fund © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e135 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kelly R. Pekala More articles by this author Daniel Sjoberg More articles by this author Matthew B. Clements More articles by this author Benjamin Beech More articles by this author Thomas Atkinson More articles by this author Yuelin Li More articles by this author Andrew Vickers More articles by this author Harry Herr More articles by this author S. Machele Donat More articles by this author Amy Tin More articles by this author Guido Dalbagni More articles by this author Bernard H. Bochner More articles by this author Expand All Advertisement PDF downloadLoading ...