Quality Of Life Metrics Research Articles

Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes

BackgroundSeveral orthotopic transcatheter strategies have been developed to treat severe tricuspid regurgitation (TR); however, many patients are deemed unsuitable. Caval valve implantation with the TricValve system addresses this unmet need. ObjectivesThis study sought to determine the impact of TricValve on systemic congestion and quality of life (QOL) at 1 year. MethodsThe TRICUS (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) and TRICUS EURO studies were prospective, nonblinded, nonrandomized, single-arm trials representing the early-in-man experience of the TricValve system in NYHA functional class III or IV severe TR patients, optimally medicated and ineligible for open heart surgery, with significant caval backflow. The primary endpoint was QOL metrics and functional status. The 1-year results of the combined cohort are described here. ResultsForty-four patients were included. Mean age was 76.2 ± 7.5 years, 81.0% were women, and the TRISCORE (risk score model for isolated tricuspid valve surgery) was 5.3 ± 1.3. Clinical improvement at 1 year was achieved in 42 (95.5%) patients, measured by (at least 1 of) an increase in ≥15 points from baseline in 12-item Kansas City Cardiomyopathy Questionnaire score, improvement to NYHA functional class to I or II, or an increase ≥40 m in the 6-minute walk test. There were 3 (6.8%) deaths at 1-year follow-up (1 cardiovascular), and the heart failure rehospitalization rate was 29.5%. Stent fracture, conduction system disturbances, or clinically significant leaflet thrombosis were not detected. Abolished hepatic vein backflow was achieved and persisted in 63.8% of the patients, contributing towards a reduction in congestive symptoms, N-terminal pro–B-type natriuretic peptide levels (P = 0.032), and diuretic treatment. ConclusionsCaval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality rates. (TRICUS Study – Safety and Efficacy of the TricValve® Device; NCT03723239)

Hemophilia A Research Program (HARP): A Novel Study Design for a Multicenter and Decentralized Prospective Observational Longitudinal Cohort Study in Hemophilia A

Background: Hemophilia A is a rare X-linked bleeding disorder caused by factor VIII (FVIII) deficiency. There is a compelling need in hemophilia to better understand the causes of bleeding in females and the factors underlying FVIII inhibitor development. To meet this need we are establishing a new NHLBI funded Hemophilia A Analytical Cohort Research Program (HARP) as part of a public-private partnership to support an Intergenerational Precision Medicine Program for the study of factor VIII (FVIII) immunogenicity in severe hemophilia A (Harpf8.org). The HARP objectives are: 1) Longitudinal assessment of bleeding in females with a severe hemophilia A genotype beginning in pregnancy; 2) Longitudinal assessment of anti-FVIII antibody formation in severe hemophilia A from birth through at least the first 2 years of life; 3) Studies of causes of bleeding in females with a severe hemophilia A genotype; 4) Studies of the immune response to FVIII in severe hemophilia A; 5) Development of a well-curated annotated data set of genetic, hemophilia, immune, environmental, psychosocial, and quality of life metrics; 6) Development of a multi-omics and immunologic biospecimen resource; and 7) Development of the hemophilia analytical Portal (F8portal.org). Study design: The HARP is a multicenter and decentralized prospective observational longitudinal cohort study beginning in pregnancy. It will follow 50 mother-baby pairs where the babies have severe hemophilia A and the mothers have a severe hemophilia A genotype. The private Clinical Consortium (CC) will oversee the study throughout the U.S., including sites that care for the mothers (up to 200 sites) and sites that care for the child (up to 70 sites). The CC will also conduct decentralized aspects of the study including collection of patient reported outcomes and local sample collection. The primary maternal endpoint is primary postpartum hemorrhage; the primary pediatric endpoint is rate of development of humoral immune response to FVIII and proportion that progress to clinical inhibitors. Mother and child secondary endpoints reflect the diverse research the HARP resource will support. Inclusion criteria for the pregnant person are: Pregnant and prior to 37 weeks gestation, known or at-risk to have a severe hemophilia A genotype, pregnant with a fetus at-risk for severe hemophilia A, ability to give informed consent, and > 18 years old. Inclusion criteria for the child are: severe hemophilia A, born to a person in the study. Exclusion/discontinuation criteria are: Presence of another significant bleeding disorder in mother or child; mother age <18 years; no fetus is at-risk to inherit severe hemophilia A; the child does not have severe hemophilia A; the child has a severe immune disorder; the mother or child participates in another study with blood collection volumes that exceed safety limits; mother's or child's healthcare will be outside the U.S.; the mother is a prisoner; any other reason that in the opinion of the investigator a subject is unsuitable for the study Summary: The HARP innovates in multiple areas of clinical study design to conduct a national prospective longitudinal intergenerational study in a rare disorder beginning in pregnancy. The structure includes a new multidisciplinary CC, systematic inclusion of Lived Experience Experts, strategies for broad community engagement, recruitment, and retention, and decentralized operations. This cohort will enable deep characterization, including genomics and other -omics, on pregnancy-associated bleeding and drivers of FVIII inhibitors in hemophilia A. The HARP Shareable Resource will be comprised of well annotated data and biological samples accessible to researchers through a portal, F8portal.org, and a linked biorepository.

Pilot study to test the safety, tolerability and feasibility of dulaglutide during a low-energy diet for weight loss and improved glycaemic control

IntroductionDiabetes and obesity are significant public health concerns. Previous studies have demonstrated that low energy diets are effective in promoting weight loss and inducing diabetes remission. However, hunger is a...

Face-down positioning or posturing after macular hole surgery.

Face-down positioning or posturing after macular hole surgery.

CTNI-48. SURVIVAL, TOXICITY, AND PATIENT REPORTED QOL OUTCOMES FOLLOWING PULSED REDUCED DOSE RATE RE-IRRADIATION WITH CONCURRENT BEVACIZUMAB FOR RECURRENT GRADE 4 GLIOMAS: RESULTS OF A PHASE II STUDY

Abstract Grade 4 gliomas are aggressive primary brain tumors with dismal prognosis despite maximal treatment. Recurrent disease is typically found within the prior radiation treatment field, complicating reirradiation. Pulsed reduced dose rate (PRDR) radiation is a treatment technique that reduces effective dose rate and increases treatment time allowing for intrafraction repair. Bevacizumab is a systemic VEGF inhibitor with efficacy in treating gliomas. We conducted a phase 2 prospective trial combining PRDR radiation with biweekly bevacizumab (10 mg/kg) in patients with recurrent grade 4 gliomas. Radiation was delivered with reduced dose rate delivered in 20 cGy pulses every 3 minutes in 2 Gy daily fractions to a total dose of 54 Gy. Kaplan Meier analysis was utilized to calculate progression free survival (PFS) and overall survival (OS). Toxicities were evaluated based on Common Terminology Criteria for Adverse Event v5.0 criteria. Mini Mental Status Examination (MMSE), as well as FACT-Brain, and FACIT-Fatigue patient reported quality of life (QoL) surveys were collected at baseline and follow up visits. Minimal important difference scores were calculated using by ½ standard deviation method. A total of 36 patients were enrolled, with 77% having previously received additional therapy for recurrent disease prior to study enrollment. Median PFS was 4.9 months and median OS was 6.9 months. No grade 4+ toxicity was observed. Two patients had grade 3 treatment related toxicity (seizure and radiation necrosis, both PRDR related). Treatment related grade 2 toxicity was seen in 44% of patients, primarily fatigue (30%). Clinically significant decrease in mean MMSE score, and FACT-BR QoL metrics across all sub-domains were noted in follow up. No clinically significant difference in mean FACIT-Fatigue QoL metric was observed. In this prospective phase 2 trial, PRDR with concurrent bevacizumab resulted in encouraging survival outcomes with acceptable toxicity in patients with recurrent grade 4 gliomas.

NCOG-36. IMPACT OF COLLAGEN TILE BRACHYTHERAPY AS TREATMENT FOR RECURRENT GLIOBLASTOMAS ON FUNCTIONAL STATUS AND QUALITY OF LIFE

Abstract BACKGROUND Recurrent glioblastoma is an aggressive disease with dismal prognosis despite advances in standard therapy, making the maintenance of functional status and quality of life (QOL) in patients an important endpoint during treatment. Here, we report functional status (KPS) and QOL metrics (LASA and FACT-Br) at 6-months post-treatment for recurrent glioblastoma patients treated with maximal safe resection followed by intraoperative placement of collagen tile brachytherapy with Cesium-131 (Surgically Targeted Radiation Therapy or STaRT), a novel brachytherapy carrier. OBJECTIVE To assess the impact of STaRT on KPS and QOL among patients with recurrent glioblastoma (rGBM) at 6-months post-treatment. METHODS Patients were treated between 10/2020 and 05/2023 as part of a multi-institutional registry study (NCT#04427384). KPS was used to measure functional status. Linear Analog Self-Assessment (LASA) and Functional Assessment of Cancer Therapy – Brain (FACT-Br) were used to measure QOL. All assessments were collected at pre-surgery, and 1,3, and 6-months post-treatment. RESULTS 57 rGBM patients were treated on the Registry between 10/2020 and 05/2023. Of the 57 participants, 47 participants remain in the study, with 21 participants reaching the 6-month time point (5 exits, 5 deaths). Median age was 60 years (range 28-81). Methylguanine methyltransferase (MGMT) promoter was methylated in 17.5%, unmethylated in 38.5%, and unknown in 44%. Gross total resection was achieved in 72% of participants. Median KPS was 80% (range 40%-100%) at screening versus 70% (range 40%-90%) at 6 months post-treatment. Median LASA was 37 (range 8-50) at pre-surgery versus 34 (range 5-48) at 6-months post-treatment. Minimally important differences (MID) were noted between pre-surgery (136.9 ± 29.5) and 6-months post-treatment (112.5 ± 35.7) for the FACT-Br Total Score. CONCLUSION This interim data analysis supports further investigation of STaRT as a treatment for recurrent glioblastomas as a means of providing stable functional status and quality of life.

Tracking of Systemic Lupus Erythematosus (SLE) Longitudinally Using Biosensor and Patient-Reported Data: A Report on the Fully Decentralized Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals-The OASIS Study.

(1) Objective: Systemic lupus erythematosus (SLE) is a complex disease involving immune dysregulation, episodic flares, and poor quality of life (QOL). For a decentralized digital study of SLE patients, machine learning was used to assess patient-reported outcomes (PROs), QOL, and biometric data for predicting possible disease flares. (2) Methods: Participants were recruited from the LupusCorner online community. Adults self-reporting an SLE diagnosis were consented and given a mobile application to record patient profile (PP), PRO, and QOL metrics, and enlisted participants received smartwatches for digital biometric monitoring. The resulting data were profiled using feature selection and classification algorithms. (3) Results: 550 participants completed digital surveys, 144 (26%) agreed to wear smartwatches, and medical records (MRs) were obtained for 68. Mining of PP, PRO, QOL, and biometric data yielded a 26-feature model for classifying participants according to MR-identified disease flare risk. ROC curves significantly distinguished true from false positives (ten-fold cross-validation: p < 0.00023; five-fold: p < 0.00022). A 25-feature Bayesian model enabled time-variant prediction of participant-reported possible flares (P(true) > 0.85, p < 0.001; P(nonflare) > 0.83, p < 0.0001). (4) Conclusions: Regular profiling of patient well-being and biometric activity may support proactive screening for circumstances warranting clinical assessment.

Going Going Gonad: Assessing Iron Staining Impact on Fertility for Patients with Sickle Cell Disease

Introduction: Medical advances in the care of patients with sickle cell disease (SCD) and other hemoglobinopathies have allowed for the focus of care to shift and incorporate long-term quality of life metrics, such as fertility. Concerns for reproductive health in patients with SCD stem from the underlying disease itself as well as from medical therapies that are offered such as hydroxyurea, chronic red blood cell transfusions, and stem cell transplant (SCT). Iron deposition from chronic transfusions in other tissues is known to result in end organ damage and lifelong consequences. While little is known about iron overload and fertility, one study noted testicular iron deposition on MRI in pubertal males with transfusion-dependent beta-thalassemia; results were notable for lower sperm concentrations and a lower percentage of sperm with normal morphology, indicating that iron overload likely has an impact on fertility for patients. Iron deposition has not been studied in the pre-pubertal hemoglobinopathy population. Fertility counseling in this patient population does not often occur until patients are considering SCT as a curative therapy option, as the conditioning regimens for SCT are gonadotoxic. Without a good understanding of the impact of chronic transfusions on fertility for patients with hemoglobinopathies, it is difficult to determine the optimal time to offer fertility preservation to families. We aim to assess iron overload on testicular tissue to gain a better understanding of the impact that medical management and chronic transfusions can have on fertility for a patient with SCD. Methods: Our study is a cross-sectional evaluation of patients with SCD who underwent testicular tissue cryopreservation (TTC) as a part of a multicenter research protocol through the University of Pittsburgh Medical Center (UPMC) prior to SCT. As part of the TTC protocol, each patient provided a small piece of tissue for research, with the remaining cryopreserved for patient use. All samples were evaluated for the presence of germ cells. For this study, demographics, treatment data, imaging results, and labs pertinent to hormonal profile and iron status were obtained. All samples from patients with SCD and thalassemia will undergo additional pathology review to evaluate for the presence of germ cells and iron. At the time of this abstract, the tissue for two patients had been analyzed. Results: Banked research tissue from UPMC includes 77 patients with SCD and 21 patients with beta thalassemia major. Of the 77 SCD patient samples, 42 were found to have germ cells, 34 have not yet been analyzed and 1 had no germ cells present. Of the 21 samples from patients with beta thalassemia major, 17 were found to have germ cells, 3 were not yet analyzed and 1 had no germ cells present. To date, we have obtained pathology review on two patients, both with Hb SS genotype and were on the maximum tolerated dose of hydroxyurea prior to TTC. Patient 1 had been on hydroxyurea for 7 years and had 13 units of blood transfusions, and Patient 2 on hydroxyurea for 4 years and 6units of blood transfusions prior to TTC. Both patients were found to have normal testicular tissue histopathology with presence of germ cells and without evidence of iron on staining (Table 1). Conclusions: Based on our preliminary data it can be noted that patients without significant iron burden, based on low ferritin and a limited transfusion history may not have a significant impact on their testicular histopathology with their iron staining being negative. We will expand our patient cohort to include patients who have a severe disease course requiring more blood transfusions to determine whether this is associated with increased iron deposition in their testicular tissue and/or reduced germ cell numbers. This information will allow teams to optimize the timing of fertility discussions and possible preservation in this patient population, even outside of curative treatment.

Comparing functional and quality of life outcomes in transcatheter aortic valve implantation and surgical aortic valve replacement for aortic stenosis: a systematic review and meta-analysis

BackgroundTo compare functional and health related quality of life outcomes post-transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in patients with critical aortic stenosis (AS) across low to high-risk surgical candidates. These patient-centred factors will be compared between both groups in the short to medium term time frames and will aid in shared decision making between patients and healthcare workers.Materials and methodsWe conducted a systematic review and meta-analysis of randomised controlled trials which compared TAVI with SAVR and reported on quality of life (QoL) and functional scores.The scores used were the Kansas City Cardiomyopathy Questionnaire (KCCQ), Euroqol-5DL (EQ5DL), the short form-36/12 (SF-36/12) and the NYHA.ResultsWe identified eight trials with a total of 8898 participants. Both groups showed improvements from baseline at one month. At one month there was a statistically significant difference in standardised mean difference (SMD) in favour of TAVI for EQ5DL (SMD 0.37, 95% CI 0.26,0.49), KCCQ (SMD 0.53,95% CI 0.48, 0.58), SF physical summary (SMD 0.55, 95% CI 0.31 – 0.78) and SF mental summary (SMD 0.34, 95% CI 0.27 – 0.40). At one year there was no statistically significant difference between any of these QoL metrics. For NYHA, no significant difference in odds ratio of class III/IV was observed at one month between TAVI and SAVR (OR 0.94, 95% CI 0.83, 1.07), however, TAVI was associated with reduced odds ratio of NYHA class I/II at one year (OR 0.87, 95% CI 0.78, 0.98).ConclusionBoth groups were associated with improvements in QoL and functional outcomes with TAVI reporting more significant improvements in QoL at one-month post-procedures. No significant improvements between groups were seen at one year. This is the largest meta-analysis comparing post-operative health-related quality of life outcomes post SAVR and TAVI and has major implications in shared decision making for the treatment of aortic stenosis.

Echocardiographic and Clinical Outcomes in Symptomatic Patients With Less Than Severe Aortic Stenosis After Supra-Annular Self-Expanding Transcatheter Aortic Valve Replacement

Optimal timing for aortic valve replacement in symptomatic patients with less than severe aortic stenosis (AS) is not well defined. There is limited information on the benefit of valve replacement in these patients. Symptomatic patients with less than severe AS, defined as a mean aortic gradient ≥20 and <40mm Hg, peak aortic velocity >3 and <4m/s, and aortic valve area >1.0 and <1.5cm2, enrolled in the Society for Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry and who underwent attempted supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) were reviewed. Site-reported valve hemodynamics, clinical events, and quality of life metrics were analyzed at 30days and 1year after the procedure. A total of 1,067 patients with attempted TAVR (mean age 78.4 ± 8.4years; Society for Thoracic Surgery score 4.7 ± 3.4%) were found to have symptoms but less than severe AS. From baseline to postprocedure, mean gradient decreased (29.9 ± 4.9 vs 8.4 ± 4.8mm Hg, p <0.001), and aortic valve area increased (1.2 ± 0.1 vs 2.2 ± 0.7cm2, p <0.001). Clinical events included 30-day and 1-year all-cause mortality (1.5% and 9.6%), stroke (2.2% and 3.3%), and new pacemaker implantation (18.1% and 20.9%). There were statistically significant improvements in the New York Heart Association functional class and Kansas City Cardiomyopathy Questionnaire at 30days and 1year. In conclusion, patients with symptomatic but less than severe AS who underwent supra-annular, self-expanding TAVR experienced improved valve hemodynamics and quality of life measures 1year after the procedure. Randomized studies of TAVR versus a control arm in symptomatic patients with less than severe AS are ongoing.

Utility of the "All of Us" Database for Radiation Oncology Research.

We provide an overview the All of Us Research Program, a National Institutes of Health funded research database, and report on the utility of this database for Radiation Oncology research. The All of Us Research Program aims to create a large and diverse health database with participants from across the US. Patients consent to join the database and agree to share electronic health records, complete surveys, provide physical measurements, and donate at least one biospecimen. In this observational study, we used the public data browser feature of the All of Us Dataset to evaluate utility for future radiation oncology research. Within the database, we report on the number of cases of common cancers in the US, using ICD10 codes, and also the number of patients treated with common radiotherapy procedures, using CPT4 codes. We then qualitatively report on additional data of interest. Of note, public patient counts in All of Us is rounded to the nearest interval of 20. Additional tiers of data access exist, including individual level data, which were not used in this survey of public data. The database includes 372,380 participants, of which 46,380 patients have a diagnosis of cancer. Within the identified top 10 cancers according to ACS, there were a total of 26,540 primary malignant cancers. The most common type of cancers were breast cancer (ICD10 - c50 [n = 6,960]), Prostate (ICD10 - c61 [n = 4,500]), Non-Hodgkin lymphoma (ICD10 - c85 [n = 2860]), Lung & bronchus (ICD10 - c34 [n = 2000]), Colon (ICD10 - c18 [n = 1940]), Melanoma of the skin (ICD10 - c43 [n = 1740]), Thyroid(ICD10 - c73 [n = 1720]), Kidney (ICD10 - c64 [n = 1300]), Urinary bladder (ICD10 - c67 [n = 1140]). The most common radiation therapy procedures were Computerized Tomography simulation (CPT - 77290 [n = 4,040]), Intensity Modulated Radiation Therapy (CPT - 77386 [n = 780]), 3D conformal radiation therapy (CPT - 77412 [n = 1,720]), Stereotactic Body Radiation Therapy (CPT - 77373 [n = 400]), Brachytherapy (CPT - 77770- 77772 [n = 240]), and Proton Therapy (CPT - 77520-77525 [n = 140]). Qualitatively, other data within All of Us include labs values, drug exposures, comorbidities, other procedures, physical measurements, and wearable biometrics (Fitbit) data. Genomic data typically includes germline testing using whole genome sequencing or genotyping array. Patient surveys include data on personal medical history, family health history, lifestyle, social determinants of health, COVID19 experience, and overall health. Potential outcome variables of interest to oncology research in the database include survival, cause of death, additional procedures or diagnoses after cancer treatment, and quality of life metrics derived from the survey instruments. The All Of Us Research Database includes a large number of cancer cases, of which a substantial number received radiotherapy. Future work will focus on focused hypothesis-driven research questions.

Peer Support in Rheumatic Diseases: A Narrative Literature Review.

Rheumatic diseases are a group of chronic conditions that are associated with significant morbidity, impaired physical function, psychosocial stress, and cost to the healthcare system. Peer support interventions have been shown to have a positive impact on health outcomes in several chronic conditions, but no review has specifically assessed the impact of peer support on rheumatic conditions. The aim of this narrative literature review was to understand how peer support has been applied in the field of rheumatology, with a specific focus on the impact of observational and randomized studies of direct peer support interventions on various outcome measures across rheumatic conditions. We also examined studies exploring patient attitudes and preferences toward peer support. The majority of studies included focused on peer support in rheumatoid arthritis and systemic lupus erythematosus. Generally, patients across the spectrum of rheumatic disease perceive peer support as a useful tool. Peer support interventions, while highly variable, were generally associated with positive impacts on health-related quality of life metrics (both perceived and measured), although these differences were not always statistically significant. Important limitations include variability in study design, selection bias among study participants, and short follow-up periods across most peer support interventions.

Sexual Function and Dosimetric Relationships to Erectile Structures among Patients Treated Definitively with Pd-103 LDR Prostate Brachytherapy

Sexual potency and erectile function are important quality of life metrics for many men and is a significant consideration when planning and treating prostate cancer. There are limited long-term data correlating post-implant dosimetry with patient-reported sexual toxicity outcomes following LDR prostate brachytherapy using Pd-103, specifically as it pertains to genital substructures. Our aim was to correlate dosimetric patterns with quality-of-life outcomes to determine if dose to the pudendal arteries and neurovascular bundles is a significant consideration when planning prostate LDR brachytherapy. We analyzed a prospectively collected IRB-approved database of men receiving LDR prostate brachytherapy between 11/2014-04/2019 at our institution. Patients received either LDR brachytherapy only, or combined with intensity-modulated radiation therapy (IMRT) to the prostate with or without pelvic lymph node coverage. Patients were given quality of life questionnaires at consultation and at subsequent follow up visits. Outcomes data related to sexual toxicity were evaluated based on the Sexual Health Inventory (SHIM) Questionnaire. The right/left pudendal arteries, and right/left neurovascular bundles (NVB) were contoured retrospectively on CT-MRI fusion sequences. Dosimetric data for each of the erectile substructures was analyzed. Statistical analyses included generalized linear mixed effects models with random intercept for patient to explore the association between dose and SHIM confidence. A total of 50 patients met criteria for inclusion in the analysis. 5 patients received combined IMRT to 45 Gy with Pd-103 (90-100 Gy) and 45 patients received Pd-103 monotherapy (125 Gy). Median follow-up was 18 months for 50 patients; 40 (80%) patients had follow-up greater than 2 years, and 15 (30%) greater than 5 years. There were 344 individual questionnaires completed. 28% of records reported low or very low confidence level (Question #1 of SHIM questionnaire). Likelihood of moderate-very high confidence increased up to 2 years after beginning of treatment (p = 0.052) and then subsequently decreased between 2- and 5 years post treatment (p = 0.042). NVB doses were not associated with SHIM confidence level. D100 greater than 150 cGy to either pudendal artery was associated with worse SHIM confidence score after treatment (p = 0.003). Sexual function is variable in the post treatment setting following definitive prostate radiation with Pd-103 LDR-brachytherapy. Avoiding pudendal artery dose may improve sexual outcomes and should be considered when planning prostate brachytherapy. Further investigation with a larger prospective, cohort may be warranted.

Relationship of Hepatocellular Carcinoma Stage and Hepatic Function to Health-Related Quality of Life: A Single Center Analysis.

Health-related quality of life (HRQoL) is known to be an important prognostic indicator and clinical endpoint for patients with hepatocellular carcinoma (HCC). However, the correlation of the Barcelona Clinic Liver Cancer (BCLC) stage with HRQoL in HCC has not been previously studied. We examined the relationship between BCLC stage, Child-Pugh (CP) score, and Eastern Cooperative Oncology Group (ECOG) performance status on HRQoL for patients who presented at a multidisciplinary liver cancer clinic. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. Fifty-one patients met our inclusion criteria. The FACT-Hep total and subscales showed no significant association with BCLC stages (p = 0.224). Patients with CP B had significantly more impairment in FACT-Hep than patients with CP A. These data indicate that in patients with HCC, impaired liver function is associated with reduced quality of life, whereas the BCLC stage poorly correlates with quality of life metrics. Impairment of quality of life is common in HCC patients and further studies are warranted to determine the impact of early supportive interventions on HRQoL and survival outcomes.

Well-being at midlife: Correlates of mental health in ambulatory menopausal women with multiple sclerosis

Background: A majority of women with multiple sclerosis (MS) are diagnosed prior to menopause, yet their experiences during this transition are not well characterized. Objectives: To explore associations between mental health, sleep, and other quality of life metrics, and vasomotor symptoms (VMSs) in ambulatory, menopausal women with MS. Methods: A secondary analysis was performed of baseline data from two trials enrolling ambulatory peri/postmenopausal women with MS: NCT02710214 (N = 24, bothersome VMS) and NCT04002934 (ongoing, N = 35, myelin repair). Measures analyzed were 36-Item Short-Form Survey (SF-36) (primary scale: general mental health), subjective sleep quality (Pittsburg Sleep Quality Index), VMS (daily diary, interference), mood (Center for Epidemiologist Studies—Depression Scale (CES-D)), walking impairment (timed 25-foot walk (T25FW)), and global disability (Expanded Disability Status Scale (EDSS)). Results: Participants’ characteristics (N = 59) were: mean age 51.8 years (SD = 3.4), mean disease duration 11.3 years (SD = 7.6), median EDSS 3.0 (IQR = 2.0–4.0). Mental health was associated with better sleep quality (rho = −0.41, p = 0.019) and better mood (rho = −0.75, p < 0.001), but not with EDSS or T25FW (rho < 0.20, p > 0.10). Worse sleep quality also correlated with more frequent VMS (rho = 0.41, p = 0.02) and VMS interference (rho = 0.59, p < 0.001). Conclusions: Findings suggest that optimizing sleep quality, mood, and hot flash quantity/interference could substantially improve mental health in menopausal women with MS—and highlight an important care gap in this population.

Maintenance Treatment for Metastatic Pancreatic Cancer: Balancing Therapeutic Intensity with Tolerable Toxicity.

Metastatic pancreatic ductal adenocarcinoma is typically treated with multi-agent chemotherapy until disease progression or intolerable cumulative toxicity. For patients whose disease shows ongoing control or response beyond a certain timeframe (≥3-4 months), options include pausing chemotherapy with close monitoring or de-escalating to maintenance therapy with the goal of prolonging progression-free and overall survival while preserving quality of life. There is currently no universally accepted standard of care and a relative dearth of randomized clinical trials in the maintenance setting. Conceptually, such therapy can entail continuing the least toxic components of a first-line regimen and/or introducing novel agent(s) such as the poly(ADP-ribose) polymerase inhibitor olaparib, which is presently the only approved drug for maintenance treatment and is limited to a genetically defined subset of patients. In addition to identifying new therapeutic candidates and combinations in the maintenance setting, including targeted agents and immunotherapies, future research should focus on better understanding this unique biologic niche and how treatment in the maintenance setting may be distinct from resistant/refractory disease; identifying molecular predictors for more effective pairing of specific treatments with patients most likely to benefit; and establishing patient-reported outcomes in clinical trials to ensure accurate capture of quality of life metrics.

Protocol paper for SMART OPS: Shared decision-making Multidisciplinary Approach – a Randomised controlled Trial in the Older adult Population considering Surgery

IntroductionThe Australian population presenting with surgical pathology is becoming older, frailer and more comorbid. Shared decision-making is rapidly becoming the gold standard of care for patients considering high-risk surgery to...

Considerations for Pain Assessments in Cancer Patients: A Narrative Review of the Latin American Perspective.

Cancer incidence in Latin America is lower than in Europe or the United States but morbidity and mortality rates are disproportionately high. A barrier to adequate pain control is inadequate pain assessment, which is a relatively easy and inexpensive metric. The objective of this narrative review is to describe pain assessment for cancer patients in Latin America. Cultural factors may influence pain perception, including contextualizing pain as noble or natural suffering and aspects of what is now called "spiritual pain." Unlike other painful conditions, cancer pain may be strongly associated with existential fear, psychosocial distress, anxiety, and spiritual concerns. Pain assessment allows not just quantification of pain intensity but may elucidate pain mechanisms involved or psychosocial aspects that may color the pain. Many current pain assessment instruments capture only pain intensity, which is but one aspect of the pain experience; some have expanded to include functional assessments, mental health status evaluations, and quality of life metrics. A quality-of-life assessment may be appropriate for cancer patients since chronic pain can severely impact function, which can in turn create a vicious cycle by exacerbating pain. The incidence of cancer in Latin America is expected to increase in the ensuing years. Better pain assessment and clinician education are needed to help manage pain in this large and growing patient population.

Patient Perspectives and Quality of Life after Breast Reconstruction and the Impact of Subsequent Revisions.

Patients undergoing mastectomy with immediate implant-based or autologous free-flap breast reconstruction from 2008 to 2020 were reviewed. These patients were categorized by revisions (0-1, 2-3, and 4+) and surveyed on QoL metrics using BREAST-Q and Was It Worth It? (WIWI) questionnaires. BREAST-Q QoL, satisfaction, and WIWI metrics between revision groups were evaluated. Among 252 patients, a total of 150 patients (60%) underwent zero to one revisions, 72 patients (28%) underwent two to three revisions, and 30 patients (12%) underwent four or more revisions. Median follow-up was 6 years (range, 1-11 years). BREAST-Q satisfaction among patients with four or more revisions was significantly lower (P = 0.03), while core QoL domains (chest physical, psychosocial, and sexual well-being) did not significantly differ. Analysis of unplanned reoperations due to complications and breast satisfaction showed no significant difference in QoL scores between groups (P = 0.08). Regarding WIWI QoL metrics, four or more revisions were associated with a higher rate of worse QoL (P = 0.035) and worse overall experience (P = 0.001). Most patients in all revision groups felt it was worthwhile to undergo breast reconstruction (86%), would choose breast reconstruction again (83%), and would recommend breast reconstruction to others (79%). Overall, a majority of patients undergoing revisions after breast reconstruction still have a worthwhile experience. Although reoperations after breast reconstruction do not significantly impact long-term BREAST-Q QoL domains, patients undergoing four or more revisions have significantly lower breast satisfaction, worse QoL, and a postoperative experience worse than expected.

Hospital Anxiety and Depression Scale (HADS) score trends among testicular cancer survivors: A longitudinal study.

5042 Background: The rarity of testicular germ cell tumors, in conjunction with the young age of its patients, makes it challenging to study its long-term adverse effects. We sought to investigate the changes in Hospital Anxiety and Depression Scale (HADS) scores over time in our institutional cohort of testicular cancer (TC) survivors, hypothesizing that anxiety and depression indices will improve over time, and specifically after treatment completion. Methods: A longitudinal analysis of TC survivors at the University of Pennsylvania between 2013 and 2020, quality of life metrics were measured annually during routine clinic visits. A validated HADS score was utilized to calculate indices of anxiety and depression. Multivariable linear mixed-effects regression models adjusted for pathology type, stage, treatment type, age, marital status, education, income, insurance, employment status, living situation, and time from diagnosis to first survey administration were used to calculate the mean predicted HADS, HADS-Anxiety, and HADS-Depression scores. ANOVA was used to test for parallelism and changes between survey scores. Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-21 for each sub-scale with a cut-off point of 8/21 for anxiety or depression. Results: A total of 353 patients were included in the study. Baseline mean scores were 7.3, 4.9, and 2.4 for HADS overall, HADS-Anxiety, and HADS-Depression, respectively. Mean scores did not change over time, ANOVA testing of p=0.84, p=0.78, and p=0.0.65 for overall HADS, HADS-Anxiety, and HADS-Depression, respectively. Stratification by pathology, stage, or treatment did not show any significant interaction. Conclusions: Our data demonstrates that there was no significant change over time in HADS scores, thus considering the risks associated with depression and anxiety, such as suicide, it is essential to consider early referrals to psychiatric services. Our results are from a single institution, limited by a small sample size, and data lacks granularity, including mental health history. Nonetheless, our findings serve as a framework for future prospective studies of TC survivors.