Quality Of Life Outcomes In Patients Research Articles

Quality of Life and Nutritional Outcomes of Stomach-Preserving Surgery for Early Gastric Cancer: A Secondary Analysis of the SENORITA Randomized Clinical Trial.

The Sentinel Node Oriented Tailored Approach (SENORITA) randomized clinical trial evaluated quality of life (QoL) and nutritional outcomes between the laparoscopic sentinel node navigation surgery (LSNNS) and laparoscopic standard gastrectomy (LSG). However, there has been no report on the QoL and nutritional outcomes of patients who underwent stomach-preserving surgery among the LSNNS group. To compare long-term QoL and nutritional outcomes between patients who underwent stomach-preserving surgery and those who underwent standard gastrectomy and to identify factors associated with poor QoL outcomes in patients who underwent stomach-preserving surgery. This study is a secondary analysis of the SENORITA trial, a randomized clinical trial comparing LSNNS with LSG. Patients from 7 tertiary or general hospitals across the Republic of Korea were enrolled from March 2013 to December 2016, with follow-up through 5 years. Data were analyzed between August and September 2022. Among trial participants, patients who underwent actual laparoscopic standard gastrectomy in the LSG group and those who underwent stomach-preserving surgery in the LSNNS group were included. Patients who did not complete the baseline or any follow-up questionnaire were excluded. Stomach-preserving surgery vs standard gastrectomy. Overall European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30) and stomach module (STO22) scores, body mass index, hemoglobin, protein, and albumin levels. A total of 194 and 257 patients who underwent stomach-preserving surgery and standard gastrectomy, respectively, were included in this study (mean [SD] age, 55.6 [10.6] years; 249 [55.2%] male). The stomach-preserving group had better QoL scores at 3 months postoperatively in terms of physical function (87.2 vs 83.9), dyspnea (5.9 vs 11.2), appetite loss (13.1 vs 19.4), dysphagia (8.0 vs 12.7), eating restriction (10.9 vs 18.2), anxiety (29.0 vs 35.2), taste change (7.4 vs 13.0), and body image (19.5 vs 27.2). At 1 year postoperatively, the stomach-preserving group had significantly higher body mass index (23.9 vs 22.1, calculated as weight in kilograms divided by height in meters squared) and hemoglobin (14.3 vs 13.3 g/dL), albumin (4.3 vs 4.25 g/dL), and protein (7.3 vs 7.1 g/dL) levels compared to the standard group. Multivariable analyses showed that tumor location (greater curvature, lower third) was favorably associated with global health status (β, 10.5; 95% CI, 3.2 to 17.8), reflux (β, -8.4; 95% CI, -14.7 to -2.1), and eating restriction (β, -5.7; 95% CI, -10.3 to -1.0) at 3 months postoperatively in the stomach-preserving group. Segmental resection was associated with risk of diarrhea (β, 40.6; 95% CI, 3.1 to 78.1) and eating restriction (β, 15.1; 95% CI, 1.1 to 29.1) at 3 years postoperatively. Stomach-preserving surgery after sentinel node evaluation was associated with better long-term QoL and nutritional outcomes than standard gastrectomy. These findings may help facilitate decision-making regarding treatment for patients with early-stage gastric cancer. ClinicalTrials.gov Identifier: NCT01804998.

Association of the medication protocols and longitudinal change of COVID-19 symptoms: a hospital-based mixed-statistical methods study

ABSTRACT The objective of this study was to identify the relationship between hospitalization treatment strategies leading to change in symptoms during 12-week follow-up among hospitalized patients during the COVID-19 outbreak. In this article, data from a prospective cohort study on COVID-19 patients admitted to Khorshid Hospital, Isfahan, Iran, from February 2020 to February 2021, were analyzed and reported. Patient characteristics, including socio-demographics, comorbidities, signs and symptoms, and treatments during hospitalization, were investigated. Also, to investigate the treatment effects adjusted by other confounding factors that lead to symptom change during follow-up, the binary classification trees, generalized linear mixed model, machine learning, and joint generalized estimating equation methods were applied. This research scrutinized the effects of various medications on COVID-19 patients in a prospective hospital-based cohort study, and found that heparin, methylprednisolone, ceftriaxone, and hydroxychloroquine were the most frequently prescribed medications. The results indicate that of patients under 65 years of age, 76% had a cough at the time of admission, while of patients with Cr levels of 1.1 or more, 80% had not lost weight at the time of admission. The results of fitted models showed that, during the follow-up, women are more likely to have shortness of breath (OR = 1.25; P-value: 0.039), fatigue (OR = 1.31; P-value: 0.013) and cough (OR = 1.29; P-value: 0.019) compared to men. Additionally, patients with symptoms of chest pain, fatigue and decreased appetite during admission are at a higher risk of experiencing fatigue during follow-up. Each day increase in the duration of ceftriaxone multiplies the odds of shortness of breath by 1.15 (P-value: 0.012). With each passing week, the odds of losing weight increase by 1.41 (P-value: 0.038), while the odds of shortness of breath and cough decrease by 0.84 (P-value: 0.005) and 0.56 (P-value: 0.000), respectively. In addition, each day increase in the duration of meropenem or methylprednisolone decreased the odds of weight loss at follow-up by 0.88 (P-value: 0.026) and 0.91 (P-value: 0.023), respectively (among those who took these medications). Identified prognostic factors can help clinicians and policymakers adapt management strategies for patients in any pandemic like COVID-19, which ultimately leads to better hospital decision-making and improved patient quality of life outcomes.

Quality of Life After Cataract Surgery in Patients with Age-Related Macular Degeneration: A Literature Review

Abstract
 Introduction & Objectives : Age-related macular degeneration (AMD) is a common ocular disease that affects millions of people worldwide. Cataract surgery is one of the most performed surgical procedures in the world and is effective to improve visual function and quality of life (QoL) in individuals with cataracts. Both cataract and AMD are conditions that occur in late age. However, the presence of AMD may complicate the postoperative outcomes and QoL of these patients. This review aims to examine the impact of cataract surgery on the QoL of patients with AMD.
 Methods : A search of the literature was conducted using electronic databases. Studies were included if they evaluated QoL outcomes in patients with AMD who underwent cataract surgery.
 Results : The results of the review suggest that cataract surgery can improve visual acuity and QoL in patients with AMD. However, the degree of improvement is influenced by the severity of AMD. Patients with mild to moderate AMD tended to have greater improvements in QoL and visual acuity compared to those with advanced AMD. Incidentally, it is still cost effective to perform cataract surgery in patients with advanced AMD.
 Conclusion : Overall, patients with AMD who underwent cataract surgery experienced improvements in their QoL. Nevertheless, individual characteristics including severity of AMD must be considered to optimize the procedure outcomes. Further research, particularly with longer follow up times, is needed to determine the long-term effects of cataract surgery on QoL in patients with AMD.

QUALITY OF LIFE AFTER CATARACT SURGERY IN PATIENTS WITH AGE-RELATED MACULAR DEGENERATION: A LITERATURE REVIEW

Objective: Age-related macular degeneration (AMD) is a common ocular disease that affects millions of people worldwide. Cataract surgery is one of the most performed surgical procedures in the world and is effective to improve visual function and quality of life (QOL) in individuals with cataracts. Both cataract and AMD are conditions that occur in late age. However, the presence of AMD may complicate the postoperative outcomes and quality of life (QOL) of these patients. This review aims to examine the impact of cataract surgery on the QOL of patients with AMD. Methods: A search of the literature was conducted using electronic databases. Studies were included if they evaluated QOL outcomes in patients with AMD who underwent cataract surgery. Result: The results of the review suggest that cataract surgery can improve visual acuity and QOL in patients with AMD. However, the degree of improvement is influenced by the severity of AMD. Patients with mild to moderate AMD tended to have greater improvements in QOL and visual acuity compared to those with advanced AMD. Incidentally, it is still cost effective to perform cataract surgery in patients with advanced AMD. Conclusion: Overall, cataract surgery is found to be able to improve QOL and visual acuity in patients with AMD. Nevertheless, individual characteristics including severity of AMD must be considered to optimize the outcomes. Further research, particularly with longer follow up times, is needed to determine the long-term effects of cataract surgery on QOL in patients with AMD.

Dyspnea-Related Dimensions And Self-Efficacy: Associations With Well-Being in Advanced Lung Cancer

ContextDyspnea is a complex, multidimensional symptom comprising sensory-perceptual, affective, and functional domains that commonly persists in patients with lung cancer and impairs mental health and quality of life (QOL). However, data are lacking on how dyspnea's dimensions or self-efficacy to manage dyspnea are associated with patient outcomes. ObjectivesTo assess the associations of dyspnea dimensions (dyspnea-related sensory–perceptual experience, affective distress, and functional impact) and dyspnea self-efficacy with depression, anxiety, and QOL in patients with advanced lung cancer reporting dyspnea. MethodsWe conducted a secondary analysis of baseline clinical trial data testing a supportive care intervention for dyspnea. Patients with advanced lung cancer reporting at least moderate dyspnea (≥2 on the Modified Medical Research Council Dyspnea Scale) self-reported dyspnea and patient outcome measures. Hierarchical regressions tested the associations of the dyspnea dimensions with depressive and anxiety symptoms (Hospital Anxiety and Depression Scale) and QOL (Functional Assessment of Cancer Therapy-Lung) while adjusting for variables known to affect these outcomes. ResultsThe sensory–perceptual experience of dyspnea (effort) was associated with worse depressive symptoms (b = 0.21, P < 0.01) and QOL (b = −0.53, P = 0.01). Dyspnea self-efficacy was associated with improved depressive (b = −1.26, P < 0.01) and anxiety symptoms (b = −1.72, P < 0.01) and QOL (b = 3.66, P < 0.01). The affective and functional dimensions of dyspnea were not associated with the patient outcomes in the final models. ConclusionsDyspnea-related sensory–perceptual experience and self-efficacy were associated with mental health and QOL outcomes in patients with lung cancer. Examining the individual contributions of dyspnea's multiple dimensions provides a nuanced understanding of its patient impact.

Do Clinical Outcomes and Quality of Life Differ by the Number of Antianginals for Stable Ischemic Heart Disease? Insights from the BARI 2D Trial

Medical therapy, including antianginal treatment, is the cornerstone in the management of stable ischemic heart disease (SIHD). However, it remains unclear whether combining antianginal agents provides benefits beyond monotherapy in terms of quality of life (QoL) and cardiovascular outcomes. We used data from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial, which compared cardiovascular and QoL outcomes in patients with SIHD and diabetes mellitus randomized to revascularization with intensive medical therapy or intensive medical therapy alone. We categorized patients into 3 groups: ≥2 versus 1 versus 0 antianginals. We compared patient characteristics, QoL metrics, and cardiovascular end points at baseline and at 5 years, creating a multivariable model to adjust for key clinical confounders. Of 2,368 patients, 348 patients (14.7%) were on 0 antianginals, 1,020 patients (43.1%) were on 1 antianginal, and 1,000 patients (42.2%) were on ≥2 antianginals at baseline. The most common antianginal class was β blockers. At baseline, patients on 0 antianginals had better QoL metrics (self-health score, Duke activity status index, and energy rating) than patients on ≥2 antianginals. However, at the 1-year follow-up, patients taking only 1 antianginal showed greater QoL improvement than those taking 0 antianginal, without any incremental benefit in QoL metrics seen in patients taking ≥2 antianginal agents, even after adjusting for multiple covariates such as age, heart failure, diabetes control, and myocardial jeopardy index. Lastly, at the 5-year follow-up, after adjustment, there were no differences in all-cause mortality, major adverse cardiovascular events, or myocardial infarction between patients taking different numbers of antianginals. Adults on a single antianginal for SIHD and diabetes mellitus had similar or better improvements in QoL than those on 2 or more antianginal agents at 1 year of follow-up. These findings merit further research to better understand the impact of medical therapy intensity on QoL in patients with SIHD and associated co-morbidities.

Gender Differences in Quality-of-Life Outcome in Patients Undergoing Endoscopic Endonasal Skull Base Surgery

Abstract Background Prior studies showed that female patients with chronic rhinosinusitis (CRS) suffer a worse disease-specific quality of life (QoL). Goal The aim of this study is to investigate gender differences in sinonasal QoL outcomes in patients requiring endoscopic endonasal skull base surgeries (EESBS). Methods Cross-sectional analysis of patients presenting to our clinic from August 2020 to December 2022 with skull base tumors, spontaneous cerebrospinal fluid (CSF) rhinorrhea, or Grave's orbitopathy (for orbital decompression) was performed. Baseline and postsurgical QoL were measured using the 22-item Sinonasal Outcome Test (SNOT-22). Patients' demographics and comorbidities were reviewed. Patients with concomitant CRS were excluded. Results Eighty-six patients were included (54 with skull base tumors, 17 Grave's orbitopathy, and 15 spontaneous CSF rhinorrhea). The mean age of the patients was 52 years (range: 12.4–81.5 years), and 51.6% of the patients were females. There was no age difference between female and male patients. Smoking history, asthma, and allergic rhinitis were also similar between the two groups. Female patients had a significantly higher incidence of depression (58.3 vs. 32.4%, p = 0.018) and migraine (50.0 vs. 21.6%, p = 0.007). Female patients had a significantly worse overall SNOT-22 scores at baseline (33.6 vs. 18.2, p = 0.001), at the 3-month follow-up (29.7 vs. 15.5, p = 0.002), and at the 6-month follow-up (33.5 vs. 14.9, p = 0.005). This worse QoL was seen mainly in the ear/facial, sleep, and psychological domains. Linear regression of the SNOT-22 scores and its subdomains adjusting for comorbidities showed that migraine was found to be the most significant determinant of gender differences in the QoL. Conclusion Female patients who undergo EESBS show higher overall SNOT-22 scores secondary to higher incidence of migraine.

What are the Most Important Objectives of Patients Undergoing Radical Prostatectomy? A Narrative Review.

This study aimed to evaluate what objectives are most important to men undergoing radical prostatectomy to allow treating physicians to personalize perioperative counselling and improve patient quality of life outcomes. A predefined search protocol of the Medline and Embase databases was performed from database inception to May 2023. The search was limited to English language and full text. All articles with a specific consideration of patient objectives, preferences or reasons for decision to undergo radical prostatectomy were included for review. Ten articles out of 375 screened met inclusion criteria for review. All 10 articles utilized a qualitative design and originated across 5 countries across the developed world. A common theme of men placing importance on having their tumor physically removed was found. Methodologies allowing free response beyond predefined categories identified a breadth of considerations including personal circumstance, personal belief and current function in the decision-making process. An investigation on radical prostatectomy performed robotically found some men placed preference on the quicker treatment time with surgery compared to radiation therapy, reflective of shorter recovery times with the robotic approach. Variability in results across studies highlights the heterogeneity in patient preferences. Directed investigation of patient objectives with an open-ended questioning approach would personalize the perioperative experience and may improve patient satisfaction and quality of life outcomes.

NCOG-31. TUMOR TREATING FIELDS: REAL-WORLD SURVIVAL AND QUALITY OF LIFE OUTCOMES ON THE XCELSIOR PLATFORM

Abstract OBJECTIVE xCures operates a direct-to-patient, real-world evidence platform according to the nationwide observational research protocol XCELSIOR (NCT03793088), which aggregates medical data in an FDA-compliant electronic database. We used this platform to analyze advanced registry survival and Quality of Life (QoL) outcomes associated with the use of Tumor Treating Fields (TTFields) for treatment of high grade central nervous system (CNS) tumors. METHODS XCELSIOR participants with high grade CNS tumors were invited weekly to complete the EuroQol 5-Dimension (EQ-5D-5L) QoL questionnaire over the course of one year. A EuroQol-endorsed model was used to estimate health state utilities from patients’ EQ-5D responses. The participating patients’ clinical data was accessed from the XCELSIOR platform to enable study of clinical factors and survival outcomes. RESULTS 225 patients with high grade CNS tumors in total completed at least one EQ-5D questionnaire. 88 patients (39%) had ever used TTFields and 58 of these patients (26%) were currently using TTFields. Patients currently using TTFields had significantly higher average health state utility estimates compared to non-users (p=.00183), with a mean improvement in utility of .14 (SE=.04), indicating significantly higher overall QoL in TTFields users. Mortality events were recorded for 40 participating patients, 14 (35%) of which had used TTFields. From these 40 events the mean/median overall survival (OS) for patients who had used TTFields was 23.39/20.15 months vs 15.77/12.72 months for patients who had not used TTFields, showing significantly higher average OS in patients who had used TTFields (p=.04139). CONCLUSION The XCELSIOR platform has enabled the study of real-world clinical and QoL outcomes for patients with CNS tumors. The results show that use of TTFields is associated with improved survival as well as improved overall Quality of Life for patients in a real-world setting, corroborating results seen in trial settings as well as results seen in other real-world studies.

Establishing Meaningful Change Thresholds in Patient-Reported Outcomes Among Patients With Anaplastic Lymphoma Kinase-Positive Non–Small Cell Lung Cancer in ALTA-1L Trial

ObjectivesAn earlier study from the ALTA-1L trial of patients with anaplastic lymphoma kinase-positive non–small cell lung cancer demonstrated that brigatinib produces superior health-related quality of life (QoL) outcomes over crizotinib. This study aimed to derive meaningful change thresholds (MCTs) for European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-LC13 to refine the earlier results. MethodsPatients from the ALTA-1L trial were administered the EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires. Responses were analyzed using anchor-based analysis, graphical analysis, distribution-based analysis, longitudinal responder analysis, and time to deterioration. ResultsThe patient-reported outcome population comprised 262 patients who completed the EORTC QLQ-C30 at baseline and at least 1 follow-up timepoint. Both anchors (QLQ-C30 items for overall health and QoL) had correlations >0.40 or < −0.40 with all functioning domains, fatigue, pain, appetite loss, and all dyspnea scores. Within-group analysis for most scales found the derived MCT was consistent with a cutoff of 10 points for classifying individual-patient change, except for 3-item dyspnea. The probability of improvement/remaining stable was significantly greater in the brigatinib group over crizotinib for the EORTC QLQ-C30 emotional functioning, appetite loss, and constipation domains. ConclusionsThis study derived MCTs for EORTC QLQ-C30 and QLQ-LC13 domains that may be applied in future studies and again demonstrated the superiority of brigatinib over crizotinib in health-related QoL outcomes in patients with non–small cell lung cancer.

Adult attachment in couples facing stage IV lung cancer: associations with patient quality-of-life outcomes and sense of life completion

Abstract Background: Adult attachment insecurity is associated with poor psychosocial and cancer-related symptom outcomes in patients with cancer; however, there is a paucity of research around the role of the spousal caregivers' attachment in patient quality of life (QOL) at the end of life (EOL). Attachment styles may be particularly relevant for couples coping with prolonged metastatic disease, where the threat of death or disease progression is highly salient. Methods: We conducted secondary analyses on a sample of patients with stage IV non–small cell lung cancer and their spouses. Participants separately completed questionnaires of attachment style (ECR-S), relationship closeness (PAIR), illness-related communication (holding back one's fear of death or disease progression), and cancer-related distress (IES). Patients additionally completed questionnaires on sense of life completion and QOL at EOL (QUAL-E Completion Subscale and Overall QOL Item) and symptom burden (MDASI-LC). Results: For patients, greater attachment avoidance was associated with lower sense of life completion (r = −0.31, P = .009) and lower overall QOL (r = −0.35, P = .003). Greater patient attachment anxiety was also associated with a lower sense of life completion (r = −0.26, P = .034). Greater caregiver attachment avoidance and attachment anxiety were associated with patient reports of lower overall QOL (r = −0.38, P = .001, r = −0.36, P = .002, respectively). In addition, greater caregiver attachment anxiety was associated with greater patient symptom burden (r = 0.24, P = .048) controlling for patient's own attachment anxiety. For both patients and caregivers, greater attachment anxiety was associated with more “holding back” from communicating their fear of death or disease progression with their spouse (r = 0.25, P = .036; r = 0.31, P = .011, respectively). Dyadic analyses revealed a positive association within the couple for attachment avoidance (r = 0.41, P &lt; .01) and anxiety (r = 0.31, P &lt; .01). Conclusion: Both spousal caregiver and patient attachment styles are highly relevant to illness communication patterns and patient QOL outcomes.

The ANZ hernia repair practices study: low consensus on inguinal and small ventral hernia management and infrequent long-term follow-up.

The ANZ hernia repair practices study: low consensus on inguinal and small ventral hernia management and infrequent long-term follow-up.

Moving beyond the physical: exploring the holistic benefits of a therapy-based physical activity program for individuals with Parkinson’s disease

In individuals diagnosed with Parkinson’s Disease (PD), a chronic neurodegenerative disorder affecting movement and functionality, therapy-based physical activity (PA) that includes repetitive, quick motions benefits physical and cognitive functioning and can positively impact the disease course. Furthermore, the benefits of therapeutic PA participation may extend beyond physiological outcomes by positively influencing social and psychological well-being, thus increasing the overall quality of life (QoL). The current research examined a regional healthcare system-supported group therapeutic boxing/PA program for PD using a biopsychosocial lens to synthesize the holistic benefits of long-term program participation. Researchers conducted semi-structured focus group interviews with program participants (n = 18) and their caregivers (n = 7) to explore the perceived benefits of a combination boxing/PA program that included 30 minutes of boxing and 30 minutes of an alternate rotating PA 1-3 times per week. Results indicated a positive impact on participants’ and caregivers’ QoL by increasing socialization and empowerment and improving/maintaining physical function. These results demonstrate the importance of using a biopsychosocial approach in program design and evaluation of PA-based PD interventions. In addition to addressing PD-specific physical needs, PA programs should be constructed to include supportive social atmospheres and consider non-physical needs and overall QoL outcomes of patients and caregivers.

The Economic and Humanistic Burden of Pediatric-Onset Multiple Sclerosis.

Background: Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system. Pediatric-onset MS (POMS), defined as onset of MS before 18 years of age, is estimated to account for 2% to 5% of the MS population worldwide. Objectives: To conduct a literature review focused on the healthcare resource utilization and cost as well as quality-of-life (QOL) outcomes among patients with POMS. Methods: We conducted a systematic literature review of English-language studies published after September 2010 in MEDLINE and Embase to describe the global economic healthcare resource utilization and costs and humanistic (QOL) burden in patients with POMS. Results: We found 11 studies that reported on healthcare resource utilization, cost, or insurance coverage and 36 studies that reported on QOL outcomes in patients with POMS. Patients with POMS had higher rates of primary care visits (1.41 [1.29-1.54]), hospital visits (10.74 [8.95-12.90]), and admissions (rate ratio, 4.27 [2.92-6.25];OR, 15.2 [12.0-19.1]) compared with healthy controls. Mean per-patient costs in the United States were $5907 across all settings per year of follow-up between 2002 and 2012; mean costs per hospital stay were $38 543 (in 2015 USD) between 2004 and 2013. Three studies reported psychosocial scores between 71.59 and 79.7, and 8 studies reported physical health scores between 74.62 to 82.75 using the Pediatric Quality of Life Measurement Model (PedsQLTM). Twelve studies used the PedsQL™ Multidimensional Fatigue Scale. Mean scores on the self-reported general fatigue scale ranged from 63.15 to 78.5. Quality-of-life scores were lower than those of healthy controls. Discussion: Our review presents a uniquely broad and recent overview of the global economic and humanistic burden of patients with POMS. Additional research on healthcare resource utilization and cost would provide a more robust understanding of the economic burden in this population. Conclusions: Healthcare resource utilization and costs are high in this population, and patients report reduced QOL and significant fatigue compared with healthy children and adolescents.

Revision paraesophageal hernia repair outcomes in patients with typical and atypical reflux.

Revision laparoscopic anti-reflux surgery (RLARS) is effective in alleviating the typical symptoms of gastroesophageal reflux disease (GERD). RLARS outcomes in patients with atypical GERD symptoms has not been well established. A composite Reflux Symptom Index (RSI) score greater than 13 indicates extraesophageal manifestation of pathological reflux. In this study, we analyzed the differences in quality-of-life (QOL) and perioperative outcomes between patients with atypical versus typical GERD who underwent RLARS. A retrospective review was conducted of a prospectively maintained database of patients with pathologic reflux who underwent RLARS from February 2003 to October 2019. The cohort was divided into two groups, those with typical versus atypical manifestations of GERD, as defined by their RSI score. Patients with a RSI score of > 13 were assigned to the Atypical group and those ≤ 13 were assigned to the Typical group. Patient QOL outcomes were prospectively followed using the RSI survey. Significance was defined by p-value less than 0.05. A total of 133 patients (Typical 61, Atypical 72) were included in the final analysis. The two groups were similar (p > 0.05) in mean age (58.1 ± 13.3 vs. 55.3 ± 15.5years), body mass index (29.6 ± 5.0 vs. 30.3 ± 5.4), female sex distribution (60.7% vs. 59.7%) and age adjusted Charlson score (1.76 ± 1.58 vs. 1.98 ± 1.94). The Typical group had a higher frequency of type III hiatal hernia (62.3% vs. 29.2%) and Collis gastroplasty (29.5% vs. 5.6%). The groups had similar rates of partial and complete fundoplication with similar median length of stay (Typical: 3.0 ± 3.4days vs. Atypical: 2.4 ± 1.7days). After a mean follow-up of 30.2 ± 33.6months, both groups reported similar rates of improvement in RSI outcome from baseline (58.1% vs 43.3%, p = .149). However, the RSI outcome at the latest follow-up for the Typical group was significantly better than the Atypical group after RLARS (2.8 ± 5.3 vs. 15.9 ± 11.1, respectively). Patients who undergo revision paraesophageal hernia repair with objective findings of GERD and subjective complaints of atypical reflux symptoms may show long-term improvement in QOL outcomes. However, these results are contingent on proper patient selection and a thorough work-up for pathological reflux in this population. Further research is needed to determine universal diagnostic criteria to assist in the early detection and surgical treatment of patients with atypical GERD.

Quality of Life Outcomes Over Time in Patients With Unruptured Intracranial Aneurysms With and Without Preventive Occlusion: A Prospective Cohort Study.

In counseling patients with an unruptured intracranial aneurysm (UIA), quality of life (QoL) outcomes are important for informed decision making. We evaluated QoL outcomes in patients with and without preventive aneurysm occlusion at multiple time points during the first year after UIA diagnosis and studied predictors of QoL outcomes. We performed a prospective cohort study in patients aged ≥18 years with a newly diagnosed UIA in 2 tertiary referral centers in the Netherlands between 2017 and 2019. Patients were sent QoL questionnaires at 7 (aneurysm occlusion) or 5 (no occlusion) moments during the first year after diagnosis. We collected baseline data on patient and aneurysm characteristics, passive coping style (Utrecht Coping List), occlusion modality, and neurologic complications. We assessed health-related QoL (HRQoL) with the EuroQol 5 dimensions (EQ-5D), emotional functioning with the Hospital Anxiety and Depression Scale (HADS), and restrictions in daily activities with the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P). We used a linear mixed-effects model to assess the course of QoL over time and to explore predictors of QoL outcomes. Of 153 eligible patients, 99 (65%) participated, of whom 30/99 (30%) underwent preventive occlusion. Patients undergoing occlusion reported higher baseline levels of passive coping, anxiety and depression, and restrictions than patients without occlusion. During recovery after occlusion, patients reported more restrictions compared with baseline (adjusted USER-P decrease 1 month post occlusion: -12.8 [95% CI -23.8 to -1.9]). HRQoL and emotional functioning gradually improved after occlusion (EQ-5D increase at 1 year: 8.6 [95% CI 0.1-17.0] and HADS decrease at 1 year: -5.4 [95% CI -9.4 to -1.5]). In patients without occlusion, the largest HRQoL improvement occurred directly after visiting the outpatient aneurysm clinic (EQ-5D increase: 9.2 [95% CI 5.5-12.8]). At 1 year, QoL outcomes were comparable in patients with and without occlusion. Factors associated with worse QoL outcomes were a passive coping style in all patients, complications in patients with occlusion, and higher rupture risks in patients without occlusion. After UIA diagnosis, QoL improves gradually after preventive occlusion and directly after counseling at the outpatient clinic in patients without occlusion, resulting in comparable 1-year QoL outcomes. A passive coping style is an important predictor of poor QoL outcomes in all patients with UIA.

The impact of treatment with bile acid sequestrants on quality of life in patients with bile acid diarrhoea

BackgroundBile acid diarrhoea (BAD) can be severely debilitating and negatively affect patients’ quality of life (QoL). We carried out a multi-centre prospective study exploring QoL outcomes in patients with BAD after treatment with colesevelam.MethodsPatients with or without a positive 23-seleno-25-homotaurocholic acid (SeHCAT) scan were recruited and categorised into four groups: SeHCAT negative control group (CG), idiopathic BAD, post-cholecystectomy (PC) and post-terminal ileal resection for Crohn’s disease (CD). Patients with a positive SeHCAT were treated with colesevelam and dosing was titrated to symptomatic response. Patients were reviewed at 4- and 8-weekly intervals and QoL was evaluated by EQ-5D-3L, SF-36, IBDQ-32 at each visit (where relevant). Patients with a negative SeHCAT (CG cohort) completed one set of questionnaires before being discharged from the study.Results47 patients (BAD = 24, PC = 12, CD = 11) completed paired QoL questionnaires before and after treatment and 30 CG patients completed a baseline questionnaire. There was a significant improvement in IBDQ-32 mean scores before and after treatment in CD patients [134.6 (95%CI 112.5–156.6) and 158.4 (136.1–180.6), respectively (p = 0.007). Following treatment, BAD patients had significantly improved mean SF-36 scores in the “Role limitation due to physical health” dimension (p = 0.02) and in the overall mental component summary (p = 0.03). Prior to starting treatment, BAD patients had the lowest scores in the ‘activity’ dimension of the EQ-5D-3L (p = 0.04), which improved significantly after treatment (p = 0.002). Overall, the BAD and CD cohort showed improved mean scores with treatment in all components of the SF-36 and EQ-5D-3L, while the PC cohort showed a general decline in mean scores after treatment. 55% of patients clinically responded to treatment of which 41.7%, 58.3% and 81.8% responded from the BAD, PC and CD groups respectively. Correlations between those deemed as responders with improvements on the SF-36 and EQ-5D dimensions were not statistically significant.ConclusionOur results demonstrate improved QoL in the BAD and CD cohort with treatment. Further larger studies are recommended specifically investigating the PC cohort and whether patients may improve with newer treatments such as FXR agonists.Trial registration Ethical approval REC Ref: 16/LO/1325.

PCR8 Using Customized PRO Profiles to Evaluate Expected Patient Quality of Life Outcomes

Patient Reported Outcomes (PROs) are routinely employed in patient-focused drug development programs. However, PRO data are often under-utilized. Better approaches could employ trial data to describe expected patient outcomes. The objective of this work was to present a method for leveraging PRO-based patient profiles to project and thereby anticipate expected patient outcomes.

SO-18 Reinforcing clinical outcomes with patient-reported QoL outcomes in patients with mCRC receiving FTD/TPI: Pooled analysis of PRECONNECT and TALLISUR studies

Trifluridine/tipiracil (FTD/TPI) is approved for use in patients with metastatic colorectal cancer (mCRC) who have progressed on, or who cannot tolerate, standard therapies. PRECONNECT was an international, multicentre, open-label, phase IIIb trial, and TALLISUR was a prospective, multicentre, open-label phase IV trial; both assessed efficacy, safety and quality of life (QoL) in patients with mCRC receiving FTD/TPI. Here, we present the pooled QoL results from PRECONNECT and TALLISUR and explore whether there is an association between QoL and Eastern Cooperative Oncology Group performance status (ECOG PS) changes. In both studies, patients with mCRC received FTD/TPI (35 mg/m2 twice-daily) on days 1–5 and 8–12 of each 28-day cycle, between 2016 and 2020. Patients completed the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (Version 3.0) questionnaire during each treatment cycle. QLQ-C30 analysis was conducted on all patients who answered the questionnaire at baseline and at least once post baseline. Clinically relevant deterioration in QoL was defined as >10-point change in QLQ-C30 score from baseline or death. ECOG PS was evaluated at baseline and during each cycle, and the time of ECOG PS deterioration to ≥2 or death was analysed. The association between changes in ECOG PS and QLQ-C30 Global Health Status (GHS) over time was evaluated. There were 1100 patients treated in the pooled population (PRECONNECT: N=914; TALLISUR N=186), with baseline ECOG PS scores of 0 (n=506), 1 (n=545), 2 (n=20) or not reported (n=29). For the population as a whole, the mean QLQ-C30 GHS score did not deviate from baseline by >10 points at any time point up to cycle 7. However, 450/975 (46.2%) patients had clinically meaningful deteriorations in QLQ-C30 GHS at some point over the study period (median time to deterioration 3.9 months [95%CI: 3.6, 4.5]). ECOG PS was improved or maintained from baseline in 63.0% of patients at the end of the study period. Better ECOG PS at baseline was associated with better QLQ-C30 GHS at baseline (baseline mean QLQ-C30 GHS score was 67.8, 58.9 and 52.6 in patients with ECOG PS or 0, 1 and 2, respectively). Furthermore, better ECOG PS at baseline resulted in slower deterioration of QLQ-C30 GHS (median 4.2 months [95% CI: 3.7, 5.3] and 3.5 months [95% CI: 2.9, 4.3] with ECOG PS 0 and 1, respectively). At last post-baseline evaluation, patients whose ECOG PS improved from baseline had no deterioration in QLQ-C30 GHS scores (n=45; mean change +0.74), patients whose ECOG PS stayed unchanged (n=544) or deteriorated (n=340) had decreased QLQ-C30 GHS scores (mean change -2.84 and -8.88, respectively). In a Cox regression analysis, the association between time to ECOG PS deterioration and change in QLQ-C30 GHS score over time (change of ≥10 versus < 10) was significant (HR 1.707 [95% CI: 1.4, 2.2]; p < 0.0001). In this pooled analysis, QoL and ECOG PS were maintained in most patients with mCRC receiving treatment with FTD/TPI. These data also show an association between time to ECOG PS deterioration and change in QLQ-C30 GHS score over time.

Quality of Life and Healthcare Resource Use in a Real-world Patient Population with Idiopathic Pulmonary Fibrosis: The PROOF Registry.

IntroductionThe PROOF registry is a prospective, observational study that aimed to monitor disease progression in a real-world cohort of patients with idiopathic pulmonary fibrosis (IPF). Here, longitudinal quality-of-life (QoL) outcomes, healthcare resource use (HCRU), and the association between QoL and mortality in patients enrolled in the PROOF registry are presented.MethodsQoL outcomes (St. George’s Respiratory Questionnaire [SGRQ], EuroQoL-5 dimensions-5 levels Health Questionnaire [EQ-5D-5L], EuroQoL-5 dimensions Health Questionnaire [EQ-5D] visual analogue scale [VAS] and cough VAS) and HCRU were collected for all patients. Associations between baseline QoL and mortality were assessed using univariate and multivariate analyses. During multivariate analyses, individual QoL measures were adjusted for the following covariates: age, sex, percent predicted forced vital capacity, percent predicted diffusing capacity of the lungs for carbon monoxide, smoking status, and supplementary oxygen use at registry inclusion.ResultsIn total, 277 patients were enrolled in the PROOF registry. During the follow-up period, worsening in cough VAS score, SGRQ symptom score, and SGRQ activity score was observed, while EQ-5D VAS, SGRQ total score, and SGRQ impact score remained stable. During univariate analyses, EQ-5D VAS and all SGRQ sub-scores and total score at baseline were associated with mortality; however, during multivariate analyses, only the SGRQ total score, SGRQ impact score, and SGRQ symptom score at baseline were associated with mortality. During the follow-up period, 261 (94.2%) patients required an outpatient consultation (IPF- or non-IPF-related) and there were 182 hospitalizations in total, most of which were respiratory related (66.5%).ConclusionsThe PROOF registry provided valuable, real-world data on the association between baseline QoL and mortality, and longitudinal HCRU and QoL outcomes in patients with IPF over 24 months and identified that SGRQ may be an independent prognostic factor in IPF.Supplementary InformationThe online version contains supplementary material available at 10.1007/s41030-022-00187-8.