Longitudinal Health-related Quality Of Life Research Articles

Longitudinal assessment of quality of life in indolent non-Hodgkin lymphomas managed with active surveillance

There are limited data describing the impact of active surveillance on longitudinal health-related quality of life (HRQoL) in patients with indolent non-Hodgkin lymphomas (NHL). A cohort of untreated indolent NHL patients completed FACT-LYM questionnaires at 6, 12, 18, 24, and 36 months after diagnosis. Longitudinal FACT-LYM scores were analyzed by ANOVA and generalized linear mixed models. Indolent NHL scores were compared to norm general population scores. A total of 52 patients were identified, of which 46 (88%) remained on active surveillance at 36 months. There was no significant change in any of the FACT-LYM scores over 36 months. As compared to the general population, indolent NHL patients had higher, clinically meaningful scores in physical, functional, and social well-being, but not emotional well-being. Patients with indolent NHL on active surveillance have globally preserved HRQoL for up to 3 years after diagnosis. Emotional well-being continues to be an unmet need during active surveillance.

Prospective longitudinal evaluation of treatment-related toxicity and health-related quality of life during the first year of treatment for pediatric acute lymphoblastic leukemia

BackgroundPediatric acute lymphoblastic leukemia (ALL) therapy is accompanied by treatment-related toxicities (TRTs) and impaired quality of life. In Australia and New Zealand, children with ALL are treated with either Children’s Oncology Group (COG) or international Berlin-Frankfurt-Munster (iBFM) Study Group-based therapy. We conducted a prospective registry study to document symptomatic TRTs (venous thrombosis, neurotoxicity, pancreatitis and bone toxicity), compare TRT outcomes to retrospective TRT data, and measure the impact of TRTs on children’s general and cancer-related health-related quality of life (HRQoL) and parents’ emotional well-being.MethodsParents of children with newly diagnosed ALL were invited to participate in the ASSET (Acute Lymphoblastic Leukaemia Subtypes and Side Effects from Treatment) study and a prospective, longitudinal HRQoL study. TRTs were reported prospectively and families completed questionnaires for general (Healthy Utility Index Mark 3) and cancer specific (Pediatric Quality of Life Inventory (PedsQL)-Cancer Module) health related quality of life as well the Emotion Thermometer to assess emotional well-being.ResultsBeginning in 2016, 260 pediatric patients with ALL were enrolled on the TRT registry with a median age at diagnosis of 59 months (range 1–213 months), 144 males (55.4%), majority with Pre-B cell immunophenotype, n = 226 (86.9%), 173 patients (66.5%) treated according to COG platform with relatively equal distribution across risk classification sub-groups. From 2018, 79 families participated in the HRQoL study through the first year of treatment. There were 74 TRT recorded, reflecting a 28.5% risk of developing a TRT. Individual TRT incidence was consistent with previous studies, being 7.7% for symptomatic VTE, 11.9% neurotoxicity, 5.4% bone toxicity and 5.0% pancreatitis. Children’s HRQoL was significantly lower than population norms throughout the first year of treatment. An improvement in general HRQoL, measured by the HUI3, contrasted with the lack of improvement in cancer-related HRQoL measured by the PedsQL Cancer Module over the first 12 months. There were no persisting differences in the HRQoL impact of COG compared to iBFM therapy.ConclusionsIt is feasible to prospectively monitor TRT incidence and longitudinal HRQoL impacts during ALL therapy. Early phases of ALL therapy, regardless of treatment platform, result in prolonged reductions in cancer-related HRQoL.

Sequential Multiple Imputation for Real-World Health-Related Quality of Life Missing Data after Bariatric Surgery.

One of the main challenges for the successful implementation of health-related quality of life (HRQoL) assessments is missing data. The current study examined the feasibility and validity of a sequential multiple imputation (MI) method to deal with missing values in the longitudinal HRQoL data from the Scandinavian Obesity Surgery Registry. All patients in the SOReg who received bariatric surgery between 1 January 2011 and 31 March 2019 (n = 47,653) were included for the descriptive analysis and missingness pattern exploration. The patients who had completed the short-form 36 (SF-36) at baseline (year 0), and one-, two-, and five-year follow-ups were included (n = 3957) for the missingness pattern simulation and the sequential MI analysis. Eleven items of the SF-36 were selected to create the six domains of SF-6D, and the SF-6D utility index of each patient was calculated accordingly. The multiply-imputed variables in previous year were used as input to impute the missing values in later years. The performance of the sequential MI was evaluated by comparing the actual values with the imputed values of the selected SF-36 items and index at all four time points. At the baseline and year 1, where missing proportions were about 20% and 40%, respectively, there were no statistically significant discrepancies between the distributions of the actual and imputed responses (all p-values > 0.05). In year 2, where the missing proportion was about 60%, distributions of the actual and imputed responses were consistent in 9 of the 11 SF-36 items. However, in year 5, where the missing proportion was about 80%, no consistency was found between the actual and imputed responses in any of the SF-36 items. Relatively high missing proportions in HRQoL data are common in clinical registries, which brings a challenge to analyzing the HRQoL of longitudinal cohorts. The experimental sequential multiple imputation method adopted in the current study might be an ideal strategy for handling missing data (even though the follow-up survey had a missing proportion of 60%), avoiding significant information waste in the multivariate analysis. However, the imputations for data with higher missing proportions warrant more research.

Predicting panel attrition in longitudinal HRQoL surveys during the COVID-19 pandemic in the US

BackgroundOnline longitudinal surveys may be subject to potential biases due to sample attrition. This study was designed to identify potential predictors of attrition using a longitudinal panel survey collected during the COVID-19 pandemic.MethodsThree waves of data were collected using Amazon Mechanical Turk (MTurk), an online crowd-sourced platform. For each wave, the study sample was collected by referencing a US national representative sample distribution of age, gender, and race, based on US census data. Variables included respondents’ demographics, medical history, socioeconomic status, COVID-19 experience, changes of health behavior, productivity, and health-related quality of life (HRQoL). Results were compared to pre-pandemic US norms. Measures that predicted attrition at different times of the pandemic were identified via logistic regression with stepwise selection.Results1467 of 2734 wave 1 respondents participated in wave 2 and, 964 of 2454 wave 2 respondents participated in wave 3. Younger age group, Hispanic origin (p ≤ 0.001) and higher self-rated survey difficulty (p ≤ 0.002) consistently predicted attrition in the following wave. COVID-19 experience, employment, productivity, and limited physical activities were commonly observed variables correlated with attrition with specific measures varying by time periods. From wave 1, mental health conditions, average daily hours worked (p = 0.004), and COVID-19 impact on work productivity (p < 0.001) were associated with a higher attrition rate at wave 2, additional to the aforementioned factors. From wave 2, support of social distancing (p = 0.032), being Republican (p < 0.001), and having just enough money to make ends meet (p = 0.003) were associated with predicted attrition at wave 3.ConclusionsAttrition in this longitudinal panel survey was not random. Besides commonly identified demographic factors that contribute to panel attrition, COVID-19 presented novel opportunities to address sample biases by correlating attrition with additional behavioral and HRQoL factors in a constantly evolving environment. While age, ethnicity, and survey difficulty consistently predicted attrition, other factors, such as COVID-19 experience, changes of employment, productivity, physical health, mental health, and financial situation impacted panel attrition during the pandemic at various degrees.

Health-related quality of life following FDG-PET/CT for cytological indeterminate thyroid nodules.

ObjectiveThis study assessed the health-related quality of life (HRQoL) in patients undergoing 2-[18F]fluoro-2-deoxy-D-glucose (FDG)-PET/CT for an indeterminate (Bethesda III/IV) thyroid nodule. FDG-PET/CT accurately rules out malignancy and prevents 40% of futile diagnostic surgeries in these nodules.DesignSecondary analyses of HRQoL data from a randomised controlled multicentre trial (NCT02208544) in 126 patients from 15 hospitals in the Netherlands were done.MethodsLongitudinal HRQoL assessment was performed using the EuroQol 5-dimension 5-level (EQ-5D-5L), the RAND 36-item Health Survey v2.0 (RAND-36), and the Thyroid Patient-Reported Outcome (ThyPRO) questionnaire on baseline, 3, 6, and 12 months, relative to the date of the FDG-PET/CT scan.ResultsPatients who were randomised to active surveillance following an FDG-negative nodule instead of diagnostic surgery reported stable HRQoL scores throughout the year. Univariate analysis indicated better HRQoL for patients undergoing surveillance than surgical patients with benign histopathology on multiple physical and psychosocial domains. Univariate within-group analysis suggested both temporary and continued HRQoL deteriorations in patients with benign histopathology over time. Multivariate within-group analysis demonstrated no significant longitudinal HRQoL changes in patients undergoing active surveillance. In contrast, in patients with benign histopathology, worse HRQoL was observed with regard to ThyPRO cognitive impairment (P = 0.01) and cosmetic complaints (P = 0.02), whereas goitre symptoms (P < 0.001) and anxiety (P = 0.04) improved over time. In patients with malignant histopathology, anxiety also decreased (P = 0.05).ConclusionsThe reassurance of a negative FDG-PET/CT resulted in sustained HRQoL throughout the first year of active surveillance. Diagnostic surgery for a nodule with benign histopathology resulted in more cognitive impairment and physical problems including cosmetic complaints, but improved goitre symptoms and anxiety. Anxiety was also reduced in patients with malignant histopathology.

Health-Related Quality of Life in Colorectal Cancer Patients Treated With Liver Transplantation Compared to Chemotherapy.

Liver transplantation (LT) for patients with non-resectable colorectal liver metastases (CRLM) offers improved survival and has gained increased interest internationally the last years. The aim of this study was to describe the health-related quality of life (HRQoL) in patients with non-resectable CRLM receiving LT and how baseline HRQoL factors affect overall survival (OS). HRQoL data in the SECA (SEcondary CAncer) LT cohort was compared to data obtained from colorectal cancer patients starting first-line chemotherapy for metastatic disease in a clinical trial and data from a Norwegian normal population. HRQoL data from the QLQ-C30 questionnaire used in the SECA LT study and the NORDIC- VII study were reported. The relationship between patient-reported symptom burden at baseline and OS was investigated. In the SECA study longitudinal HRQoL assessment was used to describe the time until definitive deterioration as well as mean values at different time points. Patients in the SECA and NORDIC-VII studies reported similar baseline HRQoL. The median time until definitive deterioration in the transplanted patients was estimated to 36 months. In the SECA study appetite loss and pain at baseline had negative impact on OS (25.3 versus 71.7 months, p = 0.002 and 39.7 versus 71.7 months, p = 0.038, respectively). Despite a relapse in most of the LT patients the Global Health Score (GHS) remained good. Pain, and especially appetite loss at time of transplantation is associated with poor outcome after LT.

Utility values and its time to deterioration in breast cancer patients after diagnosis and during treatments.

The potential effects of breast cancer (BC) on health-related quality of life (HRQoL) should be considered in clinical and policy decision-making, as the economic burden of BC management is currently assessed. In the last decades, time-to-HRQoL score deterioration (TTD) has been proposed as an approach to the analysis of longitudinal HRQoL in oncology. The main objectives of the current study were to investigate the evolution of the utility values in BC patients after diagnosis and during follow-ups and to evaluate the TTD in utility values among women in all stages of BC. Health-state utility values (HSUV) were assessed using the EuroQol 5-Dimension 3-Level at diagnosis, at the end of the first hospitalization and 3 and 6months after the first hospitalization. For a given baseline score, HSUV was considered to have deteriorated if this score decreased by ≥ 0.08 points of the EQ-5D utility index score and ≥ 7 points of the EQ visual analogue scale. TTD curves were calculated using the Kaplan-Meier estimation method. Overall 381 patients were enrolled between February 2006 and February 2008. The highest proportions of respondents at the baseline and all follow-ups reporting some and extreme problems were in pain discomfort and anxiety/depression dimensions; more than 80% of patients experienced a deterioration in EQ-5D utility index score and EQ VAS score with a median TTD of 3.15months and 6.24 Months, respectively. BC patients undergoing therapy need psychological support to cope with their discomfort, pain, depression, anxiety, and fear during the process of diagnosis and treatment to improve their QoL.

Factors associated with health-related quality of life (HRQoL) deterioration in glioma patients during the progression-free survival period.

Maintenance of functioning and well-being during the progression-free survival (PFS) period is important for glioma patients. This study aimed to determine whether health-related quality of life (HRQoL) can be maintained during progression-free time, and factors associated with HRQoL deterioration in this period. We included longitudinal HRQoL data from previously published clinical trials in glioma. The percentage of patients with stable HRQoL until progression was determined per scale and at the individual patient level (i.e. considering all scales simultaneously). We assessed time to a clinically relevant deterioration in HRQoL, expressed in deterioration-free survival and time-to-deterioration (the first including progression as an event). We also determined the association between sociodemographic and clinical factors and HRQoL deterioration in the progression-free period. Five thousand five hundred and thirty-nine patients with at least baseline HRQoL scores had a median time from randomization to progression of 7.6 months. Between 9-29% of the patients deteriorated before disease progression on the evaluated HRQoL scales. When considering all scales simultaneously, 47% of patients deteriorated on ≥1 scale. Median deterioration-free survival period ranged between 3.8-5.4 months, and median time-to-deterioration between 8.2-11.9 months. For most scales, only poor performance status was independently associated with clinically relevant HRQoL deterioration in the progression-free period. HRQoL was maintained in only 53% of patients in their progression-free period, and treatment was not independently associated with this deterioration in HRQoL. Routine monitoring of the patients' functioning and well-being during the entire disease course is therefore important, so that interventions can be initiated when problems are signaled.

Prospective quality of life in men choosing open vs. robotic radical prostatectomy: long-term results from a racially diverse multi-institutional database.

To compare 5-year health-related quality of life (HRQoL) outcomes between prostate cancer (CaP) patients who underwent robotic-assisted laparoscopic radical prostatectomy (RALP) versus open radical retropubic prostatectomy (RRP) and assess for racial disparities between Caucasian American (CA) and African American (AA) men undergoing surgery. A prospective cohort study of HRQoL data was conducted on patients diagnosed with CaP from 2007 to 2017 and enrolled in the Center for Prostate Disease Research (CPDR) Multicenter National Database. Using the EPIC and SF-36 instruments, changes in urinary, sexual, bowel, and hormonal domains, as well as physical and mental component summary scores were compared across surgery type (RALP versus RRP) at pre-treatment ("baseline"), and annually for 5years. We further compared HRQoL outcomes in CA and AA men undergoing surgery. Longitudinal HRQoL patterns were modeled using generalized estimating equations (GEE), adjusting for baseline HRQoL and other characteristics. 448 CaP patients (22% AA) met study inclusion criteria, 66% underwent RALP and 34% underwent RRP. At baseline, HRQoL domains were comparable across treatment group (RALP vs. RRP). In the adjusted low-risk cohort, there were only three time points that met a statistically significant HRQoL difference in EPIC scores between RALP and RRP. Urinary function score during year 4 of follow-up showed a 7.5 (95% CI 3.1-11.9, P = 0.01) points difference in favor of RRP. Bowel bother scores favored RRP in year 1 with a difference of 3.1 (95% CI 0.7-5.4, P = 0.04) points, and in year 5 with a difference of 3.8 (95% CI 1.1-6.4, P = 0.03) points. In the intermediate/high-risk cohort, there were no statistically significant differences in any of the domain scores between RALP and RRP during follow-up. The robotic and open approach to radical prostatectomy led to comparable HRQoL outcomes at a follow-up length of 60months. No HRQoL racial disparities were found between AA and CA men during long-term follow-up.

Phase II trial of organ preservation program using short-course radiation and folfoxiri for rectal cancer (SHORT-FOX).

TPS218 Background: Locally advanced rectal cancer is treated with preoperative chemoradiotherapy followed by total mesorectal excision (TME). While this trimodal approach achieves low rates of local recurrences, distant metastasis rates can exceed 25%. Total neoadjuvant therapy (TNT) has been shown in OPRA, RAPIDO, and PRODIGE23 to reduce risk of distant metastasis and improve rates of pathological complete response compared to standard preoperative chemoradiotherapy. Thus, TNT not only addresses distant disease, but gives opportunity to reduce locoregional morbidity through organ preservation. We propose a treatment approach that incorporates TNT with FOLFOXIRI and up-front short-course radiation with the goal of increasing clinical complete response (cCR) rates and thereby eligibility for organ preservation. Currently, clinical response following neoadjuvant therapy is best assessed by a multidisciplinary team and includes flexible endoscopy and MRI. Circulating tumor DNA (ctDNA) analysis can be used as a noninvasive method for tumor monitoring. Biomarker development is essential to better select patients for treatment de-escalation and monitor for recurrence in order not to jeopardize the excellent cure rates following standard of care therapy. Methods: This is a single-arm, open-label, non-randomized study of an organ preservation approach using short-course radiation followed by FOLFOXIRI for patients with &gt; T2N0 or low T2N0, M0 rectal adenocarcinoma (NCT04380337). Patients undergo radiation (25 Gy/5 fractions + 5 Gy/1 fraction boost) followed by 8 cycles of FOLFOXIRI. Patients are assessed for response at 8 weeks following chemotherapy completion using pelvic MRI (MRI Tumor Regression Grading), flexible sigmoidoscopy, and digital rectal exam. Those who achieve a cCR can defer TME and be surveilled. The primary objective is to assess cCR, with the hypothesis that this approach will achieve higher cCR rates than historical controls (40 versus 20%). Secondary objectives include assessing toxicity, local regrowth rate, disease-free survival, colostomy-free survival, overall survival, and longitudinal health-related quality of life. ctDNA will be collected throughout treatment and surveillance, and correlative studies will assess the association between ctDNA levels and cCR, local regrowth, and disease-free survival. A Simon 2-stage design addressed our primary objective. Assuming a one-sided type 1 error of 0.1, power of 0.9, a null cCR of 0.2 versus an alternate cCR of 0.4, we plan to enroll 37 patients. The null hypothesis will be rejected if &gt; = 11 patients have cCR. Seventeen patients have been enrolled and the trial is currently on hold for planned interim analysis for futility and safety. If &lt; = 3 patients have cCR or if &gt; = 7 patients have non-hematologic grade 4+ toxicity, the study will be stopped. Otherwise, we will continue to enroll 20 more patients. Clinical trial information: NCT04380337.

Evaluating the Role of Baseline Geriatric Assessment in Predicting Quality of Life in Older Adults with Non-Hodgkin Lymphoma on Oral Targeted Therapies

Background:Oral targeted therapies (OTT) have transformed the care of patients with non-Hodgkin lymphoma (NHL) with significantly improved survival outcomes compared to chemo-immunotherapy. While data from clinical trials suggest improvement in global health and some symptom scores, there is limited data on health-related outcomes in older adults who are more vulnerable to treatment-related adverse effects. Geriatric assessments can predict chemotherapy-related toxicity in older adults and the presence of geriatric impairments is associated with inferior quality of life. The role of geriatric assessment (GA) in predicting health-related quality of life (HRQoL) and treatment toxicity in patients with NHL on OTT is unknown. In this prospective study, we describe the association between OTT and HRQoL in older adults with NHL. We further describe the relationship between baseline geriatric assessment and longitudinal HRQoL parameters.Methods:We included patients (pts) ≥70 years (yrs) of age with NHL, initiating or already receiving OTT. A GA, including assessment of function, depression, cognition, physical performance and comorbidities, was performed at baseline. Pts were followed monthly for the first 3 months (mos), then every 3 mos for 1 year. Quality of life (QoL) was measured at each visit using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 (EORTC QLQ-C30) and EORTC QLQ - chronic lymphocytic leukemia 16 (EORTC QLQ-CLL16). The log QoL scores were modeled as a function of visit and mean scores at 6 months were compared to baseline using a linear mixed model. A change in score of >10 was considered clinically significant based on previous work.Results:We enrolled 25 pts with a median age of 77 yrs (71-93 yrs). Median follow up was 6.3 mos (range, 2.7-8.8 mos). The most common diagnosis was chronic lymphocytic leukemia (n=21) followed by mantle cell lymphoma (n=3) and marginal zone lymphoma (n=1). Most pts (72%) were on OTT at study entry and the most frequently used OTTs were ibrutinib (n=17) and venetoclax (n=5). GA revealed the presence of a geriatric syndrome (GS) in more than 90% of pts, including cognitive impairment (28%), depression (24%), polypharmacy (92%) and recent falls (12%); 48% of pts had ≥2 GS. Nine pts (36%) had impaired 4-meter gait speed and/or timed-up-and-go (TUG); 20 pts (80%) had an adjusted CIRS-G score of ≥6. At baseline, dependence in independent activities of daily living (IADL) was associated with inferior global health status scores (69.1 vs 86.1, p=0.023) and physical functioning scores (66.7 vs 88.1, p=0.008). Similarly, an abnormal TUG (>10 seconds) was associated with a lower global health score (71.3 vs 86.1, p=0.037). Dependence in 2 or more activities of daily living (ADL) was also associated with lower baseline physical functioning scores (57.8 vs 88.0, p=0.003) and role functioning scores (61.1 vs 90.8, p=0.030). During the 6-month follow up, there was significant worsening of global health status (mean difference -5.4, p=0.024) and cognitive functioning scores (mean difference -9.6, p<0.001) in the entire cohort. There were no changes in other functional scales (physical, role, emotional and social functioning, fatigue scale, infection scale, social problems and future health) over time (Figure 1). Trends in symptom scores were mixed with improvement in some scores (pain, fatigue) and worsening of others (dyspnea, diarrhea, constipation), none of which met the predefined criteria for clinical relevance (absolute difference of >10). Presence of various geriatric impairments at baseline did not impact changes noted in global health, physical, emotional, social and role functioning over time. Interestingly, we found a greater improvement in symptom scores in patients with baseline impairments in IADL (fatigue, pain), ADL (pain) and a CIRS-G score of ≥6 (insomnia).Conclusion:The presence of geriatric syndromes is common in older adults with NHL with almost half of the patients in our cohort with ≥2 GS. Older adults with GS had lower baseline global health status and physical functioning scores but experienced greater improvement in symptoms scores and maintenance of longitudinal HRQoL than those without GS at baseline. Chronological age had no impact on baseline or longitudinal HRQoL, underscoring the need to incorporate GA into clinical practice rather than relying on age alone. [Display omitted] DisclosuresWildes: Janssen: Consultancy; Carevive: Consultancy; Seattle Genetics: Consultancy; Sanofi: Consultancy. Torka: TG Therapeutics: Membership on an entity's Board of Directors or advisory committees.

Health-related Quality of Life for Patients Undergoing Radical Cystectomy: Results of a Large Prospective Cohort

BackgroundRadical cystectomy (RC) has the potential for profound changes to health-related quality of life (HRQOL). ObjectiveTo evaluate a broad range of HRQOL outcomes in a large RC cohort. Design, setting, and participantsA single-center prospective study enrolled RC patients from 2008 to 2014. We collected 14 separate patient-reported outcome measures at the presurgical visit and at 3, 6, 12, 18, and 24 mo after RC. Outcome measurements and statistical analysisTo visualize the patterns of recovery over time across domains, we used generalized estimating equations (GEEs) with nonlinear terms. Given substantial differences in patient selection for the type of urinary diversion, we separately modeled longitudinal HRQOL within conduit and continent diversion groups. The mean pre-RC scores were compared to illustrate the baseline HRQOL differences between diversion groups. Results and limitationsThe analyzed cohort included 411 patients (n = 205 ileal conduit, n = 206 continent diversion). At baseline, patients receiving continent diversion reported better mean physical (p < 0.001), urinary (p = 0.006), and sexual function (p < 0.001), but lower social function (p = 0.015). After RC, GEE modeling showed physical function scores decreasing 5/100 points by 6 mo, and subsequently stabilizing or returning to baseline. By 12 mo, social function improved by 10/100 points among continent diversions, while remaining stable among ileal conduits. Global quality of life exceeded baseline scores by 6 mo. Sexual function scores were low before RC, with limited recovery. Psychosocial domains were stable or improved, except for 10/100-point worsening of body image among ileal conduits. ConclusionsRC patients reported favorable HRQOL recovery within 24 mo in most areas other than body image (ileal conduits) and sexual function (both). Importantly, large measurable decreases in scores were not reported by 3 mo after RC. These contemporary outcomes and the excellent locoregional control provided by RC further support it as the gold standard therapy for high-risk bladder cancer. Patient summaryWe review quality of life in the 24 mo following radical cystectomy. Large decreases in health-related quality of life were not reported, with most areas returning to, or exceeding, baseline, except for sexual function and body image.

PL03.4.A Factors associated with health-related quality of life (HRQoL) deterioration in glioma patients during the progression-free survival period

Abstract BACKGROUND Maintenance of functioning and wellbeing during the progression-free survival (PFS) period is important for glioma patients. This study aimed to determine whether health-related quality of life (HRQoL) can be maintained during progression-free time, and factors associated with HRQoL deterioration in this period. MATERIAL AND METHODS We included longitudinal HRQoL data from previously published clinical trials in glioma. The percentage of patients with stable HRQoL until progression was determined per scale and at the individual patient level (i.e. considering all scales simultaneously). We assessed time to a clinically relevant deterioration in HRQoL, expressed in deterioration-free survival and time-to-deterioration (the first including progression as an event). We also determined the association between sociodemographic and clinical factors and HRQoL deterioration in the progression-free period. RESULTS 5539 patients with at least baseline HRQoL scores had a median time from randomization to progression of 7.6 months. Between 9%-29% of the patients deteriorated before disease progression on the evaluated HRQoL scales. When considering all scales simultaneously, 47% of patients deteriorated on ≥1 scale. Median deterioration-free survival period ranged between 3.8–5.4 months, and median time-to-deterioration between 8.2–11.9 months. For most scales, only poor performance status was independently associated with clinically relevant HRQoL deterioration in the progression-free period. CONCLUSION HRQoL was maintained in only 53% of patients in their progression-free period, and treatment was not independently associated with this deterioration in HRQoL. Routine monitoring of the patients’ functioning and well-being during the entire disease course is therefore important, so that interventions can be initiated when problems are signalled.

Clinical use of expanded prostate cancer index composite-based health-related quality of life outcomes after robot-assisted radical prostatectomy for localized prostate cancer.

BackgroundThis study aimed to assess the longitudinal health-related quality of life (HRQOL) using the Expanded Prostate Cancer Index Composite (EPIC) and HRQOL change between the nerve-sparing technique in Japanese men treated with robot-assisted radical prostatectomy (RARP).MethodsA total of 573 patients who received RARP were included in this study. EPIC questionnaire was administered before treatment and up to 36 months after RARP. Clinical recovery was defined as half of the standard deviation of the baseline score for each domain. We divided all patients into recovery group or nonrecovery group. The time from survey to each domain recovery was calculated using the Kaplan–Meier method. We compared the sexual and urinary score change between groups using analysis of variance to confirm the effect of nerve-sparing technique.ResultsThe median age was 67 years (interquartile range, 62–71 years). The mean score of all urinary domains worsened noticeably after 1 month. All postoperative urinary summary, function, and incontinence scores were significantly lower than preoperative scores up to 3 years post-RARP. Postoperative sexual summary and functional scores were significantly lower than preoperative score at all follow-up times throughout the 36 months. The recovery rate for the urinary incontinence domain was the lowest (44.5%), whereas the recovery rate for the urinary irritative–obstructive domain was the highest (73.7%). In the sexual domain, the bother domain had a higher recovery rate (73.0%) than the functional domain (29.7%). Although the recovery of sexual domains was slower compared with other domains, by 36 months after RARP, almost all values had recovered. Compared with other technique groups, bilateral intrafascial nerve-sparing group showed significantly decreased change in subscale scores before and after RARP in several sexual and urinary domain.ConclusionThe time course and extent of functional and bother domain recovery documented in this study may prove useful for RARP patient selection in Japan.

Health-related quality of life in locally advanced hepatocellular carcinoma treated by either radioembolisation or sorafenib (SARAH trial)

BackgroundThe aim of this ancillary study of the SARAH trial is to compare health-related quality of life (HRQoL) in patients with locally advanced or inoperable hepatocellular carcinoma (HCC) treated with transarterial radioembolisation (TARE) or sorafenib. MethodsThis study included randomised patients who received either TARE or at least one dose of sorafenib with no major deviation in the protocol and who had at least one QoL follow-up assessment in addition to the baseline evaluation. QoL was assessed from the date of randomisation using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire, until disease progression or other reasons for stopping study participation. Data were analysed using linear mixed and time-dependent models. ResultsA total of 285 patients were included (122 and 163, in the TARE and sorafenib groups, respectively). Questionnaire completion rates were similar (77.5% versus 80.4%, in the TARE and sorafenib groups, respectively, p = 0.25). Longitudinal HRQoL analysis showed a significant treatment and time effects for fatigue and global health status, and significant treatment, time and treatment by time interaction effects for appetite loss, diarrhoea and social functioning. The median time to deterioration for the global health status was 3.9 months (95% confidence interval [CI] 3.7–4.3) versus 2.6 months (95% CI 2.0–3.0) in the TARE and sorafenib groups, respectively. ConclusionsHRQoL was preserved longer with TARE than with sorafenib in locally advanced HCC. These data could be used to optimise management of patients with advanced or inoperable HCC.

Investigation of measurement invariance in longitudinal health-related quality of life in preemptive or previously dialyzed kidney transplant recipients.

Kidney transplantation (KT) can impact patients' evaluation of health-related quality of life (HRQoL) as they adapt to their new life with a graft and its changes. Patients may adapt to KT in a different way, depending on whether they were on dialysis prior to transplantation or not (i.e. preemptive group). This may result in lack of measurement invariance between these patients' groups and/or over time (i.e. response shift, RS) which may invalidate the between-group comparison of HRQoL change scores. The aim of this study was to investigate and compare RS before and after KT between these two patients' groups. Measurement invariance was investigated between groups and over time with three measurement occasions. Adult patients completed the SF-36 at the last visit before KT, and 3, 6months after. A structural equation model-based procedure was used to (i) detect and take into account measurement non-invariance between groups and RS, if appropriate, (ii) identify the period of occurrence of RS, (iii) study the heterogeneity of RS between the two groups. Before KT (i.e. baseline), measurement invariance was not rejected between dialyzed (n = 196) and preemptive (n = 178) patients' groups. Between baseline and 3 months after KT, similar uniform recalibration was detected on the general health domain in both groups. Uniform recalibration was found between 3- and 6 months after KT on the vitality domain for preemptive patients only. HRQoL, adjusted for RS, increased overall for preemptive and dialyzed kidney transplant patients after transplantation. RS may reflect differing adaptation processes following KT.

Longitudinal changes in physical and mental health of older adults with chronic hepatitis B infection: Trajectories and predictors.

Despite the increasing health burden of chronic hepatitis B (CHB) in aging populations, little is known about the course of health-related quality of life (HRQoL) changes. We aimed to assess individual-level longitudinal HRQoL changes in elderly patients with CHB and to examine their correlates. A prospective 5.1years-cohort study was conducted in community-dwelling adults aged 55years with hepatitis B surface antigen-positive. Participants underwent serial measurement of HRQoL using the short-form (12) health survey version 2. Of 503 participants, 82.7% remained in good physical health throughout the study period, whereas 9.1% had declining physical health and 8.2% were in poor physical health. We likewise identified three trajectories of mental health changes ("good mental health" [86.9%], "declining mental health" [6.8%], and "poor mental health" [6.4%]). Three baseline characteristics were independently associated with a lower likelihood of remaining physically or mentally healthy: sarcopenic obesity (odds ratio [OR] with 95% confidence interval [95% CI] of 7.5 [2.8-20.5] for poor physical health, 3.1 [1.1-8.4] for declining physical health, 4.3 [1.4-13.0] for poor mental health), a higher number of metabolic abnormalities (OR [95% CI] of 3.6 [1.6-8.0] for poor physical health) and depressed mood (OR [95% CI] of 21.7 [5.8-81.0] for poor physical health, 5.3 [1.4-19.9] for declining physical health, 83.1 [19.7-350.2] for poor mental health, 13.6 [2.9-64.8] for declining mental health). In conclusion, in a cohort of elderly patients with CHB, we demonstrated the heterogeneity and nonlinearity of HRQoL changes and their associations with variations in specific extrahepatic organs/systems.

Trajectories of Health Changes in Older Adults with Chronic Hepatitis B Infection

Despite the increasing burden of chronic hepatitis B (CHB) in aging populations, little is known about the course of health-related quality of life (HRQoL) changes during older adulthood in CHB patients. We aimed to assess individual-level longitudinal HRQoL changes in older patients with CHB and to examine their correlates. A 5-year prospective cohort study was conducted in 503 hepatitis B surface antigen-positive community-dwelling adults aged 55 years or older. Participants underwent comprehensive assessments at baseline and serial measurement of HRQoL using the short-form (12) health survey version 2. Of these participants, 82.7% remained in good physical health throughout the study period, whereas 9.1% had declining physical health and 8.2% were in poor physical health. We likewise identified three trajectories of mental health changes (“good mental health” [86.9%], “declining mental health” [6.8%], and “poor mental health” [6.4%]). Three baseline characteristics were independently associated with a lower likelihood of remaining physically or mentally healthy during older adulthood: sarcopenic obesity (odds ratio [OR] with 95% confidence interval [95% CI] of 7.5[2.8-20.5] for poor physical health, 3.1 [1.1-8.4] for declining physical health, 4.3 [1.4-13.0] for poor mental health), higher number of metabolic abnormalities (OR [95% CI] of 3.6 [1.6-8.0] for poor physical health) and depressed mood (OR [95% CI] of 21.7 [5.8-81.0] for poor physical health, 5.3 [1.4-19.9] for declining physical health, 83.1 [19.7-350.2] for poor mental health, 13.6 [2.9-64.8] for declining mental health). In conclusion, we demonstrated the heterogeneity and nonlinearity of HRQoL changes and their associations with variations in specific extrahepatic organs/systems.

Health-related quality of life following total minimally invasive, hybrid minimally invasive or open oesophagectomy: a population-based cohort study.

Minimally invasive oesophagectomy has been shown to reduce the risk of pulmonary complications compared with open oesophagectomy, but the effects on health-related quality of life (HRQoL) and oesophageal cancer survivorship remain unclear. The aim of this study was to assess the longitudinal effects of minimally invasive compared with open oesophagectomy for cancer on HRQoL. All patients who had surgery for oesophageal cancer in Sweden from January 2013 to April 2018 were identified. The exposure was total or hybrid minimally invasive oesophagectomy, compared with open surgery. The study outcome was HRQoL, evaluated by means of the European Organisation for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-OG25 at 1 and 2 years after surgery. Mean differences and 95 per cent confidence intervals were adjusted for confounders. Of the 246 patients recruited, 153 underwent minimally invasive oesophagectomy, of which 75 were hybrid minimally invasive and 78 were total minimally invasive procedures. After adjustment for age, sex, Charlson Co-morbidity Index score, pathological tumour stage and neoadjuvant therapy, there were no clinically and statistically significant differences in overall or disease-specific HRQoL after oesophagectomy between hybrid minimally invasive and total minimally invasive surgical technique versus open surgery. In this population-based nationwide Swedish study, longitudinal HRQoL after minimally invasive oesophagectomy was similar to that of the open surgical approach.

Health-related quality of life trajectory of treatment-naive patients with Merkel cell carcinoma receiving avelumab

AimTo evaluate changes in health-related quality of life (HRQoL) in a Phase II trial (NCT02155647) of treatment-naive patients with metastatic Merkel cell carcinoma treated with avelumab (15-month follow-up).Materials & methodsMixed-effect Models for Repeated Measures were applied to HRQoL data (FACT-M; EQ-5D-5L) to assess changes over time. Clinically derived progression-free survival was compared with HRQoL deterioration-free survival.ResultsOverall, we saw relative stability in HRQoL among 116 included patients, with nonprogression associated with statistically and clinically meaningful better HRQoL compared with progressive disease. Deterioration-free survival rates (49–72% at 6 months, 40–58% at 12 months) were consistently higher/better compared with progression-free survival rates (41/31% at 6/12 months).ConclusionThese findings show unique longitudinal HRQoL data for treatment-naive metastatic Merkel cell carcinoma patients treated with avelumab.Clinical trial registration: NCT02155647 (ClinicalTrials.gov).