Changes In Health-related Quality Of Life Scores Research Articles

Quality of life measurement in assessing treatment effectiveness in urticaria: European experts position statement.

In this study, the European Academy of Dermatology and Venereology (EADV) Task Forces on Quality of Life and Patient-Oriented Outcomes and Urticaria and Angioedema has examined the Health-Related Quality of Life (HRQoL) measurement in the treatment of urticaria. The Dermatology Life Quality Index was the most frequently used HRQoL instrument in clinical trials on urticaria. Many reports of clinical trials of urticaria gave no exact numeric results related to HRQoL changes, making clear conclusions and comparisons with other studies impossible. The interpretation of HRQoL impairment data is more difficult when assessed by instruments without severity stratification systems. The minimal clinically significant difference (MCID) is a more clinically oriented and relevant parameter than depending on statistically significant changes in HRQoL scores. Therefore, using HRQoL instruments with established MCID data in clinical trials and clinical practice is preferred.

Health-related quality of life does not deteriorate while waiting for anterior cruciate reconstruction.

The aim of this study was to determine how preoperative health-related quality of life (HRQoL) is affected by the duration of the wait time (WT) for anterior cruciate ligament reconstruction (ACLR) once a decision is made to proceed with surgery. This was a multi-centre prospective cohort study. One hundred and twenty-two patients 14 years of age and above waiting for ACLR completed the International Knee Documentation Committee (IKDC) demographic, current health assessmentand subjective knee evaluation (SKF) forms on the day of decision to operate and the day of surgery. Changes in scores were analyzed for the entire cohort, adjusted for WTsand a subset was compared for patients with isolated anterior cruciate ligament (ACL) tears and ACL tears with concurrent meniscal involvement. Changes in HRQoL scores from the day of the decision to operate to the 9-month postoperative appointments were also assessed. Energy/Fatigue (p < 0.05), Pain (p < 0.05), General Health (p < 0.05)and the IKDC-SKF Score (p < 0.05) significantly increased between the day of the decision to operate and the day of surgery. Only the change in IKDC-SKF score remained significantly higher after adjusting for WT. Baseline HRQoL scores significantly improved by the 9-month postoperative appointment. The length of time waiting for ACLR did not adversely influence HRQoL in this study. However, low preoperative HRQoL and the significant improvement in HRQoL of patients followed postoperatively suggest that timely surgery is beneficial for this patient population. Level II.

Longitudinal health outcomes in caregivers of military members with traumatic brain injury.

To examine longitudinal change in health-related quality of life (HRQOL) in caregivers of service members/veterans with traumatic brain injury and factors associated with clinically elevated symptoms. Caregivers (N = 220) completed nine HRQOL outcome measures and 10 risk factor measures at a baseline evaluation and follow-up evaluation 3 years later. Caregiver's responses on the nine HRQOL outcome measures were classified into four clinical change categories based on the presence/absence of clinically elevated T-scores (≥ 60 T) at baseline and follow-up: (a) Persistent (baseline ≥ 60T + follow-up ≥ 60 T), (b) Developed (baseline < 60 T + follow-up ≥ 60 T), (c) Improved (baseline ≥ 60 T + follow-up < 60 T), and (d) Asymptomatic (baseline < 60 T + follow-up < 60 T). A clinical change composite score was calculated by summing the number of Persistent or Developed HRQOL outcome measures and used to create three clinical change groups: (a) No Symptoms (n = 69, zero measures), (b) Some Symptoms (n = 88, one to three measures), and (c) Numerous Symptoms (n = 63, four to nine measures). Of the nine HRQOL outcome measures, Bodily Pain, Perceived Stress, Sleep-Related Impairment, and Fatigue were most frequently classified as Persistent or Developed from baseline to follow-up in the entire sample. A linear relationship was found between the vast majority of risk factors across the three clinical change groups at baseline and follow-up (Numerous > Some > None). The risk factors were correlated with the number of elevated HRQOL symptoms at baseline and follow-up. Most Asymptomatic or Persistent caregivers did not have meaningful change (≥ 1 SD) in HRQOL scores. A sizable proportion of Developed or Improved caregivers had either meaningful or no change in HRQOL scores. There is a need for ongoing clinical services for military caregivers. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Evaluation of health-related quality of life in patients receiving outpatient parenteral antimicrobial therapy (OPAT) in a UK setting

ABSTRACT Background Studies assessing the benefits of outpatient parenteral antimicrobial therapy (OPAT) have paid less attention to patient-centered factors such as patients’ experiences and their health-related quality of life (HRQoL). Research design and methods Prospective before-and-after quasi-experimental study enrolled adult patients receiving OPAT at a tertiary hospital in Derbyshire, UK, between October 2022 and October 2023. Consenting patients completed paired EQ-5D-3 L questionnaires before OPAT initiation and upon completion of therapy or 30 days after its commencement (whichever occurred first). Changes and predictors of change in HRQoL indicators and associations with clinical outcomes (treatment failure, adverse events, and 30-day unplanned readmission) were examined. Results Health state index and visual analogue scale (EQ VAS) scores of 162 enrolled patients at baseline were significantly lower than the UK population averages, but the patients experienced significant improvements in both scores and in four EQ-5D dimensions (mobility, self-care, usual activities, and pain/discomfort). Baseline health index and EQ VAS scores were significant independent predictors of positive changes in HRQoL scores. Conclusions OPAT is associated with improved patient-reported quality of life and facilitates early return to work or school. Nevertheless, it is crucial to closely monitor patients with a lower baseline quality of life to optimize their overall OPAT experience.

Differential associations of sex and age with changes in HRQoL during outpatient cardiac rehabilitation.

Cardiovascular diseases (CVD) represent the world's leading cause of death. Health-related quality of life (HRQoL) is a widely applied concept of patients' perceived health and is directly linked to CVD morbidity, mortality, and re-hospitalization rates. Cardiac rehabilitation (CR) improves both cardiovascular outcomes and HRQoL. Regrettably, CR is still underutilized, especially in subgroups like women and elderly patients. The aim of our study was to investigate the predictive potential of sex and age on change of HRQoL throughout outpatient CR. 497 patients of outpatient CR were retrospectively assessed from August 2015 to September 2019 at the University Hospital Zurich. A final sample of 153 individuals with full HRQoL data both at CR entry and discharge was analyzed. HRQoL was measured using the 36-Item Short Form Survey (SF-36) with its physical (PCS) and mental (MCS) component scale. In two-factorial analyses of variance, we analyzed sex- and age-specific changes in HRQoL scores throughout CR, adjusting for psychosocial and clinical characteristics. Age was grouped into participants over and under the age of 65. In both sexes, mean scores of physical HRQoL improved significantly during CR (p <.001), while mean scores of mental HRQoL improved significantly in men only (p =.003). Women under the age of 65 had significantly greater physical HRQoL improvements throughout CR, compared with men under 65 (p =.043) and women over 65 years of age (p =.014). Sex and age did not predict changes in mental HRQoL throughout CR. Younger women in particular benefit from CR with regard to their physical HRQoL. Among older participants, women report equal improvements of physical HRQoL than men. Our results indicate that sex- and age-related aspects of HRQoL outcomes should be considered in CR.

Final Analysis of a Phase III Controlled Randomized Study of Stereotactic Body Proton Therapy or Conventionally Fractionated Proton Therapy for Early Prostate Cancer: PCG GU002

To determine if stereotactic body proton therapy (SBPT) is non-inferior to conventionally fractionated proton therapy (CFPT) in patients with early prostate cancer. Multicenter, randomized, controlled, open-label, non-inferiority phase 3 trial that included patients with histologically confirmed low-risk prostate adenocarcinoma defined by Gleason score ≤6, PSA <10 ng/mL, and clinical stage T1-2a N0 M0 by AJCC 7th Ed. Eligible participants were randomly assigned (initially 1:1 and later 2:1 ratio) to CFPT (79.2 Gy in 44 fractions for 9 weeks) or SBPT (38 Gy in 5 fractions for 1 week). Concurrent or adjuvant androgen deprivation therapy was not allowed. The primary endpoint was freedom from failure (FFF) at 2 years, defined as the first occurrence of local, regional, or distant recurrence, biochemical failure by the Phoenix definition (increase of PSA ≥2 ng/mL over the nadir PSA), or the start of salvage therapy including ADT. Secondary endpoints included GI and GU grade ≥2 toxicity according to CTCAE v4 criteria, as well as health-related quality of life (HRQoL) metrics assessed by AUASI and EPIC scores. Non-inferiority would be declared if the 1-sided 95% confidence interval limit for the difference in 2-year FFF rate was below 4.2% between both groups by Clopper-Pearson exact method. Between November 2010 and September 2020, 133 patients were enrolled and randomly assigned to CFPT (n = 45) or SBPT (n = 88). Median follow-up was 5 years (IQ 3.9-5.2), with the last patient enrolled followed for at least 2 years. The 2-year FFF was 100% for both groups, fulfilling the pre-specified criteria for non-inferiority of SBPT compared to CFPT. By KM estimates, 5-year FFF was 97.4% and 100% (P = 0.1), and the 5-year OS was 97.1% and 95.5% (P = 0.46) for patients treated with CFPT and SBPT, respectively. The cumulative incidence of any grade ≥3 toxicities at 5 years was 0% and 5.7% (P = 0.14) for patients treated with CFPT and SBPT, respectively. The frequency of GI grade ≥2 toxicity at 6 months was of 0% and 2.3% (P = 0.55), and at 2 years was of 6.7% and 3.4% (P = 0.69) for patients treated with CFPT and SBPT, respectively. The frequency of GU grade ≥2 toxicity at 6 months was of 2.2% and 5.7% (P = 0.42), and at 2 years was of 8.9% and 5.7% (P = 0.54) for patients treated with CFPT and SBPT, respectively. Changes in HRQoL scores at 2 years were similar between groups (Table). SBPT is non-inferior to CFPT regarding FFF and associated with similar long-term toxicity rates and HRQoL metric scores.

Health-related quality of life among adults newly diagnosed with pulmonary tuberculosis in Lagos State, Nigeria: a prospective study.

Tuberculosis (TB) has far-reaching effects on the social, mental, and emotional well-being of patients and consequently, their health-related quality of life (HRQOL). Few studies in Nigeria have examined changes in quality of life over the course of treatment. changes in (PTB) and factors associated with HRQOL. A prospective cohort study was conducted with patients recruited from health facilities in Lagos State. The World Health Organization Quality of Life Instrument, Short-Form (WHOQOL-BREF) was used to assess HRQOL. A semi-structured questionnaire was also administered to elicit information on socio-demographic characteristics and the medical and social history of the respondents. Data were analysed using Statistical Package for the Social Sciences (SPSS) version 23. A repeated measures analysis of variance (ANOVA) test with polynomial contrasts was used to assess how domain scores varied over time. Multivariable analysis was conducted using generalized estimating equations (GEE) to assess change in HRQOL and its predictors. Two hundred and ten patients, predominantly male [108 (63.3%)] were recruited. The mean age was 36.7 ± 12.3years. The HRQOL was impaired in all four domains at baseline. However, HRQOL scores increased over the treatment period with the largest improvement being in the 'environment' domain, where mean scores increased from 45.27 ± 14.59 to 61.28 ± 15.86. The proportion of respondents that expressed satisfaction with their health increased from 13.5% at baseline to 55.7% at the end of treatment. Low socio-economic status, delay in presentation, and an HIV-positive status were found to be significantly associated with reduced HRQOL at baseline (p < 0.05). In the multivariable longitudinal analysis, patients who were employed had higher HRQOL scores while persistent symptoms and a delay in presentation (≥ 4weeks) were negatively associated with change in HRQOL scores over the course of treatment. The HRQOL of respondents progressively improved over the six-month treatment period. However, change in HRQOL was influenced by a delay in presentation and persistence of symptoms. The study also highlights the need for increased recognition of patient-reported outcomes as an adjunct outcome measure.

A Matching-adjusted Indirect Comparison of Nivolumab Plus Cabozantinib Versus Pembrolizumab Plus Axitinib in Patients with Advanced Renal Cell Carcinoma

BackgroundThe comparative efficacy and health-related quality of life (HRQoL) outcomes of nivolumab plus cabozantinib versus pembrolizumab plus axitinib as first-line treatments for advanced renal cell carcinoma (aRCC) have not been assessed in head-to-head trials. ObjectiveTo assess the efficacy and HRQoL outcomes of nivolumab plus cabozantinib versus pembrolizumab plus axitinib. Design, setting, and participantsPatient-level data for nivolumab plus cabozantinib from the CheckMate 9ER trial and published data for pembrolizumab plus axitinib from the KEYNOTE-426 trial were used. CheckMate 9ER data were reweighted to match the key baseline characteristics as reported in KEYNOTE-426. InterventionNivolumab (240 mg every 2 wk) plus cabozantinib (40 mg once daily) and pembrolizumab (200 mg every 3 wk) plus axitinib (5 mg twice daily, initially). Outcome measurements and statistical analysisHazard ratios (HRs) for progression-free survival (PFS), duration of response, overall survival (OS), and deterioration in HRQoL were assessed using weighted Cox proportional-hazard models, with sunitinib as a common anchor. Objective response rates (ORRs) and changes in HRQoL scores from baseline were assessed as difference-in-differences for the two treatments relative to sunitinib. Results and limitationsAfter balancing patient characteristics between the trials, nivolumab plus cabozantinib was associated with significantly improved PFS (HR [95% confidence interval {CI}] 0.70 [0.53–0.93]; p = 0.01) and a significantly decreased risk of confirmed deterioration in HRQoL (Functional Assessment of Cancer Therapy—Kidney Symptom Index—Disease-related Symptoms: HR [95% CI] 0.48 [0.34–0.69]) versus pembrolizumab plus axitinib. OS was similar between treatments (HR [95% CI] 0.99 [0.67–1.44]; p = 0.94). Nivolumab plus cabozantinib was associated with numerically greater ORRs (difference-in-difference [95% CI] 8.4% [–1.7 to 18.4]; p = 0.10) and longer duration of response (HR [95% CI] 0.79 [0.47–1.31]; p = 0.36) than pembrolizumab plus axitinib. Comparative studies using data with a longer duration of follow-up are warranted. ConclusionsNivolumab plus cabozantinib significantly improved PFS and HRQoL compared with pembrolizumab plus axitinib as first-line treatment for aRCC. Patient summaryThis study was conducted to indirectly compare the results of two immunotherapy-based combinations—nivolumab plus cabozantinib versus pembrolizumab plus axitinib—for patients who have not received any treatment for advanced renal cell carcinoma. Patients who received nivolumab plus cabozantinib had a significant improvement in the length of time without worsening of their disease and in their perceived physical and mental health compared with pembrolizumab plus axitinib; patients remained alive for a similar length of time from the start of either treatment. This analysis further adds to our current knowledge of the relative benefits of these two treatment regimens and will help with physician and patient treatment decisions.

Quality of life after treatment with immune checkpoint inhibitors for lung cancer; the impact of age

IntroductionImmune checkpoint inhibitors (ICIs) have revolutionized lung cancer treatment. However, it remains unclear as to whether changes in Health-Related Quality-of-Life (HRQoL) are associated with the age of lung cancer patients treated using ICIs. This study aimed to evaluate this possible association and to compare ICI-treated patients’ HRQoL scores with normative data of an age-matched non-cancer general population. MethodsLung cancer patients from the OncoLifeS data-biobank were included if they were treated with ICIs, irrespective of other treatments, at the University Medical Center Groningen between 2015 and 2021 and had completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30), both at the start of ICI treatment and after six months. Association of age as a continuous variable (per 10 years) and changes in HRQoL scores between baseline and 6 months was assessed using multivariable regression analyses. Clinical relevance of differences in HRQoL scores between OncoLifeS and the general population was classified into trivial, small, medium, and large, for three age groups (<60, 60–69 and ≥ 70 years). Results151 patients were included with a mean age of 65.8 years. An increase in age per 10 years was associated with a larger decrease in the summary HRQoL score(β = -3.28,CI95%-6.42;-0.14), physical(β = -4.8, CI95% −8.71;-0.88), cognitive(β = −4.51,CI95%-8.24;−0.78), role functioning(β = −5.41,CI95%-10.78;−0.05), symptom burden(β = −3.66,CI95%-6.6;-0.73), and smaller negative changes in financial difficulties(β = 6.5 95 % CI 3.16; 9.85). OncoLifeS HRQoL scores were lower than those of the general population and differences were most often classified as large and medium. ConclusionOlder lung cancer patients experience larger deteriorations in most HRQoL domains after 6 months of ICI treatment. Also, these patients showed significantly lower HRQoL scores compared to the general population.

Health-Related Quality of Life Following Allogeneic Hematopoietic Cell Transplantation with Omidubicel versus Umbilical Cord Blood

Omidubicel is an advanced cell therapy derived from umbilical cord blood (UCB) for use in allogeneic hematopoietic cell transplantation (HCT). A recent randomized phase 3 clinical trial demonstrated faster engraftment, shorter length of hospital stays, and lower rates of infection with omidubicel compared with standard UCB transplantation in patients with high-risk hematologic malignancies. Despite the proven clinical benefits of omidubicel, its impact on health-related quality of life (HRQL) from the patient's perspective has not been described. This study analyzed patient-reported HRQL measures collected prospectively in the randomized phase 3 trial comparing omidubicel to standard UCB transplantation. A total of 108 patients at 33 international stem cell transplantation centers underwent myeloablative allogeneic HCT with either omidubicel or standard UCB. Patients completed serial HRQL questionnaires at screening and on days 42, 100, 180, and 365 post-transplantation. The HRQL surveys included the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT), a 50-item cancer-specific questionnaire assessing physical, functional, emotional, social/family, and HCT-specific well-being, and the EuroQol 5-Dimension 3-Level, a 5-item generic HRQL survey. A mixed model with repeated measures was used to compare changes in HRQL from baseline in the 2 treatment arms. The average change in HRQL scores over time was compared by estimating the difference in the area under the curve (AUC) in each treatment group. Seventy-five patients (omidubicel arm, n=37; standard UCB arm, n=38) who completed the FACT-BMT at baseline and on 1 or more follow-up visits were included in this study. Baseline characteristics were similar in the 2 treatment arms. Over the first year post-transplantation, the AUCs of mean changes in physical, functional, and total FACT-BMT scores indicated significantly better HRQL with omidubicel (P < .05), with mean differences across time points ranging from 1.4 to 3.1 points, 1.6 to 3.2 points, and 7.2 to 11.0 points, respectively. The minimal clinically important difference was exceeded at 1 or more time points for each of these measures. The HRQL improvements with omidubicel were observed as early as 42 days post-transplantation and persisted at 1 year, indicating the potential long-term benefits of omidubicel on HRQL. Across all patients, adverse clinical outcomes, such as grade 3 viral infections and lower rates of neutrophil engraftment, were associated with worse HRQL scores. The observed improvements in HRQL measures may reflect the known clinical benefits of omidubicel. Compared with standard UCB, allogeneic HCT with omidubicel resulted in significant and clinically meaningful improvements in patient-reported HRQL measures.

Trajectory of health-related quality of life during the last year of life in patients with advanced non-small–cell lung cancer

BackgroundThe aims of this study were to assess the trajectory of health-related quality of life (HRQOL) during the last year of life in patients with advanced non-small–cell lung cancer (NSCLC) and to explore when and to what degree deterioration of symptoms and physical functioning accelerate towards the end of life.MethodsData from two RCTs of first-line chemotherapy in advanced NSCLC was analyzed. HRQOL was assessed repeatedly using the EORTC QLQ-C30 and LC13. Changes in HRQOL scores were investigated relative to the time of death.ResultsThe study sample included 730 patients, with a median of four HRQOL assessments per patient (range 1–9). Fatigue, dyspnea, appetite loss, and cough were the most pronounced symptoms in all phases of the disease trajectory. The deterioration rates of global quality of life, physical function, and key symptoms were relatively slow until 4 months before death. Then, the decline accelerated, and for physical function, fatigue, and dyspnea, there was a very rapid decline in the last 2 months.ConclusionsPatients with advanced NSCLC experience a high symptom burden that worsens over time, especially in the last 4 months. Regular symptom monitoring may help identify where patients are in the disease trajectory, serve as a trigger for changes in anticancer and symptomatic treatment, and facilitate discussions about end-of-life care.

Changes in health-related quality of life in adolescents and the impact of gender and selected variables: a two-year longitudinal study

BackgroundIncreased knowledge about factors that can impact changes in adolescents’ health-related quality of life (HRQOL) is needed. The present study aimed to investigate possible HRQOL changes in adolescents at 14 and 16 years, and assess the impact of sociodemographic factors, gender, pain, self-esteem, self-efficacy, loneliness, and stress on HRQOL changes over time. Further, to assess HRQOL stratified by gender.MethodsA longitudinal study involving 211 adolescents was conducted. Sociodemographic variables, pain, self-esteem, self-efficacy, loneliness, and stress were all assessed with well-validated instruments. KIDSCREEN-27 was used to measure HRQOL. Data were analyzed using independent t-tests, paired samples t-tests, and linear mixed models for repeated measures.ResultsWhen all variables were added to the linear mixed models, stress, loneliness, and pain were significantly, independently associated with a reduction in HRQOL change scores for four of the five KIDSCREEN subscales. Time was significantly associated with a reduction in physical and psychological well-being. Self-efficacy and self-esteem were significantly associated with an increase in HRQOL change scores for four and two subscales, respectively. Male gender was significantly negatively associated with changes in social support and peers compared to female gender.ConclusionOur results demonstrated a significant decline in adolescents’ HRQOL regarding physical and psychological well-being for the age range 14–16 years. Furthermore, we found that stress, loneliness, and pain have a significant negative impact on HRQOL changes, whereas self-esteem and self-efficacy have a significant positive impact. Our results highlight the importance of increased understanding regarding factors associated with changes in adolescents’ HRQOL to enable accurate and strategic interventions.

Association of changes in histologic severity of nonalcoholic steatohepatitis and changes in patient-reported quality of life.

Nonalcoholic steatohepatitis (NASH) is a prevalent chronic disease that is associated with a spectrum of liver fibrosis and can lead to cirrhosis. Patients with NASH report lower health‐related quality of life (HRQoL) than the general population. It remains uncertain how changes in histologic severity are associated with changes in HRQoL. This is a secondary analysis of the Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment (FLINT) and Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis (PIVENS) randomized controlled trials in patients with biopsy‐proven NASH. HRQoL was assessed using short form‐36 at baseline and at follow‐up biopsy (at 72 and 96 weeks, respectively). Adjusted linear regression models were used to examine the association between changes in liver fibrosis (primary analysis), nonalcoholic fatty liver disease (NAFLD) activity score (secondary analysis), and changes in HRQoL scores. Compared with stable fibrosis, improvement of fibrosis by at least one stage was significantly associated with improvements only in the physical function component by 1.8 points (95% confidence interval, 0.1, 3.5). Worsening of fibrosis by at least one stage was not associated with statistically significant changes in any HRQoL domain compared with stable fibrosis. Associations between HRQoL and NAFLD disease activity score in the secondary analysis were of similar magnitude. Weight loss was associated with small improvements in physical function, general health, and energy levels. Conclusion: Improvements in fibrosis stage were associated with improvements in the physical component of HRQoL, but the clinical impact was modest. As improving fibrosis may not meaningfully improve well‐being, treatment for NASH will be cost effective only if it prevents long‐term hepatic and cardiovascular disease.

Recurrent Clostridioides difficile infection worsens anxiety-related patient-reported quality of life

BackgroundClostridioides difficile infection (CDI) is associated with high recurrence rates impacting health-related quality of life (HrQOL). However, patient-reported data are lacking particularly in the outpatient setting. We assessed changes in HrQOL over time in patients treated with bezlotoxumab at US infusion centers and determined clinical factors associated with HrQOL changes.MethodsThe HrQOL survey was conducted in adult patients with CDI, who received bezlotoxumab in 25 US outpatient infusion centers. The survey was adapted from the Cdiff32 instrument to assess anxiety-related changes to HrQOL and completed on the day of infusion (baseline) and at 90 days post bezlotoxumab (follow-up). Demographics, disease history, CDI risk factors, and recurrence of CDI (rCDI) at 90-day follow-up were collected. Changes in HrQOL scores were calculated and outcomes assessed using a multivariable linear regression model with P < 0.05 defined as statistically significant.ResultsA total of 144 patients (mean age: 68 ± 15 years, 63% female, median Charlson index: 4, 15.9% rCDI) were included. The overall mean baseline and follow-up HrQOL scores were 26.4 ± 11.5 and 56.4 ± 25.0, respectively. At follow-up, this score was significantly higher for patients who had primary CDI (34.5 ± 21.7) compared to those with multiple rCDI (24.7 ± 21.0; P = 0.039). The mean HrQOL change at follow-up was significantly higher for patients without rCDI (34.1 ± 28.8 increase) compared to patients with rCDI (6.7 ± 19.5 increase; P < 0.001), indicating improvement in anxiety.ConclusionsUsing the Cdiff32 instrument, we demonstrated that HrQOL worsened significantly in patients with further rCDI. These findings support the use of Cdiff32 in assessing CDI-related humanistic outcomes.

Assessment of health-related quality of life in cancer patients undergoing treatment using Health Utilities Index (HUI-3®) in East Delhi, India.

Health-related quality of life (HRQOL) is a construct that focuses on the capacity for living afforded by the health status of a patient. Measurement of HRQOL allows a composite estimation of the capacity for living of a patient and can help capture the suffering experienced by the patient due to adverse effects of therapeutic interventions. This study was conducted to understand the health-related quality of life of cancer patients undergoing various modalities of treatment to generate evidence source for need-based intervention, to assess patients diagnosed with cancers, using Health Utilities Index - 3 (HUI-3®) and assign them single-score values to gauge HRQOL and to measure the various domains of HRQOL and change in HRQOL after a period of three months of treatment. A descriptive, longitudinal study was conducted amongst patients aged more than 18 years, who were diagnosed with cancer at a tertiary care multispecialty hospital in New Delhi. They were administered a standardized HUI-3 Questionnaire® and their responses were recorded, simultaneously. Statistical significance for change in HRQOL score was assessed with paired t-test. Multivariate linear regression was used to identify the various correlates of HRQOL. The mean (± standard deviation) overall HRQOL score for all participants was 0.71 (± 0.262) [range=-0.09 to 1.00]. A follow-up assessment was carried out after three months and changes in health scores were subsequently recorded. A significant decrease in mean overall HRQOL score was seen for the entire group after three months of having been administered treatment. Single-attributes of emotion and ambulation were maximally affected amongst cancer patients after three months of treatment. On linear regression analyses, baseline HRQOL was a significant correlate of HRQOL at follow-up after three months. ">Addressing the HRQOL of a cancer patient before starting treatment would address morbidity that might be present even after three months.

Health-related quality of life outcomes in adults with nonmuscle-invasive bladder cancer receiving a mitomycin-containing reverse thermal gel as a primary treatment (Optima II: Phase 2b, single-arm, open-label trial).

270 Background: The standard of care for low-grade non‐muscle‐invasive bladder cancer (LG NMIBC) is transurethral resection of the bladder tumor, which can worsen health‐related quality of life (HRQOL). The “OPTimized Instillation of Mitomycin for Bladder Cancer Treatment” (Optima II, clinicaltrials.gov: NCT03558503) is a Phase 2b, open label, single arm, multicenter trial evaluating a nonsurgical alternative as a primary treatment. Patients receive six weekly instillations of UGN-102, a mitomycin-containing reverse thermal gel with a sustained release time of up to 8 hours. We report on HRQOL changes between baseline and the primary endpoint of 3 months. Methods: A total of 63 patients enrolled in the Optima II trial at 20 sites in the U.S. and 2 sites in Israel between October 2018 and October 2020. Of the 63 patients enrolled, 44 were in the HRQOL cohort and completed a quarterly questionnaire. The QLQ-NMIBC24 has six subscales (urinary symptoms, malaise, future health worries, bloating and flatulence, sexual functioning, and male sexual problems) and five single items (intravesical treatment issues, sexual intimacy, worry about contaminating partner, sexual enjoyment, and female sexual problems) assessed with 24 items. Items were rescaled to 0-100 and reverse-coded so that higher scores indicate worse symptom burden. Longitudinal score changes were evaluated using the Sign test. We examined demographic and clinical characteristics associated with HRQOL change scores with regression modeling. A p-value of ≤0.01 was used. Results: The HRQOL cohort was 61% men, 57% age 65+, and 89% non-Hispanic White. Clinically, most LG NMIBC patients had multiple tumors (88%) with prior NMIBC episodes (77%), and two or more prior transurethral resection of bladder procedures (TURBT) (85%). Approximately half (55%) had their most recent TURBT surgery within 12 months of trial enrollment. No patients had missing HRQOL data at baseline or the primary end point of 3 months. The chemoablative reverse thermal gel used as a primary treatment did not cause decrements in patient-reported urinary symptoms, bloating/ flatulence, malaise, fever, general health, or future health worries. Sexual function mildly worsened between baseline and 3 months, and abated by 6 months. Demographic and clinical characteristics were not correlated with HRQOL change scores. By 3 months, 31/44 (70%) LG NMIBC patients achieved a complete response (negative endoscopic examination, cytology, and for-cause biopsy) and 0 experienced a recurrence. By 12 months, 8/44 (18%) patients had a recurrence. Conclusions: Adults with LG NMIBC in a Phase 2b trial who received a mitomycin-containing reverse thermal gel with sustained release maintained their HRQOL through 3 months. A Phase 3 trial is warranted. Clinical trial information: NCT03558503.

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.

Modifying the quality-adjusted life year calculation to account for meaningful change in health-related quality of life: insights from a pragmatic clinical trial.

We propose a modified quality-adjusted life year (QALY) calculation that aims to be consistent with guidance for interpreting change in patient-reported outcomes. This calculation incorporates the minimally important difference (MID) in generic preference-based health-related quality of life (HRQL) change scores to reflect what might be considered meaningful HRQL improvement/deterioration. In doing so, we review common issues in QALY calculations such as adjustment for baseline scores and standardizing for between-group differences. Using EQ-5D-5L outcome data from the Alberta TEAMCare-Primary Care Network trial in the management of depression for patients with type 2 diabetes (n = 98), this study compared results from different QALY calculation methods to investigate the impact of (i) adjusting for baseline HRQL score, (ii) standardizing between-group differences at baseline, and (iii) adjusting for 'meaningful' HRQL changes. The following QALY calculation methods are examined: area under curve (QALY-AUC), change from baseline (QALY-CFB), regression modelling (QALY-R), and incorporating an MID for HRQL changes from baseline (QALY-MID). The incremental QALY-AUC estimate favoured the Collaborative Care group (0.031) while the incremental QALY-CFB (-0.028) estimate favoured Enhanced Care. Adjusting for meaningful HRQL changes resulted in a crude incremental QALY-MID of -0.023; however, after adjusting for between-group differences at baseline, QALY-R and adjusted incremental QALY-MID estimates were -0.007 and -0.001, respectively. In addition, recursive regression analyses showed that very low baseline HRQL scores impact incremental QALY estimates. Uncertainty in incremental QALY estimates reflects uncertainty in the value of small within-individual change as well as the impact of small differences between groups at baseline. Applying a responder-definition approach yielded crude and adjusted QALY-MID estimates that were more in favour of Collaborative Care than QALY-CFB and QALY-R estimates, respectively, suggesting that ambiguous small changes in HRQL scores have the potential to influence QALY outcomes used in economic or non-economic applications.

Improvement in Health-Related Quality of Life in Food-Allergic Patients: A Meta-Analysis

Food allergy (FA) is a growing global problem that can affect patients' health-related quality of life (HRQoL) owing to increased anxiety as well as social and economic restrictions. Interventions such as oral food challenges (OFCs) and oral immunotherapy (OIT) have been shown to improve HRQoL. However, meta-analyses and systematic synthesis of these data are lacking. To review and quantitatively synthesize potential benefits of interventions (OIT and OFC) systematically to address FA to a variety of foods. We conducted a systematic search through PubMed and Cochrane Medical Library databases and performed a meta-analysis focusing on studies assessing changes in HRQoL after OIT and/or OFCs in FA participants and caregivers from 2010 to July 2020. Random effects model and I2 statistics were used to assess overall intervention effects and heterogeneity across studies. We included 13 publications in this meta-analysis (OIT= 7; OFCs= 6). Mean change in HRQoL scores after OIT and OFCs was -1.25 (P < .001) and -0.78 (P= .052), with a significant I2 of 87% (P < .001) and 90% (P < .001), respectively. Five OIT studies found significant improvements in HRQoL in the OIT group compared with the placebo group, with an overall standardized mean difference of -0.56 (P=.007; I2= 42%, P= .099). This meta-analysis showed that in FA patients, both OIT and OFCs are associated with an improvement in HRQoL. Well-designed and long-term HRQoL studies are necessary to ascertain sustained benefits of OIT and OFCs.

Comprehensive geriatric assessment and management for Canadian elders with Cancer: The 5C study.

12011 Background: Comprehensive Geriatric Assessment (CGA) is recommended by ASCO for older adults with cancer undergoing chemotherapy to identify issues that can interfere with treatment delivery and optimize functional status and quality of life. However, few randomized controlled trials have been completed so far. Our objective is to evaluate the effectiveness of CGA on improving quality of life for older adults receiving cancer treatment. Methods: Eligible patients were aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, speaking English/French, and with an Eastern Collaborative Oncology Group Performance Status 0–2. The CGA was done by a nurse and geriatrician followed by monthly phone calls by the study nurse for 6 months. Patients were randomly assigned (1:1) to receive either the intervention (CGA plus follow-up by geriatric trained team in addition to usual oncology care) or usual care alone. All participants received a monthly healthy aging booklet for attention control. Randomization was stratified by center and treatment intent (curative/adjuvant versus palliative). Our primary outcome was health-related quality of life (HRQOL) assessed with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 global health scale (items 29 and 30). Secondary outcomes include functional status (Instrumental Activities of Daily Living). Outcome data collection was completed monthly for the first 6 months, then at 9 and 12 months. For the primary outcome we used a pattern mixture model using an intent-to-treat approach (at 0, 3, and 6 months). The last data collection took place March 8 2021. Results: From May 2017 to March 2020, 351 participants from 8 hospitals across Canada were enrolled. All patients were seen on or after day 1 of treatment for the intervention per patient request. Patient characteristics at baseline were similar in both arms. The average age was 75.7 (SD = 4.8), 60.4% was male and 54.3% had treatment with palliative intent. Change in HRQOL scores did not differ by arm (p =.80). Neither group exceeded the MCID of 10 points. There was also no difference in IADL between the groups (p = 0.82). Conclusion: CGA was not effective in improving quality of life for older adults receiving cancer treatment in this study. CGA may need to be performed prior to treatment initiation to achieve benefits. Clinical trial information: NCT03154671.