Health-related Quality Of Life Benefits Research Articles

Patient-reported outcomes in metastatic renal cell carcinoma trials using combinations versus sunitinib as first-line treatment.

Over the past 5 years, several new immunotherapy treatments have been tested for metastatic renal cell carcinoma (mRCC). Clinical trials assessing combinations of different immunotherapies, or of an immunotherapy with a tyrosine kinase inhibitor (TKI), have reported improved clinical outcomes compared with the standard of care - that is, treatments using TKIs alone. However, to understand the holistic impact of new treatments on patients, physicians must also consider effects on health-related quality of life (HRQoL). As patient-reported outcome measures (PROMs) on HRQoL are often treated as a secondary outcome in clinical trials, their collection and reporting are non-standardized and, therefore, difficult to compare and interpret. However, results from six clinical trials indicate that two immunotherapy treatments overwhelmingly outperform sunitinib in HRQoL measurements: nivolumab plus cabozantinib (CheckMate 9ER) and atezolizumab plus bevacizumab (IMmotion151). An additional two treatments generally outperform sunitinib: nivolumab plus ipilimumab (CheckMate 214) and lenvatinib plus pembrolizumab (CLEAR). Of three studies that reported no difference from sunitinib, two suffered design flaws that might have obscured HRQoL benefits (JAVELIN Renal 101and KEYNOTE-426). To ensure future HRQoL data are of the highest quality and comparable across trials, future studies should adopt best practices for the design, analysis and reporting of PROMs.

Impact of Uterine Fibroids on Perceived Health-Related Quality of Life among Women in Selected Tertiary Institutions across Nigeria: A Prospective Cross-Sectional Survey

Abstract Introduction: Uterine fibroids can be associated with poor health-related quality of life (HRQoL) when symptomatic. Our objective was to assess the severity of uterine fibroid symptoms (UFSs) and its impact on perceived HRQoL among women with uterine fibroids attending selected secondary and tertiary health institutions across Nigeria. Materials and Methods: This was a prospective and questionnaire-based cross-sectional survey. Data collected included demographics, symptoms severity, medical/gynecological history, mental health status, perceived HRQoL, and myomectomy benefits. The study was conducted between May 1, 2019 and August 31, 2019, across the six geopolitical zones in Nigeria, namely: Northeast, Northwest, North Central, South–South, Southeast, and Southwest zones, including Lagos. A total of 464 women were interviewed. Results: The average age of the respondents was 37 years (range 18–59 years). About 81%–87% experienced UFS-related menstrual disorders, with 50% experiencing moderate to severe symptoms. Overall, up to 70% of the women indicated that UFS impacted their HRQoL, with the majority reporting moderate to severe impact across all domains, including concern (55.6 ± 26.6), control (54.3 ± 26.4), self-conscious (53.5 ± 27.3), energy/mood (52.1 ± 24.5), and sexual function (49.1 ± 26.4). About 75% reported improvements after myomectomy. Conclusion: This study revealed that a significant number of women with uterine fibroids had symptoms affecting their perceived HRQoL. Many of the respondents reported a decreased overall HRQoL with significant improvement after myomectomy. Early recourse to definitive care is therefore imperative in the quest to improve overall HRQoL, including reproductive health.

HTA90 Use of General Population Utilities in NICE Highly Specialised Technology Appraisals of Treatments With the Potential to Restore Normal Physiology

Rare diseases can have a considerable impact on patients’ health-related quality of life (HRQoL). The National Institute for Health and Care Excellence’s (NICE) Highly Specialised Technologies (HST) process evaluates treatments indicated for very rare diseases. For interventions that have the potential to restore normal physiology in rare disease sufferers, capturing long-term impact on HRQoL in economic evaluations may be particularly challenging, due to sparsity of data. The aim of this study is to explore how long-term HRQoL benefit was modelled in NICE HSTs of treatments that could restore patient health to near that of the general population.

Systematic Review and Network Meta-analysis of Neurostimulation for Painful Diabetic Neuropathy.

Different waveforms of spinal cord stimulation (SCS) have now been evaluated for the management of painful diabetic neuropathy (PDN). However, no direct or indirect comparison between SCS waveforms has been performed to date. To conduct a systematic review and network meta-analysis to evaluate the effectiveness of SCS for PDN. MEDLINE, CENTRAL, Embase, and WikiStim were searched from inception until December 2021. Randomized controlled trials (RCTs) of SCS for PDN were included. Pain intensity, proportion of patients achieving at least a 50% reduction in pain intensity, and health-related quality of life (HRQoL) data were extracted. Significant reductions in pain intensity were observed for low-frequency SCS (LF-SCS) (mean difference [MD] -3.13 [95% CI -4.19 to -2.08], moderate certainty) and high-frequency SCS (HF-SCS) (MD -5.20 [95% CI -5.77 to -4.63], moderate certainty) compared with conventional medical management (CMM) alone. There was a significantly greater reduction in pain intensity on HF-SCS compared with LF-SCS (MD -2.07 [95% CI -3.26 to -0.87], moderate certainty). Significant differences were observed for LF-SCS and HF-SCS compared with CMM for the outcomes proportion of patients with at least 50% pain reduction and HRQoL (very low to moderate certainty). No significant differences were observed between LF-SCS and HF-SCS (very low to moderate certainty). Limited number of RCTs and no head-to-head RCTs conducted. Our findings confirm the pain relief and HRQoL benefits of the addition of SCS to CMM for patients with PDN. However, in the absence of head-to-head RCT evidence, the relative benefits of HF-SCS compared with LF-SCS for patients with PDN remain uncertain.

31085 Bimekizumab early treatment response translates into cumulative benefits in health-related quality of life in patients with moderate to severe plaque psoriasis: Pooled results from three multicenter, randomized, double-blinded phase 3 trials

Introduction: Speed of clinical response is an important treatment goal for patients with plaque psoriasis. We examined how early clinical response translated into cumulative health-related quality of life (HRQoL) benefits in patients with moderate to severe plaque psoriasis treated with bimekizumab (BKZ) over 1 year. Methods: Data were pooled for patients randomized to BKZ 320 mg every 4 weeks (wks)(Q4W) in BE SURE, BE READY, and BE RADIANT. Through Wks16–48, data were combined for both BKZ maintenance doses (BKZ 320 mg Q4W and Q8W). The proportions of patients achieving DLQI0/1 (no effect of skin disease on patient’s life) are reported at Wk4 by PASI90 status; cumulative HRQoL benefits through 48 wks were estimated using total area under the curve (AUC0–48) for patients achieving DLQI0/1 by Wk4 PASI90 status. Missing data were imputed as nonresponse (NRI). Results: At Wk4, 352/880 (40.0%) patients achieved PASI90. 57.4% of Wk4 PASI90 responders achieved DLQI0/1, compared with 40.5% of Wk4 PASI90 nonresponders. Total AUC0–48 for achievement of DLQI0/1 was greater in Wk4 PASI90 responders vs Wk4 PASI90 nonresponders: 3664 vs 3263. Patients who achieved PASI90 at Wk4 achieved DLQI0/1 for a greater number of days throughout the 48-wk trial compared with patients who did not achieve PASI90 at Wk4: 256 vs 228 days. Conclusions: BKZ demonstrated fast skin clearance. Early treatment response on BKZ translated into cumulative benefits in HRQoL: Wk4 PASI90 responders achieved DLQI0/1 for a greater number of days during the 48-wk trial than Wk4 PASI90 nonresponders.

1553O Health-related quality of life (HRQoL) in the phase III TROPiCS-02 trial of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (MBC)

The antibody-drug conjugate SG comprises an anti-Trop-2 antibody coupled to SN-38 via a hydrolyzable linker. In the ongoing randomized TROPiCS-02 trial, SG is being evaluated vs single-agent chemotherapy treatment of physician’s choice (TPC) after CDK 4/6 inhibitor, endocrine therapy, and at least 2 chemotherapies in HR+/HER2- MBC setting. Here we assess the impact of SG on HRQoL in TROPiCS-02. Patients (pts) with locally determined HR+/HER2- MBC following (2-4 prior chemotherapies) for metastatic disease, were randomized to receive SG (10 mg/kg IV on days 1 and 8 of a 21-day treatment [Tx] cycle) or TPC (capecitabine, eribulin, gemcitabine, or vinorelbine). HRQoL was assessed at baseline (BL), day 1 of each Tx cycle (CxDx) and at end of treatment visit using the EORTC QLQ-C30. The analysis included all pts with valid HRQoL assessments at BL and ≥1 post-BL visit. Linear mixed-effect models for repeated measures were used to estimate differences in overall least-square mean changes from BL between Tx arms, using on-Tx data up to C11D1 (n ≥25 in both arms). The analysis included 446 pts (236 SG, 210 TPC; median age 56 y). The EORTC QLQ-C30 completion rate was ≥85% up to C13D1 in both Tx arms. Mean HRQoL scores at BL were generally similar for SG and TPC. The SG arm showed a trend of improvement in most HRQoL domains. A significantly greater improvement in physical functioning and dyspnea was observed for SG vs TPC and greater worsening in diarrhea (table).Table: 1553OEORTC QLQ-C30 least-square mean change from baselineSG vs TPC (95% CI)Global health status/QoL2.4 (-0.7, 5.5)FunctioningPhysical3.9 (0.9, 6.9)Role3.1 (-1.2, 7.4)Emotional0.9 (-2.4, 4.3)Cognitive-0.2 (-3.3, 2.9)Social0.8 (-3.2, 4.7)Summary Score0.6 (-1.8, 3.1)SymptomsFatigue-3.3 (-7.1, 0.5)Pain-1.6 (-5.5, 2.3)Nausea/Vomiting1.4 (-0.9, 3.8)Dyspnea-4.3 (-8.5, -0.1)Insomnia-3.7 (-8.1, 0.8)Appetite Loss-3.3 (-7.3, 0.8)Constipation-1.0 (-5.5, 3.4)Diarrhea10.4 (6.3, 14.5)Financial Difficulties0.9 (-2.5, 4.2)Positive value represents improvement for functioning and worsening for symptoms.SG, sacituzumab govitecan; TPC, treatment of physician’s choice. Open table in a new tab SG, sacituzumab govitecan; TPC, treatment of physician’s choice. Despite the association with worsening diarrhea, SG demonstrated an overall HRQoL benefit in heavily-pretreated patients with HR+/HER2- MBC.

Effects of a home-based Radio-Taiso exercise programme on health-related quality of life in older adults with frailty: protocol for an assessor-blind randomised controlled trial

IntroductionFew clinical trials have examined the effects of home-based exercise programmes on health-related quality of life (HR-QoL) in older adults with frailty. Radio-Taiso is the most famous exercise programme in...

Health-related quality of life with enzalutamide versus flutamide in castration-resistant prostate cancer from the AFTERCAB study

BackgroundPatient-reported outcome (PRO) measures can provide valuable information in evaluating patients’ health-related quality of life (HRQoL). Post hoc analysis of the AFTERCAB study was conducted to evaluate the HRQoL benefit of enzalutamide plus androgen deprivation therapy (ADT) compared to flutamide plus ADT for the treatment of patients with castration-resistant prostate cancer (CRPC) in Japan.MethodsThe open-label AFTERCAB study was conducted from November 2016 to March 2020 in Japanese men aged ≥ 20 years with asymptomatic or mildly symptomatic CRPC. Patients received enzalutamide plus ADT or flutamide plus ADT, respectively, as first-line alternative androgen therapy (AAT). HRQoL was analyzed through the Functional Assessment of Cancer Therapy–Prostate, EuroQoL 5-Dimension 5-Level instruments, Brief Pain Inventory–Short Form, and Brief Fatigue Inventory. The longitudinal changes in HRQoL, HRQoL deterioration based on minimally important difference (MID), and time to HRQoL deterioration were evaluated for first-line AAT.ResultsOverall, HRQoL between the enzalutamide and flutamide groups was similar during first-line treatment. No statistically significant HRQoL difference in change from baseline to week 61 (least square mean difference; p value) was observed. Furthermore, proportions of pain progression, symptom worsening, and HRQoL deterioration based on MID, were not significantly different between groups.ConclusionsThe results were similar in all subscales of each PRO, demonstrating similar HRQoL deterioration based on MID criteria between the enzalutamide and flutamide groups.

Quality of Life after Bariatric Surgery-A Systematic Review.

Background: Most studies analyzing the health-related quality of life (HRQOL) after bariatric treatment ceased at five years post-surgery or even earlier, and it is unclear whether the HRQOL benefit persists for a longer time. This paper reviews sparse evidence regarding HRQOL in patients who underwent bariatric surgery at least nine years prior. Materials and Methods: A of PubMed, Scopus and Google Scholar between 2007–2021 was carried out for the studies investigating HRQOL as an outcome measure in patients after bariatric surgery of any type and having at least a 9-year follow-up. Inconsistent reporting of weight loss or postgraduate study results unrelated to QoL were not included in the study. The study used the PICO procedure. Results: The review of 18 identified publications demonstrated that bariatric treatment seems to provide a persistent benefit in terms of HRQOL, especially its physical component score. Due to psychological predispositions, some patients appear to be less likely to benefit from bariatric treatment, whether in terms of HRQOL or bodyweight reduction. Inconsistent and imprecise studies may limit the evidence included in a review. Conclusions: The early identification of such patients and providing them with holistic care, including psychological intervention, would likely further improve the outcomes of bariatric treatment.

Factors associated with increased health‐related quality‐of‐life benefits in hereditary transthyretin amyloidosis polyneuropathy patients treated with inotersen

Hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN) is a genetic condition associated with significant morbidity and mortality. In this study we aimed to identify patient subgroups exhibiting the greatest health-related quality of life (HRQL) benefit from inotersen treatment. We examined data from the inotersen phase 2/3 randomized, controlled trial for ATTRv-PN, NEURO-TTR (NCT01737398, 66 weeks). LASSO regression models predicted changes in Norfolk QoL-DN total score (TQoL, range -4 to 136; higher scores indicate poorer HRQL) from baseline in the inotersen and placebo arm, respectively. Individualized efficacy scores (ES) were calculated as differences between predicted change scores had patients received inotersen vs placebo. Patients were ranked by ES to define the greatest-benefit subpopulation (top 50%). Characteristics of the top 50% and bottom 50% of patients were compared. The overall mean ± standard deviation TQoL change was -0.20 ± 19.13 for inotersen (indicating no change) and 10.77 ± 21.13 for placebo (indicating deterioration). Within the highest-benefit patients, mean TQoL change was -11.03 ± 17.06 (improvement) for inotersen and 11.24 ± 22.97 (deterioration) for placebo (P < .001). Compared with the overall population, patients in the greatest-benefit subpopulation were younger, more likely to have polyneuropathy disability (PND) scores 1 or 2, less likely to have received prior tafamidis or diflunisal treatment, and more likely to have Val30Met mutations and higher (worse) baseline TQoL. Patients who were younger and/or at earlier polyneuropathy stages experienced greater HRQL benefits from inotersen over 66 weeks. These findings underscore the need for early diagnosis and treatment initiation, especially among more severely affected patients in early stages of ATTRv-PN.

Is health-related quality of life (HRQoL) reporting keeping pace with new drug approvals in hematology and oncology: A five-year analysis of 245 drug approvals.

6519 Background: HRQoL data in cancer clinical trials can inform tolerability of new drugs, facilitate informed decision-making, and influence health care and policy decisions, but are frequently underreported. We reviewed all registration trials that informed Food and Drug Administration (FDA) approval between 2015-2020 for latency and quality of HRQoL reporting. Methods: HRQoL data for each clinical trial associated with FDA drug approval between 7/2015-5/2020 was collected retrospectively from multiple sources including the FDA and clinicaltrials.gov website, conference abstracts, and journal manuscripts. The aim of the study was to analyze the proportion of trials reporting HRQoL, quality of HRQoL data, latency between FDA approval and first reporting of HRQoL data, and association between changes in HRQOL and overall survival (OS) and progression-free survival (PFS) outcomes. Results: Of the 259 trials involving 245 drug approvals, majority involved solid tumors (61.4%), were phase III (59.1%), and led to approval based on a non-PFS/OS endpoint (52.9%). HRQoL was a pre-specified endpoint in 55.2% and reported in 49.8% trials. HRQoL data was published by the time of FDA approval in only 41.8% cases, 24.8% reported HRQoL data &gt; 12 mo after approval. Further, among trials reporting HRQoL (n = 129), HRQoL data was first reported in the primary paper in only 34.1%, and either in an ancillary paper in 41.9% or an ancillary abstract in 24% trials. Of the 129 trials with HRQoL data, an improvement in HRQoL was seen in 44.2%, no significant change in 41.9%, mixed results in 11.6%, and worsening in 2.3% of trials. Overall, by the time of FDA approval, OS and PFS data were reported in 59% (152/259) and 65% (168/259) trials respectively with an OS benefit seen in 23.9% (62/259) trials, and PFS benefit in 38.6% (100/259) trials. Of the 84 trials that led to FDA approvals based solely on response rate, HRQoL was reported in only 23.8% (n = 24) with a HRQoL benefit seen in only 9.5% (n = 8) trials. Trials reporting either no significant impact on HRQoL or a mixed impact on HRQoL reported median OS benefit of 4.6 months and 4.2 months respectively. In trials reporting HRQoL data &gt; 6 mo from FDA approval, OS benefit of &lt; 3 mo was seen in 17.8% (8/45) trials. No significant time trends were noted during the study period. Conclusions: There was significant underreporting of HRQoL outcomes in trials ( &lt; 50%) associated with FDA drug approvals between 2015-2020 with majority of trials reporting HRQoL data in an ancillary paper/abstract, and at a much later time than the FDA approval. While it is widely accepted that timely dissemination of HRQoL data from cancer drug trials are vital for clinical and regulatory decisions, no improvement in reporting rates were noted over past 5 years. Only 10% of drugs approved on the basis of response rates showed improvement in HRQoL in the registration trials.

Impact of remission and low disease activity on health-related quality of life in patients with systemic lupus erythematosus.

To investigate the impact of remission and lupus low disease activity state (LLDAS) on health-related quality of life (HRQoL) in systemic lupus erythematosus. Short-Form 36 (SF-36), three-level EQ-5D (EQ-5D-3L)and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatiguedata from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials were used. Duration in remission/LLDAS required to reach a HRQoL benefit ≥ minimal clinically important differences (MCIDs) during and post-treatment was determined using quantile regression and generalized estimating equations. Patients (n = 1684) were assessed every fourth week (15 visits). Four cumulative (β = 0.60) or four consecutive (β = 0.66) visits in remission were required to achieve a benefit ≥MCID in SF-36 physical component summary (PCS) scores, and six cumulative (β = 0.44) or five consecutive (β = 0.49) for a benefit ≥MCID in mental component summary (MCS) scores. Eight cumulative (β = 0.30 for both) or eight consecutive (β = 0.32 for both) visits in LLDAS were required for a benefit in PCS/MCS ≥MCID, respectively. For EQ-5D-3L index scores ≥MCID, six cumulative (β = 0.007) or five consecutive (β = 0.008) visits in remission were required, and eight cumulative (β = 0.005) or six consecutive (β = 0.006) visits in LLDAS. For FACIT-Fatigue scores ≥MCID, 12 cumulative (β = 0.34) or 10 consecutive (β = 0.39) visits in remission were required, and 17 cumulative (β = 0.24) or 16 consecutive (β = 0.25) visits in LLDAS. Remission and LLDAS contribute to a HRQoL benefit in a time-dependent manner. Shorter time in remission than in LLDAS was required for a clinically important benefit in HRQoL, and longer time in remission for a benefit in mental compared with physical HRQoL aspects. When remission/LLDAS was sustained, the same benefit was achieved in a shorter time.

Canadian Expert Opinion on Breast Reconstruction Access: Strategies to Optimize Care during COVID-19.

Background:Breast reconstructive services are medically necessary, time-sensitive procedures with meaningful health-related quality of life benefits for breast cancer survivors. The COVID-19 global pandemic has resulted in unprecedented restrictions in surgical access, including access to breast reconstructive services. A national approach is needed to guide the strategic use of resources during times of fluctuating restrictions on surgical access due to COVID-19 demands on hospital capacity.Methods:A national team of experts were convened for critical review of healthcare needs and development of recommendations and strategies for patients seeking breast reconstruction during the pandemic. Following critical review of literature, expert discussion by teleconference meetings, and evidenced-based consensus, best practice recommendations were developed to guide national provision of breast reconstructive services.Results:Recommendations include strategic use of multidisciplinary teams for patient selection and triage with centralized coordinated use of alternate treatment plans during times of resource restrictions. With shared decision-making, patient-centered shifting and consolidation of resources facilitate efficient allocation. Targeted application of perioperative management strategies and surgical treatment plans maximize the provision of breast reconstructive services.Conclusions:A unified national approach to strategically reorganize healthcare delivery is feasible to uphold standards of patient-centered care for patients interested in breast reconstruction.

Health-related quality of life (HRQoL) in previously untreated patients with advanced renal cell carcinoma (aRCC) in CheckMate 214: Five-year follow-up results.

307 Background: Nivolumab + ipilimumab (N+I) demonstrated durable, long-term survival in the phase 3 CheckMate 214 trial as first-line treatment for intermediate/poor (I/P)-risk patients (pts) with aRCC. After a minimum follow-up of 5 years, N+I maintained superior overall survival and response benefits vs sunitinib (S) in both I/P-risk pts and across all randomized pts. We report the HRQoL results from the 5-year follow-up. Methods: Pts were randomized 1:1 to receive N 3 mg/kg + I 1 mg/kg every 3 weeks (wks) for 4 cycles followed by N 3 mg/kg every 2 wks or S 50 mg/d orally for 4 wks (6-wk cycle). HRQoL was assessed using the FKSI-19, FACT-G, and EQ-5D-3L instruments at baseline (BL) and on day 1 of wks 1 and 4 of the first 2 cycles, on day 1 of wks 1 and 5 of the next 2 cycles, and on day 1 of wk 1 of subsequent cycles. The analyses included mixed-model repeated measures (MMRM) for change from BL across 59 months (while on-treatment) and time to confirmed deterioration (TCD). Bother with treatment side effects (item GP5 in FKSI-19) was assessed using a generalized estimating equations model with response dichotomized as minimal bother (“not at all” or “a little bit”) vs notable bother (“somewhat”, “quite a bit”, and “very much”). Results: 1096 pts were randomized to N+I (I/P-risk: 425; favorable [F]-risk: 125) and S (I/P-risk: 422; F-risk: 124). In the overall and I/P-risk populations, N+I pts reported improved mean FKSI-19 total scores over time compared with a decline observed with S. Overall changes from BL through 59 months favored N+I over S with significant differences between arms observed for all outcomes (Table). Median TCD was significantly longer with N+I vs S for all FKSI-19 scores, as well as FACT-G total and physical domains for both populations ( P &lt; 0.05). Pts in the N+I arm were 76% (odds ratio [95% CI]: 0.24 [0.16–0.35]) and 73% (0.27 [0.18–0.40]) less likely to be notably bothered by side effects than pts in the S arm in the total and I/P-risk populations, respectively. Conclusions: Pts reported HRQoL benefits with N+I vs S. Treatment with N+I showed a decreased risk of being bothered by treatment side effects and of experiencing clinically meaningful deterioration in HRQoL in contrast with S. These results suggest that the superior efficacy of N+I over S comes with the additional benefit of improved long-term HRQoL. Clinical trial information: NCT02231749. [Table: see text]

A Systematic Literature Review of Health-related Quality of Life Measures for Women with Hypoactive Sexual Desire Disorder and Female Sexual Interest/Arousal Disorder

Hypoactive Sexual Desire Disorder (HSDD) / Female Sexual Interest/Arousal Disorder (FSIAD) impacts health-related quality of life (HRQoL) of women and their partners, yet existing measures fail to adequately capture relevant concepts (ie, what is essential to measure including symptoms/impacts) important to women with HSDD/FSIAD. To identify HRQoL tools used to assess women with HSDD/FSIAD, and to evaluate their psychometric properties (ie, reliability, validity, and responsiveness). We conducted searches in PubMed, Embase and PsychINFO from June 5, 1989 to September 30, 2020 for studies in women with HSDD/FSIAD and psychometric analyses (English only). Principles of the Preferred Reporting Items for Systematic reviews and Meta-Analyses, the COnsensus-based Standards for the selection of health Measurement INstruments Risk of Bias Checklist and other psychometric criteria were applied. Based on this search, 56 papers were evaluated including 15 randomized-controlled trials, 11 observational/single arm/open label studies, and 30 psychometric studies. Of the 18 measures identified, the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) were included in most studies (> 50%). General HRQoL instruments were not used in any of the clinical trials; the SF-12, SF-36 and EQ-5D-5L were reported in two observational studies. No instruments achieved positive quality ratings across all psychometric criteria. The FSFI, FSDS-R, Sexual Event Diary (SED) and the Sexual Desire Relationship Distress Scale (SDRDS), were the only measures to receive a positive rating for content validity. Reliable and valid HRQoL measures that include sexual desire and distress are needed to provide a more systematic and comprehensive assessment of HRQoL and treatment benefits in women with HSDD/FSIAD. While inferences about HRQoL are limited due to the lack of uniformity in concepts assessed and limited psychometric evaluation of these measures in women with HSDD/FSIAD, opportunities exist for the development of reliable and validated tools that comprehensively measure the most relevant and important concepts in women with HSDD/FSIAD. Lim-Watson MZ, Hays RD, Kingsberg S, etal. A systematic literature review of health-related quality of life measures for women with Hypoactive Sexual Desire Disorder and Female Sexual Interest/Arousal Disorder. Sex Med Rev 2022;10:23-41.

Updated Health-Related Quality of Life Results from the KarMMa Clinical Study in Patients with Relapsed and Refractory Multiple Myeloma Treated with the B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T Cell Therapy Idecabtagene Vicleucel (ide-cel, bb2121)

Updated Health-Related Quality of Life Results from the KarMMa Clinical Study in Patients with Relapsed and Refractory Multiple Myeloma Treated with the B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T Cell Therapy Idecabtagene Vicleucel (ide-cel, bb2121)

Factors associated with greater health-related quality of life benefits in people with hATTR amyloidosis with polyneuropathy treated with

Hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN) is a genetic condition that shortens lifespan and carries significant morbidity. We aimed to identify factors associated with greater benefits from inotersen, measured by changes in Norfolk QOL–DN total score (TQOL, score range − 4 to 136, higher scores indicating poorer QOL).

668P Matching-adjusted indirect comparison (MAIC) of health-related quality of life (HRQoL) of nivolumab plus cabozantinib (N+C) vs pembrolizumab plus axitinib (P+A) in previously untreated advanced renal cell carcinoma (aRCC)

The landscape for first-line (1L) aRCC is rapidly evolving, with P+A and N+C recommended as standard of care irrespective of risk group by the European Association of Urology and the European Society for Medical Oncology. P+A and N+C have similar modes of action and demonstrated a significant efficacy benefit versus sunitinib (S), although no head-to-head data exist. As aRCC significantly impacts HRQoL, understanding HRQoL benefits of these 2 treatments is of interest to inform clinical decision making. An anchored MAIC was conducted using patient-level data from the CheckMate 9ER trial (NCT03141177; N+C vs S) and aggregate published data from the KEYNOTE-426 trial (NCT02853331; P+A vs S). Outcomes included Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index – Disease Related Symptoms (FKSI-DRS) and EQ-5D visual analog scale (EQ VAS) due to limited published HRQoL data from KEYNOTE-426. Hazard ratios for time to first and confirmed deteriorations (TTFD and TTCD, respectively) and baseline to week 30 least squares mean differences in these outcomes were re-estimated for CheckMate 9ER using a weighted population and indirectly compared with those in KEYNOTE-426 via a Bayesian framework. A total of 651 CheckMate 9ER patients (pts) were matched to 861 KEYNOTE-426 pts using age, region, risk group, sites of metastatic disease, and prior nephrectomy. Results from the MAIC favored N+C versus P+A in all outcomes with statistically significant differences for FKSI-DRS and TTFD in EQ VAS score (Table).Table: 668POutcomeMAIC results, N+C vs P+ATTFD, HR (95% CrI) EQ-5D VAS0.73 (0.55–0.96)aTTCD, HR (95% CrI) EQ-5D VAS0.72 (0.52–1.01) FKSI-DRS0.48 (0.33–0.69)aChange from baseline at week 30,LSMD (95% CrI) EQ-5D VAS2.55 (–0.88 to 5.98) FKSI-DRS1.85 (0.96–2.74)baThe 95% CrI does not contain 1. HR < 1 favors N+C over P+A. bThe 95% CrI does not contain 0. LSMD > 0 favors N+C over P+A. CrI, credible interval; HR, hazard ratio; LSMD, least squares mean difference. Open table in a new tab aThe 95% CrI does not contain 1. HR < 1 favors N+C over P+A. bThe 95% CrI does not contain 0. LSMD > 0 favors N+C over P+A. CrI, credible interval; HR, hazard ratio; LSMD, least squares mean difference. In pts with 1L aRCC, MAIC analyses indicate that compared with P+A, N+C demonstrated a significant improvement in DRS and significantly delayed deterioration in HRQoL. These results, combined with the efficacy and favorable safety profile of N+C, may further inform treatment decisions of clinicians and pts with 1L aRCC.

Chronic non-invasive ventilation for chronic obstructive pulmonary disease.

Chronic non-invasive ventilation for chronic obstructive pulmonary disease.

Health-Related Quality of Life in Adults Treated with Blinatumomab Using the Acute Lymphoblastic Leukemia Symptom Scale

Health-Related Quality of Life in Adults Treated with Blinatumomab Using the Acute Lymphoblastic Leukemia Symptom Scale