Changes In Health-related Quality Of Life Research Articles

The Impact of Hospital Admission for Vaso-Occlusive Crisis on Health-Related Quality of Life in Children with Sickle Cell Disease

Background: Sickle cell disease (SCD) is the most common inherited hemoglobinopathy characterized by chronic hemolytic anemia, vaso-occlusive crises (VOCs), sensitivity to bacterial infections and multi-organ failure. Painful VOCs may severely impair the life of children with SCD and their families, resulting in limited health-related quality of life (HRQoL). Currently, there is limited information how HRQoL changes over time following hospitalization for VOC. Therefore, the aim of this study is to evaluate the longitudinal impact of hospital admission for VOCs on the HRQOL in children with SCD. Methods: In this retrospective cohort study, children between the age of 8 and 18 years with SCD treated at the Amsterdam University Medical Centers were included. As part of standard care, once a year, these children completed patient reported outcomes measures (PROMs) on the KLIK PROM portal (www.hetklikt.nu). HRQoL was measured with the Pediatric Quality of Life Inventory (PedsQL). The score is ranging from 0-100, and a higher score indicates better QoL. Data were analysed from the medical files of patients, who filled out at least two PedsQL questionnaires between 2012 and 2021. The effect of the occurrence and frequency of hospital admissions for VOCs on the HRQoL was evaluated 3, 6, 9 and 12 months following hospital admission, using a linear mixed model adjusted for age and SCD genotype. Results: In total, 94 children were included with a median age of 11.8 years (interquartile range: 9.3 - 14.1), including 57 patients (61%) with the severe genotype: HbSS or HbSβ0 thalassemia. During follow-up, 37 patients (41%) had been admitted to the hospital for a VOC. Hospitalization for VOC in the last 12 months led to a decrease of 3.2 points (p=0.053) in HRQoL as compared to patients without hospitalization. Recurrent admissions for VOC in the previous 12 months further decreased HRQoL with 2.3 points for every additional admission (p=0.035). The significantly affected domains were physical functioning at 6, 9 and 12 months, and school performance 12 months after hospitalization. Conclusion: Hospitalization for VOC in children with SCD is associated with a decreased HRQoL persisting up to 12 months after admission. These findings highlight the importance of using patient-reported outcomes in children with SCD to screen for the need for extra support after hospitalization for VOCs to optimize HRQoL.

Health-Related Quality of Life of CML Patients Under 2nd or 3rd Line Bosutinib Is Not Impaired Significantly By Gastrointestinal Toxicity (GI Tox) but Influenced By Sex - Results from a Subanalysis of the Bosutinib Dose Optimization (BODO) Study (CML-VII) Trial of the German CML Study Group

Introduction: Patient-reported outcome measures (PROMs) are an important tool to assess the impact of disease and their treatments on daily living and thereby on Health-related quality of life (HrQoL). Impact of side effects and gender-specific differences have been partly been addressed in Chronic myeloid leukemia (CML) in the past. The "Bosutinib Dose Optimization (BODO) Study" is a multicenter, open-label single arm phase II study testing tolerability and efficacy of 2nd&3rd line bosutinib step-in dosing (i.e. starting with 300 mg QD) in chronic phase CML patients (pts) intolerant and/or refractory to previous imatinib, and/or nilotinib, and/or dasatinib therapy with the ultimate goal to decrease GI toxicity rates. PROMs were assessed via the EORTC-QLQ-C30 and EORTC-CML24 questionnaires to correlate HrQoL changes with the rate and severity of GI toxicity and gender. Methods: The BODO Study (NCT02577926) had to be terminated prematurely after 57 of 127 projected pts due to delayed recruitment but included detailed analysis of PROMs reported here. Summary statistics of the HrQoL questionnaires were calculated at baseline (BL), month 3, and month 6. Depending on the observed distribution of differences of a score (component), comparisons between groups (e.g., males vs. females) were performed using methods based on the normal distribution assumption (t test) or a non-parametric test (Mann-Whitney U test or Wilcoxon signed rank test). Results: 57 pts with a median age of 51 years (median duration of pretreatment: 19.8 months) were included in the BODO trial. Even though 74%, 53% and 26% of pts suffered from any grade of GI-toxicity (e.g., diarrhea, nausea and vomiting) during the study, GI toxicity triggered treatment discontinuation in only one patient. Median duration of GI toxicity was 15 days (range: 1-1281) and was self-limiting in most pts. Median time to first onset of diarrhea was 23 days, and the median duration of any grade diarrhea was 14 days (range: 1-960). HrQoL-results were available for 51, 44 and 35 pts at baseline, end of month 3 and end of months 6 visits, respectively (for median scores over time see figure 1A-C). PROM results were analyzed according to occurrence of GI toxicity: The only symptom reported to be aggravated in the 15 pts without vs. the 42 with diarrhea during the first 6 months was the insomnia symptom scale (52 vs. 23, p=0.02). Nausea and vomiting did not significantly impact symptom burden. As most of the AEs have an early onset, the 3 month visit was assessed. Again, no significant differences in HrQoL could be detected between pts with or without GI toxicity at 3 months. At baseline, women seemed to be more affected by necessity of treatment change than males: there were statistically significant differences in physical (87 vs. 72, p=0.0055) and role functioning (82 vs. 60, p=0.0043). Higher functional scores were reported in male pts. Regarding symptoms, statistically significant differences were found for fatigue (31 vs. 51, p=0.01) and insomnia (24 vs. 42, p=0.04). Female pts reported higher symptom burden. In addition, the impact on daily life was found to be lower in male pts than in females (24 vs. 34, p=0.04). At 3 months, emotional (79 vs. 57, p=0.003) and cognitive functioning (88 vs. 68, p=0.008), insomnia (17 vs. 39, p<0.05) and symptom burden (19 vs. 26, p=0.03) differed. Male pts reported higher functional scores and lower symptom burden than female pts. At 6 months, male pts reported statistically significantly higher scores in emotional functioning (75 vs. 56, p=0.04) than female pts. Regarding the CML-24 questionnaire, symptom burden showed a statistically significant increase from BL to month 6 (25 vs. 26, p=0.02) with no statistically significant difference in any scale between month 3 and 6. Conclusion: Although the analysis is limited by relatively small number of pts in the respective subgroups and by the pre-selected time points of PROM assessment, the data suggests that HrQoL from pts with chronic phase CML treated with bosutinib within the BODO trial is not significantly impaired by the presence of GI toxicity and that there are significant differences in HrQoL and symptom burden between male and female pts which should be addressed in future trials. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Older Adults with Acute Myeloid Leukemia (AML) Treated in a Pragmatic Trial: How Do Patients’ Function and Health-Related Quality of Life Change with Treatment?

Background: Over one-third of older adults with AML do not receive chemotherapy because of fear of toxicities and functional decline. This highlights the critical and urgent need to generate knowledge of functional changes following newer treatments. Methods: As a part of a pragmatic single-center phase II investigator-initiated trial (ClinicalTrials.gov ID: NCT03226418), we enrolled older adults (≥60 years) with a new diagnosis of AML. We repeated geriatric assessment (GA) and health-related quality of life (HRQOL) before and 3 months after chemotherapy initiation. GA included measures of physical function (e.g. short physical performance battery or SPPB), Montreal Cognitive Assessment (MoCA), Hematopoietic Cell Transplantation Comorbidity Index, Patient Health Questionnaire-9 (PHQ-9), Mini Nutritional Assessment-Short Form. Frailty was defined as impairment in 2 or more domains on geriatric assessment (excluding MoCA). HRQOL was measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (v 3.0). Established cutoffs were used to determine a clinically meaningful change in various measures from baseline to 3 months. Results: 59 eligible patients were enrolled and had median age of 69 years and median KPS of 80. Patients received treatment with predominantly low-intensity chemotherapy (hypomethylating agent +/-venetoclax or midostaurin); six patients received intensive chemotherapy. 56% of patients had ≥2 comorbid conditions, and 69% each had impaired MoCA scores and impaired objective physical function at baseline. Whereas 29% had an established diagnosis of depression or anxiety, 66% had abnormal PHQ-9 with a score of 5 or more. 61% had impaired nutritional screen. A total of 43 patients completed some or all of the optional follow-up assessments at 3 months. Cognitive function or MoCA scores improved (64.5%) or stabilized (9.6%) from baseline to 3 months after treatment (Figure 1). We also noted improvement (51.6%) or stabilization (22.6%) in objective physical function (Figure 2). PHQ-9 scores showed improvement or stabilization in about 90% of patients. Nutritional scores showed variable changes with 40% demonstrating improvement. On HRQOL assessment, global health status score, and role functioning moderately improved from baseline to three-month after enrollment. Longitudinal cognitive function over 3 months differed based on the presence of frailty and multimorbidity (≥2 comorbid conditions) at baseline. Improvement in MoCA scores was noted in 31.8% (95% CI 16.4-52.7%) and 50.0% (95% CI 23.7-76.3%) of patients with versus without baseline frailty. The risk of worsening of cognitive function was 31.5% (95% CI 15.4-54.0%) for patients with multimorbidity at baseline versus 16.7% (95% CI 4.7-44.8%) for those without. Conclusion: We demonstrated an overall improvement or stabilization of functional status and HRQOL in a high proportion of older adults with AML, despite high prevalence of functional impairments and significant comorbidity burden at baseline. These results should encourage oncologists to offer chemotherapy even to older adults with multiple comorbid conditions or poor functional status at the time of diagnosis of AML. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Assessment of clinical outcomes of medicinal cannabis therapy for depression: analysis from the UK Medical Cannabis Registry

ABSTRACT Background Although pre-clinical experiments associate cannabinoids with reduced depressive symptoms, there is a paucity of clinical evidence. This study aims to analyze the health-related quality of life changes and safety outcomes in patients prescribed cannabis-based medicinal products (CBMPs) for depression. Methods A series of uncontrolled cases from the UK Medical Cannabis Registry were analyzed. The primary outcomes were changes from baseline in the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Sleep Quality Scale (SQS), and EQ-5D-5 L at 1, 3, and 6 months. Secondary outcomes included adverse events incidence. Results 129 patients were identified for inclusion. Median PHQ-9 at baseline was 16.0 (IQR: 9.0–21.0). There were reductions in PHQ-9 at 1-month (median: 8.0; IQR: 4.0–14.0; p < 0.001), 3-months (7.0; 2.3–12.8; p < 0.001), and 6-months (7.0; 2.0–9.5; p < 0.001). Improvements were also observed in GAD-7, SQS, and EQ-5D-5L Index Value at 1, 3, and 6 months (p < 0.050). 153 (118.6%) adverse events were recorded by 14.0% (n = 18) of participants, 87% (n = 133) of which were mild or moderate. Conclusion CBMP treatment was associated with reductions in depression severity at 1, 3, and 6 months. Limitations of the study design mean that a causal relationship cannot be proven. This analysis provides insights for further study within clinical trial settings.

Change Toward Healthier Lifestyles Is Associated With Better Health-Related Quality of Life in Long-Term Colorectal Cancer Survivors.

Little is known about how changes in a constellation of lifestyle factors affect health-related quality of life (HRQoL) in colorectal cancer (CRC) survivors. Our study aimed to investigate the association between changes in healthy lifestyle and HRQoL over time in survivors of stage I-IV CRC. We included 2,283 long-term (≥5 years postdiagnosis) survivors. A healthy lifestyle score (HLS) comprising smoking, alcohol consumption, diet, physical activity, and body fatness was derived at diagnosis and 5-year follow-up (5YFU) and categorized as low, moderate, or high. We assessed HRQoL with the EORTC Quality of Life Questionnaire-Core 30 at 5YFU and 10-year follow-up. We used multivariable linear regression and linear mixed models to explore associations between changes in HLS and HRQoL over follow-up. A low baseline HLS was associated with poorer functioning and global health/QoL and a higher symptom burden at 5YFU compared with a high baseline HLS. An improved HLS from baseline to 5YFU was associated with better functioning, higher global health/QoL, and fewer symptoms at 5YFU than a maintained-high HLS. In longitudinal analyses, improved HLS was associated with better functioning at follow-up. Survivors with a maintained-high or an improved HLS reported generally less fatigue, pain, and dyspnea at follow-ups compared with survivors with a maintained-low or decreased HLS. Change toward a healthier lifestyle since diagnosis was associated with better HRQoL in long-term CRC survivors. Our results support the importance of maintaining and/or promoting a healthier lifestyle among CRC survivors postdiagnosis.

Health Related Quality of Life Outcomes Following Stereotactic Body Radiotherapy in Patients with Oligo-Metastatic Disease: An Individual Patient Data Meta-Analysis

<h3>Purpose/Objective(s)</h3> Health-related quality of life (HRQOL) outcomes are lacking in patients with oligo-metastatic disease (OMD) receiving stereotactic body radiotherapy (SBRT). The aim of this individual patient data meta-analysis was to determine the effect of SBRT on the HRQOL of patients with OMD. <h3>Materials/Methods</h3> As part of a previously described systematic review (PROSPERO 2021 CRD42021238506), the primary outcome of this individual patient data meta-analysis was change in HRQOL at 12-months from baseline in patients with OMD who received SBRT (versus not), reported as standardized mean difference (SMD). Random effects models implemented in RevMan (Cochrane Collaboration) were used for meta-analyses of scores. <h3>Results</h3> Of 7556 publications identified, four studies met inclusion criteria (2 single arm interventional studies and 2 randomized controlled trials [RCTs]). Individual patient data were available from three studies (175 patients). In the two RCTs, there was no statistically significant difference in the SMD between patients who received SBRT and those that did not (0.09 [95% CI -0.32, 0.5], P=0.66). On meta-analysis of patients (N=107) who received SBRT, SMD was -0.23 (95% CI [-0.42, -0.04] versus -0.25 (95% CI [-0.57, 0.07]) in those who did not (N=37) receive SBRT, demonstrating a small deterioration from baseline. For all patients (SBRT and SOC) measured by the Global Health/Quality of Life (GHQOL) EORTC QLQ-C30 (N=80), a small deterioration was found in both the GHQOL change score from baseline to 12-months (-0.27, 95% CI -0.49, -0.05) and in those who received SBRT alone (N=57) (-0.27, 95% CI -0.52, -0.02). <h3>Conclusion</h3> In patients with OMD, there is no difference in HRQOL at 12-months from baseline between patients who received SBRT and those that did not. However, a small HRQOL deterioration was found in both groups of patients. More robust assessment and reporting of HRQOL in studies of OMD is needed to better inform patient decision-making.

Health-related quality of life in the phase III ASCENT trial of sacituzumab govitecan versus standard chemotherapy in metastatic triple-negative breast cancer

BackgroundThe antibody–drug conjugate sacituzumab govitecan (SG) prolongs progression-free survival and overall survival in patients with refractory/relapsed metastatic triple-negative breast cancer (mTNBC). Here, we investigated its effect on health-related quality of life (HRQoL). MethodsThis analysis was based on the open-label phase III ASCENT trial (NCT02574455). Adults with refractory/relapsed mTNBC who had received ≥2 prior systemic therapies (≥1 in the metastatic setting) were randomised 1:1 to SG or treatment of physician's choice (TPC; capecitabine, eribulin, vinorelbine, or gemcitabine). HRQoL was assessed on day 1 of each treatment cycle using the EORTC QLQ-C30. Score changes from baseline were analysed using linear mixed-effect models for repeated measures. Stratified Cox regressions evaluated time to first clinically meaningful change of HRQoL. ResultsThe analysis population comprised 236 patients randomised to SG and 183 to TPC. For global health status (GHS)/QoL, physical functioning, fatigue, and pain, changes from baseline were superior for SG versus TPC. Compared with TPC, SG was inferior regarding changes from baseline for nausea/vomiting and diarrhoea but non-inferior for other QLQ-C30 domains. Median time to first clinically meaningful worsening was longer for SG than for TPC for physical functioning (22.1 versus 12.1 weeks, P < 0.001), role functioning (11.4 versus 7.1 weeks, P < 0.001), fatigue (7.7 versus 6.0 weeks, P < 0.05), and pain (21.6 versus 9.9 weeks, P < 0.001). ConclusionsSG was generally associated with greater improvements and delayed worsening of HRQoL scores compared with TPC. This supports the favourable profile of SG as an mTNBC treatment.

Long-term changes of health-related quality of life in patients with peripheral vascular malformations – a prospective observational study

The aim of this observational study was to assess health-related quality of life (HRQOL) changes in patients with vascular malformations, over a period of almost eight years, and to assess clinical and demographic characteristics possibly associated with HRQOL changes. Eighty out of 111 patients who were included in a previously published comparative HRQOL study accepted inclusion in this follow-up study. HRQOL at baseline and follow-up was assessed with the Short-Form 36-item questionnaire (SF-36). Median observation time was 7.9 years. Linear mixed models and linear regression models were applied to assess HRQOL change and possible associations with demographic and clinical variables. The median age of the patient cohort at baseline evaluation (n=111) was 27.0 years. Ninety-six out of 111 (86.5%) patients were diagnosed with venous malformations. Significantly higher SF-36 scores at follow-up were found for the physical domains Role limitations due to (RLDT) physical problems (difference=13.5; 95% CI [1.6, 25.3]) and Bodily pain (difference=11.3; 95% CI [3.8, 18.8]). No deterioration of HRQOL was found in any domain. In multivariate analyses, female gender, muscle/bone involvement, and higher age were associated with a positive relative change in SF-36 in the domains Physical functioning, RLDT physical problems, and RLDT emotional problems, respectively. Invasive treatment was not associated with long-term HRQOL change. Over a period of almost eight years, significant improvement of SF-36 scores was observed in the physical domains RLDT physical problems and bodily pain. Female gender, muscle/bone involvement, and higher age were associated with HRQOL improvement in certain domains.

Oral Health-Related Quality of Life Changes after Clinical Remounting of Existing Dentures.

The clinical remount is an accurate and efficient way to reset the occlusion of delivered removable dentures if major occlusal correction is required. Although previous studies have reported that clinical remounting of existing dentures enhances patients’ oral function, little subjective feedback is available. This retrospective study reports short-term changes in oral-health-related quality of life (OHRQoL) and masticatory function after clinical remounting of existing dentures. Three time points were defined: before adjustment (T0), immediately after adjustment (T1), and 1 week after adjustment (T2). The medical records of seven patients were analyzed. The mean age of participants was 77.71 years, and the mean service period of their prostheses was 9.43 months. The mean scores of the OHIP-EDENT-J questionnaire at the respective time points were 35, 21.14, and 22.14. The mean readings of masticatory function at the respective time points were 76.71, 89.29, and 111.86. Significant differences in the OHIP-EDENT-J were found between T0 and T1, and T0 and T2; and in masticatory function between T1 and T2, and T0 and T2. The results indicated that after rebalancing of the occlusion of the existing dentures, the patient-reported OHRQoL was improved immediately and maintained at least for a short time, and masticatory function was enhanced over a 1-week period.

Peer-supported exercise intervention for persons with mild cognitive impairment: a waitlist randomised controlled trial (the BRAin Vitality Enhancement trial).

motivating older people with cognitive impairment to remain physically active is challenging. this study aimed to examine the effects of a peer-supported exercise intervention on the cognitive function and health-related quality of life (HRQoL) of persons with mild cognitive impairment (MCI). a two-arm randomised controlled trial. community-dwelling persons with MCI were recruited from community centres for older adults in Hong Kong. participants randomised to the intervention group received an 8-week group-based peer-supported multicomponent exercise intervention, while the waitlist control group received usual care. A battery of neuropsychological tests and the Short Form-36 were administered at baseline, immediately post-intervention and 3months post-intervention. two hundred and twenty-nine participants were randomised to the intervention (n = 116) or control (n = 113) group. Compared with the control group, participants in the intervention group showed significantly greater improvements in processing speed and attention measured by the Colour Trails Test 1 (β = 7.213, 95% confidence interval [CI] = 2.870-11.557, P = 0.001) and working memory measured by the Digit Span Backward Test (β = 0.540, 95% CI = 0.199-0.881, P = 0.002) immediately post-intervention. The effects were sustained at 3months post-intervention. Similarly, significantly greater improvements in sequencing and mental flexibility measured by the Colour Trails Test 2 were observed in the intervention group 3months post-intervention (β = 6.979, 95% CI = 3.375-10.584, P < 0.001). Changes in global cognition, short-term memory and HRQoL were not significant. the peer-supported exercise intervention was effective at sustaining improvements in executive function, attention and working memory in persons with MCI.

Do Not Go Gentle into That Deaf Night: A Holistic Perspective on Cochlear Implant Use as Part of Healthy Aging

Research suggests that cochlear implant (CI) use in elderly people improves speech perception and health-related quality of life (HRQOL). CI provision could also prevent dementia and other comorbidities and support healthy aging. The aim of this study was (1) to prospectively investigate potential changes in HRQOL and speech perception and (2) to identify clinical action points to improve CI treatment. Participants (n = 45) were CI recipients aged 60–90 with postlingual deafness. They were divided into groups, according to age: Group 1 (n = 20) received a CI between the age of 60–70 years; group 2 (n = 25) between the age of 71–90 years. HRQOL and speech perception were assessed preoperatively, and three and twelve months postoperatively. HRQOL and speech perception increased significantly within one year postoperatively in both groups. No difference between groups was found. We conclude that CI treatment improves speech perception and HRQOL in elderly users. Improvement of the referral process for CI treatment and a holistic approach when discussing CI treatment in the elderly population could prevent auditory deprivation and the deterioration of cognitive abilities.

Changes in health-related quality of life following percutaneous coronary intervention – a nationwide prospective cohort study

Abstract Background In addition to mortality and morbidity, improved health-related quality of life (HRQOL) is a goal of treatment in patients suffering of cardiovascular heart disease. There is a limited knowledge of changes in HRQOL following percutaneous coronary intervention (PCI). Aims The aims of this study were to determine total and gender specific changes in HRQOL at baseline and four-years following PCI. Methods This study use data from the Norwegian Coronary Stent Trial which included 9013 patients undergoing first time percutaneous coronary intervention in Norway during September 2008–February 2011. HRQOL was assessed using the Short-Form-12 (SF-12) at baseline and at four years of follow up in a representative subgroup (n=775). Results The mean age was 64 years (SD 9.2) and 75% were male. Eighty percent were living with a partner and 67% had a higher level of education. The majority of the patients had stable angina as indication for PCI (40%). There was a significant improvement in all domains of SF-12 from baseline to four years of follow up (p&amp;lt;0.001). The highest changes were in Role Physical (43.6 vs. 48.2), Bodily Pain (44.8 vs. 50.1) and Vitality (44.1 vs. 49.3). Analysing gender differences at four years follow-up, men had a higher improvement in the physical component summary score than women (4.8 vs 2.8, p=0.04), but not in the mental component summary score (2.8 vs 4.4, p=0.11). Conclusion In patients undergoing first time PCI, HRQOL improved significant from baseline to four years of follow up. Both at baseline and at five years of follow up males report a higher HRQOL compared to females. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Northern Norway Regional Health Authority

Perioperative cerebral microinfarction and quality of life following mitral valve surgery

Abstract Introduction Mitral regurgitation (MR) is the second most common valvular pathology worldwide. When untreated, severe MR is associated with significant morbidity and mortality. Mitral valve surgery is recommended in symptomatic patients and those with evidence of adverse left atrial or left ventricular remodelling. Although uncommon, stroke is a recognised complication of mitral valve surgery and is associated with unfavourable outcomes. While silent cerebral microinfarction has been described following cardiac surgery, its incidence in mitral valve surgery and its impact on quality of life is presently unknown. The main aim of this study was to assess the incidence of perioperative cerebral microinfarction following mitral valve surgery and its impact on medium-term health-related quality of life (HRQoL). Methods Cerebral diffusion-weighted magnetic resonance imaging (DWI-MRI) was conducted pre-operatively and prior to discharge in 31 patients undergoing mitral valve surgery for mitral regurgitation. Blinded analysis was conducted by a neuro-radiologist. HRQoL assessment was undertaken at baseline and at a 6-month follow up with EuroQoL-5 dimensions (EQ-5D-5L) and Hospital Anxiety and Depression Scale (HADS) questionnaires. Results Thirty-one patients underwent paired cerebral DWI-MRI (mitral valve replacement (MVR) n=16 [52%] and mitral valve repair (MVr) n=15 [48%]). Prevalence of atrial fibrillation was similar in both groups (MVR n=9 [56%] vs. MVr n=7 [47%], p=0.59). Peri-operative cerebral microinfarction occurred in 9 patients (29%). Embolic events were numerically higher in the MVR group versus MVr group, but not statistically significant (n=7 [44%] vs. n=2 [13%], p=0.06). Presence of multiple lesions, large lesions &amp;gt;5mm, small lesions &amp;lt;5mm and the total number of lesions did not differ significantly between the two groups. Median volume of lesions was higher in the MVR group versus MVr (0 [0–0.4] vs 0 [0–0], p=0.04) (Table 1). There was no difference in the mean change in HRQoL during 6m follow up between patients with peri-operative cerebral microinfarction and those with no detectable embolic events (Table 2). Within group comparison (MVR group and MVr group) also did not demonstrate any significant difference. Conclusions Peri-operative cerebral microinfarction occurred in almost a third of patients undergoing mitral valve surgery, with higher volume of lesions following MVR. These lesions however, did not exhibit significant impact on medium term health-related quality of life. Funding Acknowledgement Type of funding sources: None.

Calidad de vida relacionada con la salud y adhesión terapéutica a la presión positiva continua en la vía aérea (CPAP) en pacientes con apnea obstructiva del sueño (AOS)

IntroductionThe benefits of CPAP in patients with obstructive sleep apnea (OSA) are not achieved without therapeutic adherence (TA). The perception of benefit is one of the main predictors of adherence. However, it is unknown whether the impact of CPAP on health-related quality of life (HRQoL) is related to TA. Objective1) To evaluate whether changes in HRQoL after initiating CPAP are associated with AT. 2)To analyze the influence of various TA determinants, including baseline HRQoL. MethodsProspective observational and longitudinal study on a cohort of patients with moderate-severe OSA and indication of CPAP. Baseline and after-therapy HRQoL were evaluated using the Quebec Sleep Questionnaire (QSQ), as well as other possible AT determinants. A multivariate analysis was performed. ResultsA total of 364 patients (78% men) were included, with mean age of 55 ±11years and apnea-hypopnea index of 42 ±19/hour. 33.3% without TA. There was no association between HRQoL changes after 3months of CPAP and AT and between QSQ baseline score and AT. A higher ODI4%, a global improvement and social interactions (QSQ), were associated with AT. Baseline anxiety-depressive symptoms, worsening anxiety, and side effects with CPAP were associated with worse AT. ConclusionsThe impact of CPAP on HRQoL with respect to the perception of social interactions seems to condition TA. The basal impact of the disease, in terms of HRQoL, is not associated with AT.

Long term changes in health-related quality of life for people with heart failure: the ECHOES study.

Heart failure (HF) impairs all aspects of health-related quality of life (HRQoL), but little is known about the effect of developing HF on HRQoL over time. We aimed to report changes in HRQoL over a 13-year period. HRQoL was measured in the Echocardiographic Heart of England Screening (ECHOES) study and the ECHOES-X follow-up study (N=1618) using the SF-36 questionnaire (Version 1). Mixed modelling compared changes in HRQoL across diagnostic groups, adjusting for potential predictors and design variables. Patients who had developed HF with reduced ejection fraction (HFrEF) or HF with preserved ejection fraction (HFpEF) at rescreening had significantly greater reduction in physical functioning (PF) and role physical (RP) scores compared with those without HF; adjusted mean difference in PF: HFrEF -16.1, [95% confidence interval (CI) -22.2 to -10.1]; HFpEF -14.6, (95% CI -21.2 to -8.1); in RP: HFrEF -20.7, (95% CI -31.8 to -9.7); HFpEF -19.3, (95% CI -31.0 to -7.6). Changes in HRQoL of those with a HF diagnosis at baseline and rescreen, with exception of role emotion, were similar to those without HF but started from a much lower baseline score. People with a new diagnosis of HF at rescreening had a significant reduction in HRQoL. Conversely, for those with HF detected on initial screening, little change was observed in HRQoL scores on rescreening. Further research is required to understand the development of HF over time and to test interventions designed to prevent decline in HRQoL, potentially through earlier diagnosis and treatment optimization.

Examining Contextual Influences Affecting health-related Quality of life Among under-resourced Appalachian Patients Attending pop-up Medical Clinics.

Appalachian residents face substantial barriers to accessing health care and these barriers have negative ramifications for this community's health-related quality of life (HRQoL) [1, 2]. Pop-up medical clinics address some of these barriers by offering a range of free health care services throughout Appalachia. Although these services are undoubtedly helpful, information on how these clinics may be linked to HRQoL changes among under-resourced communities is limited. The present study is among the first to examine how (1) individuals attending pop-up medical clinics present on HRQoL indicators, (2) how HRQoL changes 3-months post-clinic, and (3) how individual, social, and community factors interact with HRQoL at presentation and change in HRQoL 3-months post-clinic. Data were collected from 243 individuals attending one of seven pop-up medical clinics across Central, South Central, and Southern Appalachia. During the week of the clinic, participants completed a survey assessing individual, social, and community factors as well as HRQoL variables (i.e., overall health, depressive symptoms, pain, sleep quality, and several physical symptoms). Participants completed the same survey 3-months post-clinic. Results revealed that baseline individual, social, and community factors were predictive of HRQoL indicators at baseline; individual and social factors also uniquely predicted change in HRQoL at 3-months post-clinic. Within the Social Ecological Framework, these data emphasize the significance of individual and social level factors on an individual's HRQoL. Clinical implications and directions for future research are discussed.

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.

Lung-function trajectories in COVID-19 survivors after discharge: A two-year longitudinal cohort study.

SummaryBackgroundData on the long-term trajectories of lung function are scarce in COVID-19 survivors.MethodsWe re-analyzed the data from a prospective longitudinal cohort follow-up study of COVID-19 survivors over 2 years after infection. All participants were divided into scale 3, scale 4 and scale 5-6 groups according to seven-category ordinal scale. The changes of pulmonary function tests (PFTs), the Modified Medical Research Council (mMRC) Dyspnea Scale, 6-min walking test health-related quality of life (HRQoL) across the three serial follow-up visits were evaluated, and compared among three groups. We performed liner regression to determine potential factors that were associated with changes of PFTs and distance walked in 6 minutes (6MWD).FindingsIn this study, 288 participants generally presented an improvement of PFTs parameters from 6 months to 1 year after infection. The scale 5-6 group displayed a significantly higher increase of PFTs compared with scale 3 and scale 4 groups (all p<0.0167), and corticosteroids therapy was identified as a protective factor for the PFTs improvement with a correlation coefficient of 2.730 (0.215–5.246) for forced vital capacity (FVC), 2.909 (0.383–5.436) for total lung capacity (TLC), and 3.299 (0.211–6.387) for diffusion capacity for carbon monoxide (DLco), respectively. From 1-year to 2-year follow-up, the PFTs parameters generally decreased, which was not observed to be associated with changes of 6MWD and HRQoL. Dyspnea (mMRC≥1) generally decreased over time (23.3% [61/262] for 6-month, 27.9% [67/240] for 1-year, 13.4% [35/261] for 2-year), and 6MWD increased continuously (500.0 m vs 505.0 m vs 525.0 m).InterpretationCorticosteroids therapy during hospitalization was a protective factor for PFTs improvement from 6 months to 1 year. The relatively fast decline trend of PFTs from 1 year to 2 years needs to be paid attention and further validated in the future follow-up study.FundingsThis work was supported by Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (CIFMS 2021-I2M-1-048) and the National Key Research and Development Program of China (2021YFC0864700).

Health-related quality of life from 20 to 32 years of age in very low birth weight individuals: a longitudinal study

BackgroundPreterm birth with very low birth weight (VLBW, birth weight < 1500 g) is associated with health problems later in life. How VLBW individuals perceive their physical and mental health-related quality of life (HRQoL) is important to understand their putative burden of disease. Previous studies have shown mixed results, and longitudinal studies into adulthood have been requested. This study aimed to investigate differences in HRQoL between preterm VLBW and term born individuals at 32 years of age, and to study changes in HRQoL from 20 to 32 years.MethodsIn a geographically based longitudinal study, 45 VLBW and 68 term born control participants completed the Short Form 36 Health Survey (SF-36) at 32 years of age. Data from three previous timepoints was also available (20, 23 and 28 years of age). The SF-36 yields eight domain scores as well as a physical and a mental component summary. Between-group differences in these variables were investigated. We also performed subgroup analyses excluding individuals with disabilities, i.e., cerebral palsy and/or low estimated intelligence quotient.ResultsAt 32 years of age, the physical component summary was 5.1 points lower (95% confidence interval (CI): 8.6 to 1.6), and the mental component summary 4.1 points lower (95% CI: 8.4 to − 0.3) in the VLBW group compared with the control group. For both physical and mental component summaries there was an overall decline in HRQoL from 20 to 32 years of age in the VLBW group. When we excluded individuals with disabilities (n = 10), group differences in domain scores at 32 years were reduced, but physical functioning, bodily pain, general health, and role-emotional scores remained lower in the VLBW subgroup without disabilities compared with the control group.ConclusionWe found that VLBW individuals reported lower HRQoL than term born controls at 32 years of age, and that HRQoL declined in the VLBW group from 20 to 32 years of age. This was in part, but not exclusively explained by VLBW individuals with disabilities.

Effects of high-intensity interval training on health-related quality of life in chronic lymphocytic leukemia: A pilot study

IntroductionChronic lymphocytic leukemia (CLL) is the most common incurable leukemia/lymphoma in the United States. Individuals with CLL are at risk for disability, frailty, and cancer-specific complications that negatively affect health-related quality of life (HRQOL). High-intensity interval training (HIIT) and resistance training (RT) are safe and feasible for individuals with chronic diseases and when combined, they may be beneficial for reducing cancer-related fatigue, symptom burden, and global quality of life. However, no studies have examined the impact of HIIT or RT on HRQOL in CLL. The purpose of this study was to investigate the effects of a 12-week HIIT and RT (HIIT+RT) intervention on HRQOL in adults with treatment naïve CLL. Materials and MethodsChanges in HRQOL was a secondary outcome in this pilot study. Individuals with CLL (63.9 ± 8.5 yrs) were non-randomly assigned to 12 weeks of HIIT+RT or a control group. The HIIT+RT protocol consisted of three 30-min sessions/week of HIIT and two sessions/week of RT. The control group maintained usual daily activities. We assessed pre and post HRQOL using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire with domains of physical (PWB), social (SWB), emotional (EWB), functional (FWB), and general (FACT-G) well-being as well as a lymphoma-specific subscale (LymS). We used a two-way mixed analysis of variance to assess changes in HRQOL. We calculated effect size (ES) using Cohen's d. ResultsFifteen participants (HIIT+RT: n = 9; Control: n = 6) completed the study and questionnaire. Scores for FWB improved following HIIT+RT (21.7 ± 3.4 to 23.9 ± 3.2; ES = 1.38) compared to controls (25.7 ± 2.2 to 25.7 ± 2.3). The HIIT+RT group experienced clinically meaningful improvements in total FACT-Lym, FWB, FACT-G, and LymS. The control group had clinically meaningful changes only in LymS. DiscussionThe large effect sizes and clinically meaningful improvements associated with 12 weeks of HIIT+RT support the potential benefits of this type of exercise program for FWB, lymphoma-specific symptoms, and general well-being in CLL. A future randomized trial with an adequately powered sample size is needed to evaluate these findings.Trial Registration: NCT04950452