EuroQol-5 Dimensions Research Articles

A phase 4, multicenter, global clinical study to evaluate discontinuation and rechallenge of pexidartinib in patients with tenosynovial giant cell tumor previously treated with pexidartinib.

Pexidartinib is effective in patients with tenosynovial giant cell tumor (TGCT) for whom surgery is not feasible. Durability of response after discontinuation of pexidartinib and the safety and efficacy of restarting pexidartinib have not been previously recorded. This phase 4 study was designed to mimic the real-world experience with pexidartinib to evaluate the effects of discontinuation of and retreatment with pexidartinib in patients with TGCT who previously benefited from the drug. This was a global, multicenter, phase 4 study that enrolled patients with TGCT who were experiencing clinical benefit from pexidartinib in one of four prior phase 1 or phase 3 studies investigating pexidartinib in the disease. Patients could choose to continue pexidartinib at the same dose (the treatment-continuation cohort) or discontinue treatment with the option to restart pexidartinib (the treatment-free/retreatment cohort). Tumor progression determined by Response Evaluation Criteriain Solid Tumors (RECIST) version 1.1, patient-reported outcomes (the Patient-Reported Outcomes Measurement Information System-Physical Function [PROMIS-PF] questionnaire and the EuroQol 5-dimension, 5-level [EQ-5D-5L] visual analog scale), and safety were assessed every 3 months. The primary end point was the proportion of patients in the treatment-free/retreatment cohort who remained treatment-free at month 12 and 24; this did not depend on disease progression. Thirty-two patients were enrolled: 21 chose to enter the treatment-continuation cohort, and 11 entered the treatment-free/retreatment cohort. During the treatment-free period, six of 11 (54.5%) patients in the treatment-free/retreatment cohort had progressive disease (PD) according to RECIST, version 1.1, whereas no patient in the treatment-continuation cohort had disease progression. Over the 24-month study, three of 11 (27.3%) patients in the treatment-free/retreatment cohort restarted treatment because of RECIST version 1.1 PD, symptomatic progression, or both (n=1 each). The probability of remaining treatment-free in the treatment-free/retreatment cohort was 73% (95% confidence interval, 37%-90%). In the treatment-free/retreatment cohort, the median progression-free survival of the treatment-free period was 22.8 months (95% confidence interval, 1.6 months to not estimable). By 6 months of retreatment, all retreated patients achieved new disease stabilization with no new safety concerns; two patients had clinically significant improvements in PROMIS-PF and EQ-5D-5L visual analog scale scores. The mean PROMIS-PF and EQ-5D-5L scores remained stable throughout the study. There was no hepatotoxicity and no new safety signal in either cohort. In this small phase 4 study designed to evaluate outcomes in patients who stopped and restarted pexidartinib, 54.5% of patients who discontinued pexidartinib showed PD, with a median progression-free survival of 22.8 months. Each of the three patients who restarted pexidartinib stopped progressing, and some reported a new gain in physical function. No PD was detected in patients who remained on treatment, and the safety profile did not indicate long-term hepatotoxicity or any new safety concerns. Pexidartinib is a medication for people with tenosynovial giant cell tumor (TGCT) for whom surgery is not recommended. This study examined what happens when patients stop taking pexidartinib (after it has helped them) to see whether it is safe and effective to restart if needed. Thirty-two patients were followed for 2 years: 21 chose to continue pexidartinib and did not experience disease progression, while 11 chose to stop pexidartinib; 54.5% of them had disease progression within 2 years. Three patients who stopped pexidartinib restarted treatment after their tumor size increased or their symptoms worsened. Restarting pexidartinib was safe and effective in these patients.

CONTExT-RA—a cross-sectional study evaluating disease activity, quality of life and the socio-demographic profile of Irish patients with rheumatoid arthritis

Abstract Objectives CONTExT-RA is a cross-sectional, non-interventional multicentre study which enrolled patients diagnosed with rheumatoid arthritis (RA) and receiving disease-modifying anti-rheumatic drug (DMARD) treatment in a secondary care setting. The study evaluated disease control and associated disease burden amongst this Irish population. Methods Patients with RA attending six Irish rheumatology centres, were invited to participate. Each consented patient attended a single routine study visit. Disease activity was assessed using Clinical Disease Activity Index (CDAI). The primary endpoint was EuroQol-5 dimensions (EQ-5D-5L) stratified by CDAI, compared using a non-parametric Wilcoxon Rank-Sum test. Results 130 patients were included. Using CDAI, 34 (26.2%) patients were in clinical remission (CR), 42 (32.3%) had low disease activity (LDA), 41 (31.5%) had moderate disease activity (MDA) and 13 (10.0%) had high disease activity (HDA). QoL (EQ-5D-5L index (median)) scores were significantly (p < 0.001) greater for patients in CR or CR/LDA than for those with MDA/HDA, 0.866 (0.920), 0.777 (0.822) vs 0.578 (0.691), respectively. Patients in CR reported higher levels of work productivity, mean (SD) rating of 1.7 (2.52) vs those in MDA/HDA of 4.2 (3.28) (higher rating indicates greater impairment). Similar findings were observed for non-work-related activities. Conclusion Disease control for many patients with RA, treated in secondary care in Ireland, is sub-optimal with only 1 in 4 in CDAI remission. The impact of poor disease control on QoL is significant, and the superior outcomes for patients in CR provide compelling evidence that by achieving greater disease control, the burden of disease on patients can be greatly reduced.

Safety of Simultaneous vs Sequential mRNA COVID-19 and Inactivated Influenza Vaccines

Limited randomized clinical trial data exist on the safety of simultaneous administration of COVID-19 and influenza vaccines. To compare the reactogenicity, safety, and changes in health-related quality of life (HRQOL) after simultaneous vs sequential receipt of messenger RNA (mRNA) COVID-19 vaccine and quadrivalent inactivated influenza vaccine (IIV4). This randomized, placebo-controlled clinical trial was conducted between October 8, 2021, and June 14, 2023, at 3 US sites. Participants were nonpregnant persons aged 5 years or older with the intention of receiving both influenza and mRNA COVID-19 vaccines. Intramuscular administration in opposite arms of either IIV4 or saline placebo simultaneously with mRNA COVID-19 vaccine at visit 1. Those who received placebo at visit 1 received IIV4 and those who received IIV4 at visit 1 received placebo 1 to 2 weeks later at visit 2. The primary composite reactogenicity outcome was the proportion of participants with fever, chills, myalgia, and/or arthralgia of moderate or greater severity within 7 days after vaccination visits 1 and/or 2, using a 10% noninferiority margin. Secondary outcomes were solicited reactogenicity events and unsolicited adverse events (AEs) for 7 days after each visit separately and HRQOL after visit 1, assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index. Serious AEs (SAEs) and AEs of special interest (AESIs) were assessed for 121 days. Outcomes were compared between groups. A total of 335 persons (mean [SD] age, 33.4 [15.1] years) were randomized (169 to the simultaneous group and 166 to the sequential group); 211 (63.0%) were female, and 255 (76.1%) received bivalent BNT162b2 mRNA COVID-19 vaccine. The proportion with the primary composite reactogenicity outcome in the simultaneous group (25.6% [n = 43]) was noninferior to the proportion in the sequential group (31.3% [n = 52]) (site-adjusted difference, -5.6 percentage points [pp]; 95% CI, -15.2 to 4.0 pp). Respective proportions in each group were similar after each visit separately (visit 1, 40 [23.8%] vs 47 [28.3%]; visit 2, 5 [3.0%] vs 9 [5.4%]). No significant group differences in participants with AEs (21 [12.4%] vs 16 [9.6%]), SAEs (1 [0.6%] vs 1 [0.6%]), and AESIs (19 [11.2%] vs 9 [5.4%]) were observed in the simultaneous vs sequential groups, respectively. Among participants with severe reactogenicity, the mean (SD) EQ-5D-5L Index score decreased from 0.92 (0.08) to 0.92 (0.09) prevaccination to 0.81 (0.09) to 0.82 (0.12) postvaccination. In this randomized clinical trial assessing simultaneous vs sequential administration of mRNA COVID-19 and IIV4 vaccines, reactogenicity was comparable in both groups. These findings support the option of simultaneous administration of these vaccines. ClinicalTrials.gov Identifier: NCT05028361.

Prognostic nutritional index (PNI) is an independent predictor for functional outcome after hip fracture in the elderly: a prospective cohort study

SummaryThe prognostic nutritional index (PNI) is a useful tool for assessing nutritional status using serum albumin and lymphocyte count. This study indicates that a higher preoperative PNI correlates with improved mobility and health-related quality of life during the initial postoperative period in elderly patients with hip fractures.PurposeTo investigate the prognostic value of the prognostic nutritional index (PNI) in predicting mobility and health-related quality of life (HRQoL) in elderly hip fracture patients after surgery.MethodsWe prospectively involved patients aged 65 and above, who could walk freely before injury and underwent surgery between 2018 and 2019. Admission PNI was calculated as serum albumin (g/L) + 5 × total lymphocyte count (× 109/L). Patients were classified into two groups based on PNI median value. All patients were followed up by telephone for four times (30-day, 120-day, 1-year, and 3-year after surgery). The Fracture Mobility Score (FMS) and EuroQol 5-Dimension 5-Level (EQ-5D 5L) were used to evaluate mobility and HRQoL, respectively.ResultsOf 705 eligible patients, 487 completed all assessments. Patients in the higher PNI group had a significantly increased possibility of achieving unrestricted mobility at the 120-day follow-up (OR 1.69, 95% CI 1.10–2.61, P.adj = 0.017), while no significant differences were observed at other follow-ups. Additionally, patients in the higher PNI group had a significantly higher EQ-5D utility value at the 30-day follow-up (P.adj = 0.015). A linear regression model with adjusting for all confounders showed that admission PNI value was positively associated with EQ-5D utility values at 30-day, 120-day, and 1-year follow-up assessments (P.adj = 0.011, P.adj = 0.001, and P.adj = 0.030, respectively). However, this correlation was not observed at the 3-year time point (P.adj = 0.079).ConclusionThe PNI is a valuable predictor of functional outcomes in elderly patients with hip fractures following surgery.

Development of a Predictive Model for Chewing Difficulty Using EuroQol-5 Dimension Among Korean Older Adults.

We aimed to develop a predictive model for chewing difficulty using the EuroQol-5 dimension measure (EQ-5D). We included 6643 individuals aged ≥ 65 years (mean age: 72.6 ± 4.96 years; women: 3761 [56.6%]) who had completed the sixth (2013-2015) and seventh (2016-2018) Korea National Health and Nutrition Examination Survey (KNHANES). The participants were further divided into young-old (65-74 years) and old-old (≥ 75 years) adults. Data from the sixth KNHANES were used to establish an internal validation model (overall, young-old and old-old adult populations were 3472, 2271 and 1201, respectively). Data from the seventh KNHANES were used to establish an external validation model (overall, young-old and old-old adult populations were 3171, 1879 and 1292 participants, respectively). We evaluated chewing difficulty using the EQ-5D (Model 1) and comparative models, subjective oral health status indicators (SOHSI) and objective oral health status indicators (OOHSI). Compared with SOHSI and OOHSI, EQ-5D showed similar predictive utility for chewing difficulty in both the internal and external validation models. Effect sizes, quantified using Cohen's d, indicated that EQ-5D parameters had a moderate impact on the prediction accuracy for chewing difficulties.

Effects of Palliative Surgical Treatment for Spinal Metastases on the Patient's Quality of Life With a Focus on the Segment of the Metastasis: A Prospective Multicenter Study.

Prospective multicenter study. Palliative surgery is crucial for maintaining the quality of life (QOL) in patients with spinal metastases. This study aimed to compare the short-term outcomes of QOL after palliative surgery between patients with metastatic spinal tumors at different segments. We prospectively compared the data of 203 patients with spinal metastases at 2-3 consecutive segments who were divided into the following three groups: cervical, patients with cervical spine lesions; thoracic, patients with upper-middle thoracic spine lesions; and TL/L/S, patients with lesions at the thoracolumbar junction and lumbar and sacral regions. Preoperative and postoperative EuroQol 5-dimension (EQ5D) 5-level were compared. All groups exhibited improvement in the Frankel grade, performance status, pain, Barthel index, EQ5D health state utility value (HSUV), and EQ5D visual analog scale (VAS) postoperatively. Although preoperative EQ5D HSUVs did not significantly differ between the groups (cervical, 0.461 ± 0.291; thoracic, 0.321 ± 0.292; and TL/L/S, 0.376 ± 0.272), the thoracic group exhibited significantly lower postoperative EQ5D HSUVs than the other two groups (cervical, 0.653 ± 0.233; thoracic, 0.513 ± 0.252; and TL/L/S, 0.624 ± 0.232). However, postoperative EQ5D VAS was not significantly different between the groups (cervical, 63.4 ± 25.8; thoracic, 54.7 ± 24.5; and TL/L/S, 61.7 ± 21.9). Palliative surgery for metastatic spinal tumors provided comparable QOL improvement, irrespective of the spinal segment involved. Patients with upper and middle thoracic spinal metastases had poorer QOL outcomes than those with metastases in other segments; however, sufficient QOL improvement was achieved.

Quality of Life Based Health Economics Research on Pharmaceutical Intervention in Cancer Chemotherapy

The adverse chapter of cancer chemotherapy negatively impact QOL, and pharmacists play a key role in improving QOL by providing optimal drug therapy through pharmaceutical interventions. Although outpatient cancer chemotherapy is now common, the impact of pharmaceutical interventions from a QOL perspective has not been thoroughly studied. Therefore, this study investigated the impact and cost-effectiveness of pharmaceutical interventions on QOL using the EuroQol 5 Dimension (EQ-5D) and Quality of Life Questionnaire for Cancer Patients Treated with Anticancer Drugs (QOL-ACD). The study was conducted between 2013 and 2015 on 39 patients who underwent their first outpatient chemotherapy for breast cancer at Gifu Municipal Hospital. The results showed that pharmaceutical interventions improved social relationship QOL in patients experiencing fatigue during the first cycle and enhanced psychological QOL in patients with adverse events of nausea during the second cycle. Furthermore, the maximum incremental cost-effectiveness ratio (ICER) was found to be 1.3 million yen per quality-adjusted life years (QALY) according to cost utility analysis. The pharmaceutical interventions by pharmacists in outpatient cancer chemotherapy improve QOL, and the ICER remains well below the Japanese threshold, signifying clear medical and economic benefits.

Correlation between severity of preoperative low back pain and postoperative outcomes in lumbar disc herniation surgery: A retrospective cohort study.

BACKGROUND CONTEXTLow back pain (LBP) frequently occurs in patients with lumbar disc herniation (LDH), however the extent to which discectomy ameliorates it and how preoperative LBP influences postoperative outcomes remains unclear. PURPOSETo evaluate the improvement in LBP and its impact on postoperative patient-reported outcome measures (PROMs). STUDY DESIGN/SETTINGMulticenter retrospective observational study. PATIENT SAMPLEPatients undergoing discectomy for LDH at eight hospitals from April 2017 to March 2021. OUTCOME MEASURESData were collected on patients’ backgrounds, operative factors, and PROMs, including the Numeric Rating Scale (NRS) for pain in the low back, buttock, or leg, EuroQol 5 Dimension (EQ-5D), Oswestry Disability Index (ODI) scores, and postoperative satisfaction. METHODSPatients were categorized into mild (NRS 0–3), moderate (NRS 4–7), or severe (NRS 8–10) LBP groups. Inverse probability weighting with propensity scores was used to adjust for demographic and clinical differences between groups. Chi-square tests and one-way analysis of variance were conducted to compare background data and clinical characteristics. Additionally, multivariate logistic regression was performed to identify risk factors for less than 50% improvement in LBP. RESULTSThis study included 928 patients: 270 mild, 343 moderate, and 315 severe. After adjustment, preoperative NRS scores were significantly different across groups, with scores of 1.6 (SD 1.3), 5.6 (SD 1.0), and 8.8 (SD 0.9), respectively. Postoperative NRS scores also varied significantly, with worse outcomes observed in the severe group compared to the mild group, yet similar to the moderate group. A total of 46.8% of the mild group, 86.6% of the moderate group, and 72.9% of the severe group achieved a 50% decrease in NRS scores of LBP. Preoperative EQ-5D and ODI scores were significantly worse in the severe group compared to the mild or moderate groups, but postoperative scores were not significantly different between the severe and moderate groups. No significant differences in postoperative satisfaction were observed among the groups. Being female was a significant risk factor for less than 50% improvement in LBP (odds ratio = 1.56, p = 0.022). CONCLUSIONSDiscectomy significantly improved LBP in patients with LDH, including those with moderate or severe LBP. Patients with severe LBP showed similar improvements in PROMs as those with moderate LBP. Female gender emerged as a significant risk factor for less than optimal improvement in LBP.

Early high-dose cryoprecipitate to reduce mortality in adult patients with traumatic haemorrhage: the CRYOSTAT-2 RCT with cost-effectiveness analysis.

Traumatic haemorrhage is common after severe injury, leading to disability and death. Cryoprecipitate, a source of fibrinogen, may improve outcomes for patients with traumatic haemorrhage. To investigate the effects of early fibrinogen supplementation in the form of 3 pools (15 units, approximately 6g of fibrinogen) of cryoprecipitate on 28-day mortality. A randomised, parallel-group, unblinded, multicentre, international trial and economic evaluation. Patients were randomised to either the intervention (early cryoprecipitate) or the comparator (standard major haemorrhage protocol) arm via opaque, sealed envelopes in the emergency department or the transfusion laboratory/blood bank. All analyses were performed on an intention-to-treat basis. A cost-effectiveness analysis was undertaken. Twenty-five major trauma centres in the UK and one level 1 trauma centre in the USA. Adults who had traumatic haemorrhage following severe injury requiring activation of the major haemorrhage protocol and had received a blood transfusion. Early cryoprecipitate - 3 pools (equivalent to 15 single units of cryoprecipitate or 6 g of fibrinogen supplementation), infused as rapidly as possible, within 90 minutes of arrival at hospital in addition to standard major haemorrhage protocol or standard major haemorrhage protocol only. The primary outcome was all-cause mortality at 28 days. The secondary outcomes were all-cause mortality at 6 hours, 24 hours, 6 months and 12 months from admission; death from bleeding at 6 hours and 24 hours; transfusion requirements at 24 hours from admission; destination of participant at discharge; quality-of-life measurements (EuroQol-5 Dimensions, five-level version and Glasgow Outcome Scale) at discharge/day 28 and 6 months after injury; and hospital resource use up to discharge or day 28 (including ventilator-days, hours spent in critical care and inpatient stays). Eight hundred and five patients were randomised to receive the standard major haemorrhage protocol (control arm). Seven hundred and ninety-nine patients were randomised to receive an additional three pools of cryoprecipitate in addition to standard care (intervention arm). Baseline characteristics appeared well matched. Patients had a median age of 39 (interquartile range 26-55) years, and the majority (79%) were male. All-cause 28-day mortality (n=1531 patients; intention to treat) was 25.3% in the intervention arm compared with 26.1% in the control arm (odds ratio 0.96; p=0.74). There was variability in the timing of cryoprecipitate administration, with overlap between the treatment arms, limiting the degree of intervention separation. There was no evidence that early empiric administration of high-dose cryoprecipitate reduced the risk of death in unselected patients with traumatic haemorrhage. There was also no difference in adverse events. The cost-effectiveness of the intervention was similar to that of standard care. Research to evaluate if fibrinogen replacement is more beneficial for selected patients, for example those with low fibrinogen blood levels, is needed, as is further exploration of whether there is a difference in outcome according to mechanism of injury. This trial is registered as ISRCTN14998314. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/57/02) and is published in full in Health Technology Assessment; Vol. 28, No. 76. See the NIHR Funding and Awards website for further award information.

Health-related quality of life and nutrient intake of the elderly with type 2 diabetes according to comorbidity burden: a cross-sectional study

Objectives: This study aimed to explore the cross-sectional association between health-related quality of life (HRQoL) according to the number of comorbidities in older adults with type 2 diabetes mellitus (T2DM) using the Euro Quality of Life-5 Dimensions (EQ-5D) index. Methods: This study included 3,553 participants aged ≥ 65 years from the 2008–2020 Korea National Health and Nutrition Examination Survey. Dietary data were collected through 24-hour recall interviews by trained researchers, and demographic and lifestyle information via self-administered questionnaires. HRQoL was measured using a modified EQ-5D scale. Multivariable linear regression analyzed the associations between EQ-5D scores, nutrients and comorbidity, controlling for sociodemographic and health variables. Results: Most participants reported ‘no problems’ in the EQ-5D scores, although approximately 17% to 47% of participants reported ‘some problems’ or ‘extreme problems,’ depending on the dimension. As comorbidities increased, significant declines were observed across all dimensions, particularly in mobility, usual activities, pain/discomfort, and anxiety/ depression. Nutrient intake analysis revealed that participants with three or more comorbidities consumed less carbohydrates, but more fat. Conclusion: Our findings demonstrate that among older adults with T2DM, a higher number of comorbidities is associated with decreased HRQoL. Additionally, there are differences in nutrient intake patterns among those with more comorbidities, specifically decreased carbohydrate intake and increased fat intake. These results emphasize the need for comprehensive and tailored management strategies that consider both diabetes and the co-occurring health conditions. By addressing the complex healthcare needs of individuals with multiple comorbidities, it is possible to enhance their HRQoL and overall well-being.

The Association Between Physical Activity Levels and Health-related Quality of Life in Korean Elderly: The Eighth Korea National Health and Nutrition Examination Survey

OBJECTIVES This study identified the association between physical activity levels and health-related quality of life in Korean elderly.METHODS A cross-sectional study was conducted using data collected from the 8th Korea National Health and Nutrition Examination Survey. The data for the analysis included socioeconomic variables, adherence to WHO-recommended levels of aerobic physical activity and resistance exercise, subjective perceived health and health-related quality of life as measured by the EuroQol-5 Dimension (EQ-5D). Odds ratio and 95% confidence interval were calculated for the association using the complex samples logistic regression analysis.RESULTS There were significant differences in subjective perceived health and health-related quality of life based on the levels of aerobic physical activity and resistance exercise. Elderly individuals who engaged in aerobic physical activity and resistance exercise at levels recommended by the WHO had higher perceived health and better health-related quality of life. And it was confirmed that the level of physical activity and health-related quality of life had a significant association even after adjusting for socioeconomic factors.CONCLUSIONS The findings of this study indicate that performing aerobic activity and resistance exercise at levels recommended by the WHO significantly improved health-related quality of life in Korean elderly.

Prevalence and Pathophysiology of Loose Stools and Their Impact on Clinical Severity and Quality of Life in Women With Fecal Incontinence.

To compare the impact of fecal consistency with anorectal sphincter dysfunctions on clinical severity and quality of life (QoL) in women with fecal incontinence (FI). FI affects up to 24% of middle-aged women, significantly impacting their QoL. Pathophysiological studies have focused more on sphincter and anorectal dysfunctions than on the role of fecal consistency. A cross-sectional observational study evaluating anorectal physiology, neurophysiology, and fecal consistency with regard to clinical severity and QoL. Patients with a Bristol Stool Chart (BSC) score of 5 or more (BSC ≥5) underwent a breath test to detect bacterial overgrowth (small intestinal bacterial overgrowth), lactose or fructose/sorbitol malabsorption, and/or a cholestyramine test to detect bile acid malabsorption. We compared anorectal physiology, clinical severity, and QoL of those with BSC ≥5 with BSC <5. The study included 150 women with an average age of 64.81 ± 11.96. FI types varied: 64.38% had urge FI, 15.06% had passive FI, and 19.18% had both. Among them, 56.2% had BSC ≥5, linked to bile acid malabsorption (20.5%), lactose malabsorption (17.9%), small intestinal bacterial overgrowth (14.3%), and fructose/sorbitol malabsorption (14.3%). Anorectal dysfunctions were highly prevalent, with 49.1% showing external anal sphincter insufficiency, 9.8% internal, and 34.7% both. Those with BSC ≥5 experienced significantly worse clinical severity and QoL (St. Mark 17.3 ± 2.69 vs 12.9 ± 3.27), and more pronounced issues in Fecal Incontinence Quality of Life Scale dimensions of lifestyle, coping, depression, and EuroQol 5-dimension of anxiety/depression and pain/discomfort. Fecal consistency of BSC ≥5 significantly worsens clinical severity and QoL in women with FI. Specific diagnostic and therapeutic approaches addressing loose stools are needed before any rehabilitation treatment.

Sex-related differences in health-related quality-of-life measured using the EuroQol 5-Dimension questionnaire across the LVEF spectrum in DAPA-HF and DELIVER

Abstract Background Although sex-related differences in response to disease-specific health-related quality-of-life (HRQL) instruments such as the KCCQ have been investigated in patients with heart failure (HF), this is not the case for generic HRQL instruments. Purpose To assess the sex-specific differences in health status measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) in patients with HF with reduced and mildly reduced or preserved ejection fraction (HFrEF and HFmrEF/HFpEF), and to assess the effect of dapagliflozin on EQ-5D-5L index scores. Methods Using patient-level data from the DAPA-HF and DELIVER trials comparing dapagliflozin to placebo, we analysed patient-reported outcomes for each dimension of the EQ-5D index scores between men and women. The 5 dimensions of the descriptive section of the EQ-5D-5L include mobility ("walking around"), self-care ("washing or dressing self"), usual activities ("e.g., work, study, housework, family or leisure activities"), pain/discomfort ("pain or discomfort"), and anxiety/depression ("anxious or depressed"). Each dimension is divided into 5 levels (1-5) i.e., no problem, slight problem, moderate problem, severe problem, and extreme problem (cannot do activity/extreme symptom). Results Of 4744 patients with HFrEF, 4390 completed the EQ-5D-5L index scores (3408 men and 982 women, 77.6% vs. 22.4%). The correresponding numbes in 6263 patients with HFmrEF/HFpEF were 5745 overall and 3320 men vs. 2425 women (57.8% vs. 42.2%). Regardless of HF phenotype, women had significantly worse (lower) baseline index scores overall compared to men (0.849 vs. 0.899 in HFrEF and 0.844 vs. 0.884 in HFmrEF/HFpEF, both p&amp;lt;0.001). Although scores varied markedly by question, women generally had worse health status in all the dimensions as compared with men in patients with HFrEF (39% vs. 29% reporting a moderate or greater problem for mobility, 17% vs. 9% for self-care, 36% vs. 25% for usual activities, 29% vs. 19% for pain/discomfort, and 21% vs. 13% for anxiety/depression, all p&amp;lt;0.001) (Figure, top panel). A broadly similar pattern was observed in HFmrEF/HFpEF (Figure, bottom panel). In all patients, across the range of LVEF, there dapagliflozin led to a significant placebo corrected increase (improvement) in index score (0.008, 95% CI 0.002 to 0.014), with no interaction between sex and the effect of dapagliflozin (p for interaction with sex = 0.50). Conclusions Women reported significantly poorer health status in both HFrEF and HFmrEF/HFpEF compared to men. Dapagliflozin treatment improved EQ-5D index scores irrespective of sex across the range of ejection fraction. Figure Sex differences in the distribution of responses to EQ-5D-5L questionnaire. EQ-5D-5L, EuroQol 5-Dimension 5-Level questionnaire; HFmrEF, heart failure with mildly reduced ejection fraction; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction.

Assessment of quality of life using EuroQol 5-Dimension questionnaire level sum score in patients with HFrEF, HFmrEF, and HFpEF: a patient-level meta-analysis of DAPA-HF and DELIVER

Abstract Background The impact of SGLT2 inhibitors on generic quality of life in heart failure (HF) has not been evaluated. Purpose To quantify individual dimension scores and the Level Sum Score of the EQ-5D-5L (EQ-5D-LSS) in patients with HFrEF and HFmrEF/HFpEF, the association between these scores and outcomes, and the impact of treatment with dapagliflozin on these scores. Methods The 5 dimensions of the descriptive section of the EQ-5D-5L include mobility ("walking around"), self-care ("washing or dressing self"), usual activities ("e.g., work, study, housework, family or leisure activities"), pain/discomfort ("pain or discomfort"), and anxiety/depression ("anxious or depressed"). Each dimension is divided into 5 levels (1-5) i.e., no problem, slight problem, moderate problem, severe problem, and extreme problem (cannot do activity/extreme symptom). All dimensions and severity levels contribute equally when calculating the LSS. The individual dimension scores and the LSS were analyzed in patients with HFrEF and HFmrEF/HFpEF in the DAPA-HF and DELIVER trials, which compared dapagliflozin to placebo. Results Scores varied markedly by question with 37/30/33% of patients reporting no, a slight, or a moderate or greater problem for mobility; 67/20/13% for self-care; 40/33/27% for usual activities; 45/32/23% for pain/discomfort; and 57/27/16% for anxiety/depression. Compared to lower (better) LSS, patients with higher (worse) LSS were more often female, had more comorbidities, and had worse HF status. Compared to patients free from any problem across all dimensions (i.e. LSS of 5), the hazard ratios (95% CI) for time to first cardiovascular death or worsening HF were 1.27 (1.10-1.47), 1.70 (1.46-1.98), and 2.31 (1.88-2.85) in those with LSSs of 6-10, 11-15, 16-25 points, respectively. Patients randomized to dapagliflozin experienced greater improvement and less worsening across all EQ-5D-5L dimensions except pain/discomfort (Figure). Conclusions The EQ-5D-5L individual dimension questions revealed problems not often associated with (pain) or quantified in (anxiety/depression) HF and demonstrated the marked limitation of ordinary activities experienced by many patients with HF. Most EQ-5D-5L domain questions, including anxiety/depression, improved with dapagliflozin. The LSS, incorporating these domains was associated with clinical outcomes.

The Effect of Blood Flow Restriction Exercise Prior to Total Knee Arthroplasty on Postoperative Physical Function, Lower Limb Strength and Patient-Reported Outcomes: ARandomized Controlled Trial.

30-s sit to stand (30STS). Timed Up&Go, 40-m walk test (40mWT), knee range of motion (ROM) 1-repetition maximum (1RM) leg press and knee extensor strength, maximal isometric contraction (MVIC) for the knee extensors and flexors, Knee injury and Osteoarthritis Outcome Score (KOOS), and Euroqol 5-dimensions (EQ-5D-L5) questionnaire. Data were collected at baseline (12 weeks pre-surgery), ~3 days pre-surgery, 3 and 12 months postoperatively. Intention-to-treat analysis revealed no significant between-group differences in the change from baseline to 3 and 12 months postoperatively on 30STS, TUG, or 40mFWT. Significant between-group differences were observed at 3 but not 12 months postoperatively for the corresponding changes in 1RM leg press strength, 1RM knee extensor strength, and MVIC knee extensor favoring BFR-RT. No between-group differences were observed for the delta changes from baseline in knee ROM, KOOS subscales or EQ-5D-L5 at any postoperative time points. These findings suggest that preoperative BFR-RT offered no superior effects compared with usual preoperative care on postoperative physical function or patient-reported outcomes. Preoperative BFR-RT produced amplified gains in lower limb muscle strength at 3 months postoperatively. NCT04081493.

Impacts of chronic diseases and multimorbidity on health-related quality of life among community-dwelling elderly individuals in economically developed China: evidence from cross-sectional survey across three urban centers

ObjectiveAs the ageing process in China further accelerates and the average life expectancy increases, chronic disease prevalence and multimorbidity rates are constantly rising, especially among elderly individuals. However, few previous studies have explored the impacts of chronic diseases and multimorbidity on health-related quality of life (HRQoL). This study aimed to investigate this association among community-dwelling elderly individuals in China.MethodsA cross-sectional study was conducted in communities in three cities (Suzhou, Qingdao, and Guangzhou). The basic characteristics, chronic diseases and HRQoL of participants were collected, and HRQoL was measured by the EuroQol 5-Dimensions 3-Level version (EQ-5D-3L). Logistic regression, Tobit regression and generalized linear models were used to assess the impacts of chronic diseases and multimorbidity on HRQoL.ResultsApproximately 83.2 percent of the 1,218 respondents had chronic conditions, with 30 percent having multimorbidity. After controlling for sociodemographic and health behaviour factors, patients with stroke were more likely to report problems in all five dimensions of the EQ-5D and had a lower EQ-5D utility index (UI) (b = -0.342) than patients with other chronic conditions. Patients with chronic pulmonary obstruction had a lower EuroQol Visual Analog Scale (EQ-VAS) (b = -11.169) than patients with other chronic conditions. Furthermore, patients with multimorbidity had worse HRQoL (P < 0.001).ConclusionsBoth chronic condition probability and multimorbidity rates were high among Chinese community-dwelling elderly individuals. Different disease types had varying degrees of impact on HRQoL, and patients with multimorbidity had worse HRQoL. This study proposes that the government enhance the quality of life of community-dwelling elderly individuals with multimorbidity by establishing long-term care insurance and expanding comprehensive community-based home health care services.

Improved health-related quality of life in patients with recurrent Clostridioides difficile infection after treatment with faecal microbiota transplantation

Background Clostridioides difficile is a major burden for both healthcare systems and the patients. Faecal microbiota transplantation (FMT) is becoming more common as a treatment since it reduces the risk of recurrent Clostridioides difficile infection (rCDI). Objectives To evaluate how treatment with FMT is affecting the health-related quality of life (HRQoL) in patients with rCDI. Methods A prospective observational cohort study was conducted where patients who were offered FMT as a treatment for rCDI were asked to fill in a questionnaire based on the Short Health Scale (SHS) and EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) about their HRQoL before and after treatment. Results Patients with rCDI had poor HRQoL, which improved following FMT. Conclusions Since FMT cures, reduces the risk of new recurrences of CDI and improves the HRQoL of the patients, it should be offered as a treatment for patients with rCDI. Also, SHS is a useful and reliable instrument for measuring HRQoL in patients with rCDI.

Determinants of poor health-related quality of life among outpatients with rheumatoid arthritis in Jordan.

The purpose of this study was to assess the health-related quality of life (HRQOL) and investigate the variables contributing to reduced HRQOL in patients with rheumatoid arthritis. The present cross-sectional study was conducted on patients diagnosed with rheumatoid arthritis at two teaching hospitals in Jordan using a convenience sampling technique. The participants were interviewed face-to-face during the scheduled appointment at the outpatient rheumatology clinic. The HRQOL was evaluated by the validated EuroQol-5 Dimension (EQ-5D) questionnaire, which included the EQ-5D utility index that evaluated HRQOL in terms of 5 domains, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and the EQ-5D visual analogue scale (EQ-5DVAS), which evaluated HRQOL on a vertical scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). The validated short version of the 19-item Compliance Questionnaire for Rheumatology (CQR-5) was used to evaluate medication adherence. The Clinical Disease Activity Index (CDAI) was used to assess disease activity among the study participants. A stepwise quantile regression model (q = 0.5) was conducted to explore the factors associated with the EQ-5DUtility Index and EQ-5DVAS scores. In total, 261 patients with RA participated in the study. The median (interquartile range) of the EQ-5DUtility Index and EQ-VAS scores was 0.552 (0.006-0.726) and 0.506 (0.233-0.690), respectively. Regression analysis results demonstrated that medication non-adherence (regression coefficient (β) = -0.348, P<0.01), not performing regular physical activity (β = -0.209, P<0.01), and higher disease activity as measured by the CDAI score (β = -0.015, P<0.01) were significant predictors of a lower EQ-5DUtility Index score. In addition, medication non-adherence (β = -0.199, P<0.01), not performing regular physical activity (β = -0.117, P<0.01), increased body mass index (BMI) (β = -0.009, P<0.01), and higher CDAI score (β = -0.009, P<0.01) were significant predictors of low EQ-5DVAS score. Patients with RA experienced significantly impaired HRQOL. Medication non-adherence, not performing regular physical activity, increased body weight, and increased disease activity were identified as determinants of poor HRQOL among patients with RA in the present study. Treating physicians should encourage regular physical activity, maintaining a healthy body weight, and controlling disease activity to improve HRQOL in patients with RA.

Enhanced Recovery After Surgery Protocols in One- or Two-Level Posterior Lumbar Fusion: Improving Postoperative Outcomes.

Background/Objectives: Enhanced recovery after surgery (ERAS) protocols optimize perioperative care and improve recovery. This study evaluated the effectiveness of ERAS in one- or two-level posterior lumbar fusion surgeries, focusing on perioperative medication use, pain management, and functional outcomes. Methods: Eighty-eight patients undergoing lumbar fusion surgery between March 2021 and February 2022 were allocated into pre-ERAS (n = 41) and post-ERAS (n = 47) groups. Outcomes included opioid and antiemetic consumption, pain scores (numerical rating scale (NRS)), functional recovery (Oswestry Disability Index (ODI) and EuroQol 5 Dimension (EQ-5D)), and complication rates. Pain was assessed daily for the first four postoperative days and at 6 months. Linear Mixed Effects Model analysis evaluated pain trajectories. Results: The post-ERAS group showed significantly lower opioid (p = 0.005) and antiemetic (p < 0.001) use. No significant differences were observed in NRS pain scores in the first 4 postoperative days. At 6 months, the post-ERAS group reported significantly lower leg pain (p = 0.002). The time:group interaction was not significant for back (p = 0.848) or leg (p = 0.503) pain. Functional outcomes at 6 months, particularly ODI and EQ-5D scores, showed significant improvement in the post-ERAS group. Complication rates were lower in the post-ERAS group (4.3% vs. 19.5%, p = 0.024), while hospital stay and fusion rates remained similar. Conclusions: The ERAS protocol significantly reduced opioid and antiemetic use, improved long-term pain management and functional recovery, and lowered complication rates in lumbar fusion patients. These findings support the implementation of ERAS protocols in spinal surgery, emphasizing their role in enhancing postoperative care.

Application of WeChat-based cognitive behavioural stress management for early-stage cervical cancer patients: a randomised controlled study

Background This randomised controlled study was aimed at investigating the effects of WeChat-based cognitive behavioural stress management (WB-CBSM) on the mental health of patients with early-stage cervical cancer treated with surgical resection. Methods A total of 184 patients with early-stage cervical cancer were randomised to receive either WB-CBSM (n = 92) or normal care (NC) (n = 92) for 8 weeks. Results Compared with the NC group, the WB-CBSM group exhibited reduced Hospital Anxiety and Depression Scale (HADS)–anxiety scores at months (M)1 (t = 2.022, P = 0.045), M3 (t = 2.575, P = 0.011), and M6 (t = 2.709, P = 0.007); anxiety rates at M3 (χ2 = 4.834, P = 0.028) and M6 (χ2 = 5.182, P = 0.023); HADS–depression scores at M3 (t = 2.069, P = 0.040) and M6 (t = 2.449, P = 0.015); and depression rates at M6 (χ2 = 4.268, P = 0.039). Moreover, the WB-CBSM group showed increased Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being scale scores at M1 (t = −2.001, P = 0.047), M3 (t = −2.281, P = 0.024), and M6 (t = −3.501, P = 0.001); the Quality of Life Questionnaire-Core 30 (QLQ-C30) global health score at M3 (t = −2.034, P = 0.043) and M6 (t = −2.426, P = 0.016); and QLQ-C30 function score at M3 (t = −2.009, P = 0.046). However, the groups exhibited decreased EuroQol-5 dimension scores at M3 (t = 2.056, P = 0.041) and M6 ((t = 2.242, P = 0.026) and QLQ-C30 symptom scores at M1 (t = 2.026, P = 0.044) and M3 (t = 2.210, P = 0.028). Conclusion WB-CBSM reduced anxiety and depression and improved the spiritual well-being and quality of life of patients with early-stage cervical cancer treated with surgical resection.