EQ-5D VAS Research Articles

The self-medication behaviors of residents and the factors related to the consideration of drug efficacy and safety-A cross-sectional study in China.

Background: Over-the-counter (OTC) drugs facilitates residents self-medication. However, inappropriate self-medications have become a serious problem in China and even all over the world. Objectives: To make an investigation on the current status of Chinese residents' self-medication behaviors and important considerations, and to explore the factors related to the considerations of drug efficacy and safety. Design: A quantitative, cross-sectional study. Methods: Multi-stage sampling was used to conduct a cross-sectional investigation in China 22 provinces, 5 autonomous regions and 4 municipalities directly under the Central Government. State that an interviewer-administrated questionnaire, was used for data collection. The questionnaire that was used in the investigation included demographic sociological characteristics, health literacy scale-short form (HLS-SF), the 10-item Big Five Inventory (BFI-10), the EuroQol-5D visual analogue scale (EQ-5D VAS), self-medication status and important considerations when self-medicating. Descriptive statistics were performed, and the Chi-square test was used for univariate analysis. Log-binomial regression was used for multivariate analysis on whether residents regard drug efficacy or safety as an important consideration. Results: 9256 respondents were included in the data analysis. The self-medication rate of Chinese adults was as high as 99.1%. Paracetamol and other analgesics were the most common types of OTC medication that respondents purchased, followed by vitamins/minerals. Medical staff recommendations, drug safety and efficacy were the top three important considerations. The residents in the east, central and western regions who consider safety is 63.5%, 61.5%, and 66.8% respectively. The proportion of curative effect was 60.2%, 55.7%, and 61.4% respectively. Log-binomial regression showed that western respondents, retired people, those who mainly used ways including basic medical insurance for employees, commercial medical insurance, free medical treatment to cover their medical cost, respondents with high neuroticism, high health literacy were more likely to consider drug safety as an important factor (p < 0.05). Eastern respondents, employed, main way of medical expenses borne was Out-of-pocket Payment, those with chronic disease were more likely to consider drug efficacy as an important factor (p < 0.05). Female, respondents with high levels of agreeableness, conscientiousness, openness, and self-rated health status were more likely to regard both drug safety and efficacy as important considerations (p < 0.05). Conclusion: Self-medication is practiced by most Chinese adults. Whether Chinese adults take drug efficacy or safety as an important consideration is related to their demographic and sociological characteristics, Big Five personality characteristics, health literacy and self-assessed health status. There is a need to strengthen the management of OTC drugs and public education about self-medication.

Real-world treatment and quality of life (QOL) in locally advanced or metastatic urothelial carcinoma (la/mUC) in Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey.

462 Background: Little is known about treatment and QOL of la/mUC in Saudi Arabia, South Korea, Turkey, and Taiwan. Therefore, this study assessed patient (pt), tumor, and disease characteristics; treatment sequencing; and QOL in pts with la/mUC treated in these countries. Methods: Data were drawn from the Adelphi mUC Disease-Specific Programme, a real-world, multinational, point-in-time study using validated methodology (Anderson et al. Curr Med Res Opin. 2008;24:3063-72) and included physician surveys, chart reviews, and pt questionnaires (Saudi Arabia, Turkey, and Taiwan only). Data were collected (12/2021–3/2022) from oncologists and urologists and adult pts with confirmed la/mUC. EQ-5D visual analogue scale (VAS; scores: 0 [worst health] to 100 [best health]) and the global health status (QL2) from the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (scores: 0 [low functioning] to 100 [high functioning]) questionnaires were used to assess QOL. Results: Data were provided by 175 physicians for 988 pts (Turkey, n=300; Saudi Arabia, n=240; South Korea, n=298; Taiwan, n=150) with la/mUC. Mean pt age was 66.3 y; 77% were men. Most (77%) pts had no family history of urothelial carcinoma (UC); 30% recorded no risk factors (eg, genetic risk, smoking, occupational exposure). At initial UC diagnosis, the bladder was the initial tumor location in 82% of pts, of whom 67% had la/mUC, and 83% of pts had an Eastern Cooperative Oncology Group performance status 0–2. At data collection, the most common metastatic sites were the lymph nodes (53%), lungs (29%), liver (27%), and bone (21%). Biomarker/tumor testing was not done in 45% of pts. In pts initially diagnosed with nonmetastatic UC (n=346), 28% received neoadjuvant and 31% received adjuvant therapy. Of pts receiving ≥1 line of therapy (LOT) for la/mUC (n=988), 74% received gemcitabine, 60% received cisplatin, 18% received carboplatin, 17% received a programmed cell death protein 1/ligand 1 (PD-1/L1) inhibitor, and 4% received best supportive care (BSC) in the first-line (1L) setting; mean duration of therapy (DOT) in 1L was 5.7 mo. Of pts receiving ≥2 LOTs for la/mUC (n=290), 63% received a PD-1/L1 inhibitor and 35% received chemotherapy in the second-line (2L) setting; mean DOT in 2L was 4.9 mo. Of pts receiving ≥3 LOTs for la/mUC (n=87), 59% received chemotherapy (most often cisplatin [46%] or gemcitabine [38%]), 34% received a PD-1/L1 inhibitor, and 10% received BSC only in the third-line (3L) setting; mean DOT in 3L was 4.3 mo. Questionnaires were available for 319 pts. Mean (SD) EQ-5D VAS score was 51.8 (15.6); EORTC QL2 score was 44.6 (19.9). Conclusions: Pts with la/mUC in this multinational study generally received 1L platinum-based and 2L PD-1/L1 inhibitor therapies. These results highlight the need for therapies that improve clinical and QOL outcomes.

Health-related quality of life (HRQoL) associated with fruquintinib in the global phase 3, placebo-controlled, double-blind FRESCO-2 study.

67 Background: The global phase 3 FRESCO-2 study, (NCT04322539) demonstrated that fruquintinib (F) vs placebo (P) significantly improved OS (HR=0.66 [95% CI: 0.55-0.80]; p&lt;0.001) and PFS (HR=0.32 [95% CI: 0.27-0.39]; p&lt;0.001) in heavily pre-treated patients (pts) with refractory metastatic colorectal cancer (mCRC). F safety profile was consistent with the established monotherapy profile. Here we report the HRQoL and tolerability results. Methods: Pts were randomized 2:1 to F + BSC or P + BSC. EORTC QLQ-C30 and EQ-5D-5L were assessed at baseline and on Day (D) 1 of each Cycle (C) until treatment discontinuation, and ECOG PS was assessed at baseline, D1 of each C, and D21 of C1 to C3. Least-squares mean (LSM) change from baseline to post-baseline visits and the difference between F and P in QLQ-C30 scale scores (e.g. global health status [GHS]/QoL) and EQ-5D-5L scale scores (e.g. visual analog scale [VAS]) were calculated using mixed model repeated measures approach. For each scale, the appropriate minimally important difference (MID) thresholds were determined to evaluate the improvement or deterioration. Time to deterioration (TTD), defined as worsening from baseline in scale-specific MID or death, was analyzed using Kaplan-Meier method, adjusted log-rank test, and stratified Cox PH model. QLQ-C30 and EQ-5D-5L analyses were conducted on the ITT population, and ECOG PS was on the safety population. Results: 691 pts were randomized (F: 461 vs P: 230) and 686 pts received study drug (F: 456 vs P: 230). Median treatment Cycles received (range) were 3 (1, 20) for F vs 2 (1, 13) for P. More than 79% of pts on both arms had a baseline and ≥1 post-baseline assessment for QLQ-C30, EQ-5D-5L, and ECOG PS. GHS/QoL was similar between F and P at baseline; the LSM differences between F and P were 1.7 (95% CI: -1.7, 5.0) for C2 and 1.6 (95% CI: -3.2, 6.4) for C3. At C4, &lt;30 P patients were available. The % of patients who remained stable (MID -6.38 to &lt;8.43) or improved (≥8.43) was numerically higher for F vs P (C2: 61.5% vs 57.1%; C3: 56.4% vs 50.9%). Median TTD was 2.1 months in F and 1.8 months in P (HR=0.9; 95% CI: 0.7-1.0; P=0.098). EQ-5D VAS was similar between F and P at baseline; the LSM differences between F and P were 0.6 (95% CI: -2.3, 3.5) for C2 and 1.4 (95% CI: -2.8, 5.6) for C3. The % of patients who remained stable (MID -7 to &lt;7) or improved (≥7) was similar for F and P (C2: 64.6% vs 58.3%; C3: 64.2% vs 64.8%). Median TTD was 2.6 months in F and 1.9 months in P (HR=0.8; 95% CI: 0.6-0.9; P=0.001). The % of patients with ≥1-point increase from baseline in ECOG PS was 52.1% in F vs 54.0% in P. Conclusions: HRQoL is not negatively impacted by treatment with F. TTD in health utility instrument EQ-5D is improved for patients receiving F. These results, along with improved OS and PFS and favorable toxicity profile, further support F as a potential new treatment option for patients with refractory mCRC. Clinical trial information: NCT04322539 .

THE TRANSLATED PROXIMAL HUMERUS FRACTURE: A COMPARISON OF OPERATIVE AND NONOPERATIVE MANAGEMENT

There is very limited literature describing the outcomes of management for proximal humerus fractures with more than 100% displacement of the head and shaft fragments as a separate entity. This study aimed to compare operative and non-operative management of the translated proximal humerus fracture.A prospective cohort study was performed including patients managed at a Level 1 trauma centre between January 2010 to December 2018. Patients with 2, 3 and 4-part fractures were included based on the degree of translation of the shaft fragment (≥100%), resulting in no cortical contact between the head and shaft fragments. Outcome measures were the Oxford Shoulder Score (OSS), EQ-5D-5L, and radiological outcomes. Complications recorded included further surgery, loss of position/fixation, and non-union/malunion. Linear and logistic regression models were used to compare management options.There were 108 patients with a proximal humerus fracture with ≥100% translation; 76 underwent operative management and 32 were managed non-operatively with sling immobilisation. The mean (SD) age in the operative group was 54.3 (±20.2) and in the non-operative group was 73.3 (±15.3) (p&lt;0.001). There was no association between OSS and management options (mean 38.5(±9.5) operative vs mean 41.3 (±8.5) non-operative, p=0.48). Operative management was associated with improved health status outcomes; EQ-5D utility score adjusted mean difference 0.16 (95%CI 0.04-0.27, p=0.008); EQ-5D VAS adjusted mean difference 19.2 (95%CI 5.2-33.2, p=0.008). Operative management was further associated with a lower odds of non-union (adjusted OR 0.30, 95%CI 0.09-0.97, p=0.04), malunion (adjusted OR 0.14, 95%CI 0.04-0.51, p=0.003) and complications (adjusted OR 0.07, 95%CI 0.02-0.32, p=0.001).Translated proximal humerus fractures with ≥100% displacement demonstrate improved health status and radiological outcomes following surgical fixation. Patients with this injury should be considered for operative intervention.

Health Expectations and Quality of Life After Acute Respiratory Failure: A Multicenter Prospective Cohort Study

Patients often have high expectations for recovery after critical illness, but the impact of these expectations on subsequent quality of life (QoL) after serious illnesses has not been evaluated empirically. Among adult survivors of acute respiratory failure (ARF), are met vsunmet expectations for health associated with self-reported QoL 6months after discharge? This was a prospective longitudinal cohort study enrolling consecutive adult patients with ARF managed in ICUs at five academic medical centers. At hospital discharge, we evaluated participants' expected health 6months in the future via a visual analog scale (VAS; range, 0-100), with higher scores representing better expected health. At 6-month follow-up, perceived health was assessed using the EQ-5D VAS, and QoL was assessed using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) instrument. Participants' health expectations were categorized as having been met when perceived health at 6months was no more than eight points lower than their expectation at study enrollment. The primary analysis compared WHOQOL-BREF domain scores (range, 0-100) at 6months after discharge in patients with met vsunmet health expectations using the nonparametric Mann-Whitney U test. Secondary analysis modeled WHOQOL-BREF domain scores using multivariate regression, and sensitivity analyses assessed QoL using EQ-5D-5L index values. In the primary analysis, QoL was significantly better among participants with met vsunmet health expectations across all domains of the WHOQOL-BREF: physical health (estimated difference in scores: median, 19 [interquartile range (IQR), 12-15]; P< .001), psychological health (median, 12 [IQR, 6-18]; P< .001), social relationships (median, 6 [IQR, 0-13]; P= .02), and environmental health (median, 12 [IQR, 6-13]; P< .001). In multivariate regression, the difference between expected and perceived health remained associated significantly with the physical health domain score. Fulfillment of health expectations is associated with better QoL after ARF, suggesting a mechanism underpinning successful ICU recovery programs that incorporate normalization and expectation management.

Knee function, quality of life, pain, and living conditions after distal femoral resection knee arthroplasty for non-tumor indications

BackgroundDistal femoral resection knee arthroplasty is a limb salvage procedure. The impact of distal femoral resection arthroplasty on patient function and health status is unknown. The aim of this study was to report knee function, quality of life, knee pain, and living conditions after distal femoral resection knee arthroplasty for non-tumor indications.MethodsOf 52 patients (52 knees) undergoing distal femoral resection knee arthroplasty in a single institution between 2012 and 2021, 22 were excluded as 3 patients had ≤90 days follow-up, 6 had died, and 13 declined or were unable to participate for unrelated reasons. Thus, 30 patients were included and interviewed by telephone in March 2021 (mean follow-up 3.5 years after surgery). Patient completed the Oxford Knee Score (0–48, 48 best), EQ-5D-5L, and the Copenhagen Knee ROM, and information on pain and living conditions was obtained.ResultsThe mean age was 67.9 years (SD 13.6), and 21 (70%) were female.Mean total Oxford Knee Score was 29.9 (SD 10.5), mean Copenhagen Knee ROM flexion was 116° (SD 21.6), and mean extension was − 2° (SD10.1). Mobility aids were used by 18 (60%) patients, i.e. a cane (30%), walker (26.7%) or wheelchair (3.3%).Mean EQ-5Dindex score was 0.70 (SD 0.22) and mean EQ-5D VAS score was 55.4 (SD 23.9). Nine (30%) patients used paracetamol or NSAID and 2 (6.7%) used opioids for knee pain. Mean VAS knee pain score was 1.30 (SD 2.2) at rest and 2.8 (SD 3.1) when walking.Most (90%) patients lived in their own home, with only 3 patients in nursing homes. Two-thirds (66.7%) required no home care, 5 (16.6%) received home care 1–2 times over 2 weeks, and 5 (16.6%) every day.ConclusionDistal femoral resection knee arthroplasty appears to be a viable treatment option for non-tumor indications. Acceptable patient outcomes were achieved in terms of functional status and quality of life, especially considering treatment alternatives such as femoral amputation.

Real-World Outcomes of Adalimumab Treatment for Moderate and Severe Psoriasis in Korean Patients (RAPSODI Study).

Psoriasis imposes a significant treatment burden on patients, particularly impacting well-being and quality of life (QoL). The psychosocial impact of psoriasis treatments remains unexplored in most patient populations. To assess the impact of adalimumab on health-related QoL (HRQoL) in Korean patients with psoriasis. This 24-week, multicenter, observational study, assessed HRQoL in Korean patients treated with adalimumab in a real-world setting. Patient-reported outcomes (PROs) including European Quality of Life-5 Dimension scale (EQ-5D), EQ-5D VAS, SF-36, and DLQI were evaluated at week 16 and 24, versus baseline. Patient satisfaction was assessed using TSQM. Among 97 enrolled patients, 77 were assessed for treatment effectiveness. Most patients were male (52, 67.5%) and mean age was 45.4 years. Median baseline body surface area and Psoriasis Area and Severity Index (PASI) scores were 15.00 (range 4.00~80.00) and 12.40 (range 2.70~39.40), respectively. Statistically significant improvements in all PROs were observed between baseline and week 24. Mean EQ-5D score improved from 0.88 (standard deviation [SD], 0.14) at baseline to 0.91 (SD, 0.17) at week 24 (p=0.0067). The number of patients with changes in PASI 75, 90, or 100 from baseline to week 16 and 24 were 65 (84.4%), 17 (22.1%), and 1 (1.3%); and 64 (83.1%), 21 (27.3%), and 2 (2.6%), respectively. Overall treatment satisfaction was reported, including effectiveness and convenience. No unexpected safety findings were noted. Adalimumab improved QoL and was well-tolerated in Korean patients with moderate to severe psoriasis, as demonstrated in a real-world setting. Clinical trial registration number (clinicaltrials.gov: NCT03099083).

Reach and efficacy of the eHealth application Oncokompas, facilitating partners of incurably ill cancer patients to self-manage their caregiver needs: a randomized controlled trial

PurposeMany partners of incurably ill cancer patients experience caregiver burden. The eHealth application “Oncokompas” supports these partners to manage their caregiver needs and to find optimal supportive care for themselves. The aim of this randomized controlled trial (RCT) was to investigate the reach of Oncokompas and its efficacy on caregiver burden, self-efficacy, and health-related quality of life (HRQOL).MethodsThe reach was estimated based on eligibility, participation rate, and an evaluation of the recruitment process. Efficacy on caregiver burden was measured using the Caregiver Strain Index + (CSI +). Secondary outcomes were self-efficacy (General Self-Efficacy Scale (GSE)) and HRQOL (EQ-5D VAS). Assessments were scheduled at baseline, 2 weeks after randomization and 3 months after baseline. Linear mixed models were used to compare longitudinal changes between the experimental and control group from baseline to the 3-month follow-up.ResultsThe reach, in terms of eligibility and participation rate, was estimated at 83–91%. Partners were most likely reached via palliative care consultants, patient organizations, and palliative care networks. In the one-and-a-half-year recruitment period and via the 101 organizations involved, 58 partners were included. There were no significant effects of Oncokompas on caregiver burden, self-efficacy, or HRQOL.ConclusionThe reach of Oncokompas among interested individuals was high, but the difficulties that were encountered to include partners suggest that the reach in real life may be lower. This study showed no effect of Oncokompas on caregiver burden, self-efficacy, or HRQOL in partners of incurably ill cancer patients.RelevanceThe results of this study may be used in the process of developing, efficacy testing, and implementing eHealth applications for caregivers of incurably ill cancer patients.Trial registrationNetherlands Trial Register identifier: NTR7636/NL7411. Registered on November 23, 2018 (https://www.trialregister.nl/).

Improved health-related quality of life after cardioneuroablation in patients with vasovagal syncope.

As the most common cause of syncope, vasovagal syncope (VVS) is mediated by parasympathetic overactivity and/or sympathetic withdrawal. Although catheter ablation of ganglionated plexi or cardioneuroablation has been used to treat VVS, its role in quality of life (QoL) has not been formally evaluated. The aim of this study was to demonstrate if this novel treatment results in improvement QoL of patients with VVS. Twenty-seven consecutive patients (age: 34 ± 14years, 51.8% male) with dominant cardioinhibitory type VVS were prospectively enrolled in the study. After confirmation of > 3s asystole on head-up tilt testing (HUT), all patients underwent cardioneuroablation. ECGs were obtained prior to procedure and at 12-month follow-up visit. HUTs were repeated 1month after cardioneuroablation procedures. QoL was assessed with the use of SF-36, EQ-5D, and EQ VAS questionnaires. ECG, HUT, and QoL data were available in all patients. At 12-month follow-up, heart rate on rest ECG significantly increased (from 74 ± 15 to 84 ± 14bpm, p = 0.003). Repeated HUTs were negative in 23 (85.1%) patients. All of 27 patients remained free of syncope. QoL assessed by SF-36 score significantly improved in postprocedural follow-up (92 ± 9 and 96 ± 11, p = 0.016). Similarly, significant improvements in mobility, self-care, and usual activity domains of EQ-5D were observed (mean scores of 3.0 ± 1.5 and 2.1 ± 1.3, p < 0.001; 1.3 ± 0.9 and 1.2 ± 0.6, p = 0.041; 1.7 ± 1.0 and 1.4 ± 0.8 respectively). EQ-VAS score also improved significantly (39 ± 24 to 77 ± 18, p < 0.001). Our findings suggest that cardioneuroablation may be associated with intermediate term improvement in QoL in patients with VVS.

Quality of life in patients with non-small cell lung cancer treated with PD-1/PD-L1 inhibitors: a systematic review and meta-analysis

BackgroundImmune checkpoint inhibitors (ICIs) have dramatically prolonged survival in non-small cell lung cancer (NSCLC) patients, but little research had focused on its impact on quality of life (QoL). The purpose of our study was to compare the QoL in patients with NSCLC treated with programmed cell death protein-1/programmed cell death-ligand 1 (PD-1/PD-L1) inhibitors versus chemotherapy.MethodsWe searched for randomized controlled trials utilizing the Quality of Life Questionnaire Core 30 items (QLQ-C30) and the EuroQol Five Dimensions Questionnaire-3L (EQ-5D-3L) to assess the QoL of NSCLC treated with PD-1/PD-L1 inhibitors versus chemotherapy. We collected hazard ratios (HRs) for the time from baseline to the first clinically significant deterioration (TTD) and effect size as the difference in mean change between and within treatment groups in patients’ reported outcomes (PROs). (PROSPERO registration number: CRD42022296680).ResultsIn the five trials reported by QLQ-C30, TTD was longer in PD-1/PD-L1 inhibitors compared with control groups (HR = 0.86; 95% CI = 0.76, 0.97; P = 0.013), with similar results in terms of physical function, role function, and pain. The difference in mean change between the PD-1/PD-L1 inhibitors group and the chemotherapy group in QLQ-C30 and EQ-5D VAS was 3.64 (95% CI = 1.62, 5.66; P = 0.001) and 4.74 (95% CI = 2.65, 6.83; P = 0.001), which supported PD-1/PD-L1 inhibitors. However, for the EQ-5D utility index, there was no statistically significant difference between the two groups, with a mean change difference of 0.03 (95% CI = −0.01, 0.07; P = 0.094). The mean change from baseline to follow-up in PD-1/PD-L1 inhibitors group was 2.57 (95% CI = 0.43, 4.71; P = 0.019), and chemotherapy group was −1.31 (95% CI = −3.71, 1.09; P = 0.284), correspondingly. The subgroup analysis showed that no difference was observed between open-label and double-blind trials in patients treated with chemotherapy or PD-1/PD-L1 inhibitors.ConclusionIn conclusion, PD-1/PD-L1 inhibitors could improve the QoL of patients with NSCLC compared to chemotherapy and reduce unfavorable symptoms during treatment.

The relationship between depression, anxiety, quality of life levels, and the chronic kidney disease stage in the autosomal dominant polycystic kidney disease.

Decreased quality of life, anxiety, depression, and other negative psychosocial factors in autosomal dominant polycystic kidney disease (ADPKD) may lead to the patient's attitudes that reduce treatment effectiveness. We aimed to evaluate the relationship between the depression, anxiety, perceived social support, genetic psychosocial risk and quality of life levels, and chronic kidney disease (CKD) stage in ADPKD and to investigate the relationship between these variables/parameters and the dietary compliance that is an essential factor in the course of the disease. 100 ADPKD patients were enrolled in this cross-sectional study. EuroQol-5D-3L (EQ-5D-3L) health-related quality of life ındex, EuroQol-5D-3L visual analog scale (EQ-5D-3L VAS), multidimensional scale of perceived social support (MSPSS), patient health questionnaire (PHQ)-9, and genetic psychosocial risk ınstrument (GPRI) were applied to the patients. There is a relationship with negative regression coefficient between the CKD stage and the total scores of the EQ-5D-3L and EQ-5D-3L VAS scales (p < 0.000 and β = - 5.355, p < 0.000, and β = - 8.394, respectively). There is a relationship with positive regression coefficient between the CKD stage and MSPSS total score and level (p < 0.000 and β = 0.364, p < 0.000 and β = 0.331, respectively). There is no relationship between the CKD stage and GPRI total score (p = 0.800). In addition, there is a relationship with positive regression coefficient between the dietary compliance and EQ-5D and EQ-5D VAS total scores (p = 0.006 and β = 2.687, p = 0.004 and β = 3.148, respectively). There is a relationship with negative regression coefficient between the dietary adherence and PHQ-9 total score and CKD stage (p = 0.003, p = 0.006, and β = - 0.692, respectively). As the CKD stage increases in the ADPKD patients, the quality of life decreases, whereas the level of anxiety and depression increases. It has been seen that the ADPKD patients with more depressive complaints have less dietary compliance. In this particular patient group, the early detection and treatment of psychosocial difficulties and the work to improve the quality of life that affect the course of the ADPKD may be as important as the medical treatment. To determine the needs of ADPKD patients with multiple physical and psychosocial difficulties and to perform appropriate interventions, we think that there is a necessity for a specific scale that evaluates these effective components together in the ADPKD process.

WORLD HEALTH ORGANIZATION FUNCTIONAL CLASS AND HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION: REAL-WORLD FINDINGS IN LATIN AMERICA

WORLD HEALTH ORGANIZATION FUNCTIONAL CLASS AND HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION: REAL-WORLD FINDINGS IN LATIN AMERICA

VOCAL (Views of Ovarian Cancer patients-how maintenance therapy Affects their Lives) study: A lens into the financial and quality of life (QoL) impact of disease burden and ethnic disparities reported directly by the patient.

274 Background: Limited real-world (RW) financial burden and QoL data exist for patients (pts) with advanced ovarian cancer (aOC). Differences in QoL have yet to be explored based on ethnicity. Methods: This cross-sectional online survey included US aOC pts who completed first line (1L) treatment, were ≥18 years, and eligible for 1L maintenance (1Lm). Financial burden was measured by employment status, health insurance coverage, household income, and expenses. QoL was measured by 2 validated patient-reported outcome (PRO) measures: EQ-5D-3L (mobility, self care, activities, pain/discomfort, and anxiety/depression; reported as no, some, or extreme problems) and EORTC QLQ-C30 (functional and symptomatic items). Results: 152 pts from 27 states were surveyed. The most common ethnicities were White (W; 104 [68%]), Black/African American (B/AA; 19 [12%]), Hispanic and Latino (H/L; 11 [7%]). 76 (50%) were not working (unemployed, retired, on disability, or long-term sick leave); 45 of these did not work due to aOC (W: 27/104 [26%], B/AA: 10/19 [53%], H/L: 4/11 [36%]). W pts spent the most on medical costs (mean [SD]: $396.60 [SD: 996.10]) and tests/labs ($133.50 [483.89]). Active surveillance was the most common aOC treatment (39% [W: 41%; B/AA: 32%, H/L: 36%]). Over a quarter of W (27%) and H/L (27%) pts, and nearly half of B/AA (48%) pts were receiving IV 1Lm for aOC. Fewer H/L and B/AA pts were offered genetic testing compared with W pts (27% and 58% vs 83%, respectively). On EQ-5D-3L dimensions, a higher proportion of W pts reported no problem with walking (W: 72%, B/AA: 53%, H/L: 55%), self care (W: 94%, B/AA: 79%, H/L: 64%), usual activities (W: 53%, B/AA: 26%, H/L: 27%), and no pain/discomfort (W: 52%, B/AA: 32%; H/L: 36%). B/AA pts reported the lowest current health status score (mean [SD] EQ-5D VAS score: 53.5 [18.46]). 19% of pts reported extreme anxiety/depression, the highest proportion was seen for H/L (5; 45%) followed by B/AA (7; 37%) and W (10; 10%) pts. Of the EORTC-QLQ-C30 functioning items (100 = highest functioning), the highest impact was seen on emotional functioning (mean [SD]: 59.8 [26.56]; W: 65.5 [23.83], B/AA: 48.2 [28.13], H/L: 53.0 [29.17]). Of the symptom items (100 = highest impact), the highest score was seen for insomnia (mean [SD] 39.5 [30.79]; W: 39.4 [28.54], B/AA: 35.1 [30.38], H/L: 48.5 [45.62]) and fatigue (mean [SD] 36.1 [26.89]; W: 34.4 [26.34], B/AA: 46.2 [29.22], H/L: 33.3 [32.96]). Conclusions: This novel assessment of RW financial burden and PROs by ethnicity signals important health disparities for B/AA and H/L vs W pts, highlighting a need to improve quality of care and support for pts of these ethnicities.

Quality of life following medial patellofemoral ligament reconstruction combined with medial tibial tubercle transfer in patients with recurrent patellar dislocation: a retrospective comparative study

BackgroundBecause the patients undergoing medial patellofemoral ligament reconstruction (MPFLr) combined with medial tibial tubercle transfer (TTT) procedure are usually young and active, the quality of life (QoL) is also an important prognostic factor for patients with recurrent patellar dislocation. Assessing QoL can provide more useful and accurate evidence for the effects of this procedure. This study aimed to evaluate QoL following MPFLr combined with TTT, compared with isolated MPFLr (iMPFLr).MethodsFifty-one patients who underwent iMPFLr + TTT and 48 patients who underwent iMPFLr were included. Clinical evaluation included QoL (EQ-5D-5L and EQ-5D VAS), functional outcomes (Kujala, Lysholm and Tegner activity scores), physical examinations (patellar apprehension test and range of motion) and redislocation rates. Radiological evaluation included patellar tilt angle and bisect offset. These preoperative and postoperative results were compared between groups at baseline and the final follow-up. The paired and independent t tests were used for the data following a normal distribution. Otherwise, the Wilcoxon and Mann–Whitney U tests were used to analyze the differences. Categorical variables were compared by chi-square or Fisher’s exact test.ResultsAll of the QoL (EQ-5D-5L and EQ-5D VAS), clinical results and radiological outcomes significantly improved in both groups at the final follow-up, with no significant differences between groups. There was no significant difference in five dimensions of EQ-5D at the final follow-up, although percentages of people with problems of mobility and pain/discomfort were higher in the MPFLr + TTT group. Female patients had lower EQ-5D index and EQ-5D VAS compared with male patients in both groups at the final follow-up, but there was only a significant difference in the EQ-5D VAS.ConclusionsBoth MPFLr + TTT and iMPFLr groups obtained similar and satisfactory improvements in the QoL, clinical results and radiological outcomes, indicating that MPFLr combined with TTT is a safe and effective procedure, which can significantly improve the QoL for patients with recurrent patellar dislocation in cases of pathologically lateralized TT. However, female patients obtained lower QoL than males.

135MO HRQoL with neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: Results from KEYNOTE-522

In the phase III KEYNOTE-522 study (NCT03036488), neoadjuvant (neoadj) pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo followed by adjuvant (adj) pembro vs pbo in patients (pts) with early-stage TNBC showed a statistically significant improvement in pCR (ypT0/Tis ypN0) and EFS (dual primary endpoints). We present PRO endpoint results from KEYNOTE-522. Pts with previously untreated, nonmetastatic, centrally confirmed TNBC (stage T1c N1-2 or T2-4 N0-2 per AJCC) were randomized 2:1 to neoadj pembro 200 mg Q3W or pbo, both given with 4 cycles of paclitaxel + carboplatin then 4 cycles of doxorubicin or epirubicin + cyclophosphamide. After surgery, pts received adj pembro or pbo for up to 9 cycles. PROs measured with EORTC QLQ-30 and QLQ-BR23 were prespecified secondary objectives, and with EQ-5D VAS were exploratory objectives. PROs were assessed during the neoadj and adj treatment phases and analyzed for pts who received at least 1 study treatment and completed ≥1 PRO assessment within the neoadj and adj treatment phases. Between-group differences in LS mean change from baseline to the latest time point with ≥60%/80% completion/compliance were assessed using a longitudinal model (no alpha assigned). A threshold of 10 points has been published as a meaningful change. PRO analyses for QLQ-C30 included 1145 pts in the neoadj phase (pembro + chemo; n = 762; pbo + chemo, n = 383) and 847 in the adj phase (n = 539; n = 308). Completion/compliance rates at wk 21 in neoadj phase and wk 24 in adj phase were ≥80% in both pembro and pbo groups. There were no meaningful differences between treatment group in PRO results (Table).Table: 135MOBetween-group difference in LS mean change from baseline to Wk 21 (Neoadj) or Wk 24 (Adj) in PRO endpoints in all pts with TNBCPrespecified ScaleaBetween-Group Difference (Pembro vs Pbo) LS Mean (95% CI)NeoadjbAdjcQLQ-C30- GHS/QoL−1.04 (−3.46, 1.38)−0.41 (−2.60, 1.77)- Emotional functioning−0.69 (−3.13, 1.75)−0.60 (−2.99, 1.79)- Physical functioning−2.85 (−5.11, −0.60)−1.57 (−3.36, 0.21)QLQ-BR23−0.13 (−1.92, 1.65)0.29 (−2.05, 2.63)EQ-5D VAS−1.61 (−3.87, 0.64)−0.59 (−2.40, 1.23)aPRO score range: 0–100.bQLQ-C30 (pembro + chemo, n = 762; pbo + chemo, n = 383); QLQ-BR23 (n = 759; n = 382); EQ-5D VAS (n = 762; n = 384).cQLQ-C30 (n = 539; n = 308); QLQ-BR23 (n = 538; n = 306); EQ-5D VAS (n = 540; n = 310). Open table in a new tab aPRO score range: 0–100. bQLQ-C30 (pembro + chemo, n = 762; pbo + chemo, n = 383); QLQ-BR23 (n = 759; n = 382); EQ-5D VAS (n = 762; n = 384). cQLQ-C30 (n = 539; n = 308); QLQ-BR23 (n = 538; n = 306); EQ-5D VAS (n = 540; n = 310). Neoadj pembro + chemo followed by adj pembro did not have a negative meaningful impact on HRQoL vs pbo control in pts with previously untreated early-stage TNBC, reinforcing the clinical benefit seen with this regimen.

Do the newly proposed realignment targets for C2 and T1 slope bridge the gap between radiographic and clinical success in corrective surgery for adult cervical deformity?

Surgical correction of cervical deformity (CD) has been associated with superior alignment and functional outcomes. It has not yet been determined whether baseline or postoperative T1 slope (T1S) and C2 slope (C2S) correlate with health-related quality-of-life (HRQoL) metrics and radiographic complications, such as distal junctional kyphosis (DJK) and distal junctional failure (DJF). The objective of this study was to determine the impact of T1S and C2S deformity severity on HRQoL metrics and DJF development in patients with CD who underwent a cervical fusion procedure. All operative CD patients with upper instrumented vertebra above C7 and preoperative (baseline) and up to 2-year postoperative radiographic and HRQoL data were included. CD was defined as meeting at least one of the following radiographic parameters: C2-7 lordosis < -15°, TS1-cervical lordosis mismatch > 35°, segmental cervical kyphosis > 15° across any 3 vertebrae between C2 and T1, C2-7 sagittal vertical axis > 4 cm, McGregor's slope > 20°, or chin-brow vertical angle > 25°. Spearman's rank-order correlation and linear regression analysis assessed the impact of T1S and C2S on HRQoL metrics (Neck Disability Index [NDI], modified Japanese Orthopaedic Association [mJOA] scale, EuroQOL 5-Dimension Questionnaire [EQ-5D] visual analog scale [VAS] score, and numeric rating scale [NRS]-neck) and complications (DJK, DJF, reoperation). Logistic regression and a conditional inference tree (CIT) were used to determine radiographic thresholds for achieving optimal clinical outcome, defined as meeting good clinical outcome criteria (≥ 2 of the following: NDI < 20 or meeting minimal clinically important difference, mild myelopathy [mJOA score ≥ 14], and NRS-neck ≤ 5 or improved by ≥ 2 points), not undergoing reoperation, or developing DJF or mechanical complication by 2 years. One hundred five patients with CD met inclusion criteria. By surgical approach, 14.7% underwent an anterior-only approach, 46.1% a posterior-only approach, and 39.2% combined anterior and posterior approaches. The mean baseline radiographic parameters were T1S 28.3° ± 14.5° and C2S 25.9° ± 17.5°. Significant associations were found between 3-month C2S and mJOA score (r = -0.248, p = 0.034), NDI (r = 0.399, p = 0.001), EQ-5D VAS (r = -0.532, p < 0.001), NRS-neck (r = 0.239, p = 0.040), and NRS-back (r = 0.264, p = 0.021), while significant correlation was also found between 3-month T1S and mJOA score (r = -0.314, p = 0.026), NDI (r = 0.445, p = 0.001), EQ-5D VAS (r = -0.347, p = 0.018), and NRS-neck (r = 0.269, p = 0.049). A significant correlation was also found between development of DJF and 3-month C2S (odds ratio [OR] 1.1, 95% confidence interval [CI] 1.01-1.1, p = 0.015) as well as for T1S (OR 1.1, 95% CI 1.01-1.1, p = 0.023). Logistic regression with CIT identified thresholds for optimal outcome by 2 years: optimal 3-month T1S < 26° (OR 5.6) and C2S < 10° (OR 10.4), severe 3-month T1S < 45.5° (OR 0.2) and C2S < 38.0° (no patient above this threshold achieved optimal outcome; all p < 0.05). Patients below both optimal thresholds achieved rates of 0% for DJK and DJF, and 100% met optimal outcome. The severity of CD, defined by T1S and C2S at baseline and especially at 3 months, can be predictive of postoperative functional improvement and occurrence of worrisome complications in patients with CD, necessitating the use of thresholds in surgical planning to achieve optimal outcomes.

Differences in postoperative quality of life in young, early elderly, and late elderly patients undergoing surgical treatment for degenerative cervical myelopathy.

Cervical spondylotic myelopathy (CSM) is a common progressive spine disorder affecting predominantly middle-aged and elderly populations. With increasing life expectancy, the incidence of CSM is expected to rise further. The outcomes of elderly patients undergoing CSM surgery and especially their quality of life (QOL) postoperatively remain undetermined. This study retrospectively reviewed patients to identify baseline differences and validated postoperative patient-reported outcome (PRO) measures in elderly patients undergoing CSM surgery. The multi-institutional, neurosurgery-specific NeuroPoint Quality Outcomes Database was queried to identify CSM patients treated surgically at the 14 highest-volume sites from January 2016 to December 2018. Patients were divided into three groups: young (< 65 years), early elderly (65-74 years), and late elderly (≥ 75 years). Demographic and PRO measures (Neck Disability Index [NDI] score, modified Japanese Orthopaedic Association [mJOA] score, EQ-5D score, EQ-5D visual analog scale [VAS] score, arm pain VAS, and neck pain VAS) were compared among the groups at baseline and 3 and 12 months postoperatively. A total of 1151 patients were identified: 691 patients (60%) in the young, 331 patients (28.7%) in the early elderly, and 129 patients (11.2%) in the late elderly groups. At baseline, younger patients presented with worse NDI scores (p < 0.001) and lower EQ-5D VAS (p = 0.004) and EQ-5D (p < 0.001) scores compared with early and late elderly patients. No differences among age groups were found in the mJOA score. An improvement of all QOL scores was noted in all age groups. On unadjusted analysis at 3 months, younger patients had greater improvement in arm pain VAS, NDI, and EQ-5D VAS compared with early and late elderly patients. At 12 months, the same changes were seen, but on adjusted analysis, there were no differences in PROs between the age groups. The authors' results indicate that elderly patients undergoing CSM surgery achieved QOL outcomes that were equivalent to those of younger patients at the 12-month follow-up.

Korean LupusPRO: Cross-Cultural validation study for systemic lupus erythematosus.

To establish the reliability and validity of the Korean version of LupusPRO version 1.7 (v1.7) for systemic lupus erythematosus (SLE) patients. LupusPRO v1.7 was translated into Korean, followed by pretesting among five native Korean speakers. We administered the LupusPRO v1.7 survey to five SLE patients and made minor changes to clarify the language. Then, 133 SLE patients participated in the validation procedure. In each domain, the internal consistency reliability (ICR) and test-retest reliability (TRR) were assessed using Cronbach's alpha and the intra-class correlation coefficient (ICC), respectively. Criterion validity was evaluated using Spearman's correlation coefficient with the other measures such as SF-36, EQ-5D VAS, and SELENA-SLEDAI PGA. Construct validity was assessed by confirmatory factor analysis (CFA) using the unweighted least square estimation method. The mean age of the 133 patients was 36.14 years, and 97% of them were women. Analysis of 130 returned questionnaires revealed that most ICRs of the Korean LupusPRO v1.7 domains were acceptable, with Cronbach's alphas in the range of 0.579-0.949, and most TRRs were good with ICCs from 0.582 to 0.851. Criterion validities presented significant correlations between the LupusPRO v1.7 and other measures validated. In the analysis of the CFA model, the goodness of fit indices demonstrated an acceptable fit. Factor loadings for most individual items were between 0.548 and 0.985. The average variance extracted (AVE) and composite reliability (CR) of most domains were greater than 0.5 and 0.7, respectively, demonstrating acceptable convergent and discriminant validities. The Korean version of LupusPRO v.17 had acceptable reliability and validity.

The assessment of psychometric properties for the subjective wellbeing-5 dimensions (SWB-5D) questionnaire in the general Dutch population

PurposeFinancial resources for health care are limited, so assessment of intervention effectiveness in terms of health in relation to its costs is important. Measuring health outcomes in cost-effectiveness analyses is usually done by health-related quality of life measures, like the EQ-5D. However, over the past decade, innovations on the conceptual level of health have evolved and novel approaches are rising such as the capability approach, subjective wellbeing, and Positive Health. This study assesses the psychometric properties of the subjective wellbeing-5 dimension (SWB-5D) outcome measure.MethodsA quantitative, cross-sectional study design was used to determine the concurrent and construct (convergent and known group) validity for the SWB-5D. Concurrent and convergent validity were estimated as correlations between the SWB-5D and the Dutch version of the EQ-5D, ICECAP-A, and PH-17. Assessment of known-groups validity was based on the variables illness, education, and the overall happiness (Cantril Ladder) and overall health scale (EQ-5D VAS).ResultsA representative sample of 1016 respondents of the Dutch population completed an online questionnaire. The SWB-5D showed reasonable concurrent validity and showed good convergent and known-group validity. The SWB-5D had a lower ceiling effect compared to the EQ-5D and ICECAP-A.ConclusionCompared to traditional health measurement approaches, novel approaches are more focused on the mental and social pillars of health. The SWB-5D shows psychometric feasibility of comprehensive measurement of health, as indicated by a range of validity measures in a large representative sample of the Dutch population.

Long-term results after isolated iliac wing fractures

IntroductionIsolated iliac wing fracture is a rare pelvic fracture that is considered benign in the literature. As there is a complete lack of information on function and quality of life in patients with this injury, the primary aim of this study was to evaluate the long-term functional results, and secondly to evaluate the patients’ clinical function and fracture healing. Patients and MethodsAll patients treated in Oslo University Hospital, Ullevaal (OUH-U), the Norwegian National Pelvic Service, in the time period 2006–2016 were included. Nine of 13 eligible patients (69%) were evaluated by the Patient Reported Outcome Measures (PROM); EQ-5D-3L and Majeed Score. For the secondary outcomes, the patients were clinically examined for Range of Motion (ROM) in the hips, pain, muscular function and nerve deficiencies. Finally, the patients underwent X-rays (AP-view and iliac and obturator oblique views). ResultsAll patients were injured in high-energy trauma with severe associated injuries. Five patients were operated and four received conservative treatment. At the time of follow-up (median seven years after injury), the mean EQ-5D VAS was 84, and the mean Majeed score was 87. Two out of nine reported moderate level of pain, three reported mild pain, and the rest reported no pain. Six patients were still working, two were retired, and the last one was receiving disability benefit of other reasons than the iliac fracture. One patient had difference in range of external rotation of >10° between the hips, while the rest had no differences in ROM. The follow-up X-rays showed healed fractures in all the patients. ConclusionPatients with isolated iliac wing fractures seem to have a good general state of health, scoring high on the PROMs, with minor and insignificant clinical sequela. This original finding is in accordance with the general assumption amongst pelvic surgeons that the injury is a benign one.