EQ-5D-5L Research Articles

Evaluating health-related quality of life and subjective wellbeing among infertility patients: a cross-sectional study in mainland China.

This study aimed to explore the health-related quality of life (HRQoL) and subjective wellbeing (SWB) of infertility patients in mainlandChina and to investigate the relationships between HRQoL and SWB instruments in infertility patients. We conducted this cross-sectional study in the Hospital for Reproductive Medicine Affiliated of Shandong University between April 2019 and November 2019. Participants self-completed the five-level EQ-5D (EQ-5D-5L) questionnaire, the Assessment of Quality of Life (AQoL)-8D, and the WHO-5 wellbeing index (WHO-5). The agreements between EQ-5D-5L and AQoL-8D were assessed employing intraclass correlation coefficient (ICC) and Bland-Altman plots. Exploratory factor analysis (EFA) was conducted to examine the difference in descriptive systems among the three instruments. We analyzed a valid sample of 618 infertility patients (84.4%). The mean scores of the total EQ-5D-5L, AQoL-8D, and WHO-5 were 0.96 (95%CI 0.96, 0.96), 0.80 (95%CI 0.79, 0.81), and 16.92 (95%CI 16.52, 17.31), respectively. Patients diagnosed with primary infertility had significantly lower HRQoL and SWB than those with secondary infertility. The ICC of EQ-5D-5L and AQoL-8D was 0.14. The AQoL-8D (r = 0.625) was more strongly correlated with WHO-5 than with the EQ-5D-5L (r = 0.262). The EFA results indicated that HRQoL instruments and the WHO-5 instruments were complementary rather than substitutable. Poorer HRQoL and SWB were found that primary than secondary infertility patients. There exists a poor agreement between EQ-5D-5L and AQoL-8D and the difference in the psychosocial components may explain the difference. Measuring both HRQoL and SWB could provide complementary information for infertility patients.

Personality and psychopathological profile of patients and botulinum therapy for blepharospasm

Background. Blepharospasm (BS) includes non-motor symptoms manifested by psychopathological disorders. The impact of these disorders on patients' quality of life and therapy of motor symptoms with botulinum toxin is poorly understood.
 Aim. To analyze the correlation of different characterological personality abnormalities (CPA) with the BS severity and the response to botulinum toxin therapy (BT).
 Materials and methods. Forty-six BS patients (29 females, 17 males) aged 30 to 85 years (6111.5) with BS were examined. The control group included 46 healthy individuals (39 females and 7 males, with a mean age of 56.49.67). Patients were examined before and after BT (after 12 months) using the BS severity scale (BSDI), EQ-5D (EQ-5D-3L) quality of life assessment scales, General Anxiety Disorder (GAD-7) scale, Brief Fear of Negative Evaluation Scale (BFNE-S), and SCID-II-PD structured personality questionnaire.
 Results. In the BS group of patients, unemployed and non-married were more common (p0.05) than in healthy individuals. In the BS patient group, there was an increase in anxiety (15.525.6 vs 4.283.5 control group by GAD-7 scale) and fear of negative evaluation (42.449.2 in the main group vs 21.347.3 in the control group). Quality of life was lower in BS patients (65.43, median 62 vs 88.2, median 92, p0.05). The prevalence of cluster C CPA (anxiety disorders) in patients with BS and, in particular, the obsessive-compulsive disorder was revealed. Patients with different personality profiles showed no differences in the BS severity before BT. The BT efficacy was higher in patients with cluster C CPA.
 Conclusion. BS patients often have anxious type CPA; in these patients, BT is more effective than in other CPAs.

Cross-Attribute Level Effects Models for Modeling Modified 5-Level Version of EQ-5D Health State Values: Is Less Still More?

ObjectivesCross-attribute level effects (CALE) model has demonstrated better predictive accuracy for out-of-sample health states than the conventional additive main-effects model in cross-validation analysis of the 5-level version of EQ-5D (EQ-5D-5L) composite time trade-off (cTTO) datasets. In this study, we aimed to further test the performance of CALE model using a different design and modified EQ-5D-5L states. MethodsA total of 29 EQ-5D-5L self-care bolt-off states, 30 EQ-5D-5L states, and 31 EQ-5D-5L vision bolt-on states were selected from the same orthogonal array. A total of 600 university students were interviewed face-to-face to value a subset of these health states using the cTTO method. For each type of health state, we fitted both the conventional main-effects model and the CALE model. Predictive accuracy was assessed in a series of cross-validation analysis using the leave-one-state-out method. ResultsOverall, the CALE model outperformed the conventional model for each of the 3 types of health states in predicting the cTTO values of out-of-sample health states. The prediction accuracy of using the CALE model improved with the number of dimensions in health states, for example, the MAE decreased about 24%, 67%, and 77% for the EQ-5D-5L self-care bolt-off, EQ-5D-5L, and EQ-5D-5L vision bolt-on states, respectively, when using CALE models. ConclusionOur study supported the strengths of the CALE model for modelling the utility values of both original and modified EQ-5D-5L health states. Investigators with limited resources may consider using the CALE model to lower the costs for their valuation studies for EQ-5D-5L or similar health state descriptive systems.

EQ-5D full health state after therapy heralds reduced hazard to accrue subsequent organ damage in systemic lupus erythematosus.

To investigate whether self-reported EQ-5D full health state (FHS) after therapeutic intervention for active systemic lupus erythematosus (SLE) is associated with a reduced risk to accrue organ damage. In a separate analysis, we sought to investigate associations between experience of "no problems" in each one of the five dimensions of EQ-5D and the risk to accrue damage. Data from the open-label extension periods of the BLISS-52 and BLISS-76 trials of belimumab in SLE (NCT00724867; NCT00712933) were used (N = 973). FHS was defined as an experience of "no problems" in all five EQ-5D dimensions. Organ damage was assessed annually using the Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (SDI). Associations between the three-level version of the EQ-5D (EQ-5D-3L) responses at open-label baseline and the first documented increase in organ damage were investigated using Cox regression accounting for age, sex, ancestry, SDI at baseline, and background therapy, and associations with SDI items were investigated using phi (φ) correlation analyses. A total of 147 patients (15.1%) accrued organ damage during follow-up, with the first increase in their SDI score occurring after a mean time of 29.1 ± 19.6 months. Lower proportions of FHS respondents accrued damage over a course of up to 7.9 years of open-label follow-up compared with no FHS respondents (p = 0.004; derived from the logrank test). FHS was associated with a reduced hazard to accrue subsequent organ damage (HR: 0.60; 95% CI: 0.38-0.96; p = 0.033) after adjustments, as was experience of "no problems" in mobility (HR: 0.61; 95% CI: 0.43-0.87; p = 0.006). "No problems" in mobility was negatively correlated with musculoskeletal damage accrual (φ = -0.08; p = 0.008) and associated with a lower hazard to accrue musculoskeletal damage in Cox regression analysis (HR: 0.38; 95% CI: 0.19-0.76; p = 0.006). Experience of EQ-5D-3L FHS and "no problems" in mobility after therapeutic intervention heralded reduced hazard to accrue subsequent organ damage, especially musculoskeletal damage, suggesting that optimisation of these health-related quality of life aspects constitutes a clinically relevant treatment target in patients with SLE, along with clinical and laboratory parameters.

Effect of using a structured pacing protocol on post-exertional symptom exacerbation and health status in a longitudinal cohort with the post-COVID-19 syndrome.

Post-exertional symptom exacerbation (PESE) is a characteristic symptom of post-COVID syndrome(PCS).This prospective study investigated the effect of a 6-week structured World Health Organization (WHO) Borg CR-10 5-phase pacing protocol on PESE episodes and quality of life in a cohort of individuals with long-standing PCS (average duration of symptoms was 17 months).Participants received weekly telephone calls with a clinician to complete the Leeds PESE questionnaire (LPQ) and identify the appropriate phase of the pacing protocol. EQ-5D 5L was completed at the intervention's beginning and end to measure overall health.Thirty-one participants completed the 6-week protocol, with a statistically and clinically significant reduction in the average number of PESE episodes (from 3.4 episodes in Week 1to 1.1 in Week 6), with an average decrease of 16% (95% CI: 9%-24%; p < 0.001) each week, and reduction across all three exertional triggers (physical, cognitive, and emotional). Physical activity levels showed moderate improvements during the intervention period. Mean EQ-5D 5L scores improved from 51.4to 60.6 points (paired difference of 9.2 points, 95% CI: 3.2-15.2 points; p = 0.004).A structured pacing protocol significantly reduces PESE episodes and improves overall health in PCS.

Validation and Functional Relevance of the Short Form of the Perceived Deficits Questionnaire for Depression for Japanese Patients with Major Depressive Disorder.

To validate the five-item version of the Perceived Deficits Questionnaire for Depression (PDQ-D-5) for assessing subjective cognitive function in Japanese patients with major depressive disorder (MDD) using data from the PERFORM-J study. A total of 518 Japanese outpatients diagnosed with MDD were assessed on severity of depressive symptoms, cognitive function, social and work function, and quality of life (QoL) over 6 months following initiation of antidepressant therapy. This post hoc analysis evaluated the internal consistency and convergent validity of the PDQ-D-5 in relation to the original PDQ-D-20. Correlations of scores on these measures were examined at each time point and over time. The same set of analyses was explored between PDQ-D-5 and the Patient Health Questionnaire-nine-item (PHQ-9), Montgomery-Asberg Depression Rating Scale (MADRS), Digit Symbol Substitution Test (DSST), five-level version of EQ-5D (EQ-5D-5L), Sheehan Disability Scale (SDS), and Work Productivity and Activity Impairment (WPAI) questionnaire. PDQ-D-5 scores showed good internal consistency. Strong positive correlations were observed between PDQ-D-5 and PDQ-D-20 at each time point (correlation coefficient: baseline, 0.94; month 1, 0.94; month 2, 0.96; month 6, 0.96) and over time (0.92) (all p < 0.0001). Longitudinally, there were positive correlations between PDQ-D-5 scores versus those on the PHQ-9, MADRS, and SDS. Similarly, negative correlations were noted between PDQ-D-5 scores and EQ-5D-5L and DSST scores to a variable degree. There were moderate positive correlations over time between PDQ-D-5 and all WPAI subscale scores except those on absenteeism. PDQ-D-5 scores rated in Japanese patients with MDD were found to adequately represent scores on the PDQ-D-20. The short version also showed associations with several measures of functional outcome, depression severity and QoL. This validates the PDQ-D-5 as a feasible and clinically reliable tool to assess subjective experience on cognition, which is applicable to time-limited consultations. UMIN000024320.

Cross-cultural adaptation and validation of the Chinese version of the Spine Oncology Study Group Outcomes Questionnaire.

Patients with spinal metastases always have a poor health-related quality of life (HRQoL) and disease- and treatment-related adverse outcomes. The Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ) has been verified and validated in English for patients with spinal metastases but not in Chinese. This paper aimed to complete the cross-cultural adaptation of the Chinese version of the SOSGOQ, to verify its reliability and validity, and to report on the HRQoL of Chinese patients with spinal metastases. This is a single-center, prospective, observational cross-sectional study. Seventy-six patients were enrolled in this study. The SOSGOQ is made up of five HRQoL domains (physical function, neurological function, pain, mental health, social function) and post-therapy questions. The EQ-5D 3L questionnaire covers five items in mobility, self-care, usual activities, pain discomfort, and anxiety-depression, each with three answer options. The SF-36 comprises 36 items divided into eight domains. A single-center, prospective, observational cross-sectional study involving patients with spinal metastases who underwent surgery was conducted. HRQoL was evaluated using the Chinese version of the SOSGOQ, the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36), and the EuroQol 5-Dimension questionnaire (EQ-5D). Demographic, tumor, symptom, and treatment data, as well as Eastern Cooperative Oncology Group (ECOG) information, were collected. Internal consistency reliability, convergent validity, concurrent validity, and clinical validity were used to evaluate reliability. A Spearman's correlation analysis was used to analyze the relationship between variables. This study enrolled 76 patients, with a mean age of 55.8 years. The kidney was the most common primary tumor site, and the thoracic spine was the most affected. The internal consistency of the overall SOSQOQ (0.907) was higher than the EQ-5D (0.819), and all items of the SOSQOQ had a high convergent validity (>0.40). The SOSGOQ was significantly correlated with the EQ-5D in respective domains (p < 0.001) and overall score (p < 0.001), whereas the SF-36 was related to the overall SOSGOQ score and most domains. Total SOSGOG was significantly sensitive to changes in ECOG (p = 0.017), prior surgery (p = 0.001), and tumor type (p = 0.026). The SOSGOQ is a reliable and effective tool for evaluating HRQoL in patients with spinal metastases, with high sensitivity and specificity. Surgical treatment can significantly improve patients' HRQoL.

ASSESSMENT OF EFFICIENCY OF ALPHA-LIPOIC ACID AND IPIDACRINE HYDROCHLORIDE TREATMENT FOR PREVENTION OF PACLITAXEL-INDUCED PERIPHERAL NEUROPATHY USING THE EQ-5D 5L QUALITY OF LIFE QUESTIONNAIRE

Introduction. Paclitaxel is the most common chemotherapeutic agent from the taxane family, which is effective in treating many cancer types, including breast cancer. Despite the benefits of taxane-containing treatment regimens, patients develop neurosensory and neuromotor symptoms associated with the treatment, a condition known as chemotherapy-induced peripheral neuropathy.&#x0D; The aim of the study. To evaluate the efficacy of a combination of alpha-lipoic acid and acetylcholinesterase inhibitor ipidacrine hydrochloride to prevent the development of paclitaxel-induced peripheral neuropathy and improve its course in patients with breast cancer using the data of the EQ-5D 5L Quality of Life Questionnaire.&#x0D; Materials and methods. The study was conducted on 70 patients with breast cancer (T1-4N0-3M0-1), who were hospitalized at the Precarpathian Clinical Oncology Center of Ivano-Frankivsk Regional Council in 2014-2022. All patients received six cycles of chemotherapy according to the AT or ET regimens: paclitaxel at a dose of 175 mg/m2 as a 3-hour infusion + doxorubicin 60 mg/m2 (AT), or paclitaxel at a similar dose + epirubicin 90 mg/m2 (ET) once in 3 weeks in neoadjuvant, adjuvant or palliative modes. Patients were randomized into two groups: patients of group I (n = 35) received polychemotherapy without the use of drugs for the prevention of neuropathy, and patients of group II (n = 35) received polychemotherapy and a preventive treatment of neuropathy. The scheme for the prevention of paclitaxel-induced peripheral neuropathy included a combination of alpha-lipoic acid with an acetylcholinesterase inhibitor ipidacrine hydrochloride. In order to assess the quality of life and effectiveness of the studied paclitaxel-induced peripheral neuropathy prevention regimen in patients with breast cancer, we have used the EQ-5D 5L quality of life questionnaire before and after the 3rd and 6th cycles of paclitaxel chemotherapy.&#x0D; Results. The study of breast cancer patients showed a statistically significant deterioration in all five aspects of quality of life included in the EQ-5D 5L quality of life questionnaire, which progressed with increasing cumulative dose of paclitaxel. In addition, the application of the study scheme for the prevention of paclitaxel-induced peripheral neuropathy in patients of group II, in contrast to patients of group I, led to a statistically significant improvement according to their answers to questions about pain or discomfort, both after 3 and after 6 cycles of chemotherapy with paclitaxel - by 14.09 % (p &lt; 0.05) and 19.49 % (p &lt; 0.01), respectively. According to the questionnaire data, after 6 cycles of chemotherapy self-care of patients of group II in contrast to patients of group I significantly improved (by 21.21 %, p &lt; 0.05). Patients' answers to questions about the other three aspects of quality of life (mobility, normal daily activities, anxiety or depression) did not show a significant improvement in patients of group II, both after 3 and 6 cycles of paclitaxel chemotherapy. The mean value of the assessment of the general condition according to the visual-analog scale significantly improved after 3 and 6 cycles of chemotherapy with paclitaxel in patients of group II, in contrast to patients of group I - by 6.80 % (p &lt; 0.001) and 13.40 % (p &lt; 0.001), respectively.

Zone 1 and 2 flexor tendon repair via a longitudinal incision crossing the volar distal interphalangeal joint: functional and cosmetic outcomes.

The primary aim of this study was to present patient-reported functional outcomes after zone 1 and 2 flexor tendon repair using a novel longitudinal volar approach crossing the distal interphalangeal joint (DIPJ) perpendicularly. The secondary aims were to investigate the cosmetic outcomes, satisfaction and complication rates associated with this technique. Over a 6-year period, 75 patients underwent flexor tendon repair using this technique. The quick version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), five-level EQ-5D (EQ-5D-5L), Patient and Observer Scar Assessment Scale (POSAS) and satisfaction questionnaires were collected. QuickDASH scores were available for 59 patients (79%), and POSAS scores were available for 45 patients (60%) at a mean follow-up of 48 months. Concomitant nerve repairs were undertaken in 24 cases. The median QuickDASH score was 4.5 (interquartile range [IQR] 1.1-12.5) and median POSAS score was 12 (IQR 8-16). No significant difference was observed in median QuickDASH score between patients with and without a concomitant nerve repair (4.5 vs 6.8; p = 0.36). Fifty-six patients (94%) were satisfied. Two patients required open tenolysis, and a single case of early re-rupture occurred that required revision open repair. Utilising validated patient-reported functional outcomes, this study demonstrated that a direct longitudinal incision over the DIPJ for zone 1 and 2 flexor tendon repairs can result in excellent functional and cosmetic outcomes, with high rates of patient satisfaction and low rates of complications. This challenges previously held dogma that longitudinal incisions crossing flexion creases should be avoided.

The effect of risankizumab on achieving minimal clinically important differences in patient-reported outcomes in patients with psoriatic arthritis: results from KEEPsAKE 1 and 2.

Psoriatic arthritis (PsA) is a chronic inflammatory disease that reduces the quality of life. This study assessed the effects of risankizumab (RZB) on the achievement of minimal clinically important differences (MCID) in patient-reported outcomes (PROs). KEEPsAKE-1 and -2 are randomized, placebo-controlled Phase 3 clinical studies assessing RZB (150 mg) vs. placebo (PBO) in adult patients with PsA with inadequate response or intolerance to disease-modifying antirheumatic drugs and/or biologics. Patients were randomized 1:1 to receive RZB or PBO for 24 weeks; starting at Week 24, all patients received RZB 150 mg through Week 52. PROs assessed were Patient's Global Assessment of Disease Activity (PtGA), Patient's Assessment of Pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Short-Form 36 Physical and Mental Component Summary scores (PCS and MCS, respectively), 5-Level EQ-5D (EQ-5D-5L), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), and Work Productivity and Activity Impairment (WPAI). The proportion of patients achieving MCID at Weeks 24 and 52 are reported. Odds ratios of achieving MCID with RZB treatment at Week 24, relative to PBO, were estimated by logistic regression controlling for baseline and stratification factors. In KEEPsAKE-1, RZB- vs. PBO-treated patients were more likely to report MCID in all PROs at Week 24; similar results were obtained in KEEPsAKE-2, except for SF-36 MCS and WPAI presenteeism domain. In KEEPsAKE-1 and KEEPsAKE-2, 65% and 62% of RZB-treated patients, respectively, reported MCID in PtGA at Week 24, which increased to 74% and 68%, respectively, at Week 52. Approximately 48% of all PBO-treated patients reported MCID in PtGA at Week 24 and, after initiating RZB, >65% reported MCID at Week 52. Results were similar in the remaining PROs. These data demonstrate that patients with PsA receiving RZB treatment are more likely to report clinically important improvements in PROs compared with patients receiving PBO.

Costs and Quality of Life in Patients With Systemic Arterial Hypertension in Slovenia

ObjectivesSystemic arterial hypertension (SAH) is one of the most critical risk factors for morbidity in chronic noncommunicable diseases. The aim of this study was to estimate the costs incurred by and the health-related quality of life (HRQoL) for a sample of patients with AH aged ≥ 65, in 2019. MethodsA sample of 142 patients who were taking medicines for SAH was selected from the urban and rural areas. The patients consented to participate in the study. Patients also reported their out-of-pocket expenditures connected to SAH and their HRQoL. HRQoL was measured using generic 5-level version of EQ-5D (EQ-5D-5L) and the disease-specific MINICHAL questionnaires. Descriptive analysis was used to present the results. Calculations were made using R (v4.01) software. ResultsA sample of 141 patients filled out 17-item MINICHAL and 142 filled out the EQ-5D-5L questionnaire. Patients’ MINICHAL mood and somatic domain scores were 5.5 and 3.5, respectively. EQ-5D-5L mean index utility score was 0.7 and the mean EQ VAS was 70.9. Pain/discomfort was the most affected health dimension as 60.6% of patients reported having problems. The 2 HRQoL questionnaires are moderately correlated (–0.215). The average annual costs of SAH treatment amounted to €274.3 per patient. The largest share of costs is represented by pharmacological treatment (30.5%) and out-of-pocket expenses (28.2%). ConclusionsOur study is the first study in Slovenia to assess the costs incurred by and HRQoL of patients with SAH using bottom-up approach and societal perspective. It offers important input in a decision-analytic model to assess cost-effectiveness of interventions to reduce the burden of SAH.

The Use of Generic Patient-Reported Outcome Measures in Emergency Department Surveys: Discriminant Validity Evidence for the Veterans RAND 12-Item Health Survey and the EQ-5D

ObjectivesThis study aimed to compare discriminant validity evidence of 2 generic patient-reported outcome measures (PROMs), the Veterans RAND 12-Item Health Survey (VR-12) and level 5 of EQ-5D (EQ-5D-5L), for use in emergency departments (EDs). MethodsData were obtained via a cross-sectional survey of 5876 patients in British Columbia (Canada) who completed a questionnaire after visiting an ED in 2018. We compared the extent to which the VR-12 and the EQ-5D-5L distinguished among groups of ED patients with different levels of comorbidity burden and self-reported physical and mental or emotional health status. Multivariable logistic regression was used to evaluate the ability of the 2 PROMs to identify patients presenting with a mental health (MH) condition. ResultsAll the measures produced small effect sizes (ESs) for discriminating comorbidity levels (R2 range: 0.00 [VR-12 mental component summary {MCS}] to 0.10 [VR-12 physical component summary score]). The EQ-5D visual analog scale offered the largest ES for discriminating self-reported physical health (R2 = 0.48), whereas the MCS, the VR-12 MH domain, and the EQ-5D-5L anxiety/depression dimension had the largest ESs for discriminating self-reported mental or emotional health (R2 = 0.42, 0.40, and 0.38, respectively). The MCS produced a medium ES (R2 = 0.42) along with the VR-12 utility score (R2 = 0.27) compared with the EQ-5D-5L index (R2 = 0.19). Having a MH condition was predominantly identified by the MCS (Pratt index = 0.56). ConclusionsThe VR-12 PROM provides a more comprehensive measurement of MH than the EQ-5D-5L, which is important to inform healthcare service needs for patients who present in EDs with MH challenges.

Cost-Utility Analysis of Planned Early Delivery or Expectant Management for Late Preterm Pre-eclampsia (PHOENIX)

AimThere is currently limited evidence on the costs associated with late preterm pre-eclampsia beyond antenatal care and post-natal discharge from hospital. The aim of this analysis is to evaluate the 24-month cost-utility of planned delivery for women with late preterm pre-eclampsia at 34+0–36+6 weeks’ gestation compared to expectant management from an English National Health Service perspective using participant-level data from the PHOENIX trial.MethodsWomen between 34+0 and 36+6 weeks’ gestation in 46 maternity units in England and Wales were individually randomised to planned delivery or expectant management. Resource use was collected from hospital records between randomisation and primary hospital discharge following birth. Women were followed up at 6 months and 24 months following birth and self-reported resource use for themselves and their infant(s) covering the previous 6 months. Women completed the EQ-5D 5L at randomisation and follow-up.ResultsA total of 450 women were randomised to planned delivery, 451 to expectant management: 187 and 170 women, respectively, had complete data at 24 months. Planned delivery resulted in a significantly lower mean cost per woman and infant(s) over 24 months (− £2711, 95% confidence interval (CI) − 4840 to − 637), with a mean incremental difference in QALYs of 0.019 (95% CI − 0.039 to 0.063). Short-term and 24-month infant costs were not significantly different between the intervention arms. There is a 99% probability that planned delivery is cost-effective at all thresholds below £37,000 per QALY gained.ConclusionThere is a high probability that planned delivery is cost-effective compared to expectant management. These results need to be considered alongside clinical outcomes and in the wider context of maternity care.Trial registration: ISRCTN registry ISRCTN01879376. Registered 25 November 2013.Supplementary InformationThe online version contains supplementary material available at 10.1007/s41669-022-00355-1.

Reliability, validity, and responsiveness of the Thai version of the Dry Eye-Related Quality-of-Life Score questionnaire

Dry eye disease (DED) is a common and growing eye problem worldwide. Chronic DED symptoms can, subsequently, affect the patients' quality of life (QOL). This prospective cross-sectional study aimed to assess the reliability, validity, and responsiveness of the Thai version of the Dry Eye-Related Quality-of-Life Score (DEQS-Th) questionnaire and to evaluate its accuracy in DED screening. Psychometric validation was conducted on DED participants. All participants completed the DEQS-Th and other measurements including the Ocular Surface Disease Index (OSDI) and the 5-level EQ-5D (EQ-5D-5L). Internal consistency, concurrent validity, convergent, and discriminant validity were evaluated. The standardized response mean (SRM) was used to evaluate the responsiveness of the DEQS-Th. The optimal cut-off score of DEQS-Th for DED screening was assessed. Among 100 participants with a mean age of 50.9 ± 14.4 years, and 89.0% female, the internal consistency of the DEQS-Th was excellent (Cronbach's alpha: 0.80-0.92). The test-retest intraclass correlation was 0.82-0.92. It showed concurrent validity with the OSDI (r = 0.694, p < .001) and EQ-5D-5L index scores (r = -0.578, p < .001). DED is suspected if the DEQS-Th score ≥ 18.33 (AUC = 0.897, sensitivity 90.0%, specificity 76.7%) or its Short Form score ≥ 3 (AUC 0.857, sensitivity 93.0%, specificity 63.3%). The SRM of the symptom subscale of DEQS-Th was 0.82, indicating relatively large responsiveness, whereas the impact on daily life subscale and the summary score was small. In conclusion, the DEQS-Th is valid and reliable for evaluating the multifaceted effects of DED on a patient's QOL. It can be useful for primary assessment and monitoring of DED in routine clinical practice.

Health-Related Quality of Life among Patients with Oral Potentially Malignant Disorder and Oral Cancer in Malaysia

Presently there is a lack of health-related quality of life (HRQOL) measure and its corresponding utility values for oral cancer and oral potentially malignant disorders (OPMD). This limits patient-centered outcomes for cost-effectiveness evaluations. The study aimed to determine post-treatment HRQOL of patients and ascertained differences between OPMD, early and late-stage oral cancer. A crosssectional survey was conducted among patients in oral maxillofacial specialist clinics in two public tertiary hospitals. Consented participants were required to complete the EQ-5D-5L questionnaire with the EQ Visual Analogue System (VAS). Kruskal-Wallis test was used to explore differences in values between stages. Multiple linear regression was used to explore factors that influenced the HRQOL. A total of 50 OPMD and 52 oral cancer patients were surveyed. The mean EQ-5D 5L health utility values was 0.842 (n = 50, SD = 0.139), 0.822 (n = 10, SD = 0.150) and 0.626 (n = 42, SD = 0.310) for OPMD, early- and late-stage cancer, respectively. The mean values of the EQ-5D-5L index and EQ-VAS scale showed significant differences between groups and between early- and late-stage cancer with good discriminative properties. Results of the multiple linear regression indicated that ethnicity, income, residency, diagnosis, and treatment modality were able to significantly account for 25% of EQ-5D-5L utility values, F(10,91) = 3.83, p &lt; 0.001, R2 = 0.360. Indian ethnicity, rural location, income less than RM4,360, late-stage cancer, and multi-modal therapies were all predictors of poorer HRQOL. This study evidenced disease severity and treatment modality to greatly impact the HRQOL of patients, in addition to socio-demographic factors such as ethnicity and income.

Comparison of functional outcome and patient satisfaction between patients with socket prosthesis and patients treated with transcutaneous osseointegrated prosthetic systems (TOPS) after transfemoral amputation

PurposeThe aim of this retrospective analysis was to investigate and evaluate differences in functional outcome and satisfaction of patients treated with a TOPS and patients using socket prosthesis after transfemoral amputation.MethodsThis retrospective comprehensive analysis included patients from a single hospital, and was conducted between February 2017 and December 2018. Overall n = 139 patients with prosthesis were included and divided into two comparable groups (socket- and TOPS group). Incomplete data sets were excluded. This led to n = 36 participants for the socket- and n = 33 for the TOPS group. Functional outcome and satisfaction were evaluated by Patient Reported Outcome Measures (PROMs). The used PROMs were: Questionnaire for Persons with a Transfemoral Amputation (Q-TFA), EQ5D-5L, Satisfaction with Prosthesis Questionnaire (SAT-PRO), Prosthesis Mobility Questionnaire (PMQ 2.0) and Functional Independence Measure (FIM).ResultsSignificant results in favor of TOPS patients were identified for the EQ-5D 5L (p = 0.004), Q-TFA (p = 0.000), SAT-PRO (p = 0.000) and PMQ 2.0 (p = 0.000). For FIM, no statistical significance was found (p = 0.318).ConclusionIn this study, transfemoral amputees treated with an osseointegrated prosthetic attachment (TOPS) showed significantly higher scores for mobility and satisfaction. This demonstrates the high potential of TOPS in the prosthetic treatment of patients with transfemoral amputation with regard to their functional abilities in daily life.

Stress, anxiety, and depression: A comparative study of perceptions of patients in the ICU, other wards and their family caregivers in a low middle income country

Developed countries report higher ICU-related mental-health complications. The absence of non-ICU comparators limits interpretation and comparability across socioculturally diverse populations. Having found low levels of mental health complications in our ICU patients, we compared anxiety, depression, posttraumatic stress symptoms (PTSS), quality of life (QOL), and self-reported stressors in ICU (n ​= ​28), ward (n ​= ​34) patients and family caregivers (n ​= ​30) in a cross-sectional study in a tertiary teaching hospital. Hospital Anxiety and Depression Scale (HADS), Impact of Events revised IES-R, European Quality of Life 5 Dimensions 3 levels (EQ5D 3L) were used. Clinically relevant anxiety, depression (HADS ≥8), and PTSS (IES-R ≥30) were comparable amongst the ICU patients (46.4%, 46.4%, 10.7%), ward patients (53.3%, 30.0%, 6.7%), and caregivers (55.9%, 29.4%, 0%) respectively. Avoidance as PTSS subgroup was significantly higher in ICU patients and caregivers. IES-R scores were significantly less when only the ICU experiences were considered. QOL was significantly worse in ICU patients. Self-reported stressors were comparable in the groups; however after correcting baseline factors, unemployment contributed significantly to higher PTSS, anxiety and depression. While the rates of anxiety/depression were similar, lower PTSS in comparison to reports from developed countries suggest future studies to focus ICU experience, confounding non-clinical stressors and cultural issues. 1. Anxiety, depression, and stress of caregivers, ICU and ward patients were similar. 2. Avoidance was significantly higher in ICU patients and caregivers. 3. Quality of life was significantly worse in ICU patients. 4. Nonclinical factors contributed significantly to stress, anxiety and depression. 5. Indian sample had lower posttraumatic stress compared to the developed countries.

Diagnosis of first relapse and its impact on quality of life in patients with advanced ovarian cancer (AGO-OVAR 19/II).

e17609 Background: Maintenance or improvement of health-related quality of life (QoL) is one of the major goals for patients with advanced ovarian cancer (OC). QoL is influenced by symptoms of disease on the one and beneficial or adverse effects of surgical and systemic treatment on the other side. In addition, QoL is also an important patient centered endpoint in clinical trials to support primary endpoints such as progression-free survival (PFS). This analysis evaluates the impact of the diagnosis of first relapse on QoL. Methods: Patients with primary OC were included before start of treatment. QoL was assessed by the cancer-specific questionnaires EORTC QLQ‐C30 and QLQ‐OV28 and the generic EQ‐5D 3L at baseline and every 3 months thereafter, to describe the influence of treatment and course of disease on QoL. QoL data within 100 days before and after the first relapse were compared (part 2 of NCT02828618). QoL scales were analyzed by repeated measures regression. We report model-based pre- and post-recurrence means and p-values for the difference in means. Results: In total, 269 had a PFS event with a median PFS of 20.3 months. This analysis includes 186 patients; 122 with QoL assessment before and after relapse and 50 and 14 with assessment only before or after relapse. Median age was 62.5 years (range 31 – 90). The number of evaluable answers for each domain ranged between 166 and 172 before recurrence and 135 and 137 after recurrence. Global QoL decreased from 61.4 to 48.4 points (p &lt; 0.001) with the diagnosis of recurrence. The following scales showed a deterioration of at least 10 points: Social functioning (65.7- &gt; 52.6), fatigue (55.8 - &gt; 44.5), appetite loss (22.5 - &gt; 33.4), emotional functioning (65.2 - &gt; 54.9), role functioning (56.5 - &gt; 46.4); (all p &lt; 0.001). EQ-5D 3L visual analogue scale showed a deterioration from 66.4 to 55.0 (p &lt; 0.001). Conclusions: The event of first relapse is associated with a significant and clinically relevant deterioration of global QoL including several subscales. Therefore, prolongation of PFS preserves QoL, which supports the role of PFS as meaningful primary endpoint in ovarian cancer trials. Clinical trial information: NCT02828618.

Patient-reported Outcomes from JAVELIN Bladder 100: Avelumab First-line Maintenance Plus Best Supportive Care Versus Best Supportive Care Alone for Advanced Urothelial Carcinoma

BackgroundIn JAVELIN Bladder 100, avelumab first-line maintenance plus best supportive care (BSC) significantly prolonged overall survival (OS; primary endpoint) versus BSC alone in patients with advanced urothelial carcinoma (aUC) without disease progression with first-line platinum-containing chemotherapy. ObjectiveTo evaluate patient-reported outcomes (PROs) with avelumab plus BSC versus BSC alone. Design, setting, and participantsA randomized phase 3 trial (NCT02603432) was conducted in 700 patients with locally advanced or metastatic urothelial carcinoma that had not progressed with first-line gemcitabine plus cisplatin or carboplatin. PROs were a secondary endpoint. InterventionAvelumab plus BSC (n = 350) or BSC alone (n = 350). Outcome measurements and statistical analysisNational Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBlSI-18) and EuroQol five-level EQ-5D (EQ-5D-5L) assessments were analyzed using descriptive statistics and mixed-effect models. Time to deterioration (TTD; prespecified definition: a ≥3-point decrease from baseline in the FBlSI-18 disease-related symptoms–physical subscale for two consecutive assessments) was evaluated via Kaplan-Meier analyses. Results and limitationsCompletion rates for scheduled on-treatment PRO assessments were >90% (overall and average per assessment). Results from descriptive analyses and mixed-effect or repeated-measures models of FBlSI-18 and EQ-5D-5L were similar between arms. TTD was also similar, both in the prespecified analysis (hazard ratio 1.26 [95% confidence interval: 0.90, 1.77]) and in the post hoc analyses including off-treatment assessments and different event definitions. Limitations included the open-label design and limited numbers of evaluable patients at later time points. ConclusionsAddition of avelumab first-line maintenance to BSC in patients with aUC that had not progressed with first-line platinum-containing chemotherapy prolonged OS, with a relatively minimal effect on quality of life. Patient summaryIn this trial of people with advanced urothelial carcinoma who had benefited from first-line chemotherapy (ie, had stable disease or reduced tumor size), treatment with avelumab maintenance plus best supportive care (BSC) versus BSC alone improved survival significantly, without compromising quality of life, as reported by the patients themselves.

Role of neuroticism and perceived stress on quality of life among patients with dry eye disease

This hospital-based, cross-sectional observational study aimed to examine whether neuroticism has an impact on stress that is related to dry eye disease (DED) and quality of life (QOL). One hundred participants who had DED completed the Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire, a 5-level EQ-5D (EQ-5D-5L), Neuroticism Inventory (NI), and 10-Item Perceived Stress Scale (PSS). Hierarchical linear regression was applied to determine the predictive effect of the independent variables. Participants’ mean age was 50.91 ± 14.3 years, and females totalled 89.0%. Hierarchical linear regression analysis showed that DESQ-Ocular symptoms were the strongest predictor for QOL either assessed by DEQS or EQ-5D, and its effect was lessened when perceived stress and neuroticism were added to the model. The final model explained up to 30–39% variance of the QOL, compared with 13–32% by DESQ-Ocular symptoms alone. QOL of the patients with DED, is not only related to eye symptoms but perceived stress. Moreover, neuroticism was a strong predictor contributing to the QOL among patients with DED. The study showed a significant association between perceived stress, neuroticism and the QOL of patients with DED. Personality has some impact on both subjective dry eye symptoms and impact on daily life, along with the general health-related QOL.