EQ-VAS Scores Research Articles

Development and Implementation of an Integrated Pharmaceutical Care Program for patients with COPD in a Rehabilitation Hospital.

Background: Chronic obstructive pulmonary disease (COPD) is a progressive disease associated with airflow limitation and prolonged respiratory problems. The treatment requires an interdisciplinary approach with a holistic view of the patient. A cornerstone of the treatment consists of inhalation therapy. Inhalation errors are abundant and medication adherence towards inhalation therapy is low. We aimed (1) to develop a standardized pharmaceutical care protocol for hospitalized patients with COPD and (2) to evaluate the effect and feasibility of protocol implementation.
 Methods: This study took place at the rehabilitation hospital Koningin Elisabeth Instituut (RH-KEI) in Oostduinkerke, Belgium from January 2021 to April 2022. The protocol was based on the PHARMACOP protocol, tailored to the specific setting using in-depth interviews with all HCPs involved in the pharmaceutical care of patients with COPD (physicians, pharmacists, pharmacy technicians, nurses, physiotherapists and an occupational therapist). The finalized protocol consisted of six additional patient contacts (3 evaluation moments, 2 educational moments and 1 evaluation moment two weeks after discharge), mainly between the hospital pharmacist and the patients. Consequently, from January 2022 to April 2022, adult patients with COPD were included to follow the complete protocol. Patient outcomes were evaluated using standardized questionnaires (i.e. mMRC, BMQ, CAT, EQ-D and EQ-VAS). The feasibility was assessed during a focus group discussion with all involved HCPs and a patient survey after discharge.
 Results: Before the start of the study, the hospital pharmacist in RH-KEI had no patient contact and there were no (recurrent) training sessions about inhaler use. The in-depth interviews elucidated that most involved health care providers (HCPs) had insufficient knowledge of the correct use of inhalers. This is however needed as 37% of included patients made at least one critical inhalation error at hospitalization. The adapted PHARMACOP protocol was tested in 13 patients, after which a significant improvement was noted in mMRC (p = 0.047), BMQ concerns (p = 0.011) and CAT score (p = 0.002). A trend towards improvement was noted in the EQ-5D and EQ-VAS score (resp. p = 0.065, p = 0.590). Finally, mean inhalation technique scores had significantly improved (p = 0.003). Transferring information to primary care HCPs seemed difficult as only a third of patients had handed over their discharge letter to their community pharmacist. The in-hospital HCPs concluded that the protocol was feasible for implementation with some adjustments, such as a more prominent role of the (hospital) pharmacist, the possibility to tailor the program to the patient and a set timing for interdisciplinary (patient) discussions. 
 Conclusion: An interdisciplinary pharmaceutical care program can improve outcomes in patients with COPD. Additional attention should be given to the inclusion of primary care HCPs to guarantee continuity of care concerning inhalation therapy for COPD management.

Assessing health-related quality of life of people with diabetes in Nigeria using the EQ-5D-5L: a cross-sectional study

Assessing the health-related quality of life (HRQoL) of people with diabetes is important to evaluate treatment effectiveness and identify interventions that would be beneficial to the patients. This descriptive cross-sectional study aimed to assess the HRQoL of people with diabetes visiting 15 community pharmacies in Akwa Ibom State, Nigeria, and to identify its determinants. The English (Nigeria) version of the EQ-5D-5L was administered to 420 eligible patients between August and September 2021. Data were analyzed with SPSS (IBM version 25.0) and presented descriptively; differences in HRQoL scores were examined using inferential statistics. Statistical significance was set at p < 0.05. Most participants (56.8%) were female; 193 (49.6%) were between the ages of 30 and 49. The median (interquartile range, IQR) for the EQ VAS and EQ-5D-5L index scores, respectively, were 80.0 (65.0–85.0) and 0.77 (0.62–0.90). Most participants reported problems with usual activities (52.7%), pain/discomfort (60.2%), and anxiety/depression (57.6%). The EQ VAS score and EQ-5D-5L utility index were significantly (p < 0.05) associated with respondents' age, marital status, work status, and personal monthly income. The HRQoL of participants was relatively high. Nevertheless, implementing strategies aimed at pain management and providing psychological support for people with diabetes in Nigeria may improve their HRQoL.

Housing conditions, cooking fuels, and health-related quality of life among rural middle-aged and elderly in northwest China: A ten-year balanced panel study

ObjectiveTo investigate the impacts of improving housing conditions and transitioning to clean cooking fuels on health-related quality of life (HRQOL) among middle-aged and elderly populations in rural China. Methods: Using a 10-year longitudinal follow-up study, we examined changes in housing conditions, cooking fuel use, and HRQOL among 690 Chinese adults aged 45 above in rural areas. HRQOL was assessed using the European Quality of Life-5 Dimensions 3 Levels (EQ-5D-3L) questionnaire. Generalized estimating equations were utilized to analyze correlations between variables. Results: Using four-period balanced panel data of 10 years, there were significant differences in the self-reporting of mobility, self-care, usual activities, pain / discomfort and anxiety / depression in rural middle-aged and elderly people (p < 0.05). In terms of the EQ-5D index score and EQ-VAS score, showed a decreasing trend (p < 0.05). The housing area, housing material type, utilization of sanitary toilets, separation of housing and kitchen were separated and non-solid fuels used as cooking fuel were significantly associated with high HRQOL (p < 0.05). Conclusions: This study found that good housing conditions and the use of non-solid cooking fuel had positive effects on health-related quality of life of middle-aged and elderly people in rural areas of northwest China.

Health-related quality of life is improved after coronary artery bypass graft surgery: a 1-year follow-up study

Objectives: The purpose of this study was to detect changes in QoL after coronary artery bypass grafting surgeries (CABG) in one year, and to identify the possible predictive factors associated with the change. Design: A single-center prospective study of 501 patients was conducted between 2013 and 2018 using the EQ-5D VAS questionnaire for estimating the QoL. The patients filled in a questionnaire preoperatively, at 6 and at 12 months postoperatively. Univariate and multivariable logistic regression analyses were used to find out if certain pre-selected factors or EQ5D dimensions had independent effects on the observed EQ VAS scores. Results: QoL improved in all EQ-5D dimensions and in EQ VAS scores at 6 and at 12 months: the greatest changes in the number of reported problems were in the dimensions “mobility” (–34.2%, p<.001), “self-care” (–36.7%, p=.001) and “pain or discomfort” (–31.0%, p<.001). With the multivariable regression model, we could show that normal left ventricle ejection fraction (LVEF) and improvement in mobility and pain/discomfort dimensions were in association with improvement of EQ VAS score at 6 months. At 12 months this association was no longer detectable. Conclusions: CABG procedure can improve patient’s QoL when judged with EQ5D dimensions and related overall self-rated health (VAS). This improvement was seen both at 6 and at 12 months postoperatively. Except for LVEF, the other patient-specific risk factors we examined did not seem to affect QoL in the long term.

Improvements in Patient-Reported Outcomes in Relapsed or Refractory Large B-Cell Lymphoma Patients Treated With Epcoritamab

BackgroundPatient-reported outcomes were evaluated in EPCORE NHL-1 in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) treated with epcoritamab monotherapy (NCT03625037). Materials and MethodsAdults with R/R CD20+ LBCL and ≥2 prior systemic antilymphoma therapies, including anti-CD20, completed the Functional Assessment of Cancer Therapy–Lymphoma (FACT-Lym) and EQ-5D-3L. A subgroup of patients provided additional feedback in one-on-one qualitative interviews. FACT-Lym and EQ-5D-3L score changes from baseline (CFB) to cycle 9 or end of treatment were interpreted using published minimally important differences (MID). ResultsIn total, 157 patients (88.5% with diffuse LBCL) were treated (median age, 64 years). In total, 70.7% had ≥3 prior treatments, 61.1% had primary refractory disease, and 82.8% were refractory to last systemic therapy. FACT-Lym scores exceeded MID thresholds: mean (SD) CFB were 4.4 (15.2), MID 3.0 to 7.0 (FACT-General); 5.9 (7.6), MID 2.9 to 5.4 (FACT-Lymphoma subscale); 8.4 (15.2), MID 5.5 to 11.0 (FACT-Trial Outcome Index); 10.3 (20.2), MID 6.5 to 11.2 (FACT-Lym total score). EQ-5D-3L index scores, 0.09 (0.20), MID 0.08, and EQ-VAS scores, 16.6 (22.8), MID 7.0, improved. In 20 qualitative interviews, 88.2% reported symptom improvements; 80.0% were “very satisfied” or “satisfied” with epcoritamab. ConclusionsR/R LBCL patients reported consistent, clinically meaningful improvements in symptoms and HRQoL and satisfaction with epcoritamab.

Psychometric performance of EQ-5D-5L and SF-6DV2 in measuring health status of populations in Chinese university staff and students

AimsTo compare measurement properties of EQ-5D-5L and SF-6DV2 in university staff and students in China.MethodsA total of 291 staff and 183 undergraduates or postgraduates completed the two instruments assigned in a random order. The health utility scores (HUS) of EQ-5D-5L and SF-6DV2 were calculated using the respective value sets for Chinese populations. The agreement of HUSs was examined using intraclass correlation coefficients (ICC) and Bland-Altman plot. Convergent validity of their HUSs and similar dimensions were assessed using Spearman’s correlation coefficient. Known-group validity of the HUSs and EQ-VAS score was assessed by comparing the scores of participants with and without three conditions (i.e., disease, symptom or discomfort, and injury), as well as number of any of the three conditions; their sensitivity was also compared.ResultsThe ICCs between the two HUSs were 0.567 (staff) and 0.553 (students). Bland-Altman plot found that EQ-5D-5L HUSs were generally higher. Strong correlation was detected for two similar dimensions (pain/discomfort of EQ-5D-5L and pain of SF-6DV2; anxiety/depression of EQ-5D-5L and mental health of SF-6DV2) in both samples. The correlation between the two HUSs were strong (0.692 for staff and 0.703 for students), and were stronger than their correlations with EQ-VAS score. All the three scores could discriminate the difference in three known-groups (disease, symptom or discomfort, number of any of the three conditions). The two HUSs were more sensitive than EQ-VAS score; and either of them was not superior than the other.ConclusionsBoth EQ-5D-5L and SF-6DV2 HUSs have acceptable measurement properties (convergent validity, known-groups validity, sensitivity) in Chinese university staff and students. Nevetheless, only EQ-5D-5L (PD and AD) and SF-6DV2 (PN and MH) showed indicated good convergent validity as expected. Two types of HUSs cannot be used interchangeably, and each has its own advantages in sensitivity.

Personalized surveillance and aftercare for non-metastasized breast cancer: the NABOR study protocol of a multiple interrupted time series design

BackgroundFollow-up of curatively treated primary breast cancer patients consists of surveillance and aftercare and is currently mostly the same for all patients. A more personalized approach, based on patients’ individual risk of recurrence and personal needs and preferences, may reduce patient burden and reduce (healthcare) costs. The NABOR study will examine the (cost-)effectiveness of personalized surveillance (PSP) and personalized aftercare plans (PAP) on patient-reported cancer worry, self-rated and overall quality of life and (cost-)effectiveness.MethodsA prospective multicenter multiple interrupted time series (MITs) design is being used. In this design, 10 participating hospitals will be observed for a period of eighteen months, while they -stepwise- will transit from care as usual to PSPs and PAPs. The PSP contains decisions on the surveillance trajectory based on individual risks and needs, assessed with the ‘Breast Cancer Surveillance Decision Aid’ including the INFLUENCE prediction tool. The PAP contains decisions on the aftercare trajectory based on individual needs and preferences and available care resources, which decision-making is supported by a patient decision aid. Patients are non-metastasized female primary breast cancer patients (N = 1040) who are curatively treated and start follow-up care. Patient reported outcomes will be measured at five points in time during two years of follow-up care (starting about one year after treatment and every six months thereafter). In addition, data on diagnostics and hospital visits from patients’ Electronical Health Records (EHR) will be gathered. Primary outcomes are patient-reported cancer worry (Cancer Worry Scale) and overall quality of life (as assessed with EQ-VAS score). Secondary outcomes include health care costs and resource use, health-related quality of life (as measured with EQ5D-5L/SF-12/EORTC-QLQ-C30), risk perception, shared decision-making, patient satisfaction, societal participation, and cost-effectiveness. Next, the uptake and appreciation of personalized plans and patients’ experiences of their decision-making process will be evaluated.DiscussionThis study will contribute to insight in the (cost-)effectiveness of personalized follow-up care and contributes to development of uniform evidence-based guidelines, stimulating sustainable implementation of personalized surveillance and aftercare plans.Trial registrationStudy sponsor: ZonMw. Retrospectively registered at ClinicalTrials.gov (2023), ID: NCT05975437.

Improvements in Health-Related Quality of Life after Exagamglogene Autotemcel in Patients with Transfusion-Dependent Beta-Thalassemia

Background: Transfusion-dependent β-thalassemia (TDT), an inherited hematological disorder which requires life-long, chronic red blood cell transfusion (RBC) and regular iron chelation therapy, has a substantial negative impact on health-related qualify of life (HRQoL). Exagamglogene autotemcel (exa-cel) is a one-time, non-viral, ex vivo CRISPR-Cas9 gene-edited cell therapy in phase 3 clinical trials that has been shown to eliminate the need for RBC transfusions and achieve transfusion independence. Here, we report HRQoL data from a pre-specified interim analysis of the exa-cel CLIMB TDT-111 study. Methods: CLIMB TDT-111 is an ongoing, 24-mo, phase 3 trial of a single dose of exa-cel in patients aged 12-35 years with TDT and a history of ≥100 mL/kg/year or ≥10 U/year of packed RBC transfusions for 2 years prior to screening. Changes in patient-reported outcome (PRO) measures including EuroQol Quality of Life Scale 5 dimensions 5 levels of severity (EQ-5D-5L, including descriptive system and visual analog scale [VAS]) and Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT, including FACT-General [FACT-G] and bone marrow transplant subscale [BMTS]) for adults and the EuroQol Quality of Life Scale 5 dimensions youth (EQ-5D-Y) and Pediatric Quality of Life Inventory (PedsQL) for adolescents were assessed through month 24 as a secondary endpoint in the trial. Data are presented as of 16 January 2023 for the 24 adults (aged ≥18-35 years) and 11 adolescents (aged ≥12 to &amp;lt; 18 years) who had been followed for ≥16 months after exa-cel infusion. Results: Clinically meaningful improvements, exceeding the minimal clinically important difference (MCID) thresholds, were observed in all PRO measures in adults. Baseline mean EQ-5D-5L health utility US index score (n=24, mean [SD]: 0.85 [0.18]) was near the general population norm and in line with baseline scores previously reported for adult patients with TDT. By month 24, both EQ-5D-5L health utility US index scores and EQ VAS scores showed substantial improvement (mean [SD] changes at month 24 [n=15]: 0.12 [0.26] and 10.2 [20.9] points; MCIDs 0.078 and 7 to 10, respectively). FACT-G Total Score improved from baseline by month 12 and was sustained through month 24 (mean [SD] change at month 24 [n=15] 10.3 [17.0] points; MCID 3 to 7), with improvements observed in all 4 subscales (physical, social/family, emotional, and functional well-being). BMTS score improved by month 12 and was sustained through month 24 (mean [SD] change at month 24 [n=15] 6.8 [4.7] points; MCID 2 to 3). For adolescents, EQ VAS scores improved through month 18 (mean [SD] change from baseline 4.8 [6.1] points). Total PedsQL score improved by month 6 and was sustained through month 18 (mean [SD] change from baseline [n=7] 14.1 [9.2] points; MCID 4.36). Physical functioning and psychosocial health scores, sub-components of PedsQL, both showed sustained improvement through month 18 (mean [SD] change [n=7] 19.2 [9.1] and 11.4 [10.9] points; MCID of 6.66 and 5.30 points, respectively). Improvement in psychosocial score was observed in all 3 subscales (social, emotional, and school functioning). Conclusion: Adults and adolescents infused with exa-cel reported sustained and clinically meaningful improvements in their HRQoL, with improvements observed across different instruments and domains, including physical, emotional, social/family and functional well-being and overall health status. These results demonstrate the broad clinical benefits of exa-cel in patients with TDT.

Improvements in Health-Related Quality of Life after Exagamglogene Autotemcel in Patients with Severe Sickle Cell Disease

Background: Severe sickle cell disease (SCD), which is characterized by recurrent vaso-occlusive crises (VOCs), has a substantial negative impact on health-related quality of life (HRQoL). Exagamglogene autotemcel (exa-cel) is a one-time, non-viral, ex vivo CRISPR/Cas9 gene-edited autologous cell therapy in phase 3 clinical trials that has been shown to eliminate VOCs. Here, we report HRQoL data from a pre-specified interim analysis of the exa-cel CLIMB SCD-121 study. Methods: CLIMB SCD-121 is an ongoing phase 3 trial of a single dose of exa-cel in patients ages 12-35 years with SCD and a history of ≥2 VOCs/year in each of the 2 years prior to screening. Changes in patient reported outcomes measures EuroQol Quality of Life Scale 5 dimensions 5 levels of severity (EQ-5D-5L, including descriptive system and visual analog scale [VAS]), Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT, including FACT-General [FACT-G] and bone marrow transplant subscale [BMTS]), Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me), and the 11-point pain Numerical Rating Scale (NRS ) were assessed from baseline through month 24 as a secondary endpoint in the trial. Data is presented as of 10 Feb 2023 for the 17 adult patients (aged ≥18-35 years) who had been followed for ≥16 months after exa-cel infusion. Results: Substantial and clinically meaningful improvements exceeding minimal clinically important difference (MCID) thresholds were observed in all assessed patient reported outcomes measures. At baseline, the EQ-5D-5L health utility US index (n=17; mean [SD]: 0.71 [0.23]) and EQ VAS (63.5 [22.5]) scores were lower than the US general population norm and similar to baseline scores reported for adult SCD patients with recurrent VOCs. By month 6, both EQ-5D-5L health utility US index score and EQ VAS score showed substantial improvements, which were maintained through month 24 (mean changes [SD] at month 24 [n=8]: 0.23 [0.20]; MCID 0.078 and 28.3 [16.2]; MCID 7 to 10, respectively). FACT-G Total Score improved from baseline at month 24 (mean [SD] change at month 24 [n=8]: 29.8 [17.2]; MCID 3 to 7), with improvements observed in all 4 subscales (physical, social/family, emotional, and functional well-being). BMTS score improved by month 6 and was sustained through month 24 (mean [SD] change at month 24 [n=8]: 3.9 [5.7]; MCID 2 to 3). All subscales of the ASCQ-Me, including emotional (mean [SD] change [n=7] 17.7 [9.8]), social (23.8 [6.7]), stiffness (7.9 [12.9]), and sleep impact (8.4 [8.3]), demonstrated clinically meaningful improvements from baseline through month 24. For the ASCQ-Me pain-related subscales evaluating pain impact, pain episode frequency and pain severity, the largest numerical improvement was observed in pain episode frequency (mean [SD] change at month 24 [n=8]: -22.8 [8.2]; MCID -5). Improvements in the pain NRS were observed by month 12 and sustained through Month 24 (mean [SD] change at month 24 [n=8]: -1.8 [3.1]; MCID -1). Conclusion: Adults infused with exa-cel reported sustained and clinically meaningful improvements in their HRQoL, with improvements observed across different instruments and domains, including physical, emotional, social/family, and functional well-being, pain experience, and overall health status. These results demonstrate the broad clinical benefits of exa-cel in patients with SCD.

The mediating role of negative emotions in the relationship between smoking and health-related quality of life among Chinese individuals: A cross-sectional study.

Although the negative impact of smoking on health has been confirmed in various studies, few have explored psychological factors mediating the relationship between smoking and health-related quality of life (HRQOL). This study aimed to investigate the relationship between smoking and HRQOL in the Chinese population and the mediating role of negative emotions (NEs). Survey data were derived from a cross-sectional study conducted in China from 20 June to 31 August 2022. We recruited participants from 148 cities across the country using a stratified multistage sampling method. The HRQOL of the dependent variable was measured using the Chinese version of European Quality of Life-5 Dimensions (EQ-5D-5L). The Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), and Perceived Stress Scale (PSS-4) were used to measure NE parameters including depression, anxiety, and perceived stress, as the intermediate variables. A multiple parallel mediation model was used to analyze the mediating role of NEs in smoking and HRQOL. A total of 21916 valid questionnaires were collected, of which 3010 (13.7%) and 18906 (86.3%) were categorized into smokers and non-smokers, respectively. The HRQOL (EQ-VAS score) of smokers (71.70 ± 23.08) was lower than that of non-smokers (73.69 ± 21.32), whereas the depression and anxiety levels of smokers were higher than those of non-smokers (all p<0.001). Moreover, smoking, NEs (depression and anxiety), and HRQOL showed pairwise correlations. According to the mediation analysis, depression (β= -0.461; 95% BCa CI: -0.664 - -0.268) and anxiety (β= -0.279; 95% BCa CI: -0.435 - -0.138) mediated the relationship between smoking and HRQOL after adjusting for demographic and life factors. These findings emphasize the necessity of studying the interaction between smoking, HRQOL, and Nes, and complementing the research on the impact of psychological factors on the HRQOL of smokers. Public health activities should focus on mental health and take targeted measures for the prevention, treatment, and rehabilitation of smokers.

Patients with depression symptoms are more likely to experience improvements of internet-based cognitive behavioral therapy: a secondary analysis of effect modifiers in patients with non-cardiac chest pain in a randomized controlled trial

BackgroundNon-cardiac chest pain is common and associated with increased anxiety and reduced health-related quality of life. Randomized controlled trials on psychological interventions for patients with non-cardiac chest pain have reported mixed results. Patients with non-cardiac chest pain are a heterogeneous group. Identifying sub-groups that could potentially benefit more (or less) from an intervention would be valuable knowledge. We have conducted a randomized controlled trial where internet-based cognitive behavioural therapy (iCBT) had effect on reducing cardiac anxiety and increasing health-related quality of life at 12-month follow-up. The aim of the present study was to explore potential effect modifiers of iCBT in patients with non-cardiac chest pain on cardiac anxiety and/or health related quality of life at 12-month follow-up.MethodsWe analysed data from our randomized, controlled trial where 161 patients with non-cardiac chest pain were included and randomized to either iCBT or a treatment as usual (control). Cardiac anxiety measured by the Cardiac Anxiety Questionnaire and health-related quality of life measured by the EuroQol Visual Analog Scale at 12 month follow-up were the primary outcomes. Four potential baseline characteristics where identified as potential effect modifiers by a theory-based approach: (1) depression measured by the Patient Health Questionnaire; (2) anxiety measured by the Body Sensations Questionnaire; (3) prior healthcare contacts measured by a self-developed question; and (4) chest pain frequency measured by a self-developed question. Each potential effect modifier was analysed in a linear regression model where cardiac anxiety and EQ-VAS scores at 12-month follow-up, separately, were used as dependent variables. The potential differential treatment effect for each effect modifier was assessed by the interaction term: effect modifier x treatment group.ResultsDepression symptoms at baseline predicted a differential treatment effect at 12-month follow-up on health-related quality of life in favor of the iCBT group (regression coefficient of the interaction term: -1.85 (CI -3.28 to -0.41), p = 0.01), but not on cardiac anxiety at 12-month follow-up. Fear of bodily symptoms, chest pain frequency and prior health care contacts at baseline did not predict a treatment effect on either health-related quality of life or cardiac anxiety.ConclusionsDepression symptoms at baseline predicted a positive treatment effect of iCBT on health-related quality of life in patients suffering from non-cardiac chest pain. This indicates that it is important to identify patients with non-cardiac chest pain and co-occurring depression symptoms given that they are particularly likely to benefit from iCBT.Trial registrationClinicalTrials.gov NCT03096925.

Empowerment and enablement and their associations with change in health-related quality of life after a supported osteoarthritis self-management programme – a prospective observational study

BackgroundOsteoarthritis is a leading cause of disability worldwide. Current treatment supports coping strategies to improve health-related quality of life (HRQoL). The need to predict response to treatment has been raised to personalise care. This study aims to examine change in HRQoL from baseline to three and nine months follow-up after participating in a Supported Osteoarthritis Self-Management Programme (SOASP) and to examine if empowerment and/or enablement were associated with change in HRQoL after a SOASP.MethodsPatients participating in a SOASP were recruited consecutively between April 2016 and June 2018. The EQ-5D was used to measure HRQoL, the Swedish Rheumatic Disease Empowerment Scale (SWE-RES-23) (score range 1–5) to measure empowerment and the Patient Enablement Instrument (PEI) (score range 0–12) to measure enablement. The instruments were answered before (EQ-5D, SWE-RES-23) and after (EQ-5D, SWE-RES-23, PEI) the SOASP. A patient partner was involved in the research process to enhance the patient perspective. Changes in outcome were examined with paired sample t-test and standardized effect sizes (Cohen´s d). Multiple linear regression analysis was performed to assess potential associations.ResultsOne hundred forty-three patients participated in baseline measurement. Mean EQ-5D-5 L index score increased significantly from baseline to three months corresponding to a standardised effect size (Cohen´s d) of d = 0.43, 95% CI [0.24, 0.63] (n = 109), and from baseline to nine months d = 0.19, 95% CI [0.01, 0.37] (n = 119). The average EQ VAS score increased significantly from baseline to three months corresponding to a standardised effect size of d = 0.26, 95% CI [0.07, 0.45] (n = 109), and from baseline to nine months d = 0.18, 95% CI [0.00, 0.36] (n = 119). Neither SWE-RES-23 nor PEI at three months follow-up nor the change in the SWE-RES-23 score from baseline to three months follow-up were associated with change in either EQ-5D-5 L index (p > 0.05) or the EQ VAS (p > 0.05).ConclusionsHealth-related quality of life increased after participating in a SOASP. Empowerment and enablement as measured with the SWE-RES-23 and the PEI were not associated with change in HRQoL among patients participating in a SOASP.Trial registrationClinicalTrials.gov. Identification number: NCT 02974036. First registration 28/11/2016, retrospectively registered.

Prevalence and perceptions of pain in people with haemophilia: A UK study.

Joint bleeds in haemophilia cause destruction of articular structures, impaired function and pain. Up to 70% of people with haemophilia (PWH) report chronic pain. Little is known about the pain experiences in PWH in the UK. To identify prevalence and perceptions of pain among PWH living in the UK. A cross-sectional, non-interventional survey study conducted among PWH (all severities). The survey incorporated elements from validated tools (EQ-5D; EQ-VAS) and was distributed via participating treatment centres. Five hundred and ninety-nine PWH responded, 91% aged>18. 81% used factor prophylactically or on demand. More pain was reported by those treated on demand versus prophylaxis particularly in those who reported daily pain. 65% reported 'problem joints' based on individual impact rather than medically defined 'target joints', 2/3 reported multiple joint issues. The ankle was most commonly affected. 59% reported frequent pain, with 56% aware of pain constantly or most of the time and were more likely to report less favourable EQ-5D or EQ-VAS scores (p<.001). Pain frequency/awareness was consistent across all severities. Most discussed pain with care teams, 31% only when asked; 25% did not discuss it. Pain discussions resulted in physiotherapy referral (63%) analgesia prescription (48%), and a minority specialist pain referral (9%). Most felt well supported with regard to their pain, but 70% reported learning to live with it. Pain affects PWH of all ages and severities even in a well-resourced country significantly impacting quality of life. Clinicians must be more aware of chronic pain in PWH. Biopsychosocial approaches to pain assessment and management are recommended.

Psychometric properties of EQ-5D-5L for use in patients with Graves’ disease

BackgroundThe EQ-5D-5 L is a commonly used generic measure of health. This study aimed to evaluate the psychometric properties of the EQ-5D-5 L in patients with Graves’ disease (GD).MethodsA prospective cohort of patients with GD recruited at three public hospitals in Hong Kong completed the EQ-5D-5 L and ThyPRO-39 questionnaires at baseline, 1-month, and 6-month follow-ups. Convergent validity was tested by examining the Spearman correlation between EQ-5D-5 L and ThyPRO-39 scores at baseline. 1-month test-retest reliability was assessed by Intraclass Correlation Coefficient (ICC), Gwet’s Agreement Coefficient 2 (AC2), and percentage agreement. Responsiveness of EQ-5D-5 L index and EQ-VAS scores was assessed using effect size statistics (standardized effect size [SES] and standardized response mean [SRM]).ResultsOf 125 recruited patients, 101 (80.8%) and 100 (80.0%) patients were followed up at 1- and 6-month, respectively. For convergent validity, there was a moderate negative correlation between EQ-5D-5 L index or EQ-VAS score and ThyPRO-39 overall QoL-impact score (-0.350, -0.451), between EQ-VAS score and composite score (-0.483), and strong negative correlation between EQ-5D-5 L index score and composite score (-0.567). The Gwet’s AC2 and percentage agreement were the highest in self-care (0.964 and 0.967), followed by mobility (0.952 and 0.962), usual activities (0.934 and 0.948), pain/discomfort (0.801 and 0.887), and anxiety/depression (0.788 and 0.882). The ICC for the EQ-5D-5 L index and the EQ-VAS was 0.707 and 0.700. For patients who reported having ‘worsened’ health at 6-month follow-up, the SES and SRM were − 0.66 and − 0.42 for EQ-5D-5 L index and − 1.15 and − 1.00 for EQ-VAS, respectively.ConclusionsThe EQ-5D-5 L demonstrated convergent validity, test-retest reliability, and responsiveness to worsened health status among patients with GD.

Treatment regimens, patient reported outcomes and health-related quality of life in children with moderate and severe hemophilia A in China: using real-world data

BackgroundProphylaxis therapy for children with moderate and severe hemophilia A (HA) is the optimal treatment regimen. The real-world treatment regimens, patient-reported outcomes, and health-related quality of life (HRQoL) in children with moderate and severe HA in China are less known.ObjectiveThis study aimed to describe real-world treatment regimens and evaluate the association of treatment regimens with comprehensive patient-reported outcomes including bleeds, chronic pain, target joints, disability, and HRQoL in children under 18 years old with HA in China.MethodsReal-world data of a nationwide online cross-sectional survey in 2021 and patients’ coagulation factor utilization data from self-management records from 2020 to 2021 were merged. 373 eligible children were included and categorized by treatment regimens according to the Chinese guideline: on-demand, short-term prophylaxis, and long-term prophylaxis treatment.ResultsCurrently, in China, 4.8% of children with HA are receiving full-dose long-term prophylaxis treatment. Prophylaxis treatment was a significant positive predictor of better patient-reported outcomes and HRQoL. For children with prophylaxis treatment, there were significantly fewer annual bleeds (p < 0.001), lower frequency of chronic pain(p < 0.001), and higher health utility scores(p < 0.01) and EQ-VAS scores(p < 0.05) than children with on-demand treatment.ConclusionAccessible long-term prophylaxis treatment should be promoted for children with moderate and severe HA in China and regular monitoring of their outcomes and HRQoL should be carried out.

The impact of bleeding event frequency on health-related quality of life and work productivity outcomes in a European cohort of adults with haemophilia A: insights from the CHESS II study

BackgroundHaemophilia A carries a substantial healthcare burden, affecting health-related quality of life (HRQoL). The Cost of Haemophilia in Men: a Socioeconomic Survey II (CHESS II), a retrospective real-world study, characterised the burden of haemophilia and its impact on HRQoL and work productivity. The current analysis explored the impact of bleeding events on HRQoL and work productivity in Europe. This analysis focused on data collected from males aged 18 to 64 years with haemophilia A without inhibitors who were receiving replacement factor products or a monoclonal antibody and were not participating in a clinical trial at the time of study recruitment. Descriptive statistics were analysed using scores from EuroQoL’s EQ-5D-5L index and EQ-VAS analogue scale and the Work Productivity and Activity Index Specific Health Problem (WPAI:SHP) percentage scores stratified by the number of annual bleeding events (ABs) 0, 1, 2, 3–4, or ≥ 5.ResultsOf 918 males with haemophilia A in CHESS II, 318 met inclusion criteria and had data available for HRQoL measures; mean age (SD) was 33.8 (12.1) years and 96% were White. Mean (SD) ABs of 2.7 (2.9) occurred over the preceding 12 months: 20% had 3 or 4 ABs; 17% had ≥ 5 ABs. Mean EQ-5D-5L index scores for patients with 0, 1, 2, 3–4, or ≥ 5 ABs were 0.92, 0.76, 0.76, 0.71, and 0.56, respectively. Mean (SD) EQ-VAS scores were 86.9 (13.6), with 0 ABs versus 69.5 (19.1) for 3 or 4 ABs and 61.2 (17.2) for ≥ 5 ABs. Mean percentage of overall work productivity loss on the WPAI:SHP questionnaire ranged from 9.70 to 0 ABs to 47.65 for ≥ 5 ABs.ConclusionsIn this European sample of adult men with haemophilia A, HRQoL and work productivity scores were lower among those reporting more AB events. Bleeding burden appears to affect HRQoL and productivity; however, this cross-sectional analysis limits the ability to draw firm conclusions on causality.

Efficacy of Comedy on Health-Related Quality of Life and Oxidative Stress in Cancer Survivors.

Cancer survivors have reduced health-related quality of life (HRQOL) due to impaired daily functioning. In addition, daily stress leads to worsening oxidative stress. The purpose of this study is to investigate the efficacy of laughter therapy on HRQOL and oxidative stress in cancer survivors. This before-and-after study asked cancer survivors to watch a 15-minute or longer comedy video over a four-week period to assess the Functional Assessment of Cancer Therapy-General (FACT-G), EuroQOL 5 dimension 3-level (EQ-5D-3L), Hospital Anxiety and Depression Scale (HADS), biological Antioxidant Potential (BAP), Reactive Oxygen Metabolites-derived compounds (d-ROMs), Oxidative Stress Index (OSI), and the antioxidant/oxidative stress ratio. The nonparametric Friedman test showed significant increases from baseline in FACT-G and EQ-VAS scores and significant decreases in HADS-Anxiety and HADS-Depression scores. Post hoc analyses showed that these items commonly differed significantly at baseline versus three and four weeks after Bonferroni correction. T-test results in the biological analysis revealed small and moderate effects with significant differences in BAP (p < 0.01, d = 0.49), OSI (p = 0.03, d = 0.33), and BAP/d-ROMs (p < 0.01, d = 0.51). These results suggest that daily comedy viewing may be an effective intervention to improve quality of life and antioxidant capacity in cancer survivors. Considering its safety, convenience, and low cost, it should be considered a high-value intervention for cancer survivors.

Population norms for the EQ-5D-3L and EQ-5D-5L in Romania

BackgroundThe majority of patient reported outcome measures (PROMs) don’t have population norms in Romania. This is the case with the EQ-5D as well. Therefore, we aimed to estimate population norms for the Romanian versions of the EQ-5D-5L, EQ-5D-3L, their indexes, and the EQ-VAS.MethodsA cross-sectional survey was conducted in all regions of Romania from November 2018 to November 2019. A three-stage probability sampling procedure stratified by region and settlement size was used to select a representative sample. Interviews were computer-assisted and conducted in respondents’ homes by trained interviewers. Health status was assessed with the EQ-5D-5L, the EQ-5D-3L and the EQ VAS. Descriptive statistics were used to estimate population norms by age groups and sex for the EQ-5D-5L, the EQ-5D-3L, their indexes and the EQ VAS. Population norms were weighted using survey weights. Indexes for the EQ-5D questionnaires were estimated using the recently developed Romanian value sets.ResultsData from 1,649 interviews was analysed in the present study. Survey weights were used so that sex and place of residence ratios for the weighted sample matched the Romanian general population distribution. Participants’ mean age was 47.4 years (SE = 1.157) and 50.3% of them reported being in good health. The dimension for which people reported the highest number of problems for both questionnaires was the pain/discomfort dimension. Men aged 35 plus reported fewer problems with pain/discomfort than women for both the EQ-5D-5L and EQ-5D-3L. Health decreased with age as shown by the decrease from age group 18–24 to age group 75 plus in the indexes of both questionnaires: from 0.977 (SE = 0.005) to 0.765 (SE = 0.017) for EQ-5D-5L and from 0.981 (SE = 0.005) to 0.784 (SE = 0.019) for EQ-5D-3L. There was 29.9 points drop in the EQ VAS score between the youngest and oldest group.ConclusionsPopulation norms for the Romanian versions of the EQ-5D-5L, EQ-5D-3L, their indexes, and the EQ VAS are now available. These can now be used as reference values by healthcare professionals, researchers and decision-makers leading to a further development of health-related quality of life research in Romania.

Health-related quality of life and associated factors in elderly individuals with dyslipidemia in rural Northern China.

The purpose of the study was to investigate health-related quality of life (HRQOL) and its associated factors among elderly individuals with dyslipidemia in rural Northern China. A cross-sectional study was conducted on 457 elderly individuals. The EQ-5D-5L questionnaire was used to assess HRQOL. Sociodemographic, anthropometric, lifestyle and health information was collected using a structured and standardized questionnaire. The Tobit regression model and multiple linear regression analysis were used to assess factors associated with HRQOL parameters including utility index and visual analogue score (EQ-VAS). The mean age of the participating individuals was 68.04 ± 5.98years. The median utility index and EQ-VAS scores were 0.942 (P25-P75: 0.876-1.000) and 80 (P25-P75: 70-90), respectively. Pain/discomfort was the most frequently reported complaint among the five health dimensions (50.5%). Illiterate and primary education levels, unemployed, widowed, smoking, secondhand smoke exposure, with hypertension or DM, chronic disease core knowledge scores < 8, and daily sedentary time ≥ 6h were associated with lower HRQOL. Pain/discomfort dimension was the most affected problems. Education, occupation, marital status, smoking, secondhand smoke exposure, chronic disease core knowledge, comorbidities, and daily sedentary time were significantly associated with HRQOL in the present study.

Exploring the Impact of Medication Regimen Complexity on Health-Related Quality of Life in Patients with Multimorbidity

Background. Patients with multiple chronic conditions often have complex medication regimes which negatively impact their health-related quality of life (HRQoL), and there is limited evidence on this topic, particularly from the resource limiting set-up. Hence, this study is aimed at assessing the impact of medication regimen complexity on HRQoL in patients with multiple chronic conditions at a university hospital in Ethiopia. Method. A cross-sectional study was conducted on adult patients who had at least two long-term diseases and were already receiving medical therapy for the relevant disorders. The validated 65-item Medication Regimen Complexity Index (MRCI) and the EuroQol-5-Dimensions-5-Levels (EQ-5D-5L) instruments were used to assess MRC and HRQoL, respectively. The Welch test for unequal variance and Fisher’s exact test were used to assess the impact of different variables on HRQoL. Results. The study surveyed 416 participants, with a 98.3% response rate, the majority of whom were female (n = 267, 64.2%) and had two chronic conditions (n = 215, 51.7%). About 46.4% of patients were taking five or more medications, with a significantly higher proportion at the high regimen complexity level ( P = 0.001 ). The average MRCI score was 9.73 ± 3.38, indicating a high level of complexity. Patients with high MRCI scores reported more problems in mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There was a negative correlation between the MRCI score and HRQoL as measured by the EQ-5D-Index (r = −0.175; P &lt; 0.001 ) and the EuroQol-Visual Analogue Scale score (r = −0.151; P = 0.002 ). In addition, there was a statistically significant difference in the mean EQ-5D-Index ( P = 0.001 ) and EQ-VAS scores ( P = 0.001 ) across low, medium, and high MRCI levels. Conclusion. Medication regimen complexity was prevalent among patients with multimorbidity and was associated with a decrease in HRQoL. Therefore, interventions addressing medication-related issues should be a priority to improve the well-being of patients with multiple chronic conditions.