EQ-5D-5L Research Articles

A mapping study in mainland China: predicting EQ-5D-5L utility scores from the psoriasis disability index

Aims: This study aims to develop a mapping algorithm that can be used to predict 5-level EQ-5D (EQ-5D-5L) utility scores from the Psoriasis Disability Index (PDI) for further use in cost-utility analysis among psoriasis patients.Materials and Methods: A total of 321 participants with psoriasis was recruited in a dermatology clinic from a tertiary hospital in China. The EQ-5D-5L utility scores were scored using the Chinese-specific value set. Three model specifications were used and each one was estimated using three different statistical techniques, including the ordinary least squares (OLS), the Tobit regression and the generalized linear model (GLM). The goodness-of-fit of mapping performance was estimated by using two common indicators: the mean absolute error (MAE) and the mean square error (MSE).Results: A final validated sample of 321 psoriasis patients was analyzed in the study. The patients had a mean ± standard deviation (SD) age of 39.7 ± 12.9 years, and the EQ-5D-5L state utility score is 0.899 ± 0.106. Among all the models considered, the OLS linear model based on the four PDI item scores was selected as the best model due to higher accuracy (MAE = 0.1334 and 0.1557 for the estimation and validation sample separately).Limitations: The main limitation of this study is that the survey site was limited to one hospital and not more broadly representing the whole of China. Additionally, there are some missing data in the full sample and an absence of an external dataset to validate the algorithms.Conclusions: The mapping algorithms reported in this paper can be used to predict the EQ-5D-5L utilities from the PDI; however, similar to other mapping studies in the literature it can only serve as the second-best approach to elicit utilities from disease-specific instruments.

Do Rural Residents in China Understand EQ-5D-5L as Intended? Evidence From a Qualitative Study.

BackgroundThe 5-level EQ-5D (EQ-5D-5L) has been increasingly used in China to measure the health status of the general population and patients. However, its content validity among rural residents in China has not been formally evaluated. This qualitative study aims to assess the content validity of EQ-5D-5L among rural Chinese.MethodsParticipants were recruited from four regions (North, South, East and West) across China. Eligible participants were those living in the rural area in last three years and making a living by agricultural operations. Semi-structured interviews were conducted. Interview transcripts were analysed to assess the comprehensibility, relevance, clarity and comprehensiveness.ResultsSixty-two participants were included, comparable to the national figures regarding age, sex and education. For comprehensibility, participants could understand the ‘mobility’, ‘self-care’ and ‘usual activities’ domains well, but some reported confusions in ‘pain/discomfort’ (n = 42) and ‘anxiety/depression’ (n = 35). Some also reported difficulties in understanding anxiety (n = 6) and depression (n = 9), possibly due to the formal wording used. For relevance, all domains were reported as health-related and participants’ responses were based on their own health. For clarity, all could distinguish the five levels, but suggestions on reducing response levels and alternative wording for ‘slight’ were raised. For comprehensiveness, two aspects (fatigue/energy and appetite) were raised beyond the EQ-5D-5L domains. The ‘mobility’ domain was selected as the most important and ‘anxiety/depression’ as the least important.ConclusionRural Chinese reported problems on the content validity of Chinese EQ-5D-5L. It might be sensible to consider some revisions to make it more understandable for rural residents.Electronic supplementary materialThe online version of this article (10.1007/s41669-020-00212-z) contains supplementary material, which is available to authorized users.

Baseline Characteristics of Participants in the Treatment of Advanced Glaucoma Study: A Multicenter Randomized Controlled Trial

To report the baseline characteristics of participants enrolled in TAGS (Treatment of Advanced Glaucoma Study). Pragmatic randomized control trial (RCT). Participants with newly diagnosed advanced glaucoma in at least 1 eye were recruited. Participants were patients with open angle glaucoma presenting with advanced glaucoma in at least 1 eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria for severe defect. Participants were randomly allocated to receive either primary augmented trabeculectomy or primary medical management. When both eyes were eligible, the same intervention was undertaken in both eyes, and the index eye for analysis was the eye with the less severe visual field mean defect (MD). Main outcome measurements were visual field profile, defined by the HPA classification; clinical characteristics; quality of life, as measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), the EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3), and the Glaucoma Profile Instrument (GPI). A total of 453 patients were recruited. The mean visual field MD was-15.0 dB ± 6.3 in the index eye and-6.2 dB in the non-index eye. Of index eyes (HPA "severe" classification) at baseline, more than 70% of participants had a MD <-12.00 dB, and nearly 90% had more than 20 points defective at the 1% level. The mean LogMAR visual acuity of the index eye was 0.2 ± 0.3. TAGS is the first RCT to compare medical versus surgical treatments for patients presenting with advanced open angle glaucoma in a publicly funded health service. The study will provide clinical, health-related quality of life, and economic outcomes to inform future treatment choices for those presenting with advanced glaucoma.

Abstract P3-11-10: Health-related quality of life (HRQoL) in monarcHER: Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in HR+, HER2+ advanced breast cancer

Abstract Background: Abemaciclib is an oral selective inhibitor of cyclin-dependent kinases 4 and 6 approved for hormone receptor (HR)+, human epidermal growth factor receptor 2 (HER2)- metastatic breast cancer. In the randomized, 3-arm, phase 2 study monarcHER (NCT02675231) for HR+, HER2+ advanced breast cancer (ABC), abemaciclib in combination with trastuzumab (T) and fulvestrant (F) significantly improved investigator-assessed progression-free survival (whereas abemaciclib + T did not) versus (vs) T + physician’s choice of chemotherapy and demonstrated a tolerable safety profile. Here, patient-reported HRQoL, functioning, and symptoms are reported. Methods: In monarcHER, 237 postmenopausal (surgical, natural, or chemical ovarian suppression) women with ABC and ≥2 prior HER2+ directed therapies in the advanced setting were randomized 1:1:1 to abemaciclib (150 mg PO Q12H every 21 days) + T (IV infusion on D1 every 21 days) with F (500 mg IM on Cycle 1 D1 and D15 and Cycle 2 D8, then Q4W; Arm A) or without F (Arm B) vs T + physician’s choice of chemotherapy (per label every 21 days; Arm C). Supportive measures to manage diarrhea were permitted. Patient-reported outcomes were measured at baseline and at each cycle using the modified Brief Pain Inventory-short form (mBPI-sf) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The EuroQol 5-Dimension 5 Level (EQ-5D 5L) questionnaire was also collected. Higher scores on EORTC QLQ-C30 functional and health status/QoL scales indicate improvement whereas higher scores on EORTC QLQ-C30 symptom scales and mBPI-sf indicate worsening of symptoms/pain. The EQ-5D 5L index score was calculated from a set of item weights to derive a score of 0-1, with 1 representing the best health status. Treatment arm comparisons of change from baseline (all post-baseline visits) were conducted using a mixed model repeated measure, with .05 considered statistically significant. Clinical meaningfulness was defined as a ≥10-point score change from baseline (on a 0-100 scale) for EORTC QLQ-C30 and a 2-point score change from baseline for mBPI-sf. Results: Patient-reported outcome compliance rates were ≥90% through Cycle 15; the range for median duration of each treatment component of each arm was 7.5-10.0 cycles. Overall, no statistically significant or clinically meaningful changes from baseline differences were observed between treatment arms for mBPI-sf pain scores or EORTC QLQ-C30 global health score, function scales, or for symptoms of fatigue, dyspnea, appetite loss, or financial difficulties. Least square (LS) mean change from baseline differences showed statistically significant improvements in Arm A vs C for EORTC QLQ-C30 symptoms of pain (-6.81; p=.026) and insomnia (-6.39; p=.041). Worsening for the symptom of nausea/vomiting was statistically significant but not clinically meaningful in Arm A vs C (4.08; p=.043). Diarrhea showed a statistically significant and clinically meaningful worsening in Arm A vs C (19.27; p&amp;lt;.001). A by-cycle analysis showed mean nausea/vomiting and diarrhea symptom scores were generally higher during earlier visits and returned to near-baseline levels after treatment discontinuation. The EQ-5D 5L index score improved in Arm A vs C, with an LS mean change from baseline difference of .05 (p=.033). Conclusions: Quality of life was maintained for patient-reported pain, global health, functioning, and most symptoms when abemaciclib was added to T + F compared with physician’s choice of chemotherapy in patients with HR+, HER2+ ABC. Gastrointestinal-related symptoms were transient and consistent with the manageable, reversible adverse event profile. Citation Format: Sara M Tolaney, Andrew M Wardley, Stefania Zambelli, John F. Hilton, Tiffany A Troso-Sandoval, Francesco Ricci, Seock-Ah Im, Sung-Bae Kim, Stephen RD Johnston, Arlene Chan, Shom Goel, Kristen Catron, Zhengyu Yang, M. Corona Gianford, Gregory L Price, Fabrice André. Health-related quality of life (HRQoL) in monarcHER: Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in HR+, HER2+ advanced breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P3-11-10.

A vision 'bolt-on' increases the responsiveness of EQ-5D: preliminary evidence from a study of cataract surgery.

(1) To evaluate the effect of adding a vision dimension ('bolt-on') to the 5-level EQ-5D (EQ-5D-5L) and 3-level EQ-5D (EQ-5D-3L) on their responsiveness, and (2) to compare the responsiveness of a vision 'bolt-on' EQ-5D-3L (EQ-5D-3L + V) with SF-6D and Health Utilities Index Mark 3 (HUI3) to the benefit of cataract surgery. Sixty-three patients were assessed before and after their cataract surgery using the EQ-5D-3L, EQ-5D-5L, SF-6D, HUI3, as well as a 3-level and a 5-level vision dimension. Preference-based indices were calculated using available value sets for EQ-5D-3L, EQ-5D-3L + V, EQ-5D-5L, SF-6D, and HUI3, and non-preference-based indices were calculated using the sum-score method for EQ-5D-5L and EQ-5D-5L + V (vision bolt-on EQ-5D-5L). Responsiveness was assessed using the standardized response mean (SRM) and F-statistic. Among preference-based indices, mean changes from pre to post-surgery in EQ-5D-3L + V and EQ-5D-3L indices were 0.031 and 0.018, respectively. The mean changes for EQ-5D-5L, SF-6D and HUI3 indices were 0.020, 0.012 and 0.105, respectively. The SRM (F-statistic) for EQ-5D-3L + V and EQ-5D-3L indices were 0.458 (13.2) and 0.098 (0.6), respectively. The responsiveness of EQ-5D-3L + V was better than EQ-5D-5L, SF-6D; the responsiveness of HUI3 was better than all other measures. Using non-preference-based indices, mean change for EQ-5D-5L + V and EQ-5D-5L were 0.067 and 0.017, respectively. The corresponding SRM (F-statistic) were 0.709 (31.7) and 0.295 (5.4). Preliminary evidence from our study suggests that a vision 'bolt-on' may increase the responsiveness of EQ-5D-3L and EQ-5D-5L to change in health outcomes experienced by patients undergoing cataract surgery. In absence of the preference-based vision bolt-on EQ-5D-5L index, HUI3 was the most responsive measure.

Russian population health-related quality of life indicators calculated using the EQ-5D-3L questionnaire

Objectives . The paper aims was forming the first health-related quality of life population indicators using EQ-5D–3L survey that represents the Russian population by gender and age, as well as by the attained level of education. Material and methods . For compiling population indicators, we use the EQ-5D-3L questionnaire. The study was conducted on the adult Russian population aged 18 to 75 years. A representative sample was 12616 respondents. Results. 59.3 % of the sample is in good health (profile 11111). The proportion of respondents reporting any health problems increases with age. The average score on a 100-point visual analogue scale is 72.4 (standard deviation 18,1; 95 per cent confidence interval from 72,1 to 72,7). Men, on average, tend to assess their health higher than women. However there are no statistically significant differences in health scores among educational groups, taking into account gender and age data. Conclusions. Comparison of health-related quality of life estimations with normative population data allows us to track differences in health between population groups, as well as to analyze the health status and progress in treating patients. The Russian health-related quality indicators from EQ-5D-3L survey are similar to the Hungary population indices, as well as to many European countries, the USA, and Argentina for age cohorts under 45 years of age. For the cohorts of respondents older than 45 years, Russian estimations are much lower than in other countries. This evidence confirms that borrowing scales from other countries for converting EQ-5D-3L values into a preference EQ-5D-3L index is not acceptable for Russian patients, especially for the elderly.

What to expect after open heart valve surgery? Changes in health-related quality of life.

To (i) describe changes in health-related quality of life (HRQoL) pre-operatively, at discharge, and 4 weeks after discharge following open heart surgery, (ii) compare the performance of the EuroQol Questionnaire (EQ-5D 5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) against an anchor-based approach, and to (iii) investigate the association between HRQoL and 180-day readmission. A prospective, consecutive cohort (single-center study) of 291 patients completed the EQ-5D 5L and KCCQ pre-operatively, at discharge and 4 weeks post-discharge. Changes in HRQoL over time were evaluated, and the performance of the instruments was investigated. The association between HRQoL and readmission were investigated with Cox Proportional Hazard models. Scores of the EQ-5D Index and VAS decreased significantly from the pre-operative assessment to discharge and improved from discharge to 4 weeks after. The KCCQ scores significantly improved from baseline to 4 weeks after. Minimal clinically important improvements from before surgery to 4 weeks after were seen among 24% (EQ-5D Index), 45% (EQ-5D VAS), and 57% (KCCQ). More than one-third experienced worse HRQoL 1 month after discharge. Area under the curve (AUC) (performance of the instruments) demonstrated the following: EQ-5D Index AUC 0.622 (95% CI 0.540-0.704), VAS AUC 0.674 (95% CI 0.598-0.750), and KCCQ AUC 0.722 (95% CI 0.65-0.792). None of the HRQoL measurements were associated with 180-day readmission. This study revealed that HRQoL measured with the EQ-5D is significantly worse at discharge compared to before surgery, but scores increases within the first month measured with the EQ-5D and the KCCQ. The EQ-5D and KCCQ have a moderate correlation with an anchor-based approach but were not associated with readmission.

Does preoperative health-related quality of life predict survival in high-grade glioma patients? – a prospective study

Purpose: To explore if preoperative patient-reported health-related quality of life (HRQoL) provides additional prognostic value as a supplement to other preoperatively known clinical factors in patients with high-grade glioma (HGG).Methods: In a prospective explorative study, 114 patients with high-grade glioma were included. The participants completed the generic HRQoL questionnaire EQ-5D 3L, and the disease-specific questionnaires EORTC QLQ-C30 and EORTC QLQ-BN20 1–3 days before surgery. Operating neurosurgeons scored the patient’s preoperative functional level by using Karnofsky Performance Status (KPS). Univariate and multivariate Cox regression analyses were performed to identify HRQoL domains that were associated with survival. Kaplan–Meier survival curves and Log-rank tests were used to visualize differences in survival between groups.Results: In addition to preoperative KPS and age, the EORTC QLQ-BN20 subdomains ‘seizures’ (HR 0.98, p < .006), ‘itchy skin’ (HR 1.01, p < .036) and ‘bladder control’ (HR 1.01, p < .023) were statistically significant independent predictors of survival in a multivariate cox model.Conclusions: Our results suggest that in patients with HGG, certain preoperative symptom scales within EORTC QLQ-BN20 may provide additional prognostic information to supplement other clinical prognostic factors. However, further studies are required to validate our findings. Overall the instruments EQ-5D 3L and EORTC QLQ-C30 do not seem to provide much additional valuable prognostic information to already known prognostic factors.

P666Anti-platelet therapy in the primary prevention of cardiovascular disease in patients with chronic obstructive pulmonary disease: randomised controlled proof of concept trial (APPLE COPD-ICON 2)

Abstract The APPLE COPD-ICON2 trial is a prospective 2x2 factorial, double blinded proof of concept randomised controlled trial targeting patients with chronic obstructive pulmonary disease (COPD) at high risk of cardiovascular disease. The primary goal was to investigate if antiplatelet therapy (APT) will produce the predefined cut-off of platelet inhibition measured using the Multiplate test. We also assessed inflammatory biomarkers in serum. Patients were randomised to Aspirin plus placebo, ticagrelor plus placebo, Aspirin plus ticagrelor or placebo only for 6 months. The primary outcome is inhibition of arachidonic acid (ASPI-test, cut-off &lt;40) and adenosine diphosphate (ADP-test, cut-off &lt;46) induced platelet aggregation at 6 months based on intention to treat (ITT) and sensitivity per protocol (PP) analyses. Safety outcomes included rates of major/minor bleeding. Of 543 patients screened, 120 were recruited (mean age of 67.5 years). The ITT response rate to Aspirin was 48.3% (95% confidence interval [CI] 35.8–61.0%) according to ASPI-test and the response rate to ticagrelor was 41.4% (95% CI 29.3–54.6%) according to ADP-test. The PP ASPI-test response rate to Aspirin was 68.3% (95% CI 52.3–80.9%) and the PP ADP-test response rate to ticagrelor was 68.8% (95% CI 50.4–82.6%). There were no differences between the groups in the changes in Quality of Life using questionnaires (EQ5D 5L, St. George's COPD-C), inflammatory markers, carotid intima media thickness and vascular stiffness from baseline to 6-months. There were 5 type 1 bleeds according to the BARC criteria recorded in this study; 2 in the placebo arm, 2 in the Aspirin arm, and 1 in the ticagrelor arm. The MRC Dyspnoea score, FEV1 and FVC was similar across the groups. Primary outcome measures Aspirin No Aspirin Ticagrelor No Ticagrelor ITT analysis set* n 60 60 58 62 Baseline No. of responders 1 6 4 1 % (95% CI) 1.7 (0.2, 11.3) 10 (4.5, 20.8) 6.9 (2.6, 17.3) 1.6 (0.2, 10.9) 6 months No. of responders 29 7 24 2 % (95% CI) 48.3 (35.8, 61) 11.7 (5.6, 22.8) 41.4 (29.3, 54.6) 3.2 (0.8, 12.3) PP analysis set** n 41 45 32 54 6 months No. of responders 28 7 22 2 % (95% CI) 68.3 (52.3, 80.9) 15.6 (7.5, 29.6) 68.8 (50.4, 82.6) 3.7 (0.9, 14.0) *Descriptive statistics for the primary outcome of response for the comparative groups at baseline and 6 months for the ITT analysis set and **PP analysis set. Note that response is ASPI response in the Aspirin and No Aspirin columns and ADP response in the ticagrelor and No ticagrelor columns. Primary outcome measure Nearly one third of COPD patients did not have a platelet response to antiplatelet therapy with Aspirin and ticagrelor. These findings support the high pro-thrombotic milieu and the need for further research in COPD patients. Acknowledgement/Funding Astra Zeneca (Funder reference number ISSBRIL0303)

Impact of transsphenoidal surgery for pituitary adenomas on overall health-related quality of life: a longitudinal cohort study

Background: Previous studies show a moderate improvement in health-related quality of life (HRQoL) following transsphenoidal surgery for pituitary adenomas, but no consistent predictors of HRQoL outcome have been identified. We aimed to evaluate overall HRQoL changes following such surgery, and assess potential patient or tumour characteristics that predict HRQoL outcome.Materials and methods: Sixty adult patients undergoing transsphenoidal resection of pituitary adenomas were prospectively enrolled. They completed the EQ-5D 3L, a generic HRQoL questionnaire, preoperatively, and at one (n = 57) and six months (n = 56) postoperatively. HRQoL was assessed as both postoperative change in median EQ-5D 3L score, and as change greater than the minimal clinically important difference (MCID) in EQ-5D 3L score. A multivariable logistic regression analysis was performed to assess potential predictors of clinically significant HRQoL changes (>MCID) at six months postoperatively.Results: There was a slight, but statistically significant, improvement in median EQ-5D 3L scores at six months postoperatively compared to preoperatively. Sixteen patients (29%) reported a clinically significant improvement in HRQoL at six months postoperatively, and larger preoperative tumour volume was a statistically significant predictor of such improvement. Eight patients (14%) reported a clinically significant deterioration in HRQoL at six months, but none of the assessed variables predicted such deterioration.Conclusions: Patient-reported overall HRQoL improved slightly after transsphenoidal surgery for pituitary adenomas at group level. Patients with larger tumours might have more HRQoL benefits from surgery, but the mechanisms behind the predictive nature of tumour volume remain unknown.

Does Device or Connection Type Affect Health Preferences in Online Surveys?

Recent evidence has shown that online surveys can reliably collect preference data, which markedly decrease the cost of health preference studies and expand their representativeness. As the use of mobile technology continues to grow, we wanted to examine its potential impact on health preferences. Two recently completed discrete choice experiments using members of the US general population (n = 15,292) included information on respondent device (cell phone, tablet, Mac, PC) and internet connection (business, cellular, college, government, residential). In this analysis, we tested for differences in respondent characteristics, participation, response quality, and utility values for the 5-level EQ-5D (EQ-5D-5L) by device and connection. Compared to Mac and PC users, respondents using a cell phone or tablet had longer completion times and were significantly more likely to drop out during the surveys (p < 0.001). Tablet users also demonstrated more logical inconsistencies (p = 0.05). Likewise, respondents using a cellular internet connection exhibit significantly less consistency in their health preferences. However, matched samples for tablets and cell phones produced similar EQ-5D-5L utility values (mean differences < 0.06 on a quality-adjusted life-year [QALY] scale for all potential health states). Allowing respondents to complete online surveys using a cell phone or tablet or over a cellular connection substantially increases the diversity of respondents and the likelihood of obtaining a representative sample, as many individuals have cell phones but not a computer. While the results showed systematic variability in participation and response quality by device and connection type, this study did not show any meaningful changes in utility values.

Community Pharmacies Mood Intervention Study (CHEMIST): feasibility and external pilot randomised controlled trial protocol

Feasibility studyObjectives:Refine a bespoke enhanced support intervention (ESI) (including self-help materials, intervention manual and training) for implementation by community pharmacy (CP) staff to people with sub-threshold depression and long-term conditions (LTCs) based upon evidence-supported interventions in primary careDevelop and refine study procedures (recruitment strategies and set up, screening, participant recruitment, assessment, suitability of outcome measures and data collection procedures) for testing in the pilot study phaseDesign: A case series/qualitative studySetting: UK community pharmacyPopulation: Adults with long-term health conditions who screen-positive for depression but who do not reach the threshold for DSM IV Moderate Depressive disorderIntervention: Enhanced support intervention (ESI) delivered by an appropriately trained community pharmacy team member involving four to six sessions over four months. ESI is a modified form of an intervention within the collaborative care framework for sub-threshold depression validated in previous studies in UK primary care which appears suitable for implementation in community settings.Sample size: 20–30 participantsOutcomes: Study implementation (recruitment and attrition rates), quality of data collection at baseline and 4 months and ESI adherence (number of contacts, DNA and drop out) as per objectives 1a/bQualitative evaluation: Semi-structured interviews with up to 10 participants and ESI facilitators and focus group(s) (range of pharmacy staff n = 8–10) will be conducted to explore the acceptability of the intervention and feasibility of the study, training and study procedures.External pilot studyObjectives:Quantify the flow of participants (eligibility, recruitment and follow-up rate)Evaluate proposed recruitment, assessment and outcome measure collection methodsExamine the delivery of the enhanced support intervention in a community pharmacy setting (intervention uptake, retention and dose) to inform process evaluationProcess evaluation, using semi-structured interviews with participants across a range of socio-economic settings, and pharmacy staff to explore the acceptability of the ESI within community pharmacy, elements of the intervention that were considered useful (or not) and appropriateness of study proceduresDesign: Pilot randomised controlled trial, including a prospective economic and qualitative evaluationSetting: As abovePopulation: As aboveIntervention: As above with adaptations post feasibility studyComparator: Usual careSample size: 100 participantsOutcomes: Data will be used to estimate recruitment, intervention delivery and study completion rates as per objectives 2a–d. Definitive estimates of the effectiveness of ESI will not be made.Primary outcome: Depression severity (Patient Health Questionnaire 9) at four months.Secondary outcomes: Patient acceptance, uptake and attrition. ICD10 depression status, anxiety (GAD 7), health-related quality of life (SF-12v2) and health-state utility (EQ5D 3L) will be measured at four months.Economic evaluation: The incremental cost per QALY will be calculated from both the NHS and societal perspective.Process evaluation: Using mixed methods, potential mediators/moderators of the intervention, the acceptability (to participants and pharmacy staff), barriers and facilitators to the use of ESI in community pharmacy, and impact on usual practice will be examined. Semi-structured interviews with approximately 30 study participants, 20 pharmacy staff and eight GPs near participating pharmacies will be conducted.Trial registrationISRCTN: ISRCTN11290592Protocol version number: Version 4.1 (dated 16th January 2018)Study Sponsor Tees Esk and Wear Valleys NHS Foundation Trust

A Cost-Utility Study of Laparoscopic Cholecystectomy for the Treatment of Symptomatic Gallstones

BackgroundLaparoscopic cholecystectomy is a high-volume surgery that is an end-stage treatment for gallstones. There is little understanding of the surgery’s effect on the gain in patients’ health relative to its cost. The objective of this study is to measure health gain, cost and cost utility of elective laparoscopic cholecystectomy. MethodsParticipants completed the EQ-5D(3L) pre-operatively and post-operatively. Quality adjusted life years attributable to cholecystectomy were calculated by comparing health state utility values between the pre- and post-operative time points. Laparoscopic cholecystectomy cost was calculated from a health system perspective and included hospital and specialists’ fees (in 2016 Canadian dollars). Cost per QALY was calculated for the entire sample and demographic sub-groups. ResultsThe cohort consisted of 135 participants who completed surveys between February 2013 and June 2017. The response rate among eligible patients was 50%. Assuming that health gain accrued to the participant for 25 years after cholecystectomy, the mean gain in QALYs was 1.7430, corresponding to an average cost per QALY of $2102. Older patients, on average, had less gain in QALYs than younger patients. ConclusionLaparoscopic cholecystectomies are inexpensive relative to the gains in health they provide patients. The gains in health were not uniform across age categories. These results should provide health system planners confidence that incremental increases in surgical capacity for elective cholecystectomies is beneficial.

Responsiveness of the EQ-5D-3L and EQ-5D-5L in patients following total hip or knee replacement.

To examine the responsiveness of the EQ-5D-3L and EQ-5D-5L among total hip/knee replacement (THR/TKR) patients. The EQ-5D (3L or 5L) and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) have been routinely administered to all THR/TKR patients before and at 3 months after surgery in Alberta, Canada, since 2010. Patients were included in this analysis if they completed the WOMAC and the same version of EQ-5D at baseline and 3-month follow-up. The WOMAC was used as an anchor to categorize patients into 9 subgroups according to the relative change from baseline, i.e., no change, and 4 categories each for the amount of deterioration or improvement: large (≥ 70%), moderate (50% ≤ change < 70%), small but important (20% ≤ change < 50%), and very mild (0 < change ≤ 20%). The responsiveness of the EQ-5D-3L and EQ-5D-5L for each subgroup was assessed using effect size, standardized response mean, and Guyatt's Responsiveness Index. A total of 1594 patients completed the EQ-5D-3L and WOMAC (60% females, mean age 66years, N = 646 [41%] THR), and 3180 completed the EQ-5D-5L and WOMAC (60% females, mean age 66years, N = 1352 [43.2%] THR) at baseline and 3-month follow-up. For both THR and TKR patients with "small but important" improvement, the EQ-5D-5L was consistently more responsive than the EQ-5D-3L. Our study demonstrated that the EQ-5D-5L is more responsive than the EQ-5D-3L in identifying health-related quality of life changes in THR/TKR patients. We recommend using the EQ-5D-5L in longitudinal studies in this patient population.

Exploring the Internal Structure of the EQ-5D Using Non–Preference-Based Methods

BackgroundWhen the EuroQol EQ-5D is applied in settings other than resource allocation, a non–preference-based score may be more appropriate than societal, preference-weighted utility. To develop a psychometric score for the EQ-5D, its structural relationship, ie, how the 5 items/dimensions interrelate, must be understood to inform appropriate methods of summarizing the instrument. ObjectivesTo explore psychometrically derived approaches of elucidating the 5-level EQ-5D (EQ-5D-5L) item structure. MethodsThree measurement models were assessed. All 5 items were modeled as reflective indicators using confirmatory factor analysis. EQ-5D-5L items were conceptualized as formative indicators, and other health scales (eg, the short form 36 health survey) were conceptualized as reflective indicators in Multiple Indicators Multiple Causes models (external MIMIC). The EQ-5D-5L items were modeled as a combination of formative and reflective indicators in internal MIMIC models. Results across 9 data sets from various countries and patient groups were examined to determine their robustness. ResultsAll items loaded well (0.63-0.96) in the confirmatory factor analysis except for anxiety/depression (0.20-0.66, excluding 1 outlier). The model fit statistics of the external MIMIC models were poor, and the coefficients of the Self-Care dimension were small. The internal MIMIC model with Mobility, Pain/Discomfort, and Anxiety/Depression as formative indicators and Self-Care and Usual Activities as reflective indicators fit best. The model results of the Spanish valuation data set were outliers. ConclusionsAlthough there were some variations in results across subgroups, the relationship between the items remained robust. The evidence calls for testing of formative/reflective combination approaches to summarize the EQ-5D-5L.

PNS66 EQ-5D DERIVED POPULATION NORMS OF GENERAL POPULATION OF AZAD JAMMU AND KASHMIR (AJK) BY DEMOGRAPHIC CHARACTERISTICS

This study aimed to measure and analyze EQ-5D derived population norms of general population of Azad Jammu and Kashmir (AJK) by demographic characteristics. A cross-sectional study was conducted in Azad Jammu and Kashmir. Population sample (n = 2582) was collected by using stratified sampling approach. The EQ-5D 3L tool was used to measure health-related quality of life (HRQOL) of healthy population of by socio-economic demographic characteristics. The descriptive and inferential statistics have been done by using SPSS version 20. Result showed that mean age of respondents was 33.13 years. Maximum respondents 54.2% were male. Majority of respondents 33.5% had 10k-20k PKR income. Most of respondents 24.9% were having matric education. Occupation wise maximum respondents 60.2% were doing private job. Maximum were 54.4% were from rural locality. 73.3% were married and most of respondents 70.3% had their own house. Total of 37 health states reported by the respondents of which most prevailing was having no problems in any domain. EQ-5D descriptive score and EQ-VAS score were 0.69 ± 0.28 and 0.69 ± 0.21 respectively. The percentage of people responding to any problems in the five EQ-5D-3L dimensions increased with age and females have better health as compared to male in all age groups. Comparison of mean score and inferential statistics shown all demographics were significantly associated (P<0.01) with mean EQ5D score and VAS. This study showed federal territory population HRQOL data measured by the EQ-5D tool. Current study concluded that health status of AJK married people have better EQ5D index score compared to others. Concern should be made to improve general health status of male population by improving ther jobs and earning facilities

Surgical or Radiation Therapy for the Treatment of Cervical Spine Metastases: Results From the Epidemiology, Process, and Outcomes of Spine Oncology (EPOSO) Cohort.

Study Design:Ambispective cohort study design.Objectives:Cervical spine metastases have distinct clinical considerations. The aim of this study was to determine the impact of surgical intervention (± radiotherapy) or radiotherapy alone on health-related quality of life (HRQOL) outcomes in patients treated for cervical metastatic spine tumours.Methods:Patients treated with surgery and/or radiotherapy for cervical spine metastases were identified from the Epidemiology, Process, and Outcomes of Spine Oncology (EPOSO) international multicentre prospective observational study. Demographic, diagnostic, treatment, and HRQOL (numerical rating scale [NRS] pain, EQ-5D (3L), SF-36v2, and SOSGOQ) measures were prospectively collected at baseline, 6 weeks, 3 months, and 6 months postintervention.Results:Fifty-five patients treated for cervical metastases were identified: 38 underwent surgery ± radiation and 17 received radiation alone. Surgically treated patients had higher mean spinal instability neoplastic scores compared with the radiation-alone group (13.0 vs 8.0, P < .001) and higher NRS pain scores and lower HRQOL scores compared to the radiation alone group (P < .05). From baseline to 6 months posttreatment, surgically treated patients demonstrated statistically significant improvements in NRS pain, EQ-5D (5L), and SOSGOQ2.0 scores compared with nonsignificant improvements in the radiotherapy alone group.Conclusions:Surgically treated cervical metastases patients presented with higher levels of instability, worse baseline pain and HRQOL scores compared with patients who underwent radiotherapy alone. Significant improvements in pain and HRQOL were noted for those patients who received surgical intervention. Limited or no improvements were found in those treated with radiotherapy alone.

The EQ-5D-5L Is Superior to the -3L Version in Measuring Health-related Quality of Life in Patients Awaiting THA or TKA

As a generic measure of health-related quality of life among patients awaiting THA or TKA, the three-level version of the EQ-5D (EQ-5D-3L), which has three response levels of severity (no problems, some problems, and extreme problems/unable) to five questions, is widely used. Previous studies indicated that the ceiling effect of the EQ-5D-3L limits its application. The five-level version of the EQ-5D (EQ-5D-5L) was developed to enhance the measurement properties of the tool by adding two levels: slight problems and severe problems. However, only a few small studies have compared the EQ-5D-3L and EQ-5D-5L in patients awaiting THA and TKA. The purpose of this study was to examine the performance of the EQ-5D-3L and EQ-5D-5L among patients awaiting THA or TKA in terms of (1) response patterns, (2) convergent construct validity, (3) known-group validity, and (4) informativity and discriminatory power. This is a retrospective analysis of the Alberta Bone and Joint Health Data Repository, which recorded information on all patients receiving hip or knee arthroplasties between April 2010 and March 2017 in Alberta, Canada (n = 37,377). Patients receiving THA or TKA and who completed the EQ-5D and WOMAC at baseline (presurgery) were included in this study (n = 24,766). The EQ-5D-3L was administered to all patients in 2010, and was gradually replaced by the EQ-5D-5L between 2013 and 2016; the EQ-5D-5L reached full application in all clinics by 2017.A propensity score was used to match patients 1:1 who completed either the EQ-5D-3L or EQ-5D-5L before surgery. Response patterns have been explored using ceiling and floor effects and distribution across severity levels of each dimension. Convergent construct validity was examined using Spearman's correlation (rho) against the WOMAC. Known-group validity was examined by gender, preoperative risk factors, mental health, obesity, and WOMAC physical function score. Informativity and discriminatory power were examined using the Shannon (H') and Shannon evenness (J') indices. A total of 3446 pairs of patients awaiting THA (55% women; mean age, 66 years) and 5428 pairs of patients awaiting TKA (59% women; mean age 67 years) were included in this analysis; the study group included all patients who were kept in the propensity score matching. Ceiling and floor effects were comparable and small (less than 0.5%) for both versions; the responses across severity levels for each dimension were more evenly distributed for the EQ-5D-5L. Convergent construct validity was stronger for the EQ-5D-5L as it consistently had stronger correlations with the WOMAC overall and domain scores than the EQ-5D-3L (rho(3L-THA), -0.77 to -0.31; rho(3L-TKA), -0.71 to -0.24; rho(5L-THA), -0.71 to -0.17; rho(5L-TKA), -0.64 to -0.17; all p values < 0.001). The hypotheses of known-group analyses were confirmed for both versions. The EQ-5D-5L demonstrated stronger informativity and discriminatory power than the EQ-5D-3L, particularly for the mobility dimension (THA, H'(5L/3L)=1.66/0.37, J'(5L/3L)=0.72/0.23; TKA, H'(5L/3L)=1.66/0.41, J'(5L/3L)=0.71/0.26). This study demonstrates the superior construct validity, and informativity and discriminatory power of the EQ-5D-5L compared with the EQ-5D-3L among patients awaiting THA or TKA. Compared with the three-level version, the five-level version of the EQ-5D differentiates between patients awaiting THA and TKA much better based on their mobility, which is a key health aspect or outcome in these patients. Our findings suggest that the EQ-5D-5L is more appropriate for this population.

Do preoperative patient-reported outcomes predict hospital length of stay for surgically-treated end-stage ankle osteoarthritis patients?

BackgroundEnd-stage ankle arthritis is often debilitating, associated with diminished mobility, pain, and reduced health related quality of life. Direct hospital costs of AA and TAA differ, with hospital length of stay being a major contributor. The objective of this study is to test the association between four patient-reported outcome measures with hospital length of stay, potentially important for preoperative planning and care. MethodsThis study is based on a prospective cohort of patients scheduled for AA or TAA for end-stage ankle arthritis in the Vancouver Coastal Health authority, Canada. Participants completed a condition-specific instrument, the AOS, and three generic instruments, the PHQ-9, PEG and EQ-5D(3L) shortly after being scheduled for surgery. Multivariate mixed-effects Poisson regression models were used to measure the association between preoperative patient-reported outcome measures and length of stay. ResultsAmong the 183 patients eligible to participate, the participation rate was 48.5%. There were 89 participants. Participants reported a high level of preoperative ankle impairment and pain. The adjusted results found no relationship between the AOS, EQ-5D(3L) VAS or PHQ-9 values and participants’ LOS. Participants with at least one chronic health condition and lowest SES category had longer LOS. ConclusionsThis study found no evidence of an association between four PROs collected prior to AA or TAA with hospital LOS. This finding suggests collecting these PROs preoperatively may not help with discharge planning.

Comparison of the EQ-5D 3L and the SF-6D (SF-36) contemporaneous utility scores in patients with chronic kidney disease in Sri Lanka: a cross-sectional survey

ObjectivesThe aim of this study was to compare utility weights of EuroQoL-five-dimension-3 levels (EQ-5D-3L) and Short-Form six-dimension (SF-6D) in a representative cohort of patients with chronic kidney disease (CKD). A...