Construct validity of EQ-5D-5L among patients with inflammatory bowel disease-a study based on real-world data from the Swedish Inflammatory Bowel Disease Registry.

OBJECTIVES: The Swedish Inflammatory Bowel Disease Registry (SWIBREG) includes approximately 84% of all patients with inflammatory bowel disease (IBD) treated with immunomodulators, biologics or surgery in Sweden. Data on health-related quality of life (HRQoL) have been collected using EQ-5D-5L in the registry since 2012. Nevertheless, there are few studies assessing the validity of EQ-5D-5L in this patient population. Thus, the aim of this study was to assess the construct validity of EQ-5D-5L amongst patients with IBD (ulcerative colitis and Crohn's disease). METHODS: Individual-level data on EQ-5D-5L and other disease-specific measures were extracted from SWIBREG. Known-groups validity was assessed by analysing whether the EQ-5D-5L captured expected differences between patient groups with different activity levels of the disease. Convergent validity was assessed by analysing whether the reported problems in the dimensions of EQ-5D-5L, EQ VAS, and the EQ-5D-5L index value correlated, as hypothesized, with the four dimensions in the Short Health Scale, a symptom index question, and the Physician Global Assessment (PGA) score. RESULTS: In total, 9769 patients with IBD were included in the study. Patients with active IBD reported more health problems in the EQ-5D-5L descriptive system than patients being in remission. The effect sizes for the differences in reported problems between patients with active and inactive disease were at least small (≥0.1) or medium (≥0.3) in all dimensions except self-care. Differences in the mean EQ-5D-5L index and EQ-VAS score between patients with active and inactive disease were statistically significant (p < 0.001) and larger than pre-defined cut-offs for minimally important differences (>0.08 for the index and >11.0 for EQ-VAS). The analysis of convergent validity showed that EQ-5D-5L results correlated as expected with the disease-specific measures in 16 of the 21 analyses. In total, 22 (79%) of the 28 hypotheses were supported. CONCLUSION: The findings support the construct validity of EQ-5D-5L amongst patients with IBD and contribute to the scarce literature on the validity of the five-level version of EQ-5D in this patient population. These findings have important implications for the choice of HRQoL measure in routine health care registries like SWIBREG as well as for future clinical or health economic studies considering using EQ-5D-5L as a measure of HRQoL.

Association between pulse width and health-related quality of life after electroconvulsive therapy in patients with unipolar or bipolar depression: an observational register-based study.

AIMS: To examine the association between pulse width and HRQoL measured within one week after electroconvulsive therapy (ECT) and at six-month follow-up in patients with unipolar or bipolar depression. METHODS: This was an observational register study using data from the Swedish National Quality Registry for ECT (2011-2019). Inclusion criteria were: age ≥18 years; index treatment for unipolar/bipolar depression; unilateral electrode placement; information on pulse width; EQ-5D measurements before and after ECT. Multiple linear regressions were performed to investigate the association between pulse width (<0.5 ms; 0.5 ms; >0.5 ms) and HRQoL (EQ-5D-3L index; EQ VAS) one week after ECT (primary outcome) and six months after ECT (secondary outcome). RESULTS: The sample included 5,046 patients with unipolar (82%) or bipolar (18%) depression. At first ECT session, 741 patients (14.7%) had pulse width <0.5 ms, 3,639 (72.1%) had 0.5 ms, and 666 (13.2%) had >0.5 ms. There were no statistically significant associations between pulse width and HRQoL one week after ECT. In the subsample of patients with an EQ-5D index recorded six months after ECT (n = 730), patients receiving 0.5 ms had significantly lower HRQoL (-0.089) compared to <0.5 ms, after adjusting for demographic and clinical characteristics (p = .011). The corresponding analysis for EQ VAS did not show any statistically significant associations. CONCLUSION: No robust associations were observed between pulse width and HRQoL after ECT. On average, significant improvements in HRQoL were observed one week and six months after ECT for patients with unipolar or bipolar disease, independent of the pulse width received.

Obesity is associated with pain and impaired mobility despite therapy in systemic lupus erythematosus.

Objective: To investigate whether abnormal BMI is associated with health-related quality of life (HRQoL) impairments, defined as patient-reported problems within the different dimensions of the three-level EQ-5D (EQ-5D-3L), before and after treatment for active systemic lupus erythematosus (SLE). Patients and methods: We conducted a post-hoc analysis of data from two phase III clinical trials of belimumab in SLE, i.e., BLISS-52 (n = 865) and BLISS-76 (n = 819). Underweight was defined as BMI <18.5 kg/m2, normal weight as BMI ≥18.5 but <25 kg/m2, pre-obesity as BMI ≥25 but <30 kg/m2, and obesity as BMI ≥30 kg/m2. We investigated associations between BMI groups and problems (level 2 or 3) within each one of the five EQ-5D dimensions before treatment initiation and at week 52, using logistic regression analysis adjusting for age, ethnicity, disease activity, and glucocorticoid dose, and for the post-treatment analysis also for belimumab treatment and baseline EQ-5D-3L responses. Results: Of 1,684 patients included, 73 (4%) were classified as underweight, 850 (50%) as normal weight, 438 (26%) as pre-obese, and 323 (19%) as obese. At baseline, obesity was associated with mild to severe problems in all EQ-5D dimensions (p < 0.05 for all), yielding the strongest association with problems in mobility (adjusted odds ratio, aOR: 2.1; 95% confidence interval, CI: 1.6-2.8; p < 0.001). Pre-obesity was also associated with problems in mobility (aOR: 1.4; 95% CI: 1.1-1.8; p = 0.005). Post-intervention, obesity was associated with problems in mobility and pain/discomfort, and pre-obesity with problems in mobility and self-care (p < 0.05 for all). Conclusion: Our study adds to the evidence that high BMI negatively affects SLE patients' HRQoL, with obesity being associated with pain and impaired mobility despite therapy.

Direct costs of blood drawings with pre-analytical errors in tertiary paediatric hospital care.

BACKGROUND: Blood drawings is a common hospital procedure involving laboratory and clinical disciplines that is important for the diagnosis and management of illnesses in children. Blood drawings with pre-analytical error (PAE) can lead to increased costs for hospitals and healthcare organisations. The direct cost of blood drawings after a PAE is not fully understood in paediatric hospital care. AIM: The aim of this study was to estimate the average direct cost of PAE per year and per 10,000 blood drawings in tertiary paediatric care. METHODS: A cost analysis using a bottom-up approach was conducted on the basis of combined information from the hospital's laboratory register for the period 2013-2014 and clinical in-ward observations at a tertiary children's referral hospital in Sweden, the Astrid Lindgren Children's Hospital. For the analysis, we hypothesised the re-collection of all blood drawings with PAE and included the average costs of the sampling materials, the time of the healthcare personnel, the laboratory analyses, and in-ward premises based on the time spent on the blood sampling procedure. RESULTS: The annual cost of PAE was estimated to be 74,267 euros per 54,040 blood drawings, which corresponds to 13,756 euros per 10,000 blood drawings or 1.5 euros per draw. The personnel cost represented 60.1% (45,261 euros per year) of the cost due to PAE, followed by costs for hospitalisation (25.2%), laboratory analyses (8.1%), and materials (5.7%). CONCLUSION: PAEs lead to substantial increases in the costs in tertiary paediatric hospital care. If these PAEs can be avoided, costs related to the re-collection of blood drawings with PAE may be re-allocated to other health-promoting activities for children visiting hospital institutions.

Sensitivity analysis of EQ-5D-3L index scores in terms of discriminative and known-groups validity in SLE: introducing Adequate Health State.

OBJECTIVES: To investigate the ability of different EuroQol 5-Dimensions 3-Levels (EQ-5D-3L) index scores to discriminate between verum drug and placebo (discriminant validity) as well as between responders and non-responders (known-groups validity) in the SLE patient population of two phase III clinical trials of belimumab. METHODS: Data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials (N = 1684), which both showed superiority of belimumab to placebo, were utilized. Responders were defined as SLE Responder Index 4 (SRI-4) achievers at week 52. The Pearson's χ2 and Mann-Whitney U tests were used for comparisons, and logistic regression analysis was used for adjustments for confounders and assessment of independence. RESULTS: While full health state (FHS; EQ-5D index score 1) showed the best ability to discriminate between belimumab and placebo [adjusted odds ratio (OR) 1.47; 95% CI 1.11, 1.96; P = 0.008] and between SRI-4 responders and non-responders (adjusted OR 3.47; 95% CI 1.29, 10.98; P = 0.020), the discriminative ability of EQ-5D index scores 0.800 or more reached statistical significance for both discriminant validity (adjusted OR 1.29; 95% CI 1.02, 1.63; P = 0.036) and known-groups validity (adjusted OR 3.08; 95% CI 1.16, 9.69; P = 0.034). CONCLUSION: Overall, higher EQ-5D index scores were associated with increasing ability to discriminate between belimumab and placebo, and between responders and non-responders. EQ-5D index scores less stringent than FHS may be clinically relevant health-related quality of life goals of treatment in patients with SLE, introducing the concept of EQ-5D adequate health state when FHS is not achievable.

Cost-effectiveness of Prostate Cancer Screening Using Magnetic Resonance Imaging or Standard Biopsy Based on the STHLM3-MRI Study.

Importance: The combination of prostate-specific antigen (PSA) testing with magnetic resonance imaging (MRI) for prostate cancer detection has rarely been evaluated in a screening context. The STHLM3-MRI screening-by-invitation study (NCT03377881) has reported the benefits of using MRI with subsequent combined targeted and standard biopsies compared with using standard biopsies alone. Objective: To investigate the cost-effectiveness of prostate cancer screening using MRI with combined targeted and standard biopsies compared with standard biopsies alone among men aged 55 to 69 years in Sweden, based on evidence from the STHLM3-MRI study. Design, Setting, and Participants: This economic evaluation study was conducted from a lifetime health care perspective using a microsimulation model to evaluate no screening and screening strategies among adult men in Sweden. Men aged 55 to 69 years in Sweden were simulated for no screening and screening strategies. Input parameters were obtained from the STHLM3-MRI study and recent reviews. One-way and probabilistic sensitivity analyses were performed in May 2022. Interventions: No screening, quadrennial PSA screening using standard biopsies alone, and MRI-based screening using combined targeted and standard biopsies. Main Outcomes and Measures: The number of tests, incidence, deaths, costs, quality-adjusted life-years (QALY), and incremental cost-effectiveness ratios (ICERs) were estimated. Results: A total 603 men were randomized to the standard arm, 165 of these participants (27.4%) did not undergo standard biopsy; 929 men were randomized to the experimental arm, 111 (11.9%) of whom did undergo MRI or any biopsy. Compared with no screening, the screening strategies were associated with reduced lifetime prostate cancer-related deaths by 6% to 9%. Screening with MRI and the combined biopsies resulted in an ICER of US $53 736, which is classified as a moderate cost per QALY gained in Sweden. Relative to screening with standard biopsies alone, MRI-based screening reduced the number of both lifetime biopsies and overdiagnosis by approximately 50% and had a high probability of being cost-effective than the traditional PSA screening. Conclusions and Relevance: For prostate cancer screening, this economic evaluation study found that PSA testing followed by MRI with subsequent combined targeted and standard biopsies had a high probability to be more cost-effective compared with the traditional screening pathway using PSA and standard biopsy. MRI-based screening may be considered for early detection of prostate cancer in Sweden.

Cost-Effectiveness of the Stockholm3 Test and Magnetic Resonance Imaging in Prostate Cancer Screening: A Microsimulation Study.

BACKGROUND: Stockholm3 is a risk model that combines the prostate-specific antigen (PSA) test, other plasma protein biomarkers, single nucleotide polymorphisms, and clinical variables. The STHLM3-MRI study (NCT03377881) found that the Stockholm3 test with magnetic resonance imaging (MRI) and combined targeted and systematic biopsies maintained the sensitivity for clinically significant cancers, and reduced the number of benign biopsies and clinically insignificant cancers. OBJECTIVE: To assess the cost-effectiveness of MRI-based screening for prostate cancer using either Stockholm3 as a reflex test or PSA alone. DESIGN, SETTING, AND PARTICIPANTS: A cost-utility analysis was performed from a lifetime societal perspective using a microsimulation model for men aged 55-69 yr in Sweden. Test characteristics were estimated from the STHLM3-MRI study. INTERVENTION: No screening and three quadrennial screening strategies, including either PSA ≥3 ng/ml or Stockholm3 with reflex test thresholds of PSA ≥1.5 or 2 ng/ml as criteria for referral to MRI, were performed, and those who were MRI positive had combined targeted and systematic biopsies. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Predictions included the number of tests, cancer incidence and mortality, costs, and quality-adjusted life-years. Uncertainties in key parameters were assessed using sensitivity analyses. RESULTS AND LIMITATIONS: Compared with no screening, the screening strategies were predicted to reduce prostate cancer deaths by 7-9% across a lifetime. The use of Stockholm3 with PSA ≥2 ng/ml resulted in a 60% reduction in MRI compared with screening using PSA. This Stockholm3 strategy was cost-effective with a probability of 70% at a cost-effectiveness threshold of €47 218 (500 000 Swedish Kronor). As a potential limitation, the economic perspective was specific to Sweden. CONCLUSIONS: Screening with the Stockholm3 test at a reflex threshold of PSA ≥2 ng/ml and MRI was predicted to be cost-effective in Sweden. PATIENT SUMMARY: The Stockholm3 test with image-based screening may reduce screening-related harms and costs, while maintaining the health benefits from early detection of prostate cancer.

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

Objectives: 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. Methods: 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. Results: 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). Conclusion: 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.

Health-related quality of life in patients with lower limb amputation - an assessment of the measurement properties of EQ-5D-3L and EQ-5D-5L using data from the Swedish Amputation and Prosthetics Registry.

PURPOSE: To assess the measurement properties of EQ-5D-3L and EQ-5D-5L in patients with a major lower limb amputation (LLA). METHODS: This was a retrospective register-based study using data from the Swedish Amputation and Prosthetics Registry (SwedeAmp). Patients with a six-months follow-up (including either EQ-5D-3L or EQ-5D-5L) after a major unilateral LLA were included. The measurement properties of EQ-5D-3L and EQ-5D-5L were compared in terms of feasibility, response patterns, informativity, and convergent and known-group validity. RESULTS: The sample included 700 patients with below-knee amputation (76%), above-knee amputation (18%), or knee disarticulation (7%). Responses to EQ-5D-3L and -5L were similar regarding feasibility (98% completion rate) and the proportion reporting no problems (7% and 6%). Compared to EQ-5D-3L, EQ-5D-5L showed higher absolute and relative informativity in all dimensions, with the largest improvement in the mobility dimension. In the analyses of convergent validity, the EQ-5D-5L generally showed stronger correlations with disease-specific measures. Only EQ-5D-5L was able to discriminate between subgroups with different amputation levels. CONCLUSION: The findings support the use of EQ-5D-5L over EQ-5D-3L in patients with an LLA, mainly due to improved informativity and improved convergent and known-group validity.Implications for rehabilitationThe measurement properties of two EQ-5D versions, EQ-5D-3L and EQ-5D-5L, has so far not been evaluated in patients with a lower limb amputation (LLA)The results support the use of EQ-5D-5L over the use of EQ-5D-3L, mainly due to improved informativity and stronger correlations with disease-specific patient-reported outcome measuresThe five-level version of EQ-5D is recommended for future applications of EQ-5D in clinical outcome studies, health economic evaluations, and in the routine follow-up of patients with a major LLAIn the early rehabilitation process six months after an LLA, the majority of patients reported problems with mobility, pain/discomfort, and usual activities.

Cost-Effectiveness of Magnetic Resonance Imaging in Prostate Cancer Screening: A Microsimulation Study.

OBJECTIVE: This study aimed to assess the cost-effectiveness of magnetic resonance imaging (MRI) with combinations of targeted biopsy (TBx) and systematic biopsy (SBx) for early prostate cancer detection in Sweden. METHODS: A cost-utility analysis was conducted from a lifetime societal perspective using a microsimulation model. Five strategies included no screening and quadrennial screening for men aged 55 to 69 years using SBx alone, TBx on positive MRI (MRI + TBx), combined TBx/SBx on positive MRI (MRI + TBx/SBx), and SBx on negative MRI with TBx/SBx on positive MRI (MRI - SBx, MRI + TBx/SBx). Test characteristics were based on a recent Cochrane review. We predicted the number of biopsies, costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios. RESULTS: The screening strategies were classified in Sweden as high costs per QALY gained compared with no screening. Using MRI + TBx and MRI + TBx/SBx reduced the number of biopsy episodes across a lifetime by approximately 40% compared with SBx alone. Both strategies showed strong dominance over SBx alone and MRI - SBx, MRI + TBx. Compared with MRI + TBx, the MRI + TBx/SBx strategy had an incremental cost-effectiveness ratio of more than €200 000 per QALY gained, which was classified in Sweden as a very high cost. These predictions were robust in the probabilistic sensitivity analysis. Limitations included generalizability of the model assumptions and uncertainty regarding the health-state values and study heterogeneity from the Cochrane review. CONCLUSIONS: MRI + TBx and MRI + TBx/SBx showed strong dominance over alternative screening strategies. MRI + TBx resulted in similar or marginally lower gains in QALYs and lower costs than MRI + TBx/SBx. MRI + TBx was considered the optimal choice among the screening strategies.

The cost-effectiveness of prostate cancer screening using the Stockholm3 test.

OBJECTIVES: The European Randomized Study of Screening for Prostate Cancer found that prostate-specific antigen (PSA) screening reduced prostate cancer mortality, however the costs and harms from screening may outweigh any mortality reduction. Compared with screening using the PSA test alone, using the Stockholm3 Model (S3M) as a reflex test for PSA ≥ 1 ng/mL has the same sensitivity for Gleason score ≥ 7 cancers while the relative positive fractions for Gleason score 6 cancers and no cancer were 0.83 and 0.56, respectively. The cost-effectiveness of the S3M test has not previously been assessed. METHODS: We undertook a cost-effectiveness analysis from a lifetime societal perspective. Using a microsimulation model, we simulated for: (i) no prostate cancer screening; (ii) screening using the PSA test; and (iii) screening using the S3M test as a reflex test for PSA values ≥ 1, 1.5 and 2 ng/mL. Screening strategies included quadrennial re-testing for ages 55-69 years performed by a general practitioner. Discounted costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) were calculated. RESULTS: Comparing S3M with a reflex threshold of 2 ng/mL with screening using the PSA test, S3M had increased effectiveness, reduced lifetime biopsies by 30%, and increased societal costs by 0.4%. Relative to the PSA test, the S3M reflex thresholds of 1, 1.5 and 2 ng/mL had ICERs of 170,000, 60,000 and 6,000 EUR/QALY, respectively. The S3M test was more cost-effective at higher biopsy costs. CONCLUSIONS: Prostate cancer screening using the S3M test for men with an initial PSA ≥ 2.0 ng/mL was cost-effective compared with screening using the PSA test alone.

EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus.

OBJECTIVES: The objectives of this study were to investigate the discriminative ability of EQ-5D-3L full health state (FHS) in clinical trials of SLE, and to identify factors associated with FHS after treatment. METHODS: Data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials of belimumab (N = 1684) were utilized. FHS was defined as a response of no problems in all five EQ-5D-3L dimensions, yielding an index score of 1. The Pearson's χ2 or Fisher's exact test was employed for comparisons, and logistic regression for adjustments and assessment of independence. RESULTS: We demonstrated higher EQ-5D-3L FHS frequencies among patients given standard therapy (ST) plus the licensed belimumab dose vs ST alone (26.1% vs 19.4%; P = 0.001; week 52), and within SRI-4 responders vs non-responders (27.0% vs 19.8%; P < 0.001; week 52) from weeks 36 to 52. In multivariable regression analysis, SLEDAI-2K (OR: 0.90; 95% CI: 0.87, 0.94; P < 0.001) and SLICC/ACR Damage Index (OR: 0.79; 95% CI: 0.69, 0.91; P = 0.001) scores were independently associated with lower FHS frequencies at week 52, while adding monthly infusions of belimumab 10 mg/kg to ST favoured FHS perception (OR: 1.60; 95% CI: 1.15, 2.24; P = 0.006). Add-on belimumab 10 mg/kg yielded higher FHS frequencies in antimalarial users vs non-users (29.9% vs 20.1%; P = 0.011), and in anti-dsDNA- and anti-Sm- positive vs negative patients (31.4% vs 13.4%; P < 0.001 and 33.0% vs 22.6%; P = 0.010, respectively), whereas no significant differences were observed in patients given ST alone. CONCLUSION: EQ-5D-3L FHS distinguished belimumab from placebo and responders from non-responders, and exhibited known-group validity in subgroup analysis. FHS may prove a useful patient-reported outcome in SLE studies.

Reporting and valuing one's own health: a think aloud study using EQ-5D-5L, EQ VAS and a time trade-off question among patients with a chronic condition.

BACKGROUND: The EQ-5D-5L, the EQ VAS, and the time trade-off (TTO) are commonly used to report and value health. Still, there is a need to better understand how these questionnaires and methods are perceived by the respondents, as well as the thoughts and motives behind their responses. The aim of this study was to increase knowledge of how individuals think and reason when reporting and valuing their own current health, using EQ-5D-5L, EQ VAS, and an open-ended TTO question. METHODS: Twenty patients with type 1 diabetes participated in qualitative individual think aloud interviews in Stockholm, Sweden. Participants were asked to describe their thoughts when responding to three assessments. The interviews were transcribed verbatim and analyzed using thematic analysis. RESULTS: The analysis showed that participants conducted the assessments by contextualizing and interpreting instructions, relating the questions to their own health, using different recall periods and time perspectives, and using personal, interpersonal, or normative comparators. It was challenging to reduce the experience of everyday life into a response option, and the thoughts behind the responses differed between the assessments. Before deciding on what to include, participants thought of the purpose and context of the assessments. Current health or past experiences of health were applied in the EQ-5D descriptive system and in EQ VAS, while participants focused on the future in the TTO. Thoughts about the impact on others, personal goals, and expectations on future health were more clearly integrated in the TTO assessment. All participants considered the trade-off between life years and health. However, despite the use of different comparators, the concept of 'full health' was found difficult to imagine or relate to. CONCLUSIONS: This study provides insights as to how responses to the EQ-5D-5L, EQ VAS, and TTO assessments are complementary and where these assessments differ in adults with a chronic condition. The findings may contribute to a better understanding when interpreting the quantitative results and contribute to the literature pertaining to possible explanations for differences in health state values depending on the valuation method.

Volar locking plate versus external fixation for unstable dorsally displaced distal radius fractures-A 3-year cost-utility analysis.

AIM: To investigate the cost-effectiveness of Volar Locking Plate (VLP) compared to External Fixation (EF) for unstable dorsally displaced distal radius fractures in a 3-year perspective. METHODS: During 2009-2013, patients aged 50-74 years with an unstable dorsally displaced distal radius fracture were randomised to VLP or EF. Primary outcome was the incremental cost-effectiveness ratio (ICER) for VLP compared with EF. Data regarding health effects (Quality-adjusted life years, QALYs) was prospectively collected during the trial period until 3 years after surgery. Cost data was collected retrospectively for the same time period and included direct and indirect costs (production loss). RESULTS: One hundred and thirteen patients (VLP n = 58, EF n = 55) had complete data until 3 years and were used in the analysis. At one year, the VLP group had a mean incremental cost of 878 euros and a gain of 0.020 QALYs compared with the EF group, rendering an ICER of 43 900 euros per QALY. At three years, the VLP group had a mean incremental cost of 1 082 euros and a negative incremental effect of -0.005 QALYs compared to the EF group, which means that VLP was dominated by EF. The probability that VLP was cost-effective compared to EF at three years, was lower than 50% independent of the willingness to pay per QALY. CONCLUSION: Three years after distal radius fracture surgery, VLP fixation resulted in higher costs and a smaller effect in QALYs compared to EF. Our results indicate that it is uncertain if VLP is a cost-effective treatment of unstable distal radius fractures compared to EF.

Collection and use of EQ-5D for follow-up, decision-making, and quality improvement in health care - the case of the Swedish National Quality Registries.

BACKGROUND: The Swedish National Quality Registries (NQRs) contain individual-level health care data for specific patient populations, or patients receiving specific interventions. Approximately 90% of the 105 Swedish NQRs include any patient-reported outcome measure, with EQ-5D being the most common. As there has been no general overview of EQ-5D data within the NQRs, this study fills a knowledge gap by reporting how the data are collected, presented, and used at different levels of the Swedish health care system. METHODS: All 46 NQRs with a license for the use of EQ-5D were included. Information was retrieved from the registries' annual reports or from websites, using a template that was subsequently sent to each registry for completion and confirmation. If considered necessary, the contact was followed-up with an interview, either in-person or over the telephone. The uses of EQ-5D were categorised as denoting usage for follow-up, decision-making, or quality improvement in Swedish health care. RESULTS: In total, 41 of the 46 licensed registries reported collection of EQ-5D data. EQ-5D is most commonly collected within registries related to the musculoskeletal system, but it has a wide application also in other disease areas. Thirty-six registries provide EQ-5D results to patients, clinicians, or other decision-makers. Twenty-two of the registries reported that EQ-5D data are being used for follow-up, decision-making or quality improvement. The registries most commonly reported use of data for assessing interventions, and in quality indicators to follow-up the quality of care at a national level. CONCLUSION: Collection and use of EQ-5D data vary across the Swedish NQRs, which may partly be accounted for by the different purposes of the registries. The provided examples of use illustrate how EQ-5D data can inform decisions at different levels of the health care system. However, there is potential for improving the use of EQ-5D data.

The economic burden of prostate cancer - a Swedish prevalence-based register study.

BACKGROUND: Incidence and prevalence of prostate cancer in Sweden have increased markedly due to prostate-specific antigen (PSA) testing. Moreover, new diagnostic tests and treatment technologies are expected to further increase the overall costs. Our aims were (i) to estimate the societal costs for existing testing, diagnosis, management and treatment of prostate cancer, and (ii) to provide reference values for future cost-effectiveness analyses of prostate cancer screening and treatment. METHODS: Taking a societal perspective, this study aimed to investigate the annual cost of prostate cancer in Sweden using a prevalence-based cost-of-illness approach. Resource utilisation and related costs within Stockholm Region during 2016 were quantified using data from the Stockholm PSA and Biopsy Register and other health and population registers. Costs included: (i) direct medical costs for health care utilisation at primary care, hospitals, palliative care and prescribed drugs; (ii) informal care; and (iii) indirect costs due to morbidity and premature mortality. The resource utilisation was valued using unit costs for direct medical costs and the human capital method for informal care and indirect costs. Costs for the Stockholm region were extrapolated to Sweden based on cancer prevalence and the average costs by age and resource type. RESULTS: The societal costs due to prostate cancer in Stockholm in 2016 were estimated to be €64 million Euro (€Mn), of which the direct medical costs, informal care and productivity losses represented 62, 28 and 10% of the total costs, respectively. The total annual costs extrapolated to Sweden were calculated to be €281 Mn. The average direct medical cost, average costs for informal care and productivity losses per prevalent case were €1510, €828 and €271, respectively. These estimates were sensitive to assumptions related to the proportion of primary care visits associated with PSA testing and the valuation method for informal care. CONCLUSION: The societal costs due to prostate cancer were substantial and constitute a considerable burden to Swedish society. Data from this study are relevant for future cost-effectiveness evaluations of prostate cancer screening and treatment.

Electroconvulsive Therapy in Depression: Improvement in Quality of Life Depending on Age and Sex.

OBJECTIVES: It is uncertain if there are variations in the improvement of quality in life between sexes and age groups after electroconvulsive therapy (ECT). The aim of this study was to investigate how health-related quality of life changed after treatment and to examine differences in the results between sex and age groups. METHODS: This register-based study used data from the Swedish national quality register for ECT. The study population was patients diagnosed with depression who had received ECT. Health-related quality of life was quantified using the 3-level version the EuroQol 5-dimensional questionnaire (EQ-5D 3 L). Analysis of variance was used to compare change in EQ-5D score from pretreatment to posttreatment between sex and age groups. RESULTS: There was a statistically significant improvement in EQ-5D index score and EQ visual analog scale (VAS) score in all patient groups after ECT. The mean improvement in EQ-5D index score and EQ-VAS score ranged from 0.31 to 0.46 and 28.29 to 39.79, respectively. Elderly patients had greater improvement in EQ-5D index score and EQ-VAS score than younger patients. There was no significant difference in improvement between the sexes. The mean improvement in EQ-5D index score was 0.40 for male patients and 0.41 for female patients. CONCLUSIONS: Electroconvulsive therapy had a considerable effect on health-related quality of life in patients with depression of both sexes and all age groups. The improvement was greatest in elderly patients, who more often had psychotic features. More studies are needed to investigate the long-term effects of ECT and to further explain the varying treatment results between elderly and younger patients.

Influence of elicitation procedure and phrasing on health state valuations in experience-based time trade-off tasks among diabetes patients in China.

PURPOSE: Open-ended and iteration-based time trade-off (TTO) tasks can both be used for valuation of health states. It has so far not been examined how the elicitation procedure affects the valuation of experience-based health states. The purpose of this study is to investigate the influence of elicitation procedure on experience-based health state values elicited by the TTO method. METHODS: 156 Chinese adults with type 2 diabetes participated in face-to-face interviews with an open-ended or an iteration-based TTO task. The association between the type of TTO task and the valuation of health states was investigated through multiple linear regression analyses. A modified open-ended TTO task was also developed (n = 33) to test whether different phrasings of open-ended TTO tasks influence TTO values. RESULTS: Higher TTO values were observed in the original open-ended TTO task compared to the iteration-based task, which indicates that the elicitation procedure influences the valuation of health states. When the modified open-ended task was introduced, the difference between the two elicitation procedures was no longer statistically significant, suggesting that the phrasing and/or visual presentation of the TTO task may influence the valuation of health states. CONCLUSIONS: The choice of elicitation procedure as well as the description of experience-based TTO tasks may influence the valuation of health states. Further research is warranted, also in other cultural contexts, to further explore these findings.

Treatment of radius or ulna fractures in the elderly: A systematic review covering effectiveness, safety, economic aspects and current practice.

BACKGROUND: The objective of the present study was to evaluate effectiveness, complications and cost-effectiveness of any surgical or non-surgical treatment for radius or ulna fractures in elderly patients. Secondary objectives were to analyze present treatment traditions of distal radius fractures (DRF) in Sweden and to calculate resource usage for its treatment. METHODS AND FINDINGS: The assessment contains a systematic review of clinical and health economic studies comparing treatment options for radius or ulna fractures. The results regarding the effectiveness of the treatments are summarized in meta-analyses. In addition, the assessment contains a cost analysis for different treatment options commonly used for DRF care, and an analysis of registry data on the incidence and treatment of DRF. In total 31 randomized controlled trials were included in meta-analyses. When comparing functional outcome for plate fixation versus non-surgical treatment for DRF, there were no clinically important differences at one-year follow-up (mean difference [MD], -3.29, 95% CI, -7.03; 0.44). Similar results were found when comparing plating and percutaneous methods with respect to functional outcome (standardized mean difference [SMD], -0.07, 95% CI, -0.21; 0.07) and grip strength (MD, -3.47, 95% CI, -11.21; 4.28). There were no differences for minor complications, (risk difference [RD], -0.01, 95% CI, -0.07; 0.05) whereas major complications were less common for the percutaneous group, (RD, 0.02, 95% CI, 0.02; 0.03). Given the low number of studies, the evidence above was rated as moderate certainty. The cost for plate fixation versus plaster cast was estimated to 1698 compared to 137 US dollars. For DRF, plate fixation increased in Sweden between 2005 and 2013, and was the most common surgical method in 2013. CONCLUSIONS: Surgical treatment of moderately displaced distal radius fractures in elderly patients offers no clear benefit compared to non-surgical treatment. Plating procedures have become more common during the second millennium and involve higher costs and higher risk of major complications than percutaneous options.