Cost-effectiveness of brentuximab vedotin compared with conventional chemotherapy for relapsed or refractory classic Hodgkin lymphoma in China.

BACKGROUND: Relapsed or refractory classic Hodgkin lymphoma (RRcHL) associates with poor prognosis and heavy disease burden to patients. This study evaluated the cost-effectiveness of brentuximab vedotin (BV) in comparison to conventional chemotherapy in patients with RRcHL, from a Chinese healthcare perspective. METHODS: The lifetime cost and quality adjusted life years (QALYs) were estimated through a partitioned survival model with three health states (progression free, post progression, and death). Two cohorts for each BV arm and chemotherapy arm were built, representing patients with and without transplant after BV or chemotherapy, respectively. Clinical parameters were retrieved from BV trials and the literature. Resource utilization data were mainly collected from local expert surveys and cost parameters were reflecting local unit prices. Utility values were sourced from the literature. A discount rate of 5% was employed according to the Chinese guideline. A series of deterministic and probabilistic sensitivity analyses were conducted to evaluate the robustness and uncertainty associated with the model. RESULTS: Results of the base case analysis showed that the incremental cost-effectiveness ratio (ICER) for BV versus chemotherapy was $2,867 (¥19,774). The main model driver was the superior progression-free and overall survival benefits of BV. The ICERs were relatively robust in a series of sensitivity analyses, all under a conventional decision threshold (1 time of Chinese per capita GDP). With this conventional threshold, the probability of BV being cost-effective was 100%. CONCLUSIONS: Brentuximab vedotin can be considered a cost-effective treatment versus conventional chemotherapy in treating relapsed or refractory classic Hodgkin lymphoma in China.

Evaluating the Preferences and Willingness-to-Pay for Oral Antidiabetic Drugs Among Patients with Type 2 Diabetes Mellitus in China: A Discrete Choice Experiment.

PURPOSE: To quantify the preferences for an oral antidiabetic drug (OAD) among patients with type 2 diabetes mellitus (T2DM) in China. METHODS: A discrete choice experiment (DCE) with hypothetical OAD profiles was performed among patients with T2DM recruited from both online and offline sources. Each patient completed 12 DCE choice tasks. The attributes, elicited through mixed methods, include blood glucose level decrease, blood glucose level stability, frequency of medication, gastrointestinal side effects, dose adjustment and out-of-pocket expense. The conditional logit regression model was used to analyze the data. Patients' willingness-to-pay (WTP) was also calculated. Subgroup analyses based on patient characteristics were also conducted. RESULTS: A total of 741 respondents were included in the analysis sample, covering 456 respondents online and 285 offline. The result showed that all attributes and levels were statistically significant, except one level "dose adjustment required for patients with hepatic or renal insufficiency" in the attribute of dose adjustment. WTP results showed that patients were willing to pay 12.06 and 23.20 yuan, respectively to reduce the frequency of medication from "once per day" and "three times per day" to "once every 2 weeks", respectively. Subgroup analyses showed that the frequency of medication (once versus two to three times per day) had the largest impact and influenced most coefficient estimates. CONCLUSION: The results suggest that Chinese patients with T2DM prioritized better efficacy, less frequency of medication, lower gastrointestinal side effects, no dose adjustment required for patients with hepatic or renal insufficiency, and less out-of-pocket expense of OAD treatment.

Understanding Canadian stakeholders' views on measuring and valuing health for children and adolescents: a qualitative study.

OBJECTIVE: Valuing child health is critical to assessing the value of healthcare interventions for children. However, there remain important methodological and normative issues. This qualitative study aimed to understand the views of Canadian stakeholders on these issues. METHODS: Stakeholders from health technology assessment (HTA) agencies, pharmaceutical industry representatives, healthcare providers, and academic researchers/scholars were invited to attend an online interview. Semi-structured interviews were designed to focus on: (1) comparing the 3-level and 5-level versions of the EQ-5D-Y; (2) source of preferences for valuation (adults vs. children); (3) perspective of valuation tasks; and (4) methods for valuation (discrete choice experiment [DCE] and its variants versus time trade-off [TTO]). Participants were probed to consider HTA guidelines, cognitive capacity, and potential ethical concerns. All interviews were recorded and transcribed verbatim. Framework analysis with the incidence density method was used to analyze the data. RESULTS: Fifteen interviews were conducted between May and September 2022. 66.7% (N = 10) of participants had experience with economic evaluations, and 86.7% (N = 13) were parents. Eleven participants preferred the EQ-5D-Y-5L. 12 participants suggested that adolescents should be directly involved in child health valuation from their own perspective. The participants were split on the ethical concerns. Eight participants did not think that there was ethical concern. 11 participants preferred DCE to TTO. Among the DCE variants, 6 participants preferred the DCE with duration to the DCE with death. CONCLUSIONS: Most Canadian stakeholders supported eliciting the preferences of adolescents directly from their own perspective for child health valuation. DCE was preferred if adolescents are directly involved.

Mapping IWQOL-Lite onto EQ-5D-5L and SF-6Dv2 among overweight and obese population in China.

PURPOSE: To develop the mapping functions from the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) scores onto the EQ-5D-5L and SF-6Dv2 utility values among the overweight and obese population in China. METHODS: A representative sample of the overweight and obese population in China stratified by age, sex, body mass index (BMI), and area of residence was collected by online survey and the sample was randomly divided into development (80%) and validation (20%) datasets. The conceptual overlap between the IWQOL-Lite and the EQ-5D-5L or SF-6Dv2 was evaluated by Spearman's correlation coefficients. Five models, including OLS, Tobit, CLAD, GLM, and PTM were explored to derive mapping functions using the development dataset. The model performance was assessed using MAE, RMSE, and the percentage of AE > 0.05 and AE > 0.1 in the validation dataset. RESULTS: A total of 1000 respondents (48% female; mean [SD] age: 51.7 [15.3]; mean [SD] BMI: 27.4 [2.8]) were included in this study. The mean IWQOL-Lite scores and the utility values of EQ-5D-5L and SF-6Dv2 were 78.5, 0.851, and 0.734, respectively. The best-performing models predicting EQ-5D-5L and SF-6Dv2 utilities both used IWQOL-Lite total score as a predictor in the CLAD model (MAE: 0.083 and 0.076 for the EQ-5D-5L and SF-6Dv2; RMSE: 0.125 and 0.103 for the EQ-5D-5L and SF-6Dv2; AE > 0.05: 20.5% and 27.5% for the EQ-5D-5L and SF-6Dv2; AE > 0.10: 9.5% and 15.0% for the EQ-5D-5L and SF-6Dv2). CONCLUSION: CLAD models with the IWQOL-Lite total score can be used to predict both the EQ-5D-5L and SF-6Dv2 utility values among overweight and obese population in China.

Comparative performance and mapping algorithms between EQ-5D-5L and SF-6Dv2 among the Chinese general population.

OBJECTIVES: To explore the comparative performance and develop the mapping algorithms between EQ-5D-5L and SF-6Dv2 in China. METHODS: Respondents recruited from the Chinese general population completed both EQ-5D-5L and SF-6Dv2 during face-to-face interviews. Ceiling/floor effects were reported. Discriminative validity in self-reported chronic conditions was investigated using the effect sizes (ES). Test-retest reliability was evaluated using intra-class correlation coefficient (ICC) and Bland-Altman plots in a subsample. Correlation and absolute agreements between the two measures were estimated with Spearman's rank correlation coefficient and ICC, respectively. Ordinary least squares (OLS), generalized linear model, Tobit model, and robust MM-estimator were explored to estimate mapping equations between EQ-5D-5L and SF-6Dv2. RESULTS: 3320 respondents (50.3% males; age 18-90 years) were recruited. 51.1% and 12.2% of respondents reported no problems on all EQ-5D-5L and SF-6Dv2 dimensions, respectively. The mean EQ-5D-5L utility was higher than SF-6Dv2 (0.947 vs. 0.827, p < 0.001). Utilities were significantly different across all chronic conditions groups for both measures. The mean absolute difference of utilities between the two tests for EQ-5D-5L was smaller (0.033 vs. 0.043) than SF-6Dv2, with a slightly higher ICC (0.859 vs. 0.827). Fair agreement (ICC = 0.582) was observed in the utilities between the two measures. Mapping algorithms generated by the OLS models performed the best according to the goodness-of-fit indicators. CONCLUSIONS: Both measures showed comparable discriminative validity. Systematic differences in utilities were found, and on average, the EQ-5D-5L generates higher values than the SF-6Dv2. Mapping algorithms between the EQ-5D-5L and SF-6Dv2 are reported to enable transformations between these two measures in China.

Canada population norms for the EQ-5D-5L.

OBJECTIVE: In Canada, population norms are only available for 2 provinces, Alberta and Quebec. The objective of this study was to derive the population norms for the EQ-5D-5L based on a representative sample of the Canadian general population. METHODS: Data from the Canadian EQ-5D-5L valuation study, a cross-sectional study, were used. A quota sampling method was used to recruit a representative sample of the Canadian general population in terms of age, sex, and education. EQ-5D-5L utilities and EQ VAS were summarized using descriptive statistics and the impact of demographic characteristics on the EQ-5D-5L utilities was evaluated using statistical hypothesis testing and Tobit regression. RESULTS: 1207 eligible participants were included in the analysis. Pain/discomfort (53.1%) was the most frequently reported domain with any problem, and self-care (7.6%) domain was the least. The mean (standard deviation [SD]) EQ-5D-5L utility was 0.864 (0.121) and the mean (SD) EQ VAS was 82.3 (14.23). The highest mean EQ-5D-5L utility was 0.881 in age group 25-34 while the lowest was 0.839 in age group 55-64. Participants who had full-time employment, were married, a higher annual household income and no chronic health conditions had significantly higher EQ-5D-5L utilities. CONCLUSION: This article reports the first Canadian population norms for the EQ-5D-5L and can be used as population references for economic evaluations and clinical research.

Endovascular Thrombectomy with or without Bridging Thrombolysis in Acute Ischemic Stroke: A Cost-Effectiveness Analysis.

BACKGROUND: There is unclear added benefit of intravenous thrombolysis (IVT) with endovascular thrombectomy (EVT). We performed a cost-effectiveness analysis to assess the cost-effectiveness of comparing EVT with IVT versus EVT alone. METHODS: We used a decision tree to examine the short-term costs and outcomes at 90 days after the occurrence of index stroke to compare the cost-effectiveness of EVT alone with EVT plus IVT for patients with stroke. Subsequently, we developed a Markov state transition model to assess the costs and outcomes over 1-year, 5-year, and 20-year time horizons. We estimated total and incremental cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio. RESULTS: The average costs per patient were estimated to be $47,304, $49,510, $59,770, and $76,561 for EVT-only strategy and $55,482, $57,751, $68,314, and $85,611 for EVT with IVT over 90 days, 1 year, 5 years, and 20 years, respectively. The cost saving of EVT-only strategy was driven by the avoided medication costs of IVT (ranging from $8,178 to $9,050). The additional IVT led to a slight decrease in QALY estimate during the 90-day time horizon (loss of 0.002 QALY), but a small gain over 1-year and 5-year time horizons (0.011 and 0.0636 QALY). At a willingness-to-pay threshold of $50,000 per QALY gained, the probabilities of EVT only being cost-effective were 100%, 100%, and 99.3% over 90-day, 1-year, and 5-year time horizons. CONCLUSION: Our cost-effectiveness model suggested that EVT only may be cost-effective for patients with acute ischemic stroke secondary to large vessel occlusion.

Health state utility values for children and adolescents with type 1 diabetes: A systematic review and meta-analysis.

BACKGROUND: Type 1 diabetes mellitus (T1DM) is one of the most burdensome chronic diseases in the world. Health utility values are an important tool for quantifying this disease burden and conducting cost-utility analyses. This review aimed to derive a reference set of health utility values for children and adolescents with T1DM. METHODS: We searched MEDLINE and Embase from inception to March 2023 for health utility values of T1DM children and adolescents (aged ≤18 years) measured using direct and indirect preference elicitation approaches. Utility estimates were pooled by meta-analyses with subgroup analyses to evaluate differences by populations and elicitation approaches. RESULTS: Six studies involving 1276 participants were included in this study. Meta-analysis showed the overall utility value of children and adolescents with T1DM was 0.91 (95% CI 0.89-0.93). The utility value of T1DM children and adolescents with complications was 0.90 (95% CI 0.88-0.92), which was lower than those without complications (0.96, 95% CI 0.95-0.97). The utility value of children (aged <13 years) was higher than adolescents (aged 13-18 years) (0.90 vs. 0.85). The utility value measured by the EQ-5D-3L (0.91) was higher than the HUI3 (0.89), the SF-6Dv1 (0.83), and the time trade-off (0.81). The parent proxy-reported was similar to the patient self-reported (0.91 vs. 0.91). CONCLUSIONS: This study developed a reference set of pooled utility estimates for children and adolescents with T1DM, which is helpful for understanding the overall health status of T1DM and conducting economic evaluations. Further studies are needed to explore the utilities of T1DM with different types of complications.

Fatigue and health-related quality of life in patients with immune thrombocytopenia: a longitudinal assessment in China.

BACKGROUND: There is lacking studies of longitudinally assessment of fatigue and health-related quality of life (HRQoL) among Chinese immune thrombocytopenia (ITP) adults. We aimed to evaluate changes in fatigue and HRQoL and identify the associated factors. METHODS: Patients' characteristics, Functional Assessment of Chronic Illness Therapy (FACIT-F) and the ITP-specific Patient Assessment Questionnaire (ITP-PAQ) scores at admission (T0), at discharge (T1), and three months after discharge (T2) were collected. Linear mixed effects models were used to examine changes over time. RESULTS: We included 175 patients. The mean score of FACIT-F at T0 was 37.2 and increased at T1 (39.0), while then decreased at T2 (34.7). Patients who were single, retired, had persistent ITP, splenomegaly had more severe fatigue, whereas those who had not received any prior treatment and had a bleeding score of 0 at admission had milder fatigue. The mean score of ITP-PAQ was 57.7 at T0, then gradually increased to 60.3 at T1 and 62.8 at T2. Patients with persistent ITP and those who have never received treatment for ITP have better HRQoL. CONCLUSION: ITP adults' fatigue and HRQoL were impaired. Patients' fatigue improved at discharge but worsened at three months after discharge, while HRQoL gradually improved over time.

Comparison of the measurement properties of the EQ-5D-5L and SF-6Dv2 among overweight and obesity populations in China.

OBJECTIVE: To evaluate and compare the measurement properties of the EQ-5D-5L and SF-6Dv2 among Chinese overweight and obesity populations. METHODS: A representative sample of Chinese overweight and obesity populations was recruited stratified by age, gender, body mass index (BMI), and area of residence. Social-demographic characteristics and self-reported EQ-5D-5L and SF-6Dv2 responses were collected through the online survey. The agreement was assessed using intraclass correlation coefficients (ICC). Convergent validity and known-group validity were examined using Spearman's rank correlation and effect sizes, respectively. The test-retest reliability was assessed using among a subgroup of the total sample. Sensitivity was compared using relative efficiency and receiver operating characteristic. RESULTS: A total of 1000 respondents (52.0% male, mean age 51.7 years, 67.7% overweight, 32.3% obesity) were included in this study. A higher ceiling effect was observed in EQ-5D-5L than in SF-6Dv2 (30.6% vs. 2.1%). The mean (SD) utility was 0.851 (0.195) for EQ-5D-5L and 0.734 (0.164) for SF-6Dv2, with the ICC of the total sample was 0.639 (p < 0.001). The Spearman's rank correlation (range: 0.186-0.739) indicated an acceptable convergent validity between the dimensions of EQ-5D-5L and SF-6Dv2. The EQ-5D-5L showed basically equivalent discriminative capacities with the SF-6Dv2 (ES: 0.517-1.885 vs. 0.383-2.329). The ICC between the two tests were 0.939 for EQ-5D-5L and 0.972 for SF-6Dv2 among the subgroup (N = 150). The SF-6Dv2 had 3.7-170.1% higher efficiency than the EQ-5D-5L at detecting differences in self-reported health status, while the EQ-5D-5L was found to be 16.4% more efficient at distinguishing between respondents with diabetes and non-diabetes. CONCLUSIONS: Both the EQ-5D-5L and SF-6Dv2 showed comparable reliability, validity, and sensitivity when used in Chinese overweight and obesity populations. The two measures may not be interchangeable given the systematic difference in utility values between the EQ-5D-5L and SF-6Dv2. More research is needed to compare the responsiveness.

Valuing Chinese medicine quality of life-11 dimensions (CQ-11D) health states using a discrete choice experiment with survival duration (DCETTO).

OBJECTIVE: To explore generating a health utility value set for the Chinese medicine Quality of life-11 Dimensions (CQ-11D), a utility instrument designed to assess patients' health status while receiving TCM treatment, among the Chinese population. METHODS: The study was designed to recruit at least 2400 respondents across mainland China to complete one-to-one, face-to-face interviews. Respondents completed ten discrete choice experiment with survival duration (DCETTO) tasks during interviews. The conditional logit models were used to generate the health utility value set for the CQ-11D using the DCETTO data. RESULTS: A total of 2,586 respondents were invited to participate in the survey and 2498 valid interviews were completed (a completion rate of 96.60%). The modified conditional logit model with combing logically inconsistent levels was ultimately selected to construct the health utility value set for the CQ-11D instrument. The range of the measurable health utility value was -0.868 ~ 1. CONCLUSION: The study provides the first utility value set for the CQ-11D among the Chinese population. The CQ-11D and corresponding utility value set can be used to measure the health utility values of patients undergoing traditional Chinese medicine interventions, and further facilitate relevant cost-utility analyses. The application of the CQ-11D can support TCM resource allocation in China.

Whose Time Trade-Off Should Be Used? Anchoring Discrete Choice Experiment Latent Utilities in Health State Valuation.

OBJECTIVES: To compare anchored discrete choice experiment (DCE) utility values using own versus others' time trade-off (TTO) responses in the valuation of SF-6Dv2. METHODS: A representative sample of the general population was recruited in China. Through face-to-face interviews, both DCE and TTO data were collected from a randomly selected half of the respondents (own TTO sample), whereas only TTO data were collected from the other half (others' TTO sample). Conditional logit model was used to estimate DCE latent utilities. Three anchoring methods, including using the observed and the modeled TTO values for the worst state, and mapping DCE values onto TTO, were used to scale the latent utilities to health utilities. Prediction accuracy was assessed using intraclass correlation coefficient, mean absolute difference, and root mean squared difference compared with the mean observed TTO values between the anchoring results using the own versus others' TTO data. RESULTS: Demographic characteristics were comparable between the own TTO sample (n = 252) and the others' TTO sample (n = 251). The mean (SD) observed TTO value for the worst state was -0.259 (0.591) for the own TTO sample and -0.236 (0.616) for the others' TTO sample. Anchoring DCE using own TTOs consistently showed a better prediction accuracy than using others' TTOs across the 3 anchoring methods in terms of the intraclass correlation coefficient (0.835-0.873 vs 0.771-0.804), mean absolute difference (0.127-0.181 vs 0.146-0.203), and root mean squared difference (0.164-0.237 vs 0.192-0.270). CONCLUSION: When anchoring DCE-derived latent utilities onto the health utility scale, respondents' own TTO data would be preferred to TTO data obtained from a different sample.

Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of pulmonary embolism.

BACKGROUND: Pulmonary embolism (PE) is a potentially life-threatening condition in which a clot can migrate from the deep veins, most commonly in the leg, to the lungs. Conventional treatment of PE used unfractionated heparin (UFH), low molecular weight heparin (LMWH), fondaparinux, and vitamin K antagonists (VKAs). Recently, two forms of direct oral anticoagulants (DOACs) have been developed: oral direct thrombin inhibitors (DTIs) and oral factor Xa inhibitors. DOACs have characteristics that may be favourable to conventional treatment, including oral administration, a predictable effect, no need for frequent monitoring or re-dosing, and few known drug interactions. This review reports the efficacy and safety of these drugs in the long-term treatment of PE (minimum duration of three months). This is an update of a Cochrane Review first published in 2015.  OBJECTIVES: To assess the efficacy and safety of oral DTIs and oral factor Xa inhibitors versus conventional anticoagulants for the long-term treatment of PE. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, the World Health Organization International Clinical Trials Registry Platform and the ClinicalTrials.gov trials registers to 2 March 2022. We checked the reference lists of relevant articles for additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in which people with a PE confirmed by standard imaging techniques were allocated to receive an oral DTI or an oral factor Xa inhibitor compared with a conventional anticoagulant or compared with each other for the long-term treatment of PE (minimum duration three months). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were recurrent PE, recurrent venous thromboembolism (VTE), and deep vein thrombosis (DVT). Secondary outcomes were all-cause mortality, major bleeding, and health-related quality of life. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We identified five additional RCTs with 1484 participants for this update. Together with the previously included trials, we have included ten RCTs with a total of 13,073 participants. Two studies investigated an oral DTI (dabigatran) and eight studies investigated oral factor Xa inhibitors (three rivaroxaban, three apixaban, and two edoxaban). The studies were of good methodological quality overall.  Meta-analysis showed no clear difference in the efficacy and safety of oral DTI compared with conventional anticoagulation in preventing recurrent PE (odds ratio (OR) 1.02, 95% confidence interval (CI) 0.50 to 2.04; 2 studies, 1602 participants; moderate-certainty evidence), recurrent VTE (OR 0.93, 95% CI 0.52 to 1.66; 2 studies, 1602 participants; moderate-certainty evidence), DVT (OR 0.79, 95% CI 0.29 to 2.13; 2 studies, 1602 participants; moderate-certainty evidence), and major bleeding (OR 0.50, 95% CI 0.15 to 1.68; 2 studies, 1527 participants; moderate-certainty evidence). We downgraded the certainty of evidence by one level for imprecision due to the low number of events. There was also no clear difference between the oral factor Xa inhibitors and conventional anticoagulation in the prevention of recurrent PE (OR 0.92, 95% CI 0.66 to 1.29; 3 studies, 8186 participants; moderate-certainty evidence), recurrent VTE (OR 0.83, 95% CI 0.66 to 1.03; 8 studies, 11,416 participants; moderate-certainty evidence), DVT (OR 0.77, 95% CI 0.48 to 1.25; 2 studies, 8151 participants; moderate-certainty evidence), all-cause mortality (OR 1.16, 95% CI 0.79 to 1.70; 1 study, 4817 participants; moderate-certainty evidence) and major bleeding (OR 0.71, 95% CI 0.36 to 1.41; 8 studies, 11,447 participants; low-certainty evidence); the heterogeneity for major bleeding was significant (I2 = 79%). We downgraded the certainty of the evidence to moderate and low because of imprecision due to the low number of events and inconsistency due to clinical heterogeneity. None of the included studies measured health-related quality of life. AUTHORS' CONCLUSIONS: Available evidence shows there is probably little or no difference between DOACs and conventional anticoagulation in the prevention of recurrent PE, recurrent VTE, DVT, all-cause mortality, and major bleeding. The certainty of evidence was moderate or low. Future large clinical trials are required to identify if individual drugs differ in effectiveness and bleeding risk, and to explore effect differences in subgroups, including people with cancer and obesity.

China Health Related Outcomes Measures (CHROME): development of a descriptive system to support cardiovascular disease specific preference-based measure for the Chinese population.

PURPOSE: Preference-based measures have been increasingly recommended to measure health outcomes for economic evaluation. However, none of existing cardiovascular disease (CVD)-specific health-related quality of life (HRQoL) instruments are preference-based. This study aimed to develop the descriptive system of preference-based HRQoL instrument for Chinese patients with CVDs under the Initiative of China Health Related Outcomes Measures (CHROME). METHODS: Qualitative face-to-face interviews were conducted with Chinese patients with CVDs. Content analysis was employed to generate candidate items for the instrument. Then expert consultation and cognitive debriefing interviews were conducted to guide further selection and revision of the items. RESULTS: We interviewed 127 CVD patients with 67.7% being male and 63.8% living in the urban area. A hierarchical code book comprised of four themes, 20 categories, 62 sub-categories, and 207 codes, was developed. Candidate items were selected based on the criteria set by the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology and ISPOR PRO guidance. An online survey and meeting with an expert advisory panel (n = 15) followed by cognitive debriefing interviews with 20 patients and 13 physicians were conducted to further select and revise the candidate items. The descriptive system of CHROME-CVD consists of 14 items, namely frequency and severity of chest pain, chest tightness, palpitation, shortness of breath, dizziness, fatigue, appetite, sleeping, mobility, daily activities, depression, worry, and social relationship. Four or five level responses were selected based on cognitive debriefing results to each item. CONCLUSION: The current study developed the descriptive system (items and response options) of CHROME-CVD, the future CVD-specific preference-based HRQoL instrument for Chinese CVD patients.

Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair.

BACKGROUND: Abdominal aortic aneurysms (AAAs) are a vascular condition with significant risk attached, particularly if they rupture. Therefore, it is critical to identify and repair these as an elective procedure before they rupture and require emergency surgery. Repair has traditionally been an open surgical technique that required a large incision across the abdomen. Endovascular abdominal aortic aneurysm repairs (EVARs) are now a common alternative. In this procedure, the common femoral artery is exposed via a cut-down approach and a graft is introduced to the aneurysm in this way. This Cochrane Review examines a totally percutaneous approach to EVAR. This technique gives a minimally invasive approach to femoral artery access that may reduce groin wound complication rates and improve recovery time. However, the technique may be less applicable in people with, for example, groin scarring or arterial calcification. This is an update of the previous Cochrane Review published in 2017. OBJECTIVES: To evaluate the benefits and harms of totally percutaneous access compared to cut-down femoral artery access in people undergoing elective bifurcated abdominal endovascular aneurysm repair (EVAR). SEARCH METHODS: We used standard, extensive Cochrane search methods The latest search was 8 April 2022. SELECTION CRITERIA: We included randomised controlled trials in people diagnosed with an AAA comparing totally percutaneous versus surgical cut-down access endovascular repair. We considered all device types. We only considered studies investigating elective repairs. We excluded studies reporting emergency surgery for ruptured AAAs and those reporting aorto-uni-iliac repairs. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. short-term mortality, 2. failure of aneurysm exclusion and 3. wound infection. Secondary outcomes were 4. major complications (30-day or in-hospital); 5. medium- to long-term (6 and 12 months) complications and mortality; 6. bleeding complications and haematoma; and 7. operating time, duration of intensive treatment unit (ITU) stay and hospital stay. We used GRADE to assess the certainty of evidence for the seven most clinically relevant primary and secondary outcomes. MAIN RESULTS: Three studies with 318 participants met the inclusion criteria, 189 undergoing the percutaneous technique and 129 treated by cut-down femoral artery access. One study had a small sample size and did not adequately report the method of randomisation, allocation concealment or preselected outcomes. The other two larger studies had few sources of bias and good methodology; although one study had a high risk of bias in selective reporting. We observed no clear difference in short-term mortality between groups, with only one death occurring overall, in the totally percutaneous group (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.06 to 36.18; 2 studies, 181 participants; low-certainty evidence). One study reported failure of aneurysm exclusion. There was one failure of aneurysm exclusion in the surgical cut-down femoral artery access group (RR 0.17, 95% CI 0.01 to 4.02; 1 study, 151 participants; moderate-certainty evidence). For wound infection, there was no clear difference between groups (RR 0.18, 95% CI 0.01 to 3.59; 3 studies, 318 participants; moderate-certainty evidence). There was no clear difference between percutaneous and cut-down femoral artery access groups in major complications (RR 1.21, 95% CI 0.61 to 2.41; 3 studies, 318 participants; moderate-certainty evidence), bleeding complications (RR 1.02, 95% CI 0.29 to 3.64; 2 studies, 181 participants; moderate-certainty evidence) or haematoma (RR 0.88, 95% CI 0.13 to 6.05; 2 studies, 288 participants). One study reported medium- to long-term complications at six months, with no clear differences between the percutaneous and cut-down femoral artery access groups (RR 0.82, 95% CI 0.25 to 2.65; 1 study, 135 participants; moderate-certainty evidence). We detected differences in operating time, with the percutaneous approach being faster than cut-down femoral artery access (mean difference (MD) -21.13 minutes, 95% CI -41.74 to -0.53 minutes; 3 studies, 318 participants; low-certainty evidence). One study reported the duration of ITU stay and hospital stay, with no clear difference between groups. AUTHORS' CONCLUSIONS: Skin puncture may make little to no difference to short-term mortality. There is probably little or no difference in failure of aneurysm exclusion (failure to seal the aneurysms), wound infection, major complications within 30 days or while in hospital, medium- to long-term (six months) complications and bleeding complications between the two groups. Compared with exposing the femoral artery, skin puncture may reduce the operating time slightly. We downgraded the certainty of the evidence to moderate and low as a result of imprecision due to the small number of participants, low event rates and wide CIs, and inconsistency due to clinical heterogeneity. As the number of included studies was limited, further research into this technique would be beneficial.

The trend in quality of life of Chinese population: analysis based on population health surveys from 2008 to 2020.

BACKGROUND: Quality of life (QoL) is one of the most important indicators for evaluating an individual's overall health status. However, evidence exploring the trend in QoL of the Chinese population is still lacking. This study aimed to investigate the trend in QoL of the Chinese population measured by the EQ-5D from 2008 to 2020, as well as compare the changing trends in QoL categorized by populations with different socio-demographic characteristics. METHODS: Data were obtained from the 2008, 2013, and 2020 waves of the Health Services Surveys conducted in Tianjin, China. Respondents completed the EQ-5D (EQ-5D-3L in 2008 and 2013 and EQ-5D-5L in 2020) through face-to-face interviews or self-administration. Responses of the EQ-5D-3L in 2008 and 2013 were mapped onto the EQ-5D-5L responses, and then converted to utility values using the Chinese value set. The trend in QoL was explored by comparing the percentage of any reported problems on each EQ-5D dimension and the corresponding utility values across the three waves. Subgroup analyses were performed to compare trends in utility values stratified by socio-demographic indicators. The effect of the time variable (year) on utility values was assessed by multiple linear regression analyses using the pooled data. RESULTS: By analyzing and comparing the three waves of the data (N = 25,939 in the 2008 wave, N = 22,138 in 2013, and N = 19,177 in 2020), an upward trend was observed in the percentages of reporting problems on all five dimensions (p < 0.001), resulting in a decreasing trend in utility values (2008: 0.948, 2013: 0.942, 2020: 0.939, p < 0.001). Utility values declined more over time among the female, the elder, the recipients of medical assistance, the widowed, the unemployed, and respondents with primary or lower education. The effect of the year (Coef. for 2013 = - 0.009, p < 0.001; Coef. for 2020 = - 0.010, p < 0.001) confirmed the downward trend in the utility values. CONCLUSIONS: The overall QoL of the Chinese population decreased over the period from 2008 to 2020. The QoL of the disadvantaged or vulnerable populations in terms of socioeconomic characteristics declined more over time.

Facilitators, barriers and strategies for health-system guidance implementation: a critical interpretive synthesis protocol.

BACKGROUND: As systematically developed statements regarding possible courses of action, health system guidance (HSG) can assist with making decisions about addressing problems or achieving goals in health systems. However, there are conceptual and methodological challenges in HSG implementation due to the complexity of health-system policy-making, the diversity of available evidence and vast differences in contexts. To address these gaps, we aim to develop a theoretical framework for supporting HSG implementation as part of a broader effort to promote evidence-informed policy-making in health systems. METHODS: To develop a theoretical framework about facilitators, barriers and strategies for HSG implementation, we will apply a critical interpretive synthesis (CIS) approach to synthesize the findings from a range of relevant literature. We will search 11 electronic databases and seven organizational websites to identify relevant published and grey literature. We will check the references of included studies and contact experts to identify additional eligible papers. Finally, we will conduct purposively sampling of the literature to fill any identified conceptual gaps. We will use relevance and five quality criteria to assess included papers. A standardized form will be developed for extracting information. We will use an interpretive analytic approach to synthesize the findings, including a constant comparative method throughout the analysis. Two independent reviewers will conduct the literature screening and relevance assessment, and disagreements will be resolved through discussion. The principal investigator will conduct data extraction and synthesis, and a second reviewer will check the sample of extracted data for consistency and accuracy. DISCUSSION: A new theoretical framework about facilitators, barriers and strategies for HSG implementation will be developed using a CIS approach. The HSG implementation framework could be widely used for supporting the implementation of HSG covering varied topics and in different contexts (including low-, middle- and high-income countries). In later work, we will develop a tool for supporting HSG implementation based on the theoretical framework. Registration PROSPERO CRD42020214072. Date of Registration: 14 December 2020.

China Health Related Outcomes Measures (CHROME): Development of a New Generic Preference-Based Measure for the Chinese Population.

BACKGROUND AND OBJECTIVES: Existing generic preference-based measures were all developed in Western countries. Evidence shows that the Chinese population may have different perceptions about health and health-related quality of life. This study aimed at developing a descriptive system of a new generic preference-based measure under the initiative of China Health Related Outcomes Measures (CHROME). METHODS: Qualitative data were collected through semi-structured interviews conducted in-person or online. Respondents were recruited from both the general public and populations with chronic diseases. Open-ended questions about the respondent's perception of general health and important aspects of health-related quality of life were asked. Probing questions based on a systematic review of existing generic preference-based measures were also used. The framework analysis was used to synthesize the qualitative data. Candidate items for the descriptive system were selected following the ISPOR and COSMIN guidelines. Expert panel review and cognitive debriefings were conducted for further revisions. RESULTS: Qualitative interviews were conducted among 68 respondents, with 48.5% male and a mean age of 47.8 years (range 18-81 years). In total, 1558 codes were identified and then aggregated to 31 sub-themes and corresponding six themes to inform the development of the initial version of the descriptive system. Feedback from the expert panel survey and meeting (n = 15) and the cognitive debriefing interviews (n = 30) was incorporated into the revised version of the measure. Finally, the generic version of CHROME (CHROME-G) included 12 items across six domains, namely, pain, fatigue, appetite, mobility, vision, hearing, sleeping, daily activities, depression, worry, memory, and social interactions. The descriptive system used a mix of four-level and five-level response options and a 7-day recall period. CONCLUSIONS: The CHROME-G is the first generic preference-based measure to be developed based on the inputs from the Chinese populations.

Comparison of the measurement properties of SF-6Dv2 and EQ-5D-5L in a Chinese population health survey.

BACKGROUND: SF-6Dv2, the latest version of SF-6D, has been developed recently, and its measurement properties remain to be evaluated and compared with the EQ-5D-5L. The aim of this study was to assess and compare the measurement properties of the SF-6Dv2 and the EQ-5D-5L in a large-sample health survey among the Chinese population. METHODS: Data were obtained from the 2020 Health Service Survey in Tianjin, China. Respondents were randomly selected and invited to complete both the EQ-5D-5L and SF-6Dv2 through face-to-face interviews or self-administration. Health utility values were calculated by the Chinese value sets for the two measures. Ceiling and floor effects were firstly evaluated. Convergent validity and discriminate validity were examined using Spearman's rank correlation and effect sizes, respectively. The agreement was assessed using intraclass correlation coefficients (ICC). Sensitivity was compared using relative efficiency and receiver operating characteristic. RESULTS: Among 19,177 respondents (49.3% male, mean age 55.2 years, ranged 18-102 years) included in this study, the mean utility was 0.939 (0.168) for EQ-5D-5L and 0.872 (0.184) for SF-6Dv2. A higher ceiling effect was observed in EQ-5D-5L than in SF-6Dv2 (72.8% vs. 36.1%). The Spearman's rank correlation (range: 0.30-0.69) indicated an acceptable convergent validity between the dimensions of EQ-5D-5L and SF-6Dv2. The SF-6Dv2 showed slightly better discriminative capacities than the EQ-5D-5L (ES: 0.126-2.675 vs. 0.061-2.256). The ICC between the EQ-5D-5L and SF-6Dv2 utility values of the total sample was 0.780 (p < 0.05). The SF-6Dv2 had 29.0-179.2% higher efficiency than the EQ-5D-5L at distinguishing between respondents with different external health indicators, while the EQ-5D-5L was found to be 8.2% more efficient at detecting differences in self-reported health status than the SF-6Dv2. CONCLUSIONS: Both the SF-6Dv2 and EQ-5D-5L have been demonstrated to be comparably valid and sensitive when used in Chinese population health surveys. The two measures may not be interchangeable given the moderate ICC and the systematic difference in utility values between the SF-6Dv2 and EQ-5D-5L. Further research is warranted to compare the test-retest reliability and responsiveness.