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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.
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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.
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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 graL 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 cutdown 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.
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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.
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