Abstract Objectives To estimate a five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) value set for China using the health preferences of residents living in the urban areas of the country. ...Methods The values of a subset of the EQ-5D-5L–defined health states (n = 86) were elicited using the time trade-off (TTO) technique from a sample of urban residents (n = 1271) recruited from five Chinese cities. In computer-assisted personal interviews, participants each completed 10 TTO tasks. Two additive and two multiplicative regression models were evaluated for their performance in describing the relationship between TTO values and health state characteristics using a cross-validation approach. Final values were generated using the best-performed model and a rescaling method. Results The 8- and 9-parameter multiplicative models unanimously outperformed the 20-parameter additive model using a random or fixed intercept in predicting values for out-of-sample health states in the cross-validation analysis and their coefficients were estimated with lower standard errors. The prediction accuracies of the two multiplicative models measured by the mean absolute error and the intraclass correlation coefficient were very similar, thus favoring the more parsimonious model. Conclusions The 8-parameter multiplicative model performed the best in the study and therefore was used to generate the EQ-5D-5L value set for China. We recommend using rescaled values whereby 1 represents the value of instrument-defined full health in economic evaluation of health technologies in China whenever the EQ-5D-5L data are available.
AbstractObjectiveTo develop an instrument to evaluate the credibility of anchor based minimal important differences (MIDs) for outcome measures reported by patients, and to assess the reliability of ...the instrument.DesignInstrument development and reliability study.Data sourcesInitial criteria were developed for evaluating the credibility of anchor based MIDs based on a literature review (Medline, Embase, CINAHL, and PsycInfo databases) and the experience of the authors in the methodology for estimation of MIDs. Iterative discussions by the team and pilot testing with experts and potential users facilitated the development of the final instrument.ParticipantsWith the newly developed instrument, pairs of masters, doctoral, or postdoctoral students with a background in health research methodology independently evaluated the credibility of a sample of MID estimates.Main outcome measuresCore credibility criteria applicable to all anchor types, additional criteria for transition rating anchors, and inter-rater reliability coefficients were determined.ResultsThe credibility instrument has five core criteria: the anchor is rated by the patient; the anchor is interpretable and relevant to the patient; the MID estimate is precise; the correlation between the anchor and the outcome measure reported by the patient is satisfactory; and the authors select a threshold on the anchor that reflects a small but important difference. The additional criteria for transition rating anchors are: the time elapsed between baseline and follow-up measurement for estimation of the MID is optimal; and the correlations of the transition rating with the baseline, follow-up, and change score in the patient reported outcome measures are satisfactory. Inter-rater reliability coefficients (ĸ) for the core criteria and for one item from the additional criteria ranged from 0.70 to 0.94. Reporting issues prevented the evaluation of the reliability of the three other additional criteria for the transition rating anchors.ConclusionsResearchers, clinicians, and healthcare policy decision makers can consider using this instrument to evaluate the design, conduct, and analysis of studies estimating anchor based minimal important differences.
Many healthcare systems around the world have been increasingly using patient-reported outcome measures (PROMs) in routine outcome measurement to enhance patient-centered care and incorporate the ...patient’s perspective in health system performance evaluation. One of the key steps in using PROMs in health systems is selecting the appropriate measure(s) to serve the purpose and context of measurement. However, the availability of many PROMs makes this choice rather challenging. Our aim was to provide an integrated approach for PROM(s) selection for use by end-users in health systems.
The proposed approach was based on relevant literature and existing guidebooks that addressed PROMs selection in various areas and for various purposes, as well as on our experience working with many health system users of PROMs in Canada. The proposed approach includes the following steps: (1) Establish PROMs selection committee; (2) Identify the focus, scope, and type of PROM measurement; (3) Identify potential PROM(s); (4) Review practical considerations for each of the identified PROMs; (5) Review measurement properties of shortlisted PROMs; (6) Review patient acceptance of shortlisted PROMs; (7) Recommend a PROM(s); and (8) Pilot the selected PROM(s). The selection of appropriate PROMs is one step in the successful implementation of PROMs within health systems, albeit, an essential step. We provide guidance for the selection of PROMs to satisfy all potential usages at the micro (patient-clinician), meso (organization), and macro (system) levels within the health system. Selecting PROMs that satisfy all these purposes is essential to ensure continuity and standardization of measurement over time. This is an iterative process and users should consider all the available information from all presented steps in selecting PROMs. Each of these considerations has a different weight in diverse clinical contexts and settings with various types of patients and resources.
This article aims to report the comprehensive and up-to-date analysis and evidence of the insertion rate, expulsion rate, removal rate, and utilization rate of immediate placement of intrauterine ...devices (IUDs) versus delayed placement after artificial abortion. PubMed, Embase, Cochrane, Web of Science, CNKI, and Wanfang databases were comprehensively searched up to January 12, 2024 for studies that compared immediate versus delayed insertion of IUDs after abortion. The evaluation metrics included the number of IUD insertion after surgical or medical abortions, the frequency of expulsion and removal at 6 months or 1 year, the number of continued usage, pain intensity scores, the number of infections, the duration of bleeding, and instances of uterine perforation during or after IUD insertion. Ten randomized controlled articles were eligible, comprising 11 research projects, of which 3 projects involved the placement of an IUD after surgical abortion, and 8 projects involved the placement of an IUD after medical abortion. This included 2025 patients (977 in the immediate insertion group and 1,048 in the delayed insertion group). We summarized all the extracted evidence. The meta-analysis results indicated that for post-surgical abortions, the immediate insertion group exhibited a higher IUD placement rate than the delayed insertion group. After medical abortions, the immediate insertion group showed higher rates of IUD placement, utilization, and expulsion at 6 months or 1 year. The two groups showed no statistically significant differences in the removal rate, post-insertion infection rate, pain scores during insertion, and days of bleeding during the follow-up period. Compared to delayed placement, immediate insertion of IUDs can not only increase the usage rate at 6 months or 1 year but also enhance the placement rate.
Si-Wu-Tang (SWT), a traditional Chinese medicine formula firstly recorded from the Tang dynasty, has been reported to alleviate gynecological and liver diseases. We preliminarily demonstrated that ...SWT could improve liver fibrosis via modulating intestinal microbiota, but little was known about the mechanisms linking its therapeutic effects to the reshaped immune microenvironment within fibrotic livers. Thus, we established a bile duct ligation (BDL)-induced liver fibrosis murine model to evaluate the hepatoprotective effects and potential mechanisms of SWT. The high-performance liquid chromatography, RNA sequencing and other molecular biological techniques were also performed in our study. Our data demonstrated that SWT significantly improved BDL-induced liver fibrosis and inflammatory responses by inhibiting the expression of genes associated with extracellular matrix synthesis and degradation. Combined with the analysis of immune cell infiltration and gene set enrichment analysis (GSEA), we found that SWT remarkably repaired the unbalanced immune microenvironment by modulating the biological functions of different immune cells, especially for macrophages, neutrophils and CD8+ T cells. In addition, SWT significantly inhibited the activation of M2-like macrophages to reduce the release of profibrotic-cytokines and prevented the activation of neutrophils to suppress neutrophil extracellular trap formation. SWT also efficiently promoted the apoptosis of activated hepatic stellate cells via Fas/FasL signaling pathway, which might be mediated by CD8+ tissue-resident memory T cells. In conclusion, our research not only unraveled the intricate mechanisms underlying the hepatoprotective activities of SWT against liver fibrosis but also provided a novel therapeutic strategy for the treatment of liver fibrosis and its relative complications.
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•Si-Wu-Tang (SWT) exerted an anti-hepatic fibrosis effect on bile duct ligation-induced liver fibrosis•SWT restored the immune microenvironment in livers via regulating multiple immune cells, especially for macrophages, neutrophils and CD8+T cells•SWT might increase the number of CD8+T cells and promote activated HSCs apoptosis through the activation of FAS pathway
The objective of the study was to develop an inventory summarizing all anchor-based minimal important difference (MID) estimates for patient-reported outcome measures (PROMs) available in the medical ...literature.
We searched MEDLINE, EMBASE, CINAHL, PsycINFO, and the Patient-Reported Outcome and Quality of Life Instruments Database internal library (January 1989–October 2018). We included primary studies empirically calculating an anchor-based MID estimate for any PROM in adults and adolescents. Pairs of reviewers independently screened and selected studies, extracted data, and evaluated the credibility of the MIDs.
We identified 585 eligible studies, the majority conducted in Europe (n = 211) and North America (n = 179), reporting 5,324 MID estimates for 526 distinct PROMs. Investigators conducted their studies in the context of patients receiving surgical (n = 105, 18%), pharmacological (n = 85, 15%), rehabilitation (n = 65, 11%), or a combination of interventions (n = 194, 33%). Of all MID estimates, 59% (n = 3,131) used a global rating of change anchor. Major credibility limitations included weak correlation (n = 1,246, 23%) or no information regarding the correlation (n = 3,498, 66%) between the PROM and anchor and imprecision in the MID estimate (n = 2,513, 47%).
A large number of MIDs for assisting in the interpretation of PROMs exist. The MID inventory will facilitate the use of MID estimates to inform the interpretation of the magnitude of treatment effects in clinical research and guideline development.
To develop an EQ-5D-3L social value set based on Chinese rural population's preferences using the time trade-off (TTO) method, and to compare the differences in preferences on health states between ...China urban and rural population.
Between Sep 2013 and Nov 2013, a total of 1201 participants were recruited from rural areas of five Chinese cities (Beijing, Chengdu, Guiyang, Nanjing, and Shenyang) using a quota sampling method. Each respondent valued 13 health states using the TTO, and a total of 97 EQ-5D-3L health states were directly valued for estimating the value set. Various models with different specifications were explored at both aggregate and individual levels. The final model was determined by a set of predefined selection criteria.
An ordinary least square model at the aggregate level included 10 dummy variables for specifying the level 2 and 3 for each dimension and an N3 term presenting any dimension on level 3 was selected as the final model. The final model provides a value set ranges from - 0.218 to 0.859. The predicted utility values were highly correlated with but consistently lower than that of the published Chinese EQ-5D-3L value set (for urban population).
The availability of the China rural value set provides a set of social preferences weights for researchers and policy decision-makers for use in China rural area.
Purpose
The Edmonton Symptom Assessment System-Revised: Renal (ESAS-r: Renal) is a disease-specific patient-reported outcome measure (PROM) that assesses symptoms common in chronic kidney disease ...(CKD). There is no preference-based scoring system for the ESAS-r: Renal or a mapping algorithm to predict health utility values. We aimed to develop a mapping algorithm from the ESAS-r: Renal to the Canadian EQ-5D-5L index scores.
Methods
We used data from a multi-centre cluster randomized-controlled trial of the routine measurement and reporting of PROMs in hemodialysis units in Northern Alberta, Canada. In two arms of the trial, both the ESAS-r: Renal and the EQ-5D-5L were administered to CKD patients undergoing hemodialysis. We used data from one arm for model estimation, and data from the other for validation. We explored direct and indirect mapping models; model selection was based on statistical fit and predictive power.
Results
Complete data were available for 506 patient records in the estimation sample and 242 in the validation sample. All models tended to perform better in patients with good health, and worse in those with poor health. Generalized estimating equations (GEE) and generalized linear model (GLM) on selected ESAS-r: Renal items were selected as final models as they fitted the best in estimation and validation sample.
Conclusion
When only ESAS-r: Renal data are available, one could use GEE and GLM to predict EQ-5D-5L index scores for use in economic evaluation. External validation on populations with different characteristics is warranted, especially where renal-specific symptoms are more prevalent.
PROMs are part of routine measurement for hip and knee replacement in Alberta, Canada. We provide an overview of how PROMs are implemented in routine care, and how we use PROMs data for ...decision-making at different levels within the health system. The Alberta Bone and Joint Health Institute (ABJHI) ran a randomized controlled trial to determine the effectiveness and cost-effectiveness of an evidence-based care pathway for hip and knee arthroplasty in 2004. The study included several PROMs questionnaires: Western Ontario and McMaster Universities Osteoarthritis Index, Health Utility Index, Short Form 36 and the EQ-5D-3L. Subsequently, the focus shifted to spread and scale of the care pathway provincially. WOMAC and EQ-5D-3L and a patient experience survey were selected for provincial adoption – captured before surgery, three-months post-surgery, and 12-months post-surgery. These PROMs data were integrated into research and routine clinical practice at the micro, meso and macro levels. At the micro level, PROMs data are used at the individual patient and provider level for patients to provide input on their care and as a tool to communicate with their healthcare providers. We examined the relationship of appropriateness and patient reported outcomes in a prospective cohort study. We evaluated whether routinely collected PROMs could be integrated into a patient decision aid to better inform shared decision making. At the meso level, continuous quality improvement reports are provided routinely to individual health care providers, hospitals and clinics on their performance against the measurement framework and standard key performance indicators. At the macro level, PROMs data are used to evaluate system performance by comparing outcomes across different jurisdictions or over time and support health policy decision making. Combined with administrative databases, we have used simulation models to reflect transition through the continuum of care from disease onset through end-stage care regarding the burden of disease, healthcare resource requirements and associated healthcare costs. The addition of PROMs data in clinical repositories and analyses enables the system to identify and address issues of continuous quality improvement against a measurement framework of performance indicators and to explicitly recognize the trade-offs that are inherent in any resource-constrained system.
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