Updated CRUSADE score to predict in-hospital bleeding: External validation in the Thai percutaneous coronary intervention registry.

BACKGROUND: The Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) score has been recommended to predict in-hospital bleeding risk in non-ST segment elevation myocardial infarction (NSTEMI) patients. The evaluation of the CRUSADE risk score in Asian patients undergoing contemporary percutaneous coronary intervention (PCI) for NSTEMI is necessary. AIMS: We aimed to validate and update the CRUSADE score to predict in-hospital major bleeding in NSTEMI patients treated with PCI. METHOD: The Thai PCI registry is a large, prospective, multicenter PCI registry in Thailand enrolling patients between May 2018 and August 2019. The CRUSADE score was calculated based on 8 predictors including sex, diabetes, prior vascular disease (PVD), congestive heart failure (CHF), creatinine clearance (CrCl), hematocrit, systolic blood pressure, and heart rate (HR). The score was fitted to in-hospital major bleeding using the logistic regression. The original score was revised and updated for simplification. RESULTS: Of 19,701 patients in the Thai PCI registry, 5976 patients presented with NSTEMI. The CRUSADE score was calculated in 5882 patients who had all variables of the score available. Thirty-five percent were female, with a median age of 65.1 years. The proportion of diabetes, PVD, and CHF was 46%, 7.9%, and 11.2%, respectively. The original and revised models of the CRUSADE risk score had C-statistics of 0.817 (95% CI: 0.762-0.871) and 0.839 (95% CI: 0.789-0.889) respectively. The simplified CRUSADE score which contained only four variables (hematocrit, CrCl, HR, and CHF), had C-statistics of 0.837 (0.787-0.886). The calibration of the recalibrated, revised, and simplified model was optimal. CONCLUSIONS: The full and simplified CRUSADE scores performed well in NSTEMI treated with PCI in Thai population.

External validation and revision of Penn incisional hernia prediction model: A large-scale retrospective cohort of abdominal operations.

BACKGROUND: Incisional hernia (IH) manifests in 10%-15% of abdominal surgeries and patients at elevated risk of this complication should be identified for prophylactic intervention. This study aimed to externally validate the Penn hernia risk calculator. METHODS: The Ramathibodi abdominal surgery cohort was constructed by linking relevant hospital databases from 2010 to 2021. Penn hernia risk scores were calculated according to the original model which was externally validated using a seven-step approach. An updated model which included four additional predictor variables (i.e., age, immunosuppressive medication, ostomy reversal, and transfusion) added to those of the three original predictors (i.e., body mass index, chronic liver disease, and open surgery) was also evaluated. The area under the receiver operating characteristic curve (AUC) was estimated, and calibration performance was compared using the Hosmer-Lemeshow goodness-of-fit method for the observed/expected (O/E) ratio. RESULTS: A total of 12,155 abdominal operations were assessed. The original Penn model yielded fair discrimination with an AUC (95% confidence interval (CI)) of 0.645 (0.607, 0.683). The updated model that included the additional predictor variables achieved an acceptable AUC (95% CI) of 0.733 (0.698, 0.768) with the O/E ratio of 0.968 (0.848, 1.088). CONCLUSION: The updated model achieved improved discrimination and calibration performance, and should be considered for the identification of high-risk patients for further hernia prevention strategy.

Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial.

BACKGROUND: Obstructive sleep apnea (OSA) during pregnancy is a risk factor for preeclampsia possibly through a link to placental physiology. This study evaluates the efficacy of continuous positive airway pressure (CPAP) on the modulation of blood pressure and the reduction in preeclampsia in women with high-risk pregnancy and OSA. METHODS: A multicenter open-label, randomized controlled trial comparing CPAP treatment versus usual antenatal care was conducted in three academic hospitals in Bangkok, Thailand. Participants included singleton pregnant women aged older than 18 years with any high-risk condition (i.e., chronic hypertension, obesity, history of preeclampsia or gestational diabetes in the previous pregnancy, or diabetes), and OSA (respiratory disturbance index 5-29.99 events/hour by polysomnography), who presented either in the first trimester (gestational age, GA 0-16 weeks) or subsequently developed OSA during the 2nd trimester (GA 24-28 weeks). The primary endpoint was blood pressure during antenatal care. Secondary endpoints included the incidence of preeclampsia. An intention-to-treat analysis was performed with additional per-protocol and counterfactual analyses for handling of nonadherence. RESULTS: Of 340 participants, 96.5% were recruited during the first trimester. Thirty participants were later excluded leaving 153 and 157 participants in the CPAP and usual-care groups for the modified-intention-to-treat analysis. CPAP adherence rate was 32.7% with average use of 2.5 h/night. Overall, CPAP treatment significantly lowered diastolic blood pressure (DBP) by - 2.2 mmHg [95% CI (- 3.9, - 0.4), p = 0.014], representing approximately - 0.5 mmHg per hour of CPAP use [95%CI (- 0.89, - 0.10), p = 0.013]. CPAP treatment also altered the blood pressure trajectory by continuously lowering DBP throughout pregnancy with mean differences (95% CI) of - 3.09 (- 5.34, - 0.93), - 3.49 (- 5.67, - 1.31) and - 3.03 (- 5.20, - 0.85) mmHg at GA 18-20, 24-28, and 32-34 weeks, respectively compared to 0-16 weeks. Preeclampsia rate was 13.1% (20/153 participants) in the CPAP and 22.3% (35/157 participants) in the usual-care group with a risk difference (95% CI) of - 9% (- 18%, - 1%, p-value = 0.032) and a number-needed-to-treat (95% CI) of 11 (1, 21). CONCLUSIONS: CPAP treatment in women with even mild-to-moderate OSA and high-risk pregnancy demonstrated reductions in both DBP and the incidence of preeclampsia. CPAP treatment also demonstrated a sustained reduction in DBP throughout gestation. Trial registration ClinicalTrial.GovNCT03356106, retrospectively registered November 29, 2017.

Evaluation of the Effectiveness of Behavioral Economic Incentive Programs for Goal Achievement on Healthy Diet, Weight Control and Physical Activity: A Systematic Review and Network Meta-analysis.

BACKGROUND: Healthy diet, weight control and physical activity to reduce obesity can be motivated by financial incentives (FI). Behavioral-economic approaches may improve the incentivization effectiveness. This study compares and ranks the effectiveness of standard and behavioral incentivization for healthy diet, weight control, and physical activity promotion. PURPOSE: To investigate whether behavioral-economic insights improve incentivization effectiveness. METHODS: A systematic search of Medline and Scopus was performed from database inception to December 2020. Study characteristics, program designs, and risk ratio (RR) were extracted. A two-stage network meta-analysis pooled and ranked intervention effects. RESULTS: There were 35 eligible RCTs. For diet-weight control, standard FI, deposit contract (deposit), lottery-based incentive (lottery), and standard-FI + lottery increased goal achievement compared to no-FI but only deposit was statistically significant with pooled RRs and 95% confidence intervals (CI) of 1.21 (0.94, 1.56), 1.79 (1.04, 3.05), 1.45 (0.99, 2.13), and 1.73 (0.83, 3.63). For physical activity, standard-FI, deposit, and lottery significantly increased goal achievement compared to no-FI, with pooled RRs of 1.38 (1.13, 1.68), 1.63 (1.24, 2.14) and 1.43 (1.14, 1.80), respectively. In a follow-up period for physical activity, only deposit significantly increased goal achievement compared to no-FI, with pooled RRs of 1.39 (1.11, 1.73). CONCLUSION: Deposit, followed by lottery, were best for motivating healthy diet, weight control and physical activity at program end. Post-intervention, deposit then standard-FI were best for motivating physical activity. Behavioral insights can improve incentivization effectiveness, although lottery-based approaches may offer only short-term benefit regarding physical activity. However, the imprecise intervention effects were major concerns.

Healthy diet, weight control and physical activity to reduce obesity can be motivated by financial incentives (FI). Behavioral-economic approaches may improve the effectiveness of FI programs. This study aims to investigate whether behavioral-economic insights improve incentivization effectiveness for healthy diet, weight control, and physical activity promotion. We conducted a systematic review of published randomized controlled trials (RCTs), then pooled the interested results, compared and ranked the effectiveness of standard and behavioral incentivization programs by a two-stage network meta-analysis. There were 35 eligible RCTs. For diet-weight control, standard FI, deposit contract (deposit), lottery-based incentive (lottery), and standard-FI + lottery increased goal achievement compared to no-FI but only deposit was statistically significant. For physical activity, standard-FI, deposit, and lottery significantly increased goal achievement compared to no-FI. In a follow-up period for physical activity, only deposit significantly increased goal achievement compared to no-FI. In conclusion, deposit, followed by lottery, were best for motivating healthy diet, weight control and physical activity at program end. Post-intervention, deposit then standard-FI were best for motivating physical activity. This shows that behavioral insights can improve incentivization effectiveness, although lottery-based approaches may offer only short-term benefit regarding physical activity.

Pneumococcal Vaccination in Children: A Systematic Review and Meta-Analysis of Cost-Effectiveness Studies.

OBJECTIVES: Pneumococcal conjugate vaccines (PCVs) have significantly reduced disease burden caused by Streptococcus pneumoniae, a leading cause of childhood morbidity and mortality globally. This systematic review and meta-analysis aimed to assess the incremental net benefit (INB) of the 13-valent PCV (PCV13) and 10-valent PCV (PCV10) in children. METHODS: We performed a comprehensive search in several databases published before May 2022. Studies were included if they were cost-effectiveness or cost-utility analyses of PCV13 or PCV10 compared with no vaccination or with each other in children. Various monetary units were converted to purchasing power parity, adjusted to 2021 US dollars. The INBs were calculated and then pooled across studies stratified by country income level, perspective, and consideration of herd effects, using a random-effect model. RESULTS: Seventy studies were included. When herd effects were considered, PCV13 was cost-effective compared with PCV10 from the payer perspective in both high-income countries (HICs) (INB, $103.94; 95% confidence interval, $75.28-$132.60) and low- and middle-income countries (LMICs) (INB, $53.49; 95% confidence interval, $30.42-$76.55) with statistical significance. These findings were robust across a series of sensitivity analyses. PCV13 was cost-effective compared with no vaccination across perspectives and consideration of herd effects in both HICs and LMICs, whereas findings were less consistent for PCV10. CONCLUSION: PCVs were generally cost-effective compared with no vaccination in HICs and LMICs. Our study found that PCV13 was cost-effective compared with PCV10 when herd effects were considered from the payer perspective in both HICs and LMICs. The results are sensitive to the consideration of herd effects.

Cost-effectiveness analysis of isolation strategies for asymptomatic and mild symptom COVID-19 patients.

BACKGROUND: Management of COVID-19 patients with mild and moderate symptoms could be isolated at home isolation (HI), community isolation (CI) or hospitel. However, it was still unclear which strategy was more cost-effective. Therefore, this study was conducted to evaluate this. METHODS: This study used data from patients who initially stayed at HI, CI, and hospitel under supervision of Ramathibodi Hospital between April and October 2021. Outcomes of interest were hospitalisation and mortality. An incremental cost-effectiveness ratios (ICER) was calculated based on hospital perspective using home isolation as the reference. RESULTS: From 7,077 patients, 4,349 2,356, and 372 were admitted at hospitel, HI, and CI, respectively. Most patients were females (57.04%) and the mean age was 40.42 (SD = 16.15). Average durations of stay were 4.47, 3.35, and 3.91 days for HI, CI, and hospitel, respectively. The average cost per day for staying in these corresponding places were 24.22, 63.69, and 65.23 US$. For hospitalisation, the ICER for hospitel was at 41.93 US$ to avoid one hospitalisation in 1,000 patients when compared to HI, while CI had more cost, but less cases avoided. The ICER for hospitel and CI were at 46.21 and 866.17 US$ to avoid one death in 1,000 patients. CONCLUSIONS: HI may be cost-effective isolated strategy for preventing hospitalisation and death in developing countries with limited resources.

Incremental net monetary benefit of biologic therapies in moderate to severe asthma: a systematic review and meta-analysis of economic evaluation studies.

OBJECTIVES: This meta-analysis was conducted to quantitatively pool the incremental net benefit (INB) of using biologic therapies as an add-on treatment to standard therapy in patients with moderate to severe asthma. METHODS: We performed a comprehensive search in several databases published until April 2022. Studies were included if they were cost-effectiveness analyses reporting cost per quality-adjusted life-year or life-year on any biologic therapies as an add-on treatment for moderate to severe asthma in patients of all ages. Various monetary units were converted to purchasing power parity, adjusted to 2021 US dollars. The INBs were pooled across studies using a random-effects model, stratified by country income level (high-income countries (HICs) and low- and middle-income countries (LMICs)) and perspectives (health care or payer perspective (HCPP) and societal perspective (SP)) and age group (>12 years and 6-11 years). Heterogeneity was assessed using the I2 statistic. RESULTS: A total of 32 comparisons from 25 studies were included. Pooled INB indicated that the use of omalizumab as an add-on treatment to standard therapy in those aged >12 years was not cost-effective in HICs from the HCPP (n = 8, INB, -6,341 (95% CI, -$25,000 to $12,210), I2=86.18%) and SP (n = 5, -$14,000 (-$170,000 to $140,000), I2=75.64%). A similar finding was observed in those aged 6-11 years from the HCPP in LMICs (n = 2, -$45,000 (-$73,000 to $17,000), I2=00.00%). Subgroup analyses provided no explanations of the potential sources of heterogeneity. CONCLUSION: The use of biologic therapies in moderate to severe asthma is not cost-effective compared to standard treatment alone.

Optimizing the Yield of Abnormal Preoperative Chest Radiographs in Elective Non-cardiothoracic Surgery: Development of a Risk Prediction Score and External Validation.

BACKGROUND: Guideline recommendations for preoperative chest radiographs vary to the extent that individual patient benefit is unclear. We developed and validated a prediction score for abnormal preoperative chest radiographs in adult patients undergoing elective non-cardiothoracic surgery. METHODS: Our prospective observational study recruited 703 adult patients who underwent elective non-cardiothoracic surgery at Ramathibodi Hospital. We developed a risk prediction score for abnormal preoperative chest radiographs with external validation using data from 411 patients recruited from Thammasat University Hospital. The discriminative performance was assessed by receiver operating curve analysis. In addition, we assessed the contribution of abnormal chest radiographs to perioperative management. RESULTS: Abnormal preoperative chest radiographs were found in 19.5% of the 703 patients. Age, pulmonary disease, cardiac disease, and diabetes were significant factors. The model showed good performance with a C-statistics of 0.739 (95% CI, 0.691-0.786). We classified patients into four groups based on risk scores. The posttest probabilities in the intermediate-, intermediate-high-, and high-risk groups were 33.2%, 59.8%, and 75.7%, respectively. The model fitted well with the external validation data with a C statistic of 0.731 (95% CI, 0.674-0.789). One (0.4%) abnormal chest radiograph from the low-risk group and three (2.4%) abnormal chest radiographs from the intermediate-to-high-risk group had a major impact on perioperative management. CONCLUSIONS: Four predictors including age, pulmonary disease, cardiac disease, and diabetes were associated with abnormal preoperative chest radiographs. Our risk score demonstrated good performance and may help identify patients at higher risk of chest abnormalities.

Proteomic analysis investigating kidney transplantation outcomes- a scoping review.

BACKGROUND: Kidney transplantation is the optimal treatment option for most patients with end-stage kidney disease given the significantly lower morbidity and mortality rates compared to remaining on dialysis. Rejection and graft failure remain common in transplant recipients with limited improvement in long-term transplant outcomes despite therapeutic advances. There is an unmet need in the development of non-invasive biomarkers that specifically monitor graft function and predict transplant pathologies that affect outcomes. Despite the potential of proteomic investigatory approaches, up to now, no candidate biomarkers of sufficient sensitivity or specificity have translated into clinical use. The aim of this review was to collate and summarise protein findings and protein pathways implicated in the literature to date, and potentially flag putative biomarkers worth validating in independent patient cohorts. METHODS: This review followed the Joanna Briggs' Institute Methodology for a scoping review. MedlineALL, Embase, Web of Science Core Collection, Scopus and Google Scholar databases were searched from inception until December 2022. Abstract and full text review were undertaken independently by two reviewers. Data was collated using a pre-designed data extraction tool. RESULTS: One hundred one articles met the inclusion criteria. The majority were single-centre retrospective studies of small sample size. Mass spectrometry was the most used technique to evaluate differentially expressed proteins between diagnostic groups and studies identified various candidate biomarkers such as immune or structural proteins. DISCUSSION: Putative immune or structural protein candidate biomarkers have been identified using proteomic techniques in multiple sample types including urine, serum and fluid used to perfuse donor kidneys. The most consistent findings implicated proteins associated with tubular dysfunction and immunological regulatory pathways such as leukocyte trafficking. However, clinical translation and adoption of candidate biomarkers is limited, and these will require comprehensive evaluation in larger prospective, multicentre trials.

Rituximab for the treatment of relapsing-remitting multiple sclerosis in Thailand: an economic evaluation and budget impact analysis.

BACKGROUND: Multiple sclerosis is an inflammatory demyelination process in the central nervous system (CNS) causing neurological disability and poor quality of life. Currently, Thai Food and Drug Administration (FDA)-approved disease-modifying therapy is costly, and most patients with multiple sclerosis are ineligible for treatment in Thailand as previous studies have challenged its cost-effectiveness. Off-label use of rituximab is inexpensive and highly effective in treating multiple sclerosis, but evidence of its cost-effectiveness in Thailand is yet to be collected. METHODS: This study aimed to evaluate the cost-utility and budget impact of rituximab for multiple sclerosis treatment compared with best supportive care, the standard practice in Thailand to treat the disease. A Markov model with a one-month cycle length and lifetime horizon was applied to compare the costs and outcomes of rituximab and best supportive care based on a societal perspective. Accordingly, incremental cost-effectiveness ratios were estimated. Probabilistic and one-way sensitivity analyses were conducted to investigate parameter uncertainty. In addition, the Markov model was used to assess the 5-year budget impact from the government perspective. RESULTS: A rituximab biosimilar demonstrated higher effectiveness and lower associated costs, compared to best supportive care, with the highest probability of being cost-effective (96%). The probability of relapse was the most sensitive parameter according to the one-way sensitivity analysis. The calculated budget impact of treating patients with multiple sclerosis in Thailand was 26,360,000 Thai baht (THB) or 844,255 United States dollars (USD) in the first fiscal year, and approximately 20,810,000-23,080,000 THB (666,608-739,388 USD) in the next four fiscal years. CONCLUSION: In Thailand, a rituximab biosimilar would reduce the overall costs of multiple sclerosis treatment and should, therefore, be included in the National List of Essential Medicines.

Comparison of the immunogenicity of ChAdOx1 nCoV-19 vaccine against the wild-type and delta variants in kidney transplant recipients and healthy volunteers.

Little is known about immunogenicity after ChAdOx1 nCov-19 vaccination after transplantation. We assessed the vaccine response by antibody testing, surrogate neutralization test (sVNT) against wild-type (WT) and delta variant (DT), and T cell assay in 83 kidney transplant recipients (KTRs) and 52 healthy volunteers (HVs). For KTRs, a positive anti-RBD antibody was seen in 2.8% after one dose and 15.7% after two doses of the vaccine. After two doses, the positivity rate by sVNT was equal (4.9% each, for WT and DT) and was 13.4% by T cell response. Post two doses, KTRs had significantly lower geometric mean titer than HVs (1.93 [95% CI: 1.39-2.69] vs. 248.3 [95% CI: 203.7-302.6] BAU/ml, respectively, p < .001). Daily mycophenolate dose of ≥1000 mg significantly associated with negative seroconversion [risk ratio (RR) of 0.33, 95% CI: 0.15-0.72, p = .005]. Compared with cyclosporine, daily tacrolimus dose of ≤3 mg and >3 mg of tacrolimus significantly associated with negative seroconversion [RR = 0.38 (95% CI, 0.17-0.85, p = .018) and RR = 0.16 (95% CI, 0.37-0.73, p = .018)], respectively. The vaccine was safe and well-tolerated but the immune response after the two doses of ChAdOx1 nCov-19 vaccine in KTRs was very low.

Effects of second-line antihyperglycemic drugs on the risk of chronic kidney disease: applying a target trial approach to a hospital-based cohort of Thai patients with type 2 diabetes.

BACKGROUND: The reno-protective effect of second-line treatments in type 2 diabetes has been assessed by clinical trials but generalizability to routine clinical practice is still uncertain. We aimed to assess the effectiveness of these treatments, when added to metformin, on the risk of chronic kidney disease (CKD). METHODS: A real-world, hospital-based, type 2 diabetes cohort was retrospectively assembled at Ramathibodi Hospital from 2010 to 2019. Patients who received sulfonylureas (SU), thiazolidinediones (TZD), dipeptidyl peptidase-4 inhibitors (DPP4i), or sodium-glucose cotransporter-2 inhibitors (SGLT2i), as second-line antihyperglycemic treatment were included. Treatment effect models with inverse probability weighting and regression adjustment were used to estimate CKD risk according to treatment. RESULTS: CKD was identified in 4,132 of the 24,777 patients with type 2 diabetes (16.7%). The CKD incidence (95% CI) was 4.1% (2.2%, 6.9%), 13.5% (12.5%, 14.6%), 14.8% (13.5%, 16.1%), and 18.0% (17.4%, 18.5%) for patients receiving SGLT2i, DPP4i, TZD, and SU treatment, respectively. The average treatment effects (i.e., the difference in CKD risk) for SGLT2i, DPP4i, and TZD compared to SU were - 0.142 (- 0.167, - 0.116), - 0.046 (- 0.059, - 0.034), and - 0.004 (- 0.023, 0.014), respectively, indicating a significant reduction in CKD risk of 14.2% and 4.6% in the SGLT2i and DPP4i groups, respectively, compared to the SU group. Furthermore, SGLT2i significantly reduced CKD risk by 13.7% (10.6%, 16.8%) and 9.5% (6.8%, 12.2%) when compared to TZD and DPP4i, respectively. CONCLUSIONS: Our study identified 14.2%, 13.7%, and 9.5% reduced CKD risk in Thai patients with type 2 diabetes who were treated with SGLT2i compared to those treated with SU, TZD, and DPP4i, respectively, in real-world clinical data. Previous evidence of a reno-protective effect of SGLT2i reported in other populations is consistent with our observations in this Southeast Asian cohort.

Comparative efficacy and safety of pharmacologic interventions to prevent mother-to-child transmission of hepatitis B virus: a systematic review and network meta-analysis.

OBJECTIVE: This study investigated the efficacy and safety of pharmacologic interventions to prevent vertical transmission of the hepatitis B virus. DATA SOURCES: Medline, Cochrane, and Scopus databases were searched up to October 28, 2020. STUDY ELIGIBILITY CRITERIA: All randomized controlled trials reporting vertical hepatitis B virus transmission with pharmacologic intervention were included. METHODS: Risk of bias was assessed using the Cochrane Risk-of-Bias tool, version 2. Treatment efficacy was estimated using stratified network meta-analysis on the basis of maternal hepatitis B envelope antigen status. RESULTS: Nineteen studies were included for mothers positive for hepatitis B surface and envelope antigens. Pooling indicated that a combination of hepatitis B vaccination and hepatitis B immunoglobulin in infants significantly reduced transmission risk compared with vaccination alone, with a risk ratio of 0.52 (95% confidence interval; 0.30-0.91). Only the addition of maternal tenofovir disoproxil fumarate, but not telbivudine, lamivudine, or maternal hepatitis B immunoglobulin further reduced transmission risk compared with a combination of hepatitis B vaccination and hepatitis B immunoglobulin in infants, with a pooled risk ratio of 0.10 (0.03-0.35). Twelve studies conducted in mothers with hepatitis B surface antigen positivity and mixed, unknown, or negative hepatitis B envelope antigen status provided limited evidence to suggest that maternal hepatitis B immunoglobulin combined with hepatitis B vaccination and immunoglobulin in infants was the likely best treatment, but this failed to reach statistical significance compared with a combination of hepatitis B vaccination and immunoglobulin in infants. Similarly, infant hepatitis B immunoglobulin, added to vaccination, likely provides additional benefit but failed to reach statistical significance. CONCLUSION: A combination of hepatitis B vaccination and immunoglobulin in infants is the cornerstone for prevention of vertical transmission for mothers positive for both hepatitis B surface and envelope antigens. The addition of maternal tenofovir to this infant combination regimen was considered the likely most effective treatment. For infants of mothers with hepatitis B surface antigen positivity and mixed, unknown, or negative hepatitis B envelop antigen status, no additional agents provided further benefit beyond hepatitis B vaccination alone.

Patient Characteristics, Procedural Details, and Outcomes of Contemporary Percutaneous Coronary Intervention in Real-World Practice: Insights from Nationwide Thai PCI Registry.

Background: Percutaneous coronary intervention (PCI) practice and outcomes vary substantially in different parts of the world. The contemporary data of PCI in Asia are limited and only available from developed Asian countries. Objectives: To explore the pattern of practice and results of PCI procedures in Thailand as well as a temporal change of PCI practice over time compared with the registry from other countries. Methods: Thai PCI Registry is a prospective nationwide registry that was an initiative of the Cardiac Intervention Association of Thailand (CIAT). All cardiac catheterization laboratories in Thailand were invited to participate during 2018-2019, and consecutive PCI patients were enrolled and followed up for 1 year. Patient baseline characteristics, procedural details, equipment and medication use, outcomes, and complications were recorded. Results: Among the 39 hospitals participated, there were 22,741 patients included in this registry. Their mean age (standard deviation) was 64.2 (11.7) years and about 70% were males. The most common presentation was acute coronary syndrome (57%) with a high proportion of ST-elevation myocardial infarction (28%). Nearly two-thirds of patients had multivessel disease and significant left main stenosis was reported in 11%. The transradial approach was used in 44.2%. The procedural success rate was very high (95.2%) despite the high complexity of the lesions (56.9% type C lesion). The incidence of procedural complications was 5.3% and in-hospital mortality was 2.8%. Conclusion: Thai PCI Registry provides further insights into the current practice and outcomes of PCI in Southeast Asia. The success rate was very high, and the complications were very low despite the high complexity of the treated lesions.

Fascial Dehiscence and Incisional Hernia Prediction Models: A Systematic Review and Meta-analysis.

BACKGROUND: Fascial dehiscence (FD) and incisional hernia (IH) pose considerable risks to patients who undergo abdominal surgery, and many preventive strategies have been applied to reduce this risk. An accurate predictive model could aid identification of high-risk patients, who could be targeted for particular care. This study aims to systematically review existing FD and IH prediction models. METHODS: Prediction models were identified using pre-specified search terms on SCOPUS, PubMed, and Web of Science. Eligible studies included those conducted in adult patients who underwent any kind of abdominal surgery, and reported model performance. Data from the eligible studies were extracted, and the risk of bias (RoB) was assessed using the PROBAST tool. Pooling of C-statistics was performed using a random-effect meta-analysis. [Registration: PROSPERO (CRD42021282463)]. RESULTS: Twelve studies were eligible for review; five were FD prediction model studies. Most included studies had high RoB, especially in the analysis domain. The C-statistics of the FD and IH prediction models ranged from 0.69 to 0.92, but most have yet to be externally validated. Pooled C-statistics (95% CI) were 0.80 (0.74, 0.86) and 0.81 (0.75, 0.86) for the FD (external-validation) and IH prediction model, respectively. Some predictive factors such as body mass index, smoking, emergency operation, and surgical site infection were associated with FD or IH occurrence and were included in multiple models. CONCLUSIONS: Several models have been developed as an aid for FD and IH prediction, mostly with modest performance and lacking independent validation. New models for specific patient groups may offer clinical utility.

Economic evaluation of hepatitis A vaccines by income level of the country: A systematic review.

Background & objectives: Although several reviews of economic evaluation (EE) studies on hepatitis A virus (HAV) vaccine exist, there remains a need to corroborate such data from time to time. This study aimed to systematically review the literature for reports on EE of HAV vaccination by type of population, characteristics of intervention and income level of the country. Methods: PubMed and Scopus were searched to identify relevant studies from inception up to May 2021 using topic-specific key words in various combinaiton. Full EE studies comparing HAV vaccination to no vaccine or immunoglobulin were included. The risk of bias was assessed by using the ECOBIAS checklist. Results: Among the 1984 identified studies, 43 were found eligible. Of these, 27 were from high-income countries (HICs), 15 from middle-income countries (MICs), and one from low income country. Majority of the studies used Markov model and/or decision tree (n=26). Eight studies used a dynamic model. The discount rate, perspective and time horizon varied across the studies. Universal HAV vaccination without screening was cost-effective among children (14/16, 87.5%) and adolescents (1/5, 20%) but not in adults (0/4, 0%). Analysis by the level of income found that universal HAV vaccination among children without screening was cost-effective in 81.8 per cent of the studies conducted in MICs (9/11) as compared to 66.7 per cent in HICs (4/6). About one-third of the studies conducted among children found that screening and HAV vaccination were cost-effective compared to no vaccination. Interpretation & conclusions: The finding of this review suggest that universal vaccination of children without screening was likely to be cost-effective, especially in MICs. Nevertheless, it should be noted that the methodology varied across studies. Several aspects should also be considered in transferring the EE results across jurisdictions.

Efficacy and safety of urate-lowering agents in asymptomatic hyperuricemia: systematic review and network meta-analysis of randomized controlled trials.

BACKGROUND: Asymptomatic hyperuricemia was found to be associated with increased cardiovascular disease risk but the potential benefits of urate-lowering therapy (ULT) remain controversial. We conducted a systematic review and network meta-analysis (NMA) with frequentist model to estimate the efficacy and safety of ULT in asymptomatic hyperuricemia. METHODS: MEDLINE, Embase, and Scopus were searched without language restrictions. Randomized controlled trials (RCT) of adults with asymptomatic hyperuricemia were eligible if they compared any pair of ULTs (i.e., allopurinol, febuxostat, probenecid, benzbromarone, sulfinpyrazone, rasburicase, lesinurad, and topiroxostat) and placebo or no ULT, and had outcomes of interest, including composite renal events, major adverse cardiovascular events, serum urate levels, estimated glomerular filtration rate (eGFR), systolic blood pressure, and adverse events. RESULTS: NMA with frequentist approach was applied to estimate relative treatment effects, i.e., risk ratio (RR) and mean difference (MD). A total of 23 RCTs were eligible. NMA identified beneficial effects of ULT on composite renal events and eGFR but not for other outcomes. Allopurinol and febuxostat had significantly lower composite renal events than placebo (RR 0.39, 95% confidence interval [CI] 0.23 to 0.66, and RR 0.68, 95% CI 0.46 to 0.99, respectively). Both treatments also resulted in significantly higher eGFR than placebo (MD 3.69 ml/min/1.73 m2, 95% CI 1.31 to 6.08, and MD 2.89 ml/min/1.73 m2, 95% CI 0.69 to 5.09, respectively). No evidence of inconsistency was identified. CONCLUSIONS: Evidence suggests that allopurinol and febuxostat are the ULTs of choice in reducing composite renal events and improving renal function. TRIAL REGISTRATION: This study was registered with PROSPERO: CRD42019145908. The date of the first registration was 12th November 2019.

Meta-analysis of economic evaluation studies: data harmonisation and methodological issues.

BACKGROUND: In the context of ever-growing health expenditure and limited resources, economic evaluations aid in making evidence-informed policy decisions. Cost-utility analysis (CUA) is often used, and CUA data synthesis is also desirable, but methodological issues are challenged. Hence, we aim to provide a step-by-step process to prepare the CUA data for meta-analysis. METHODS: Data harmonisation methods were constructed specifically considering CUA methodology, including inconsistent reports, economic parameters, heterogeneity (i.e., country's income, time horizon, perspective, modelling approaches, currency, willingness to pay). An incremental net benefit (INB) and its variance were estimated and pooled across studies using a basic meta-analysis by COMER. RESULTS: Five scenarios show how to obtain INB and variance with various reported data: Study reports the mean and variance (Scenario 1) or 95% confidence interval (Scenario 2) of ΔC, ΔE, and ICER for INB/variance calculations. Scenario 3: ΔC, ΔE, and variances are available, but not for the ICER; a Monte Carlo was used to simulate ΔC and ΔE data, variance and covariance can be then estimated leading INB calculation. Scenario-4: Only the CE plane was available, ΔC and ΔE data can be extracted; means of ΔC, ΔE, and variance/covariance can be estimated accordingly, leading to INB/variance estimates. Scenario-5: Only mean cost/outcomes and ICER are available but not for variance and the CE-plane. A variance INB can be borrowed from other studies which are similar characteristics, including country income, ICERs, intervention-comparator, time period, country region, and model type and inputs (i.e., discounting, time horizon). CONCLUSION: Out data harmonisation and meta-analytic methods should be useful for researchers for the synthesis of economic evidence to aid policymakers in decision making.

Cost-effectiveness analysis of mesh fixation techniques for laparoscopic and open inguinal hernia surgeries.

PURPOSE: This study reports economic evaluation of mesh fixation in open and laparoscopic hernia repair from a prospective real-world cohort study, using cost-effectiveness analysis (CEA) and cost-utility analysis (CUA). METHODS: A prospective real-world cohort study was conducted in two university-based hospitals in Thailand from November 2018 to 2019. Patient data on hernia features, operative approaches, clinical outcomes, associated cost data, and quality of life were collected. Models were used to determine each group's treatment effect, potential outcome means, and average treatment effects. An incremental cost-effectiveness ratio was used to evaluate the incremental risk of hernia recurrences. RESULTS: The 261 patients in this study were divided into six groups: laparoscopic with tack (LT, n = 47), glue (LG, n = 26), and self-gripping mesh (LSG, n = 30), and open with suture (OS, n = 117), glue (OG, n = 18), and self-gripping mesh (OSG, n = 23). Hernia recurrence was most common in LSG. The mean utility score was highest in OG and OSG (both 0.99). Treatment costs were generally higher for laparoscopic than open procedures. The cost-effectiveness plane for utility and hernia recurrence identified LSG as least cost effective. Cost-effectiveness acceptability curves identified OG as having the highest probability of being cost effective at willingness to pay levels between $0 and $3,300, followed by OSG. CONCLUSION: Given the similarity of hernia recurrence among all major procedures, the cost of surgery may impact the decision. According to our findings, open hernia repair with adhesive or self-gripping mesh appears most cost-effective.

Economic evaluation of peritoneal dialysis and hemodialysis in Thai population with End-stage Kidney Disease.

BACKGROUND: This study aimed to conduct a cost-utility analysis of the "Peritoneal Dialysis (PD)-First" policy in 2008 under a universal health coverage scheme and hemodialysis (HD) in Thai patients with End-stage Kidney Disease (ESKD) using updated real-practice data. METHODS: Markov model was used to evaluate the cost-utility of two modalities, stratified into five age groups based on the first modality taken at 20, 30, 40, 50, and 60 years old from government and societal perspectives. Input parameters related to clinical aspects and cost were obtained from 15 hospitals throughout Thailand and Thai Renal Replacement Therapy databases. Both costs and outcomes were discounted at 3%, adjusted to 2021, and converted to USD (1 USD = 33.57 Thai Baht). One-way analysis and probabilistic sensitivity analysis were performed to assess the uncertainty surrounding model parameters. RESULTS: From the government perspective, compared to PD-first policy, the incremental cost-effectiveness ratio (ICER) was between 19,434 and 23,796 USD per QALY. Conversely, from a societal perspective, the ICER was between 31,913 and 39,912 USD per QALY. Both are higher than the willingness to pay threshold of 4,766 USD per QALY. CONCLUSION: By applying the updated real-practice data, PD-first policy still remains more cost-effective than HD-first policy at the current willingness to pay. However, HD gained more quality-adjusted life years than PD. This information will assist clinicians and policymakers in determining the future direction of dialysis modality selection and kidney replacement therapy reimbursement policies for ESKD patients.