Cost-Effectiveness and Clinical Outcomes of Lateral Lumbar Interbody Fusion With Tricalcium Phosphate and Iliac Bone Graft Compared With Posterior Lumbar Interbody Fusion With Local Bone Graft in Single-Level Lumbar Spinal Fusion Surgery in Thailand.

BACKGROUND: Nowadays, minimally invasive lateral lumbar interbody fusion (LLIF) is used to treat degenerative lumbar spine disease. Many studies have proven that LLIF results in less soft tissue destruction and rapid recovery compared with open posterior lumbar interbody fusion (PLIF). Our recent cost-utility study demonstrated that LLIF was not cost-effective according to the Thai willingness-to-pay threshold, primarily due to the utilization of an expensive bone substitute: bone morphogenetic protein 2. Therefore, this study was designed to use less expensive tricalcium phosphate combined with iliac bone graft (TCP + IBG) as a bone substitute and compare cost-utility analysis and clinical outcomes of PLIF in Thailand. METHODS: All clinical and radiographic outcomes of patients who underwent single-level LLIF using TCP + IBG and PLIF were retrospectively collected. Preoperative and 2-year follow-up quality of life from EuroQol-5 Dimensions-5 Levels and health care cost were reviewed. A cost-utility analysis was conducted using a Markov model with a lifetime horizon and a societal perspective. RESULTS: All enrolled patients were categorized into an LLIF group (n = 30) and a PLIF group (n = 50). All radiographic results (lumbar lordosis, foraminal height, and disc height) were improved at 2 years of follow-up in both groups (P < 0.001); however, the LLIF group had a dramatic significant improvement in all radiographic parameters compared with the PLIF group (P < 0.05). The fusion rate for LLIF (83.3%) and PLIF (84%) was similar and had no statistical significance. All health-related quality of life (Oswestry Disability Index, utility, and EuroQol Visual Analog Scale) significantly improved compared with preoperative scores (P < 0.001), but there were no significant differences between the LLIF and PLIF groups (P > 0.05). The total lifetime cost of LLIF was less than that of PLIF (15,355 vs 16,500 USD). Compared with PLIF, LLIF was cost-effective according to the Thai willingness-to-pay threshold, with a net monetary benefit of 539.76 USD. CONCLUSION: LLIF with TCP + IBG demonstrated excellent radiographic and comparable clinical health-related outcomes compared with PLIF. In economic evaluation, the total lifetime cost was lower in LLIF with TCP + IBG than in PLIF. Furthermore, LLIF with TCP + IBG was cost-effective compared with PLIF according to the context of Thailand. CLINICAL RELEVANCE: LLIF with less expensive TCP + IBG as bone graft results in better clinical and radiographic outcomes, less lifetime cost, and cost-effectiveness compared with PLIF. This suggests that LLIF with TCP + IBG could be utilized in lower- and middle-income countries for treating patients with degenerative disc disease.

Health-related quality of life in Thai patients with chronic hepatitis B.

Background: Chronic hepatitis B (CHB) significantly impacts the health-related quality of life (HRQoL), but remains underexplored in the Thai population. Health state utilities (HSU) are indicators reflecting HRQoL which serve as fundamental inputs for economic evaluation analyses. This study aimed at assessing differences in HRQoL across five CHB stages in Thai patients, including non-cirrhotic CHB, compensated cirrhosis, decompensated cirrhosis, early-/intermediate-stage hepatocellular carcinoma (HCC) and advanced-/terminal-stage HCC. Methods: We conducted a cross-sectional study to collect HRQoL data from patients with CHB at five stages. The study included patients with CHB who were followed up at a super-tertiary care centre between March 2021 and February 2022. The participants completed the EQ-5D-5L questionnaire and provided demographic data. Disease stage and relevant data were obtained from medical records. HSU and Euroqol-visual analogue scale (EQ-VAS) scores, calculated using Thai-specific conversion coefficients, were assessed. Results: Among 422 patients, 236 did not have cirrhosis, 92 had compensated cirrhosis, 13 had decompensated cirrhosis, 55 had early-/intermediate-stage HCC, and 26 had advanced-/terminal-stage HCC. The HSU scores for non-cirrhotic, compensated cirrhosis, decompensated cirrhosis, early-/intermediate-stage HCC and advanced-/terminal-stage HCC were 0.95 ± 0.08, 0.89 ± 0.16, 0.79 ± 0.19, 0.89 ± 0.12 and 0.52 ± 0.39, respectively. Similarly, the EQ-VAS scores for various CHB stages were 83.56 ± 12.90, 80.48 ± 13.03, 68.76 ± 17.40, 79.00 ± 14.38 and 62.92 ± 20.62, respectively. A significant correlation (r = 0.469, P < 0.001) was observed between the HSU and EQ-VAS scores. The disease progression led to a notable HSU decline, particularly in the advanced-/terminal-stage HCC group (regression coefficient: -0.436, P < 0.001). The EQ-VAS scores indicated reduced quality of life in advanced liver disease. Conclusions: Later CHB stages compromise the HRQoL. Decompensated cirrhosis and advanced-/terminal-stage HCC profoundly affect physical health and quality of life, whereas patients with compensated cirrhosis and early-/intermediate-stage HCC report better HRQoL.

Beverage consumption in patients with metabolic syndrome and its association with non-alcoholic fatty liver disease: a cross-sectional study.

Introduction: Previous research has examined the association between coffee and tea consumption and non-alcoholic fatty liver disease (NAFLD). Preclinical studies have indicated the potential hepatoprotective properties of cocoa/chocolate. However, clinical research on the consumption of cocoa/chocolate and soft drinks and their relation to NAFLD, particularly among individuals with metabolic syndrome, is limited. This study primarily aimed to assess the association between beverage consumption and NAFLD in these patients. Methods: This cross-sectional study enrolled adult patients with metabolic syndrome visited the Medicine Outpatient Department at Siriraj Hospital, Thailand, from November 2011 to January 2013. The exclusion criteria were secondary causes of hepatic steatosis, such as excessive alcohol use, viral hepatitis, or drug-induced hepatitis. Participants completed a 23-item self-administered questionnaire covering their beverage consumption habits, including type, frequency, volume, duration, and additives in drinks, namely, coffee, tea, cocoa/chocolate, and soft drinks. To ensure accurate responses, these questionnaires were supplemented by face-to-face interviews. Ultrasonography was employed early in the methodology to diagnose NAFLD. Univariable analyses were used to compare the beverage consumption behaviors of participants with and without NAFLD. Multivariable logistic regression was used to adjust for potential confounders, including total beverage energy intake, age, anthropometric data, laboratory results, and comorbidities. Results: This study included 505 patients with metabolic syndrome. Of these, 341 (67.5%, 95%CI: 63.2-71.6%) were diagnosed with NAFLD. The consumption rates of coffee, cocoa/chocolate, and soft drinks were similar between the two groups. However, tea consumption was significantly more common in patients with NAFLD (68.3% vs. 51.8%, p < 0.001). The groups had no significant differences in caffeine intake or total energy intake from beverages. Notably, daily intake of three or more cups of coffee was correlated with a reduced prevalence of NAFLD, with an adjusted odds ratio of 0.35 (95%CI: 0.14-0.89). Conclusion: This study revealed that patients with metabolic syndrome, irrespective of NAFLD status, exhibited similar patterns of beverage consumption. While no definitive associations were identified between the intake of coffee, tea, cocoa/chocolate, or soft drinks and NAFLD, a notable exception was observed. A higher consumption of coffee (≥3 cups daily) was associated with a lower prevalence of NAFLD.

Effect of Laser and Energy-based Device Therapies to Minimize Surgical Scar Formation: A Systematic Review and Network Meta-analysis.

Utilization of lasers and energy-based devices for surgical scar minimization has been substantially evaluated in placebo-controlled trials. The aim of this study was to compare reported measures of efficacy of lasers and energy-based devices in clinical trials in preventing surgical scar formation in a systematic review and network meta-analyses. Five electronic databases, PubMed, Scopus, Embase, ClinicalTrials.gov, and the Cochrane Library, were searched to retrieve relevant articles. The search was limited to randomized controlled trials that reported on clinical outcomes of surgical scars with treatment initiation no later than 6 months after surgery and a follow-up period of at least 3 months. A total of 18 randomized controlled trials involving 482 participants and 671 postsurgical wounds were included in the network meta-analyses. The results showed that the most efficacious treatments were achieved using low-level laser therapy) (weighted mean difference -3.78; 95% confidence interval (95% CI) -6.32, -1.24) and pulsed dye laser (weighted mean difference -2.46; 95% CI -4.53, -0.38). Nevertheless, low-level laser therapy and pulsed dye laser demonstrated comparable outcomes in surgical scar minimization (weighted mean difference -1.32, 95% CI -3.53, 0.89). The findings of this network meta-analyses suggest that low-level laser therapy and pulsed dye laser are both effective treatments for minimization of scar formation following primary closure of surgical wounds with comparable treatment outcomes.

Cost-utility and budget impact analyses of cervical cancer screening using self-collected samples for HPV DNA testing in Thailand.

INTRODUCTION: Cervical cancer ranks as the third most prevalent cancer among women in Thailand. However, the effectiveness of cervical cancer screening programs is limited by several factors that impede the screening rate. The utilization of self-collected samples for screening purposes has the potential to alleviate barriers to screening in Thai women. This study assessed the cost-utility and budget impact of implementing cervical cancer screening using self-collected samples for human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing in Thailand. MATERIALS AND METHODS: We employed a decision tree integrated with a Markov model to estimate the lifetime costs and health benefits associated with the cervical cancer screening program for women aged 25-65. The analysis was conducted from a societal perspective. Four screening policy options were compared: (1) additional self-collected samples for HPV DNA testing, (2) clinician-collected samples for HPV DNA testing only, (3) clinician-collected samples for cytology test (i.e., status quo), and (4) no screening. The model inputs were based on unvaccinated women. The screening strategies and management in those with positive results were assumed followed to the Thai clinical practice guideline. Costs were reported in 2022 Thai baht. Sensitivity analyses were conducted. The ten-year budget impacts of the additional self-collected samples for HPV DNA testing were calculated from a payer perspective. RESULTS: All screening policies were cost-saving compared to no screening. When comparing the additional self-collected samples for HPV DNA testing with the clinician-collected samples policy, it emerged as the dominant strategy. The incremental benefit in cervical cancer prevention achieved by incorporating self-collected samples for screening was observed at any additional screening rate that could be achieved through their use. Sensitivity analyses yielded consistently favorable results for the screening policies. The average annual budget impact of the additional self-collected samples for screening policy amounted to 681 million Thai baht. This budget allocation could facilitate cervical cancer screening for over 10 million women. CONCLUSIONS: An addition of self-collected samples for HPV DNA testing into the cervical cancer screening program is cost-saving. The benefits of this screening policy outweigh the associated incremental costs. Policymakers should consider this evidence during the policy optimization process.

Clinical Predictive Score for Identifying Metabolic Dysfunction-Associated Steatotic Liver Disease in Individuals with Prediabetes Using Transient Elastography.

Scoring systems for metabolic dysfunction-associated steatotic liver disease (MASLD) in individuals with prediabetes have not been extensively explored. This study aimed to investigate the prevalence of MASLD and to develop predictive tools for its detection in high cardiometabolic people with prediabetes. A cross-sectional study was conducted using baseline data from the prediabetes cohort. All participants underwent transient elastography to assess liver stiffness. MASLD was defined using a controlled attenuation parameter value > 275 dB/m and/or a liver stiffness measurement ≥ 7.0 kPa. Cases with secondary causes of hepatic steatosis were excluded. Out of 400 participants, 375 were included. The observed prevalence of MASLD in individuals with prediabetes was 35.7%. The most effective predictive model included FPG ≥ 110 mg/dL; HbA1c ≥ 6.0%; sex-specific cutoffs for HDL; ALT ≥ 30 IU/L; and BMI levels. This model demonstrated good predictive performance with an AUC of 0.80 (95% CI 0.73-0.86). At a cutoff value of 4.5, the sensitivity was 70.7%, the specificity was 72.3%, the PPV was 58.8%, and the NPV was 81.5%. Our predictive model is practical, easy to use, and relies on common parameters. The scoring system should aid clinicians in determining when further investigations of MASLD are warranted among individuals with prediabetes, especially in settings with limited resources.

Cost-Utility and Budget Impact Analyses of Oral Chemotherapy for Stage III Colorectal Cancer: Real-World Evidence after Policy Implementation in Thailand.

This study conducted a cost-utility analysis and a budget impact analysis (BIA) of outpatient oral chemotherapy versus inpatient intravenous chemotherapy for stage III colorectal cancer (CRC) in Thailand. A Markov model was constructed to estimate the lifetime cost and health outcomes based on a societal perspective. Eight chemotherapy strategies were compared. Clinical and cost data on adjuvant chemotherapy were collected from the medical records of 1747 patients at Siriraj Hospital, Thailand. The cost-effectiveness results were interpreted against a Thai willingness-to-pay threshold of USD 5003/quality-adjusted life year (QALY) gained. A 5-year BIA was performed. Of the eight strategies, CAPOX then FOLFIRI yielded the highest life-year and QALY gains. Its total lifetime cost was also the highest. An incremental cost-effectiveness ratio of CAPOX then FOLFIRI compared to 5FU/LV then FOLFOX, a commonly used regimen USD was 4258 per QALY gained.The BIA showed that when generic drug prices were applied, 5-FU/LV then FOLFOX had the smallest budgetary impact (USD 9.1 million). CAPOX then FOLFIRI required an approximately three times higher budgetary level (USD 25.1 million). CAPOX then FOLFIRI is the best option. It is cost-effective compared with 5-FU/LV then FOLFOX. However, policymakers should consider the relatively high budgetary burden of the CAPOX then FOLFIRI regimen.

Dynamics of colorectal cancer screening in low and middle-income countries: A modeling analysis from Thailand.

BACKGROUND: Low and middle-income countries face constraints for early colorectal cancer (CRC) detection, including restricted access to care and low colonoscopy capacity. Considering these constraints, we studied strategies for increasing access to early CRC detection and reducing CRC progression and mortality rates in Thailand. METHODS: We developed a system dynamics model to simulate CRC death and progression trends. We analyzed the impacts of increased access to screening via fecal immunochemical test and colonoscopy, improving access to CRC diagnosis among symptomatic individuals, and their combination. RESULTS: Projecting the status quo (2023-2032), deaths per 100K people increase from 87.5 to 115.4, and CRC progressions per 100K people rise from 131.8 to 159.8. In 2032, improved screening access prevents 2.5 CRC deaths and 2.5 progressions per 100K people, with cumulative prevented 7K deaths and 9K progressions, respectively. Improved symptom evaluation access prevents 7.5 CRC deaths per 100K with no effect on progression, totaling 35K saved lives. A combined approach prevents 9.3 deaths and 1.8 progressions per 100K, or 41K and 7K cumulatively. The combined strategy prevents most deaths; however, there is a tradeoff: It prevents fewer CRC progressions than screening access improvement. Increasing the current annual colonoscopy capacity (200K) to sufficient capacity (681K), the combined strategy achieves the best results, preventing 15.0 CRC deaths and 10.3 CRC progressions per 100K people, or 54K and 30K cumulatively. CONCLUSION: Until colonoscopy capacity increases, enhanced screening and symptom evaluation are needed simultaneously to curb CRC deaths, albeit not the best strategy for CRC progression prevention.

Curcumin and proton pump inhibitors for functional dyspepsia: a randomised, double blind controlled trial.

OBJECTIVE: To compare the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia. DESIGN: Randomised, double blind controlled trial, with central randomisation. SETTING: Thai traditional medicine hospital, district hospital, and university hospitals in Thailand. PARTICIPANTS: Participants with a diagnosis of functional dyspepsia. INTERVENTIONS: The interventions were curcumin alone (C), omeprazole alone (O), or curcumin plus omeprazole (C+O). Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days. MAIN OUTCOME MEASURES: Functional dyspepsia symptoms on days 28 and 56 were assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events. RESULTS: 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (-4.83, -5.46 and -6.22), non-pain (-2.22, -2.32 and -2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (-7.19, -8.07 and -8.85), non-pain (-4.09, -4.12 and -3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred. CONCLUSION: Curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect. TRIAL REGISTRATION NUMBER: TCTR20221208003.

Chlorogenic acid in green bean coffee on body weight: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Supplemental green bean coffee extract (GBCE) with caffeine has been shown to prevent weight gain. There are different dosages of GBCE that contain chlorogenic acid (CGA), and the data for their effectiveness in preventing weight gain (500 mg/day) is currently out of date. To better understand the effects of GBCE containing CGA on body weight, the present study sets out to perform a systematic review and meta-analysis of these studies. METHODS: Using electronic databases, including Scopus, Embase, PubMed, and Cochrane Library databases, literature was searched up to October 13, 2022. For the meta-analysis examining the impact of GBCE containing CGA (500 mg/day) on body weight with a random-effects model, the randomized controlled trials (RCTs) were considered. We calculated weighted mean differences and 95% confidence intervals (CIs). To gauge study heterogeneity, the Cochran Q statistic and I-squared tests (I2) were employed. RESULTS: The meta-analysis includes three RCTs with 103 individuals (case = 51, control = 52). The combined findings of GBCE with CGA at least 500 mg/day result in body weight reduction (WMD: - 1.30 and 95% CI: - 2.07 to - 0.52, p = 0.001) without study heterogeneity (I2 = 0%, p = 0.904) and without publication bias estimated using Egger's and Begger's test (p = 0.752 and p = 0.602, respectively). CONCLUSIONS: According to the meta-analysis, GBCE with CGA 500 mg/day lowers body weight. Nevertheless, despite its limited sample size and short-term study, this study was successful. Long-term research on the effectiveness and safety of GBCE and CGA on body weight require more clinical trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021254916.

Long-term multiple metabolic abnormalities among healthy and high-risk people following nonsevere COVID-19.

Few studies have identified the metabolic consequences of the post-acute phase of nonsevere COVID-19. This prospective study examined metabolic outcomes and associated factors in nonsevere, RT-PCR-confirmed COVID-19. The participants' metabolic parameters, the prevalence of long-term multiple metabolic abnormalities (≥ 2 components), and factors influencing the prevalence were assessed at 1, 3, and 6 months post-onset. Six hundred individuals (mean age 45.5 ± 14.5 years, 61.7% female, 38% high-risk individuals) with nonsevere COVID-19 attended at least one follow-up visit. The prevalence of worsening metabolic abnormalities was 26.0% for BMI, 43.2% for glucose, 40.5% for LDL-c, 19.1% for liver, and 14.8% for C-reactive protein. Except for lipids, metabolic-component abnormalities were more prevalent in high-risk hosts than in healthy individuals. The prevalence of multiple metabolic abnormalities at the 6-month follow-up was 41.3% and significantly higher in high-risk than healthy hosts (49.2% vs 36.5%; P = 0.007). Factors independently associated with a lower risk of these abnormalities were being female, having dyslipidemia, and receiving at least 3 doses of the COVID-19 vaccine. These findings suggest that multiple metabolic abnormalities are the long-term consequences of COVID-19. For both high-risk and healthy individuals with nonsevere COVID-19, healthcare providers should monitor metabolic profiles, encourage healthy behaviors, and ensure complete vaccination.

A cost-effectiveness analysis of the 13-valent pneumococcal conjugated vaccine and the 23-valent pneumococcal polysaccharide vaccine among Thai older adult.

Introduction: This study aims to assess the economic impact of introducing the 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent pneumococcal polysaccharide vaccine (PPSV23) to Thai older adult aged ≥ 65 years who are healthy or with chronic health conditions and immunocompromised conditions from a societal perspective in order to introduce the vaccine to Thailand's National Immunization Program for the older adult. Methods: A Markov model was adopted to simulate the natural history and economic outcomes of invasive pneumococcal diseases using updated published sources and Thai databases. We reported analyses as incremental cost-effectiveness ratios (ICER) in USD per quality-adjusted life year (QALY) gained. In addition, sensitivity analyses and budget impact analyses were conducted. Results: The base-case analysis of all interventions (no vaccinations [current standard of care in Thailand], PPSV23, and PCV13) showed that PPSV23 was extendedly dominated by PCV13. Among healthy individuals or those with chronic health conditions, ICER for PCV13 was 233.63 USD/QALY; meanwhile, among individuals with immunocompromised conditions, ICER for PCV13 was 627.24 USD/QALY. PCV13 are economical vaccine for all older adult Thai individuals when compared to all interventions. Conclusions: In the context of Thailand, PCV13 is recommended as the best buy and should be primarily prioritized when both costs and benefits are considered. Also, this model will be beneficial to the two-next generation pneumococcal vaccines implementation in Thailand.

An effectiveness and economic analyses of tricalcium phosphate combined with iliac bone graft versus RhBMP-2 in single-level XLIF surgery in Thailand.

STUDY DESIGN: Retrospective study. OBJECTIVES: To perform effectiveness and economic analyses using data from a retrospective study of patients who underwent XLIF surgery using tricalcium phosphate combined with iliac bone graft (TCP + IBG) or BMP-2 in Thailand. METHODS: Data were collected from retrospective review of the medical charts and the spine registry of Siriraj Hospital, Bangkok, Thailand. The patients were divided into two groups (TCP + IBG group and BMP-2 group). Demographic, perioperative data, radiographic, clinical results, and quality of life related to health were collected and analyzed at 2-year follow-up. All economic data were collected during the perioperative period and presented as total charge, bone graft, implant/instrumentation, operative service, surgical supply, transfusion, medication, anesthesia, laboratory, and physical therapy. RESULTS: Twenty-five TCP + IBG and 30 BMP-2 patients with spondylolisthesis and spinal stenosis as primary diagnosis were included. There were no significant differences in all demographic parameters (gender, age, underlying disease, diagnosis, and level of spine) between these two groups. During the perioperative period, the TCP + IBG group had more mean blood loss and more postoperative complications compared to the BMP-2 group. At 2 years of follow-up, there were no significant differences between the radiographic and clinical outcomes of the TCP + IBG and BMP-2 groups. The fusion rate for TCP + IBG and BMP-2 at 2 years of follow-up was 80% and 96.7%, respectively, and no statistically significant differences were observed. All clinical outcomes (Utility, Oswestry Disability Index, and EuroQol Visual Analog Scale) at 2-year follow-up improved significantly compared to preoperative outcomes, but there were no significant differences between the TCP + IBG and BMP-2 groups, either at preoperatively or at 2-year follow-up. The total charge of TCP + IBG was statistically significantly lower than that of BMP-2. Furthermore, the charges of TCP + IBG and BMP-2 during the perioperative period in Thailand were up to three times less than those in the United States. CONCLUSIONS: Using TCP + IBG as a standalone bone substitution for XLIF surgery with additional posterior instrumentation resulted in significantly lower direct medical charge compared to those using BMP-2 in the perioperative period. However, we could not detect a difference in the long-term radiographic and clinical outcomes of patients with TCP + IBG and BMP-2. These suggest that TCP + IBG may be a valuable alterative bone graft, especially in low- and middle-income countries.

Cost-utility Analysis of Anterior Cervical Discectomy and Fusion for Cervical Spondylosis Patients Comparing Polyetheretherketone Versus Tricortical Iliac Crest Bone Graft.

STUDY DESIGN: Prospective cohort study. OBJECTIVES: To perform a cost-utility analysis and to investigate the clinical outcomes and patient's quality of life after anterior cervical discectomy and fusion (ACDF) to treat cervical spondylosis compared between fusion with polyetheretherketone (PEEK) and fusion with tricortical iliac bone graft (IBG) in Thailand. SUMMARY OF BACKGROUND DATA: ACDF is one of the standard treatments for cervical spondylosis. The fusion material options include PEEK and tricortical IBG. No previous studies have compared the cost-utility between these 2 fusion material options. PATIENTS AND METHODS: Patients with cervical spondylosis who were scheduled for ACDF at Siriraj Hospital (Bangkok, Thailand) during 2019-2020 were prospectively enrolled. Patients were allocated to the PEEK or IBG fusion material group according to the patient's choice of fusion material. EuroQol-5 dimensions 5 levels and relevant costs were collected during the operative and postoperative periods. A cost-utility analysis was performed using a societal perspective. All costs were converted to 2020 United States dollars (USD), and a 3% discount rate was used. The outcome was expressed as the incremental cost-effectiveness ratio. RESULTS: Thirty-six patients (18 ACDF-PEEK and 18 ACDF-IBG) were enrolled. Except for Nurick grading, there was no significant difference in patient baseline characteristics between groups. The average utility at 1 year after ACDF-PEEK and ACDF-IBG were 0.939 ± 0.061 and 0.798 ± 0.081, respectively ( P < 0.001). The total lifetime cost of ACDF-PEEK and ACDF-IBG was 83,572 USD and 73,329 USD, respectively. The incremental cost-effectiveness ratio of ACDF-PEEK when compared with that of ACDF-IBG showed a gain of 4468.52 USD/quality-adjusted life-years, which is considered cost-effective at the Thailand willingness-to-pay threshold of 5115 USD/quality-adjusted life-year gained. CONCLUSIONS: ACDF-PEEK was found to be more cost-effective than ACDF-IBG for treating cervical spondylosis in Thailand. LEVEL OF EVIDENCE: Level II.

Pneumococcal carriage among high-risk adults in a country with nonmandatory pneumococcal vaccination during the coronavirus disease 2019 pandemic.

BACKGROUND: Streptococcus pneumoniae carriage is a prerequisite for clinical infections and is used to make public health decisions on vaccine licensure. Pneumococcal carriage data among high-risk Thai adults are needed before national vaccine program introduction. The association between coronavirus disease 2019 (COVID-19) and pneumococcal carriage were also investigated. METHODS: During the COVID-19 pandemic, a multi-center cross-sectional study was conducted among high-risk Thai adults from September 2021 to November 2022. Pneumococcal carriage and serotypes were investigated using both conventional and molecular methods. Demographics and co-morbidities were determined for carriage while accounting for case clustering from various study sites. RESULTS: A total of 370 individuals were enrolled. The prevalence of pneumococcal carriage, as determined by the molecular method, was 30.8 % (95 % confidence interval (CI): 26.1-35.8), while after excluding non-typeable pneumococci from the oropharyngeal sample, the carriage prevalence was 20.8 % (95 % CI: 16.79-25.31). The serotype coverage rates by pneumococcal vaccine were 12.3 %, 13.1 %, and 16.4 % for PCV13, PCV15 or PCV20, and PPSV23, respectively, while the non-vaccine type was the majority (45.1 %). The most common serotype was 19B/C (35.5 %), followed by 6 A/B/C/D (10.7 %). The age group under 65 years was associated with a higher pneumococcal carriage rate than the age group 85 and older (odds ratio (OR): 5.01, 95 % CI: 1.75-14.36). There was no significant difference between SARS-CoV-2 and carriage status. CONCLUSIONS: The prevalence of pneumococcal carriage in Thais was high. The majority of serotypes were not covered by the vaccine. Further studies on the link between carriage serotypes and disease are required. The magnitude and serotype distribution of carriage were comparable in the SARS-CoV-2 positive and negative groups.

Effects of ketogenic diet on health outcomes: an umbrella review of meta-analyses of randomized clinical trials.

BACKGROUND: Systematic reviews and meta-analyses of randomized clinical trials (RCTs) have reported the benefits of ketogenic diets (KD) in various participants such as patients with epilepsy and adults with overweight or obesity. Nevertheless, there has been little synthesis of the strength and quality of this evidence in aggregate. METHODS: To grade the evidence from published meta-analyses of RCTs that assessed the association of KD, ketogenic low-carbohydrate high-fat diet (K-LCHF), and very low-calorie KD (VLCKD) with health outcomes, PubMed, EMBASE, Epistemonikos, and Cochrane database of systematic reviews were searched up to February 15, 2023. Meta-analyses of RCTs of KD were included. Meta-analyses were re-performed using a random-effects model. The quality of evidence per association provided in meta-analyses was rated by the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) criteria as high, moderate, low, and very low. RESULTS: We included 17 meta-analyses comprising 68 RCTs (median [interquartile range, IQR] sample size of 42 [20-104] participants and follow-up period of 13 [8-36] weeks) and 115 unique associations. There were 51 statistically significant associations (44%) of which four associations were supported by high-quality evidence (reduced triglyceride (n = 2), seizure frequency (n = 1) and increased low-density lipoprotein cholesterol (LDL-C) (n = 1)) and four associations supported by moderate-quality evidence (decrease in body weight, respiratory exchange ratio (RER), hemoglobin A1c, and increased total cholesterol). The remaining associations were supported by very low (26 associations) to low (17 associations) quality evidence. In overweight or obese adults, VLCKD was significantly associated with improvement in anthropometric and cardiometabolic outcomes without worsening muscle mass, LDL-C, and total cholesterol. K-LCHF was associated with reduced body weight and body fat percentage, but also reduced muscle mass in healthy participants. CONCLUSIONS: This umbrella review found beneficial associations of KD supported by moderate to high-quality evidence on seizure and several cardiometabolic parameters. However, KD was associated with a clinically meaningful increase in LDL-C. Clinical trials with long-term follow-up are warranted to investigate whether the short-term effects of KD will translate to beneficial effects on clinical outcomes such as cardiovascular events and mortality.

Dynamics of Antibody Responses after Asymptomatic and Mild to Moderate SARS-CoV-2 Infections: Real-World Data in a Resource-Limited Country.

The dynamics of humoral immune responses of patients after SARS-CoV-2 infection is unclear. This study prospectively observed changes in anti-receptor binding domain immunoglobulin G (anti-RBD IgG) and neutralizing antibodies against the Wuhan and Delta strains at 1, 3, and 6 months postinfection between October 2021 and May 2022. Demographic data, clinical characteristics, baseline parameters, and blood samples of participants were collected. Of 5059 SARS-CoV-2 infected adult patients, only 600 underwent assessment at least once between 3 and 6 months after symptom onset. Patients were categorized as immunocompetent (n = 566), immunocompromised (n = 14), or reinfected (n = 20). A booster dose of a COVID-19 vaccine was strongly associated with maintained or increased COVID-19 antibody levels. The booster dose was also more strongly associated with antibody responses than the primary vaccination series. Among patients receiving a booster dose of a mRNA vaccine or a heterologous regimen, antibody levels remained steady or even increased for 3 to 6 months after symptom onset compared with inactivated or viral vector vaccines. There was a strong correlation between anti-RBD IgG and neutralizing antibodies against the Delta variant. This study is relevant to resource-limited countries for administering COVID-19 vaccines 3 to 6 months after infection.

The Association of Pre-operative Serum Albumin Levels and Post-operative In-Hospital Death in Patients Undergoing Gastrointestinal Surgeries in Thailand: A Retrospective Cohort Study.

BACKGROUND: Pre-operative hypoalbuminemia is known to predict negative outcomes for patients undergoing major surgeries. However, various cut-off points for starting exogenous albumin have been recommended. OBJECTIVE: This study investigated the association between pre-operative severe hypoalbuminemia, in-hospital death, and length of hospital stay in patients undergoing gastrointestinal surgery. METHODS: A retrospective cohort study using a database analysis was undertaken on hospitalized patients who underwent major gastrointestinal surgery. The pre-operative serum albumin level was classified into three groups: severe hypoalbuminemia (< 2.0 mg/dL) and non-severe hypoalbuminemia (≥ 2.0-3.4 g/dL) and normal level (3.5-5.5 g/dL). To compare between different cut-offs, a sensitivity analysis using another albumin level classification as severe hypoalbuminemia (< 2.5 mg/dL) and non-severe hypoalbuminemia (≥ 2.5-3.4 g/dL) and normal level (3.5-5.5 g/dL) was applied. The primary outcome was post-operative in-hospital death. Propensity-score adjusted regression analyses were applied. RESULTS: A total of 670 patients were included. Their average age was 57.4 ± 16.3 years, and 56.1% were men. Only 59 patients (8.8%) had severe hypoalbuminemia. Overall, a total of 93 in-hospital deaths (13.9%) occurred among all included patients, but there were 24/59 (40.7%) deaths among patients with severe hypoalbuminemia, 59/302 (19.5%) deaths among patients with non-severe hypoalbuminemia, and 10/309 (3.2%) deaths among patients with normal albumin level. The adjusted odds ratio for post-operative in-hospital death comparing patients with severe hypoalbuminemia and patients with normal albumin level was 8.11 (3.31-19.87; p < 0.001), while the odds ratio for in-hospital death comparing patients with non-severe and patients with normal albumin level was 3.89 (1.87-8.10; p < 0.001). A sensitivity analysis showed similar findings, the odds ratio for in-hospital death for severe hypoalbuminemia (cut-off as < 2.5 g/dL) was 7.44 (3.38-16.36; p < 0.001), while the odds ratio for in-hospital death for severe hypoalbuminemia (cut-off as 2.5-3.4 g/dL) was 3.02 (1.40-6.52; p = 0.005). CONCLUSIONS: Severe pre-operative hypoalbuminemia in patients undergoing gastrointestinal surgery was associated with an increased risk of in-hospital mortality. The risk of death for patients with severe hypoalbuminemia was relatively similar when using different cut-offs such as < 2.0 and <2.5 g/dL.

Cost-Utility and Cost-Effectiveness Analysis of Spinal Cord Stimulation for Chronic Refractory Pain in the Context of Developing Country.

BACKGROUND: Spinal cord stimulation (SCS) is an effective treatment for chronic refractory pain. The evidence of pain reduction, improvement of function, quality of life, and cost-effectiveness are strong in developed countries. Nevertheless, there is still a lack of economic studies of SCS in the context of low- and middle-income countries. OBJECTIVES: To evaluate the cost-effectiveness and cost-utility of additional SCS to conventional management (CMM) in patients with chronic refractory pain in Thailand. STUDY DESIGN: Prospective observational study. SETTING: The pain clinic at Siriraj Hospital, a tertiary care center in Thailand. METHODS: This study recruited patients undergoing SCS implants due to refractory pain to CMM from varieties of conditions and followed up to 36 months. The clinical outcomes, quality of life, and costs of treatment were collected before and after SCS implantation. A decision tree and Markov model were developed to estimate the total lifetime costs and health benefits of SCS using a societal perspective. The results were presented as an incremental cost-utility ratio (ICUR) in 2021 Thai Baht (THB) per quality-adjusted life year (QALY) gained and an incremental cost-effective ratio (ICER) in 2021 THB per numeric rating pain score (NRS) reduction. RESULTS: Twenty-nine patients who underwent SCS implantation reported pain intensity and increased utility at every point in time. Compared to pre-implantation, the QALY gained in both rechargeable and non-rechargeable SCS was 2.13 QALYs. The economic analysis showed the ICUR in the rechargeable and non-rechargeable SCS + CMM group was 660,106.96, and 620,120.59 THB/QALY gained, respectively, which was higher than Thais' willingness-to-pay (WTP) threshold at 160,000 THB/QALY gained. Pain score reduction was 2.49/10 at the 3-year point, and the ICER was 496,932.08 and 337,341.77 THB/NRS reduction for rechargeable and non-rechargeable SCS, respectively. LIMITATIONS: As this is a single-center prospective cohort study, the results might be subject to selection bias and may not truly represent all patients from a developing country. The cost-effectiveness results should also be carefully interpreted for generalizability. CONCLUSION: Spinal cord stimulation is effective in pain control and improves the quality of life for patients with chronic refractory pain. However, the ICUR of SCS is above the WTP, leading to the interpretation that SCS is still not a cost-effective treatment in the current context in Thailand.

"MURAL" model to predict bleeding from mural-based lesions in potential small bowel bleeding may improve diagnostic capability and decrease cost.

In potential small bowel bleeding, video capsule endoscopy (VCE) is excellent to detect mucosal lesions, while mural-based lesions are better detected by computed tomography enterography (CTE). A predictive tool to identify mural-based lesions should guide selecting investigations. In this retrospective study, we developed and validated the "MURAL" model based on logistic regression to predicts bleeding from mural-based lesions. Cost-effectiveness analysis comparing diagnostic strategy among VCE, CTE, and MURAL model was performed. Of 296 patients, 196 and 100 patients were randomly included in the derivative and validation cohorts, respectively. The MURAL model comprises 5 parameters: age, presence of atherosclerosis, chronic kidney disease, antiplatelet use, and serum albumin level. The area under the receiver operating characteristic curve was 0.778 and 0.821 for the derivative and validation cohorts, respectively. At a cutoff value of 24.2%, the model identified mural-based lesions with 70% sensitivity and 83% specificity in the validation cohort. Cost-effectiveness analysis revealed that application of the MURAL model demonstrated a comparable missed lesion rate but had a lower missed tumor rate, and lower cost compared to VCE strategy. The model for predicting mural-based lesions provide some guidance in investigative decision-making, which may improve diagnostic efficiency and reduce costs.