Mortality Rates and a Clinical Predictive Model for the Elderly on Maintenance Hemodialysis: A Large Observational Cohort Study of 17,354 Asian Patients.

INTRODUCTION: Mortality following hemodialysis initiation may influence the decision to initiate hemodialysis in elderly patients. Our objective is to demonstrate mortality following hemodialysis initiation in elderly patients (≥70 years) and to derive a prediction risk score based on clinical and laboratory indicators to determine risk of all-cause mortality in patients aged ≥80 years. METHODS: We identified elderly patients (≥70 years) who initiated maintenance hemodialysis between January 2005 and December 2016 using data from the Thai Renal Replacement Therapy (TRT) registry. The mortality rate was determined based on age categories. A predictive risk score for all-cause mortality was created for 4,451 patients aged ≥80 years by using demographics, laboratory values, and interview-based parameters. Using a flexible parametric survival analysis, we predicted mortality 3 months, 6 months, 1 year, 5 years, and 10 years after hemodialysis initiation. RESULTS: 17,354 patients (≥70 years) were included, mean age 76.9 ± 5.1 years, 46.5% male, and 6,309 (36.4%) died. Patients aged <80 years had a median survival time of 110.6 months. A 9-point risk score was developed to predict mortality in patients aged ≥80 years: age >85 years, male, body mass index <18.5 kg/m2, hemoglobin <10.0 g/dL, albumin <3.5 g/dL, substantial assistance required in daily living (1 point each), and Karnofsky Performance Status (KPS) score <50 (3 points). C-statistic of 0.797 indicated high model discrimination. Internal validation demonstrated good agreement between observed and anticipated mortalities. CONCLUSIONS: Hemodialysis is appropriate for patients aged 70-80 years. A risk score for mortality in patients aged ≥80 years has been developed. The score is based on seven readily obtainable and evaluable clinical characteristics.

Psychometric Evaluation of the Multidimensional Scale-Uremic Pruritus in Dialysis Patients (UP-Dial): Comparison in Hemodialysis and Peritoneal Dialysis Patients with Chronic Pruritus.

BACKGROUND: High-quality patient-reported outcome (PRO) measures for dialysis patients with chronic pruritus are urgently needed. However, no known, well-validated multidimensional tools have been investigated to measure pruritus symptoms in dialysis patients. OBJECTIVES: To examine the psychometric properties of a multidimensional tool of chronic pruritus, the Uremic Pruritus in Dialysis (UP-Dial) 14-item, by comparing hemodialysis and peritoneal dialysis modality. METHODS: This validation study used data from the Thai Renal Outcomes Research-Uremic Pruritus, a prospective, multicenter, longitudinal study. Data for this study were collected from February 1, 2019, to May 31, 2022. The adult sample of 226 hemodialysis and 327 peritoneal dialysis patients fulfilled the criteria of chronic pruritus based on the International Forum for the Study of Itch. Psychometric properties of the UP-Dial included validity and reliability, as measured across hemodialysis and peritoneal dialysis patients. Patients completed a set of anchor-based measurement tools, including global itching, Dermatology Life Quality Index (DLQI), EuroQoL-5 dimension-5 level (EQ-5D-5L), Kidney Disease Quality of Life-36 (KDQOL-36), Pittsburgh Sleep Quality Index (PSQI), global fatigue, Somatic Symptom Scale-8 (SSS-8), and Patient Health Questionnaire-9 (PHQ-9). RESULTS: From the patient's perspective, face validity was satisfactory for both dialysis samples. Psychometric analyses of the UP-Dial for each dialysis sample had good convergent validity. Spearman rho correlations indicate a positively strong correlation (0.73 to 0.74) with global itching, a positively moderate correlation (0.33 to 0.58) with DLQI, PSQI, global fatigue, SSS-8, and PHQ-9, and a negatively moderate correlation (-0.39 to -0.58) with EQ-5D-5L and KDQOL-36. The discriminant validity was satisfactory with a group of moderate and severe burden of pruritus for both dialysis samples. For scale reliability, the UP-Dial revealed excellent internal consistency (Cronbach's α = 0.89 and McDonald's ω = 0.90) and reproducibility (intraclass correlation: 0.84 to 0.85) for both dialysis samples. Regarding psychometric properties, no statistically significant differences between dialysis samples were observed (all P > 0.05). CONCLUSIONS: The findings reaffirm good measurement properties of the UP-Dial 14-items in hemodialysis and peritoneal dialysis patients with chronic pruritus. These suggest a transferability of the UP-Dial as a PRO measure in clinical trial and practice settings.

Cost-effectiveness analysis of pharmacist interventions in patients with heart failure in Thailand.

INTRODUCTION: Patients with heart failure (HF) are likely to have multiple diseases with complex therapy regimens. Pharmacist intervention in HF treatment can reduce all-cause mortality and hospitalization, but the economic outcome is not known. OBJECTIVE: This study aimed to assess the cost-effectiveness of pharmacist contribution in HF setting compared with usual care. METHODS: A decision analytical model was developed to estimate the cost and outcome from a health care system perspective in Thailand. Clinical inputs were obtained from literature review. Pharmacist costs, hospitalization cost for HF, risk of hospitalization death, risk of nonhospitalization death, and readmission rate were based on data from Thailand. The cost and outcome were discounted at 3% annually. OUTCOME MEASURES: The incremental cost-effectiveness ratio (ICER) was calculated and presented for the year 2020. A series of sensitivity analysis was also performed. RESULTS: Pharmacist intervention incurred higher total costs than usual care, because total cost of pharmacists was 186,040 THB (5936 USD) whereas usual care cost was 151,654 THB (4839 USD). It also provided more quality-adjusted life years (QALYs) than usual care, from 2.4 to 2.8. In addition, patient life years (LY) were increasing from 3.3-3.8. This yielded an ICER of 77,398 THB/LY (2467 USD/LY) or 103,037 THB/QALYs (3288 USD/QALYs). This ICER is considered to be cost-effective at the willingness-to-pay level of 160,000 THB/QALY (5191.87 USD). CONCLUSION: At this current situation in Thailand, pharmacists may represent good value for the nation's limited health care resources. The information should be used in national policies to plan for pharmacist work force implementation and production line in the near future.

Association of job loss, income loss, and financial burden with adverse mental health outcomes during coronavirus disease 2019 pandemic in Thailand: A nationwide cross-sectional study.

BACKGROUND: Economic crises during the coronavirus disease (COVID-19) pandemic severely impacted mental health outcomes. However, there is limited evidence on this issue in Thailand. We aimed to evaluate the association of economic burden during the first phase of the pandemic and the risk of adverse mental health outcomes in the Thai population. METHODS: We recruited 2,303 participants aged 18 years or above with employment/full-time jobs before the national lockdown in April-May 2020. The measures of economic burden were job loss, income loss, and financial problems related to the outbreak. The outcomes included depressive symptoms, anxiety, and perceived stress. The association between economic burden and adverse mental health outcomes was evaluated using multivariable logistic regression models. RESULTS: Individuals who lost their jobs during the COVID-19 pandemic had a higher risk of perceived stress compared to those who maintained their job (adjusted odds ratio [OR], 2.40; 95% confidence interval [CI], 1.28-4.51; p = .006). A higher risk of anxiety was observed in individuals with a monthly income loss of 50% (adjusted OR, 1.42; 95% CI, 1.03-1.99; p = .035; individuals without income loss, reference group) or over. Self-reported financial problems were significantly associated with adverse mental health outcomes (nonexperienced financial problems, reference group): Adjusted ORs of 1.84 (95% CI, 1.34-2.51; p < .001) for depressive symptoms, 2.00 (95% CI, 1.48-2.71; p < .001) for anxiety, and 2.12 (95% CI, 1.51-2.95; p < .001) for perceived stress. CONCLUSIONS: Economic burden, especially self-reported financial problems, was associated with adverse mental health outcomes. However, long-term studies are needed to address the mental health consequences of COVID-19 and economic downturns.

Exposure to COVID-19-Related Information and its Association With Mental Health Problems in Thailand: Nationwide, Cross-sectional Survey Study.

BACKGROUND: The COVID-19 pandemic has had a negative impact on both the physical and mental health of individuals worldwide. Evidence regarding the association between mental health problems and information exposure among Thai citizens during the COVID-19 outbreak is limited. OBJECTIVE: This study aimed to explore the relationship between information exposure and mental health problems during the COVID-19 pandemic in Thailand. METHODS: Between April 21 and May 4, 2020, we conducted a cross-sectional, nationwide online survey of the general population in Thailand. We categorized the duration of exposure to COVID-19-related information as follows: <1 h/day (reference group), 1-2 h/day, and ≥3 h/day. Mental health outcomes were assessed using the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 scale, the Perceived Stress Scale-10, and the Insomnia Severity Index for symptoms of depression, anxiety, perceived stress, and insomnia, respectively. Multivariable logistic regression models were used to evaluate the relationship between information exposure and the risk of developing the aforementioned symptoms. An ancillary analysis using multivariable multinomial logistic regression models was also conducted to assess the possible dose-response relationship across the severity strata of mental health problems. RESULTS: Of the 4322 eligible participants, 4004 (92.6%) completed the online survey. Of them, 1481 (37.0%), 1644 (41.1%), and 879 (22.0%) participants were exposed to COVID-19-related information for less than 1 hour per day, 1 to 2 hours per day, or 3 or more hours per day, respectively. The major source of information related to the COVID-19 pandemic was social media (95.3%), followed by traditional media (68.7%) and family members (34.9%). Those exposed to information for 3 or more hours per day had a higher risk of developing symptoms of depression (adjusted odds ratio [OR] 1.35, 95% CI 1.03-1.76; P=.03), anxiety (adjusted OR 1.88, 95% CI 1.43-2.46; P<.001), and insomnia (adjusted OR 1.52, 95% CI 1.17-1.97; P=.001) than people exposed to information for less than 1 hour per day. Meanwhile, people exposed to information for 1 to 2 hours per day were only at risk of developing symptoms of anxiety (adjusted OR 1.35, 95% CI 1.08-1.69; P=.008). However, no association was found between information exposure and the risk of perceived stress. In the ancillary analysis, a dose-response relationship was observed between information exposure of 3 or more hours per day and the severity of mental health problems. CONCLUSIONS: These findings suggest that social media is the main source of COVID-19-related information. Moreover, people who are exposed to information for 3 or more hours per day are more likely to develop psychological problems, including depression, anxiety, and insomnia. Longitudinal studies investigating the long-term effects of COVID-19-related information exposure on mental health are warranted.

Efficacy of Furosemide, Oral Sodium Chloride, and Fluid Restriction for Treatment of Syndrome of Inappropriate Antidiuresis (SIAD): An Open-label Randomized Controlled Study (The EFFUSE-FLUID Trial).

RATIONALE & OBJECTIVE: First-line therapy for syndrome of inappropriate antidiuresis (SIAD) is fluid restriction. Additional treatment for patients who do not respond to fluid restriction are water restriction with furosemide or water restriction with furosemide and salt supplementation. However, the efficacy of these treatments has never been tested in a randomized controlled study. The objective of this study was to investigate whether, combined with fluid restriction, furosemide with or without sodium chloride (NaCl) supplementation was more effective than fluid restriction alone in the treatment of hyponatremia in SIAD. STUDY DESIGN: Open-label randomized controlled study. SETTING & PARTICIPANTS: Patients with serum sodium concentrations ([Na+]) ≤ 130mmol/L due to SIAD. INTERVENTION(S): Random assignment to 1 of 3 groups: fluid restriction alone (FR), fluid restriction and furosemide (FR+FM), or fluid restriction, furosemide, and NaCl (FR+FM+NaCl). Strictness of fluid restriction (<1,000 or<500mL/d) was guided by the urine to serum electrolyte ratio. Furosemide dosage was 20 to 40mg/d. NaCl supplements were 3g/d. All treatments were continued for 28 days. OUTCOMES: The primary outcome was change in [Na+] at days 4, 7, 14, and 28 after randomization. RESULTS: 92 patients were recruited (FR, n=31; FR+FM, n=30; FR+FM+NaCl, n=31). Baseline [Na+] was 125±4mmol/L, and there were no significant differences between groups. Mean [Na+] on day 4 in all treatment groups was significantly increased from baseline by 5mmol/L (P<0.001); however, the change in [Na+] was not significantly different across groups (P=0.7). There was no significant difference in percentage of patients or time to reach [Na+] ≥ 130 or≥135mmol/L across the 3 groups. Acute kidney injury and hypokalemia (potassium≤3.0mmol/L) were more common in patients receiving furosemide. LIMITATIONS: Open-label treatment. CONCLUSIONS: In patients with SIAD, furosemide with NaCl supplement in combination with fluid restriction did not show benefits in correction of [Na+] compared with treatment with fluid restriction alone. Incidences of acute kidney injury and hypokalemia were increased in patients receiving furosemide. FUNDING: None. TRIAL REGISTRATION: Registered at the Thai Clinical Trial Registry with study number TCTR20170629004.

The association between proton pump inhibitor use and the risk of adverse kidney outcomes: a systematic review and meta-analysis.

Background: Existing epidemiological studies illustrate that proton pump inhibitors (PPIs) may be related to adverse kidney outcomes. To date, no comprehensive meta-analysis has been conducted to evaluate and quantify this association. Methods: We performed a systematic review and meta-analysis of studies to assess the association between PPI use and the risk of adverse kidney outcomes. We searched MEDLINE, Embase, SCOPUS, Web of Science, CINAHL, Cochrane Library and grey literature with no language restrictions (through 31 October 2016). Adverse kidney outcomes were acute interstitial nephritis (AIN), acute kidney injury (AKI), chronic kidney disease (CKD) and end-stage renal disease (ESRD). The risk ratios (RRs) and confidence intervals (CIs) were pooled using a random effects model. The strength of evidence (SOE) for each outcome was assessed using the Grading of Recommended Assessment, Development and Evaluation system. Results: Of 2037 identified studies, four cohort and five case-control studies with ∼2.6 million patients were included. Of these, 534 003 (20.2%) were PPI users. Compared with non-PPI users, PPI users experienced a significantly higher risk of AKI [RR 1.44 (95% CI 1.08-1.91); P = 0.013; SOE, low] and CKD [RR 1.36 (95% CI 1.07-1.72); P = 0.012; SOE, low]. Moreover, PPIs increased the risk of AIN [RR 3.61 (95% CI 2.37-5.51); P < 0.001; SOE, insufficient] and ESRD [RR 1.42 (95% CI 1.28-1.58); P < 0.001; SOE, insufficient]. Conclusion: PPI usage was associated with adverse kidney outcomes; however, these findings were based on observational studies and low-quality evidence. Additional rigorous studies are needed for further clarification.

Effect of iron supplementation during early pregnancy on the development of gestational hypertension and pre-eclampsia.

OBJECTIVE: To investigate the association between iron supplementation during early pregnancy and the presence of de novo hypertension after 20 weeks' gestation (either gestational hypertension or pre-eclampsia). STUDY DESIGN: Retrospective cohort study. METHODS: This study retrospectively reviewed the medical records of non-anemic pregnant women who received first antenatal care at the Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand, during the June 2009-December 2010 study period. All included women had blood pressure and urine albumin level data that were recorded at each antenatal visit. The study population was divided into one of the two following groups: iron supplementation starting at gestational age (GA) < 16 weeks (study group) or GA ≥ 16 weeks (control group). A comparison of the proportion of de novo hypertension arising after 20 weeks' gestation was then performed between groups. RESULTS: Four hundred non-anemic pregnant women were included, with 200 patients allocated to each groups. The overall incidence of de novo hypertension after 20 weeks' gestation was 10% (40/400), with significantly higher prevalence in the study group than that in the control group [13.5% (27/200) vs. 6.5% (13/200); relative risk: 2.14, 95%, CI 1.22-3.73; p = 0.008]. None of the women in this study developed anemia at time of delivery. There was no significant difference between groups for GA at delivery, birth weight, or birth asphyxia. CONCLUSION: In our study population, iron supplementation before 16 weeks' GA was significantly associated with increased risk of developing de novo hypertension after 20 weeks' gestation.

Effect of Curcuminoids on Contrast-Induced Acute Kidney Injury after Elective Coronary Angiography or Intervention: A Pilot Randomized, Double-Blind, Placebo-Controlled Study.

INTRODUCTION: The role of curcuminoids, a striking antioxidant, in prevention of contrast-induced acute kidney injury (CI-AKI) remains unknown. We aimed to evaluate the efficacy and safety of curcuminoids in preventing CI-AKI in patients undergoing elective coronary angiography (CAG) and/or percutaneous coronary intervention (PCI). METHODS: We randomized 114 patients who were undergoing elective CAG and/or PCI to receive curcuminoids, 4 g/day (1 day before and 1 day after the procedure, n = 56), or placebo (n = 58). Serum creatinine was assessed at baseline, 12, 24, and 48 h after contrast exposure. The primary endpoint was development of CI-AKI defined as serum creatinine increase ≥0.3 mg/dL within 48 h after contrast exposure. The secondary endpoint was the occurrence of kidney injury defined by >30% increase in urine neutrophil gelatinase-associated lipocalin (NGAL). RESULTS: Baseline characteristics were comparable between the two groups. Seven (12.7%) in curcuminoids group and eight (14.0%) in placebo group developed CI-AKI (p = 0.84). The incidence of increased urine NGAL was comparable in the placebo and curcuminoids group (39.6% vs. 50%, respectively; p = 0.34). None in both groups had drug-related adverse events. CONCLUSION: This is a pilot study to demonstrate the safety and tolerability of curcuminoids in patients undergoing elective CAG and/or PCI. Curcuminoids have no protective effects against kidney injury after elective CAG and/or PCI.

Evaluation of Pharmacological Treatments for Acute Urticaria: A Systematic Review and Meta-Analysis.

BACKGROUND: The effectiveness and safety of pharmacological treatments for acute urticaria remain unclear. OBJECTIVE: To systematically review and meta-analyze the efficacy and safety of pharmacological treatments for acute urticaria in emergency department (ED) and non-ED settings. METHODS: We searched electronic databases and gray literature up to July 8, 2023, without language restrictions. Randomized clinical trials (RCTs) relating to pharmacological interventions in patients with acute urticaria, regardless of age, were eligible for inclusion. The relevant outcomes of interest were the treatment efficacy and safety profiles. The results are presented as standardized mean differences (SMDs) or odds ratios (ORs). RESULTS: We identified 8 RCTs comprising 680 patients. Regarding the ED setting (2 trials, n = 118), intramuscular first-generation H1-antihistamine (fgAH) was more efficacious in decreasing pruritus symptoms (SMD, -0.38; 95% confidence interval [CI], -0.75 to -0.02) but had higher sedative effects than H2-blockers. With comparable pruritus symptom improvement (2 trials, n = 295), intravenous second-generation H1-antihistamine (sgAH) had favorable clinical outcomes compared with intravenous fgAH in the ED setting with a lower risk of return to any ED/clinic (OR, 0.31; 95% CI, 0.12-0.83) and lower risk of any adverse event (OR, 0.24; 95% CI, 0.09-0.63). The efficacy of adjunctive therapy with a short course of systemic glucocorticosteroids in ED and non-ED settings remains unclear. No serious concerns regarding the safety profiles were observed in any of the treatment comparisons. CONCLUSIONS: H1-antihistamine is a crucial and effective component of acute urticaria treatment, and intravenous sgAH is preferred as an initial treatment option.

Randomized Trial on the Effects of Dialysate Potassium Concentration on Intradialytic Hypertension.

Introduction: Intradialytic hypertension is not an uncommon condition during chronic hemodialysis. It is associated with unfavorable cardiovascular outcomes, including hospitalization and mortality. Several small studies have demonstrated the contradictory effects of different dialysate potassium concentrations on intradialytic blood pressure. This study is a randomized crossover trial aiming to evaluate the effects of different dialysate potassium concentrations on intradialytic hypertension. Methods: A 24-week, 2-treatment, 4-sequence, multicenter, double-blinded, randomized, crossover study was conducted at Maharaj Nakorn Chiang Mai Hospital and Lampang Hospital in Thailand among stable patients receiving chronic hemodialysis who experienced intradialytic hypertension >30% of their sessions over the past 3 months. Each participant was randomly assigned to 1 of 4 treatment sequences. During each intervention period, patients were dialyzed with dialysate potassium of either 2 mmol/l (D-K2) or 3 mmol/l (D-K3) for 4 weeks according to their preassigned sequence, separated by a 2-week washout period. The primary outcome was the incidence of intradialytic hypertension. Results: Forty eligible patients were recruited. The mean age was 61.4 ± 14.2 years and the mean systolic blood pressure (SBP) was 146.6 ± 11.2 mm Hg. Of the 40 patients, 95.5% had hypertension and their average number of antihypertensive drugs was 2.8 ± 1.9. A total of 1380 dialysis sessions were included in the analysis (695 sessions for D-K2 and 685 sessions for D-K3). The incidence of intradialytic hypertension was not significantly different between different dialysate potassium concentrations (D-K2 54.7% vs. D-K3 53.1%, P = 0.788). The changes in SBP, diastolic blood pressure (DBP), and mean arterial pressure (MAP) were not different between the 2 dialysate potassium groups. Conclusion: Dialysate potassium concentration of 2 or 3 mmol/l did not affect the incidence of intradialytic hypertension in patients receiving chronic hemodialysis who frequently developed intradialytic hypertension.

Comparative Safety Profiles of Individual Second-Generation H1-Antihistamines for the Treatment of Chronic Urticaria: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: The comparative safety and/or dosing regimens of individual second-generation H1-antihistamines (sgAHs) in patients with chronic urticaria (CU) remain poorly elucidated. OBJECTIVE: To compare the safety profiles of individual sgAHs and/or dosing regimens in adolescents or adult patients with CU using a systematic review and network meta-analysis of all available evidence. METHODS: With limited English publications, electronic databases and gray literature were searched for randomized clinical trials from inception, with searches last updated on January 20, 2023. Relevant safety outcomes included treatment unacceptability (all-cause discontinuation), tolerability (discontinuation due to any adverse events), adverse events, serious adverse events, central nervous system (CNS) side effects, and anticholinergic side effects. Regarding the network estimates, the probability of being associated with the highest adverse outcome risk was estimated for each treatment comparison. RESULTS: Fifty-one randomized clinical trials with 14 individual sgAHs and different dosing regimens, involving 7502 participants, were included. On the basis of the findings from network meta-analyses, variations in sgAH treatment comparisons were observed regarding the unacceptability of treatment, tolerability, adverse events, and CNS side effects. There were no statistically significant differences between the results of sgAH treatment for serious adverse events and those for anticholinergic side effects. On the basis of the ranking of safety profiles, emedastine 4 mg, mizolastine 10 mg, and cetirizine 10 mg were the top 3 ranked treatments with unfavorable safety profiles associated with CNS side effects and any adverse events. CONCLUSIONS: These findings suggest evidence of variations in safety profiles among sgAHs for CU treatment, particularly in terms of adverse events and CNS side effects.

Efficacy and safety of metformin for melasma treatment: a systematic review and meta-analysis.

Objective: Metformin has recently been demonstrated to have an anti-melanogenic activity. Nevertheless, clinical evidence of the effectiveness of metformin in melasma is lacking. The objective of this study was to assess the efficacy and safety of metformin in the treatment of melasma. Methods: MEDLINE, Embase, PubMed, Cochrane Library (CENTRAL), Scopus, CINAHL, and grey literature databases were searched to 4 October 2022 and updated on 26 February 2023. Randomized controlled trials (RCTs), quasi-RCTs, observational studies, case series, and case reports investigating the efficacy and safety of metformin for melasma were included. The Melasma Area Severity Index (MASI) scores that changed from baseline were pooled using fixed-effects model and expressed as standardized mean differences (SMDs) and 95% confidence intervals (CIs). Results: Three RCTs including 140 patients with melasma were included. The results demonstrated that after 8 weeks, 15% topical metformin significantly reduced the Melasma Area Severity Index (MASI) score compared to placebo (1 trial; n = 60; MD, -0.56; 95% CI, -1.07 to -0.04; p = 0.034). Furthermore, when compared to triple combination cream (TCC), 30% topical metformin demonstrated similar efficacy in reducing the MASI score after 8 weeks (2 trials; n = 80; MD, 0.19, 95% CI, -0.25 to 0.63; p = 0.390). Patients using 30% topical metformin had fewer adverse events compared to TCC users, although no statistical difference was found. Conclusion: Topical metformin was as effective as triple combination cream (TCC) in decreasing changes in the MASI score in patients with melasma, with minimum adverse events. Further studies with larger sample sizes, longer follow-up times, and well-designed trials are required. Systematic Review Registration: Identifier PROSPERO (CRD42022351966).

Evidence Gaps in Clinical Trials of Pharmacologic Treatment for H1-Antihistamine-Refractory Chronic Spontaneous Urticaria: A Systematic Review and Future Perspectives.

No data addressing issues concerning disparities in participant and trial characteristics and trial outcome reporting have been established in clinical trials for H1-antihistamine-refractory chronic spontaneous urticaria (CSU). To better harmonize and compare the different treatment interventions, we systematically evaluated the overall landscape of pharmacological treatments for H1-antihistamine-refractory CSU clinical trials published between 2000 and 2021. This systematic review included 23 randomized clinical trials involving 2480 participants from 22 countries. We found significant increases in the number of globally published and newly tested drugs, especially biologic drugs. Regarding relatively small trials, we found that people living with H1-antihistamine-refractory CSU who were identified as members of minority groups (non-white population), populations of regions other than North America/Europe, and populations of low- to lower/upper-middle-income countries are underrepresented. Most trials were designed to evaluate treatment efficacy and safety profiles; however, less than half of the included trials reported the patient's perspective in terms of patient-reported outcomes. Disparities in outcome reporting, including clinimetric tools for assessing treatment response and outcome sets, were observed. To close the evidence gap in H1-antihistamine-refractory CSU trials, strategies for improving trial and participant enrollment and standardizing core outcome sets for trial reporting are needed.

Prevalence of chronic kidney disease stages 3-5 in low- and middle-income countries in Asia: A systematic review and meta-analysis.

Chronic kidney disease (CKD) is a major public health problem in low- and middle-income countries (LMICs). Although CKD prevalence has been rapidly increasing in LMICs, particularly in Asia, quantitative studies on the current epidemiology of CKD in this region are limited. This study aimed to identify the prevalence of CKD stages 3-5 in LMICs in Asia, by subregion, country economy classification, identification of CKD, traditional and non-traditional risk factors. A systematic review and meta-analysis of observational studies was conducted through a literature search of seven electronic databases and grey literature search published until November 2021. The Newcastle-Ottawa quality assessment scale (NOS) was used to assess the risk of bias of each study. A random-effects model was used to estimate pooled prevalence. The protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO CRD42019120519). Of 4,548 potentially relevant records, 110 studies with moderate and high quality were included with 4,760,147 subjects. The average prevalence (95% CI) of CKD stages 3-5 in 14 LMICs in Asia was 11.2% (9.3-13.2%). The prevalence of CKD stages 3-5 was varied among subregions and country economic classification. CKD prevalence was 8.6% (7.2-10.2%) in east Asia, 12.0% (7.7-17.0%) in south-east Asia, 13.1% (8.7-18.2%) in western Asia, and 13.5% (9.5-18.0%) in south Asia. CKD prevalence was 9.8% (8.3-11.5%) in upper-middle-income countries and 13.8% (9.9-18.3%) in lower-middle-income countries. Prevalence of CKD stage 3-5 in LMICs in Asia is comparable to global prevalence. High level of heterogeneity was observed. Study of factors and interventions that lead to the delay of CKD progression is needed.

Disparities and Factors Associated with Coronavirus Disease-2019-Related Public Stigma: A Cross-Sectional Study in Thailand.

Coronavirus disease 2019 (COVID-19)-related public stigma is a major challenge, with scarce available evidence. This study aimed to determine the disparities and factors associated with COVID-19-related public stigma in the Thai population. We conducted a cross-sectional study involving a voluntary online survey in Thailand from 21 April 2020 to 4 May 2020. We invited 4004 participants to complete a series of questionnaires, including the validated COVID-19 public stigma scale and questions on relevant COVID-19-related psychosocial issues. Multinomial logistic regression was performed to investigate the factors associated with COVID-19-related public stigma. The prevalence of COVID-19-related public stigma was 24.2% (95% confidence interval [CI], 22.2-26.2) for no/minimal, 35.5% (95% CI, 33.4-37.6) for moderate, and 40.3% (95% CI, 38.2-42.4) for high. We observed disparities in the prevalence of COVID-19-related public stigma according to participant characteristics and psychosocial factors. Using the no/minimal group as a reference group, the six predominant risk factors significantly associated with a moderate and high degree of COVID-19-related public stigma were middle-aged or older adults, male, divorced/widowed/separated, current quarantine status, moderate/severe fear of COVID-19, and medium/high perceived risk of COVID-19. Additional risk factors significantly related to a high degree of COVID-19-related public stigma were religion (Buddhist), region of residence (non-capital city), and exposure to COVID-19-related information. Disparities in COVID-19-related public stigma due to sociodemographic and psychosocial issues are frequent in the Thai population. To reduce public stigmatization, early identification of vulnerable groups and the development of tailored mitigation strategies should be implemented during the pandemic.

Fear of COVID-19 and Perceived Stress: The Mediating Roles of Neuroticism and Perceived Social Support.

Background: Fear of COVID-19 leads to stress and may result in various kinds of mental health problems. Many factors are associated with an individual's perception of stress, including neuroticism and perceived social support. This study aimed to examine the role of neuroticism and perceived social support as mediators of fear of COVID-19 on perceived stress. Methods: Data from 3299 participants aged ≥18 years from the HOME-COVID-19 survey in 2020 were used for analysis. Measurements used included the Fear of COVID-19 and Impact on Quality of Life Scale, the Perceived Stress Scale-10, the Neuroticism inventory and the Multidimensional Scale of Perceived Social Support-12. A parallel mediation model within a structural equation modeling framework with 5000 bootstrapping sampling was used to test the mediating effect. Results: Fear of COVID-19 had a direct effect on perceived stress (B = 0.100, 95% CI = 0.080−0.121, p < 0.001), whereas neuroticism, but not perceived social support, partially mediated the relationship between fear of COVID-19 and perceived stress (B = 0.018, 95% CI = 0.000−0.036). Among all types of social support, only perceived support from friends was a significant mediator (B = 0.016, 95% CI = 0.006−0.025). Conclusions: Neuroticism and perceived support from friends are critical factors in the relationship between fear of COVID-19 and perceived stress.

Impact of Pharmacological Treatments for Chronic Spontaneous Urticaria with an Inadequate Response to H1-Antihistamines on Health-Related Quality of Life: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Recently, pharmacological treatment options for H1-antihistamine-refractory chronic spontaneous urticaria have increased dramatically; however, their effects on patient-reported outcomes, including health-related quality of life (HRQOL), remain unclear. OBJECTIVE: To compare the impact of these treatments on HRQOL among H1-antihistamine-refractory patients with chronic spontaneous urticaria. METHODS: We completed a comprehensive search of the available literature in the electronic databases, gray literature, and preprint reports up to April 19, 2021, with no language restrictions. The primary outcome for evaluation was a change in HRQOL from the baseline, and secondary outcomes included patient unacceptability and other patient-reported outcomes. We used a random-effects network meta-analysis and estimated differences in standardized mean differences (SMDs) and odds ratios with 95% CIs. Evidence-based synthesis was based on magnitudes of effect size, evidence certainty, ranking of treatment effects, and clinically meaningful improvement. RESULTS: Twelve randomized controlled trials encompassing 1866 adolescent and adult patients were included. Our evidence synthesis analyses revealed that hydroxychloroquine (SMD, -1.00 [-1.61 to -0.39]), 72 mg ligelizumab (SMD, -0.66 [-0.96 to -0.35]), 240 mg ligelizumab (SMD, -0.67 [-0.98 to -0.37]), and 300 mg omalizumab (SMD, -0.53 [-0.67 to -0.39]) significantly improved HRQOL with a moderate beneficial effect. However, the use of hydroxychloroquine seems to be limited by a higher risk of patient unacceptability of treatment. Other secondary outcomes remain inconclusive based on the available evidence. CONCLUSIONS: Both ligelizumab (72 or 240 mg) and 300 mg omalizumab appeared to be effective treatments for H1-antihistamine-refractory chronic spontaneous urticaria, because they were closely associated with improved HRQOL.