AIMS: This study aimed to examine the influence of vessel volume on bolus thermodilution measurements.
METHODS: We prospectively included patients with angina with non-obstructive coronary arteries (ANOCA) undergoing bolus and continuous thermodilution assessments. All patients underwent coronary CT angiography to extract vessel volume. Coronary microvascular dysfunction was defined as coronary flow reserve (CFR)
MATERIAL AND METHODS: A prospective cohort study "Relative Risk of Determinants of Adverse Pregnancy Outcomes Among Pregnant Mothers Attending Government Health Clinics, Peninsular Malaysia, PEN-MUM" was conducted from March 2022 until March 2023 at 20 government health clinics in Peninsular Malaysia that were randomly selected through a multistage sampling method. Malaysian pregnant mothers between 18 and 49 years old were recruited at 12-18 weeks of gestation and followed up at three time points: 1 (24-28 weeks of gestation), 2 (36-40 weeks of gestation), and 3 (post-delivery). Eight exposure factors of LBW were studied: gestational weight gain, dengue infection, urinary tract infection, COVID-19 infection, gestational hypertension, preeclampsia, maternal anemia, and gestational diabetes mellitus (GDM).
RESULTS: Among 507 participants enrolled in the cohort, 40 were lost to follow-up. A total of 467 were included in the final analysis, giving an attrition rate of 7.9%. The incidence of LBW infants in Peninsular Malaysia was 14.3%. After adjusting for three covariates (ethnicity, employment status, and gestational age at birth), three determinants of LBW were identified. The risk of giving birth to LBW infants was higher among those with inadequate gestational weight gain (aRR = 2.86, 95% CI: 1.12, 7.37, p = 0.03), gestational hypertension (aRR = 4.12; 95% CI: 1.66, 10.43; p = 0.002), and GDM (aRR = 2.21; 95% CI: 1.18, 4.14; p = 0.013) during the second and third trimesters.
CONCLUSIONS: The incidence of LBW infants in Peninsular Malaysia can be considered high. Having inadequate gestational weight gain, gestational hypertension, and GDM in the second and third trimesters increased the risk of LBW infants by threefold, fivefold, and twofold respectively. Thus, intervention strategies should target prevention, early detection, and treatment of gestational hypertension and GDM, as well as promoting adequate weight gain during antenatal care.
METHODS: We used data from a prospective cohort study of 799 pregnant women from health clinics of two states in east and west coasts of Malaysia. Baseline data were measured at the third trimester of pregnancy on ADS, AAS, socioeconomic condition, anthropometric status, reproductive history and intimate partner violence. Birth outcomes and mode of delivery were determined at the time of delivery. Univariate and multiple Cox's regressions were applied to assess the association between ADS and AAS and LBW, PTB and CS or instrumental delivery.
RESULTS: ADS was significantly associated with an increased risk of giving birth to LBW babies in both east coast (RR = 3.64; 95% CI 1.79-7.40) and west coast (RR = 3.82; 95% CI 1.86-7.84), but not with PTB. AAS was associated with increased risk of both LBW (RR = 2.47; 95% CI 1.39-4.38) and PTB (RR = 2.49; 95% CI 1.16-5.36) in the east coast, but not in west coast. The risk of CS or instrumental delivery was evident among women with ADS (RR = 2.44; 95% CI 1.48-4.03) in west coast only.
CONCLUSION: ADS predicts LBW in both coasts, AAS predicts LBW and PTB in east coast, and ADS predicts CS or instrumental delivery in west coast. Policies aimed at detection and management of ADS and AAS during antenatal check-up in health clinics may help improve birth outcomes and reduce obstetric interventions.
METHODS: A systematic search of Medline via the PubMed, Science Direct, Cochrane Review and Web of Science databases was conducted for studies on the associations between diet and PA factors and cardio-metabolic risk factors among Malaysian adolescents aged 13-18 years that were published until 31 August 2017. The search results were independently screened and extracted by two reviewers.
RESULTS: From over 2,410 references retrieved, 20 full texts articles were screened as potentially relevant. Seventeen (16 cross-sectional and one intervention) met the inclusion criteria for data extraction and analysis. All 17 studies were rated as poor quality and the majority had made insufficient adjustment for confounders. As regards the effect of diet and PA on cardio-metabolic health, the intakes of energy (n = 4) and macronutrients (n = 3) and meal frequency (n = 5) were the most commonly studied dietary factors, while the PA score and level were the most commonly studied PA factors. In addition, BMI and body weight were the most common cardio-metabolic health outcomes. The studies showed that obese and overweight adolescents consume significantly more energy and macronutrients. They are also more likely to skip their daily meals compared to their normal weight peers. In most studies, the direction of the PA effect on body weight was unclear. Some studies found that higher PA is associated with a lower risk of overweight and obesity. However, the associations are often small or inconsistent, with few studies controlling for confounding factors.
CONCLUSIONS: This review identified a lack of evidence and well-conducted prospective studies on the effect of diet and PA on cardio-metabolic health of Malaysian adolescents.
METHOD: This is a 6-month, single-center, prospective, randomized, two-arm, and parallel-group controlled trial. The trial recruits patients attending the otorhinolaryngology clinics of a tertiary referral hospital. Participants are randomized into control or intervention groups in a 1:1 ratio using permuted block randomization. The total number of participants estimated is 154, with each group requiring 77 participants. The control group receives standard pharmaceutical care, while the intervention group receives pharmacist-led education according to the AR-PRISE model. Both groups are assessed for middle turbinate endoscopy findings, disease severity, knowledge level, symptom control, medication adherence, and QoL at baseline and the end-of-study follow-up (day 180 ± 7). Depending on feasibility, intermediate follow-ups are conducted on days 60 ± 7 and 120 ± 7, either virtually or face-to-face. During intermediate follow-ups, participants are assessed for symptom control, medication adherence, and QoL. The intention-to-treat analysis includes all participants assigned to each group. An independent T-test compares the mean difference in knowledge level between the two groups. A two-way repeated measures ANOVA analysis is employed to determine between-group differences for scores of symptom control, adherence rate, and QoL. A P-value
DESIGN: AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT.
SETTING: Acute stroke units at 44 hospitals in 8 countries.
PARTICIPANTS: The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised.
MODEL: We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment.
RESULTS: The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65).
CONCLUSIONS: A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials.
TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247).
METHODS: This prospective observational study included patients requiring CRRT in a tertiary intensive care unit (ICU) from February 2022 to January 2023. They were classified to either the RCA or usual care groups based on the anticoagulation technique chosen by the treating physician, considering contraindications. The CRRT prescription follows the institutional protocol. All relevant data were obtained from the ICU CRRT-RCA charts and electronic medical records. A cost analysis was performed.
RESULTS: A total of 54 patients (27 per group) were included, with no demographic differences. Sequential Organ Failure Assessment score and lactate levels were significantly higher in the usual care group. The number of filters used were comparable (p = .108). The median filter duration in the RCA group was numerically longer (35.00 [15.50-56.00] vs. 23.00 [17.00-29.00] h), but not statistically significant (p = .253). The duration of mechanical ventilation, vasopressor requirement, and mortality were similar, but the RCA group had a significantly longer ICU stay. The rate of adverse events was similar, with four severe metabolic alkalosis cases in the RCA group. The RCA group had higher total cost per patient per day (USD 611 vs. 408; p = .013).
CONCLUSION: In this resource-limited setting, RCA for CRRT appeared safe and had clinically longer filter lifespan compared with usual care, albeit the increased cost.
METHODS: Women up to 50 years of age, in perimenopause, with vasomotor and psychosomatic symptoms of the climacteric syndrome were enrolled for the study. The trial was randomized, double-blinded, placebo-controlled, comparative, and prospective.
RESULTS: A total of 106 participants were enrolled in the trial and, per protocol, 105 completed the trial. We observed statistically significant improvements in most of the Greene Climacteric Scale symptoms, State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS), and Well-being, Activity, and Mood (WAM) scores. The intervention was well tolerated with few adverse effects reported to be mild and transient.
CONCLUSION: The use of this dietary supplement is safe and eliminates or improves vasomotor and psychosomatic symptoms of climacteric symptoms in perimenopausal women: it improves sleep and cognitive abilities, lowers depression and anxiety, improves mood and well-being, and positively affects quality of life.
GOV IDENTIFIER: NCT03897738.
METHODS: This was a planned post-hoc analysis of multicenter prospective cohort study involving 1,218 at-risk surgical patients without prior diagnosis of sleep apnea. All patients underwent home sleep apnea testing (ApneaLink Plus, ResMed) simultaneously with pulse oximetry (PULSOX-300i, Konica Minolta Sensing, Inc). The predictive performance of the 4% oxygen desaturation index (ODI) versus apnea-hypopnea index (AHI) were determined.
RESULTS: Of 1,218 patients, the mean age was 67.2 ± 9.2 years and body mass index (BMI) was 27.0 ± 5.3 kg/m2. The optimal cut-off for predicting moderate-to-severe and severe OSA was ODI ≥15 events/hour. For predicting moderate-to-severe OSA (AHI ≥15), the sensitivity and specificity of ODI ≥ 15 events per hour were 88.4% (95% confidence interval [CI], 85.7-90.6) and 95.4% (95% CI, 94.2-96.4). For severe OSA (AHI ≥30), the sensitivity and specificity were 97.2% (95% CI, 92.7-99.1) and 78.8% (95% CI, 78.2-79.0). The area under the curve (AUC) for moderate-to-severe and severe OSA was 0.983 (95% CI, 0.977-0.988) and 0.979 (95% CI, 0.97-0.909) respectively.
DISCUSSION: ODI from oximetry is sensitive and specific in predicting moderate-to-severe or severe OSA in at-risk surgical population. It provides an easy, accurate, and accessible tool for at-risk surgical patients with suspected OSA.
METHODS: HRD status was determined using the ACTHRD assay, an enrichment-based targeted next-generation sequencing assay. PD-L1 expression was assessed by SP263 immunohistochemistry assay. PD-L1 expression positivity was defined by the PD-L1 expression on ≥ 1% of immune cells. Kaplan-Meier method was utilised to analyse progression-free survival (PFS).
RESULTS: This exploratory biomarker analysis included 225 patients and tested HRD status [N = 190; positive, N = 125 (65.8%)], PD-L1 expression [N = 196; positive, N = 56 (28.6%)], and BRCA1/2 mutation status (N = 219). The HRD-positive patients displayed greater median PFS than the HRD-negative patients [17.9 months (95% CI: 14.5-22.1) versus 9.2 months (95% CI: 7.5-13.8)]. PD-L1 was predominantly expressed on immune cells. Positive PD-L1 expression on immune cells was associated with shortened median PFS in the patients with germline BRCA1/2 mutations [14.5 months (95% CI: 7.4-18.2) versus 22.2 months (95% CI: 18.3-NA)]. Conversely, positive PD-L1 expression on immune cells was associated with prolonged median PFS in the patients with wild-type BRCA1/2 [20.9 months (95% CI: 13.9-NA) versus 8.3 months (95% CI: 6.7-13.8)].
CONCLUSIONS: HRD remained an effective biomarker for enhanced olaparib efficacy in the Asian patients with PSROC. Positive PD-L1 expression was associated with decreased olaparib efficacy in the patients with germline BRCA1/2 mutations but associated with improved olaparib efficacy in the patients with wild-type BRCA1/2.
TRIAL REGISTRATION: NCT03534453. Registered at May 23, 2018.
OBJECTIVE: This research aimed to investigate the effects of the genetic polymorphisms CYP3A4*1B and CYP3A5*3 on atorvastatin treatment in Egyptians.
METHODS: In this prospective cohort study, 100 subjects were genotyped for these SNPs. All participants were screened for serum lipid profiles, liver enzymes, total bilirubin (TB), and creatine kinase (CK) before and after 40 mg postatorvastatin therapy. Atorvastatin plasma levels were assessed posttreatment; atorvastatin pharmacokinetics were evaluated in five carriers of the CYP3A4*1B (T/T) and CYP3A5*3 (C/C) genotypes.
RESULTS: The allele frequencies of the CYP3A4*1B and CYP3A5*3 SNPs were 86% and 83%, respectively. The CYP3A4*1B (T/T) and CYP3A5*3 (C/C) genotypes significantly improved the serum triglyceride (TG) level (P
DESIGN: Prospective cohort study.
SETTING: Community-dwelling older adults interviewed at baseline (2013-2016) and follow-up (2020-2022) as a part of the Malaysian Elders Longitudinal Research study were included.
PARTICIPANTS: Participants who attended face-to-face follow-up visits.
PRIMARY AND SECONDARY OUTCOME MEASURES: Fall occurrence over 12 months preceding the follow-up visit was determined. Anthropometric, bioimpedance analysis and physical performance measurements were obtained at both time points. Participants were categorised into three groups according to changes in weight and body composition using≥5% increase or decrease in weight to determine loss or gain.
RESULTS: Of the 225 participants, aged 71.8±6.8 years, 128 (56.9%) were women. Weight gain was associated with increased fall risk at follow-up compared with stable weight (adjusted rate ratio, aRR (95% confidence interval, CI)=2.86 (1.02-8.02)) following adjustments for age and body mass index (BMI), but this relationship was attenuated by low baseline percentage lean body mass (%LBM) in women. The association was strenghtened after adjusting for age, BMI, and low muscle strength (aRR (95% CI)=2.89 (1.01-8.28)). Weight change did not influence falls risk in men. No difference was observed with changes in percentage body fat and %LBM over time with fall occurrence for both genders.
CONCLUSION: Lower baseline lean body mass influenced the relationship between weight gain and falls longitudinally. Interventions addressing low lean body mass should be considered in the prevention of weight-gain-related falls in older women.
DESIGN: Prospective multicenter observational study from June 2020 to September 2022.
SETTING: Fifteen PICUs in PACCMAN.
PATIENTS: All children younger than 18 years old diagnosed with pneumonia and admitted to the PICU.
INTERVENTIONS: None.
MEASUREMENTS AND MAIN RESULTS: Clinical, microbiologic, and outcome data were recorded. The primary outcome was PICU mortality. Univariate and multivariable logistic regression was performed to investigate associations between PICU mortality and explanatory risk factors on presentation to the PICU. Among patients screened, 846 of 11,778 PICU patients (7.2%) with a median age of 1.2 years (interquartile range, 0.4-3.7 yr) had pneumonia. Respiratory syncytial virus was detected in 111 of 846 cases (13.1%). The most common bacteria were Staphylococcus species (71/846 [8.4%]) followed by Pseudomonas species (60/846 [7.1%]). Second-generation cephalosporins (322/846 [38.1%]) were the most common broad-spectrum antibiotics prescribed, followed by carbapenems (174/846 [20.6%]). Invasive mechanical ventilation and noninvasive respiratory support was provided in 438 of 846 (51.8%) and 500 of 846 (59.1%) patients, respectively. PICU mortality was 65 of 846 (7.7%). In the multivariable logistic regression model, age (adjusted odds ratio [aOR], 1.08; 95% CI, 1.00-1.16), Pediatric Index of Mortality 3 score (aOR, 1.03; 95% CI, 1.02-1.05), and drowsiness (aOR, 2.73; 95% CI, 1.24-6.00) were associated with greater odds of mortality.
CONCLUSIONS: In the PACCMAN contributing PICUs, pneumonia is a frequent cause for admission (7%) and is associated with a greater odds of mortality.
METHOD: s. A prospective cohort observational study was performed on patients who underwent prostate biopsy under LA. Visual Analogue Scale (VAS) was used during the procedure. International Prostate Symptoms Score (IPSS) and International Index of Erectile dysfunction (IIEF) were assessed before the procedure and in 14 days after the procedure. Complication for each procedure was recorded.
RESULT: A total of 128 patients with 64 patients for each group underwent prostate biopsy by TP and TR under LA. TP targeted biopsy group had comparable pain scores to those who underwent the procedure using the TR routes. The median pain score for the TP group was 2 and TR was 3, (IQR=2, range 0-10 for both groups)with no significant pain difference between both groups (P=0.48). Furthermore, there was no significant difference in urinary function(p=0.68) and sexual function (p=0.19) between the two groups post-procedure. Both groups have similar rates of complications, with no significant difference observed. Urinary tract infection incidents that did occur were rare and did not significantly differ between the groups (p=0.21). None of the patients experienced sepsis postoperatively. AUR was reported in both groups, slightly higher with 9.4%(N=6) in the TP group and 6.3%(N=4) in the TR group however no significant difference(p=0.112) was noted. Haematuria is common in both groups with TP (66%) and TR (59%) but self-limiting with Clavien-Dindo grade I without significant difference (p=0.589).
CONCLUSION: Our results showed that both Transperineal and transrectal approaches have similar tolerability with no significant difference in functional outcome or complications. Further studies are mandatory to verify our results.
METHODS: We formulated body capacitive index (BCI), C(BMI) (capacitance × height(2)/weight), body resistive index (BRI), R(BMI) (resistance × weight/height(2)), and CH(2) (capacitance × height(2)). We also studied H(2)/R, R/H, and reactance of a capacitor/height (X(C) /H). There are 3 components in this study design: (1) establishment of normal values in a control Malaysian population, (2) comparison of these with a CAPD population, and (3) prediction of survival within a CAPD population. We initially performed a BIA study in 206 female and 116 male healthy volunteers, followed by a prospective study in a cohort of 128 CAPD patients [47 with diabetes mellitus (DM), 81 non-DM; 59 males, 69 females] for at least 2 years. All the parameters during enrolment, including BIA, serum albumin, peritoneal equilibrium test, age, and DM status, were analyzed. Outcome measurement was survival.
RESULTS: In healthy volunteers, both genders had the same BCI (2.0 nF kg/m(2)). On the contrary, female normal subjects had higher BRI than male normal subjects (median 15 642 vs 13242 Ω kg/m(2), p < 0.001) due to higher fat percentage (35.4% ± 0.4% vs 28.0% ± 0.6%, p < 0.001), resulting in a lower phase angle (mean 5.82 ± 0.04 vs 6.86 ± 0.07 degrees, p < 0.001). Logistic regression showed that BCI was the best risk indicator in 128 CAPD patients versus 322 normal subjects. In age- and body mass index (BMI)-matched head-to-head comparison, BCI had the highest χ(2) value (χ(2) = 102.63), followed by CH(2) (or H(2)/X(C); χ(2) = 81.00), BRI (χ(2) = 20.54), and X(C)/H (χ(2) = 20.48), with p value < 0.001 for these parameters. In comparison, phase angle (χ(2) = 11.42), R/H (χ(2) = 7.19), and H(2)/R (χ(2) = 5.69) had lower χ(2) values. 35 (27.3%) patients died during the study period. Univariate analysis adjusted for DM status and serum albumin level demonstrated that non-surviving patients had significantly higher CH(2) (245 vs 169 nF m(2), p < 0.001) and BCI (4.0 vs 2.9 nF m(2)/kg, p = 0.005) than patients that survived. CH(2) was the best predictor for all-cause mortality in Cox regression analysis, followed by BCI, phase angle, and X(C)/H.
CONCLUSION: Measures that normalize, such as BCI and CH(2), have higher risk discrimination and survival prediction ability than measures that do not normalize, such as phase angle. Unlike phase angle, measurement of BCI overcomes the gender effect. In this study, the best risk indicator for CAPD patients versus the general population is BCI, reflecting deficit in nutritional concentration, while CH(2) reflects total nutritional deficit and thus is the major risk indicator for survival of CAPD patients.