Thai Clinical Trial Registry Research Articles

Comparing Competitive and Recreational Table Tennis Training: Impacts on Quality of life in Older Adults - A Randomized Controlled Trial

Background Owing to its combination of speed, tactics, and accuracy, table tennis is becoming a sport exercise that is suitable for older adults. Casual play is fun and relaxing, and more serious table tennis might further develop skills through focused practice. Methods A randomized controlled trial (RCT) aimed to determine how the practice of competition compared to leisure playing affects the Quality of life (QoL) of people aged 40-70. Selecting subjects at random, one group of subjects undertook a structured competitive regimen, whereas the other group was given time to play recreationally without any structured competition. QoL was measured before and after the intervention using the WHOQOL-BREF, which measures physical, psychological, social, and environmental domains. Data were analyzed using paired and independent t-test. Results The group that received structured competition reported a marked improvement in their QoL indicators, especially in physical health (p < 0.001), psychological health (p < 0.001), and social relationships (p = 0.001), when compared to the control group, which showed few improvements. No significant differences were observed in the environmental domains in either group. Conclusions Regular competitive table tennis practice improves physical condition, emotions, and social relationships, which leads to a higher QoL in older adults. Thus, these results emphasize the utility of competitive sports in the maintenance of active and healthy aging. Registration Thai Clinical Trial Registry (TCTR) ID TCTR20250105001, registered on December 28, 2024

A reduced-dose recombinant pertussis vaccine booster in Thai adolescents: a phase 2/3, observer-blinded, randomised controlled, non-inferiority trial

A resurgence of pertussis has increased the demand for low-cost vaccines. The aim of this study was to test the immunogenicity of a booster acellular monovalent pertussis vaccine containing reduced-dose (2 μg) recombinant pertussis toxin (PT) and 5 μg filamentous haemagglutinin (FHA; apgen) against a version of apgen containing tetanus and reduced-dose diphtheria toxoids (Tdapgen) and a licensed vaccine containing chemically detoxified PT and FHA combined with tetanus toxoid and reduced-dose diphtheria toxoid (Tdapchem). This phase 2/3, observer-blinded, randomised, controlled, non-inferiority trial was done in adolescents aged 9-17 years at two clinical research centres in Bangkok and Pathum Thani, Thailand. Eligible participants were screened and randomly assigned (1:1:1) to receive one booster dose of apgen, Tdapgen, or Tdapchem vaccine. Participants were followed up until day 336 post-immunisation. The primary endpoint was non-inferior seroconversion rates in Tdapgen and Tdapchem vaccine groups, with seroconversion rate defined as the proportion of participants with at least a four-fold increase on day 28 post-immunisation relative to baseline of anti-PT and anti-FHA IgG. The non-inferiority for seroconversion rates of anti-PT and anti-FHA IgG was defined as the lower bound of the two-sided 95% CI of the seroconversion rate for Tdapgen compared with Tdapchem exceeding -10%. Immunogenicity was analysed in the per-protocol population. All safety data were collected, and the prevalence of adverse events was analysed in the intention-to-treat population. This trial was registered on the Thai Clinical Trial Registry (TCTR20181031001). Between June 18, and Aug 3, 2019, 450 adolescents (mean age 12·1 years, SD 2·5) were enrolled and randomly assigned (150 participants in each group). Day 28 anti-PT IgG seroconversion rates were 141 (94%) of 150 participants who received Tdapgen (95% CI 88·8-97·0) and 105 (71%) of 149 participants who received Tdapchem (62·7-77·2; p<0·0001). Day 28 anti-FHA IgG seroconversion rates were 144 (96%) of 150 participants who received Tdapgen (91·4-98·3) and 124 (83%) of 149 participants who received Tdapchem (76·4-88·4; p<0·0001). The difference in seroconversion rates was 23·5% (95% CI 15·3-31·8) for anti-PT IgG and 12·8% (6·0-19·6) for anti-FHA IgG, when comparing the Tdapgen versus the Tdapchem vaccine group. No vaccine-related serious adverse events were reported. Recombinant Tdapgen vaccine showed non-inferior immunogenicity compared with Tdapchem at day 28 in terms of seroconversion rate of anti-PT IgG and anti-FHA IgG relative to baseline. The reduced-dose approach for Tdapgen vaccines thus presents as a potentially cost-saving booster strategy to protect adolescents against pertussis. Office of National Higher Education Science Research and Innovation Policy Council (Programme Management Unit Competitiveness), Thailand, and BioNet-Asia.

Postoperative Pain Control After ACL Reconstruction With Semitendinosus Tendon Graft: A Randomized Controlled Trial Comparing Adductor Canal Block to Local Infiltration Analgesia.

Both adductor canal block (ACB) and local infiltration (LI) are effective for postoperative pain management after arthroscopic-assisted anterior cruciate ligament (ACL) reconstruction (ACLR). While LI is a more straightforward procedure, its effectiveness remains debated. To evaluate morphine consumption within 48 hours after ACLR with a semitendinosus tendon graft, comparing ACB and LI; secondary objectives: to evaluate pain levels, patient satisfaction, quadriceps strength, range of knee motion, and complications. Randomized controlled trial; Level of evidence, 1. Patients undergoing primary ACLR with a semitendinosus tendon graft were randomized to receive either ACB (0.25% bupivacaine; 20 mL) or LI at the surgical wound, graft harvest area, and intra-articular injection. The LI group received morphine (3 mg), ketorolac (30 mg), and tranexamic acid (1 g). Morphine consumption within 48 hours was monitored using an intravenous patient-controlled analgesia device. A total of 48 patients were analyzed (n = 24 in each group); baseline characteristics were similar between groups. The LI group consumed significantly less morphine than the ACB group at 6 hours (median [interquartile range, IQR], 3 mg [0-4.8 mg] for the LI group vs 5.5 mg [2-9] for the ACB group; P = .003). However, no significant differences were observed in morphine consumption at other time points. Additionally, no significant difference was found in cumulative morphine consumption at 48 hours between the groups (median [IQR], 21.5 mg [11-34.5 mg] for the ACB group vs 16.5 mg [8.5-21.8 mg] for the LI group; P = .137). Postoperative pain scores, quadriceps strength, and patient satisfaction were similar between the 2 groups. Morphine consumption at 48 hours postoperatively was comparable between the LI and ACB groups, and no significant group differences were found in postoperative pain, quadriceps strength, or patient satisfaction. TCTR20190320003 (Thai Clinical Trial Registry).

Impact of Lactocaseibacillus (Lactobacillus) paracasei sup. paracasei TISTR 2593 Probiotic Supplementation on the Gut Microbiome of Hypercholesterolemia Patients: A Randomized Controlled Trial.

Probiotics have shown potential in managing hypercholesterolemia and related metabolic conditions. This study evaluated the effects of Lactocaseibacillus (Lactobacillus) paracasei sup. paracasei TISTR 2593 on the gut microbiome and metabolic health in patients with hypercholesterolemia, and was registered in the Thai Clinical Trial Registry (TCTR 20220917002). In a randomized, double-blind, placebo-controlled trial, 22 hypercholesterolemic participants received either the probiotic or a placebo daily for 90 days. Fecal samples collected before and after the intervention revealed significant microbiome changes, including a decrease in Subdoligranulum, linked to rheumatoid arthritis, and an increase in Flavonifractor, known for its anti-inflammatory properties. Additionally, the probiotic group exhibited a significant reduction in low-density lipoprotein cholesterol (LDL-C) levels. These findings suggest that L. paracasei TISTR 2593 can modulate the gut microbiome and improve metabolic health, warranting further investigation into its mechanisms and long-term benefits.

Acetaminophen and Chlorpheniramine Maleate Premedication among Patients with Chronic Transfusion: a Prospective, Randomized Controlled Trial

Introduction: Patients with chronic transfusion, especially those with transfusion-dependent thalassemia, are susceptible to transfusion reactions. Acetaminophen and/or chlorpheniramine maleate (CPM) are commonly used as premedication in Thailand, although their efficacy in preventing transfusion reactions remains unclear. This study aims to evaluate the efficacy of acetaminophen and CPM in preventing febrile nonhemolytic transfusion reaction (FNHTR) and allergic transfusion reaction (ATR) before leukocyte-poor packed red cells (LPRC) transfusion.Methods: This study is a prospective, randomized controlled trial involving patients with chronic transfusionaged 18 years. Patients were randomly assigned to either receive oral acetaminophen and intravenous CPM or placebo (calcium carbonate and normal saline) before LPRC transfusion. The primary endpoint was the combined incidence of FNHTR and ATR amongpatients receiving premedication compared with those receiving placebo. This study was registered at Thai Clinical Trial Registry Study ( TCTR20221011002).Results: Ninety-four patients were recruited, with 46 in the premedication arm and 48 in the placebo arm. The incidence of FNHTR and allergic transfusion reaction in the premedication arm and the placebo arm was 0% and 2.1%, respectively (P = 0.33). FNHTR occurred in one patient in the placebo arm, and no patients presented ATR. No adverse events were reported with any medication.Conclusions: Among patients with chronic transfusion receiving LPRC, the incidence of FNHTR or ATR is low. Premedication with oral acetaminophen and intravenous CPM did not have benefits in preventing transfusion reactions. Therefore, acetaminophen and CPM could be safely omitted in chronic transfused patients without a history of transfusion reactions

Effectiveness of a phone-based support program on self-care self-efficacy, psychological distress, and quality of life among women newly diagnosed with breast cancer: A randomized controlled trial

PurposeThis study aimed to determine the effectiveness of a Phone-Based Support Program (PBSP) for newly diagnosed women with breast cancer. MethodsA two-group repeated measures randomized controlled trial was designed. Participants included 94 patients aged 18–60 years who were newly diagnosed with breast cancer and undergoing chemotherapy in a tertiary hospital in China. They were randomly assigned to the intervention and the control groups. Participants in the intervention group were enrolled in a four-session PBSP, consisting of four interactive sections: learning, discussion, ask-the-expert, and personal stories, plus the routine care. Outcomes included patients’ self-care self-efficacy, psychological distress (including symptom distress, anxiety, and depression), and quality of life. These were assessed at three time points: pre-intervention (T1), post-intervention (T2), and follow-up (T3) by using the self-care self-efficacy scale, the M.D. Anderson Symptom Inventory, the hospital anxiety and depression scale, and the global health status scale. ResultsAfter completion of the intervention, participants in the intervention group had significantly (p < .001) higher self-care self-efficacy (T2: Mdiff = 11.49, T3: Mdiff = 22.33), better quality of life (T2: Mdiff = 8.18, T3: Mdiff = 17.19), lower symptom distress (T2: Mdiff =−26.68, T3: Mdiff = −54.76), less anxiety (T2: Mdiff = −2.52, T3: Mdiff = −5.11), and less depression (T2: Mdiff = −3.61, T3: Mdiff = −6.71) than those in the control group. ConclusionThese findings indicate that the PBSP is effective. Healthcare professionals, especially nurses, could utilize it to enhance self-care self-efficacy and quality of life, as well as decrease psychological distress among women newly diagnosed breast cancer. RegistrationThe Thai Clinical Trial Registry #TCTR20230321010.

SARS-CoV-2-Specific Antibodies, B Cell and T Cell Immune Responses after ChAdOx1 nCoV-19 Vaccination in Solid Organ Transplant Recipients.

Immunization against SARS-CoV-2 is essential for vulnerable solid organ transplant (SOT) recipients who are at risk of infection. However, there are concerns about suboptimal immunogenicity, especially in humoral immunity (HMI), and limited exploration of cell-mediated immune (CMI) responses. The primary objective of this study was to assess the immunogenicity of ChAdOx1 nCoV-19 vaccination in SOT recipients. The secondary endpoint was to evaluate factors that affect immunogenicity and adverse events (AEs) following immunization in SOT recipients. All adult SOT recipients who received the two-dose ChAdOx1 nCoV-19 vaccine at a 12-week interval underwent measurements of HMI by evaluating anti-receptor-binding domain (RBD) IgG levels and CMI by investigating SARS-CoV-2-specific T cell and B cell responses before and after complete vaccination, around 2-4 weeks post-vaccination, and compared to controls. AEs were monitored in all participants. The study included 63 SOT recipients: 44 kidney recipients, 16 liver recipients, and 3 heart transplant recipients, along with 11 immunocompetent controls. Among SOT recipients, 36% were female, and the median (IQR) age was 52 (42-61). The median (IQR) time since transplant was 55 (28-123) months. After the second dose, the median (IQR) anti-RBD antibody levels were significantly lower in SOT recipients compared to those in the control group (8.3 [0.4-46.0] vs. 272.2 [178.1-551.6] BAU/mL, p < 0.01). This resulted in a seroconversion rate (anti-RBD antibody > 7.1 BAU/mL) of 51% among SOT recipients and 100% among controls (p = 0.008). Receiving the vaccine beyond one year post-transplant significantly affected seroconversion (OR 9.04, 95% CI 1.04-78.56, p = 0.046), and low-dose mycophenolic acid marginally affected seroconversion (OR 2.67, 95% CI 0.89-7.96, p = 0.079). RBD-specific B cell responses were also significantly lower compared to those in the control group (0 [0-4] vs. 10 [6-22] SFUs/106 PBMCs, p = 0.001). Similarly, S1- and SNMO-specific T cell responses were significantly lower compared to those in the control group (48 [16-128] vs. 216 [132-356] SFUs/106 PBMCs, p = 0.004 and 20 [4-48] vs. 92 [72-320] SFUs/106 PBMCs, p = 0.004). AEs were generally mild and spontaneously resolved. SOT recipients who received the full two-dose ChAdOx1 nCoV-19 vaccine demonstrated significantly diminished HMI and CMI responses compared to immunocompetent individuals. Consideration should be given to administering additional vaccine doses or optimizing immunosuppressant regimens during vaccination (Thai Clinical Trial Registry: TCTR20210523002).

Factors for predicting 28‐day mortality in older patients with suspected of having sepsis in the emergency department

AbstractBackgroundOlder patients face increased sepsis risk, requiring precise prognostic tools in the emergency department (ED). This study aimed to explore factors predicting 28‐day mortality among older (≥60 years) patients with suspicion of sepsis in the ED.MethodsWe performed a retrospective cohort study. Data for all older patients with clinical suspected sepsis presenting to the ED from 1 October 2018 to 31 December 2018, were collected. Prognostic factors, characteristics, comorbidities, vital signs at triage, the emergency severity score, initial laboratory results, and sepsis bundle treatment were analyzed using univariable and multivariable Cox regression. Hazard ratios (HR) were calculated using these analytical methodologies to prognosticate 28‐day mortality.ResultsA total of 329 older patients with suspected sepsis were included. The overall 28‐day mortality was 10.33%. Independent prognostic factors that were significantly associated with 28‐day mortality were malignancy (adjusted hazard ratio [aHR]: 3.67; 95% confidence interval [CI]: 1.90, 7.09; p &lt; 0.01), oxygen saturation ≤93% (aHR: 3.37; 95% CI: 1.79, 3.43; p &lt; 0.01), and dependent status (hazard ratio [HR]: 2.27; 95% CI: 1.14, 4.53; p = 0.02).ConclusionsThis study suggests that “MOD”; M‐Malignancy, O‐Oxygen saturation ≤93%, and D‐Dependent status are significant prognostic indicators for 28‐day mortality among older patients with suspected sepsis in the ED.Trial registrationThe trial was retrospectively registered in the Thai Clinical Trial Registry on 06/05/2022, identification number TCTR20220506006.

The effects of real-time waveform analysis software on patient ventilator synchronization during pressure support ventilation: a randomized crossover physiological study

BackgroundPatient-ventilator asynchrony commonly occurs during pressure support ventilation (PSV). IntelliSync + software (Hamilton Medical AG, Bonaduz, Switzerland) is a new ventilation technology that continuously analyzes ventilator waveforms to detect the beginning and end of patient inspiration in real time. This study aimed to evaluate the physiological effect of IntelliSync + software on inspiratory trigger delay time, delta airway (Paw) and esophageal (Pes) pressure drop during the trigger phase, airway occlusion pressure at 0.1 s (P0.1), and hemodynamic variables.MethodsA randomized crossover physiologic study was conducted in 14 mechanically ventilated patients under PSV. Patients were randomly assigned to receive conventional flow trigger and cycling, inspiratory trigger synchronization (I-sync), cycle synchronization (C-sync), and inspiratory trigger and cycle synchronization (I/C-sync) for 15 min at each step. Other ventilator settings were kept constant. Paw, Pes, airflow, P0.1, respiratory rate, SpO2, and hemodynamic variables were recorded. The primary outcome was inspiratory trigger and cycle delay time between each intervention. Secondary outcomes were delta Paw and Pes drop during the trigger phase, P0.1, SpO2, and hemodynamic variables.ResultsThe time to initiate the trigger was significantly shorter with I-sync compared to baseline (208.9±91.7 vs. 301.4±131.7 msec; P = 0.002) and I/C-sync compared to baseline (222.8±94.0 vs. 301.4±131.7 msec; P = 0.005). The I/C-sync group had significantly lower delta Paw and Pes drop during the trigger phase compared to C-sync group (-0.7±0.4 vs. -1.2±0.8 cmH2O; P = 0.028 and − 1.8±2.2 vs. -2.8±3.2 cmH2O; P = 0.011, respectively). No statistically significant differences were found in cycle delay time, P0.1 and other physiological variables between the groups.ConclusionsIntelliSync + software reduced inspiratory trigger delay time compared to the conventional flow trigger system during PSV mode. However, no significant improvements in cycle delay time and other physiological variables were observed with IntelliSync + software.Trial registrationThis study was registered in the Thai Clinical Trial Registry (TCTR20200528003; date of registration 28/05/2020).

Benchmarking CRISPR-BP34 for point-of-care melioidosis detection in low-income and middle-income countries: a molecular diagnostics study

Melioidosis is a neglected but often fatal tropical disease. The disease has broad clinical manifestations, which makes diagnosis challenging and time consuming. To improve diagnosis, we aimed to evaluate the performance of the CRISPR-Cas12a system (CRISPR-BP34) to detect Burkholderia pseudomallei DNA across clinical specimens from patients suspected to have melioidosis. We conducted a prospective, observational cohort study of adult patients (aged ≥18 years) with melioidosis at Sunpasitthiprasong Hospital, a tertiary care hospital in Thailand. Participants were eligible for inclusion if they had culture-confirmed B pseudomallei infection from any clinical samples. Data were collected from patient clinical records and follow-up telephone calls. Routine clinical samples (blood, urine, respiratory secretion, pus, and other body fluids) were collected for culture. We documented time taken for diagnosis, and mortality at day 28 of follow-up. We also performed CRISPR-BP34 detection on clinical specimens collected from 330 patients with suspected melioidosis and compared its performance with the current gold-standard culture-based method. Discordant results were validated by three independent qualitative PCR tests. This study is registered with the Thai Clinical Trial Registry, TCTR20190322003. Between Oct 1, 2019, and Dec 31, 2022, 876 patients with culture-confirmed melioidosis were admitted or referred to Sunpasitthiprasong Hospital, 433 of whom were alive at diagnosis and were enrolled in this study. Median time from sample collection to diagnosis by culture was 4·0 days (IQR 3·0-5·0) among all patients with known survival status at day 28, which resulted in delayed treatment. 199 (23%) of 876 patients died before diagnosis and 114 (26%) of 433 patients in follow-up were treated, but died within 28 days of admission. To test the CRISPR-BP34 assay, we enrolled and collected clinical samples from 114 patients with melioidosis and 216patients without melioidosis between May 26 and Dec 31, 2022. Application of CRISPR-BP34 reduced the median sample-to-diagnosis time to 1·1 days (IQR 0·7-1·5) for blood samples, 2·3 h (IQR 2·3-2·4) for urine, and 3·3 h (3·1-3·4) for respiratory secretion, pus, and other body fluids. The overall sensitivity of CRISPR-BP34 was 93·0% (106 of 114 samples [95% CI 86·6-96·9]) compared with 66·7% (76 of 114 samples [57·2-75·2]) for culture. The overall specificity of CRISPR-BP34 was 96·8% (209 of 216 samples [95% CI 93·4-98·7]), compared with 100% (216 of 216 samples [98·3-100·0]) for culture. The sensitivity, specificity, speed, and window of clinical intervention offered by CRISPR-BP34 support its prospective use as a point-of-care diagnostic tool for melioidosis. Future development should be focused on scalability and cost reduction. Chiang Mai University Thailand and Wellcome Trust UK.

Primaquine in glucose-6-phosphate dehydrogenase deficiency: an adaptive pharmacometric assessment of ascending dose regimens in healthy volunteers

Background:Primaquine is an 8-aminoquinoline antimalarial. It is the only widely available treatment to prevent relapses of Plasmodium vivax malaria. The 8-aminoquinolines cause dose-dependent haemolysis in glucose-6-phosphate dehydrogenase deficiency (G6PDd). G6PDd is common in malaria endemic areas but testing is often not available. As a consequence primaquine is underused.Methods:We conducted an adaptive pharmacometric study to characterise the relationship between primaquine dose and haemolysis in G6PDd. The aim was to explore shorter and safer primaquine radical cure regimens compared to the currently recommended 8-weekly regimen (0.75 mg/kg once weekly), potentially obviating the need for G6PD testing. Hemizygous G6PDd healthy adult Thai and Burmese male volunteers were admitted to the Hospital for Tropical Diseases in Bangkok. In Part 1, volunteers were given ascending dose primaquine regimens whereby daily doses were increased from 7.5 mg up to 45 mg over 15–20 days. In Part 2 conducted at least 6 months later, a single primaquine 45 mg dose was given.Results:24 volunteers were enrolled in Part 1, and 16 in Part 2 (13 participated in both studies). In three volunteers, the ascending dose regimen was stopped because of haemolysis (n=1) and asymptomatic increases in transaminases (n=2; one was hepatitis E positive). Otherwise the ascending regimens were well tolerated with no drug-related serious adverse events. In Part 1, the median haemoglobin concentration decline was 3.7 g/dL (range: 2.1–5.9; relative decline of 26% [range: 15–40%]). Primaquine doses up to 0.87 mg/kg/day were tolerated subsequently without clinically significant further falls in haemoglobin. In Part 2, the median haemoglobin concentration decline was 1.7 g/dL (range 0.9–4.1; relative fall of 12% [range: 7–30% decrease]). The ascending dose primaquine regimens gave seven times more drug but resulted in only double the haemoglobin decline.Conclusions:In patients with Southeast Asian G6PDd variants, full radical cure treatment can be given in under 3 weeks compared with the current 8-week regimen.Funding:Medical Research Council of the United Kingdom (MR/R015252/1) and Wellcome (093956/Z/10/C, 223253/Z/21/Z).Clinical trial number:Thai Clinical Trial Registry: TCTR20170830002 and TCTR20220317004.

Self-treatment of freezing of gait in Parkinson’s disease patients using silicone pads to apply Thai acupressure to plantar acupoints: A randomised, controlled trial

IntroductionFreezing of gait (FOG) involves dysfunction of the motor and sensory systems. Peripheral sensory stimuli, including Thai acupressure, can improve proprioceptive function and decrease FOG episodes. Here, we sought to determine the efficacy of acupressure as a self-treatment to alleviate FOG in patients with Parkinson’s disease (PD). MethodsWe conducted an open-label, controlled trial of 60 PD patients with FOG while medicated, randomised into two groups: an active-treatment group using silicone pads to apply pressure to plantar acupoints on the head of the big toe and the base of the first metatarsal bone on each foot for 6 s using patient body weight while seated, repeated four times for each acupoint bilaterally, and a sham-treatment group using a similar protocol without the silicone pads. The primary outcome was stride length. Secondary outcomes included FOG episodes, FOG duration, percent duration of FOG to total gait time (%FOG), and gait parameters. A baseline-adjusted analysis of covariance was used to compare outcomes between the two groups. ResultsCompared with the sham treatment, the active treatment increased stride length, gait velocity, and cadence (all p < 0.001), and decreased FOG episodes and duration (both p < 0.001), %FOG (p = 0.011), and double-support time (p < 0.001). No adverse effects were noted. ConclusionsAcupressure using silicone pads to stimulate plantar acupoints for self-treatment is a noninvasive, simple, safe way to improve gait and alleviate FOG in patients with PD. Clinical Trial RegistrationWe registered the study prospectively in the Thai Clinical Trial Registry No. TCTR20200317001.

Optimal chest compression position for cardiopulmonary resuscitation determined by computed tomography image: retrospective cross-sectional analysis

The objective of this study was to determine the height of optimal hand position for chest compression during adult cardiopulmonary resuscitation (CPR) from the tip of the sternal xiphoid process (TOX) along with the relative heights of the left ventricular outflow tract (LVOT) and abdominal organs among the Thai population. The retrospective cross-sectional study was conducted through a review of medical records and contrast-enhanced chest computed tomography. The total of 204 Thai patients without obvious chest deformity at Ramathibodi Hospital from January to June 2018 was included as part of a multi-regional study. The heights of the level of maximal LV width (LVmax), LOVT, top of liver and stomach with respect to TOX were measured on midline sagittal image. Mean age and body mass index (BMI) were 59.5 years and 23.9 kg/m2, respectively. One hundred and one subjects (49.5%) had pulmonary diseases. Mean height of the LVmax from TOX was 37.7 mm, corresponding to 20% of the sternal length (SL) in the inspiration arm raised position (IAR). The adjusted height of LVmax from TOX in the expiration arm-down position (EAD) was 89.7 mm (48% of SL). The inter-nipple line was at 84.5 mm (45.1% of SL) from TOX on IAR. Among 178 and 109 subjects whose uppermost part of the liver and stomach were above TOX, 80.4% and 94.5% were located within the lower half of the sternum, respectively. The adjusted optimal hand position for chest compression during CPR was at approximately 89.7 mm from TOX in EAD (48% of SL). The hand position at the upper part of the lower half of the sternum is closest to the adjusted LVmax and has a better chance to avoid compression of intraabdominal organs.Trial registration This trial was retrospectively registered on 2 February 2023 in the Thai Clinical Trial Registry, identification number TCTR 20230202006.

Effectiveness of a Theory-Based Digital Animated Video Intervention to Reduce Intention and Willingness to Sext Among Diploma Students: Cluster Randomized Controlled Trial.

Sexting refers to the exchange of sexually explicit digital content in the form of texts, photos, or videos. In recent years, sexting has become a public health concern. Surveys in Malaysia show a high prevalence of young adults engaged in sexting. Given that sexting is associated with sexual risk behavior, cyberbullying, and mental health issues, this behavior needs intervention to alleviate the resulting public health burden. However, there is a scarcity of theory-based intervention programs on the prevention of intention and willingness to sext among young adults. This study aimed to develop and implement a sexting intervention module guided by the prototype willingness model (PWM), delivered using web-based animated video, and evaluate its effectiveness among diploma students from a public higher educational institution. The primary outcomes were intention and willingness to sext, while the secondary outcomes were knowledge, attitude, perceived norms, and prototype perceptions of sexting. This 2-armed, parallel, single-blinded cluster randomized controlled trial was conducted in a public higher educational institution in the state of Melaka, Malaysia. Diploma students from 12 programs were randomly allocated into intervention and control groups. Both groups answered a self-administered web-based questionnaire assessing the outcomes at the baseline. The intervention group received a newly developed intervention module based on the PWM in the form of 5 animated videos posted on a private YouTube platform, while the control group was put on the waitlist. The intervention group was encouraged to discuss any issues raised with the researchers via WhatsApp private chat after viewing the videos. All participants were observed immediately and 3 months postintervention. Data analysis was performed with SPSS (version 26; IBM Corp). A generalized linear mixed model was used to determine the effectiveness of the intervention. There were a total of 300 participants with an attrition rate of 8.3% (n=25). After adjusting for age, sex, relationship status, and the amount of time spent on the web, there were significant differences in the intention to sext (β=-.12; P=.002; Cohen d=0.23), willingness to sext (β=-.16; P<.001; Cohen d=0.40), knowledge (β=.12; P<.001; Cohen d=0.39), attitude (β=-.11; P=.001; Cohen d=0.31), perceived norms (β=-.06; P=.04; Cohen d=0.18), and prototype perceptions (β=-.11; P<.001; Cohen d=0.35) between the intervention and control groups over 3 months. In this study, the sexting intervention module using the PWM that was delivered via web-based animated videos was effective in reducing intention and willingness to sext as well as in improving knowledge of sexting, attitudes, perceived norms, and prototype perceptions. Therefore, relevant agencies involved in the promotion of sexual and reproductive health among young adults in Malaysia can consider the implementation of this module. Thai Clinical Trial Registry TCTR20201010002; https://www.thaiclinicaltrials.org/show/TCTR20201002001.

Optical Coherence Tomography Angiography (OCTA) Differences in Vessel Perfusion Density and Flux Index of the Optic Nerve and Peri-Papillary Area in Healthy, Glaucoma Suspect and Glaucomatous Eyes.

To assess the ability of vascular perfusion parameters determined by optical coherence tomography angiography (OCTA) to detect and monitor glaucoma. This prospective study included healthy, glaucoma suspect and glaucomatous eyes. All eyes underwent comprehensive glaucoma examination, including visual field tests and ocular imaging scans by OCTA. Parameters measured included retinal nerve fiber layer (RNFL) thickness, ganglion cell analysis (GCA), vascular perfusion density (VPD) and flux index (FI) of the optic nerve and peri-papillary area. Ocular parameters in healthy, glaucoma suspect, and glaucomatous eyes were compared by generalized estimating equations (GEE) with adjustments for age, with their relationships analyzed by Pearson's correlation coefficient. Rates of change per year were compared in glaucomatous eyes with and without glaucoma progression. This study enrolled 238 eyes, including 56 healthy, 79 glaucoma suspect, and 103 glaucomatous eyes. After adjustments for age, the average VPD (45.40 ± 0.19% vs 45.05 ± 0.22% vs 42.89 ± 0.32%, p < 0.001) and FI (0.4210 ± 0.0055 vs 0.4105 ± 0.0039 vs 0.3801 ± 0.0048, p < 0.001) in these three groups differed significantly. Average VPD in the glaucoma group was inversely associated with the severity of glaucoma, being 43.99 ± 0.32%, 42.63 ± 0.43% and 39.27 ± 0.48% in eyes with early, moderate and severe glaucoma, respectively (p < 0.001). Average VPD, as well as VPD in the superior and inferior quadrants correlated well with both OCT determined RNFL and visual field parameters. The decreases per year in both superior (-0.012 vs -0.001, p = 0.002) and inferior (-0.008 vs -0.003, p = 0.007) FI were significantly greater in glaucomatous eyes with than without glaucoma progression. Both VPD and FI as measured by OCTA are promising ocular parameters that can distinguish between normal and glaucomatous eyes. VPD is sensitive in comparing eyes at different glaucoma stages, whereas FI can detect rates of glaucoma progression. Thai Clinical Trial Registry, TCTR20181031002.

Thirty-day mortality among patients with acute delirium in the emergency department

PurposeThe number of visits to the emergency department (ED) is growing among older patients. Older people are at risk of acute delirium, which is associated with mortality. Our primary objective was to determine the 30-day mortality outcome between older patients with and without acute delirium. MethodsFrom August 2018 to October 2019, we conducted a prospective cohort study in the ED of a tertiary care and university hospital. Patients over the age of 65 years who presented to the ED were included in the study. Within the first 12 h after the ED visit, delirium was assessed by using the Thai version of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). We collected data on 30-day mortality, ED LOS, hospital length of stay (LOS), and the 30-day ED revisit rate. ResultsWe enrolled 173 patients in this study; 49 (28%) patients had acute delirium according to the CAM-ICU. The overall 30-day mortality was 4% (7/173). Delirium had no effect on 30-day mortality (adjusted odds ratio [OR], 2.15; 95% confidence interval [CI], 0.37–12.55; P = 0.40). Delirium was not associated with hospital LOS (adjusted mean difference −18.83 h; 95% CI, −71.94–34.28; P = 0.49) and the 30-day ED revisit rate (adjusted OR, 1.55; 95% CI, 0.59–4.11; P = 0.37). However, an increasing trend in ED LOS was observed (adjusted mean difference 16.39 h; 95% CI, −0.160–32.96; P = 0.05). ConclusionsWe found insufficient evidence to establish an association between delirium and 30-day mortality, hospital LOS, or 30-day emergency department revisits. Trial registrationThe trial was retrospectively registered in the Thai Clinical Trial Registry, identification number TCTR2021082700 on August 27, 2021.

Effect of mini-course training in communication and teamwork on non-technical skills score in emergency residents: a prospective experimental study

BackgroundNon-technical skill (NTS) teaching is a recent development in medical education that should be applied in medical education, especially in medical specialties that involve critically ill patients, resuscitation, and management, to promote patient safety and improve quality of care. Our study aimed to compare the effects of mini-course training in NTS versus usual practice among emergency residents.MethodsIn this prospective (non-randomized) experimental study, emergency residents in the 2021–2022 academic year at Ramathibodi Hospital, a tertiary care university hospital, were included as participants. They were categorized into groups depending on whether they underwent a two-hour mini-course training on NTS (intervention group) or usual practice (control group). Each participant was assigned a mean NTS score obtained by averaging their scores on communication and teamwork skills given by two independent staff. The outcome was the NTS score before and after intervention at 2 weeks and 16 weeks.ResultsA total of 41 emergency residents were enrolled, with 31 participants in the intervention group and 10 in the control group. The primary outcome, mean total NTS score after 2 weeks and 16 weeks, was shown to be significantly better in intervention groups than control groups (25.85 ± 2.06 vs. 22.30 ± 2.23; P < 0.01, 28.29 ± 2.20 vs. 23.85 ± 2.33; P < 0.01) although the mean total NTS score did not differ between the groups in pre-intervention period. In addition, each week the NTS score of each group increased 0.15 points (95% CI: 0.01–0.28, P = 0.03), although the intervention group showed greater increases than the control (0.24 points) after adjustment for time (95% CI: 0.08–0.39, P < 0.01).ConclusionEmergency residents who took an NTS mini-course showed improved mean NTS scores in communication and teamwork skills versus controls 2 weeks and 16 weeks after the training. Attention should be paid to implementing NTS in the curricula for training emergency residents.Trial registrationThis trial was retrospectively registered in the Thai Clinical Trial Registry on 29/11/2022. The TCTR identification number is TCTR20221129006.

Artificial intelligence assists operators in real-time detection of focal liver lesions during ultrasound: A randomized controlled study

PurposeDetection of hepatocellular carcinoma (HCC) is crucial during surveillance by ultrasound. We previously developed an artificial intelligence (AI) system based on convolutional neural network for detection of focal liver lesions (FLLs) in ultrasound. The primary aim of this study was to evaluate whether the AI system can assist non-expert operators to detect FLLs in real-time, during ultrasound examinations. MethodThis single-center prospective randomized controlled study evaluated the AI system in assisting non-expert and expert operators. Patients with and without FLLs were enrolled and had ultrasound performed twice, with and without AI assistance. McNemar’s test was used to compare paired FLL detection rates and false positives between groups with and without AI assistance. Results260 patients with 271 FLLs and 244 patients with 240 FLLs were enrolled into the groups of non-expert and expert operators, respectively. In non-experts, FLL detection rate in the AI assistance group was significantly higher than the no AI assistance group (36.9 % vs 21.4 %, p < 0.001). In experts, FLL detection rates were not significantly different between the groups with and without AI assistance (66.7 % vs 63.3 %, p = 0.32). False positive detection rates in the groups with and without AI assistance were not significantly different in both non-experts (14.2 % vs 9.2 %, p = 0.08) and experts (8.6 % vs 9.0 %, p = 0.85). ConclusionsThe AI system resulted in significant increase in detection of FLLs during ultrasound examinations by non-experts. Our findings may support future use of the AI system in resource-limited settings where ultrasound examinations are performed by non-experts.The study protocol was registered under the Thai Clinical Trial Registry (TCTR20201230003), which is part of the WHO ICTRP Registry Network. The registry can be accessed via the following URL: https://trialsearch.who.int/Trial2.aspx?TrialID=TCTR20201230003.

A phase 2 randomized controlled dose-ranging trial of recombinant pertussis booster vaccines containing genetically inactivated pertussis toxin in pregnant women

IntroductionDespite a decrease in infections caused by Bordetella pertussis due to COVID-19 pandemic, booster vaccination of pregnant women is still recommended to protect newborns. Highly immunogenic vaccines containing genetically inactivated pertussis toxin (PTgen) and filamentous hemagglutinin (FHA) may generate comparable anti-PT antibody concentrations, even at lower doses, to chemically inactivated acellular pertussis vaccines (Tdapchem) shown effective for maternal immunization. MethodsThis phase 2 randomized, observer-blind, active-controlled non-inferiority trial was conducted in healthy Thai pregnant women randomly assigned to receive one dose of low-dose recombinant pertussis-only vaccine containing 1 µg PTgen and 1 µg FHA (ap1gen), or tetanus, reduced-dose diphtheria combined with ap1gen (Tdap1gen), or combined with 2 µg PTgen and 5 µg FHA (Tdap2gen), or with 5 µg PTgen and 5 µg FHA (TdaP5gen, Boostagen®) or comparator containing 8 µg of chemically inactivated pertussis toxoid, 8 µg FHA, and 2.5 µg pertactin (Boostrix™, Tdap8chem). Blood was collected at Day 0 and Day 28 post-vaccination. The non-inferiority of the study vaccines was assessed based on anti-PT IgG antibody levels on Day 28 pooled with results from a similarly structured previous trial in non-pregnant women. Results400 healthy pregnant women received one dose of vaccine. Combined with data from 250 non-pregnant women, all study vaccines containing PTgen were non-inferior to comparator vaccine (Tdap8chem). Both ap1gen and TdaP5gen vaccines could be considered to have superior immunogenicity to Tdap8chem. Local and systemic solicited reactions were similar among all vaccine groups. ConclusionsVaccine formulations containing PTgen were safe and immunogenic in pregnant women. The ap1gen vaccine, with the lowest cost and reactogenicity, may be suitable for use in pregnant women when diphtheria and tetanus toxoids are not needed.This study is registered in the Thai Clinical Trial Registry (www.clinicaltrials.in.th), number TCTR20180725004.

Branched-chain amino acids supplementation improves liver frailty index in frail compensated cirrhotic patients: a randomized controlled trial

BackgroundPhysical frailty is related with morbidity and mortality in patients with cirrhosis. Currently, there is no approved treatment of frailty in these patients. Here, we evaluated the efficacy of 16 weeks branched-chain amino acids (BCAA) supplementation on frailty in frail compensated cirrhotic patients.MethodsAfter a 4-week run-in period consisted of dietary and exercise counseling, compensated cirrhotic patients with frailty, defined by liver frailty index (LFI)≥4.5, were randomly assigned (1:1) to BCAA or control group. The BCAA group received twice daily BCAAs supplementation (210 kcal, protein 13.5 g, BCAA 2.03 g) for 16 weeks. The primary outcome was frailty reversion. The secondary outcomes were changes in biochemistries, body composition evaluated by bioelectrical impedance analysis, and quality of life (QoL).Results54 patients were prospectively enrolled (age 65.5 ± 9.9 years, 51.9% female, Child-Pugh A/B 68.5%/31.5%, MELD 10.3 ± 3.1). Baseline characteristics were similar between both groups. At week 16, BCAA group had a significant improvement in LFI (-0.36 ± 0.3 vs. -0.15 ± 0.28, P = 0.01), BMI (+ 0.51 ± 1.19 vs. -0.49 ± 1.89 kg/m2, P = 0.03), and serum albumin (+ 0.26 ± 0.27 vs. +0.06 ± 0.3 g/dl, P = 0.01). The proportion of frailty reversion at week 16 was significantly higher in BCAA group (36% vs. 0%, P < 0.001). Compared with baseline, BCAA group had a significant increase in skeletal muscle index (7.5 ± 1.6 to 7.8 ± 1.5 kg/m2, P = 0.03). Regarding the QoL, only the BCAA group had a significant improvement in all 4 domains of physical component score of the SF-36 questionnaire.ConclusionsA 16-week BCAA supplementation improved frailty in frail compensated cirrhotic patients. In addition, this intervention resulted in an improvement of muscle mass and physical domain of QoL in these patients.Trial registrationThis study was registered with Thai Clinical Trial Registry (TCTR20210928001; https://www.thaiclinicaltrials.org/#).