Clinical Research Information Service Research Articles

Natural frequency tree- versus conditional probability formula-based training for medical students’ estimation of screening test predictive values: a randomized controlled trial

BackgroundMedical students and professionals often struggle to understand medical test results, which can lead to poor medical decisions. Natural frequency tree-based training (NF-TT) has been suggested to help people correctly estimate the predictive value of medical tests. We aimed to compare the effectiveness of NF-TT with conventional conditional probability formula-based training (CP-FT) and investigate student variables that may influence NF-TT’s effectiveness.MethodsWe conducted a parallel group randomized controlled trial of NF-TT vs. CP-FT in two medical schools in South Korea (a 1:1 allocation ratio). Participants were randomly assigned to watch either NF-TT or CP-FT video at individual computer stations. NF-TT video showed how to translate relevant probabilistic information into natural frequencies using a tree structure to estimate the predictive values of screening tests. CP-FT video showed how to plug the same information into a mathematical formula to calculate predictive values. Both videos were 15 min long. The primary outcome was the accuracy in estimating the predictive value of screening tests assessed using multiple-choice questions at baseline, post-intervention (i.e., immediately after training), and one-month follow-up. The secondary outcome was the accuracy of conditional probabilistic reasoning in non-medical contexts, also assessed using multiple-choice questions, but only at follow-up as a measure of transfer of learning. 231 medical students completed their participation.ResultsOverall, NF-TT was not more effective than CP-FT in improving the predictive value estimation accuracy at post-intervention (NF-TT: 87.13%, CP-FT: 86.03%, p = .86) and follow-up (NF-TT: 72.39%, CP-FT: 68.10%, p = .40) and facilitating transfer of training (NF-TT: 75.54%, CP-FT: 71.43%, p = .41). However, for participants without relevant prior training, NF-TT was more effective than CP-FT in improving estimation accuracy at follow-up (NF-TT: 74.86%, CP-FT: 58.71%, p = .02) and facilitating transfer of learning (NF-TT: 82.86%, CP-FT: 66.13%, p = .04).ConclusionsIntroducing NF-TT early in the medical school curriculum, before students are exposed to a pervasive conditional probability formula-based approach, would offer the greatest benefit.Trial registrationKorea Disease Control and Prevention Agency Clinical Research Information Service KCT0004246 (the date of first trial registration: 27/08/2019). The full trial protocol can be accessed at https://cris.nih.go.kr/cris/search/detailSearch.do?seq=15616&search_page=L.

The Consumption of Lacticaseibacillus rhamnosus HDB1258 Changes Human Gut Microbiota and Induces Immune Enhancement Through NK Cell Activation.

The gut microbiota can play an important role in enhancing the host's complex immune system. In this regard, many studies indicate that probiotics consumption has a beneficial impact on alterations in the composition of the gut microbiota. Our previous study demonstrated that the oral administration of Lacticaseibacillus rhamnosus HDB1258 (HDB1258) enhances immune cell activity and alters the composition of gut microbiota in C57BL/6 mice, thereby showing its potential as a novel immunostimulatory ingredient. Therefore, this clinical trial assessed the effects of HDB1258 on human natural killer (NK) cell activity and changes in gut microbiota. It also investigated the correlation between gut microbiota and NK cell activity following HDB1258 supplementation. Participants (n = 71) were randomized into placebo and HDB1258 groups, and NK cell activity and gut microbiota were investigated at baseline (week 0) and endline (week 8). The present study showed that HDB1258 significantly increased NK cell activity and resulted in positive regulatory effects on the gut microbial balance in subjects compared to the placebo group. HDB1258 affected the gut microbial balance by inducing the growth of beneficial bacteria such as Lactococcus and Sutterella. Especially, the changes in Escherichia-Shigella composition were negatively correlated with the changes in NK cell activity after HDB1258 consumption. There was also a positive correlation between the NK cell activity in the HDB1258 group and the composition of Prevotella 9 and Adlercreutzia. These findings suggest that HDB1258 may improve the host's intestinal environment by regulating gut bacteria related to immune response and promote NK cell activation. This study was registered at clinical research information service (CRIS: KCT0008204).

The Reliability and Validity of the Korean Version of Autism Spectrum Quotient (AQ) Children's Version.

There is no validated screening measure for children with high-functioning autism spectrum disorder (ASD) in Korea. The purpose of the present study was (1) to examine the reliability and validity of the Korean version of the Autism Spectrum-Child (K-AQ-Child); (2) to find the optimal cut-off value of the K- AQ-Child in the Korean population. A total of 144 children aged 4-11 years (male 80.6%, mean age = 7.05 ± 1.75) were recruited in this study, with 72 in the high-functioning ASD group and 72 in the non-clinical Control group. The Cronbach's alpha coefficient of the K-AQ-child was 0.962, showing excellent internal consistency. For discriminant validity, the ASD group scored significantly higher than the Control group on the total score and all the scores of the subdomains of the K-AQ-Child after controlling for sex. Significant positive correlation between total scores of the K-AQ-Child and the K-SCQ was found. The optimal cut-off value of 58.5 yielded a sensitivity of 0.931 and specificity of 0.986. K-AQ-Child is a valid and reliable measure to quantify autistic traits and identify the high-risk individuals for further diagnostic evaluation in intellectually capable children aged 4-11 years. It would be useful for both clinical practice and research purposes. Clinical Trial Registration The trial was registered at the Clinical Research Information Service (CRIS) of Republic of Korea (Registration Number: KCT0008907).

Artificial intelligence-based CT-free quantitative thyroid SPECT for thyrotoxicosis: study protocol of a multicentre, prospective, non-inferiority study

IntroductionTechnetium thyroid uptake (TcTU) measured by single-photon emission CT/CT (SPECT/CT) is an important diagnostic tool for the differential diagnosis of Graves’ disease and destructive thyroiditis. Artificial intelligence (AI) may reduce...

Prediction of immediate bleeding after cold snare polypectomy: A prospective observational study.

The risk factors for immediate post-polypectomy bleeding (IPPB) after cold snare polypectomy (CSP) are not well-known. We sought to define such risk factors and develop a predictive risk-scoring model. This prospective observational study included 161 polyps (4-9 mm in diameter) that were removed via CSP from 118 patients during the period from June to September 2019 in 2 tertiary hospitals. IPPB was defined as post-polypectomy bleeding within 24 hours or grade 3 or 4 intraprocedural bleeding requiring endoscopic hemostasis. IPPB incidences according to grade were 13.0% (21/161) (grade 3) and 0% (grade 4). Univariate analysis showed that the polyp size and morphology, as well as iatrogenic ulcer size and shape, were significantly associated with IPPB. Multivariate analysis showed that polyp size [6-9 mm vs 4-5 mm, odds ratio (OR) 3.72, 95% confidence interval (CI) 1.28-10.79], polyp morphology (polypoid vs non-polypoid, OR: 3.93, 95% CI: 1.22-12.64), and iatrogenic ulcer size (≥10 vs ≤ 9 mm, OR: 3.12, 95% CI: 1.04-9.38) were significantly associated with IPPB. We created a four-marker risk-scoring model to predict IPPB after CSP; we summed the points assigned for the 4 factors. At a cutoff of 2, the sensitivity was 85.7% and the specificity was 65.0%; at a cutoff of 3, the sensitivity was 65% and the specificity was 90.0%. Polyp size and morphology, as well as iatrogenic ulcer size and shape, were associated with IPPB after CSP. The four-marker risk-scoring model appears to effectively predict IPPB after CSP (Clinical Research Information Service: KCT0004375).

Prospective comparative analysis of three types of decompressive surgery for lumbar central stenosis: conventional, full-endoscopic, and biportal endoscopic laminectomy

Conventional open laminectomy has long been considered one of the important surgical options for lumbar central stenosis owing to its positive outcomes. However, newer approaches have emerged as alternatives, including full-endoscopic and biportal endoscopic laminectomy. Therefore, a comparison of the outcomes that are associated with each of these surgical methods is warranted. This prospective multicenter trial, initiated in February 2019, compared the outcomes of three lumbar central stenosis surgical approaches: open laminectomy (OPEN), uniportal endoscopy (UNIPORT), and biportal endoscopy (BIPORT). Among 115 participants from seven centers, one-year follow-ups assessed laboratory, radiological, and clinical outcomes. Despite all groups showing adequate decompression and clinical improvement, the OPEN group exhibited less improvement in Visual analog scale (VAS) for back pain scores (p < 0.05) and significant postoperative increases in most laboratory markers. Furthermore, the OPEN group experienced a significant decrease in multifidus muscle cross-sectional area compared to endoscopic groups (p < 0.001). Each surgical techniques produced similar clinical outcomes and dural space expansion. However, endoscopic surgery was associated with better muscle preservation and better relief of back pain. Endoscopic surgery is a reasonable alternative to conventional laminectomy for treating lumbar central stenosis.This trial was registered on CRIS (Clinical Research Information Service, KCT0004355).

The influence of sex on the dosage of remimazolam co-administered with remifentanil for loss of consciousness in adult patients: an up-and-down sequential allocation trial

BackgroundThis study aimed to determine the 50% effective dose of remimazolam co-administered with remifentanil for loss of consciousness in men and women as well as to investigate whether there are between-sex differences.MethodsUsing a modified Dixon’s up-and-down allocation approach, we sequentially enrolled male and female patients aged 19–60 years with American Society of Anesthesiologists class I or II who were scheduled for robotic surgery. For both sexes, the starting remimazolam dose was 0.15 mg/kg, with a step size of 0.05 mg/kg. After achievement of a target effect-site concentration 2.0 ng/ml of remifentanil, and administration of a bolus dose of remimazolam, we assessed whether adequate loss of consciousness (defined as a Modified Observer’s Assessment of Alertness/Sedation scale score < 2 within 2 min) was achieved.ResultsWe included 22 male and 22 female patients. Based on Dixon’s up-and-down method, the 50% effective dose of remimazolam (mean ± standard error) was 0.13 ± 0.01 mg/kg and 0.17 ± 0.01 mg/kg in the male and female groups, respectively (P = 0.34). Isotonic regression analysis revealed that the 95% effective dose (95% confidence interval) was 0.19 (0.18–0.20) mg/kg in the male group and 0.29 (0.29–0.30) mg/kg in the female group.ConclusionsThere was no between-sex difference in the 50% effective dose of remimazolam for loss of consciousness; however, the 95% effective dose was significantly higher in female patients than in male patients.Trial registrationThis study protocol was registered at Clinical Research Information Service (CRIS No. KCT0007951, 02/12/2022).

Transcutaneous electrical nerve stimulation and catheter-related bladder discomfort following transurethral resection of bladder tumour: A randomised controlled trial.

Catheter-related bladder discomfort (CRBD) is problematic in patients with a urinary catheter. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive analgesic modality used to relieve various types of pain. We evaluated the effect of TENS on CRBD after transurethral resection of bladder tumours (TURBT). A randomised controlled trial. A large university tertiary hospital, from October 2022 to March 2023. Patients requiring urinary catheterisation after TURBT. In this randomised controlled trial, patients were randomly allocated to the TENS (n = 56) or control (n = 56) groups. CRBD manifests as a burning sensation with an urge to void or discomfort in the suprapubic area. Moderate to severe CRBD was defined as patients self-reporting CRBD symptoms with or without behavioural response, including attempts to remove the urinary catheter, intense verbal reactions, and flailing limbs. TENS was performed from the end of surgery to 1 h postoperatively. The primary endpoint was considered moderate to severe CRBD immediately postoperatively. Secondary endpoints included moderate to severe CRBD at 1, 2 and 6 h postoperatively. Additionally, postoperative pain, patient satisfaction, and TENS-related adverse effects were evaluated. Moderate to severe CRBD immediately postoperatively was significantly less frequent in the TENS group than in the control group: 10 (17.9%) vs. 34 (60.7%); P < 0.001; relative risk (95% CI) = 0.294 (0.161 to 0.536); absolute risk reduction = 0.43; number needed to treat = 2.3. Moderate to severe CRBD differed between the two groups at 1 h postoperatively: 1 (1.8%) vs. 16 (28.6%); P < 0.001; relative risk = 0.06 (95% CI 0.01 to 0.46); absolute risk reduction = 0.27; number needed to treat = 3.7. The TENS group exhibited a significantly lower score for postoperative pain at 1 h (1.8 ± 0.6 vs. 2.2 ± 0.4; P < 0.001, mean difference (95% CI) = 0.4 (0.2 to 0.6) and a higher score for patient satisfaction, 5.0 (4.0 to 6.0) vs. 3.0 (3.0 to 4.0); P < 0.001; median difference (95% CI) = 2.0 (1.0 to 2.0). TENS reduced moderate to severe CRBD, decreased postoperative pain, and increased patient satisfaction after TURBT. Clinical Research Information Service (KCT0007450). http://links.lww.com/EJA/B12.

Effectiveness of mixed reality-based rehabilitation on hands and fingers by individual finger-movement tracking in patients with stroke

BackgroundMixed reality (MR) is helpful in hand training for patients with stroke, allowing them to fully submerge in a virtual space while interacting with real objects. The recognition of individual finger movements is required for MR rehabilitation. This study aimed to assess the effectiveness of updated MR-board 2, adding finger training for patients with stroke.MethodsTwenty-one participants with hemiplegic stroke (10 with left hemiplegia and 11 with right hemiplegia; nine female patients; 56.7 ± 14.2 years of age; and onset of stroke 32.7 ± 34.8 months) participated in this study. MR-board 2 comprised a board plate, a depth camera, plastic-shaped objects, a monitor, a palm-worn camera, and seven gamified training programs. All participants performed 20 self-training sessions involving 30-min training using MR-board 2. The outcome measurements for upper extremity function were the Fugl–Meyer assessment (FMA) upper extremity score, repeated number of finger flexion and extension (Repeat-FE), the thumb opposition test (TOT), Box and Block Test score (BBT), Wolf Motor Function Test score (WMFT), and Stroke Impact Scale (SIS). One-way repeated measures analysis of variance and the post hoc test were applied for the measurements. MR-board 2 recorded the fingers’ active range of motion (AROM) and Dunnett’s test was used for pairwise comparisons.ResultsExcept for the FMA-proximal score (p = 0.617) and TOT (p = 0.005), other FMA scores, BBT score, Repeat-FE, WMFT score, and SIS stroke recovery improved significantly (p < 0.001) during MR-board 2 training and were maintained until follow-up. All AROM values of the finger joints changed significantly during training (p < 0.001).ConclusionsMR-board 2 self-training, which includes natural interactions between humans and computers using a tangible user interface and real-time tracking of the fingers, improved upper limb function across impairment, activity, and participation. MR-board 2 could be used as a self-training tool for patients with stroke, improving their quality of life.Trial registration number: This study was registered with the Clinical Research Information Service (CRIS: KCT0004167).

Magnesium from Deep Seawater as a Potentially Effective Natural Product against Insulin Resistance: A Randomized Trial.

Background and Objectives: Deep seawater has been shown to restore pancreatic function in obese diabetic mice and considerably improve the homeostatic model assessment for insulin resistance, total cholesterol, and low-density lipoprotein cholesterol concentrations in patients with impaired fasting glucose or glucose tolerance. In this study, the effect of 12-week daily consumption of magnesium (Mg2+)-containing deep seawater mineral extracts on blood glucose concentration and insulin metabolism-associated indicators was investigated in patients with impaired glucose tolerance. Materials and methods: In this 12-week randomized, double-blind trial, patients (n = 37) with impaired glucose tolerance consumed deep seawater mineral extracts. Changes in blood glucose concentration and related indicators were compared between the treatment group and placebo group (n = 38). Results: The fasting insulin, C-peptide, homeostatic model assessment for insulin resistance, quantitative insulin sensitivity check index, homeostatic model assessment of beta-cell function, and Stumvoll insulin sensitivity index values in the deep seawater mineral extract group showed improvements compared with the placebo group. However, no significant differences between groups were observed in fasting blood glucose, postprandial blood glucose, glycated hemoglobin, or incremental area under the curve values. Conclusions: Oral supplementation with deep seawater mineral extracts enriched in Mg2+ markedly improves insulin sensitivity in patients with pre-diabetes. This study illustrates the potential clinical application of natural Mg2+ from deep seawater to alleviate insulin resistance in patients with pre-diabetes. Trial registration: This trial was retrospectively registered with Clinical Research information Service (CRIS), No. KCT0008695, on 8 August 2023.

One-Year Results of Ear Reconstruction with 3D Printed Implants.

External ear reconstruction has been a challenging subject for plastic surgeons for decades. Popular methods using autologous costal cartilage or polyethylene still have their drawbacks. With the advance of three-dimensional (3D) printing technique, bioscaffold engineering using synthetic polymer draws attention as an alternative. This is a clinical trial of ear reconstruction using 3D printed scaffold, presented with clinical results after 1 year. From 2021 to 2022, five adult patients with unilateral microtia underwent two-staged total ear reconstruction using 3D printed implants. For each patient, a patient-specific 3D printed scaffold was designed and produced with polycaprolactone (PCL) based on computed tomography images, using fused deposition modeling. Computed tomography scan was obtained preoperatively, within 2 weeks following the surgery and after 1 year, to compare the volume of the normal side and the reconstructed ear. At 1-year visit, clinical photo was taken for scoring by two surgeons and patients themselves. All five patients had completely healed reconstructed ear at 1-year follow-up. On average, the volume of reconstructed ear was 161.54% of that of the normal side ear. In a range of 0 to 10, objective assessors gave scores 3 to 6, whereas patients gave scores 8 to 10. External ear reconstruction using 3D printed PCL implant showed durable, safe results reflected by excellent volume restoration and patient satisfaction at 1 year postoperatively. Further clinical follow-up with more cases and refinement of scaffold with advancing bioprinting technique is anticipated. The study's plan and results have been registered with the Clinical Research Information Service (CRIS No. 3-2019-0306) and the Ministry of Food and Drug Safety (MFDS No. 1182).

Evaluation of the suitability of using ArtiSential in various renal surgery: IDEAL stage 1 study

BackgroundArtiSential, a new articulating laparoscopic instruments, addresses the limited movement associated with conventional laparoscopic instruments. This study was conducted to assess the clinical effectiveness of ArtiSential in detailed steps of various renal surgery.MethodsThis study was approved by the Institutional Review Board of our institution and registered on the Clinical Research Information Service site of the Korea Disease Control and Prevention Agency. Participants meeting all inclusion and exclusion criteria were included in the clinical trial and underwent renal surgery. The clinical effectiveness of ArtiSential was assessed in terms of the feasibility and objective and subjective parameters across 9 detailed steps.ResultsOf the 15 potential candidates enrolled from October 2021 to November 2021, 1 patient dropped out due to anaphylaxis from an anesthetic agent, and 14 patients underwent laparoscopic surgery using ArtiSential. Of the 14 patients, 2 patients were converted to laparoscopic surgery using straight-shaped instruments due to the ischemia time exceeding 30 min, and 1 patient due to excessive bleeding. The feasibility for most steps was more than 90%, except the renorrhaphy step. The median total operation time and ischemia time were 161 and 23 min, respectively. The median estimated blood loss was 58.5 mL. Two cases of venous injury occurred during renal pedicle dissection step. The accuracy of the procedure judged by reviewers and usability judged by the operator were acceptable in all steps. The surgeon’s quantitatively measured stress score was the highest during renorrhaphy step.ConclusionsLaparoscopic surgery using ArtiSential is feasible for most steps except the renorrhaphy step. The difficulty of performing renorrhaphy is attributed to prolonged ischemia time, which could be addressed by overcoming the learning curve.Trial registrationClinical Research Information Service site of the Korea Disease Control and Prevention Agency, KCT0006532. Registered 03/09/2021, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=24071.

Effectiveness and satisfaction with virtual and donor dissections: A randomized controlled trial

In recent years, human anatomy education has faced challenges with traditional donor dissection, leading to the emergence of virtual dissection as an alternative. This study aims to investigate the academic performance and satisfaction of medical students by comparing the virtual and donor dissections. An open-labeled crossover randomized controlled trial was conducted with 154 first-year medical students in Human Anatomy and Neuroanatomy laboratories, which were divided into three classes. Students were randomly assigned to either the virtual (virtual dissection followed by donor dissection) or donor (donor dissection followed by virtual dissection) groups in each class. A curriculum, incorporating head-mounted displays (HMDs), a life-sized touchscreen, and tablets, was developed. Data was evaluated through quizzes and surveys. In the Human Anatomy laboratory, each class of the donor group conducted heart extraction, dissection and observation. In observation class, the virtual group had a significantly higher mean quiz score than the donor group (p < 0.05). Compared to the donor, satisfaction was significantly higher for the HMD (understanding of concept and immersion), life-size touchscreen (esthetics, understanding of the concept, and spatial ability), and tablet (esthetics, understanding of the concept, spatial ability, and continuous use intention). In the Neuroanatomy laboratory, the virtual group showed significantly higher mean quiz scores than the donor group (p < 0.05), and tablet showed a significantly higher satisfaction than donor in terms of esthetics, understanding of the concept, and spatial ability. These results suggest that virtual dissection has the potential to supplement or replace donor dissection in anatomy education. This study is innovative in that it successfully delivered scenario-based virtual content and validated the efficacy in academic performance and satisfaction when using virtual devices compared to donor.Trial registration: This research has been registered in the Clinical Research Information Service (CRIS, https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=L&pageSize=10&page=undefined&seq=26002&status=5&seq_group=26002) with registration number "KCT0009075" and registration date "27/12/2023".

Comparison of analgesic effectiveness between nefopam and propacetamol in living kidney donors following rectus sheath block after hand-assisted living donor nephrectomy: a prospective, randomized controlled trial

BackgroundNefopam and propacetamol are the most commonly used analgesics in postoperative multimodal analgesic regimens. Distinct mechanisms are involved in each drug’s anti-nociceptive effects. No studies have compared pain relief efficacy between the two drugs in patients undergoing transplantation surgery. Here, we investigated whether the administration of nefopam or propacetamol to healthy living kidney donors who underwent rectus sheath block (RSB) for parietal pain could reduce the subsequent opioid dose necessary to produce adequate analgesia.MethodsThis prospective, randomized controlled trial included 72 donors undergoing elective hand-assisted living donor nephrectomy into two groups: propacetamol (n = 36) and nefopam (n = 36). Intraoperative RSB was performed in all enrolled donors. The primary outcome was the total volume of intravenous opioid-based patient-controlled analgesia (PCA) used on postoperative day 1 (POD 1). Additionally, the Numeric Rating Scale scores for flank (visceral) and umbilicus (parietal) pain at rest and during coughing were compared, and the Korean adaptation of the Quality of Recovery-15 Questionnaire (QoR-15 K) was evaluated on POD 1.ResultsBoth groups had similar preoperative and intraoperative characteristics. On POD 1, the total amount of PCA infusion was significantly lower in the nefopam group than in the propacetamol group (44.5 ± 19.3 mL vs. 70.2 ± 29.0 mL; p < 0.001). This group also reported lower pain scores at the flank and umbilical sites and required fewer rescue doses of fentanyl in the post-anesthesia care unit. However, pain scores and fentanyl consumption in the ward were comparable between groups. The QoR-15 K scores were similar between groups; there were substantial improvements in breathing, pain severity, and anxiety/depression levels in the nefopam group. The incidences of postoperative complications, including sweating and tachycardia, were similar between groups.ConclusionCompared with propacetamol, nefopam provides a greater analgesic effect for visceral pain and enhances the effects of blocks that reduce the opioid requirement in living kidney donors with parietal pain managed by RSB.Trial registrationThe trial was registered prior to patient enrollment in the clinical trial database using the Clinical Research Information Service (registration no. KCT0007351, Date of registration 03/06/2022).

Sex-Specific Risk Factors and Clinical Dementia Outcomes for White Matter Hyperintensities in a large South Korean Cohort.

White matter hyperintensities (WMH) on brain MRI images are the most common feature of cerebral small vessel disease (CSVD). Studies have yielded divergent findings on the modifiable risk factors for WMH and WMH's impact on cognitive decline. Mounting evidence suggests sex differences in WMH burden and subsequent effects on cognition. Thus, we aimed to identify sex-specific modifiable risk factors for WMH. We then explored whether there were sex-specific associations of WMH to longitudinal clinical dementia outcomes. Participants aged 49-89 years were recruited at memory clinics and underwent a T2-weighted fluid-attenuated inversion recovery (FLAIR) 3T MRI scan to measure WMH volume. Participants were then recruited for two additional follow-up visits, 1-2 years apart, where clinical dementia rating sum of boxes (CDR-SB) scores were measured. We first explored which known modifiable risk factors for WMH were significant when tested for a sex-interaction effect. We additionally tested which risk factors were significant when stratified by sex. We then tested to see whether WMH is longitudinally associated with clinical dementia that is sex-specific. The study utilized data from 713 participants (241 males, 472 females) with a mean age of 72.3 years and 72.8 years for males and females, respectively. 57.3% and 59.5% of participants were diagnosed with mild cognitive impairment (MCI) for males and females, respectively. 40.7% and 39.4% were diagnosed with dementia for males and females, respectively. Of the 713 participants, 181 participants had CDR-SB scores available for three longitudinal time points. Compared to males, females showed stronger association of age to WMH volume. Type 2 Diabetes was associated with greater WMH burden in females but not males. Finally, baseline WMH burden was associated with worse clinical dementia outcomes longitudinally in females but not in males. Elderly females have an accelerated increase in cerebrovascular burden as they age, and subsequently are more vulnerable to clinical dementia decline due to CSVD. Additionally, females are more susceptible to the cerebrovascular consequences of diabetes. These findings emphasize the importance of considering sex when examining the consequences of CSVD. Future research should explore the underlying mechanisms driving these sex differences and personalized prevention and treatment strategies. The BICWALZS is registered in the Korean National Clinical Trial Registry (Clinical Research Information Service; identifier, KCT0003391). Registration Date 2018/12/14.

Effectiveness of Mobile-Based Progressive and Fixed Physical Activity on Depression, Stress, Anxiety, and Quality of Life Outcomes Among Adults in South Korea: Randomized Controlled Trial.

Depression acts as a significant obstacle to the overall well-being of individuals. Given the significant consequences, timely recognition and proactive steps to manage symptoms of depression become essential. Such actions not only reduce personal distress but also play a crucial role in reducing its far-reaching impact on society as a whole. In response to this concern, the objective of this study was to explore the use of mobile-based interventions as a possible remedy. More specifically, this study aimed to investigate the effectiveness of 2 types of physical activity (PA), progressive and fixed, within a mobile-based app on depression, perceived stress, anxiety, physical health, and psychological health, aiming to contribute to the optimization of mental health benefits. Participants (N=60; mean age 25.29, SD 6.10 years) were recruited using a combination of web-based and offline methods, and the study lasted for 8 weeks. The baseline and posttest questionnaires were administered to all participants. The participants were randomly assigned to 1 of the 3 groups: progressive group (n=20; performing mobile-based progressive PA), fixed group (n=20; performing mobile-based fixed intensity PA), and control group C (n=20). Data analysis involved comparing scores between the experimental and control groups using a one-way ANOVA, paired sample t tests (2-tailed), and repeated measures ANOVA with a 3 (group)×2 (time) design. The findings revealed significant improvements in mental health indicators among participants engaged in both fixed and progressive PA groups compared with the control group. However, the fixed PA group demonstrated more significant reductions in symptoms. Specifically, the progressive PA group showed significant reductions in depression (F1,36=6.941; P=.01; ηp2=0.16) and perceived stress (F1,36=5.47; P=.03; ηp2=0.13), while the fixed PA group exhibited significant reductions in depression (F1,37=5.36; P=.03; ηp2=0.12), perceived stress (F1,37=7.81; P=.008; ηp2=0.17), and general anxiety disorder (F1,37=5.45; P=.03; ηp2=0.13) compared with the control group. This study underscores the potential of mobile-based PA in improving mental health outcomes. The findings offer significant insights for mental health professionals and researchers aiming to optimize mental well-being through innovative mobile therapies. Clinical Research Information Service KCT0009100; https://tinyurl.com/mr33fmur.

Analgesic effect of ultrasound-guided transversus abdominis plane block with or without rectus sheath block in laparoscopic cholecystectomy: a randomized, controlled trial

BackgroundUltrasound-guided transversus abdominis plane (TAP) block is commonly used for pain control in laparoscopic cholecystectomy. However, significant pain persists, affecting patient recovery and sleep quality on the day of surgery. We compared the analgesic effect of ultrasound-guided TAP block with or without rectus sheath (RS) block in patients undergoing laparoscopic cholecystectomy using the visual analog scale (VAS) scores.MethodsThe study was registered before patient enrollment at the Clinical Research Information Service (registration number: KCT0006468, 19/08/2021). 88 American Society of Anesthesiologist physical status I-III patients undergoing laparoscopic cholecystectomy were divided into two groups. RS-TAP group received right lateral and right subcostal TAP block, and RS block with 0.2% ropivacaine (30 mL); Bi-TAP group received bilateral and right subcostal TAP block with same amount of ropivacaine. The primary outcome was visual analogue scale (VAS) for 48 h postoperatively. Secondary outcomes included the use of rescue analgesics, cumulative intravenous patient-controlled analgesia (IV-PCA) consumption, patient satisfaction, sleep quality, and incidence of adverse events.ResultsThere was no significant difference in VAS score between two groups for 48 h postoperatively. We found no difference between the groups in any of the secondary outcomes: the use of rescue analgesics, consumption of IV-PCA, patient satisfaction with postoperative pain control, sleep quality, and the incidence of postoperative adverse events.ConclusionBoth RS-TAP and Bi-TAP blocks provided clinically acceptable pain control in patients undergoing laparoscopic cholecystectomy, although there was no significant difference between two combination blocks in postoperative analgesia or sleep quality.

Effects of protein-enriched nutritional support on skeletal muscle mass and rehabilitative outcomes in brain tumor patients: a randomized controlled trial

Patients with brain tumors require extensive and prolonged rehabilitation efforts as they suffer from lesion-induced motor weakness as well as treatment-related side effects, often leading to a significant decline in function. Protein supplements have shown positive effects on promoting muscle strength and physical performance in various tumor etiologies. However, reports on their effects specifically in brain tumor patients remain scarce. This study aims to investigate the feasibility and efficacy of protein supplements in enhancing rehabilitative outcomes via muscle strengthening and functional gain in brain tumor patients with neurological demise. Sixty brain tumor patients were randomly assigned to either a protein supplement or a control group, receiving either protein supplements or a placebo for 6 weeks, in conjunction with conventional rehabilitation therapy. Assessments before and after the intervention included laboratory tests, anthropometric measures using bioimpedance analysis, and functional assessments, which included the MMSE, the modified Barthel Index, the Beck Depression Inventory, the Brief Fatigue Inventory, the Timed Up and Go test, the 6-min walk test, the isokinetic quadriceps muscle strength test, and the handgrip power. After the intervention, the levels of serum hemoglobin, protein, albumin, and C-reactive protein were improved in both groups, however, the change was significant only in the protein group. The muscle strength was enhanced in both groups, however, the significant increase in pinch grasp power was only noted in the protein group (P < 0.05). The distance on 6MWT was also significantly extended at follow-up in the protein group (P < 0.01). In the subgroup analysis according to nutritional status, the moderate malnutrition group showed greater augmentation of muscle mass than those with adequate nutrition (P < 0.05). Interestingly, the amelioration of malnutrition was observed only the in protein group. This study using protein supplements to promote the rehabilitative potential of brain tumor patients revealed a significant effect on improving hemodynamic nutritional indices, muscle power reimbursement, and functional improvement, especially in malnourished patients. The safety and feasibility of protein supplements in brain tumor patients were affirmative in this study. Further studies with more patients may help confirm the secondary functional gain resulting from increased muscle power.Trial registration: This study was retrospectively registered in the Clinical Research Information Service, CRIS no. KCT0009113 on Jan 12, 2024.

Effect of Honey-based Oral Care on Oral Health of Patients With Stroke Undergoing Rehabilitation: A Randomized Controlled Trial

PurposeTo investigate the effects of honey-based oral care on the oral health of patients with stroke undergoing rehabilitation. MethodsIn this randomized controlled trial, 44 stroke patients from a tertiary hospital's rehabilitation ward were assigned to receive either honey-based oral care or normal saline, with treatments administered twice daily for 2 weeks. The study, conducted from November 2021 to July 2022, employed a double-blind method, blinding both participants and evaluators to treatment allocations. Key outcomes measured included oral status, dental plaque index (DPI), and xerostomia. The final analysis included 13 patients in the experimental group and 16 in the control group. ResultsThe intervention significantly changed the oral status, DPI, and xerostomia between the groups. The experimental group showed significantly improved oral status (Z = –4.63, p=.001), DPI (Z = –4.58, p<.001), and xerostomia (t = -6.33, p<.001) compared to the control group. The experimental group showed significant improvements in oral status (Z=-3.27, p<.001), DPI (Z=-3.19, p=.001), and xerostomia (t=7.37, p<.001) after the intervention, confirming the efficacy of honey-based oral care. ConclusionsHoney-based oral care effectively improves oral status and xerostomia, and reduces DPI in patients with stroke. Clinical Trial Registration NumberTrial registration. Clinical Research Information Service (CRIS), KCT0008201. Registered on 04 February 2023. The first patient was enrolled on November 16, 2021, at https://cris.nih.go.kr/cris/search/listDetail.do?searchWord=KCT0008201&search_yn=Y

Prevalence and clinical characteristics of Sarcopenia in older adult patients with stable chronic obstructive pulmonary disease: a cross-sectional and follow-up study

BackgroundThe relationship between sarcopenia and chronic obstructive pulmonary disease (COPD) has been increasingly reported, and there is some overlap regarding their clinical features and pulmonary rehabilitation (PR) strategies. No Korean study has reported the actual prevalence of sarcopenia in patients with stable COPD who are recommended for pulmonary rehabilitation. This study evaluated the prevalence and clinical features of sarcopenia in older adult outpatients with stable COPD and the changes after 6 months.MethodsIn this cross-sectional and 6-month follow-up study, we recruited 63 males aged ≥ 65 diagnosed with stable COPD. Sarcopenia was diagnosed using the AWGS 2019 criteria, which included hand grip strength testing, bioelectrical impedance analysis, Short Physical Performance Battery administration, and Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falling screening tool administration. A 6-minute walk test (6 MWT) was conducted, forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), maximal inspiratory and expiratory pressures (MIP and MEP, respectively) and peak expiratory flow (PEF) were assessed, and patient-reported questionnaires were administered.ResultsAt baseline, 14 (22%) patients were diagnosed with possible sarcopenia, and eight (12.6%) were diagnosed with sarcopenia. There were significant differences in the age; body mass index; Body mass index, airflow Obstruction, Dyspnea, and Exercise index; modified Medical Research Council dyspnea scores; and International Physical Activity Questionnaire scores between the normal and sarcopenia groups. Whole-body phase angle, MIP, MEP, PEF, and 6-minute walk distance (6 MWD) also showed significant differences. Over 6 months, the proportion of patients with a reduced FEV1 increased; however, the proportion of patients with sarcopenia did not increase.ConclusionA relatively low prevalence of sarcopenia was observed in older adult outpatients with stable COPD. No significant change in the prevalence of sarcopenia was found during the 6-month follow-up period.Trial registrationThe study was registered with the Clinical Research Information Service (KCT0006720). Registration date: 30/07/2021.