UNASSIGNED: The use of prophylactic drainage after laparoscopic cholecystectomy has been a routine practice for many years. However, the debate surrounding using it stems from conflicting evidence regarding its potential benefits and risks.
UNASSIGNED: Patients who underwent laparoscopic cholecystectomy from February 1, 2022, to November 30, 2022, at Aleppo University Hospital were enrolled according to our previously registered protocol (NCT05267860).
UNASSIGNED: This study included 232 patients (117 in the drainage group [DG], and 115 in the non-drainage group [NDG]). There was no statistical difference in the patients\' main characteristics, comorbidities, and laboratory findings. The duration of the surgical operation in NDG (mean = 44.92, SD = 1.85) was shorter than in DG (mean 55.14, SD = 2.14), with (p = 0.039) statistically significant, which indicates that the use of the drainage led to a prolongation of the surgical operation. The total number of complicated cases reached 22 (9.48%) cases (DG = 9 vs. NDG = 13, p = 0.348) as follows: bleeding (n = 1) (DG = 1 vs. NDG = 0; p = 0.320), bile leak with no established bile duct injury (n = 1) (DG = 1 vs. NDG = 0; p = 0.320), wound infection (n = 12) (DG = 4 vs. NDG = 8; p = 0.443), urinary tract infection (n = 3) (DG = 0 vs. NDG = 3; p = 0.079), prolonged shoulder pain (n = 2) (DG = 0 vs. NDG = 2; p = 0.152), and acute pancreatitis (n = 1) (DG = 1 vs. NDG = 0; p = 0.144).
UNASSIGNED: Based on the results of our study, the use of prophylactic drainage was safe, but ineffective, as it did not improve the outcomes statistically significantly or worsen them, which is consistent with previous studies highlighting the need for personalized patient care in this setting.

OBJECTIVE: The aim of the study was to determine the effect of WhatsApp-based BETTER sex counselling on sexual function and sexual quality of life in breast cancer survivors in a randomized control trial.
METHODS: This is a randomized controlled trial in which a total of 90 breast cancer survivors were recruited using convenience sampling and then randomly assigned to two groups of WhatsApp-based BETTER model counselling and routine care. Data collection tools consisted of a demographic questionnaire, the Sexual Quality of Life-Female (SQOL-F) and the Sexual Function Index (FSFI-BC). Participants in the intervention group were given access to the 6-week program. The program consisted of six consultation and assignment packages covering all six steps of the BETTER model. Data were analyzed using SPSS software version 20. Chi-square test, independent samples t-test and repeated measures analysis of variance were used. The significance level (p-value) was considered to be less than 0.05.
RESULTS: In the control group, the mean score of SQL scale changed from 35.16 ± 10.71 to 35.16 ± 12.97 (P > 0.05) and in the intervention group, it significantly increased from 34.76 ± 10.13 to 68.20 ± 20.48 (P < 0.001). Similarly, the comparison of mean of FSF in the control group showed a none-significant change from 58.13 ± 7.11 to 58.35 ± 6.11 (P > 0.05), and in the intervention group, it significantly improved from 59.49 ± 6.10 to 120.73 ± 25.54 (P < 0.001). The results of rANOVA indicated that there was a significant difference in the mean scores of the SQL and SFS between the two groups from pre- to post-intervention, and then over the 1-month follow-up period in the intervention group (p < 0.001). Considering partial eta squared, the effect of the intervention had the highest interaction effect on both variables of the sexual function index (η2 = 0.73) and sexual quality of life (η2 = 0.41).
CONCLUSIONS: The intervention program was a successful model for improving female sexual quality of life and female sexual function in breast cancer survivors.
BACKGROUND: IRCT20210926052601N1, 7-11-2021.

Understanding alignment and gap balancing in Total Knee Arthroplasty (TKA) can be challenging for trainee and experienced orthopedic surgeons. Traditional learning methods may not effectively translate to real-life scenarios. The advent of advanced technologies like robotic surgery and navigation systems has revolutionized intraoperative understanding of gap balancing techniques. This trial aims to investigate the effectiveness of robotic TKA planning software in educating trainees about alignment and ligament balancing. We hypothesize that a single session with the software will significantly enhance trainees\' understanding of these techniques. This UK-based single-center, two-arm, group parallel randomized controlled trial was conducted during a national robotic arthroplasty symposium. It aims to evaluate the effect of robotic knee arthroplasty software training on understanding TKA alignment and gap balancing principles using Multiple Choice Questions (MCQs). The MCQ test was crafted based on established guidelines from a different institution with expert consensus in the field. Our study revealed that baseline knowledge of gap balancing and alignment principles was generally low among all participants. However, the intervention group, which received comprehensive robotic software training, demonstrated a significant improvement in their MCQ scores compared to the control group, which did not undergo the training. In conclusion, our study demonstrates that robotic arthroplasty software training significantly improves the understanding of TKA alignment and balancing principles among orthopedic trainees. Level of Evidence II.

This study assesses the impact of financial incentives on hygienic latrine ownership by poor/near-poor households in Vietnam. Rural communes were randomly assigned to a control group and three treatment arm groups: (T1) a rebate for households that installed a hygienic latrine; (T2) a financial reward for commune governments if the proportion of hygienic latrines in their commune increased by 30 percentage points; (T3) both a household rebate and a commune reward. We find a strong and positive effect from the household rebate (treatment arms 1 and 3) but an insignificant effect from the commune reward (treatment arm 2) on household ownership of a septic tank latrine. Our analysis provides suggestive evidence that microcredit is a channel through which a rebate encourages the installation of septic tank latrines. We also find that treatment arm 3 increases people\'s knowledge regarding sanitation and the availability of water and soap for handwashing within households.

Mindfulness is a promising health promotion strategy for African Americans, and it is imperative that culturally responsive mindfulness approaches be accessible to this population. One way to address this need is to develop and test if culturally responsive mobile health (mhealth) applications are efficacious in reducing stress-related outcomes in this population. With this goal in mind, we employed a repeated-measures randomized control trial (RCT) across a 12-week intervention period to evaluate if participants in the intervention group outperformed a wait-list control group in reductions in stress, depressive symptoms, anxiety, emotional regulation difficulties as well as in increases in self-compassion, resilience, and mindfulness attitudes and behaviors. Our sample included 170 Black/African American participants who were randomly assigned to either the intervention condition (n = 84) or the wait-list control group (n = 86). Participants in the intervention condition reported more self-compassion, used more mindfulness, and had greater self-efficacy using mindfulness; yet, no other differences were evident. Participants expressed high levels of satisfaction with the app and gave it a positive rating for its relevance to their lives. These findings support the efficacy of a culturally responsive mindfulness mHealth app to enhance self-compassion and increase the use of health-promoting behaviors, like mindfulness, among African Americans. Implications for future research are discussed.

BACKGROUND: Though the prevalence of diabetes is set to increase, most serious game solutions typically target patient self-management and education. Few games target health care professions education, and even fewer consider the factors that may increase their efficacies. The impact of facilitation, a prominent feature of health professions education, is examined in the context of a rehearsal-based diabetes management serious game.
OBJECTIVE: In this mixed methods, open-label, superiority randomized controlled trial, we compare student performance, attitudes, and perceptions of a rehearsal-based diabetes management game for health care professionals.
METHODS: Student participants were randomized into 2 groups to play a diabetes management game. The control group played the game alone, and the intervention group played the same game alongside a facilitator tasked to moderate overall challenge levels and address queries. Both groups were administered the Flow Short Scale, a 13-item measure rated on a 7-point Likert scale ranging from 1 (\"not at all\") to 7 (\"very much\") immediately after the game. Students were then invited to voluntary focus group discussions to elicit their attitudes and perceptions of the game. Findings were subject to between-group comparisons and inductive thematic analysis respectively.
RESULTS: A total of 48 (26 control, 22 intervention) clinical-year undergraduates from the Lee Kong Chian School of Medicine in Singapore participated in this study, with 18 continuing to the focus group discussions. Flow Short Scale results indicated the superiority of the intervention group for overall flow (t46=-2.17, P=.04) and the absorption subdomain (t46=-2.6, P=.01). Qualitative results indicated students viewed facilitation as helpful and appropriate, and were able to identify improvable elements of the game\'s theoretical foundations and overall design.
CONCLUSIONS: While serious games are efficacious means of rehearsing previously learned knowledge, facilitation allows for their efficiency to be greatly increased. Such increases are likely crucial in the coming years with the increased digitization of health care professions education and the prevalence of diabetes.
BACKGROUND: ClinicalTrials.gov NCT05637749; https://www.clinicaltrials.gov/study/NCT05637749.

Background: The COVID-19 pandemic has had a profound global impact, although the majority of recently infected cases have presented with mild to moderate symptoms. Previous clinical studies have demonstrated that Shufeng Jiedu (SFJD) capsule, a Chinese herbal patent medicine, effectively alleviates symptoms associated with the common cold, H1N1 influenza, and COVID-19. This study aimed to assess the efficacy and safety of SFJD capsules in managing symptoms of mild to moderate COVID-19 infection. Methods: A randomized, double-blind, placebo-controlled trial was conducted from May to December 2022 at two hospitals in China. Mild and moderate COVID-19-infected patients presenting respiratory symptoms within 3 days from onset were randomly assigned to either the SFJD or placebo groups in a 1:1 ratio. Individuals received SFJD capsules or a placebo three times daily for five consecutive days. Participants were followed up for more than 14 days after their RT-PCR nucleoid acid test for SARS-CoV-2 turned negative. The primary outcome measure was time to alleviate COVID-19 symptoms from baseline until the end of follow-up. Results: A total of 478 participants were screened; ultimately, 407 completed the trial after randomization (SFJD, n = 203; placebo, n = 204). No statistically significant difference in baseline parameters was observed between the two groups. The median time to alleviate all symptoms was 7 days in the SFJD group compared to 8 days in the placebo group (p = 0.037). Notably, the SFJD group significantly attenuated fever/chills (p = 0.04) and headache (p = 0.016) compared to the placebo group. Furthermore, the median time taken to reach normal body temperature within 24 h was reduced by 7 hours in the SFJD group compared to the placebo group (p = 0.033). No deaths or instances of serious or critical conditions occurred during this trial period; moreover, no serious adverse events were reported. Conclusion: The trial was conducted in a unique controlled hospital setting, and the 5-day treatment with SFJD capsules resulted in a 1-day reduction in overall symptoms, particularly headache and fever/chills, among COVID-19-infected participants with mild or moderate symptoms. Compared to placebo, SFJD capsules were found to be safe with fewer side effects. SFJD capsules could potentially serve as an effective treatment for alleviating mild to moderate symptoms of COVID-19. Clinical Trial Registration: https://www.isrctn.com/, identifier ISRCTN14236594.

BACKGROUND: Clinician collaboration can help high-risk individuals to manage their suicidal crises. However, limited research has directly examined how higher patient-clinician collaboration during assessment and intervention can effectively reduce suicidal ideation. This novel randomized clinical trial compared a high vs. low level of patient-clinician collaboration by pairing commonly used assessment (Structured Interview vs. Narrative Assessment) and intervention approaches (Safety Planning Intervention vs. Crisis Response Planning). We hypothesized that the interventions involving higher (than lower) patient-clinician collaboration during assessment (Narrative Assessment) or intervention (Crisis Response Planning) would lead to larger reductions in suicidal ideation.
METHODS: Eighty-two participants with a history of suicide ideation and/or attempts were randomly assigned to one of the four interventions varying in patient-clinician collaboration. After attrition, sixty-six participants completed the study. Suicidal ideation via ecological momentary assessment was measured 14 days before and 14 days after treatment.
RESULTS: Although the severity of suicidal ideation decreased in all groups, the two groups that included highly collaborative assessment had larger pre-post reductions in suicidal ideation (Narrative Assessment+Safety Plan; dwithin = 0.26, and Narrative Assessment+Crisis Response Plan; dwithin = 0.19) than the groups that included a checklist-based assessment (Structured Interview).
CONCLUSIONS: Longer follow-up periods with a larger sample would have provided an understanding of the durability of intervention effects.
CONCLUSIONS: Results suggest that the inclusion of higher patient-clinician collaboration techniques during suicide risk assessment can effectively reduce suicidal thoughts. Thus, clinician-led collaborative risk assessment approaches can enhance the effects of safety planning-type interventions among patients with elevated risk for suicide versus checklist-based assessment approaches.

BACKGROUND: In response to a growing need for accessible, efficient, and effective palliative care services, we designed, implemented, and evaluated a novel palliative care at home (PC@H) model for people with serious illness that is centered around a community health worker, a registered nurse, and a social worker, with an advanced practice nurse and a physician for support. Our objectives were to measure the impact of receipt of PC@H on patient symptoms, quality of life, and healthcare utilization and costs.
METHODS: We enrolled 136 patients with serious illness in this parallel, randomized controlled trial. Our primary outcome was change in symptom burden at 6 weeks. Secondary outcomes included change in symptom burden at 3 months, change in quality of life at 6 weeks and 3 months, estimated using a group t-test. In an exploratory aim, we examined the impact of PC@H on healthcare utilization and cost using a generalized linear model.
RESULTS: PC@H resulted in a greater improvement in patient symptoms at 6 weeks (1.30 score improvement, n = 37) and 3 months (3.14 score improvement, n = 21) compared with controls. There were no differences in healthcare utilization and costs between the two groups. Unfortunately, due to the COVID-19 pandemic and a loss of funding, the trial was not able to be completed as originally intended.
CONCLUSIONS: A palliative care at home model that leverages community health workers, registered nurses, and social workers as the primary deliverers of care may result in improved patient symptoms and quality of life compared with standard care. We did not demonstrate significant differences in healthcare utilization and cost associated with receipt of PC@H, likely due to inability to reach the intended sample size and insufficient statistical power, due to elements beyond the investigators\' control such as the COVID-19 public health emergency and changes in grant funding.

UNASSIGNED: Though considered a late-onset disease, the 2020 report of the Lancet Commission emphasizes the necessity of conducting primary prevention trials with an approach of never too early in the life course for dementia prevention. Driven by the same notion, we hereby aim to compare the dementia risk reduction potential of two potential interventions, 48 weeks (12 months) of yoga and brisk walking, in middle-aged high-risk subjects.
UNASSIGNED: A randomized controlled trial.
UNASSIGNED: Community in India.
UNASSIGNED: In total, 323 at-risk dementia subjects will be recruited from community settings through health awareness camps and door-to-door surveys across Delhi, India. Participants will be randomized into yoga or brisk-walking groups (1:1). The yoga intervention group will receive 60 contact yoga sessions per 60-min/day at the community parks, followed by continued tele-supervised home practice, further followed by at-home self-practice, and will be tested at 3-time points (baseline, 24-week and 48-week, post-randomization) to test the efficacy of the intervention. The control group will be asked to do brisk walking daily for 45 minutes at their convenience, followed by weekly telephone follow-ups. Applying the intention-to-treat principle, the primary endpoint will be the change from baseline at the 12th month in the Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) Scores. Secondary outcomes will include the composite scores derived from a comprehensive neuropsychology battery, comprising the Trail Making Test, Digit Span Test, N Back, Color Trail, Animal Fluency Test, COWA (Controlled Oral Word Association Test), and Digit Symbol Substitution. The primary outcome will be analyzed using mixed-effect models for repeated measures, adjusted for covariates as fixed effects. The study has been prospectively registered (CTRI/2023/02/049746) on February 15, 2023. The protocol was conceptualized in 2021 and approved by the Institutional Ethics Committee of SVYASA. Recruitment began in February 2023 and is underway with patient enrollment.
UNASSIGNED: To our knowledge, this is the first controlled trial to investigate the longitudinal effects of a yoga-based intervention on dementia risk reduction using the CAIDE risk score. The findings of this trial will also provide insight into a better understanding of genotype-dependent responses to yoga intervention and open up avenues for understanding the implications of gene-intervention interactions for precision prevention using yoga.