Clinical Recovery Rate Research Articles

Impact of a package of point-of-care diagnostic tests, a clinical diagnostic algorithm and adherence training on antibiotic prescriptions for the management of non-severe acute febrile illness in primary health facilities during the COVID-19 pandemic in Burkina Faso

ObjectiveTo assess the impact of an intervention package on the prescription of antibiotic and subsequently the rate of clinical recovery for non-severe acute febrile illnesses at primary health centers.MethodsPatients over 6 months of age presenting to primary health care centres with fever or history of fever within the past 7 days were randomized to receive either the intervention package constituted of point-of-care tests including COVID-19 antigen tests, a diagnostic algorithm and training and communication packages, or the standard practice. The primary outcomes were antibiotic prescriptions at Day 0 (D0) and the clinical recovery at Day 7 (D7). Secondary outcomes were non-adherence of participants and parents/caregivers to prescriptions, health workers’ non-adherence to the algorithm, and the safety of the intervention.ResultsA total of 1098 patients were enrolled. 551 (50.2%) were randomized to receive the intervention versus 547 (49.8%) received standard care. 1054 (96.0%) completed follow-up and all of them recovered at D7 in both arms. The proportion of patients with antibiotic prescriptions at D0 were 33.2% (183/551) in the intervention arm versus 58.1% (318/547) under standard care, risk difference (RD) -24.9 (95% CI -30.6 to -19.2, p < 0.001), corresponding to one more antibiotic saved every four (95% CI: 3 to 5) consultations. This reduction was also statistically significant in children from 6 to 59 months (RD -34.5; 95% CI -41.7 to -27.3; p < 0.001), patients over 18 years (RD -35.9; 95%CI -58.5 to -13.4; p = 0.002), patients with negative malaria test (RD -46.9; 95% CI -53.9 to -39.8; p < 0.001), those with a respiratory diagnosis (RD -48.9; 95% CI -56.9 to -41.0, p < 0.001) and those not vaccinated against COVID-19 (-24.8% 95%CI -30.7 to -18.9, p-value: <0.001). A significant reduction in non-adherence to prescription by patients was reported (RD -7.1; 95% CI -10.9 to -3.3; p < 0.001).ConclusionThe intervention was associated with significant reductions of antibiotic prescriptions and non-adherence, chiefly among patients with non-malaria fever, those with respiratory symptoms and children below 5 years of age. The addition of COVID-19 testing did not have a major impact on antibiotic use at primary health centers.Trial registrationClinitrial.gov; NCT04081051 registered on 06/09/2019.

Prevalence, clinical presentation, and treatment-management of cerebral venous thrombosis associated with spontaneous intracranial hypotension: A combined case-series and systematic literature review approach.

Cerebral venous thrombosis (CVT) is a rare complication of spontaneous intracranial hypotension (SIH). Therefore, its correct diagnosis and the corresponding optimal treatment-management identification remains challenging. Over the last 10 years, 300 patients received a definite SIH diagnosis at our stroke center. Through thorough review of the database, we identified all patients with SIH-related CVT. In addition, we performed a systematic literature review including all publications on SIH-related CVT. Five out of our 300 SIH patients showed CVT (F/M:2/3, mean age: 51.8 ± 15.7). Through the literature search, 72 additional cases were identified. Overall, the prevalence was 1.3% and main clinical presentations were orthostatic headache, nausea, and vomiting. The CVT was predominantly located at the superior sagittal sinus. Treatment strategies included anticoagulants (ACs) (43%), epidural blood patch (EBP) (19.4%), and combined AC + EBP (33.3%). In our cohort, all but one patient received combined EBP and AC. The mean clinical and radiological follow-up were 2 years and 1.5 years, respectively. Complete clinical recovery was reported in 96% of the cases, whereas 56% showed complete radiological CVT resolution. Among patients without radiological resolution (26.4%), 57% received AC-only, while 43% received combined AC + EBP. Of our five cases, all but one patient received combined AC + EBP. The overall prevalence of SIH-related CVT was 1.3%. AC and combined AC + EBP were the most used treatment-management strategies. CVT resolution was more commonly achieved after the combined strategy. Overall, the rate of complete clinical recovery was 96%.

Ocular microbiota types and longitudinal microbiota alterations in patients with chronic dacryocystitis with and without antibiotic pretreatment

AbstractAntibiotic pretreatment is routine for chronic dacryocystitis (DC) patients. Herein, the longitudinal effects of antibiotic pretreatment before dacryocystorhinostomy for DC patients were evaluated. Conjunctival and nasal swabs were collected longitudinally from 33 DC patients with and without antibiotic pretreatment, both before dacryocystorhinostomy and at 1, 2, and 4 weeks postdacryocystorhinostomy. Additionally, conjunctival sac swabs were collected from 46 healthy volunteers and 14 other ocular diseases patients. Comparisons focused on ocular/nasal microbiota and recovery outcomes. Compared to healthy participants, DC patients without antibiotic pretreatment exhibited greater ocular microbiota diversity before dacryocystorhinostomy. Although clinical recovery rates were comparable, our results suggest that, after antibiotic pretreatment, the ocular microbiota richness and diversity, and the composition alteration tendency, significantly changed 4 weeks after surgery. This implies that the ocular microbiota was more disturbed in patients who underwent antibiotic pretreatment compared to those without such treatment. Furthermore, two types of ocular microbiota and three types of nasal microbiota were identified in ocular diseases. This study provides comprehensive data on the ocular and nasal microbiota in DC patients with and without antibiotic pretreatment, along with other ocular diseases. This finding suggested that antibiotic pretreatment may not be necessary before dacryocystorhinostomy for DC patients, especially for nonsevere cases.

“Catheter replacement in catheter-associated urinary tract infection: current state of evidence “

PurposeCatheter associated urinary tract infection (CAUTI) is the most common healthcare associated infection. A significant knowledge gap exists regarding the necessity of catheter replacement as part of CAUTI treatment. Current guidelines recommend replacement for faster recovery and to prevent recurrences, but adherence is low. In this systematic review, we aimed to assess the available evidence regarding catheter replacement for CAUTI.Materials and methodsEligible studies investigated the effect of catheter replacement in CAUTI on clinical outcomes and/or recurrence rates, irrespective of catheter type or setting. We searched electronic literature databases from inception to October 15th, 2023. Information was extracted regarding setting, eligibility criteria, definition of CAUTI, timing of replacement, and outcomes.ResultsOf the 257 identified studies, four were considered relevant and included. Two were randomized controlled trials (RCT) and two were observational studies. One RCT showed higher rates of clinical recovery and lower recurrence rates in the replacement group, while results of the other RCT favoured retainment, with a lower recurrence rate in the retainment group, although longer antimicrobial treatment in this group. Two observational studies were inconclusive.ConclusionsCurrent guidelines rely heavily on recommendations from a single study, emphasizing the need for further research. The burden of catheter replacement, including patient discomfort and resource impact, warrants careful consideration. A randomized trial is essential to provide more evidence on the effect of catheter replacement on clinical outcomes including CAUTI recurrence.

Phase III Study to Evaluate the Efficacy and Safety of Two Novel Fixed-Dose Vaginal Ovule Formulations in the Treatment of Various Vaginal Infections: One-Shot Study Running Title: Phase III study of two novel vaginal ovules

Objective: This study aimed to evaluate the efficacy and safety of two novel formulations: one containing fenticonazole nitrate 600 mg + tinidazole 1000 mg + lidocaine 100 mg (Formulation A) and the other with fenticonazole nitrate 600 mg + tinidazole 2000 mg + lidocaine 100 mg (Formulation B) in the treatment of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), trichomonas vaginitis (TV), and mixed vaginal infections (MVIs) in comparison to comparator medication (Gynomax® XL). Materials and methods: This phase III study enrolled 562 adult, pre-menopausal patients with BV, VVC, TV, or MVIs. Of these, 544 received the study medication (included in the safety analysis), and 440 completed the study (included in the efficacy analysis). Patients were randomized into Formulation A, Formulation B, or comparator medication arms. Follow-up visits were conducted two weeks post-treatment, with clinical and microbiological evaluations. Results: Initial clinical diagnoses indicated BV (62.0%), VVC (19.8%), MVIs (15.5%), and TV (2.7%). High clinical recovery rates were observed with Formulation A (96.7% of BV, 81.8% of VVC, and 96.3% of MVIs), Formulation B (97.7% of BV, 88.2% of VVC, 90.9% of MVIs), and comparator medication (98.9% of BV, 90.3% of VVC, 100.0% of MVIs). None of the patients discontinued medications due to an adverse event or intolerability. Conclusion: All formulations are considered as safe, well-tolerated, and highly effective for treating BV, VVC, and MVIs. Formulation A or B may be particularly advantageous due to anticipated greater patient compliance with their single-dose administration.

Clinical Study on the Effectiveness of Xian Fang Huo Ming Yin for Treating Cutaneous Infections and Promoting Wound Healing in Patients with Perianal Abscess

Objective: To explore the effect of the Xian Fang Huo Ming Yin (XFHM) for treating cutaneous infections and promoting wound healing in patients with perianal abscesses. Methods: Sixty-one patients with perianal abscesses who were admitted to our hospital (Xinghua City People’s Hospital) from May 2022 to May 2023 were selected and randomly divided into two groups, a control group (30 cases) and a study group (31 cases). Both groups received surgical treatment. The control group received conventional treatment and warm water fumigation, sitz bath, and surgical dressing change after surgery, while the research group received XFHM based on the control group. XFHM was taken orally and replaced with warm water for fumigation and sitz bathing. Both groups received treatment for 4 weeks but discontinued sitz bathing after 2 weeks. Various clinical indicators between the two groups were compared. Results: The total clinical effective rate and wound recovery rate of the study group were higher than that of the control group. There were differences in the wound pain scores, surrounding tissue edema, and wound secretions at different time points. Both groups experienced wound pain. The scores of wound pain, surrounding tissue edema, and wound secretions of the study group were lower than those of the control group, 7 and 14 days after surgery. The serum interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) levels, and pH values of the study group were lower than those of the control group 10 days after surgery (P &lt; 0.05). Conclusion: The application of XFHM for treating cutaneous infections and promoting wound healing in patients with perianal abscesses improved the treatment outcome, alleviated clinical symptoms, and promoted healing.

Досвід застосування пробіотика Bacillus clausii UBBC-07 при гострій водянистій діареї в дітей раннього віку в умовах стаціонарного відділення

Acute watery diarrhea in children remains an urgent problem in pediatrics due to its high prevalence and high mortality rates at an early age. Modern treatment protocols provide for a comprehensive approach to the treatment of patients. However, the main method of treatment of diarrhea - oral rehydration, does not allow for the stoppage of the progression of gastroenteritis, of the elimination of the imbalance of microflora and intestinal dysfunction. Such tasks can be solved thanks to the use of probiotics, which are recommended as a component of auxiliary therapy for children with acute infectious diarrhea. Purpose - to conduct a comprehensive clinical and epidemiological analysis of the results of the use of the spore-forming probiotic Bacillus clausii (B. clausii) strain UBBC-07 (Lactiale Germina) in the complex treatment of hospitalized young children with acute infectious watery diarrhea syndrome. Materials and methods. 85 children with acute infectious non-inflammatory diarrhea were comprehensively examined. 2 clinical groups were formed. The Group I - 50 hospitalized children (average age 3.1±0.4 years, the proportion of boys - 64.0%), who received 1 bottle of Lactiale Germina 1 time/day in complex treatment (5 ml=2×109 CFU B. clausii endospores). The Group II included 35 patients (average age 2.4±0.4 years (p&gt;0.05), the share of boys - 54.3% (p&gt;0.05)); who received standard treatment according to existing standards. According to the main clinical characteristics, the comparison groups can be considered comparable. Results. The analysis of the conducted studies established that the use of Lactial Germin increased the chances of a three-fold reduction in the frequency of bowel movements on the 4th day (absolute risk increase (ARI) - 27.0%, relative risk increase (RRI) - 34.6 (95% CI: 25.4-44.8) with the minimum number of patients who need to be treated to obtain a positive result (MNP) - 2.9 (95% CI: 0.5-8.6), led to the absence of the symptom of vomiting already for the 3rd day of inpatient treatment (ARI - 9.0%, RRI - 37.5 (95% CI: 28.0-47.7) with MNP - 2.7 (95% CI: 0.4-8.1), increased the chances of a lower need for long-term (≥3 days) parenteral rehydration (ARI - 12.9%, RRI - 13.7% (95% CI: 7.6-22.1) with MNP - 7.3 (95% CI: 2.9-14.3) and reduced the risk of needing to use antidiarrheal agents (relative risk - 3.2 (95% CI: 2.6-3.9) with an odds ratio - 7.1 (95% CI: 3,4-14,7)). Conclusions. Food supplement Lactiale Germina (probiotic strain B. clausii strain UBBC-07) in the complex treatment of children with acute watery diarrhea is effective and safe with good tolerability and rapid rates of clinical recovery. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of the participating institution. The informed consent of the patient was obtained for conducting the studies. No conflict of interests was declared by the authors.

Evaluation of the effect of therapeutic durations on small ruminant bacterial pneumonia

BackgroundSheep and goat production in Ethiopia is hindered by numerous substandard production systems and various diseases. Respiratory disease complexes (RDC) pose a significant threat to the productivity of these animals. Pneumonia is a common manifestation of respiratory disease complexes and often necessitates a prolonged course of antibiotic treatment. This study aimed to optimize and propose the ideal duration of therapy for pneumonia in sheep and goats.MethodsThe study was conducted from February to June 2021 at the Veterinary Teaching Hospital of the College of Veterinary Medicine and Agriculture, Addis Ababa University. The study recruited 54 sheep and goats presented to the hospital for treatment with a confirmed RDC as determined based on clinical signs and bacteriological methods. The animals were randomly allocated to 5 groups each group receiving 10% oxytetracycline (Phenxyl, Phenix, Belgum) intramuscularly for a duration of 3, 4, 5, 6 and 7 consecutive days. The treatment outcomes were assessed by recording vital signs (body temperature, respiratory rate, heart rate, coughing, and nasal discharges), performing lung ultrasonography (L-USG) as well as collection of nasal swabs for bacterial isolation and molecular identification before and after completion of the treatment. An ordered logistic regression model with random effects was employed to determine the optimal therapeutic duration, taking into account the cumulative scores of the outcome variables across the different groups.ResultsAmong the 54 sheep and goats treated with 10% oxytetracycline, a total of 74.07% (95% CI, 60.35–85.04) achieved complete recovery, as confirmed through clinical, ultrasound, and bacteriological methods. In Group 1 (G1), out of 12 sheep and goats, 8 (83.0%) recovered completely; in Group 2 (G2), out of 11 animals, 9 (82.0%) recovered completely; in Group 3 (G3), out of 11 animals, 10 (93.0%) recovered completely; in Group 4 (G4), out of 9 animals, 9 (100.0%) recovered completely; and in Group 5 (G5), out of 11 animals, 10 (91.0%) recovered completely. Bacteriological examination of nasal swabs indicated involvement of M. hemolytica in 27 (50.00%) and P. multocida in 13 (24.07%) of pneumonic animals. Detection of specific marker genes confirmed only five of the presumptive M. hemolytica isolates, whilst no isolates tested positive for P. multocida. Post-treatment samples collected from recovered animals did not yield any M. hemolytica nor P. multocida. Based on results from clinical signs, L-USG, and bacterial infection variables, the group of sheep and goats treated for seven consecutive days (G5) showed the highest recovery score compared to the other groups, and there was a statistically significant difference (coefficient (β) = − 2.296, p = 0.021) in variable score between G5 and G1. These findings suggest that the administration of 10% oxytetracycline for a full course of seven consecutive days resulted in symptomatic and clinical recovery rates from respiratory disease in sheep and goats.

A good life with psychosis: rate of positive outcomes in first-episode psychosis at 10-year follow-up.

More knowledge about positive outcomes for people with first-episode psychosis (FEP) is needed. An FEP 10-year follow-up study investigated the rate of personal recovery, emotional wellbeing, and clinical recovery in the total sample and between psychotic bipolar spectrum disorders (BD) and schizophrenia spectrum disorders (SZ); and how these positive outcomes overlap. FEP participants (n = 128) were re-assessed with structured clinical interviews at 10-year follow-up. Personal recovery was self-rated with the Questionnaire about the Process of Recovery-15-item scale (total score ⩾45). Emotional wellbeing was self-rated with the Life Satisfaction Scale (score ⩾5) and the Temporal Experience of Pleasure Scale (total score ⩾72). Clinical recovery was clinician-rated symptom-remission and adequate functioning (duration minimum 1 year). In FEP, rates of personal recovery (50.8%), life satisfaction (60.9%), and pleasure (57.5%) were higher than clinical recovery (33.6%). Despite lower rates of clinical recovery in SZ compared to BD, they had equal rates of personal recovery and emotional wellbeing. Personal recovery overlapped more with emotional wellbeing than with clinical recovery (χ2). Each participant was assigned to one of eight possible outcome groups depending on the combination of positive outcomes fulfilled. The eight groups collapsed into three equal-sized main outcome groups: 33.6% clinical recovery with personal recovery and/or emotional wellbeing; 34.4% personal recovery and/or emotional wellbeing only; and 32.0% none. In FEP, 68% had minimum one positive outcome after 10 years, suggesting a good life with psychosis. This knowledge must be shared to instill hope and underlines that subjective and objective positive outcomes must be assessed and targeted in treatment.

Analysis of Age-Structured Mathematical Model of Malaria Transmission Dynamics via Classical and ABC Fractional Operators

Malaria is a complex disease with many factors influencing the transmission dynamics, including age. This research analyzes the transmission dynamics of malaria by developing an age-structured mathematical model using the classical integer order and Atangana–Baleanu–Caputo fractional operators. The analysis of the model focused on several important aspects. The existence and uniqueness of solutions of fractional order were explored based on some fixed-point theorems,such as Banach and Krasnoselski. The Positivity and boundedness of the solutions were also investigated. Furthermore, through mathematical analysis techniques, we analyzed different types of stability results, and the results showed that the disease-free equilibrium point of the model is proved to be both locally and globally asymptotically stable if the basic reproduction number is less than one, whereas the endemic equilibrium point of the model is both locally and globally asymptotically stable if the basic reproduction number is greater than one. The findings from the sensitivity analysis revealed that the most sensitive parameters, essential for controlling or eliminating malaria are mosquito biting rate, density-dependent natural mortality rate, clinical recovery rate, and recruitment rate for mosquitoes. Numerical simulations are also performed to examine the behavior of the model for different values of the fractional-order alpha,and the result revealed that as the value α reduces from 1, the spread of the endemic grows slower. By incorporating these findings, this research helps to clarify the dynamics of malaria and provides information on how to create efficient control measures.

Azvudine versus paxlovid for oral treatment of COVID-19 in Chinese patients

PurposeTo explore the effect of azvudine as compared to paxlovid for oral treatment of hospitalized patients with SARS-CoV-2 infection.MethodsWe analyzed data from a cohort of patients with SARS-CoV-2 infection in Shandong provincial hospital between February 15 and March 15, 2023. The primary outcome was time to sustained clinical recovery through Day 28 and secondary outcomes included the percentage of participants who died from any cause by Day 28, the average hospitilization time and expenses, the changes in liver and kidney function and adverse events. The Kaplan–Meier method and Cox regression model was used for statistical analysis.ResultsThere was no significant difference between azvudine and paxlovid in terms of time to sustained clinical recovery (p = 0.429) and death rates (p = 0.687). As for hospitalization time and fee, no significant differences were observed between azvudine group and paxlovid group (Hospitalization time: p = 0.633; Hospitalization fee: p = 0.820). In addition, there were no significant differences in the effects of the two drugs on liver and kidney function (p > 0.05).ConclusionAmong adults who were hospitalised with SARS-CoV-2 infection, azvudine was noninferior to paxlovid in terms of time to sustained clinical recovery, death rates, hospitalization time and cost, with few safety concerns.Trial registrationChiCTR2300071309; Registered 11 May 2023.Level of evidenceLevel III; Retrospective cohort study.

The effect of serum biochemical parameters on clinical prognosis in children presenting with diabetic ketoacidosis.

The aim of this study was to determine whether diabetes mellitus has a high risk of diabetic ketoacidosis-related complications. Biochemical parameters affect the resolution time of diabetic ketoacidosis. The present study is based on a retrospective evaluation of the records of patients who presented to the Pediatrics Clinic of Adiyaman University Hospital between January 1, 2017, and October 1, 2022, with a diagnosis ofdiabetic ketoacidosis. The demographic characteristics, serum biochemical parameters, blood gas results, and time to transition to subcutaneous insulin therapy were all recorded. This study included 49 (49%) female and 51 (51%) male patients aged 1-17 years (mean age: 9.05±4.33 years). The average time to clinical improvement of the sample, that is, transition to subcutaneous insulin therapy, was 21.04±7.8 h. An evaluation of the presence of acute kidney injury based on serum urea and creatinine levels and eGFR values revealed no significant effect on the rate of clinical recovery (respective p-values: p=0.076, p=0.494, and p=0.884). A univariate analysis identified blood glucose (p=0.025), blood gas pH (p<0.001), and blood bicarbonate (p=0.004) values as prognostic factors, while a multivariate analysis revealed pH values had an independent and significant effect on the resolution time of diabetic ketoacidosis. Serum glucose, pH, and bicarbonate levels are the most important determinants of clinical prognosis in patients with diabetic ketoacidosis. These findings can serve as a guide for clinicians in the follow-up and treatment of such patients.

922. Cost-effectiveness of baloxavir marboxil versus oseltamivir or no treatment for the management of influenza in the United States

Abstract Background Influenza poses a significant burden that can be effectively mitigated with antivirals. Baloxavir marboxil is an oral, single dose first-in-class endonuclease inhibitor that improves influenza symptoms and rapidly reduces virus shedding, shortening the infectious period and potentially reducing viral transmission. This study used real-world data to inform a cost-effectiveness (CE) model of antiviral treatment with baloxavir vs oseltamivir or no treatment. Methods A decision tree CE model was developed for seasonal influenza between 2018 and 2020. Patients aged 12 and older could receive baloxavir, oseltamivir or no treatment (Figure 1). Outcomes included complications, recovery and death. Patient profile and characteristics, complications and costs were derived from the Merative™ MarketScan® Research Databases, including US commercial claims, Medicare and Medicaid Supplemental databases. Healthcare resource use included outpatient visits, hospitalizations and intensive care unit admissions. Clinical inputs, recovery rates and utilities were derived from the literature. The base case model used a lifetime time horizon with 3.0% discounting for costs and 2.7% for quality-adjusted life-years (QALYs), assuming no transmission reduction. A subgroup analysis was conducted for otherwise healthy (OwH) and high-risk groups; scenario analyses explored the impact of reduced viral transmission with baloxavir. Results In the base case analysis, baloxavir resulted in an incremental CE ratio (ICER) of $7788/QALY vs oseltamivir and $311/QALY vs no treatment; subgroup analyses showed even greater CE in the high-risk population (Table 1). Scenario analyses showed increasing net monetary benefit (NMB) with incremental reductions in viral transmission with baloxavir, where a 5% reduction in transmission yielded a NMB for baloxavir of $4153 vs oseltamivir and $13,098 vs no treatment (Figure 2). Conclusion This real-world evidence-driven model showed that baloxavir is cost-effective vs oseltamivir or no treatment from a US payer perspective. Transmission reductions with baloxavir can have a substantial health economic benefit, and baloxavir may play an important role in management of seasonal influenza and pandemic preparedness. Disclosures Svenn Hansen, n/a, F. Hoffman La Roche: Employee|F. Hoffman La Roche: Stocks/Bonds Shih-Chen Cheng, M.S., P.h.D, Genentech/F. Hoffman La Roche: Genentech Employee|Genentech/F. Hoffman La Roche: Stocks/Bonds Andy Surinach, MPH, Genentech/Roche: employee of Genesis Research which receives funding from Genentech/Roche for consulting services Vince Yau, PhD, Genentech/F. Hoffman La Roche: Genentech Employee|Genentech/F. Hoffman La Roche: Stocks/Bonds Jennie H. Best, PhD, Genentech: Stocks/Bonds Hassan Zaraket, PhD, F. Hoffman La Roche: Employee|F. Hoffman La Roche: Stocks/Bonds Hao Zhou, PhD, Genentech/F. Hoffman La Roche: Genentech Employee|Genentech/F. Hoffman La Roche: Stocks/Bonds Marie-Helene Blanchet Zumofen, PhD MBA, F. Hoffman La Roche: Employee|F. Hoffman La Roche: Stocks/Bonds

The addition of employment support alongside psychological therapy enhances the chance of recovery for clients most at risk of poor clinical outcomes.

Many people achieve positive outcomes from psychological therapies for anxiety and depression. However, not everyone benefits and some may require additional support. Previous studies have examined the demographic and clinical characteristics of people starting treatment and identified a patient profile that is associated with poor clinical outcomes. To examine whether the addition of employment-related support alongside psychological therapy was associated with a greater chance of recovery for clients belonging to this patient profile. We analysed 302 clients across three services, who were offered employment-related support alongside psychological therapy. The rate of clinical recovery (falling below clinical thresholds on measures of both anxiety and depression) was compared between individuals who accepted the offer and those who declined, while adjusting for potential confounders. Logistic regression showed that receiving employment support was significantly associated with clinical recovery after controlling for baseline anxiety and depression scores, the number of psychological treatment sessions, and other clinical and demographic variables. The odds of recovery were 2.54 times greater if clients received employment support; 47% of clients who received employment support alongside psychological therapy were classified as recovered, compared with 27% of those receiving psychological therapy only. Providing employment support alongside therapy may be particularly helpful for clients belonging to this patient profile, who represent approximately 10% of referrals to NHS Talking Therapies for Anxiety and Depression services. Services could consider how to increase the provision and uptake of employment-focused support to enhance clients' clinical outcomes.

Doxycycline vs Hydroxychloroquine + Azithromycin in the Management of COVID-19 Patients: An Open-Label Randomized Clinical Trial in Sub-Saharan Africa (DOXYCOV).

Objective We aimed to compare the safety and efficacy of a doxycycline-based regimen against Cameroon National Standard Guidelines (hydroxychloroquine plus azithromycin) for the treatment of mild symptomatic COVID-19. Methods We conducted an open-label, randomized, non-inferiority trialin Cameroon comparing doxycycline 100 mg, twice daily for seven days versus hydroxychloroquine400 mg daily for five days and azithromycin 500 mg at day 1 and 250 mg from day 2 through 5in mild COVID-19 patients. Clinical recovery, biological parameters, and adverse events were assessed. The primary outcome was the proportion of clinical recovery on days 3, 10, and 30. Non-inferiority was determined by the clinical recovery rate between protocols with a 20-percentage points margin. Results One hundred and ninety-four participants underwent randomization and were treated either with doxycycline (n = 97) or hydroxychloroquine-azithromycin (n = 97). On day 3, 74/92 (80.4%) participants on doxycycline versus 77/95 (81.1%) on hydroxychloroquine-azithromycin-based protocols were asymptomatic (p = 0.91). On day 10, 88/92 (95.7%) participants on doxycycline versus 93/95 (97.9%) on hydroxychloroquine-azithromycin were asymptomatic (p = 0.44). On day 30, all participants were asymptomatic. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) polymerase chain reaction (PCR) test was negative on day 10 in 60/92 (65.2%) participants who were assigned to doxycycline and in 63/95 (66.3%) participants who were assigned to hydroxychloroquine-azithromycin. None of the participants were admitted for worsening of the disease after treatment initiation. Conclusion Doxycycline 100 mg twice daily for seven days proved to be safe and non-inferior in terms of efficacy when compared to hydroxychloroquine-azithromycinfor preventing clinical worsening of mild symptomatic or asymptomatic COVID-19 and achieving virological suppression.

Identification of Vancomycin Resistance in Methicillin-resistant Staphylococcus aureus in two macaque species and decolonization and long-term prevention of recolonization in Cynomolgus Macaques (Macaca fascicularis).

Methicillin-resistant Staphylococcus aureus (MRSA) is a S. aureus strain with resistance to beta-lactam antibiotics, making it a global human and veterinary health concern. Specifically, immunosuppressed patients have a remarkably higher risk of clinical MRSA infections with significantly increased rates of prolonged clinical recovery, morbidity, and mortality. The current treatment of choice for MRSA is vancomycin. Importantly, we report the first known vancomycin-resistant S. aureus (VRSA) carriers in a cohort of Mauritian cynomolgus macaques (CM) imported to the Oregon National Primate Research Center (ONPRC), with a MRSA carrier rate of 76.9% (10/13 animals). All MRSA isolates also demonstrated resistance to vancomycin with prevalence of vancomycin-intermediate Staphylococcus aureus (VISA) at 30% (3/10 MRSA-positive CMs) and VRSA at 70% (7/10 MRSA-positive CMs). Additionally, we identified VRSA in a rhesus macaque (RM) housed within the same room as the VRSA-positive CMs and identified a MRSA/VISA carrier rate of 18.8% in RMs (3/16 positive for both MRSA and VISA) in unexposed recently assigned animals directly from the ONPRC RM breeding colony. Considering that the MRSA and VRSA/VISA-positive CMs future study aims included significant immunosuppression, MRSA/VRSA/VISA decolonization treatment and expanded "MRSA-free" practices were employed to maintain this status. We report the first controlled study using in-depth analyses with appropriate diagnostic serial testing to definitively show an MRSA decolonization therapy (90% success rate) and expanded barrier practice techniques to successfully prevent recolonization (100%) of a cohort of CMs MRSA-free (up to 529 days with a total of 4,806 MRSA-free NHP days).

Ashwagandha (Withania somnifera) and Shunthi (Zingiber officinale) in mild and moderate COVID-19: An open-label randomized controlled exploratory trial

BackgroundAyurveda interventions have been used for prophylaxis and care during the COVID-19 pandemic in India and have shown promising results in promoting early clinical recovery from COVID-19. ObjectiveTo assess the efficacy and safety of Ashwagandha [Withania somnifera (L.) Dunal] tablet and Shunthi (Zingiber officinale Roscoe) capsule in mild and moderate COVID-19 compared to conventional standard care. MethodsA randomized controlled exploratory trial was conducted at a designated COVID-19 care center in India with 60 participants having mild or moderate COVID-19. Ashwagandha, two tablets (250 mg each), and Shunthi, two capsules (500 mg each) twice daily for 15 days, were given orally to the participants in the Ayurveda group (AG) and the control group (CG) received conventional standard care. The outcome measures included clinical recovery rate, the proportion of participants with negative RT-PCR assay for COVID-19 on day 7 and day 15, mean time to attain clinical recovery, change in pro-inflammatory markers, serum IgG for COVID-19, HRCT chest findings, disease progression and incidence of adverse events (AE). ResultsA total of 60 participants were enrolled, and the data of 48 participants (AG = 25 and CG = 23) were considered for the statistical analysis. The mean time for clinical recovery was reduced by almost 50 % in the AG (6.9 days) compared to CG (13.0 days) (p < 0.001). The proportion of participants who attained viral clearance in AG was 76.0 % compared to 60.8 % in the CG (RR= 1.24, 95 % CI: 0.841, 1.851, p-value = 0.270). Changes in the pro-inflammatory markers, serum IgG for COVID-19, and HRCT chest findings were comparable in both groups, and no AE or disease progression was reported. ConclusionsThe Ayurveda interventions, Ashwagandha and Shunthi, can effectively reduce the duration of clinical recovery and improve time for viral clearance in mild and moderate COVID-19. These interventions were observed to be safe and well-tolerated during the duration of the trial. Trial registrationClinical Trial Registry of India - CTRI/2020/08/027224

Systematic review and Meta-analysis of Biling Weitong Granules in treatment of stomach ache disorder

This study aimed to evaluate the efficacy and safety of Biling Weitong Granules in the treatment of stomach ache disorder. Randomized controlled trial(RCT) of Biling Weitong Granules in the treatment of digestive diseases with stomach ache disorder as the primary symptom was retrieved from Chinese and English electronic databases and trial registration platforms from database inception to June 10, 2022. Two investigators conducted literature screening and data extraction according to the screening criteria. The Cochrane risk-of-bias tool(v 2.0) was used to assess the risk of bias in the included studies. Analyses were performed using RevMan 5.4 and R 4.2.2, with summary estimates measured using fixed or random effects models. The primary outcome indicators were the visual analogue scale(VAS) scores and stomach ache disorder symptom scores. The secondary outcome indicators were clinical recovery rate, Helicobacter pylori(Hp) eradication rate, and adverse reaction/events. Twenty-seven RCTs were included with a sample size of 2 902 cases. Meta-analysis showed that compared with conventional western medicine treatments or placebo, Biling Weitong Granules could improve VAS scores(SMD=-1.90, 95%CI[-2.18,-1.61], P&lt;0.000 01), stomach ache disorder symptom scores(SMD=-1.26, 95%CI[-1.71,-0.82], P&lt;0.000 01), the clinical recovery rate(RR=1.85, 95%CI[1.66, 2.08], P&lt;0.000 01), and Hp eradication rate(RR=1.28, 95%CI[1.20, 1.37], P&lt;0.000 01). Safety evaluation revealed that the main adverse events in the Biling Weitong Granules included nausea and vomiting, rash, diarrhea, loss of appetite, and bitter mouth, and no serious adverse events were reported. Egger's test showed no statistical significance, indicating no publication bias. The results showed that Biling Weitong Granules in the treatment of digestive system diseases with stomach ache disorder as the primary symptom could improve the VAS scores and stomach ache disorder symptom scores of patients, relieve stomach ache disorder, and improve the clinical recovery rate and Hp eradication rate, with good safety and no serious adverse reactions. However, the quality of the original studies was low with certain limitations. Future studies should use unified and standardized detection methods and evaluation criteria of outcome indicators, pay attention to the rigor of study design and implementation, and highlight the clinical safety of the medicine to provide more reliable clinical evidence support for clinical application.

Efficacy of transdiagnostic cognitive-behavioral therapy for assertiveness: A randomized controlled trial

Assertiveness training has been an essential component in cognitive-behavioral therapy (CBT), for example, in the treatment of social anxiety and in dialectical behavioral therapy. However, the assertiveness construct has garnered little attention in recent clinical research. The objective of this study was to investigate the efficacy of an eight-week transdiagnostic stand-alone internet-based CBT intervention specifically aimed at increasing levels of assertive behavior. Following inclusion, we randomized N = 210 participants into three groups: therapist-guided self-help, unguided self-help, and a wait-list control condition. After a one-year follow-up, we employed a linear mixed model to estimate the effects at both post-test and follow-up for the primary outcome measures of assertiveness, Adaptive and Aggressive Assertiveness Scales, the Rathus Assertiveness Schedule, and secondary outcome measures of anxiety, depression, and general well-being. We also assessed reliable clinical change. Compared to the wait list at the post-treatment, estimated between-group effect sizes on self-rated adaptive assertiveness were statistically equivalent for the two treatment groups both at the post and at the one-year follow-up time points, ranging from ES = 0.95 to 1.73, with reliable clinical recovery proportions from 19 % to 36 %. The increase in aggressive assertiveness ranged from ES = 0.62 to 0.90 compared to the wait-list condition at post. For social anxiety symptoms, the effects compared to the wait list at post-treatment ranged from ES = 0.67 to 0.93, with a reliable clinical recovery rate from 16 % to 26 %. For self-assessed well-being, the effects compared to the wait list at post ranged from ES = 0.70 to 1.05. No effects were observed for generalized anxiety, although within-group evidence was found for a medium effect on depression one year after treatment. Overall, the two treatment conditions produced similar effects. In general, participation increased healthy assertive expressions regardless of treatment condition, all the while reducing self-assessed social anxiety and, over time, possibly also depression. Participation also improved general well-being. The findings demonstrate that the assertiveness construct can be a suitable target for intervention, with reductions of both psychiatric symptoms and non-syndromal problems in daily life. The study was preregistered at ClinicalTrials.gov (NCT04240249).

Effectiveness and safety of Qingfei Dayuan granules for treating influenza and upper respiratory tract infections manifested by the pulmonary heat-toxin syndrome: A multicenter, randomized, double-blind, placebo-controlled trial.

Background: Patients diagnosed with influenza and upper respiratory tract infections (URTIs) have similar clinical manifestations and biochemical indices and a low detection rate of viral pathogens, mixed infection with diverse respiratory viruses, and targeted antiviral treatment difficulty in the early stage. According to the treatment strategy of "homotherapy for heteropathy" in traditional Chinese medicine (TCM), different diseases with the same clinical symptoms can be treated with the same medicines. Qingfei Dayuan granules (QFDY), a type of Chinese herbal preparation included in the TCM Diagnosis and Treatment Protocol for COVID-19 of Hubei Province issued by the Health Commission of Hubei Province in 2021, are recommended for patients suffering from COVID-19 with symptoms of fever, cough, and fatigue, among others. Additionally, recent studies have shown that QFDY effectively alleviates fever, cough, and other clinical symptoms in patients with influenza and URTIs. Materials and methods: The study was designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial for treatment for influenza and URTIs manifested by pulmonary heat-toxin syndrome (PHTS) with QFDY. A total of 220 eligible patients were enrolled from eight first-class hospitals in five cities of Hubei Province in China and randomly assigned to receive either 15g of QFDY or a placebo three times a day for 5days. The primary outcome was the complete fever relief time. Secondary outcomes included efficacy evaluation of TCM syndromes, scores of TCM syndromes, cure rate of each single symptom, incidence of comorbidities and progression to severe conditions, combined medications, and laboratory tests. Safety evaluations mainly involved adverse events (AEs) and changes in vital signs during the study. Results: Compared with the placebo group, the complete fever relief time was shorter in the QFDY group, 24h (12.0, 48.0) in the full analysis set (FAS) and 24h (12.0, 49.5) in the per-protocol set (PPS) (p ≤ 0.001). After a 3-day treatment, the clinical recovery rate (22.3% in the FAS and 21.6% in the PPS) and cure rate of cough (38.6% in the FAS and 37.9% in the PPS), a stuffy and running nose, and sneezing (60.0% in the FAS and 59.5% in the PPS) in the QFDY group were higher than those in the placebo group (p < 0.05). The number of patients taking antibiotics for more than 24h in the placebo group (nine cases) was significantly higher than that in the QFDY group (one case) (p < 0.05). There were no significant differences between the two groups in terms of scores of TCM syndromes, incidence of comorbidities or progression to severe conditions, combined use of acetaminophen tablets or phlegm-resolving medicines, and laboratory tests (p > 0.05). Meanwhile, no significant difference was found in the incidence of AEs and vital signs between the two groups (p > 0.05). Conclusion: The trial showed that QFDY was an effective and safe treatment modality for influenza and URTIs manifested by PHTS because it shortened the complete fever relief time, accelerated clinical recovery, and alleviated symptoms such as cough, a stuffy and running nose, and sneezing during the course of treatment. Clinical trial registration: https://www.chictr.org.cn/showproj.aspx?proj=131702, identifier ChiCTR2100049695.