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OBJECTIVES: The disease activities of rheumatoid arthritis (RA) tend to fluctuate between visits to doctors, and a self-assessment tool can help patients accommodate to their current status at home. The aim of the present study was to develop a novel modality to assess the disease activity of RA by a smartphone without the need to visit a doctor. SUBJECTS AND METHODS: This study included 65 patients with RA, 63.1 ± 11.9 years of age. The 28-joint disease activity score (DAS28) was measured for all participants at each clinic visit. The patients assessed their status with the modified Health Assessment Questionnaire (mHAQ), a self-assessed tender joint count (sTJC), and a self-assessed swollen joint count (sSJC) in a smartphone application. The patients' trunk acceleration while walking was also measured with a smartphone application. The peak frequency, autocorrelation (AC) peak, and coefficient of variance of the acceleration peak intervals were calculated as the gait parameters. RESULTS: Univariate analyses showed that the DAS28 was associated with mHAQ, sTJC, sSJC, and AC (p<0.05). In a stepwise linear regression analysis, mHAQ (β = 0.264, p<0.05), sTJC (β = 0.581, p<0.001), and AC (β = -0.157, p<0.05) were significantly associated with DAS28 in the final model, and the predictive model explained 67% of the DAS28 variance. CONCLUSIONS: The results suggest that noninvasive self-assessment of a combination of joint symptoms, limitations of daily activities, and walking ability can adequately predict disease activity of RA with a smartphone application.
IMPORTANCEPrior studies have demonstrated the effectiveness of COVID-19 vaccines in children and adolescents. However, the benefits of vaccination in these age groups with prior infection remain underexplored. OBJECTIVETo evaluate the effectiveness of COVID-19 vaccination in preventing reinfection with various Omicron subvariants (BA.1/2, BA.4/5, XBB, and later) among 5- to 17-year-olds with prior SARS-CoV-2 infection. DESIGNA target trial emulation through nested designs with distinct study periods. SETTINGThe study utilized data from the Research COVID to Enhance Recovery (RECOVER) initiative, a national electronic health record (EHR) database comprising 37 U.S. childrens hospitals and health institutions. PARTICIPANTSIndividuals aged 5-17 years with a documented history of SARS-CoV-2 infection prior to the study start date during a specific variant-dominant period (Delta, BA.1/2, or BA.4/5) who received a subsequent dose of COVID-19 vaccine during the study periods were compared with those with a documented history of infection who did not receive SARS-CoV-2 vaccine during the study period. Those infected within the Delta-Omicron composite period (December 1, 2021, to December 31, 2021) were excluded. The study period was from January 1, 2022, to August 30, 2023, and focused on adolescents aged 12 to 17 years and children aged 5 to 11 years. EXPOSURESAt least received one COVID-19 vaccination during the study period vs. no receipt of any COVID-19 vaccine during the study period. MAIN OUTCOMES AND MEASURESThe primary outcome is documented SARS-CoV-2 reinfection during the study period (both asymptomatic and symptomatic cases). The effectiveness of the COVID-19 vaccine was estimated as (1-hazard ratio) *100%, with confounders adjusted by a combination of propensity score matching and exact matching. RESULTSThe study analyzed 87,573 participants during the BA.1/2 period, 229,326 during the BA.4/5 period, and 282,981 during the XBB or later period. Among vaccinated individuals, significant protection was observed during the BA.1/2 period, with effectiveness rates of 62% (95% CI: 38%-77%) for children and 65% (95% CI: 32%-81%) for adolescents. During the BA.4/5 period, vaccine effectiveness was 57% (95% CI: 25%-76%) for children, but not statistically significant for adolescents (36%, 95% CI: -16%-65%). For the XBB period, no significant protection was observed in either group, with effectiveness rates of 22% (95% CI: -36%-56%) in children and 34% (95% CI: -10%-61%) in adolescents. CONCLUSIONS AND RELEVANCECOVID-19 vaccination provides significant protection against reinfection for children and adolescents with prior infections during the early and mid-Omicron periods. This study also highlights the importance of addressing low vaccination rates in pediatric populations to enhance protection against emerging variants. Key PointsO_ST_ABSQuestionC_ST_ABSDoes COVID-19 vaccination protect against reinfection with Omicron subvariants (BA.1/2, BA.4/5, XBB, and later) among children and adolescents aged 5-17 years with prior SARS-CoV-2 infection? FindingsCOVID-19 vaccination significantly reduced the risk of reinfection during the BA.1/2 period, with effectiveness rates of 62% in children and 65% in adolescents. During the BA.4/5 period, vaccination provided moderate protection in children, with effectiveness rates of 57%, but the effectiveness in adolescents (36%) was not statistically significant. For the XBB period and later subvariants, vaccination did not show significant protection in either group. MeaningCOVID-19 vaccination offered meaningful protection against reinfection in pediatric populations during earlier Omicron periods but became less effective with later emerging subvariants, highlighting the challenges of sustaining vaccine effectiveness as the virus continues to evolve.
Introduction and Objective: Increased intraocular pressure (IOP) during robot-assisted radical prostatectomy (RARP) is known to occur and may cause in rare cases anterior ischemic optic neuropathy. In this study, we evaluated the impact of abdominal insufflation pressures on IOP during RARP in a cohort of patients undergoing RARP. Methods: Patients undergoing RARP were recruited for this Institutional Review Board-approved study from January 2019 to October 2022 at our Center. IOP was measured for both eyes using a Tonopen (Reichert, Buffalo, NY) at six time points (T1-T6); preoperatively, in the operating room in supine position under anesthesia without insufflation, at 30ο Trendelenburg position (T position) without insufflation, at Trendelenburg position with abdominal insufflation at 10 mm Hg, 15 mm Hg, and 20 mm Hg. A mixed effects model was applied to analyze changes in IOP with changes in insufflation pressure, while controlling for age, body mass index (BMI), and systolic blood pressure. Results: For a total of 28 patients, the mean age and BMI were 61.2 ± 7.4 (SD) years, and 29.0 ± 4.6 kg/m2, respectively, while the mean systolic blood pressure was 128.1 mm Hg ± 17.0 mm Hg. The mean IOP at six time points increased from 13.6 mm Hg to 26.8 mm Hg, whereas the mean systolic blood pressure ranged from 132.1 (±17) mm Hg to 130.9 (±18) mm Hg from time points 1-6. On a mixed-effects model, a change in 1 mm Hg of abdominal insufflation pressures was associated with a 0.35 mm Hg increase in IOP (95% confidence interval [CI] = 0.29-0.4) holding all other variables constant. Furthermore, a 1 mm Hg change in systolic blood pressure was associated with a 0.06 mm Hg increase in IOP (95% CI = 0.03-0.09). Conclusion: Our findings suggest that intra-abdominal insufflation pressure and systolic blood pressure are significantly associated with IOP during RARP after accounting for the correlation of the repeated measures and controlling for age and BMI.
BACKGROUND: Diminished corticospinal excitability is theorized to contribute to poor quadriceps function after anterior cruciate ligament (ACL) reconstruction. Operant conditioning of the motor evoked torque (MEPTORQUE) is a promising approach capable of improving corticospinal excitability. However, it is unknown whether increasing corticospinal excitability can improve quadriceps function after a short-term operant conditioning intervention in patients with reconstructed ACL. HYPOTHESIS: After ACL reconstruction, patients would demonstrate increases in quadriceps strength, voluntary activation, and corticospinal excitability after a 2-week operant conditioning intervention. STUDY DESIGN: Randomized controlled clinical trial. LEVEL OF EVIDENCE: Level 1. METHODS: A total of 22 patients with reconstructed ACL were randomized into 1 of 2 groups: group 1 received 2 weeks of operant conditioning training on the reconstructed leg to improve their transcranial magnetic stimulation (TMS)-elicited MEPTORQUE responses (COND); group 2 received 2 weeks of TMS only (SHAM-COND). Quadriceps strength, voluntary activation, and corticospinal excitability on the reconstructed leg were evaluated before and after the 2-week intervention. Within-session changes in corticospinal excitability were also evaluated during the training sessions. RESULTS: The COND group demonstrated a significantly higher within-session percent increase in MEPTORQUE during training compared with the SHAM-COND group, paralleled by a significant increase in corticospinal excitability after the 2-week intervention. In addition, quadriceps strength and voluntary activation improved on the reconstructed leg after the 2-week intervention, regardless of group. CONCLUSION: Operant conditioning training can elicit improvements in corticospinal excitability after ACL reconstruction; however, improvements in quadriceps strength and voluntary activation seem not to be attributed solely to operant upconditioning training. CLINICAL RELEVANCE: Operant conditioning is a promising approach to improve corticospinal excitability after ACL reconstruction. However, optimizing the delivery of operant conditioning protocols by potentially increasing the dosage of operant conditioning and intervening earlier after surgery may be needed to translate these changes to improvements in quadriceps function.
BACKGROUND: Patients with suspected acute gallstone disease typically undergo abdominal ultrasound. MRCP is often used for patients with abnormal LFTs, potentially making ultrasound unnecessary for this group. Despite high inter-reader variability in MRCP interpretation, new AI technologies may automate and standardize detection and measurement. METHOD: Patients with suspected acute gallstone disease and abnormal liver function tests were randomized into two diagnostic pathways, direct MRCP and standard care. Admission data, healthcare resource use, and clinical outcomes were recorded. National Health Service national 20/21 tariffs were used to calculate and compare healthcare costs. MRCP scans were subsequently analysed using MRCP + software (Perspectum Ltd). RESULTS: 27 participants were enrolled over 12 months, 15 to direct MRCP and 11 to standard care. One patient was excluded from analysis. Mean patient time to diagnostic report and mean per patient associated direct medical cost and mean cost to diagnosis for the direct MRCP and standard of care group was 2.53 days, £449.54, and £647 respectively for the direct MRCP group and 4.18 days costing £742.06 and £896 for standard care. MRCP + analysis of 11 scans showed significant differences between the groups in terms of gallbladder volume (80.2mm3 gallstone present versus 30.1mm3 without, p = 0.018 and cystic duct median width (4.6 mm gallstone present versus 2.7 mm without, p = 0.042). CONCLUSIONS: Direct MRCP may be a feasible and potentially cost-effective diagnostic strategy for patients with suspected acute gallstone disease and deranged LFTs. Automated measurement of MRCP parameters shows promise in detecting obstruction. Larger trials are warranted to assess this potential. CLINICAL TRIAL NUMBER: This study is registered with ClinicalTrials.gov (NCT03709030). Registration date: October 17, 2018.
INTRODUCTION: Methamphetamine use disorder is a significant public health concern. No pharmacological treatment options currently exist for methamphetamine use disorder, and psychotherapy is only moderately effective. Preliminary evidence suggests that ketamine-assisted psychotherapy produces sustained improvements in substance use and mental health symptomatology. In addition to direct antidepressant properties, ketamine is hypothesised to increase synaptogenesis and facilitate neuroplasticity, in turn prolonging and enhancing the effects of psychotherapy. Given the withdrawal-associated dysphoria and neurocognitive impairments characterising methamphetamine use disorder, ketamine-assisted psychotherapy may improve the efficacy of psychotherapy alone by addressing these features and facilitating therapeutic engagement. This pilot study aims to investigate the safety and feasibility (time taken to recruit sample, proportion of ineligible participants at pre-screening and screening, number of participants who complete four sessions of psychotherapy, retention rate over full duration of study, acceptability of the intervention) of subanaesthetic ketamine in combination with psychotherapy (cognitive behavioural therapy) for adults with methamphetamine use disorder. Changes in methamphetamine use, cravings and withdrawal, quality of life, and treatment satisfaction will also be explored. METHODS AND ANALYSIS: This is an open-label, single-arm clinical trial. 20 adults meeting DSM-5-TR criteria for methamphetamine use disorder who are seeking to reduce or cease methamphetamine use will be enrolled in the study through a single-site specialist outpatient stimulant treatment service in inner Sydney (St Vincent's Hospital, Sydney). A 4-week course with three subcutaneous ketamine doses (0.75 mg/kg to 0.9 mg/kg, titrated according to tolerability) at weekly intervals and four sessions of cognitive behavioural therapy (one at treatment initiation and three within 24-48 hours following each ketamine administration session) will be delivered. Safety and feasibility will be assessed over an 8-week period. Secondary outcomes (changes in methamphetamine use, cravings, withdrawal, quality of life and treatment satisfaction) will be assessed over a 24-week period. ETHICS AND DISSEMINATION: This study has been approved by the St Vincent's Hospital Human Research Ethics Committee, reference 2023/ETH00530. Study findings will be disseminated through articles in scientific, peer-reviewed journals, and at national and international conferences. TRIAL REGISTRATION NUMBER: ANZCTR: ACTRN12624000895583. PROTOCOL VERSION: The trial protocol (Version 4.0) was approved on 24 June 2024.
INTRODUCTION: Heavy alcohol use has the potential to derail progress towards UNAIDS 95-95-95 targets for countries in sub-Saharan Africa (SSA). Within couples, alcohol use is closely linked with factors such as intimate partner violence and economic insecurity and can result in poor adherence to antiretroviral therapy (ART) and HIV clinical outcomes. We hypothesise that a combined economic and relationship intervention for couples that builds on the prior success of standalone economic and relationship-strengthening interventions will be efficacious for improving HIV clinical outcomes and reducing alcohol use. The synergy of these interventions has not been assessed in SSA-specifically among people living with HIV who drink alcohol. To test this hypothesis, we will test Mlambe, an economic and relationship-strengthening intervention, found to be feasible and acceptable in a pilot study in Malawi. We will conduct a full-scale, randomised controlled trial (RCT) to evaluate the efficacy and cost-effectiveness of Mlambe. METHODS AND ANALYSIS: We will enrol 250 adult married couples having at least one partner living with HIV and reporting heavy alcohol use. There will be two arms: Mlambe or an enhanced usual care control arm. Couples in the Mlambe arm will receive incentivised matched savings accounts and monthly sessions on financial literacy, relationship skills, and alcohol reduction education and counselling. Participants will be assessed at baseline, 11 months, 15 months and 20 months to examine effects on heavy alcohol use, HIV viral suppression, ART adherence and couple relationship dynamics. Study hypotheses will be tested using multilevel regression models, considering time points and treatment arms. Programmatic costs will be ascertained throughout the study and incremental cost-effectiveness ratios will be computed for each arm. ETHICS AND DISSEMINATION: The RCT has been approved by the University of California, San Francisco (UCSF) (Human Research Protection Program; Protocol Number 23-40642), and the study has been approved by the National Health Sciences Research Committee (NHSRC; Protocol Number 24/05/4431) in Malawi. Adverse events and remedial actions will be reported to authorities both in Malawi and at UCSF. Results will be disseminated to study participants, local health officials and HIV policy makers and through presentations at conferences and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Protocol Registration; NCT06367348 registered on 19 April 2024; https://register. CLINICALTRIALS: gov/. Protocol Version 1.0: 22 October 2024.
INTRODUCTION: Emotional disorders are highly prevalent among adolescents, with a high rate of comorbidity. Convenient and effective treatment options are needed to reduce costs and improve effectiveness. The unified protocol for transdiagnostic treatment of emotional disorders in adolescents (UP-A) is an evidence-based transdiagnostic approach aimed at ameliorate emotional symptoms. The objective of this study is to assess the efficacy of the UP-A in Chinese adolescents with emotional disorders using multidimensional evaluations. METHODS AND ANALYSIS: This study is a two-armed, randomised controlled trial on the efficacy of 12 week UP-A on adolescents with emotional disorders along with their parents. Forty-eight participants will be randomly assigned to either the treatment as usual (TAU) group or the TAU combined with UP-A (UP-A+TAU) group. We will evaluate the efficacy of the UP-A, through the following primary and secondary outcomes: emotional disorder severity, emotional symptoms, emotion regulation, cognitive patterns, executive function, resilience, quality of life, social and family functioning. Participants will be assessed at baseline (T1), week 4 (T2), week 8 (T3), post-treatment (T4) and 3 month follow-up (T5). DISCUSSION: This protocol outlines the first randomised controlled trial investigating the efficacy of the UP-A among Chinese adolescents with emotional disorders. The findings may contribute to providing an effective and feasible transdiagnostic intervention in Chinese clinical settings. ETHICS AND DISSEMINATION: This trial has been approved by the Ethics and Clinical Research Committees of Peking University Sixth Hospital and will be performed under the Declaration of Helsinki with the Medical Research Involving Human Subjects Act (WMO). The results will be disseminated in a peer-reviewed journal and a conference presentation. TRIAL REGISTRATION NUMBER: ChiCTR2300069354.
BACKGROUND: Major surgery is associated with significant morbidity and a reduced quality of life, particularly among older adults and individuals with frailty and impaired functional capacity. Multimodal prehabilitation can enhance functional recovery after surgery and reduce postoperative complications. Digital prehabilitation has the potential to be a resource-sparing and patient-empowering tool that improves patients' preoperative status; however, little remains known regarding their safety and accuracy as medical devices. OBJECTIVE: This study aims to test the accuracy and validity of a new software in comparison to the gold-standard electrocardiogram (ECG)-based heart rate measurement. METHODS: The PROTEGO MAXIMA trial was a prospective interventional pilot trial assessing the validity, accuracy, and safety of an app-based exercise program. The Prehab App calculates a personalized, risk-stratified aerobic interval training plan based on individual risk factors and utilizes wearables to monitor heart rate. Healthy students and patients undergoing major surgery were enrolled. A structured risk assessment was conducted, followed by a 6-minute walking test and a 37-minute supervised interval session. During the exercise, patients wore app-linked wearables for heart rate and distance measurements, which were compared with standard ECG and treadmill measurements. Safety, accuracy, and usability assessments included testing alarm signals, while the occurrence of adverse events served as the primary and secondary outcome measures. RESULTS: A total of 75 participants were included. The mean heart rate differences between wearables and standard ECG were ≤5 bpm (beats per minute) with a mean absolute percentage error of ≤5%. Regression analysis revealed a significant impact of the BMI (odds ratio 0.90, 95% CI 0.82-0.98, P=.02) and Timed Up and Go Test score (odds ratio 0.12, 95% CI 0.03-0.55, P=.006) on the accuracy of heart rate measurement; 29 (39%) patients experienced adverse events: pain (5/12, 42%), ECG electrode-related skin irritations (2/42, 17%), dizziness (2/42, 17%), shortness of breath (2/42, 17%), and fatigue (1/42, 8%). No cardiovascular or serious adverse events were reported, and no serious device deficiency was detected. There were no indications of clinically meaningful overexertion based on laboratory values measured before and after the 6-minute walking test and exercise. The differences in means and ranges were as follows: lactate (mmol/l), mean 0.04 (range -3 to 6; P=.47); creatinine kinase (U/l), mean 12 (range -7 to 43; P<.001); and sodium (mmol/l), mean -2 (range -11 to 12; P<.001). CONCLUSIONS: The interventional trial demonstrated the high safety of the exercise program and the accuracy of heart rate measurements using commercial wearables in patients before major surgery, paving the way for potential remote implementation in the future. TRIAL REGISTRATION: German Clinical Trials Register DRKS00026985; https://drks.de/search/en/trial/DRKS00026985 and European Database on Medical Devices (EUDAMED) CIV-21-07-0307311. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2022-069394.