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Instruments for measuring body image in breast cancer patients: a systematic review of measurement properties.

PURPOSE: To evaluate the psychometric properties of PROMs for measuring body image in breast cancer patients. METHODS: In December 2024, a psychometric systematic review was performed in the nine databases. The COSMIN checklist was employed to evaluate the methodological quality and psychometric properties of the included body image measures. The level of evidence was assessed using the GRADE framework, and final recommendations were formulated for the scale. RESULTS: Thirty-eight articles evaluating fifteen PROMs were included in this review. Structural validity, internal consistency, and hypothesis testing had been most frequently evaluated. Measurement error had not been assessed for all PROMs. Twelve instruments show potential application value but require further research. The BAS-BC, PSPP, and ASI-R are not recommended for use, as these instruments do not meet the strict COSMIN thresholds for full recommendation. CONCLUSION: The BIS can be recommended as a temporary screening tool for assessing body image outcome in clinical practice. The BIRS can be tentatively advised for measuring specific postoperative body image changes. However, further comprehensive studies are required to validate the psychometric properties of existing PROMs.

Female

A Triple-Blinded, Randomized, Controlled Trial Comparing Hydromorphone vs. Fentanyl for Children Undergoing Tonsillectomy.

BACKGROUND: Tonsillectomy is one of the most frequently performed pediatric surgeries; however, little evidence guides the choice of intraoperative opioids in a population at an elevated risk for perioperative respiratory complications. This study tested the hypothesis that fewer children who received hydromorphone during tonsillectomy would require postoperative "rescue" opioids compared to children who received fentanyl. METHODS: We conducted a triple-blind, randomized, controlled trial to compare intravenous hydromorphone versus fentanyl in pediatric patients undergoing tonsillectomy. Children aged 2-15 years undergoing bilateral tonsillectomy or adenotonsillectomy were assigned (1:1) to receive hydromorphone (10 mcg/kg) or fentanyl (1 mcg/kg) intraoperatively. The primary endpoint was the number of patients who required rescue intravenous opioid analgesia following endotracheal extubation. Secondary endpoints included pain scores, pulse oximetry saturations, postoperative nausea, time in the recovery room, morphine milligram equivalents in the post-anesthesia care unit, and adverse events. RESULTS: A total of 188 children underwent randomization, and 180 were analyzed (90 in each group). The median age was 5 years (interquartile range: 3-7 years). Rescue intravenous opioid was administered to 48 (53%) children who received intraoperative hydromorphone and 66 (73%) children who received intraoperative fentanyl (difference, 20.0 percentage points; 95% confidence interval, 6.2-33.8) (p = 0.005). Children who received hydromorphone also had lower mean pain scores for the first 15 min postoperatively and lower median morphine milligram equivalents. The incidence of adverse events was similar between the two groups. CONCLUSIONS: This study in children undergoing tonsillectomy found that intraoperative hydromorphone resulted in improved analgesia in the recovery room compared to fentanyl. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04230681.

Adolescent

BRAIN-Diabetes: Acceptability of an adapted FINGER multidomain intervention among adults living with type 2 diabetes in rural border regions across the island of Ireland.

BackgroundIndividuals with type 2 diabetes mellitus (T2DM) face increased risk of cognitive decline and dementia. Multidomain lifestyle interventions offer a non-pharmacological strategy to support brain health in this high-risk group.ObjectiveThis study examined the acceptability of a culturally adapted FINGER-based intervention among adults living with T2DM in rural border regions of Ireland (BRAIN-Diabetes Trial).MethodsA 6-month pilot randomized controlled trial was conducted. The intervention group received a multidomain program targeting diet, physical activity, and computerized cognitive training (CCT). The control group received standard care. Acceptability was assessed using questionnaires (all participants) and semi-structured interviews (intervention participants). Quantitative data were analyzed descriptively and qualitative data using template analysis, guided by four a-priori themes: trial participation and engagement, dietary behavior change, exercise behavior change, and CCT behavior change.ResultsQuestionnaire data (intervention: n = 28; control: n = 36) indicated high overall acceptability. Dietary and exercise components were rated most positively, while CCT component was less well received. Interviews (n = 25) highlighted facilitators to trial engagement, including perceived health improvements, and social connection, with time constraints and limited personalization as barriers. Dietary change was supported by tailored guidance but hindered by cost and availability. Facilitators for exercise included accessible resources and perceived benefits, with barriers including competing priorities. CCT engagement was mixed, with challenges including digital access and repetitiveness.ConclusionsThe Brain-Diabetes intervention was acceptable and feasible among adults with T2DM. Personalized support and accessible resources were key to engagement. Future work should refine delivery to enhance scalability and long-term adherence among high-risk groups.

Humans

Real-time intraoperative perfusion assessment using indocianine green in pediatric extrinsic ureteropelvic junction obstruction with crossing vessel.

INTRODUCTION: In vascular hitch (VH) particular attention must be paid to preserving lower pole perfusion. Hypoperfusion is normally excluded by macroscopic visual assessment of parenchyma appearance. Our aim is to explore the possible role of indocyanine green (ICG) in highlighting focal hypoperfusion. MATERIALS AND METHODS: This prospective study included pediatric patients with UPJO caused by crossing vessels, treated with robot-assisted VH. Intraoperative evaluation assessed UPJ appearance, reduction of hydronephrosis after vessel mobilization, and the adequacy of pelvic drainage during diuretic testing. ICG was used to assess renal perfusion via NIRF imaging. A 25 mg ICG solution was prepared in 10 mL and administered in 1 mL doses. Fluorescence distribution, operative time, and complications were recorded. Follow-up at 3, 6, and 12 months included clinical evaluations, blood pressure measurements, and Doppler ultrasound. RESULTS: Eight patients (median age 8years) were enrolled between October 2023 and February 2025. ICG assessed renal perfusion post-procedure; one case of focal hypoperfusion due to vessel tension was resolved with intraoperative revision. At a median follow-up of 18 months, no hypertension, pain, or UTIs were observed. Ultrasound demonstrated improved hydronephrosis and normal Doppler flow. CONCLUSION: ICG angiography is a safe and effective tool for the real-time assessment of renal perfusion during pediatric VH procedures.

Humans

Effectiveness of Yoga and Combined Exercise in Female With Rheumatoid Arthritis: Randomized Controlled Trial.

BACKGROUND: Although exercise is beneficial for Rheumatoid Arthritis (RA), the comparative efficacy of different modalities for patients in clinical remission remains unclear. This study compared the short- and long-term effects of yoga versus a combined exercise programme on pain, balance, mobility, fatigue, depression, and quality of life in females with RA in remission. METHODS: In this single-blind, randomized controlled trial, 74 female participants were allocated to yoga (n&#xa0;=&#xa0;25), combined exercise (n&#xa0;=&#xa0;25), or a usual care control group (n&#xa0;=&#xa0;24). The intervention groups underwent an 8-week supervised programme. Clinical assessments, including the Visual Analogue Scale (pain), Berg Balance Scale, Timed Up and Go Test, Beck Depression Inventory, Fatigue Severity Scale, and Short Form-36, were conducted at baseline, post-intervention (8&#xa0;weeks), and follow-up (20&#xa0;weeks). RESULTS: Both intervention groups demonstrated significant improvements in all outcome measures compared with the control group at post-treatment and follow-up (p&#xa0;<&#xa0;0.05). Notably, the yoga group exhibited superior outcomes compared to the combined exercise group in reducing pain intensity (median reduction of 4.00 vs. 2.00 points; p&#xa0;<&#xa0;0.001, &#x3b7;2&#xa0;=&#xa0;0.724), as well as in physical function, balance, fatigue, depression, and quality of life at the 20-week follow-up. These benefits may be partly attributed to the incorporation of breathing and relaxation techniques inherent to yoga practice. CONCLUSIONS: Both 8-week yoga and combined exercise programs are effective in managing residual symptoms in females with RA in clinical remission. However, yoga appears to provide superior benefits in pain management and psychosocial well-being, supporting its integration into multidisciplinary RA management protocols, particularly for addressing psychosocial burden in patients achieving remission. TRIAL REGISTRATION: This study was retrospectively registered at NCT07072754 (clinicaltrials.gov).

Humans

Effectiveness of Mobile-Delivered Exercise and Yoga Programs on Depressive Symptom Reduction in Employees: Randomized Controlled Trial.

BACKGROUND: Mental health challenges such as stress and depression are prevalent among employees. Mobile health platforms that deliver exercise or yoga interventions offer a promising approach to improve mental health outcomes in this population. OBJECTIVE: This study aimed to assess the effectiveness of 12-session adaptive moderate-intensity exercise and yoga programs delivered via a motion-detecting digital platform in reducing stress and depressive symptoms among employees. METHODS: This was an unblinded, 3-arm, parallel-group, randomized controlled trial conducted at Seoul National University Bundang Hospital and Boramae Medical Center between November 2023 and January 2024. Eligible participants were full-time employees. Seventy-five participants were randomly assigned to an exercise, a yoga, or a cognitive behavioral therapy-based self-care control group using computer-generated randomization. The exercise and yoga groups engaged in motion-detecting, adaptive physical activity training, whereas the control group accessed mobile-based, self-directed stress management educational materials. The intervention was largely automated, with no individualized therapeutic guidance provided. Allocation was concealed until trial entry. All recruitment and outcome assessments were conducted in person at the hospitals. The primary outcomes were perceived stress and depressive symptoms, whereas the secondary outcomes included posttraumatic stress, insomnia severity, cognitive stress response, occupational stress, and burnout. Physiological outcomes were assessed using heart rate variability and electroencephalography. Measurements were collected at baseline, immediately after the intervention, and at 4-week follow-up. Data were analyzed using a multivariate linear model to evaluate the main effects of time, group, and time&#xd7;group interactions. RESULTS: Of the 75 randomized participants (exercise: n=24, 32%; yoga: n=25, 33.3%; and control: n=26, 34.7%), 71 (94.7%) who completed at least 9 of the 12 sessions (&#x2265;40 min each) were included in the outcome analysis (exercise: n=21, 29.5%; yoga: n=24, 33.8%; and control: n=26, 36.6%). For the coprimary outcomes, the group&#xd7;time interaction for depressive symptoms (Patient Health Questionnaire-9) approached but did not reach the Bonferroni-corrected threshold (F4,136=2.71; P=.03; adjusted &#x3b1;=.025); however, planned pairwise comparisons revealed significantly greater improvement in the yoga group compared to the control group at 4-week follow-up (&#x3b2;=-3.67; adjusted P<.001). For the Perceived Stress Scale, the interaction was not significant (P=.29), although a significant main effect of time (P<.001) indicated overall stress reduction across all groups. For secondary outcomes, a significant group&#xd7;time interaction was found for the Cognitive Stress Responses Scale (P=.003), indicating differential trajectories of improvement. The yoga group showed a consistent linear decrease, whereas the exercise group showed immediate but less sustained gains. CONCLUSIONS: Digitally delivered adaptive yoga programs demonstrated superior and sustained improvements in depressive symptoms and Cognitive Stress Responses Scale scores compared with the active cognitive behavioral therapy-based self-care control group. However, the exercise program showed more modest and less sustained effects, warranting further investigation using larger samples.

Adult

Mediators of Change in Cognitive Behavioral and Mindfulness-Based Online-Interventions for Hypoactive Sexual Desire Dysfunction in Women.

Low sexual desire is a common sexual problem among women. When it is accompanied by significant personal distress, it may be diagnosed as hypoactive sexual desire dysfunction (HSDD). Both cognitive behavioral therapy (CBT) and mindfulness-based therapy (MBT) are effective treatments for HSDD when delivered in person or online. In this randomized controlled treatment study, CBT and MBT consisted of eight guided self-help modules delivered online, and participants completed measures at pretreatment and after 3, 6, and 12&#x2009;months. Nine variables were examined as potential mediators of treatment outcomes (i.e., sexual desire and sexual distress), namely mindfulness, self-compassion, rumination, body connection, self-consciousness, relationship satisfaction, sexual communication, depression, and anxiety. In total, 212 women diagnosed with HSDD were randomized to either CBT or MBT (Mage&#x2009;=&#x2009;36.3, SD&#x2009;=&#x2009;10.2). Improvements in self-compassion, rumination, body connection, and self-consciousness partially mediated treatment outcomes in at least one of the treatment groups. Mediation effects were mostly small, explaining up to 15% of the total effects. No systematic differences in mediation pathways between CBT and MBT were found. These findings emphasize the importance of emotion regulation, metacognitive processes, and embodiment for the effective treatment of HSDD. Future research should refine treatment components to enhance efficacy and ensure that psychological interventions adequately address common concerns among women with HSDD.

Humans

Sequential laparoscopic percutaneous extraperitoneal closure for inguinal hernia during NICU/GCU hospitalization in low birth weight infants.

BACKGROUND: Inguinal hernia is common in low birth weight infants and carries a risk of incarceration. Although laparoscopic percutaneous extraperitoneal closure (LPEC) is widely used in pediatric patients, the safety of sequential LPEC during NICU/GCU hospitalization remains unclear. This study evaluated the safety and feasibility of sequential LPEC during NICU/GCU hospitalization. METHODS: We retrospectively reviewed infants who underwent LPEC between September 2018 and July 2024. Infants aged&#x2009;&#x2264;&#x2009;6 months diagnosed with inguinal hernia and treated with sequential LPEC during hospitalization were included. For comparison, infants aged&#x2009;&#x2264;&#x2009;6 months with a history of NICU/GCU hospitalization who were diagnosed with inguinal hernia after NICU/GCU discharge and underwent LPEC were identified. RESULTS: Among 302 patients, 13 met the inclusion criteria. One patient required postoperative reintubation, postoperative testicular atrophy occurred in three patients, and no hernia recurrence was observed during a median follow-up of 48 months. Compared with infants diagnosed after NICU/GCU discharge, the sequential LPEC group had significantly lower gestational age, lower birth weight, lower body weight at surgery, and more comorbidities, whereas postoperative outcomes were comparable. CONCLUSION: Sequential LPEC during continuous NICU/GCU hospitalization is feasible and can be safely performed in low birth weight infants with appropriate technical refinements.

Humans

Ictal electroencephalography and heart rate as treatment criteria in electroconvulsive therapy: a systematic review of the literature.

BACKGROUND: Decades before the emergence of precision medicine, psychiatrists raised the question of whether specific seizure characteristics could help optimize electroconvulsive therapy (ECT), as relationships between some of these characteristics and better outcomes were found. From 1990 onward, researchers focused on electroencephalography (EEG) and cardiovascular markers, which were broadly adopted by guidelines worldwide. However, the prognostic value of these markers is still controversial. Here, we provide a systematic summary of the studies on this topic. METHODS: We conducted a literature review on the use of ictal EEG and heart rate as outcome predictors in ECT using the PubMed, EMBASE, Cochrane and PsycINFO databases. RESULTS: Thirty-seven studies addressing more than 100 quality markers fulfilled our inclusion criteria. Single EEG markers were assigned to five categories (postictal inhibition, amplitude, coherence, regularity, and seizure duration). Heart rate and composite markers were considered separately. In contrast to single EEG markers, heart rate and composite markers could be consistently linked to better outcomes in patients with depression. Only a few studies on schizophrenia could be retrieved. CONCLUSION: Multiparametric markers outperformed single markers. Furthermore, changes in heart rate during seizures were related to better outcomes. Although clinical assessment remains the cornerstone of treatment guidance decisions, EEG and cardiac monitoring could help prevent insufficient seizures during the period preceding clinical improvement. Evidence on schizophrenia remains limited. More randomized trials are needed to analyze the role of composite markers as prognostic tools.

Humans

Tranexamic acid in spontaneous&#x2002;intracerebral&#x2002;hemorrhage: an updated systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Tranexamic acid (TXA) is a well-established antifibrinolytic medication in the general population. However, its efficacy and safety for patients with spontaneous intracerebral hemorrhage (ICH) remain inconclusive. Consequently, we conducted a systematic review and meta-analysis to assess the effectiveness and safety of TXA for spontaneous ICH. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) following established methodological standards. Our search encompassed eight electronic databases from inception to April 25, 2024. The primary outcome was a reduction in all-cause mortality. The secondary outcomes included improvements in functional independence, neurological impairment, activities of daily living, and reduction in hematoma expansion (HE). Fixed-effects or random-effects model&#xa0;were performed for pooled data where eligible. RESULTS: A total of 9 RCTs that initially enrolled 3,124 patients were included. There were no significant differences observed concerning all-cause mortality (RR, 1.03; 95% CI [0.89-1.18]), hematoma expansion (RR, 0.90; 95% CI [0.80-1.00]), improvement of functional independence (RR, 1.02; 95% CI [0.92-1.12], neurological impairment (MD, -0.88 [95% CI, -2.22-0.45]), or activities in daily living (MD, -0.83 [95% CI, -29.25-12.59]). The pooled data indicated that TXA for ICH was associated with a decrease in hematoma volume from baseline (MD, -1.74; 95% CI [-2.47 to -1.02]). No significant difference in adverse events was observed between the TXA group and the control group. CONCLUSIONS: In summary, TXA does not affect all-cause mortality, functional outcomes, or neurological impairment, nor does it reduce HE, despite reducing hematoma volulume. TXA use for ICH requires careful clinical consideration.

Humans

Integrated genomic and biochemical diagnosis of a novel homozygous start-loss variant in AKR1D1 associated with neonatal cholestasis.

INTRODUCTION: Congenital bile acid synthesis defects are rare autosomal recessive disorders that typically present in early infancy with cholestasis, progressive liver dysfunction, and, in severe cases, acute liver failure. These conditions may mimic other metabolic diseases detected in newborn screening, complicating early diagnosis. The AKR1D1 gene encodes &#x394;4-3-oxosteroid 5&#x3b2;-reductase, a key enzyme in primary bile acid synthesis, and pathogenic variants cause bile acid synthesis defect type 2 (OMIM #235555). CASE DESCRIPTION: We report a 3-month-old male infant with severe neonatal cholestasis and a history of elevated tyrosine levels in newborn screening. Pregnancy was high risk and unmonitored, with birth outside a hospital. Parental consanguinity was first-degree. Early metabolic evaluation showed transient normalization of tyrosine levels, but subsequent analyses revealed recurrent hyper-tyrosinemia. Urinary organic acids showed increased 4-hydroxyphenyl metabolites, with absent succinylacetone, excluding tyrosinemia type I. Progressive cholestasis developed, accompanied by coagulopathy, hyperbilirubinemia, hyperammonemia, and markedly elevated alpha-fetoprotein. Imaging revealed no structural liver abnormalities. Clinical exome sequencing identified a novel homozygous start-loss variant in AKR1D1, likely abolishing functional enzyme production. Metabolic studies confirmed increased urinary excretion of 3-oxocholenoic acids consistent with abnormal bile acid synthesis and supporting a diagnosis of bile acid synthesis defect type 2. Oral cholic acid therapy led to stabilization and improvement in clinical and biochemical parameters. DISCUSSION/CONCLUSION: This case illustrates the diagnostic complexity of neonatal cholestasis, particularly when initial metabolic findings suggest alternative etiologies. It highlights the importance of newborn screening as a tool for broader diagnostic suspicion and the critical role of early molecular diagnosis and multidisciplinary care. Timely recognition and targeted therapy can improve outcomes, prevent liver transplantation, and enable accurate genetic counseling, especially in consanguineous families.

Humans

Internet-based acceptance and commitment therapy (iACT) improves professional psychological help-seeking attitudes: A randomized controlled trial.

BACKGROUND: Professional psychological help-seeking attitudes are crucial for addressing mental health challenges, yet the mechanisms underlying their improvement through internet-based interventions remain poorly understood. OBJECTIVE: This randomized controlled trial aimed to (1) evaluate the efficacy of Internet-based Acceptance and Commitment Therapy (iACT) in enhancing professional help-seeking attitudes, and (2) elucidate the longitudinal mediating roles of psychological rigidity and self-stigma. METHODS: A total of 91 male participants (Mean Age&#xa0;=&#xa0;21.09) were randomly assigned to either a 12-day iACT intervention group (n&#xa0;=&#xa0;46) using a self-developed mobile application or a waitlist control group (n&#xa0;=&#xa0;45). Psychological flexibility, rigidity, self-stigma, and help-seeking attitudes were measured at four time points: baseline, mid-intervention (Day 6), post-intervention (Day 12), and 1-month follow-up. Data were analyzed using repeated-measures ANOVA and latent growth modeling. RESULTS: Intention-to-treat analysis revealed the iACT group showed greater improvements in help-seeking attitudes than controls (F (3,87)&#xa0;=&#xa0;5.95, p&#xa0;<&#xa0;0.001), with medium-to-large between-group effects at post-test for reducing psychological rigidity (d&#xa0;=&#xa0;-0.77, 95% CI [-1.19, -0.34]) and self-stigma (d&#xa0;=&#xa0;-0.88, 95% CI [-1.31, -0.45]). Latent growth modeling revealed a sequential mediation effect: the iACT intervention reduced psychological rigidity (&#x3b2;&#xa0;=&#xa0;-0.53, SE&#xa0;=&#xa0;0.12), which in turn reduced self-stigma (&#x3b2;&#xa0;=&#xa0;0.61, SE&#xa0;=&#xa0;0.09) and improved help-seeking attitudes (&#x3b2;&#xa0;=&#xa0;0.47, SE&#xa0;=&#xa0;0.08). CONCLUSION: This study provides the first evidence that a self-guided iACT mobile intervention can effectively enhance professional help-seeking attitudes by reducing psychological rigidity, which in turn alleviates self-stigma. The developed app offers a scalable solution to overcoming stigma-related barriers to mental health care.

Humans

Shared Medical Appointments for Substance Use Disorders: A Systematic Review.

BACKGROUND: Shared medical appointments (SMAs) integrate group-based clinical care with individual medical management and are increasingly used in the treatment of substance use disorders (SUDs) to improve access, engagement, and care coordination. However, their use, outcomes, and implementation in SUD care have not been systematically synthesized. METHODS: We conducted a systematic review registered with PROSPERO (CRD42025639504). MEDLINE, Embase, PsycINFO, Scopus, and Cochrane Central were searched from database inception through September 2025. Randomized controlled trials, observational studies, and qualitative studies examining SMAs among adults with SUDs were included. Outcomes of interest included treatment engagement and retention, substance use outcomes, mental health and patient-reported outcomes, and implementation characteristics. Study quality was assessed across quantitative and qualitative designs, and findings were synthesized descriptively. RESULTS: Fourteen studies, representing approximately 578 participants, met inclusion criteria. Twelve studies focused exclusively on opioid use disorder, 1 included both alcohol and opioid use disorders, and 1 did not specify substance type. Treatment retention was reported in 6 studies, with a median 6-month retention of 72.9%. Three studies reported reductions in substance use outcomes, and 2 reported improvements in depression or anxiety. Qualitative studies consistently described high patient satisfaction, peer support, and shared accountability. Implementation studies demonstrated feasibility across diverse outpatient settings, with substantial heterogeneity across study designs and outcomes. CONCLUSIONS: SMAs appear feasible and acceptable for addiction care and may support treatment retention and patient experience. Evidence remains heterogeneous and largely observational, highlighting the need for rigorous comparative studies to better define effectiveness and implementation.

Humans

Clinical insights into catathrenia: A real-world analysis from a tertiary sleep center.

INTRODUCTION: Catathrenia is a rare sleep-related breathing disorder marked by groaning during prolonged expiration, often underrecognized or misdiagnosed as obstructive or central sleep apnoea (OSA or CSA) or parasomnia. Understanding its clinical and polysomnographic features is essential for accurate diagnosis and management. MATERIALS AND METHODS: We performed a retrospective observational study of adult patients diagnosed with catathrenia at Servi&#xe7;o de Medicina do Sono de Coimbra. Diagnosis was established by attended overnight polysomnography (PSG) with synchronised audio-video recording. Demographic data, symptoms, comorbidities, PSG variables, treatment modalities, and outcomes were reviewed. Catathrenia events were defined as deep inhalation followed by prolonged exhalation with monotonous groaning. RESULTS: Ten patients were included. Median age was 46&#x2009;years (range 27-78), mostly female (70%). Common comorbidities included obesity (n&#x2009;=&#x2009;4), depression (n&#x2009;=&#x2009;2), Parkinson's disease (n&#x2009;=&#x2009;1), and restless legs syndrome (n&#x2009;=&#x2009;1). Six patients (60%) had concomitant obstructive sleep apnoea (OSA). Seven patients had excessive daytime sleepiness (Epworth Sleepiness Scale&#x2009;>&#x2009;10). All catathrenia episodes occurred exclusively during REM sleep. Continuous positive airway pressure (CPAP) therapy was the most frequently used treatment and was associated with objective or subjective improvement in most patients. Two patients experienced spontaneous remission. CONCLUSION: Catathrenia remains underdiagnosed and can mimic other sleep disorders. Recognition of its REM-sleep predominance and PSG pattern is essential. Individualised treatment, often involving PAP therapy, may improve symptoms and patient outcomes.

Humans

BLIS study: a feasibility randomised controlled trial assessing compliance, acceptability and colonisation with different dosing regimens of the probiotic supplement Streptococcus salivarius K12 (Bactoblis) in adults in England.

OBJECTIVES: Streptococcus salivarius K12 (SsK12) is a bacterium used as a probiotic with some evidence for preventing acute sore throat/tonsillitis, but the optimal dosing strategy is unclear. This study aimed to evaluate two dosing regimens of SsK12 to establish (a) the prevalence and duration of colonisation with SsK12 and (b) the acceptability and feasibility of these regimens. DESIGN: A randomised, non-blinded feasibility trial. SETTING: Primary care in the south of England. PARTICIPANTS: Adults with &#x2265;2 episodes of sore throat within the 3 years before recruitment. INTERVENTIONS: Participants were randomised to take SsK12 lozenges once weekly or daily over 14 days. MAIN OUTCOME MEASURES: The primary outcome was the prevalence and duration of colonisation with SsK12. This was determined by real-time PCR conducted on self-taken whole-mouth swabs provided by participants at baseline and on days 2, 7, 14, 21 and 35. Secondary outcomes were the compliance and acceptability of the two SsK12 dosing regimens, based on questionnaire data. RESULTS: 53 participants were recruited (26 randomised to weekly and 27 to daily dosing) between 26 April and 5 December 2023. All swabs were returned by 65.4% (17/26) and 70.4% (19/27) of the weekly and daily groups respectively. Swabs at all timepoints from participants with PCR positives observed at baseline (two and four from the weekly and daily group, respectively) were excluded. Therefore, swabs from 23 participants in the weekly and 22 in the daily group did not have evidence of baseline colonisation and were included in the microbiology analysis. SsK12 colonisation was found in 59.1% (13/22, 95% CI 38.6% to 79.6%) of samples in both groups on day 2; in 13.6% (3/22, 95%&#x2009;CI 0.0% to 28.0%) and 85.7% (18/21, 95%&#x2009;CI 70.8% to 100.0%) of the weekly and daily groups, respectively, on day 7; in 19.1% (4/21, 95%&#x2009;CI 2.3% to 35.8%) and 59.1% (13/22, 95%&#x2009;CI 38.6% to 79.6%), respectively, on day 14; and in only one participant (weekly group) on days 21 and 35. The dosing regimen was reported as easy to follow by 85.0% (17/20, 95%&#x2009;CI 69.4% to 100.0%) of the weekly and 96.2% (25/26, 95%&#x2009;CI 88.8% to 100.0%) of the daily dosing groups. CONCLUSIONS: SsK12 colonisation was more prevalent with daily dosing; however, colonisation was not maintained when dosing stopped. Both dosing regimens were acceptable to participants. These findings support the use of daily dosing in a future trial to evaluate the efficacy of SsK12 in preventing recurrence of sore throat/tonsillitis. TRIAL REGISTRATION NUMBER: NCT04297878.

Humans

Postoperative complications and outcomes after surgical treatment for tophaceous gout: A systematic review and meta-analysis.

BACKGROUND: Surgical treatment remains necessary for selected patients with tophaceous gout, particularly when mechanical limitation, nerve compression, ulceration, infection, deformity, or failure of conservative treatment is present. However, postoperative outcomes after surgery for tophaceous gout have not been comprehensively quantified. This systematic review and meta-analysis evaluated postoperative complication profiles and recurrence burden after surgical treatment for tophaceous gout. METHODS: A systematic search of PubMed, Embase, Web of Science, and the Cochrane Library was conducted from database inception to March 25, 2026. Original studies reporting postoperative outcomes after surgical treatment for tophaceous gout were included. Pooled event rates with 95% confidence intervals (CIs) were calculated using a random-effects single-arm meta-analytic approach. Primary outcomes were postoperative infection, delayed wound healing, and recurrence. Secondary outcomes were reoperation, amputation, and overall complications. Functional outcomes were summarized descriptively. RESULTS: 18 retrospective studies were included. The pooled postoperative infection rate was 11.3% (95% CI 8.0%-15.7%), delayed wound healing 9.9% (95% CI 5.1%-18.2%), and recurrence 8.5% (95% CI 4.7%-14.9%). Secondary pooled rates were 9.7% (95% CI 5.5%-16.7%) for reoperation, 3.7% (95% CI 2.0%-6.8%) for amputation, and 24.0% (95% CI 14.0%-38.1%) for overall complications. Significant subgroup differences were identified only for infection according to anatomic site and intervention type. Sensitivity analyses showed that pooled estimates were robust. The certainty of evidence was very low for all outcomes. CONCLUSIONS: Surgical treatment for tophaceous gout is associated with measurable postoperative risks, particularly infection and overall complications. These findings support careful perioperative counseling, structured postoperative surveillance, integrated long-term urate-lowering management, and more standardized reporting of perioperative risk factors and postoperative outcomes in future surgical studies of tophaceous gout.

Humans

Effect of atenolol versus ivabradine on heart rate variability in patients of schizophrenia with clozapine-induced tachycardia: a randomized controlled trial.

BACKGROUND: A third of schizophrenia cases are resistant to antipsychotics, where clozapine is the only FDA-approved medication. Clozapine use is often limited by intolerable adverse effects. Persistent tachycardia occurs in approximately 25-54% patients receiving clozapine. Heart rate variability (HRV) is a non-invasive, clinically relevant marker of autonomic nervous system functioning. Atenolol and Ivabradine are usually prescribed for clozapine-induced tachycardia (CIT), although evidence guiding their optimal use remains limited. AIM: This study aimed to compare the effects of atenolol versus ivabradine on HRV in patients with treatment-resistant schizophrenia (TRS) receiving clozapine. METHODS: This open-label randomised clinical trial, conducted at a tertiary-care center over 20 months, involved TRS patients on clozapine for more than three months and having persistent tachycardia. Twenty patients received atenolol 25mg once-daily, while twenty received ivabradine 5mg twice-daily for two months. The primary outcome was the change in the frequency domain of HRV, while the secondary outcomes were time-domains, central and peripheral blood pressure, pulse rate and treatment-emergent adverse events (TEAE). RESULTS: While both drugs significantly reduced pulse-rates (atenolol: -20.56&#xb1;13.00, p<0.001; ivabradine: -21.855&#xb1;12.873, p<0.001). Within-group analysis showed that, the atenolol group had significant improvements in high-frequency [HF] power (p=0.048) and LF/HF ratio (p=0.044), along with a non-significant trend towards increased total power (p=0.053); no significant within-group changes were observed in the ivabradine group. CONCLUSION: No significant between-group differences in HRV parameters were established between atenolol and ivabradine. Ivabradine could be a viable option in patients where atenolol is either contraindicated or not tolerated. Future larger multicentric studies are needed for greater generalisability. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06505668.

Humans

Neuromuscular blocking agents for tracheal intubation of critically ill adults: a systematic review and meta-analysis.

BACKGROUND AND IMPORTANCE: Emergency tracheal intubation in critically ill adults is associated with a high risk of peri-intubation adverse events, making first-attempt success a key safety target. OBJECTIVE: This study aimed to evaluate whether the use of neuromuscular blocking agents (NMBAs) improves the proportion of first-attempt success and reduces adverse events during emergent intubations outside the operating room. METHODS: This was a systematic review and meta-analysis of randomized clinical trials or nonrandomized studies comparing sedative-hypnotic plus NMBA versus sedative-hypnotic alone in critically ill adults undergoing emergency endotracheal intubation in nonoperative settings. Animal, cadaveric, manikin/simulation, and pediatric studies were excluded. Articles were screened on 21 August 2025, in Ovid MEDLINE, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, and the Web of Science Core Collection. MAIN RESULTS: Of 4736 screened citations, 13 studies (8 cohort; 5 before-after studies) were included in the quantitative analysis, with 14&#x2005;072 participants. NMBA use was associated with higher first-attempt success, which ranged from 69 to 92% (pooled odds ratio, 2.72; 95% onfidence interval: 1.42-5.21; low-certainty evidence). Secondary outcomes related to adverse events were rated as very low certainty due to sparse data, inconsistent reporting, and serious imprecision. CONCLUSION: NMBA use during emergency intubation was associated with improved first-attempt success, although the certainty of evidence was low.

Humans