Primary Outcome Measure Research Articles

A Pilot Study Using Continuous Glucose Monitoring among Patients with a Low 1-Hour Glucose Challenge Test Result versus Controls to Detect Maternal Hypoglycemia.

A low 1-hour glucose challenge test (GCT) result (<10th percentile for population) has been associated with neonatal morbidity, including small-for-gestational-age birth weight, and it is hypothesized that underlying maternal hypoglycemia may contribute to this neonatal morbidity. We sought to assess whether eligible patients would undergo continuous glucose monitoring to allow comparison of maternal hypoglycemia between those with a low GCT result versus controls. This exploratory study enrolled patients who completed a GCT between 24 and 30 weeks' gestation from June to September 2022. English- or Spanish-speaking participants aged ≥18 years wore a blinded continuous glucose monitor (CGM) for 10 days. There were 10 participants each in the low GCT (<82 mg/dL) and normal GCT group. Proportions were calculated to determine recruitment rates and describe the low versus normal glycemic groups across clinical and sociodemographic characteristics. Maternal hypoglycemia, defined using various proposed thresholds, was analyzed as continuous data (time duration) with Student's t-tests and categorical data (number of episodes) with chi-square tests and bivariate analyses were performed comparing participants with a low versus normal GCT. Primary outcome measures were recruitment, enrollment, and adherence rates, and overall glycemic values for each group. Of 64 eligible patients, 58 (91%) were approached, and of them, 20 (35%) were enrolled. All 20 participants had CGM data to review with 100% adherence. Average glucose values were similar between participants in the low GCT and normal GCT groups (111.7 ± 18.0 vs. 111.6 ± 11.7 mg/dL, p = 0.99), and participants with a low GCT value did not demonstrate more hypoglycemia than those with a normal GCT value across five proposed thresholds on CGM analysis. In this pilot study, participants wore blinded CGMs to collect glycemic data, and those with a low GCT result did not experience more hypoglycemia than those with a normal GCT on CGM analysis. · Study participants wore continuous glucose monitors in blinded mode to gather glycemic data with 100% adherence.. · Participants with a low GCT result (<82 mg/dL) as compared with those with a normal GCT result were not more likely to demonstrate maternal hypoglycemia using several thresholds on CGM analysis.. · In our cohort, there were few participants in either glycemic group who reported food insecurity or lived in a food desert..

Mechanism of cognitive processing for acupuncture action on generalized anxiety with naturally occurring consecutive partial sleep deprivation in early adulthood: a randomized controlled study and evaluation of event-related potentials

IntroductionGeneralized anxiety disorder (GAD) is a common mental disorder that often begins in adolescence or early adulthood and is characterized by widespread and persistent anxiety. Partial sleep deprivation (PSD) is an important risk factor for GAD development and a common comorbidity. Adolescence is a period of rapid brain and nervous system development, and during this time, the occurrence of GAD can lead to neurocognitive deficits, such as impaired attention, cognitive control, and attention bias, that significantly affect cognitive function. However, relatively little research has been conducted on GAD comorbid with PSD in early adulthood compared with other psychiatric disorders. Clinical studies have demonstrated the effectiveness of acupuncture in treating GAD and sleep disorders, but the mechanism of how acupuncture modulates neurocognitive processing in patients with GAD comorbid with PSD has not been clarified.Methods/designIn this randomized clinical trial, a total of 56 participants diagnosed with GAD comorbid with naturally occurring PSD and 28 healthy controls (HCs) will be recruited. The participants diagnosed with GAD comorbid with PSD will be randomly assigned to either the acupuncture group or the sham acupuncture group at a 1:1 ratio. The primary outcome measure is the Hamilton Anxiety Rating Scale (HAMA). Secondary outcome measures are the Sleep Deprivation Index (SDI), the Self-Assessment Scale for Anxiety (SAS), the Epworth Sleepiness Scale (ESS), and the State-Trait Anxiety Inventory (STAI). Additionally, three psychological paradigms (the attentional network test, psychomotor vigilance test, and emotional face Go/No-go) and event-related potential (ERP) data. Healthy volunteers will not undergo acupuncture but will instead participate in baseline assessments for the scales, mental paradigms, and ERP data. Acupuncture and sham acupuncture interventions will be conducted for 30 min, three times a week, over a 2-week period. Evaluations will be performed at zero weeks (baseline), 1 week, and 2 weeks, with the data enumerator, outcome assessor, and participant blinded to the treatment assignment.DiscussionThis study contributes to the exploration of the effects of acupuncture on improving anxiety symptoms and cognitive functions in individuals with comorbid GAD and PSD.Trial registrationClinicalTrials.gov, ChiCTR2400082221. Registered March 25, 2024.

Outcomes of operative fixation of loose trochlear osteochondral defects: A case series with subgroup analysis

Objectives To evaluate results of open reduction and internal fixation (ORIF) of loose osteochondritis dissecans (OCD) fragments of the trochlea including identification of any cases of fixation failure and assessment of post-operative patient-reported outcomes and activity level. Methods A retrospective chart review of OCD fixation surgeries performed between 2010 and 2021 identified 12 patients who underwent ORIF of loose OCD trochlear fragments. Patient demographics, history, imaging findings, surgical factors, and skeletal maturity were all collected. Primary outcome measures included reoperation for fixation failure, Knee Osteoarthritis Outcome Scores (KOOS), and Marx scores. Results The 12 patients (12 knees) with a mean age of 17.7 ± 6.4 years (range, 13-37 years) were included in the case series. Mean trochlear OCD size was 3.20 cm2 (range, 1.69-5.06 cm2) with mean follow-up of 78.9 months (range, 8 – 145). Failure of fixation occurred in. Failure of fixation occurred in 2 patients (17%). Of the 10 patients (83%) who completed PROs, the mean KOOS global score for all patients was 86.8 ± 16.3, symptoms/stiffness sub score 90.0 ± 11.0, pain 91.2 ± 12.1, Functions of daily living 95.5 ± 8.3, Sports/recreation 82.0 ± 23.9, quality of life 75.7 ± 28.6, and a mean Marx activity score of 10.5 ± 4.9. Conclusion ORIF of loose OCD lesions of the trochlea is associated with a low risk of failure of fixation and acceptable patient-reported outcomes.

Do Swedish rock-climbers exhibit more eating disorder and body dissatisfaction symptoms than non-climbers? A cross-sectional study

ObjectivesThe inclusion of rock-climbing in the Olympic Games has increased participation in the sport and attention to athletes' health. In sports where the importance of low body weight is considerate,...

Yoga, Physical Therapy and Home Exercise Effects on Chronic Low Back Pain: Pain Perception, Function, Stress, and Quality of Life in a Randomized Trial.

Low back pain is a common health problem. In this study, we investigated the effects of yoga, physical therapy (PT), and home exercise (HE) on pain perception, function, stress, and quality of life in chronic low back pain (cLBP). We randomly assigned 54 participants to three distinct treatment groups: (a) a physical therapy group (PT) who received spinal stabilization exercises (SSE) combined with local heat and transcutaneous electrical stimulation; (b) a home exercise group (HE) who received SSE as part of the home program; and (c) a yoga group who received yoga exercises. The primary outcome measures were a Visual Analog Scale (VAS) for measuring pain, and the Oswestry Disability Index (ODI) to measure function. Secondary outcome measures were the Tampa Kinesiophobia Scale (TKS), Central Sensitization Inventory (CSI), pain sensitivity (L3 and deltoid R/L PPTs), Spielberger State-Trait Anxiety Inventory (STAI), plasma cortisol and DHEA-S levels, Transversus Abdominis (TrA) muscle activation, and the Nottingham Health Profile (NHP). Assessments were conducted before and after a six-week intervention period. All three groups demonstrated improvements in pain on the VAS, function on the ODI, pain sensitivity on the L3 and deltoid R/L PPTs, CSI, anxiety on the STAI, TrA muscle activation, and quality of life on the NHP (p < .05). The PT group exhibited a more pronounced improvement on the ODI score (p < .05) than the other groups. Cortisol levels only decreased in the PT group (p < .05). The exercises did not impact DHEA-S and NHP-S parameters. Thus, all interventions resulted in decreased stress, pain intensity, pain sensitivity, central sensitization, and improved function and quality of life; there was no singularly superior approach between interventions. These findings will aid in tailoring treatment programs for managing cLBP according to individual needs.

Duration of prehospital and in-hospital cardiopulmonary resuscitation and neurological outcome in paediatric out-of-hospital cardiac arrest

BackgroundBecause of their young age and lack of known comorbidities, paediatric patients with out-of-hospital cardiac arrest (OHCA) often undergo prolonged cardiopulmonary resuscitation (CPR). We aimed to determine the association between...

Technique of Excision of Double Head Pterygium with Conjunctival Autograft from both Eyes

Background: Pterygium is not just a degenerative disease, but may be a proliferative disorder of the ocular surface. Objective: The aim of this study was to describe a technique of conjunctival autograft from both eyes for primary double head pterygium and evaluate its post operative result. Methodology: This retrospective study was conducted in the department of Ophthalmology at Monno Medical College, Manikganj, Bangladesh from July 2022 to December 2022 for duration of six months. After fulfill the selection criteria underwent conjunctival autograft from both eyes. Primary outcome measure was recurrence rate, graft retraction, Tenon's granuloma, dellen formation. Results: The highest patients belong to 35 to 45 years age group is about 18(60.0%) in this study. The number of male patients was 10 and that of female patient 20. There was no recurrence in this study. However, there were postoperative oedema (6.66%), sub-conjunctival haemorrhage (63.33%), graft retraction (20.0%), dellen (0.0%), Tenon’s granuloma (10.0%). Conclusion: In conclusion conjunctival autograft from both eyes appears to be successful technique with 0 recurrence rate in treating double head pterygium. Journal of Monno Medical College June, 2024;10 (1):03-06

DESIGN AND SET UP OF A RANDOMISED CONTROLLED TRIAL OF MEDICINAL CANNABINOIDS IN RECURRENT GLIOBLASTOMA - THE ARISTOCRAT TRIAL

Abstract AIMS ARISTOCRAT is a unique, randomised, double-blind, placebo-controlled phase II trial of cannabinoids (nabixo- mols) alongside temozolomide in patients with MGMT-methylated recurrent GBM and is open to recruitment in 12 centres across the UK. It was rapidly funded through a crowdfunding campaign organised by The Brain Tumour Charity during the COVID-19 pandemic. METHOD This pragmatic phase II randomised trial was designed and set up by a multi-disciplinary team of co-applicants and trial management group (TMG) members comprising of clinicians, statisticians, trialists, Patient &amp; Public Involvement (PPI), pharmacists and quality of life (QoL) researchers. The protocol randomises on a 2:1 ratio between nabiximols or matched placebo with standard dose temozolomide in patients at first recurrence of IDH wild-type GBM. Unique aspects include self-titration of nabiximols based on individual tolerance, and fully blinded randomisation with matched placebo. The primary outcome measure is overall survival time with key secondary outcomes including survival at 6, 12 and 24 months, progression-free survival time, health-related QoL and adverse events. Intermediate assessment of feasibility to confirm safety, compliance and achievability of recruitment will be undertaken after 40 patients are randomised. PPI input has been critical in the trial and patient-facing information design. RESULTS The trial has promoted a high level of patient and public interest, including press coverage. The trial aims to recruit a total of 234 patients over an 18 month period. CONCLUSION ARISTOCRAT will provide unique, robust clinical data on the role of nabiximols (combined with temozolomide) in improving overall survival and the impact on QoL for patients with recurrent GBM and is the first of its kind in cancer patients.

Cochrane meta-analysis fuels invalid skepticism about compulsory community treatment effectiveness

BackgroundQuantitative research on non-randomized-samples, focused on statute-mandated-outcomes, has found positive results favoring compulsory-community-treatment (CCT) in jurisdictions fully supporting its implementation. In contrast, three randomized-studies “failed-to-find” a difference between randomly-assigned-CCT and control-groups–each study repeatedly summarized in revisions of a Cochrane-meta-analysis reporting this failure. Considering the potential health and safety threats to people with severe-mental-illness and those with whom they interact, there is a critical need for this investigation to resolve these conflicting results. MethodUsing data and procedural-descriptions from the involved-studies, this validity-focused-analysis addressed six questions. Two external-validity focused-questions addressing generalizability of study findings: 1. Did the Cochrane-meta-analysis select studies focused on the CCT-target population? 2. Assuming valid population focus did the Cochrane meta-analysis enroll individuals from among this population fitting the CCT criteria? Four internal-validity-questions: 1. Did the study-designs address the intervention's purpose? 2. Were the outcome-criteria used in the selected-studies valid-indicators of the intervention's intended-outcomes? 3. Were the studies reviewed in the Cochrane-meta-analysis, controlled-trials? And 4. Were the prescribed-Cochrane-Database-statistical-procedures appropriate for evaluating the reviewed-randomized-trials? ResultsFocused on completing randomized-investigations, two outpatient-commitment and one CTO-study failed to validly represent the CCT-population, failed to enroll qualifying-subjects, conflated their primary outcome-measure with a required-intervention-procedure, failed to control for post-randomization experiences directly related to their primary-outcome-measure, and conflated the study conditions. Two trials continuously misrepresented themselves as “randomized-controlled-trials”. All relied on univariate-contrasts in evaluating their outcomes, while without post-randomization-control the studies required multivariate-controls for contrasting the outcomes of their intervention-groups. The Cochrane-review, while listing the short-comings of these studies, placing an over-emphasis on prescriptive-methodology, without addressing study substantive-validity, has yielded spurious-conclusions suborning an invalid political-narrative regarding CCT-effectiveness. ConclusionsThe “failure-to-find” results from the Cochrane-reviewed-studies can be attributed to research shortcomings rather than intervention-ineffectiveness. The Cochrane-review has promoted undue controversy and skepticism re the use of CCT, a potentially lifesaving-procedure.

Developing a Sitting Simple Baduanjin program for advanced cancer patients with the fatigue-sleep disturbance symptom cluster: A feasibility study.

We describe a development and feasibility study of a Sitting Simple Baduanjin program for advanced cancer patients suffering from the fatigue-sleep disturbance symptom cluster. This study was to evaluate the practicality and safety of the Sitting Simple Baduanjin intervention and determine its preliminary efficacy. This work employed a single-arm mixed-methods approach. The primary outcome measures were feasibility (i.e., recruitment, adherence, and satisfaction) and safety. Validated self-report questionnaires were used to evaluate the preliminary effects of the program, including fatigue, sleep quality, and quality of life at the 4th, 8th, and 12th weeks of the intervention. Qualitative interviews were also conducted after the program. A total of 30 participants were enrolled, of which 23 (77%) completed the 12-week Sitting Simple Baduanjin program. The mean adherence rate was 88% and no adverse events were reported. Statistically significant improvements were observed in terms of fatigue, sleep quality, and quality of life after program completion. Four themes emerged from the qualitative interview data: (a) acceptability of the Sitting Simple Baduanjin technique, (b) perceived benefits of exercise, (c) barriers, and (d) facilitators. The findings support the feasibility of the Sitting Simple Baduanjin program for advanced cancer patients and show promise in improving patients' levels of the fatigue-sleep disturbance symptom cluster and quality of life.

Internet-based cognitive behavioral intervention for adolescents with anxiety disorders: a study protocol for a parallel three armed randomized controlled trial

BackgroundAnxiety disorders are among the most prevalent mental health concerns affecting children and adolescents. Despite their high prevalence, statistics indicate that fewer than 25% of individuals in this demographic seek professional assistance for their condition. Consequently, there is a pressing need to develop innovative interventions aimed at improving treatment accessibility. ObjectivesThis study aims to assess the effectiveness of Internet-delivered Cognitive Behavioral Therapy (iCBT) for adolescents with anxiety, with a specific emphasis on involving parents in the treatment process.MethodsThe study is structured as a parallel three-armed randomized controlled trial, comparing Internet-delivered Cognitive Behavioral Therapy (iCBT) with planned feedback, iCBT with on-demand feedback, and a waitlist control group, each group including 56 participants. Participants in the two iCBT conditions will undergo a 14-week treatment regimen, while those in the waitlist control group will wait for 14 weeks before starting iCBT with planned feedback. Additionally, participants in the iCBT groups will be randomly assigned to receive a booster session or not. The study design is factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). The study population comprises adolescents aged between 12 and 17 years, residing in Denmark, diagnosed with an anxiety disorder according to DSM-5 criteria. The primary outcome measures are the Youth Online Diagnostic Assessment and the Spence Children’s Anxiety Scale. Assessments will occur at baseline, post-treatment, and at 3-, 6-, and 12-month follow-ups post-treatment.DiscussionThe findings of this study are anticipated to contribute to improving the accessibility of evidence-based treatments for adolescents with anxiety.Trial registrationThe study is registered at clinicalTrials.gov, under protocol ID 22/59602. The Initial release was the 16.10.2023, first posted due to technical problems 16.04.2024. https://clinicaltrials.gov/study/NCT06368557?locStr=Odense,%20Denmark&country=Denmark&city=Odense&page=2&rank=13.

Effectiveness of a Person-Centered Interdisciplinary Rehabilitation Treatment of Post-COVID-19 Condition: Protocol for a Single-Case Experimental Design Study.

Patients with post-COVID-19 condition (PCC) experience a wide range of complaints (physical, cognitive, and mental), sometimes with high levels of disability in daily activities. Evidence of effective interdisciplinary rehabilitation treatment is lacking. A person-centered, biopsychosocial, interdisciplinary rehabilitation program, adapted to expert opinions and the patient's needs, was therefore developed. This study aims to present a study protocol for a clinical trial to evaluate the effect of a new, person-centered, interdisciplinary rehabilitation treatment for PCC. It is aimed at improving participation in society and health-related quality of life in patients with PCC who perceive a high level of disability in daily activities or participation. A total of 20 Dutch adults, aged 18 years or older, with high levels of disability in daily activities and participation in society will be included in this replicated and randomized single-case experimental design study, from October 2023 onward. The replicated and randomized single-case experimental design consists of 3 phases. The baseline phase is the observational period, in which no specific treatment will be given. In the intervention phase, patients will receive the new outpatient treatment 3 times a week for 12 weeks, followed by a 12-week follow-up phase. During the intervention phase, the treatment will be personalized according to the patient's physical, mental, and cognitive symptoms and goals. The treatment team can consist of a rehabilitation physician, physiotherapist, occupational therapist, speech therapist, and psychologist. The primary outcomes of the study are daily diaries, which consist of 8 questions selected from validated questionnaires (Utrecht Scale for Evaluation of Rehabilitation-Participation, EQ-5D-5L, and the Hospital Anxiety and Depression Scale). The other primary outcome measurements are participation in society (Utrecht Scale for Evaluation of Rehabilitation-Participation) and health-related quality of life (EQ-5D-5L). The secondary outcomes are physical tests and validated questionnaires aimed at physical, mental, and cognitive complaints. Effect evaluation based on daily assessments will include visual analysis, calculation of effect sizes (Nonoverlap of All Pairs), randomization tests, and multilevel analysis. In addition, other analyses will be based on ANOVA or a 2-tailed Student t test. Data collection for this study started in October 2023 and is planned to be completed in July 2024. The results will be published in peer-reviewed journals and presented at international conferences. This is the first study investigating the effect of an interdisciplinary rehabilitation treatment with a person-centered, biopsychosocial approach in patients with PCC. Our findings will help to improve the treatment and support of patients with PCC. German Clinical Trials Register DRKS00032636; https://drks.de/search/en/trial/DRKS00032636. DERR1-10.2196/63951.

Effect of Pilates exercises on pulmonary function, respiratory muscle strength, and functional capacity in patients with inhalation injury after flame thermal burn: A prospective randomized controlled trial

BackgroundInhalation injury is an acute respiratory tract injury that occurrs by inhalation of smoke, toxic gases, or steam. Early management is needed to reduce its mortality and morbidity. The purpose of this study was to ascertain whether Pilates training could help burn patients with inhalation injury after flame thermal burn in increasing pulmonary function, respiratory muscle strength, and functional ability. MethodsIn this prospective, randomized, controlled trial, sixty participants (26 males and 34 females) with inhalation injury and deep partial-thickness flame burns of 30–40 % total body surface area (TBSA) were randomized in blocks of four, with a 1:1 allocation ratio into two groups: Group A (Pilates Group); received Pilates training plus conventional physical therapy program, and Group B (Control Group); received conventional physical therapy program only. This study was conducted at the Faculty of Physical Therapy's outpatient clinic, Cairo University, 3 sessions/week for 12 weeks. The primary outcome measure was the forced vital capacity (FVC) measured by a spirometer, while the secondary outcome measures were peak expiratory flow rate (PEFR), forced expiratory volume in 1 s (FEV1), FEV1/FVC% assessed by a spirometer, strength of respiratory muscles (maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) assessed by the digital manovacuometer, and the functional capacity evaluated by 6-Minute Walk Test (6-MWT). ResultsA two-way mixed-design MANOVA was used to analyze the results within and between groups. There were no significant differences in demographic data between groups (P > 0.05). There were significant differences in all variables after treatment in group A compared with group B; FVC (95 % CI: 0.38, 1.13) (P = 0.001), FEV1 (95 % CI: 0.39, 0.97) (P = 0.001), FEV1/FVC % (95 % CI: 1.90, 17.19) (P = 0.02), PEFR (95 % CI: 0.47, 0.99) (P = 0.001), MIP (95 % CI: 5.12, 11.44) (P = 0.001), MEP (95 % CI: 2.57, 8.24) (P = 0.001), 6-MWT (95 % CI: 27.22, 54.96) (P = 0.001), FVC (% predicted) (95 % CI: 3.58, 12.58) (P = 0.001), FEV1 (% predicted) (95 % CI: 1.21, 11.11) (P = 0.02), PEFR (% predicted) (95 % CI: 1.33, 10.83) (P = 0.01), MIP (% predicted) (95 % CI: 2.26, 11.72) (P = 0.001) and MEP (% predicted) (95 % CI: 1.33, 10.37) (P = 0.01). ConclusionThe current study demonstrated that a Pilates exercise program in addition to a traditional physical therapy program for 12 weeks significantly improved the pulmonary function (FVC, FEV1, PEFR and FEV1/FEV), strength of respiratory muscles (MIP and MEP), and functional capacity (6-MWT) in patients with inhalation injury after flame burns. These results underscore the importance of including Pilates exercises in the rehabilitation plan for burn patients with inhalation injury. Future studies are needed to evaluate the effect of Pilates exercises on other degrees and TBSA of burn, long-term follow up, and to measure cardiopulmonary parameters.

Striking long-term beneficial effects of single dose psilocybin and psychedelic mushroom extract in the SAPAP3 rodent model of OCD-like excessive self-grooming.

Obsessive compulsive disorder (OCD) is a highly prevalent disorder that causes serious disability. Available treatments leave 40% or more of people with OCD significantly symptomatic. There is an urgent need for novel therapeutic approaches. Mice that carry a homozygous deletion of the SAPAP3 gene (SAPAP3 KO) manifest a phenotype of excessive self-grooming, tic-like head-body twitches and anxiety. These behaviors closely resemble pathological self-grooming behaviors observed in humans in conditions that overlap with OCD. Following a preliminary report that the tryptaminergic psychedelic, psilocybin, may reduce symptoms in patients with OCD, we undertook a randomized controlled trial of psilocybin in 50 SAPAP3 KO mice (28 male, 22 female). Mice that fulfilled inclusion criteria were randomly assigned to a single intraperitoneal injection of psilocybin (4.4 mg/kg), psychedelic mushroom extract (encompassing the same psilocybin dose) or vehicle control and were evaluated after 2, 12, and 21 days by a rater blind to treatment allocation for grooming characteristics, head-body twitches, anxiety, and other behavioral features. Mice treated with vehicle (n = 18) manifested a 118.71 ± 95.96% increase in total self-grooming (the primary outcome measure) over the 21-day observation period. In contrast, total self-grooming decreased by 14.60 ± 17.90% in mice treated with psilocybin (n = 16) and by 19.20 ± 20.05% in mice treated with psychedelic mushroom extract (n = 16) (p = 0.001 for effect of time; p = 0.0001 for time × treatment interaction). Five mice were dropped from the vehicle group because they developed skin lesions; 4 from the psilocybin group and none from the psychedelic mushroom extract group. Secondary outcome measures such as head-body twitches and anxiety all showed a significant improvement over 21 days. Notably, in mice that responded to psilocybin (n = 12) and psychedelic mushroom extract (n = 13), the beneficial effect of a single treatment persisted up to 7 weeks. Mice initially treated with vehicle and non-responsive, showed a clear and lasting therapeutic response when treated with a single dose of psilocybin or psychedelic mushroom extract and followed for a further 3 weeks. While equivalent to psilocybin in overall effect on self-grooming, psychedelic mushroom extract showed superior effects in alleviating head-body twitches and anxiety. These findings strongly justify clinical trials of psilocybin in the treatment of OCD and further studies aimed at elucidating mechanisms that underlie the long-term effects to alleviate excessive self-grooming observed in this study. Prepared with BioRender ( https://www.biorender.com/ ).

Prevention of perioperative venous thromboembolic complications using pneumatic compression cuffs in oral cancer patients in maxillofacial surgery

ObjectivesVenous thromboembolism (VTE) is still considered to be a significant medical issue. Physical measures to prevent perioperative venous thrombosis include early mobilization and intermittent pneumatic compression (IPC). The aim of this study was to evaluate whether IPC can reduce the incidence of postoperative thromboembolic events in patients with oral squamous cell carcinoma (OSCC) undergoing maxillofacial surgery.Materials and methodsBetween March 2020 and May 2021, 75 patients with OSCC who did not receive perioperative prophylaxis using IPC were retrospectively examined to determine the occurrence of postoperative thromboembolism. Accordingly, 79 patients who received perioperative thrombosis prophylaxis using an IPC system as part of surgical tumor therapy from May 2021 to September 2023 were included in the study. The primary outcome measure was the occurrence of postoperative thromboembolism.ResultsIn the control group without IPC, thromboembolic events were observed in five out of 75 patients during postoperative hospitalization. In the intervention group, no thromboembolic occurrences were identified among the 79 patients studied (p = 0.02). The mean Caprini score in the control group was 7.72, whereas in the intervention group it averaged 8.30 (p = 0.027).ConclusionsThe implementation of IPC-devices as supplementary perioperative thrombosis prophylaxis resulted in a notable decrease in postoperative venous thromboembolism (Number Needed to Treat = 15), which is why implementation of the system as a regular part of the clinical routine for perioperative management of OSCC patients can be considered a sensible approach.Clinical relevanceThe use of IPC enhances patient outcomes and may lead to improved postoperative care protocols in this high-risk patient population.

Early Results of PRESERFLO TM MicroShunt for Primary Open-angle Glaucoma in Caucasian Patients.

The PRESERFLO MicroShunt effectively lowered intraocular pressure in primary high and normal pressure open-angle glaucoma. To evaluate the efficacy and safety of the PRESERFLOTM MicroShunt in patients with primary open-angle glaucoma (POAG) and the two variants high (HPG) and normal pressure glaucoma (NPG) after one year. Single-center prospective interventional case series consecutively including eyes of White/European patients with POAG, who received the PRESERFLOTM MicroShunt as a primary and stand-alone glaucoma intervention. Primary outcome measures: change in mean 24-h IOP (mdIOP, mean of 6 measurements), peak IOP, IOP fluctuations, anti-glaucoma medications, and success rates. Secondary outcome measures: visual acuity, visual fields, complications, surgical interventions, and adverse events. Forty-two eyes of 42 POAG patients, 29 in the HPG and 13 in the NPG group, were analyzed after 1-year follow-ups. Median [Q25, Q75] mdIOP (mmHg) dropped by 30% from 16.5 [13.7-27.3] to 12.8 [10.2-14.5] in the HPG and by 40% from 14.3 [13.3-16.0] to 9.5 [8.3-11.1] in the NPG group, with a median postoperative medication use of 0 [0-0] in both groups. At one year, 92.5% of eyes were medication-free versus 0% preoperatively. The reduction of mdIOP (P=1.0), peak IOP (P=0.932), IOP fluctuations (P=0.142) and the rate of interventions (P=0.298) were not statistically significantly different between the HPG and NPG group. None of the patients experienced severe adverse events or loss of vision. Effective and safe intraocular pressure lowering was observed one year following MicroShunt implantation for primary HPG and NPG in white patients of European descent.

A RETROSPECTIVE REVIEW OF LONG-TERM PATIENT-REPORTED OUTCOME MEASURES COMPARING UNSTABLE ANKLE FRACTURES WITH AND WITHOUT A POSTERIOR MALLEOLUS FRACTURE

The aim of this study was to evaluate the long-term outcomes of patients who had sustained an unstable ankle fracture with a posterior malleolus fracture (PMF) and without (N-PMF).Adult patients presenting to a single academic trauma centre in Edinburgh, UK, between 2009 and 2012 with an unstable ankle fracture requiring surgery were identified. The primary outcome measure was the Olerud Molander Ankle Score (OMAS). Secondary measures included Euroqol-5D-3L Index (Eq5D3L), Euroqol-5D-VAS and Manchester Oxford Foot Questionnaire (MOXFQ).There were 304 patients in the study cohort. The mean age was 49.6 years (16.3–78.3) and 33% (n=100) male and 67% (n=204) female. Of these, 67% (n=204) had a PMF and 33% did not (n=100). No patient received a computed tomography (CT) scan pre-operatively. Only 10% of PMFs (22/204) were managed with internal fixation. At a mean of 13.8 years (11.3 – 15.3) the median OMAS score was 85 (Interquartile Range 60 – 100). There was no difference in OMAS between the N-PMF and PMF groups (85 [56.25 – 100] vs 85 [61.25 – 100]; p = 0.580). There was also no difference for MOXFQ (N-PMF 7 [0 – 36.75] vs PMF 8 [0–38.75]; p = 0.643), the EQ5D Index (N-PMF 0.8 [0.7 – 1] vs PMF 0.8 [0.7 – 1]; p = 0.720) and EQ5D VAS (N-PMF 80 [70 – 90] vs PMF 80 [60 – 90]; p = 0.224).The presence of a PMF does not affect the long-term patient reported outcomes in patients with a surgically managed unstable ankle fracture.

External evaluation of Brain Injury Guideline (BIG) low risk criteria for traumatic brain injury

BackgroundFewer than 20 % of traumatic brain injury (TBI) cases with traumatic intracranial hemorrhage (ICH) result in clinical deterioration. The Brain Injury Guideline (BIG) criteria were published in 2014 and categorize patients with TBI into three risk groups (BIG 1, 2, and 3) based on CT scan findings, neurological examination, anti-coagulant/platelet medications, and intoxication. Early data is promising, suggesting no instances of neurosurgical intervention or death in the low-risk BIG1 category within 30 days. We sought to externally validate the BIG criteria and identify patients with TBI at low risk of clinical deterioration. We hypothesized that patients meeting the BIG1 low risk criteria have less than a 1 % risk of death or neurosurgical intervention. MethodsWe performed a retrospective cohort study of a level 1 trauma center's trauma registry records from 2011 to 2022 to identify patients with head trauma. We abstracted demographics, injury characteristics, clinical course, CT imaging results, and outcomes, and we categorized patients according to the BIG criteria. The Clopper-Pearson Exact method was used to estimate outcome frequency with confidence intervals. The primary outcome was death or neurosurgical intervention within 30 days. Secondary outcomes included progression on repeat head CT (RHCT), ICU admission with neurocritical care intervention, and TBI-related hospital readmission within 30 days. ResultsA total of 1714 patients with TBI with ICH were identified from the trauma registry. 325 patients were excluded due to missing data, pregnancy, incarceration, polytrauma, or GCS < 13, leaving 1389 for analysis. 193 patients (13.9 %) were classified as BIG1. No patients classified as BIG1 experienced the primary outcome measures of death or neurosurgical intervention (95 % confidence interval [CI]: 0 %–1.9 %). The number of patients who experienced the secondary outcome measures of progression on RHCT, ICU admission with neurocritical care intervention, or TBI-related hospital readmission within 30 days were 9 (4.7 %, 95 % CI: 2.2 %–8.7 %), 1 (0.5 %, 95 % CI: 0 %–2.9 %), and 4 (2.1 %, 95 % CI: 0.6 %–5.2 %), respectively. ConclusionBIG1 criteria identified a low-risk subset of patients with TBI with ICH. However, an upper 95 % CI of 1.9 % does not exclude the risk of neurologic deterioration being <1 %. Validation of these criteria in larger cohorts is warranted.

Comparison of live birth rates following the transfer of day-6 blastocysts on the 6th versus 7th day of progesterone exposure in hormone replacement treatment–frozen embryo transfer cycles

Objective: The duration of progesterone exposure is critical for establishing and maintaining a pregnancy in hormone replacement treatment (HRT)–frozen embryo transfer (FET) cycles. This study compared the live birth rates (LBRs) of patients undergoing day-6 warmed blastocyst transfer on either the 6th or 7th day of progesterone administration in HRT-FET cycles.Methods: A retrospective cohort study was conducted using data from the central registry of Indira IVF Hospital Private Limited. In total, 2,633 patients who underwent day-6 blastocyst transfer cycles with HRT-FET were identified. The cycles were categorized based on the timing of the day-6 blastocysts transfer: P+6 vs. P+7 (initiation date: P+1). Propensity scores were calculated. The primary outcome measure was the LBR.Results: Following propensity score matching, a total of 1,401 patients were included in the final analysis (P+6: n=1,212; P+7: n=189). The number of previous attempts was significantly higher in the P+6 group, whereas the rate of preimplantation genetic testing for aneuploidy was significantly higher in the P+7 group. The LBRs were 59.2% and 54.5% in the P+6 and P+7 groups, respectively (p=0.21). Multivariate regression analysis revealed that the number of previous in vitro fertilization attempts (odds ratio [OR], 3.246; 95% confidence interval [CI], 2.429 to 4.337; p&lt;0.001), the number of blastocysts transferred (OR, 2.011; 95% CI, 1.461 to 2.768; p&lt;0.01), and endometrial thickness on the day of progesterone initiation (OR, 1.143; 95% CI, 1.022 to 1.28; p=0.02) were independent predictors of live birth.Conclusions: The LBRs were comparable in patients who underwent day-6 warmed blastocyst transfer on day 6 or 7 post-progesterone initiation in HRT-FET cycles.

Evaluating the Efficacy of Pre-Emptive Peribulbar Blocks with Different Local Anesthetics or Paracetamol Using the Adequacy of Anesthesia Guidance for Vitreoretinal Surgeries: A Preliminary Report.

Precisely selected patients require vitreoretinal surgeries (VRS) performed under general anesthesia (GA) when intravenous rescue opioid analgesics (IROA) are administered intraoperatively, despite a risk of adverse events, to achieve hemodynamic stability and proper antinociception and avoid the possibility of intolerable postoperative pain perception (IPPP). Adequacy of anesthesia guidance (AoA) optimizes the titration of IROA. Preventive analgesia (PA) techniques and intravenous or preoperative peribulbar block (PBB) using different local anesthetics (LAs) are performed prior to GA to optimize IROA. The aim was to analyze the utility of PBBs compared with intravenous paracetamol added to AoA-guided GA on the incidence of IPPP and hemodynamic stability in patients undergoing VRS. A total of 185 patients undergoing vitreoretinal surgery (VRS) were randomly assigned to one of several anesthesia protocols: general anesthesia (GA) with analgesia optimized through AoA-guided intraoperative remifentanil opioid analgesia (IROA) combined with a preemptive single dose of 1 g of paracetamol (P group), or PBB using one of the following options: 7 mL of an equal mixture of 2% lidocaine and 0.5% bupivacaine (BL group), 7 mL of 0.5% bupivacaine (BPV group), or 7 mL of 0.75% ropivacaine (RPV group). According to the PA used, the primary outcome measure was postoperative pain perception assessed using the numeric pain rating scale (NPRS), whereas the secondary outcome measures were as follows: demand for IROA and values of hemodynamic parameters reflecting quality or analgesia and hemodynamic stability. A total of 175 patients were finally analyzed. No studied PA technique proved superior in terms of rate of incidence of IPPP, when IROA under AoA was administered (p = 0.22). PBB using ropivacaine resulted in an intraoperative reduction in the number of patients requiring IROA (p = 0.002; p < 0.05) with no influence on the dose of IROA (p = 0.97), compared to paracetamol, and little influence on hemodynamic stability of no clinical relevance in patients undergoing VRS under AoA-guided GA. PA using paracetamol or PBBs, regardless of LAs used, in patients undergoing VRS proved no advantage in terms of rate of incidence of IPPP and hemodynamic stability when AoA guidance for IROA administration during GA was utilized. Therefore, PA using them seems no longer justified due to the potential, although rare, side effects.