Exclusion Criterion Research Articles

Effect of Productive Safety Net Program On Livelihood of Smallholder Farmers in Ethiopia: Meta-Analysis

One way of mitigating smallholder farmers’ vulnerability to shocks is through expanding productive safety net program in rural area which highly affected with drought and climate change. The major aim of safety net program is to build asset accumulation and to reduce food insecurity. Several numbers of scholars have made investigation on PSNP to know the effect of it on livelihood outcome and the obtained results were contradicted (positive, negative and no effect). Hence, this meta-analysis was aimed to direct and quantify the effect of safety net program on livelihood outcome (food security, income, asset accumulation and livestock holding) from the literature with productive safety net program. Based on inclusion and exclusion criterion, 20 studies published from 2011 to 2022 were included during this meta-analysis. Random effect model was used to evaluate the effect size of productive safety net intervention on farmer’s outcome in Ethiopia. Results of random effect model confirmed that program intervention were positive and significant effect on food security. Therefore, policy makers and other stakeholders should expand productive safety net program in rural areas which exaggerated with natural disaster in Ethiopia.

Effectiveness of the massed delivery of unified protocol for emotional disorders within an intensive outpatient program for military service members and veterans.

Recent evidence supports the implementation of massed delivery of disorder-specific treatments in the military service member and veteran population. However, many treatment settings serve patients with a wide range of diagnoses, and often patients present with comorbid conditions. Growing evidence suggests transdiagnostic cognitive behavioral treatments are effective for a wide range of emotional disorders and may reduce barriers to access. Little is known about the feasibility and outcomes of the massed delivery of transdiagnostic treatments. The present study examined real-world outcomes of a 2-week intensive outpatient program using the Unified Protocol for emotional disorders (UP-IOP). The sample included military service members and veterans diagnosed with a range of emotional disorders, namely trauma- and stressor-related disorders, unipolar depressive disorders, and anxiety disorders. The present study examined outcomes of UP-IOP (depression, trauma-related symptom severity, and emotion dysregulation). Participants included all patients who sought UP-IOP in its first 15 months of operation (N = 117). A diagnosis of posttraumatic stress disorder (PTSD) was an exclusion criterion because the site had an established PTSD-specific IOP treatment option. Findings indicate UP-IOP was feasible, had 94% patient retention, and was effective in reducing symptom severity (Cohen's d = 0.76 for depression symptom severity, Cohen's d = 0.80 for trauma-related symptom severity). There was no observed reduction in emotion dysregulation over the 2-week course of treatment. The intensive transdiagnostic approach resulted in effective symptom reduction in an accelerated timeframe while minimizing patient attrition. These findings indicate massed delivery of transdiagnostic cognitive behavioral therapy (CBT) treatments should continue to be explored, especially for this population. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Systemic sarcoidosis and primitive Gougerot-Sjörgen syndrome: a rare, complex yet intriguing association

Primary Sjogren’s syndrome is a chronic autoimmune disease affecting mainly the exocrine glands, typically presenting with sicca syndrome, but systemic multi-organ manifestations are possible. The diagnosis is based on the 2016 ACR-EULAR criteria. On the other hand, sarcoidosis, which is also a chronic systemic disease, is characterized by tissue infiltration with noncaseating granulomas. The granulomas may occur in any organ, but the most frequently affected sites are the lungs, lymph nodes, skin, eyes, and liver. Traditionally, sarcoidosis is considered to be an exclusion criterion for the diagnosis of primary Sjogren’s syndrome, mainly because of overlapping clinical features.We report the case of a 60-year-old female patient of North African descent, hospitalized initially for chronic dyspnea associated with other systemic manifestations such as sicca syndrome, and in whom we have objectified biological and histological features of both systemic sarcoidosis and systemic primitive Sjogren’s syndrome at the same time.The coexistence of sarcoidosis and Sjogren’s syndrome is not frequent and has been rarely reported. We aim to bring more attention to the possibility of an association of these two systemic diseases despite what is typically recommended. Subsequently, it might be of interest to remove sarcoidosis from the elimination criteria in order to avoid the possibility of misdiagnosis.

A systematic literature review of randomised controlled trials evaluating colchicine for cardiovascular prevention: There is an elephant in the room

ObjectivesTo review randomised controlled trials (RCT) investigating colchicine (COL) for cardiovascular (CV) prevention in patients at high to very high CV risk aiming to extract data that could be useful in rheumatology practice. MethodsA systematic search of multiple databases according to the PICO framework was performed from inception to April 3, 2023. Three researchers independently screened abstracts/titles and reviewed full texts reviewed. Data extraction was performed using a pilot‐tested data extraction form. ResultsA total of 14,096 references were retrieved by the search and 30 articles, describing 28 RCTs, were included in the review (Total number of patients 16,795, of which 8,463 randomised to COL; dose 0.5–2 mg/day, treatment duration 1day-29 months). Only one of the 28 RCTs provided clear information on whether patients with rheumatic diseases (more specifically gout) were enrolled in the study cohorts and previous use of COL was an exclusion criterion only in 14 (50 %) RCTs. Previous therapy with glucocorticoids and/or non-steroidal anti-inflammatory drugs and/or immune suppressive therapies was an exclusion criterion only in 9 (32 %) RCTs. ConclusionOur results highlight the need to redefine the eligibility criteria as well as the reporting of results in future RCTs in order to minimise bias or previous exposure to COL and also obtain data that could be useful in rheumatology practice.

D-dimer and sinusoidal obstructive syndrome-novel poor prognostic features of thrombotic microangiopathy in children after hematopoietic cellular therapy in a single institution prospective cohort study.

Transplant-associated thrombotic microangiopathy (TA-TMA) is a common, severe complication of allogeneic hematopoietic cellular therapy (HCT). Even when treated in many studies, morbidity and mortality rates are high. This prospective single-institution cohort study serially enrolled all allogeneic HCT recipients from August 2019-August 2022. Patients were universally screened for TA-TMA and intermediate and high-risk patients were immediately treated with eculizumab. Sub-distribution cox-proportional hazards modelswere used to identify sub-distribution hazard ratios (sHR) for multi-organ dysfunction (MOD) and non-relapse-related mortality (NRM). Of 136 patients, 36 (26%) were diagnosed with TA-TMA and 21/36 (58%) developed MOD, significantly more than those without TA-TMA, (p < .0001). Of those with TA-TMA, 18 (50%) had high-risk TA-TMA (HR-TA-TMA), 11 (31%) had intermediate-risk TA-TMA (IR-TA-TMA), and 8 (22%) had standard risk (SR-TA-TMA). Twenty-six were treated with eculizumab (1/8 SR, 7/11 IR, and 18/18 HR). Elevated D-dimer predicted the development of MOD (sHR 7.6, 95% confidence interval [CI] 1.8-32.3). Children with concurrent sinusoidal obstructive syndrome (SOS) and TA-TMA had an excess risk of MOD of 34% and data supported a biologic interaction. The adjusted NRM risk was significantly higher in the TA-TMA patients (sHR 10.54, 95% CI 3.8-29.2, p < .0001), despite prompt treatment with eculizumab. Significant RF for NRM in TA-TMA patients included SOS (HR 2.89, 95% 1.07-7.80) and elevated D-dimer (HR 3.82, 95% CI 1.14-12.84). An unrelated donor source and random urine protein to creatine ratio ≥2 mg/mg were significantly associated with no response to eculizumab (odds ratio 15, 95% CI 2.0-113.6 and OR 6.5, 95% CI 1.1-38.6 respectively). TA-TMA was independently associated with NRM despite early diagnosis and treatment with eculizumab in this large pediatric transplant cohort. Prognostic implications of D-dimer in TA-TMA merit further investigation as this is a readily accessible biomarker. Concurrent SOS is an exclusion criterion of many ongoing clinical trials, but these data highlight these patients could benefit from novel therapeutic approaches. Multi-institutional clinical trials are needed to understand the impact of TA-TMA-targeted therapies.

Prediction of 30-day and 1-year postoperative complications after balloon-assisted kyphoplasty in the elderly using the Risk Analysis Index.

Vertebral compression fracture (VCF) is the most prevalent fragility fracture. When conservative management fails, patients may undergo balloon-assisted kyphoplasty (BAK). In BAK, an expandable balloon preforms a cavity in the fractured vertebra before injection of bone cement. The aim of this study was to compare outcomes in patients stratified by age and frailty assessed by the Risk Analysis Index (RAI). A retrospective analysis of 334 BAK procedures (280 patients) for osteoporotic VCFs at a single institution was performed (2015-2022). Patients with at least 1 year of follow-up were eligible for inclusion. Patient demographics were recorded, including age, sex, BMI, RAI score, tobacco and steroid use, osteoporosis treatments, and bone density. Patients who underwent outpatient surgery were identified, and length of stay (LOS) was obtained for admitted patients. The rates of additional VCFs after kyphoplasty, 30-day and 1-year postoperative complications, and reoperation were identified. The overall rates of additional VCFs, 30-day postoperative complications, 1-year postoperative complications, and reoperation were 16.2%, 5.1%, 12.0%, and 6.3%, respectively. Patients were stratified by age: nonelderly (< 80 years; 220 patients, 263 treated vertebrae) and elderly (≥ 80 years; 60 patients, 71 treated vertebrae). There were no differences in sex (p = 0.593), tobacco use (p = 0.973), chronic steroid use (p = 0.794), treatment for osteoporosis (p = 0.537), bone density (p = 0.056), outpatient procedure (p = 0.273), and inpatient LOS (p = 0.661) between both groups. There were also no differences in the development of additional VCFs (p = 0.862) at an adjacent level (p = 0.739) or remote level (p = 0.814), 30-day and 1-year postoperative complications (p = 0.794 and p = 0.560, respectively), and reoperation rates (p = 0.420). Patients were then analyzed by RAI: nonfrail (RAI score < 30; 203 patients, 243 treated vertebrae) and frail (RAI score ≥ 31; 77 patients, 91 treated vertebrae). There were no differences in tobacco use (p = 0.959), chronic steroid use (p = 0.658), treatment for osteoporosis (p = 0.560), bone density (p = 0.339), outpatient procedure (p = 0.241), inpatient LOS (p = 0.570), and development of additional VCFs (p = 0.773) at an adjacent level (p = 0.390) or remote level (p = 0.689). However, rates of 30-day and 1-year postoperative complications in frail patients more than doubled in comparison with nonfrail patients (p = 0.031 and p = 0.007, respectively), and frail patients trended toward reoperation (p = 0.097). BAK is a safe treatment in the elderly, and age alone should not be used as an exclusion criterion during patient selection. Frailty, which can be assessed reliably using the RAI, may serve as a better predictor for postoperative complications and reoperation following BAK.

In vitro Effect of Cannabidiol on Red Blood Cells: Implication in Long-Lasting Pathology Treatment.

Cannabidiol (CBD) is the principal non-hallucinogenic compound of Cannabis plants with high clinical interest because CBD has been described as having anti-inflammatory, analgesic and anticonvulsant properties. CBD is considered a multitarget compound as it can interact with a wide range of targets, explaining their multiplicity of effects. Some clinical studies have indicated certain side effects of CBD, including somnolence, anemia and diarrhea, while the elevation of transaminases is considered as an exclusion criterion from the trial. Since the red blood cells (RBCs) are a source of transaminase, we assayed in vitro effect on RBCs stability. We performed in vitro experiments with RBCs obtained from human peripheral blood with normal hematological parameters exposed to CBD in the range of therapeutic uses. We evaluated RBCs morphological changes, membrane fragility and hemoglobin release as a reflection of hemolysis. CBD induced an increase in the hemoglobin release (3.27 μg/106 RBC), without altered RBC osmotic fragility. When RBCs suspensions were incubated with CBD the initial number of elements (RBCs + vesicles) was increased up to 65% after 20 min and returned to basal level after 40 min of incubation. In the first 20 min, the accounts of elements were enriched in the smaller vesicles that disappeared after the remaining 20 minutes. These results suggest that CBD affects the indemnity of erythrocytes in vitro, inducing the formation of hemolytic vesicles that can provide the basis for the development of anemia, transaminase elevation and underlying tissular iron overload in patients chronically treated with CBD.

Longitudinal Relationship Between Physical Activity Levels and Respiratory Function in Older Individuals : A Longitudinal Study

Aging causes various physical changes, including decreased respiratory function characterized by decreased lung elasticity, reduced chest wall compliance, and weakened respiratory muscles. This study explored the longitudinal impact of daily physical activity (PA) on respiratory function in elderly individuals aged ≥50 years in England. Using data from Waves 2 (2004–2005), 4 (2008–2009), and 6 (2012–2013), we examined the influence of different levels of PA on forced expiratory volume (FEV), forced vital capacity (FVC), and other respiratory measures. Participants were classified based on self-reported PA into three categories; “hard” (vigorous activity at least 1–3 times monthly), “middle” (moderate activity 1–3 times monthly), and “nothing” (no PA). The inclusion criteria required participants to be ≥50 years and to have valid respiratory measures. The exclusion criterion was the presence of significant respiratory or cardiovascular disease at baseline. We applied the Sequential Doubly Robust Estimator and SuperLearner ensemble methods in the analysis using inverse probability weighting to address follow up bias and found that vigorous PA significantly reduced the risk of FVC by 4.10-fold compared with no exercise. In addition, vigorous exercise was associated with a 0.63-fold reduction in the risk of restrictive ventilation disorders while moderate exercise approached significance for FVC (p = 0.08). No significant effects were found with obstructive ventilation impairment (FEV). Overall, vigorous PA appears to be crucial for maintaining respiratory function in older individuals, highlighting the importance of regular exercise in preventing respiratory decline and potentially extending a healthy lifespan. These results underscore the need to promote regular PA to improve quality of life and reduce the risk of respiratory disease.

Therapeutic Potential of Combined Herbal Medicine and Electroacupuncture in Mild Cognitive Impairment Through Cytokine Modulation: An Observational Study.

We aimed to investigate the efficacy of a combined herbal formula and electroacupuncture (EA) for mild cognitive impairment (MCI), a neurodegenerative disease leading to dementia, and its underlying mechanisms of action. This was a prospective open-label observational pilot study at Daejeon Korean Medicine Hospital of Daejeon University in South Korea from March 2022 to March 2023. We included six Korean patients (50% male) aged ≥ 45 years and < 85 years with MCI, a clinical dementia rating score of 0.5, and a Montreal Cognitive Assessment-Korea (MoCA-K) score ≤ 22. The exclusion criterion was impaired cognitive function. Patients received combined therapy, including a herbal formula and EA, for 12-24 weeks. We prescribed the herbal formulas Gamiguibi-tang, Yukmijihwang-tang, and Banhasasim-tang to the patients for at least 70% of the treatment period, in combination with EA. Moreover, we investigated changes in cognitive and cognition-related symptoms and cytokine expression in the blood following combined traditional medicine therapy. At baseline and after 12 and 24 weeks, we administered the MoCA-K and cognitive-related questionnaires. We analyzed network pharmacology to reflect the herbal formula intervention mechanism comprehensively. The median score [interquartile range] of MoCA-K at baseline was 19.5 [16.0, 22.0], which improved significantly (24.5 [24.0, 26.0], p < 0.01) over 24 weeks following combined therapy. We obtained no significant conclusion regarding cytokine changes due to the small sample size. In network pharmacology, we analyzed the brain, head, heart, peripheral nerves, peripheral nervous system, and pancreas as the enriched organs from the common targets of the three herbal formulas. Combined herbal medicine and EA improved cognitive function in patients with MCI. We assume the underlying mechanism of herbal formulas to be antioxidative and anti-inflammatory changes in cytokine expression. Combined traditional medicine has potential therapeutic application in preventing MCI progression to dementia.

Prenatal Diagnosis of Congenital Heart Disease and Voluntary Termination of Pregnancy: A Population-Based Study in Qingdao, China.

The outcomes of fetuses with isolated congenital heart disease (CHD) diagnosed prenatally have not been investigated in a population-based study in China. This population-based study aimed to evaluate the rate of voluntary termination of pregnancy after the prenatal diagnosis of isolated CHD in Qingdao, China. This was a population-based retrospective study in which data were collected from all pregnant women in Qingdao (eastern China) from August 2018 to July 2020; fetal data, maternal data and data on pregnancy outcomes were extracted from medical records regarding prenatal diagnosis of CHD. The inclusion criteria were as follows: pregnant women or their husbands who had a household registration in Qingdao and who underwent regular prenatal screening in Qingdao. The exclusion criterion was the failure to sign an informed consent form. Counseling for all parents of fetuses with CHD was provided by a multidisciplinary team of experienced pediatric cardiologists, obstetricians, geneticists, etc. According to the type and severity of CHD, the pregnancy termination rate was analyzed. Among the 126,843 pregnant women, 1299 fetuses with a prenatal diagnosis of CHD were included in the study. Among the included fetuses, 1075 were diagnosed with isolated CHD, and the overall pregnancy termination rate was 22.8%. Termination rates varied according to the complexity of CHD (low complexity vs moderate complexity, P=0.000; low complexity vs high complexity, P=0.000; moderate complexity vs high complexity, P=0.000), with rates of 6.0% for low complexity, 54.2% for moderate complexity, and 99.1% for high complexity. The decision to terminate the pregnancy in cases of isolated CHD was unrelated to maternal age (P=0.091) but was related to gestational age (p=0.000). In Qingdao, 99.1% of parents whose fetuses were diagnosed with isolated high-complexity CHD chose to voluntarily terminate the pregnancy. The pregnancy termination rate increased with increasing complexity of prenatally diagnosed CHD.

Non-endodontic periapical radiopaque jaw lesions: A mini review

Endodontic practice may be affected by periapical radiopaque/ hyperdense lesions. Oral medicine specialists and endodontists may have trouble diagnosing and treating radiopaque lesions. Inflammatory, non-inflammatory, neoplastic, dysplastic, metastatic or metabolic bone changes may occur. With the increased use of cone-beam CT, a detailed review of radiopaque lesions may help clinicians differentiate these lesions. Differentiating inflammatory, non-inflammatory and neoplastic disorders simplifies diagnosis and helps choose the best treatment. Aim: The aim of this review was to investigate the periapical radiopaque/hyperdense lesions. An extensive review of the literature was carried through. The literature search was conducted using MEDLINE (National Library of Medicine)-PubMed, Web of Science and Google scholar without restrictions concerning the date of publication. The inclusion criterion was that the article should be written in English, whereas the exclusion criterion was the opposite. This literature review covers radiopaque/hyperdense lesion differential diagnoses, clinical, radiographic, histological, and management issues. The effectiveness of root canal therapy is measured by the absence of pain, the absence or reduction of periapical lesions, and the restoration of tooth function. In endodontic practice, the diagnosis of periapical lesions is difficult because many of these lesions can mimic endodontic lesions, even when derived from different sources. For the diagnosis of periapical lesions in this scenario, a comprehensive clinical examination, in conjunction with clinical and radiographic aspects of the disease, is essential. The oral medicine specialist and endodontist must know how to diagnose radiopaque periapical lesions. Knowing how to differentiate between inflammatory, non-inflammatory, neoplastic and metabolic lesions expedites diagnosis and ensures the selection of the appropriate treatment.

Multimodal ultrasound evaluation of asymptomatic ulnar nerve dislocation at the cubital tunnel.

Ultrasonography has received broad acceptance as an effective peripheral nervous imaging examination. Shear wave elastography (SWE) can quantitatively assess the stiffness of nerves; however, little research has been conducted on elastography for ulnar nerve dislocation. The purpose of this study was thus to investigate the characteristics of multimodal ultrasound, including high-resolution ultrasonography and SWE, for asymptomatic ulnar nerve dislocation at cubital tunnel. In this prospective cross-sectional study, 41 participants were recruited in Shandong Provincial Hospital Affiliated to Shandong First Medical University in July 2022. The inclusion criteria for participants were being in good health and being 18-60 years of age. Meanwhile, the exclusion criterion was a history of upper limb pain or fractures, peripheral neuropathy, or systemic or immunological diseases. Finally, 38 participants were enrolled. Two ultrasound doctors measured the maximum diameter, the maximum cross-sectional area (CSA), and the shear modulus of the ulnar nerve at the cubital tunnel independently. Another two ultrasound doctors determined whether dislocation was present during dynamic elbow flexion and extension and divided the elbows into a dislocation group and a control group. The descriptive statistics and independent sample t-test were used for data analysis, and intragroup correlation coefficient (ICC) was used to determine the consistency of evaluation between observers. Ulnar nerve dislocation was observed in 15.8% (12/76) of the ulnar nerves. There was no significant difference in the maximum diameter between the dislocation group (0.194±0.022 cm) and the control group (0.181±0.023 cm) (t=1.888; P=0.063). The CSA and SWE of the ulnar nerve were 0.064±0.009 cm2 and 43.629±6.737 kPa in the dislocation group, respectively, and were 0.050±0.008 cm2 and 31.293±7.858 kPa in the control group, respectively. There were significant differences between the two groups in terms of CSA (P<0.001) and SWE (P<0.001). The ICCs of the maximum diameter, CSA, and SWE values between observers were 0.970, 0.900, and 0.915, respectively. Multimodal ultrasound consisting of high-resolution ultrasonography combined with elastography can comprehensively and quantitatively evaluate the morphological changes and mechanical properties of the dislocated ulnar nerve and monitor disease progress.

Interlimb and trunk asymmetry in the frontal plane of table tennis female players.

An interesting and little-reported problem in the literature is the scale of asymmetry in table tennis players, the magnitude of which should perhaps be treated as a risk for injury. Determining the degree of asymmetry in table tennis players can indicate the need to appropriately manage the training process, including compensatory or corrective exercises in the training program, especially since recent studies confirm that training interventions can reduce sporting asymmetries and improve performance. This study aimed to assess the amount of asymmetry in the trunk regarding the frontal plane and the difference between limb circumferences in female table tennis players compared to the control group (non-athletes). Twenty-two women took part in the study. Ten of them were table tennis professionals with an average training experience of 7±4.3 years (the exclusion criterion of the study was a minimum of 3 years of training experience). As a comparison group, the study included 12 female students who did not participate in competitive sports. Body posture was assessed in all subjects using equipment for computer analysis of asymmetry in the torso using the photogrammetric method. Additionally, all the subjects had their upper and lower limb circumferences measured. The results of the conducted research showed asymmetry in the frontal plane in the table tennis player group. As many as six parameters-regarding the pelvic rotation angle, angle of trunk inclination, the height of the angles of the lower shoulder blades and their distance from the spine, as well as the waist triangles, difference in the width and height of the waist triangles and the angle of trunk inclination-indicated asymmetry in this group but significantly differed from the control group (p≤0.05) only in the first parameter given above. The calculated differences in circumference between the right and left sides in the individual groups were statistically different in several cases (p≤0.05). This concerned the circumferences of the arms, forearms, elbows, and knees of table tennis players. The research carried out in this study allowed us to determine the occurrence of asymmetry in the frontal plane of the trunk and between the limbs of table tennis players. According to some studies, this may be a risk factor for injury. However, despite the lack of uniform views in the literature on the importance and threats resulting from asymmetries, it appears that, if only for aesthetic reasons, table tennis would require compensatory or corrective training aimed at developing symmetry of the body structure.

Application of Kegel Motion Combined With Warming Acupuncture at the Eight Acupuncture Points in Patients With Urinary Incontinence After Radical Prostatectomy

Purpose To study the effect of Kegel exercise combined with Baliao warming acupuncture in the treatment of urinary incontinence after radical prostatectomy. Methods A single-center, retrospective cohort study was conducted on patients with clinically localized prostate cancer. This study involved 200 patients through a specific exclusion criterion admitted to the Department of Urology of our hospital, including 100 cases in the control group (single Kegel Motion) and 100 cases in the experimental group (Kegel Motion combined with acupuncture) from July 2017 to November 2020. Time from catheter removal to full recovery of urinary continence was recorded by 1 month, 3 months, and 6 months after surgery. The International Consultation on Incontinence Questionnaire-Short Form, the “1-hour diaper test,” and the Quality of Life Incontinence Questionnaire were used to evaluate the frequency and severity of urinary incontinence, the efficacy of urinary incontinence and the patients’ qualities of life, respectively. An independent sample t test, rank sum test, and χ2 test were adopted for comparison between groups. Results None of the frequency, severity, and efficacy of urinary incontinence nor the patients’ qualities of life showed a difference between the experimental group and the control group at 1 month after surgery (P &amp;gt; 0.05) but showed significant differences at 3 months and 6 months postoperatively (P &amp;lt; 0.05). Conclusions The Kegel Motion combined with warming acupuncture at the 8 acupuncture points can reduce the incidence of urinary incontinence, improve urinary control ability, and improve the quality of life of patients with urinary incontinence after radical prostatectomy.

Antiangiogenic exclusion rules in glioma trials: Historical perspectives and guidance for future trial design.

Despite the lack of proven therapies for recurrent high-grade glioma (HGG), only 8%-11% of patients with glioblastoma participate in clinical trials, partly due to stringent eligibility criteria. Prior bevacizumab treatment is a frequent exclusion criterion, due to difficulty with response assessment and concerns for rebound edema following antiangiogenic discontinuation. There are no standardized trial eligibility rules related to prior antiangiogenic use. We reviewed ClinicalTrials.gov listings for glioma studies starting between May 2009 and July 2022 for eligibility rules related to antiangiogenics. We also reviewed the literature pertaining to bevacizumab withdrawal. Two hundred and ninety-seven studies for patients with recurrent glioma were reviewed. Most were phase 1 (n = 145, 49%), non-randomized (n = 257, 87%), evaluated a drug-only intervention (n = 223, 75%), and had a safety and tolerability primary objective (n = 181, 61%). Fifty-one (17%) excluded participants who received any antiangiogenic, one (0.3%) excluded participants who received any non-temozolomide systemic therapy. Fifty-nine (20%) outlined washout rules for bevacizumab (range 2-24 weeks, 4-week washout n = 35, 12% most common). Seventy-eight required a systemic therapy washout (range 1-6 weeks, 4-week washout n = 34, 11% most common). Nine permitted prior bevacizumab use with limitations, 18 (6%) permitted any prior bevacizumab, 5 (2%) were for bevacizumab-refractory disease, and 76 (26%) had no rules regarding antiangiogenic use. A literature review is then presented to define standardized eligibility criteria with a 6-week washout period proposed for future trial design. Interventional clinical trials for patients with HGG have substantial heterogeneity regarding eligibility criteria pertaining to bevacizumab use, demonstrating a need for standardizing clinical trial design.

Diagnostic errors and delay of keratitis fugax hereditaria

Aims/Purpose: To chart misdiagnoses associated with keratitis fugax hereditaria (KFH), an autosomal dominant periodic corneal autoinflammatory disease, and the frequency of misdiagnosed KFH in patients diagnosed with unspecified anterior uveitis, herpes keratitis, or unspecified keratitis.Methods: Charts of patients with genetically confirmed KFH (n = 94) were reviewed. Two Finnish biobanks provided 2037 DNA samples meeting the inclusion criterion of a diagnosis KFH can be misdiagnosed with and the exclusion criterion of having a common underlying cause of anterior uveitis, such as rheumatoid arthritis. The NLRP3 c.61G&gt;C variant was detected using restriction fragment length polymorphism analysis, and Sanger sequencing for confirmation. Age, sex, ocular and other diagnoses, and laboratory results were collected from patients carrying the variant.Results: The time between first symptoms and the diagnosis of KFH ranged from 0 to 62 years (median, 21; interquartile range [IQR], 8–45). Analysis of patient charts revealed that the most common misdiagnoses were acute anterior uveitis (51% of all misdiagnoses/26% of all patients), conjunctivitis (26%/13%), or recurrent erosion (21%/11%). A mild anterior chamber inflammation was observed in 30% of patients, 0.5+ or 1+ by Standardization of Uveitis Nomenclature (SUN) criteria. Of the biobank samples, 12/2037 (0.59%; 95% confidence interval [CI] 0.56%–0.61%) carried the c.61G&gt;C variant: 11 diagnosed with anterior uveitis, and one with unspecified keratitis. Three had previously been diagnosed with KFH. The age range of the 12 variant carriers varied from 38 to 79 (median, 63; IQR, 48–76) with nine females and three males.Conclusions: KFH is most frequently misdiagnosed as anterior uveitis. In Finland, it might be beneficial to add testing for the NLRP3 c.61G&gt;C variant in existing laboratory test packages for anterior uveitis.

Effect of mandibular advancement appliance use on oral and periodontal health in patients withOSA: a systematic review.

Use of a mandibular advancement appliance (MAA) is an effective treatment option for mild-to-moderate obstructive sleep apnea (OSA). MAA is well-tolerated but undesirable effects may be observed over time. The present systematic review aimed to assess the effect of MAA use on oral and periodontal health in patients with OSA. MEDLINE (PubMed), Cochrane, and Scopus were searched for randomized and non-randomized controlled trials (RCTs, NRCTs), cohorts, and case-control studies reporting on side effects of MAA treatment in OSA patients during a follow-up of at least 6months. From a total of 169 articles screened, 28 were selected. The most frequently reported MAA-related effects on oral health were: hypersalivation (weighted mean prevalence, 33.3%), occlusal changes (30.2%), muscle pain (22.9%), tooth discomfort or pain (20.2%), and xerostomia (18.3%). No MAA-related periodontal effect was reported. The periodontal status prior to MAA treatment was rarely assessed and described, but 5 studies (17.8%) stated that periodontitis was an exclusion criterion for MAA. Only one retrospective study specifically evaluated periodontal parameters and reported no significant changes in periodontally healthy patients withOSA using MAA for over 7years. MAA use is associated with a number of clinical consequences on oral health, but there is no evidence to conclude whether or notMAA affects periodontal health in patients withOSA. This aspect appears to be under-evaluated and should be further investigated in relation to the type of MAA, the duration of treatment, and prior history of periodontitis.

A Pluridisciplinary Tracheostomy Weaning Protocol for Brain-Injured Patients, Outside of the Intensive Care Unit and Without Instrumental Assessment: Results of Pilot Study

Concurrently to the recent development of percutaneous tracheostomy techniques in the intensive care unit (ICU), the amount of tracheostomized brain-injured patients has increased. Despites its advantages, tracheostomy may represent an obstacle to their orientation towards conventional hospitalization or rehabilitation services. To date, there is no recommendation for tracheostomy weaning outside of the ICU. We created a pluridisciplinary tracheostomy weaning protocol relying on standardized criteria but adapted to each patient’s characteristics and that does not require instrumental assessment. It was tested in a prospective, single-centre, non-randomized cohort study. Inclusion criteria were age > 18 years, hospitalized for an acquired brain injury (ABI), tracheostomized during an ICU stay, and weaned from mechanical ventilation. The exclusion criterion was severe malnutrition. Decannulation failure was defined as recannulation within 96 h after decannulation. Thirty tracheostomized ABI patients from our neurosurgery department were successively and exhaustively included after ICU discharge. Twenty-six patients were decannulated (decannulation rate, 90%). None of them were recannulated (success rate, 100%). Two patients never reached the decannulation stage. Two patients died during the procedure. Mean tracheostomy weaning duration (inclusion to decannulation) was 7.6 (standard deviation [SD]: 4.6) days and mean total tracheostomy time (insertion to decannulation) was 42.5 (SD: 24.8) days. Our results demonstrate that our protocol might be able to determine without instrumental assessment which patient can be successfully decannulated. Therefore, it may be used safely outside ICU or a specialized unit. Moreover, our tracheostomy weaning duration is very short as compared to the current literature.

P166: Elderly diabetic and non-diabetic patients in Portuguese RNCCI Convalescence Units: Are they different?

Objective:Diabetes Mellitus (DM) is one of the most prevalent chronic diseases, whose incidence has been increasing especially in the elderly, being estimated that over one-quarter of people over the age of 65 years have diabetes. Diabetes implications, whether due to acute or chronic complications, namely cognitive and functional impairments, can be devastating and usually determine the need for more supervision, implying a caregiver. For a better clinical characterization of DM, this study aimed to compare older adults, with and without DM, hospitalized in the Convalescence Units (CUs) of the Portuguese National Network of Integrated Continued Care (RNCCI).Methods:This cross-sectional study included older adults (≥65 years old) admitted into three CUs in northern Portugal. The inability to communicate was considered an exclusion criterion. A comprehensive assessment protocol was used, which comprised the Mini Mental State Examination (cognitive function), the Katz Index, and the Lawton Index (basic and instrumental activities of daily living). A comparative analysis between patients’ groups (with and without DM) was performed using the Mann-Whitney and Chi-Square tests.Results:The final sample included 202 older adults (99 diabetics and 101 non- diabetics), with a mean age of 77 (±7) years, mostly (69.8%) women. Comparing the patients with and without DM, the first group had more dyslipidemia (97% vs. 62.1%, p&lt;0.001) and osteoporosis (97% vs. 67%; p&lt;0.001), as well as more comorbidities (6 vs. 5; p&lt;0.001) and daily medication (9 vs. 7; p&lt;0.001). Moreover, DM patients had more cognitive impairment (52.5% vs. 34.0%; p=0.008) and greater dependence on instrumental activities of daily living (57.6% vs. 37.6%; p=0.009). A tendency was found regarding the presence of a caregiver for those with diabetes (75.8% vs. 63.1%; p=0.051).Conclusion:Patients with diabetes had more associated diseases and prescribed medicines, presented more cognitive impairment, greater dependence on instrumental activities of daily living, and were more likely to have a caregiver. This study will contribute to a better knowledge about the clinical and psychosocial characterization of older adults with DM in a specific context, allowing the development of future care plans and the adoption of better strategies for this group’s specificities.

COVID-19 outcomes in patients with sickle cell disease and sickle cell trait compared with individuals without sickle cell disease or trait: a systematic review and meta-analysis

Clinical manifestations and severity of SARS-CoV-2 infection in individuals with sickle cell disease (SCD) and sickle cell trait (SCT) are not well understood yet. We performed a systematic review and meta-analysis to assess COVID-19 outcomes in individuals with SCD or SCT compared to individuals without sickle cell disease or trait. An electronic search on PubMed, Embase, and Cochrane Library was performed on August 3, 2023. Two authors (IFM and ISP) independently screened (IFM and ISP) and extracted data (IFM and ILC) from included studies. Main exclusion criterion was the absence of the non-SCD/SCT group. Exposure effects for binary endpoints were compared using pooled odds ratio (OR) with 95% confidence intervals (CI). I2 statistics was used to assess the heterogeneity and DerSimonian and Laird random-effects models were applied for all analyses to minimize the impact of differences in methods and outcomes definitions between studies. The overall quality of evidence was assessed using the GRADE system. Review Manager 5.4 and R software (v4.2.2) were used for statistical analyses. Registered with PROSPERO, CRD42022366015. Overall, 22 studies were included, with a total of 1892 individuals with SCD, 8677 individuals with SCT, and 1,653,369 individuals without SCD/SCT. No difference in all-cause mortality was seen between SCD/SCT and non-SCD/SCT (OR 1.18; 95% CI 0.78-1.77; p=0.429; I2=82%). When considering only studies adjusted for confounders (8 studies), patients with SCD/SCT were shown to be at increased risk of death (OR 1.86; 95% CI 1.30-2.66; p=0.0007; I2=34%). No significant difference was seen between individuals with SCD and SCT (p=0.863). The adjusted for confounders analysis for hospitalisation revealed higher rates for the SCD (OR 5.44; 95% CI 1.55-19.13; p=0.008; I2=97%) and the SCT groups (OR 1.31; 95% CI 1.10-1.55; p=0.002; I2=0) compared to the non-SCD/SCT population. Moreover, it was significantly higher for the SCD group (test for subgroup difference; p=0.028). Our findings suggest that patients with SCD or SCT may present with a higher mortality and hospitalisation rates due to COVID-19 infection. None.