Prospective Nonrandomized Cohort Study Research Articles

Treatment of Posttraumatic Zygomatic Coronoid Ankylosis. Systematic Review.

Facial trauma is mostly associated with traffic accidents, fights, and sports accidents. The mandible, midface, and temporomandibular joint are usually the region's most frequently affected. Coronoid process fractures are rare, representing ∼2% of facial fractures in the literature, usually being the result of direct trauma to the zygomatic region. Due to the anatomical relationship of the coronoid process, it may be associated with other facial fractures, such as fractures of the zygomatic bone. Zygomatic-coronoid ankylosis is a rare clinical entity with variable etiology. It is most commonly associated with trauma (13%-100%), local or systemic infection (0%-53%), or systemic diseases, such as ankylosing spondylitis, rheumatoid arthritis, or psoriasis. The aim of this research is to evaluate the different treatments for ankylosis from the coronoid process to the zygoma after trauma, allowing to determine the treatment to obtain the best results. A systematic review was carried out following PRISMA "preferred reports for systematic reviews and meta-analyses" search matrix, based on a PICO question; was used PubMed, Embase, Sciencedirect, Cochrane, Google Scholar, and manual search in high-impact journals between 1946 and 2023 publications in English or Spanish, including randomized and nonrandomized clinical trials, prospective and retrospective cohort studies, case-control studies, series, and case reports. A total of 1993 articles were obtained from the 4 databases. After corroborating duplicate articles, 847 articles were excluded. Another 1112 articles were excluded in the title evaluation, and an additional 1093 after the abstract review; a total of 19 articles eligible for full-text evaluation were established and 1 article was added as a result of the manual search. After the full-text review, it was decided to include 16 articles in the study that met the objectives of the systematic review. After evaluating the different treatments described in the literature, the authors can determine that coronoidectomy through an intraoral approach is the most appropriate treatment for zygomatic coronoid ankylosis, accompanied by postoperative physiotherapy to achieve greater oral opening without recurrences.

The Effectiveness of Letrozole Alone or in Combination with Methotrexate in the Management of Ectopic Pregnancy, A Systematic Review and Meta-Analysis.

This systematic review and meta-analysis aimed to investigate the effect of letrozole alone or in combination with Methotrexate on the management of ectopic pregnancy. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were applied for reporting. The EMBASE, PubMed, Scopus, and Web of Science databases were searched for relevant studies focused on women diagnosed with ectopic pregnancy and managed non-surgically with letrozole alone or in combination with methotrexate (MTX) until April 2024. The success rate, laboratory findings, and complications were analyzed and reported. Meta-analysis was done using RevMan 5.4.1 software. Out of 129 unique studies obtained, 7 of them were found eligible for final review; of which, 3 were nonrandomized prospective cohort studies, 2 were randomized clinical trials, and 2 study were case studies. In 5 studies letrozole was used as monotherapy. While in another study letrozole was used with MTX. The meta-analysis showed a significantly lower level of β-HCG in the letrozole group compared to MTX, 7days after initiation of treatment (Fixed effect model, MD = -92.22, 95%CI: [-159.39, -25.04], P = 0.007, I2 = 0%). There was no significant difference in the level of anti-mullerian hormone (AMH) between groups (Fixed effect model, MD = 0.18, 95%CI: [-0.09, 0.45], P = 0.20, I2 = 0%). Success rate, platelet count, and level of liver enzymes seemed to be better or similar among patients receiving Letrozole compared to patients receiving Methotrexate. Letrozole exhibits potential as a therapeutic option for ectopic pregnancies; however, further randomized clinical trials are necessary to establish strong evidence.

Impact of Cardiac Rehabilitation Program on the Quality of Life of Young Adults versus Elderly Egyptians with Ischemic Heart Disease

Abstract Background Exercise-based cardiac rehabilitation is underutilized in patients after myocardial infarction, especially in the elderly population. The ageing biology of this senior population is definitely unique, and they are more likely to experience different consequences for which cardiac rehabilitation can be especially useful. Objective To investigate the impact of a 12-week completed cardiac rehabilitation program on the quality of life of two different age groups with recent myocardial infarction. Methods This non-randomized prospective cohort study was conducted on 50 patients, divided into two groups; 25 patients for each, group1 included those more than 60 years, group 2 from 18 to 60 years. Both groups underwent cardiac rehabilitation programs during the period of May 2018 to August 2020 at Ain Shams university hospitals. Quality of life assessment was performed via RAND-36 questionnaire, while depression screening was done via PHQ-9 questionnaire. Results Both groups showed improvement in the quality of life after completion of the cardiac rehabilitation program. The younger group achieved better improvement in the domains related to physical functioning, general health, role limitation due to physical health, energy/fatigue, and also showed better improvement in depressive symptoms, dyslipidemia and left ventricular Ejection fraction, whereas the senior group showed better improvement regarding role limitation due to emotional problems. Conclusion Exercise training in the context of comprehensive CR program improves quality of life in young as well as elderly patients. The young population improved mainly in the domains related to physical health while the elderly group improved regarding emotional domain in the quality of life questionnaires.

Progressive Muscle Relaxation Training During Pregnancy: Effects on Mental State, Delivery and Labour Pain - a Prospective Study.

Progressive muscle relaxation is a widely used technique for relaxation, but studies are rare about efficacy on pregnancy and perinatal outcomes. Aim of our study was to determine whether progressive muscle relaxation affects anxiety and depression levels of pregnant women, pregnancy outcomes, labour pain and analgesic requirements. 156 pregnant women were enrolled in a prospective non-randomized controlled cohort study. The control group received standard antenatal care and classes only, while the intervention group additionally received progressive muscle relaxation training once a week for six weeks. Anxiety, depression and current strain were measured in a pretest-posttest experimental design using self-report scales at baseline (1 st survey), 5 weeks later (2 nd survey) and during puerperium (3 rd survey). Numeric Rating scales were used for measuring labour pain and satisfaction with analgesic treatment in the 3 rd survey. Fifty complete questionnaires from each group were analysed. There were no differences in mental status between the groups at baseline. Progressive muscle relaxation training significantly reduced depression levels. Trait anxiety, reflecting a person's basic anxiety decreased significantly in both groups during puerperium. No differences in pregnancy outcomes, labour pain and analgesic requirements could be shown within both groups in general. Nonetheless, women attending more than five progressive muscle relaxation courses reported significantly less labour pain within the group and compared to controls. Pregnant women could benefit from progressive muscle relaxation training if used continuously. Relaxation methods should be a substantial part of prenatal care and available for everyone.

Management of Massive Irreparable Posterosuperior Cuff Tears: A Systematic Review for Clinical & Functional & Radiological Outcomes

Abstract Background The management of massive irreparable cuff tears (MIRCT) remains a highly controversial subject with many possible surgical and non-surgical interventions and no clear evidence regarding the most effective and beneficial intervention. Different management options include: conservative management, partial repair, tendon transfer, superior capsular reconstruction, subacromial spacer insertion, reverse total shoulder arthroplasty (RTSA). Aim of the Work The aim of this systematic review is to compare the various methods of management of posterosuperior cuff tears without arthropathy to reach the most effective and sustainable mode of management. Patients and Methods A randomized controlled trial, non-randomized clinical trials, prospective and retrospective comparative cohort studies and case series. We will exclude cross-sectional studies, case reports and literature not in English. Results There is no high quality evidence on management of MIRCT. There was no Level I or II evidence. We included 69 papers that studied different modalities of management of MIRCT, 31 of level III and the remaining were of level IV evidence. Consequently, it’s still difficult to recommend one method of management over the other regarding the management of irreparable cuff tears. Patient age, demands, expectations, thorough clinical examination, surgeon experience and preference are still a major deciding factor when choosing and appropriate method. Conclusion Due to the unavailability of high-quality clinical studies available for guiding management of irreparable MRCT, it is consequently not possible to recommend for or against any specific treatment strategy. Rather, clinical experience, patient factors, patient expectations, and rotator cuff tear characteristics should guide clinical decision-making. Physical therapy compared to surgical treatments may have inferior outcomes. Standardized data collection, reporting and terminology are key to enhancing the quality of evidence-based medicine.

Antiepileptic Drugs as Prophylaxis for Seizures after Excision of Brain Tumors

Abstract Background Seizures are the most common & most serious side effect of cranial surgery. The latter condition requires chronic treatment with Antiepileptic drugs (AEDs) and comes with relevant socioeconomic sequelae. The routine prophylactic use of AEDs for people undergoing tumor resection has remained controversial due to the risk of postoperative seizures. Some Neurosurgeons are advocates to the use of AEDs to reduce the risk of these seizures. Objective To evaluate the efficacy of prophylactic AEDs routinely in brain tumor patients without previous history of seizures. Primary objective has been to identify the efficacy of AEDs in perioperative seizure prophylaxis. Secondary objective has been to highlight the most common type of post-operative AEDs. Methods All available studies from 2000-2021 including randomized or non-randomized clinical trials, prospective or retrospective observational cohort studies, and case series of six or more cases that address these criteria have been collected. Results Our search concluded that the most common type of post-operative seizure is the Early seizure which is of total 87 patients representing 12.3% of seizure reported patients, yet when comparing the P-value between the Early & late seizure it has a P-value of 0.415 which is nonsignificant rendering the comparison redundant. The Most common types of AED used are Phenytoin (PHT) 89 (71.8%) & Levetiracetam (LEV) 109 (81.8%). To measure the efficacy of AEDs two groups of patients with no history of AED administration or seizures preoperatively were created, one the control group of 268 participants were not administered AEDs postoperatively only 32 (11.94%) of them suffered from seizures postoperatively. The other group of 171 participants were administered the AEDs postoperatively only 25 (14.62%) of these participants suffered from postoperative seizure. Comparing both of these results statistically it had a P-value of 0.416 which is non-Significant statistically. On interpreting these results was that the AED have no influence in controlling the seizures. Conclusion Postoperative seizures are one of the main complications of brain tumor surgery. Neurosurgeons have a strong belief more of tradition that preventing seizures with Anti-Epileptic Drugs (AEDs) as a sort of seizure prophylaxis is not only effective but also necessary. Finally, there is not enough evidence of sufficient quality available to suggest that antiepileptic drugs AEDs treatment can or cannot be recommended to reduce Post-craniotomy seizures.

The potential of indocyanine green fluorescence detection in surgical cut margin of breast conserving surgery.

Fluorescence-guided surgery (FGS) is a cutting-edge technology that uses near-infrared (NIR) fluorescence imaging to guide surgeons in surgery. Indocyanine green (ICG) is a fluorescent dye, which can be used for in vivo imaging of tumor cells. We aimed to explore the use of ICG fluorescence-guided technology as a rapid intraoperative margin assessment method for breast cancer surgery. In addition, we also compared the dose selection of ICG. This was a non-randomized prospective cohort study. Data were collected between August 2021 and October 2022 in the Division of Breast Surgery, Department of General Surgery, Nanjing Drum Tower Hospital, the Affiliated Hospital of Medical School, Nanjing University. Upon specimen removal, tumor margins were immediately analyzed by ICG fluorescence detection and then sent to the pathology department for intraoperative frozen section analysis and subsequent routine pathological examination. Abnormal margin rates were calculated and compared using intraoperative frozen section analysis and under the guidance of ICG fluorescence. The study included 69 cases of breast cancer patients who underwent tumor resection assisted by ICG fluorescence-guided technology, including 18 patients with a 0.5 mg/kg dose and 51 patients with a 1.0 mg/kg dose. According to the study findings, the ICG test achieved a sensitivity of 81.82% and a specificity of 75.82%. At a dose of 0.5 mg/kg, the sensitivity was 66.67% whereas the specificity was 93.33%. At the dose of 1 mg/kg, the sensitivity was 87.5%, and the specificity was 74.42%. Similarly, for intraoperative frozen section analysis, the sensitivity was 81.82%, but the specificity was enhanced to 94.83%. Positive surgical cut margin was not identified in 2/69 by ICG fluorescence and frozen section analysis respectively. The sensitivity of ICG fluorescence detection is comparable to that of frozen section analysis, but the specificity is poor. The sensitivity increased and the specificity decreased at 1 mg/kg compared to the 0.5 mg/kg dose. ICG fluorescence can be used as a supplementary tool for frozen section analysis. These findings support further development and clinical performance assessment of ICG fluorescence.

Prospective Outcomes of Microlaryngoscopy Versus Office Laser Photoangiolysis for Vocal Fold Polyps.

The objective of this study is to compare treatment outcomes for vocal fold polyps (VFPs) between operating room microlaryngoscopy and office-based photoangiolysis with the potassium titanyl phosphate (KTP) laser. Prospective nonrandomized cohort study of patients with VFPs undergoing microlaryngoscopy ("OR group") or KTP laser photoangiolysis ("KTP group"). Voice outcomes (patient-reported outcome measures [Voice Handicap Index-10 (VHI-10) and Singing VHI-10 (SVHI-10)], auditory-perceptual measures [Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)], videostroboscopic characteristics [Voice-Vibratory Assessment of Laryngeal Imaging (VALI)], and acoustic and aerodynamic measures) were performed at baseline and regular intervals after intervention. Forty-four subjects (17 OR group, 27 KTP group) with VFPs were enrolled. Mean VHI-10 significantly improved from baseline to each follow-up interval in both groups, except for the 1-2-week interval in the OR group. Mean SVHI-10 improved for both groups at some intervals. Growth curve models and time-to-event analyses for patient-reported outcomes did not differ between groups. There were significant improvements in all categories of auditory-perceptual voice quality and some categories of videostroboscopic characteristics in both groups. No significant trends were identified in acoustic and aerodynamic measures. Improvements in most outcomes did not significantly differ between groups or based on polyp size. There were no major complications. Significant improvements in patient-reported voice outcomes measures, auditory-perceptual voice evaluation, and videostroboscopic characteristics occur following surgical treatment of vocal fold polyps with either microlaryngoscopy or office-based KTP laser. Long-term voice outcomes do not significantly differ between treatment modalities. 3 Laryngoscope, 134:S1-S20, 2024.

Effects of Electronic Nicotine Delivery Systems Substitution on Body Weight Status: Protocol for a Systematic Review and Meta-Analysis.

Weight gain following smoking cessation is a well-documented concern, often attributed to the absence of nicotine's metabolic influence. The adoption of Electronic Nicotine Delivery Systems (ENDS) has been used to achieve smoking cessation, with claims of aiding weight control. However, existing reviews present conflicting conclusions on ENDS' impact on weight status, necessitating a rigorous evaluation. We aim to conduct a systematic review with meta-analysis to assess the actual impact of ENDS on weight status in individuals who have ceased or reduced conventional smoking. The primary goal is to provide clinicians with evidence-based insights into the potential effects of ENDS use as a smoking substitute on weight control. Adhering to PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines, our systematic review will analyze randomized and nonrandomized controlled trials, clinical trials (quasi-experimental), and prospective or retrospective cohort studies on the weight status effects of ENDS among individuals who have either quit or reduced smoking. Searches will include PubMed, Scopus, and Cochrane Library, covering the period from 2010 to January 2024. A gray literature search and supplementary searches will be performed. Data will be extracted independently by 2 reviewers and quality assessments will be conducted concurrently. Quality assessments will use Joanna Briggs Institute tools, 2020 version, along with bias assessments for internal validity and reporting bias based on the Catalogue of Bias. The included studies will be examined for any internal data reporting discrepancies by using Puljak's checklist. Meta-analysis and subgroup analyses (ie, general ENDS usage, ENDS use coupled with a reduction in smoking exceeding 50%, and exclusive ENDS use for achieving smoking cessation) are planned. Certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. The protocol has been registered in PROSPERO (CRD42023494974) and the entire systematic review is expected to be completed by April 2024. The main goal of this review is to retrieve all current human research studies investigating the influence of ENDS on weight management among individuals who have quit or reduced smoking. Furthermore, the review will assess the quality of these studies and examine potential biases to identify the most dependable evidence available. Dissemination strategies will include traditional journal publications, social media announcements, and a white paper. The latter, available for download and distributed at conferences, aims to reach a broad audience, including clinicians and ENDS users. The review will address the importance of informing health care professionals and patients about the current and robust evidence regarding the effects of transitioning to ENDS for smoking cessation on weight status. PROSPERO CRD42023494974; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=494974. PRR1-10.2196/56324.

Paris classification of colonic polyps using CT colonography: prospective cohort study of interobserver variation.

The Paris classification categorises colorectal polyp morphology. Interobserver agreement for Paris classification has been assessed at optical colonoscopy (OC) but not CT colonography (CTC). We aimed to determine the following: (1) interobserver agreement for the Paris classification using CTC between radiologists; (2) if radiologist experience influenced classification, gross polyp morphology, or polyp size; and (3) the extent to which radiologist classifications agreed with (a) colonoscopy and (b) a combined reference standard. Following ethical approval for this non-randomised prospective cohort study, seven radiologists from three hospitals classified 52 colonic polyps using the Paris system. We calculated interobserver agreement using Fleiss kappa and mean pairwise agreement (MPA). Absolute agreement was calculated between radiologists; between CTC and OC; and between CTC and a combined reference standard using all available imaging, colonoscopic, and histopathological data. Overall interobserver agreement between the seven readers was fair (Fleiss kappa 0.33; 95% CI 0.30-0.37; MPA 49.7%). Readers with < 1500 CTC experience had higher interobserver agreement (0.42 (95% CI 0.35-0.48) vs. 0.33 (95% CI 0.25-0.42)) and MPA (69.2% vs 50.6%) than readers with ≥ 1500 experience. There was substantial overall agreement for flat vs protuberant polyps (0.62 (95% CI 0.56-0.68)) with a MPA of 87.9%. Agreement between CTC and OC classifications was only 44%, and CTC agreement with the combined reference standard was 56%. Radiologist agreement when using the Paris classification at CT colonography is low, and radiologist classification agrees poorly with colonoscopy. Using the full Paris classification in routine CTC reporting is of questionable value. Interobserver agreement for radiologists using the Paris classification to categorise colorectal polyp morphology is only fair; routine use of the full Paris classification at CT colonography is questionable. • Overall interobserver agreement for the Paris classification at CT colonography (CTC) was only fair, and lower than for colonoscopy. • Agreement was higher for radiologists with < 1500 CTC experience and for larger polyps. There was substantial agreement when classifying polyps as protuberant vs flat. • Agreement between CTC and colonoscopic polyp classification was low (44%).

NSAIDS versus electro-acupuncture in management of low back pain in patients with lumbar spondylosis: a comparative cohort study

Background: Low back pain in lumbar spondylosis remains one of the most prevalent conditions, imposing a significant socio-economical burden. Objectives: To compare the effectiveness of low back pain treatment between NSAIDS and electro-acupuncture combined with infrared light (TCM) in patients with lumbar spondylosis. Materials and methods: We conducted a non-randomized prospective cohort study on lumbar spondylosis patients who had low back pain treated with either methods: NSAIDS or electro-acupuncture combined with infrared light therapy. Results: 75 patients were included, with a mean age of 53.39 ± 10.61 years. After 8 weeks of treatment, VAS scores decreased significantly from 7.5 ± 0.6 to 2.85 ± 0.4, p-value &lt; 0.05 in NSAIDS group and from 5.8 ± 0.9 to 2.7 ± 0.6, p-value &lt; 0.05 in TCM group. Schober index significantly increased over time (NSAIDS group from 10.36 ± 0.5 to 13.48 ± 0.7, TCM group from 10.88±0,8 to 13.61 ± 0.7, both with p-values &lt; 0.05), whereas ODI score in both groups decreased (NSAIDS group from 37.4 ± 5.5 to 22.2 ± 5.5, TCM group from 28.68 ± 5.4 to 15.13 ± 6.4, with p-values &lt; 0.05). The magnitude of improvement in VAS scores, Schober index, and ODI scores were more profound in NSAIDS group, with p-values &lt; 0.05. Side effect associated with TCM treatment was seen in 8% of cases with pain at acupunture sites. Meanwhile in NSAIDS group, dyspepsia and flatulence were fairly common, at 24%. Conclusions: The use of NSAIDs in the management of low back pain in lumbar spondylosis patients is associated with better outcomes compared to TCM, with a trade-off for a higher risk of treatment-related side effects. Key words: NSAIDS, electro-acupuncture, infrared light, low back pain, lumbar spondylosis

Urologists’ Approach to Nocturia: Routine vs. Standardized Approach

Objective: We aimed to compare the effect of urologists’ routine approach and standardized approach on disease management and treatment results in patients suffering from nocturia. Material and Methods: The study was designed as a non-randomized prospective cohort study between March and July 2023. In the first stage, the routine clinical approach of 6 urology specialists was evaluated. Demographic data, comorbidities, baseline nocturia number, quality of life, and multidisciplinary approach preference of the patients were recorded (Group 1). In the second stage, the patients’ demographic data, comorbidities, and additionally the voiding diary and “Targeting the individual’s Aetiology of Nocturia to Guide Outcomes” (TANGO) questionnaire were questioned (Group 2). All patients were re-evaluated in the first month of the treatments/recommendations given. The difference in the multidisciplinary approach and the change in the number of nocturia and the quality of life of the patients were compared between the two approaches. Results: Forty-seven patients were included in each group. The demographic and clinical characteristics of the patients in both groups were statistically similar. Charlson’s comorbidity index was higher in Group 2 (p=0.01). The multidisciplinary treatment approach was at a higher level in Group 2 (59.6% vs 8.5%, p=0.001). While the average number of nocturia decreased from 4.6 to 2.19 in group 1, it decreased from 5.15 to 1.21 in group 2. In the first month, the number of nocturia and quality of life scores were lower in group 2. The decrease in the average number of nocturia and quality of life in group 2 was statistically significantly higher than in group 1. Conclusion: In the approach to nocturia, questioning comorbidities and applying multidisciplinary management provides more meaningful results in nocturia treatment and increase the quality of life.

Former smoking as a risk factor for visual field progression in exfoliation glaucoma patients in Sweden.

The present study aimed to identify whether former smoking was a risk factor for visual field progression in exfoliation glaucoma patients. Prospective nonrandomised cohort study. The study included patients diagnosed with exfoliation glaucoma. All included patients were followed for three years (± three months) with reliable visual fields. At least five reliable visual fields needed to be included in the study. Exfoliation glaucoma was defined using the European Glaucoma Society Guidelines. The visual fields were tested using the 24-2 test strategy of the Humphrey Field Analyzer. Smoking was assessed through questionnaires. Outcomes: Visual field progression. Three different approaches were used: difference in mean deviation (MD), rate of progression (ROP), and guided progression analysis (GPA). In total, n = 113 patients were included; among them, n = 57 were smokers. Smoking was a significant predictor for visual field progression in the three models (MD/ROP/GPA) studied (p = 0.01/p = 0.001/p ≤ 0.001), even adjusting for intraocular pressure (IOP). Other predictors were included in the MD model: IOP at diagnosis (p = 0.04) and selective laser trabeculoplasty (SLT) treatment (p = 0.01). Other predictors were in the ROP model: Visual field index (p = 0.005), number of medications (p = 0.001) and SLT treatment (p = 0.001). The number of medications was another predictor in the GPA model (p = 0.002). Former smoking induced visual field deterioration in all models studied. Smoking status should be considered when establishing the glaucoma diagnosis. Increased glaucoma care should be provided to former smokers to slow the progression of the disease.

Impact of SARS-CoV-2 Omicron variant infection on the outcomes of patients with spontaneous intracerebral hemorrhage: A prospective cohort study

ObjectiveThis study aims to investigate the impact of the infection with the novel coronavirus Omicron variant on the outcomes of patients with severe spontaneous intracerebral hemorrhage. MethodsWe conducted a multicenter prospective non-randomized cohort study during the peak of the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) Omicron strain epidemic. Clinical data were collected from nine centers in China between December 1, 2022, and February 28, 2023. Patients were categorized into good and poor outcomes groups based on modified Rankin Scale scores at discharge. Clinical characteristics were compared, and univariate and multivariate logistic regression analyses were performed. Additionally, coagulation function was compared between SARS-CoV-2 Omicron positive and negative patients. ResultsAmong 86 included patients, 30 (35 %) had a favorable outcome, while 56 (65 %) had an unfavorable outcome. Of these, 32 (37 %) tested positive for SARS-CoV-2 Omicron, while 54 (63 %) tested negative. Multivariate analysis identified Glasgow Coma Scale score and hypertension as independent risk factors affecting outcomes (P < 0.05). Surprisingly, SARS-CoV-2 Omicron infection emerged as a protective factor for patient outcomes (P < 0.05). Additionally, SARS-CoV-2 Omicron-positive patients exhibited significantly elevated fibrinogen levels upon admission (P < 0.05). ConclusionIn comparison to patients without SARS-CoV-2 Omicron infection, patients with severe spontaneous intracerebral hemorrhage who were co-infected with SARS-CoV-2 Omicron exhibited a more favorable short-term outcome.

A Prospective Comparison of Standard and Modified Acute Malnutrition Treatment Protocols during COVID-19 in South Sudan.

A non-randomized prospective cohort study was conducted in 2022 to compare recovery rate and length of stay (LoS) for acutely malnourished children treated under South Sudan's standard Community Management of Acute Malnutrition (CMAM) protocol and a COVID-modified protocol. Children aged 6-59 months received acute malnutrition (AM) treatment under the standard or modified protocol (mid-upper-arm circumference-only entry/exit criteria and simplified dosing). Primary (recovery rate and LoS) were compared for outpatient therapeutic (OTP) and therapeutic supplementary feeding programs (TSFP) using descriptive statistics and mixed-effects models. Children admitted to OTP under both protocols were similar in age and sex; children admitted to TSFP were significantly older under the modified protocol than the standard protocol. Shorter LoS and higher recovery rates were observed under the modified protocol for both OTP (recovery: 93.3% vs. 87.2%; LoS: 38.3 vs. 42.8 days) and TSFP (recovery: 79.8% vs. 72.7%; LoS: 54.0 vs. 61.9 days). After adjusting for site and child characteristics, neither differences in adjusted odds of recovery [OTP: 2.63; TSFP 1.80] nor LoS [OTP -10.0; TSFP -7.8] remained significant. Modified protocols for AM performed well. Adjusted models indicate similar treatment outcomes to the standard protocol. Adopting simplified protocols could be beneficial post-pandemic; however, recovery and relapse will need to be monitored.

Abstract 16990: Empagliflozin Therapy is Associated With Improved Left Ventricular Diastolic Function in Patients With Transthyretin Amyloid Cardiomyopathy

Introduction: Although SGLT-2 inhibitors demonstrated beneficial clinical effects in patients with heart failure with preserved ejection fraction, their role in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) remains undefined. Hypothesis: We investigated the effects of empagliflozin on myocardial function in patients with ATTR-CM. Methods: In a prospective single-center non-randomized cohort study we enrolled 15 consecutive patients with ATT-CM receiving tafamidis 61 mg qd and standard heart failure therapy for at least six months prior to enrolment. At the time of inclusion, all patients started receiving empagliflozin 10 mg qd. Biochemical and echocardiographic parameters were evaluated at baseline and again at 6-months. Results: At the time of inclusion, the average age of patients was 74.8±5.7 years, 14 (93%) were male, and 14 (93%) had NYHA class II symptoms; 10 (67%) patients were receiving ARNI/ACEI/ARB, 5 (33%) were treated with beta blockers, and 3 (20%) were receiving mineralocorticoid receptor antagonists. At 6-months follow-up we found no change in NT-proBNP levels (1694±1237 ng/L at baseline vs. 1549±1203 ng/L at follow up; P=0.78), hs-Troponin I levels (33±19 ng/L vs. 39±26 ng/L; P=0.50), or eGFR (65.9±14.4 mL/min vs. 64.9±14.8 mL/min; P=0.87). Furthermore, we observed no changes in LVEDV (84±19 mL vs. 88±17 mL; P=0.61), LVEF (57±8% vs. 57±7%; P=0.94), LV mass (265±74 g vs. 279±88 g; P=0.67), or RVIDd (39±8 mm vs. 36±7 mm; P=0.39). However, at 6 months we found a significant decrease in E/e’ (19.2±5.1 vs. 14.9±5.4; P=0.05). When stratifying patients according to the baseline E/e’ value we found a significant improvement of right ventricular FAC (44.1±6.2% vs. 31.9±8.9%; P=0.04) and TR pressure gradient (26.0±5.7 mmHg vs. 39.7±5.2 mmHg; P=0.04) in patients with E/e’ below median compared to patients with E/e’ above median value. Conclusion: In patients with ATTR-CM, empagliflozin therapy appears to reduce left ventricular filling pressures and may be associated with improved right ventricular systolic function in a subset of this patient population.

Treatment of Hidradenitis Suppurativa Evaluation Study(THESEUS): a prospective cohort study.

Hidradenitis suppurativa (HS) is a chronic, painful disease affecting flexures and other skin regions, producing nodules, abscesses and skin tunnels. Laser treatment targeting hair follicles and deroofing of skin tunnels are standard HS interventions in some countries but are rarely offered in the UK. To describe current UK HS management pathways and influencing factors to inform the design of future randomized controlled trials (RCTs). THESEUS was a nonrandomized 12-month prospective cohort study set in 10 UK hospitals offering five interventions: oral doxycycline 200 mg daily; oral clindamycin and rifampicin both 300 mg twice daily for 10 weeks, extended for longer in some cases; laser treatment targeting hair follicles; deroofing; and conventional surgery. The primary outcome was the combination of clinician-assessed eligibility and participant hypothetical willingness to receive each intervention. The secondary outcomes were the proportion of participants selecting each intervention as their final treatment option; the proportion who switch treatments; treatment fidelity; and attrition rates. THESEUS was prospectively registered on the ISRCTN registry: ISRCTN69985145. The recruitment target of 150 participants was met after 18 months, in July 2021, with two pauses due to the COVID-19 pandemic. Baseline demographics reflected the HS secondary care population: average age 36 years, 81% female, 20% non-White, 64% current or ex-smokers, 86% body mass index ≥ 25, 68% with moderate disease, 19% with severe disease and 13% with mild disease. Laser was the intervention with the highest proportion (69%) of participants eligible and willing to receive treatment, then deroofing (58%), conventional surgery (54%), clindamycin and rifampicin (44%), and doxycycline (37%). Laser was ranked first choice by the greatest proportion of participants (41%). Attrition rates were 11% and 17% after 3 and 6 months, respectively. Concordance with doxycycline was 52% after 3 months due to lack of efficacy, participant choice and adverse effects. Delays with procedural interventions were common, with only 43% and 26% of participants starting laser and deroofing, respectively, after 3 months. Uptake of conventional surgery was too small to characterize the intervention. Switching treatment was uncommon and there were no serious adverse events. THESEUS has established laser treatment and deroofing for HS in the UK and demonstrated their popularity with patients and clinicians for future RCTs.

SP4.6 12 months analysis of the PROM-Q study: Comparison of Patient Reported Outcome Measures using the BREAST-Q questionnaire in pre- versus sub-pectoral implant based immediate breast reconstruction

Abstract Introduction There is a lack of comparative data on clinical and patient perceived outcomes on pre- versus sub-pectoral implant-based breast reconstruction (IBR). We investigated whether these different surgical approaches influenced clinical or patient perceived outcomes. Methods This prospective non-randomised longitudinal cohort study (ClinicalTrials.gov identifier: NCT04842240) recruited patients undergoing immediate IBR (Sep 2019-Sep 2021). Data collection included patient characteristics and post-operative complications. Patients completed BREAST-Q questionnaire at baseline, 2 weeks, 3 and 12 months post-surgery. Results We recruited 78 patients (46 pre-pectoral; 59% vs. 32 sub-pectoral; 41%). Patient characteristics were comparable (Table 1). Similar complication rates were observed (15.2% pre-pectoral vs. 9.4% sub-pectoral; p=0.44). Overall implant loss rate was 3.8% (6.5% pre-pectoral vs. 0% sub-pectoral; p=0.14). Median Breast-Q scores were similar between pre- and sub-pectoral IBR at 3 months; breast satisfaction (58 vs. 48; p=0.12), psychosocial well-being (60 vs. 57; p=0.9), physical well-being (68 vs. 76; p=0.53), and Animation Q scores (73 vs. 76; p=0.45). Similar findings were observed at 12 months; breast satisfaction (58 vs. 53; p=0.3), psychosocial well-being (59 vs. 60; p=0.9), physical well-being (68 vs. 78; p=0.18), and Animation Q scores (69 vs. 73; p=0.4). Conclusions This study demonstrates equivalent clinical and patient perceived outcomes between pre- and sub-pectoral IBR, thereby aiding informed decision making regarding either surgical option.

Indocyanine Green Tracer-Guided Radical Robotic Distal Gastrectomy Using the Firefly™ System Improves the Quality of Lymph Node Dissection in Patients with Gastric Cancer

BackgroundThis study investigated indocyanine green (ICG) as an intraoperative tool for improving lymph node dissection quality in radical robotic distal gastrectomy (RDG) for gastric cancer by comparing the rate of lymph node (LN) noncompliance with or without use of the Firefly™ system. MethodsPatients with potentially resectable gastric cancer including cT1-T4a, N0/ + , M0 were registered in a prospective nonrandomized cohort study at our institution between March 2019 and December 2022. Patients were assigned to the da Vinci surgical system with Firefly system (F group) or that without Firefly system (non-F group). F group patients received endoscopic peritumoral injection of ICG to the submucosa one day before surgery. Rate of LN noncompliance, number of harvested LNs, and short-term outcomes were compared. ResultsOf the 94 patients in this study, 55 underwent Firefly system-guided RDG and 39 underwent conventional RDG. The mean [SD] total number of harvested lymph nodes in F group, 31.2 [10.2], was significantly higher than that harvested in non-F group (25.6 [12.6]; p = 0.026). The LN noncompliance rate in F group was lower than that in non-F group (32.7% vs. 61.5%, p = 0.006). The mean number of LNs harvested in F group was significantly higher than that harvested in non-F group (31.2 [10.2] vs. 25.7 [12.6], p = 0.02). Significant differences were found between the F vs. non-F groups in blood loss and postoperative hospital stay (83.9 [75.1] vs. 301.9 [766.7] mL; p = 0.003 and 13.4 vs. 17.4 days, p = 0.049). ConclusionThe Firefly system-assisted ICG tracer improved LN dissection quality without compromising safety.

Legume consumption in adults and risk of cardiovascular disease and type 2 diabetes: a systematic review and meta-analysis.

This study aimed to systematically review the evidence for associations between consumption of legumes and cardiovascular disease (CVD), type 2 diabetes (T2D) and their risk factors among healthy adults. We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Scopus up to 16 May 2022 for ≥4 weeks long randomized (RCT) and non-randomized controlled trials and prospective cohort studies with follow-up ≥12 months, assessing legume intake (beans/lentils/peas/soybeans, excluding peanuts and legume-products/protein/powder/flour) as the intervention or exposure. Outcomes were CVD, coronary heart disease (CHD), stroke, T2D and in intervention trials only: changes in blood lipids, glycemic markers, and blood pressure. Risk of bias (RoB) was evaluated with Cochrane's RoB2, ROBINS-I, and US Department of Agriculture (USDA)'s RoB-NObS. Effect sizes were pooled using random-effects meta-analyses and expressed as relative risk or weighed mean differences with 95% confidence intervals, heterogeneity quantified as I2. The evidence was appraised according to World Cancer Research Fund's criteria. Of the 181 full-text articles assessed for eligibility, 47 were included: 31 cohort studies (2,081,432 participants with generally low legume consumption), 14 crossover RCTs (448 participants), one parallel RCT and one non-randomized trial. Meta-analyses of cohort studies were suggestive of null associations for CVD, CHD, stroke and T2D. Meta-analyses of RCTs suggested a protective effect on total cholesterol (mean difference -0.22 mmol/L), low density lipoprotein (LDL)-cholesterol (-0.19 mmol/L), fasting glucose (-0.19 mmol/L), and HOMA-IR (-0.30). Heterogeneity was high (I2 = 52% for LDL-cholesterol, >75% for others). The overall evidence for associations between consumption of legumes and risk of CVD and T2D was considered limited - no conclusion. Legume consumption was not found to influence risk of CVD and T2D in healthy adult populations with generally low legume consumption. However, protective effects on risk factors, seen in RCTs, lend some support for recommending legume consumption as part of diverse and healthy dietary patterns for prevention of CVD and T2D.