Mantel-Haenszel Odds Ratio Research Articles

The Prevalence of Obesity is Increased in Adolescents with Amblyopia: An Analysis of National Health and Nutrition Examination Survey Data.

Background: Amblyopia is the most common cause of vision loss in children. Amblyopia has been associated with impaired depth perception but little attention has been paid to the extent to which amblyopia increases the risk of obesity. Methods: Public-use data from the 1999-2008 National Health and Nutrition Examination Survey were used. Analyses were limited to children aged 12-18, who had a visual examination, and a best corrected visual acuity (BCVA) of at least 20/40 in the better-seeing eye. Amblyopia was defined as two or more-line interocular difference in BCVA. Obesity was defined as Body Mass Index (BMI) or body fat percentage (BFP) ≥95th percentile for age and gender. Sedentary lifestyle was defined as cardiovascular fitness level (CFL) rating of "low." We used Mantel-Haenszel odds ratios (ORs) to examine the relative prevalence of obesity in children with/without amblyopia. Results: Adolescents with amblyopia (n = 360) were more likely than those without (n = 7935) to have a high BMI [OR = 1.56; 95% confidence interval (CI): 1.24-1.98; p < 0.001]. The associations with either high BFP (OR = 1.20; 95% CI: 0.86-1.56, p = 0.167) or low CFL (OR = 1.15; 95% CI: 0.83-1.57; p = 0.267) were not statistically significant but in the direction of a priori hypotheses. Conclusions: This analysis of population-based data suggests that adolescents with amblyopia may be at higher risk of having obesity. Given the high prevalence of amblyopia and the range of morbidities associated with childhood obesity, targeted interventions to reduce the risk of obesity among children with amblyopia could be warranted.

Abstract 4145880: Incidence and Outcomes of Acute Myocardial Infarction (AMI) in Hematological Malignancy Patients: Systematic review and Meta-analysis

Background: Patients with hematological malignancies may face increased cardiovascular risks, including acute myocardial infarction (AMI). This systematic review and meta-analysis aims to evaluate the incidence and outcomes of AMI in patients with hematological malignancies compared with the general population. Methods: A comprehensive literature search was conducted using the PubMed, Embase, and Google Scholar databases. Random effect models were utilized to calculate Mantel-Haenszel odds ratios (ORs) with 95% confidence intervals (CIs). The inverse variance method with DerSimonian–Laird (DL) of Tau2 was used to calculate standardized mean differences (SMDs) with CIs. Statistical significance was set at p &lt; 0.05. The primary endpoint was the incidence of AMI, while secondary outcomes included in-hospital mortality, length of hospital stay, likelihood of undergoing invasive procedures, total hospital costs, bleeding events, and stroke outcomes. Results: Twenty-six articles, including approximately 6.33 million patients with hematological malignancies, were included in the meta-analysis. Hematological malignancies were not associated with an increased incidence of AMI compared with the general population (OR = 0.91; 95% CI 0.80 to 1.03; p&lt;0.001). AMI in hematological malignancies was associated with an increased risk of in-hospital mortality (OR = 1.71; 95% CI 1.57 to 1.86; p&lt;0.001), bleeding event (OR = 1.30; 95% CI 1.12 to 1.60; p&lt;0.001), and stroke (OR = 1.24; 95% CI 1.09 to 1.42) compared with AMI in the general population. Patients admitted due to AMI in hematologic malignancies also experienced an increased length of stay (SMD = 0.25; 95% CI 0.20 to 0.28; p&lt;0.001) compared with AMI in the general population. There was no significant difference between the two groups in terms of the likelihood of undergoing invasive procedures (OR = 0.62; 95% CI 0.56 to 0.69) or total hospital expenditure (SMD = 0.09; 95% CI -0.01 to 0.19). Conclusion: While hematological malignancies do not appear to increase the incidence of acute myocardial infarction (AMI), patients who experience AMI episodes are at higher odds of in-hospital complications.

Effect of Timing of Surgery on the Outcomes and Complications in Multi-ligament Knee Injuries: An Overview of Systematic Reviews and A Meta-analysis.

Multi-ligament knee injuries (MLKI) are serious and challenging to manage. This study aimed to elucidate the impact of surgical timing on both early and long-term outcomes following an MLKI. A comprehensive search strategy was employed across PubMed, Scopus, Web of Science, and the Cochrane Library. Studies were identified using a combination of relevant keywords encompassing "multi-ligament knee injury," "knee dislocation," "reconstruction," "repair," "surgery," and "timing," and their synonyms, along with appropriate Boolean operators. Selection of articles (systematic reviews and meta-analyses) adhered to predefined inclusion and exclusion criteria. Furthermore, a meta-analysis was conducted utilizing data extracted from primary studies. Early surgery for MLKI demonstrated a significant advantage over delayed surgery, reflected by significantly higher Lysholm scores (Mean Difference [MD] 3.51; 95% Confidence Interval [CI] 1.79, 5.22), IKDC objective scores (Mantel-Haenszel Odds Ratio [MH-OR] 2.95; 95% CI 1.30, 6.69), Tegner activity scores (MD 0.38; 95% CI 0.08, 0.69), and Mayer's ratings (MH-OR 5.47; 95% CI 1.27, 23.56). In addition, we found a significantly reduced risk of secondary chondral lesions (MH-OR 0.33; 95% CI 0.23, 0.48), lower instrumented anterior tibial translation in the early surgery group (MD -0.92; 95% CI -1.83, -0.01), but no significant difference was observed in the secondary meniscal tears, between the two groups. However, the early surgery group also exhibited a significantly increased risk of knee stiffness (MH-OR 2.47; 95% CI 1.22, 5.01) and a greater likelihood of requiring manipulation under anaesthesia (MH-OR 3.91; 95% CI 1.10, 13.87). Early surgery for MLKI improves function, and stability, and reduces further articular cartilage damage, but increases the risk of stiffness. IV. The online version contains supplementary material available at 10.1007/s43465-024-01224-1.

36-40% of Routine Care Patients With Osteoarthritis or Rheumatoid Arthritis Screen Positive for Anxiety, Depression, and/or Fibromyalgia on a Single MDHAQ.

Osteoarthritis (OA) and rheumatoid arthritis (RA) are associated with similar patient disease burdens and a high prevalence of comorbid anxiety (ANX), depression (DEP), and fibromyalgia (FM). Nonetheless, these comorbidities are infrequently assessed in routine care, in part because multiple questionnaires are not feasibly completed by patients. We analyzed the prevalence of ANX, DEP, and FM in patients with OA versus patients with RA seen in routine care using indices within a single Multidimensional Health Assessment Questionnaire (MDHAQ) and associations with \ Routine Assessment of Patient Index Data 3 (RAPID3) and its component function, pain, and patient global scores. A retrospective analysis of MDHAQ data in unselected patients with OA or RA receiving routine care at one setting included four indices within an MDHAQ: MDHAQ ANX screen, MDHAQ DEP screen, Fibromyalgia Assessment Screening Tool, and RAPID3. The prevalence of each comorbidity and associations with RAPID3 and components were analyzed in unadjusted and age-adjusted (Mantel-Haenszel) odds ratios (ORs) and 95% confidence intervals. Overall, 40.4% of 361 patients with OA and 36.3% of 488 patients with RA screened positive for ANX, DEP, and/or FM (8.1% and 7% for all three, respectively). RAPID3 and each component were elevated significantly in patients with any positive screen result for ANX, DEP, and/or FM in both diagnoses (ORs of 2.6-35.8). FM, DEP, and/or ANX rates were 40.4% in patients with OA and 36.3% in patients with RA, associated with significantly poorer patient status measures. Each of these three common comorbidities of patient distress may be feasibly screened for on a single MDHAQ in routine care.

Role of second look endoscopy in endoscopic submucosal dissection and peptic ulcer bleeding: Meta-analysis of randomized controlled trials.

Second-look endoscopy (SLE) to prevent recurrent bleeding in patients with peptic ulcer disease (PUD) and those undergoing endoscopic submucosal dissection (ESD) is routinely being performed. Conflicting evidence exists regarding efficacy, risk, benefit, and cost-effectiveness. To identify the role and effectiveness of SLE in ESD and PUD, associated rebleeding and PUD-related outcomes like mortality, hospital length of stay, need for endoscopic or surgical intervention and blood transfusions. A systematic review of literature databases PubMed, Cochrane, and Embase was conducted from inception to January 5, 2023. Randomized controlled trials that compared patients with SLE to those who did not have SLE or evaluated the role of prophylactic hemostasis during SLE compared to other conservative interventions were included. The study was conducted per PRISMA guidelines, and the protocol was registered in PROSPERO (ID CRD42023427555:). RevMan was used to perform meta-analysis, and Mantel-Haenszel Odds ratio (OR) were generated using random effect models. A total of twelve studies with 2687 patients were included in our systematic review and meta-analysis, of which 1074 patients underwent SLE after ESD and 1613 patients underwent SLE after PUD-related bleeding. In ESD, the rates of rebleeding were 7% in the SLE group compared to 4.4% in the non-SLE group with OR 1.65, 95% confidence intervals (CI) of 0.96 to 2.85; P = 0.07, whereas it was 11% in the SLE group compared to 13% in the non-SLE group with OR 0.8 95%CI: 0.50 to 1.29; P = 0.36. The mean difference in the blood transfusion rates in the SLE and no SLE group in PUD was OR 0.01, 95%CI: -0.22 to 0.25; P = 0.91. In SLE vs non-SLE groups with PUD, the OR for Endoscopic intervention was 0.29, 95%CI: 0.08 to 1.00; P = 0.05 while it was OR 2.03, 95%CI: 0.95 to 4.33; P = 0.07, for surgical intervention. The mean difference in the hospital length of stay was -3.57 d between the SLE and no SLE groups in PUD with 95%CI: -7.84 to 0.69; P = 0.10, denoting an average of approximately 3 fewer days of hospital stay among patients with PUD who underwent SLE. For mortality between SLE and non-SLE groups in PUD, the OR was 0.88, 95%CI: 0.45 to 1.72; P = 0.70. SLE does not confer any benefit in preventing ESD and PUD-associated rebleeding. SLE also does not provide any significant improvement in mortality, need for interventions, or blood transfusions in PUD patients. SLE decreases the hospital length of stay on average by 3.5 d in PUD patients.

Block-and-replace regimen versus titration of antithyroid drugs: a recent meta-analysis.

Drug therapy for Graves' disease (GD) is the first-line treatment in Europe. The use of a specific regimen for the administration of anti-thyroid drugs (ATDs) is still controversial. The objective was to compare block-and-replace therapy (BRT) with a titration (T) regimen in terms of incidence of overt hypothyroidism and development of Graves' orbitopathy (GO) over 18 months of treatment. Two databases (PubMed, Cochrane Library) and reference lists were searched. Prospective and retrospective observational cohort studies were included. Data collection and analysis were performed independently by 2 authors. Two studies with 716 GD patients (40.36% treated with BRT, 59.64% with T regimen) were included. No statistically significant differences were observed between the ATDs regimens used in terms of incidence of overt hypothyroidism during 18 months of treatment [Mantel-Haenszel (M-H) odds ratio (OR): 1.54, 95% confidence interval (CI): 0.75-3.16, p-value = 0.24]. GD patients who followed BRT were less likely to achieve control of thyroid function than patients on T regimen (M-H OR: 0.55, 95% CI: 0.34-0.88, p = 0.01). One study reported fewer thyroid function tests (TFT) during BRT than during the T regimen. The other study included patients without GO at baseline and reported a lower incidence of GO during BRT than in the T regimen (9.1% versus 17.8%), with no statistical difference between the 2 regimens (M-H OR: 0.47, 95% CI: 0.19-1.14, p = 0.10). BRT may be more useful than the T regimen for patients with complicated GD or for those who required fewer TFTs.

Associations between basic physiological observations recorded pre-thrombectomy and functional outcome: a systematic review and meta-analysis

IntroductionMechanical thrombectomy results in more favourable functional outcomes for patients with acute large vessel occlusion (LVO) stroke. Key clinical determinants of thrombectomy outcome include symptom severity, age and time from onset to treatment, but associations have also been reported with baseline physiological observations including systolic/diastolic blood pressure (SBP/DBP), blood/serum glucose, atrial fibrillation and conscious level. As these items are routinely available during initial emergency assessment, they might help to inform early prehospital and hospital triage decisions if evidence consistently shows associations with post-thrombectomy outcome. We undertook a meta-analysis of studies reporting pre-thrombectomy physiological observations and functional outcome.MethodPRISMA guidelines were followed to search electronic bibliographies, select articles and extract data. Medline, PubMed, Cochrane HTA, Cochrane Central and Embase were searched. Included articles were observational or interventional thrombectomy studies published between 01/08/2004-19/04/2023 reporting 3-month modified Rankin Scale, split as favourable (0–2) and unfavourable (3–6). A modified version of the Quality in Prognostic Studies (QUIPS) tool was used to assess risk of bias. RevMan 5 was used to calculate Inverse Variance with Weighted Mean Differences (WMD) and Mantel-Haenszel Odds Ratios (OR) for continuous and categorical factors respectively.ResultsThirty seven studies were eligible from 8,687 records. Significant associations were found between unfavourable outcome and higher blood/serum glucose as a continuous (WMD = 1.34 mmol/l (95%CI 0.97 to 1.72); 19 studies; n = 3122) and categorical (OR = 2.44 (95%CI 1.9 to 3.14) variable; 6 studies; n = 5481), higher SBP (WMD = 2.98 mmHg (95%CI 0.86 to 5.11); 16 studies; n = 4,400), atrial fibrillation (OR = 1.48 (95%CI 1.08 to 2.03); 3 studies; n = 736), and lower Glasgow Coma Scale (WMD = −2.72 (95%CI −4.01 to −1.44); 2 studies; n = 99). No association was found with DBP (WMD = 0.36 mmHg (95%CI −0.76 to 1.49); 13 studies; n = 3,614).ConclusionBasic physiological observations might assist early triage decisions for thrombectomy and could be used in combination with other information to avoid futile treatment and ambulance transfers. It is important to acknowledge that data were only from thrombectomy treated patients in hospital settings and it cannot be assumed that the predictors identified are independent or that modification can change outcome. Further work is needed to establish the optimal combination of prognostic factors for clinical care decisions.

Cardiovascular prevention with glucose-lowering drugs in type 2 diabetes: An evidence-based approach to the categories of primary and secondary prevention.

Whether to recommend specifically the glucose-lowering therapies with cardiovascular benefit only in secondary prevention, or also in patients with multiple risk factors (MRF) but without established atherosclerotic cardiovascular disease (ASCVD), is controversial across the guidelines for diabetes. We performed a meta-analysis of clinical trials with major adverse cardiovascular events (MACE) as an outcome. The definitions of ASCVD and MRF were heterogeneous across trials; nevertheless, the incidence of MACE was 2.8-fold higher in people with ASCVD in trials with sodium-glucose cotransporter 2 inhibitors (SGLT2is), and 3.9-fold in trials with glucagon-like peptide-1 receptor agonists (GLP-1 RA). Both SGLT2i and GLP-1 RA were associated with a significant reduction in the incidence of MACE in people with previous ASCVD [inverse variance-odds ratio 0.91, 95% confidence interval (0.86: 0.97) for SGLT2i, Mantel-Haenszel odds ratio 0.85, 95% confidence interval (0.81: 0.90) for GLP-1 RA], whereas no significant reduction was detected in those without; on the other hand, no significant difference in effect was found between the two groups as well. The sample of patients without ASCVD enrolled in clinical trials is insufficient to draw reliable conclusions in this population; however, even assuming the same benefit detected in people with ASCVD also in those with MRF, the number needed to treat would differ (35 for secondary, 99 for primary prevention of a MACE with a SGLT2i; 21 for secondary, 82 for primary prevention with a GLP-1 RA, respectively), given the difference in absolute cardiovascular risk at baseline. The distinction between patients with ASCVD and those without ASCVD and MRF appears therefore justified by available evidence.

Enteroviruses and risk of islet autoimmunity or type 1 diabetes: systematic review and meta-analysis of controlled observational studies detecting viral nucleic acids and proteins

Enteroviruses are routinely detected with molecular methods within large cohorts that are at risk of type 1 diabetes. We aimed to examine the association between enteroviruses and either islet autoimmunity or type 1 diabetes. For this systematic review and meta-analysis, we searched PubMed and Embase for controlled observational studies from inception until Jan 1, 2023. Cohort or case-control studies were eligible if enterovirus RNA or protein were detected in individuals with outcomes of islet autoimmunity or type 1 diabetes. Studies in pregnancy or other types of diabetes were excluded. Data extraction and appraisal involved author contact and deduplication, which was done independently by three reviewers. Study quality was assessed with the Newcastle-Ottawa Scale and National Health and Medical Research Council levels of evidence. Pooled and subgroup meta-analyses were done in RevMan version 5.4, with random effects models and Mantel-Haenszel odds ratios (ORs; 95% CIs). The study is registered with PROSPERO, CRD42021278863. The search returned 3266 publications, with 897 full texts screened. Following deduplication, 113 eligible records corresponded to 60 studies (40 type 1 diabetes; nine islet autoimmunity; 11 both), comprising 12077 participants (5981 cases; 6096 controls). Study design and quality varied, generating substantial statistical heterogeneity. Meta-analysis of 56 studies showed associations between enteroviruses and islet autoimmunity (OR 2·1, 95% CI 1·3-3·3; p=0·002; n=18; heterogeneity χ2/df 2·69; p=0·0004; I2=63%), type 1 diabetes (OR 8·0, 95% CI 4·9-13·0; p<0·0001; n=48; χ2/df 6·75; p<0·0001; I2=85%), or within 1 month of type 1 diabetes (OR 16·2, 95% CI 8·6-30·5; p<0·0001; n=28; χ2/df 3·25; p<0·0001; I2=69%). Detection of either multiple or consecutive enteroviruses was associated with islet autoimmunity (OR 2·0, 95% CI 1·0-4·0; p=0·050; n=8). Detection of Enterovirus B was associated with type 1 diabetes (OR 12·7, 95% CI 4·1-39·1; p<0·0001; n=15). These findings highlight the association between enteroviruses and islet autoimmunity or type 1 diabetes. Our data strengthen the rationale for vaccine development targeting diabetogenic enterovirus types, particularly those within Enterovirus B. Prospective studies of early life are needed to elucidate the role of enterovirus timing, type, and infection duration on the initiation of islet autoimmunity and the progression to type 1 diabetes. Environmental Determinants of Islet Autoimmunity, European Association for the Study of Diabetes, JDRF, Australian National Health and Medical Research Council, and University of New South Wales.

Use of abdominal compression device in colonoscopy: a systematic review and meta-analysis.

Colonoscopy for screening is associated with unpleasant experiences for patients, and abdominal compression devices have been developed to minimize these problems. However, there is a paucity of data supporting the therapeutic benefits of this strategy. This study examined the effects of using an abdominal compression device during colonoscopy on the cecal intubation time (CIT), abdominal compression, patient comfort, and postural changes. We searched PubMed and Scopus (from inception to November 2021) for randomized controlled trials that assessed the effects of an abdominal compression device during colonoscopy on CIT, abdominal compression, patient comfort, and postural change. A random-effects meta-analysis was performed. Weighted mean differences (WMDs) and Mantel-Haenszel odds ratios (ORs) were calculated. Our pooled analysis of seven randomized controlled trials revealed that abdominal compression devices significantly reduced CIT (WMD, -0.76 [-1.49 to -0.03] minutes; p=0.04), abdominal compression (OR, 0.52; 95% confidence interval [CI], 0.28-0.94; p=0.03), and postural changes (OR, 0.46; 95% CI, 0.27-0.78; p=0.004) during colonoscopy. However, our results did not show a significant change in patient comfort (WMD, -0.48; 95% CI, -1.05 to 0.08; p=0.09) when using an abdominal compression device. Our findings demonstrate that employing an abdominal compression device may reduce CIT, abdominal compression, and postural change but have no impact on patient comfort.

Pancreatitis and pancreatic cancer in patients with type 2 diabetes treated with glucagon-like peptide-1 receptor agonists: an updated meta-analysis of randomized controlled trials.

An association between glucagon-like peptide-1 receptor agonists (GLP1-RA) and risk of pancreatitis and pancreatic cancer has been suggested. Since its first description, several new trials (including three cardiovascular outcome trials) have been published, substantially increasing the available data set. This suggests the need for an update of the previous meta-analysis. A Medline search for GLP-1 receptor agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, or semaglutide) was performed, collecting all randomized clinical trials, with duration ≥52 weeks, enrolling patients with type 2 diabetes, and comparing a GLP-1 receptor agonist with placebo or any other non-GLP-1 receptor agonist drug. The endpoints were pancreatitis, pancreatic cancer reported as serious adverse events. Mantel-Haenszel Odds Ratio (MH-OR) with 95% confidence interval (95% CI) was calculated for all outcomes defined above, on an intention-to-treat basis. A total of 43 trials fulfilling inclusion criteria (all reporting data on pancreatitis and pancreatic cancer) was identified. GLP-1 RA showed no association with pancreatitis (MH-OR 1.24 [0.94, 1.64]; P=0.13) and pancreatic cancer (MH-OR 1.28 [0.87, 1.89]; P=0.20). No clear evidence of risk for pancreatitis was observed, whereas data on pancreatic cancer are too scarce to draw any conclusion.

Cost-Effectiveness of Dexamethasone Intravitreal Implant in Naïve and Previously Treated Patients with Diabetic Macular Edema

To compare the direct costs associated with the dexamethasone intravitreal implant (DEX-i) in treatment-naïve and previously treated eyes with diabetic macular edema (DME) in a real clinical setting. Retrospective and single-center study conducted in a real clinical scenario. Consecutive DME patients, either naïve or previously treated with vascular endothelial growth factor inhibitors (anti-VEGF), who received treatment with one or more DEX-i between May 2015 and December 2020, and who were followed-up for a minimum of 12 months, were included in the study. The cost analysis was performed from the perspective of the Andalusian Regional Healthcare Service. The primary effectiveness endpoint was the probability of achieving an improvement in best-corrected visual acuity (BCVA) ≥ 15 ETDRS letters after 1 year of treatment. The incremental cost-effectiveness ratio (ICER) of different improvements in BCVA was calculated. Forty-nine eyes, twenty-eight (57.1%) eyes from the treatment-naïve group and twenty-one (42.9%) from the previously treated group, were included in the analysis. The total cost of one year of treatment was significantly lower in the treatment-naïve eyes than in the previously treated eyes [Hodges-Lehmann median difference: EUR 819.1; 95% confidence interval (CI): EUR 786.9 to EUR 1572.8; p < 0.0001]. The probability of achieving a BCVA improvement of ≥15 letters at month 12 was significantly greater in the treatment-naïve group than in the previously treated group (rate difference: 0.321; 95% CI: 0.066 to 0.709; p = 0.0272). The Cochran-Mantel-Haenszel Odds Ratio of achieving a BCVA improvement of ≥15 letters at month 12 was 3.55 (95% CI: 1.09 to 11.58; p = 0.0309). In terms of ICER, the treatment-naïve group showed cost savings of EUR 7704.2 and EUR 5994.2 for achieving an improvement in BCVA ≥ 15 letters at month 12 and at any of the measured time points, respectively. DEX-i was found to be more cost-effective in treatment-naïve eyes than in those previously treated with anti-VEGF. Further studies are needed to determine the most cost-effective treatment based on patient profile.

Abstract P4-07-02: Toxicity profile of single agent trastuzumab deruxtecan in solid tumors: A meta-analysis

Abstract Background: Trastuzumab deruxtecan (T-DXd) has been evaluated in numerous solid tumors and has been approved for metastatic HER2-positive breast and gastric/gastroesophageal cancers. We aimed to provide a precise estimate of toxicity of T-DXd observed in clinical trials. Methods: A systematic literature search was performed in PubMed and supplemented by review of abstracts from ASCO and ESMO. Eligible studies were clinical trials (dose-expansion phase 1, phase 2, and phase 3) investigating single agent T-DXd. The search was performed in June 2022. For single-arm trials, meta-analysis comprised one-sample proportions to obtain the random effects estimates of toxicity and respective 95% confidence intervals (CI) for T-DXd, while for randomized trials, the Mantel-Haenszel odds ratio method was utilized. Results: Fifteen trials comprising 1566 participants were evaluable for toxicity. ECOG Performance Status (PS) was reported in 11 studies and was ≥ 2 in only a single patient. The median age at enrollment was reported for 13 studies and was 57.5 years. Seven trials comprising 1023 (65.3%) participants evaluated T-DXd for breast cancer. From available data, 1209/1440 (84%)of participants were female and 735/1551 (47%) were from East Asia. The median follow-up time was 11.1 months (13 studies) and median previous lines of treatment were 3 (12 studies). All-grade toxicity rate of ≥10% was reported for most toxicities; however, grade ≥3 toxicity rate of ≥10% was reported only for neutropenia and anemia; 17.4% (95%CI 12-22.8) and 14.8% (95%CI 8.6-21), respectively (Table 1). Interstitial lung disease/pneumonitis (ILD) was reported in 203 (12.4%) patients, including 160 (9.41%) grade 1-2, and 23 (1.1%) grade 3-4. Treatment-related death was reported in 20 (1%) patients, and all were due to grade 5 ILD. No significant difference in ILD was identified in subgroup analysis of trials conducted in east Asia vs. the rest of the world, breast vs. other solid tumors, 5.4mg/kg vs. other doses, median follow-up &amp;lt; 12 months vs. ≥12 months or median previous lines ≥3 vs. &amp;lt; 3. In the three randomized clinical trials, grade ≥3 toxicity was significantly higher for nausea (OR: 9.32, 95%CI: 2.53-34.32), ILD (OR: 5.35, 95%CI: 0.97, 29.48), fatigue (OR:2.5, 95%CI: 1.11-5.66), and anemia (OR:1.77 95%CI: 1.14-2.74). Conclusions: T-DXd was associated with infrequent grade ≥3 toxicities across clinical trials. Grade 1-2 ILD was more common; however, grade 3-4 ILD occurred in 1.1%. This may be related to active monitoring of this toxicity in clinical trials and discontinuation of treatment in participants with G2 ILD. There is lack of evidence for the safety of T-DXd in patients with ECOG PS ≥ 2. Citation Format: Faris Tamimi, Abhenil Mittal, Consolacion Molto Valiente, Massimo Di Iorio, Laith Al-Showbaki, Michelle Nadler, Eitan Amir. Toxicity profile of single agent trastuzumab deruxtecan in solid tumors: A meta-analysis [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-02.

Prevalence and clinical outcomes of COVID-19 in patients with pre-existing celiac disease: A systematic review and meta-analysis.

There is a scarcity of scientific evidence addressing the outcomes of COVID-19 in celiac disease (CD) patients. This systematic review and meta-analysis aimed to evaluate the correlation between pre-existing CD and COVID-19. A rigorous literature search was conducted using multiple databases. All eligible observational studies were included from around the globe. The random effect model calculated the pooled prevalence and associated 95% confidence intervals (CI). Mantel-Haenszel odds ratios were produced to report the overall effect size using random effect models for severity and mortality outcomes. Funnel plots, Egger regression tests, and Begg-Mazumdar's rank correlation test were used to appraise publication bias. Data from 11 articles consisting of 44,378 CD patients were obtained. Overall pooled random-effects estimate of SARS-CoV-2 infection in CD patients was 4.25% (95% CI, I2 =98%). Our findings also indicated that pre-existing CD was not associated with an increased risk of hospitalisation with COVID-19 illness (OR=1.04, 95% CI 0.87-1.24, I2 =0%) and mortality due to illness (OR=0.92, 95% CI 0.56-1.5, I2 =45%) compared with patients without pre-existing CD. No significant publication bias was evident in the meta-analysis. The preliminary data from our analysis suggest that SARS-CoV-2 infection in patients with pre-existing CD is not associated with an increased risk of hospitalisation or mortality. Additional studies are required to overcome the restrictions of the limited data available at present.

Impact of the COVID-19 pandemic on head and neck cancer patients: systematic review and meta-analysis.

This manuscript presents a systematic review of the impact of the COVID-19 pandemic on head and neck cancer (HNC) patients. A meta-analysis was made to compare the number of treated/operated HNC patients in pre-COVID-19 era (PCE) versus COVID-19 era (CE). This investigation is based on previous reports showing a delay in the diagnosis and treatment of new cases of cancer during the pandemic. Worsening in cancer prognosis would be expected as a result of the delayed treatments. An electronic search was conducted using the PubMed/MEDLINE, Embase, Web of Science, Scopus and The Cochrane Library databases. Relevant articles were selected based on specific inclusion criteria. A total of 8942 HNC patients were included. A higher prevalence in male (1873) in comparison to female (1695) was observed considering 3568 patients. Regarding staging, the majority of cases were stage III-IV. The treatment type more frequently described was surgery. Positive diagnosis for COVID-19 in the pre oncologic treatment was reported for 242 patients, and for post oncologic treatment in 119 patients. Mortality by COVID-19 was reported for 27 HNC patients. The meta-analysis revealed a significantly smaller number of surgeries/oncologic treatments of HNC patients performed (2666) in the CE when compared to PCE (3163) (M-H OR = 0.81, 95% CI = 0.65 to 1, P = 0.05). The impact of the COVID-19 pandemic on HNC patients occurred mainly in the number of surgeries/oncologic treatments, showing a significantly smaller number of surgeries/oncologic treatments performed in the CE rather than the PCE.

Factors Associated With Delirium in Children: A Systematic Review and Meta-Analysis.

Pediatric delirium (PD) is a neuropsychiatric syndrome caused by a complex interplay between predisposing factors (e.g., age, cognitive impairment), acute illness, and environmental triggers. PD is associated with substantial morbidity and mortality. The objective of this study is to systematically review and evaluate factors associated with PD in hospitalized pediatric patients. A systematic search of PubMed, Embase, Ovid Medline, Web- of-Science, Cochrane, CIHNAL, and Google Scholar databases was conducted for relevant studies (1990-2022). We included studies that compared pediatric patients with and without delirium. Reviews, editorials, congress abstracts, or studies that did not report factors for PD were excluded. No restrictions were imposed on language. Title and abstract were independently screened by two reviewers. Individual characteristics, study design, and outcomes were independently extracted. Categorical dichotomous data were summarized across groups using Mantel-Haenszel odds ratios (ORs) with 95% 95% CIs. Either fixed-effect or random effects models were used as indicated by the results of a heterogeneity test. Of 1,846 abstracts, 24 studies were included. We identified 54 factors studied in univariate analyses, and 27 of these were associated with PD in multivariable analyses. In pooled analyses, greater odds of PD were associated with developmental delay (OR 3.98; 95% CI 1.54-10.26), need for mechanical ventilation (OR 6.02; 95% CI 4.43-8.19), use of physical restraints (OR 4.67; 95% CI 1.82-11.96), and receipt of either benzodiazepines (OR 4.10; 95% CI 2.48-6.80), opiates (OR 2.88; 95% CI 1.89-4.37), steroids (OR 2.02; 95% CI 1.47-2.77), or vasoactive medication (OR 3.68; 95% CI 1.17-11.60). In this meta-analysis, we identified seven factors associated with greater odds of developing delirium during pediatric critical illness.

Vitamin D and preeclampsia: A systematic review and meta-analysis.

Preeclampsia is one of the most frequent pregnancy disorders, with a global incidence of 2%-8%. Serum 25-hydroxyvitamin D is an essential mineral for human health; some studies suggest link between 25-hydroxyvitamin D deficiency and preeclampsia, while others offer contradictory findings. Thus, the goal of this study is to evaluate the relationships between maternal 25- hydroxyvitamin D concentrations and the risk of preeclampsia. In addition to this, our study also evaluates the effects of 25- hydroxyvitamin D supplementation on the incidence of preeclampsia. Therefore, assessing 25- hydroxyvitamin D's potential as a possible intervention to lower the risk of preeclampsia. The Medline database was queried from inception until July 2021 for randomized controlled trials and observational studies without any restrictions. The studies assessing the association between 25-hydroxyvitamin D deficiency and preeclampsia and the impact of 25-hydroxyvitamin D supplementation on the incidence of preeclampsia were incorporated. The results were reported using a random-effects meta-analysis and the Mantel-Haenszel odds ratio. A p-value of <0.05 was considered significant for the analysis. This analysis includes 34 papers, including 10 randomized controlled trials and 24 observational studies. According to our pooled analysis, 25-hydroxyvitamin D supplementation was significantly associated with a lower risk of preeclampsia in pregnant women (OR: 0.50; 95% CI: 0.40-0.63; p = 0.00001), while 25-hydroxyvitamin D deficiency was significantly associated with an increased risk of preeclampsia (OR: 4.30; 95 % CI: 2.57-7.18; p < 0.00001, OR: 1.71; 95 % Cl: 1.27-2.32; p = 0.0005, OR 1.61; 95 % Cl: 1.21-2.16; p = 0.001). Results suggest that 25-hydroxyvitamin D has a significant relationship with preeclampsia as confirmed by the findings that low maternal 25-hydroxyvitamin D concentrations cause increased risk of preeclampsia while 25-hydroxyvitamin D supplementation reduces the incidence of preeclampsia. Our findings indicate that 25-hydroxyvitamin D supplementation can be used as a possible intervention strategy in preventing one of the most common causes of maternal mortality around the world, preeclampsia.

On Kernel-Based Estimator of Odds Ratio Using Different Stratified Sampling Schemes

The kernel-based estimator of Cochran Mantel-Haenszel odds ratio based on stratified simple and ranked set sampling is proposed. The expectation and variance of the estimator are analytically obtained. Using a simulation study, the estimator based on stratified ranked set sampling is more efficient than its counterpart based on stratified simple random sampling. Finally, the estimator's performance is investigated by using base deficit data.

318: NONALCOHOLIC FATTY LIVER DISEASE ASSOCIATION WITH HOSPITAL AND ICU ADMISSION IN COVID-19

Introduction: Association between non-alcoholic fatty liver disease (NAFLD) and metabolic-associated fatty liver disease (MAFLD) with COVID-19 is still an ongoing debate. We aimed to conduct a systematic review and meta-analysis investigating the impact of NAFLD/ MAFLD on the duration of ICU and hospital stay in COVID-19 patients. Methods: A systematic review of literature from January 2019- to June 2022 on databases PubMed, Cochrane, Embase, Science Direct, and Web of science was conducted. Observational studies or clinical trials were included. Studies that assessed NAFLD/ MAFLD using lab assessment, non-invasive imaging, or liver biopsy were included. The protocol of the study was registered in Prospero and Prisma guidelines were followed (Figure 1). The meta-analysis was performed using Revman software. Mantel-Haenszel odds ratio was generated to describe the overall effect size using random effect models. Results: ICU Admission A total of 37,109 patients from fifteen studies were included in the qualitative analysis. A total of 5624 patients were in the NAFLD group and 31,485 patients were in the Non-NAFLD group, where 3148 patients with COVID-19 required ICU admission. Out of these, 1098 (19.5%) were in the NAFLD group and 2050 (6.5%) in the Non-NAFLD group. We observed a significantly increased ICU admission among COVID-19 patients with NAFLD compared to those without NAFLD (OR 1.67, 95%CI 1.02-2.72, p-value= 0.04). (Figure 2). Hospital Admission A total of 27,683 patients from three studies were included in the qualitative analysis. A total of 1128 patients in the NAFLD group and 26,555 patients in the Non-NAFLD group, where 4019 patients with COVID-19 required hospital admission. Out of these, 518 (45.9%) were in the NAFLD group and 3501(13.1%) in the Non-NAFLD group. We observed a significant increase in hospital admissions among COVID-19 patients with NAFLD compared to those without NAFLD (OR 2.71, 95%CI 1.10-6.70, p-Value=0.03). Conclusions: The NAFLD patients may have increased ICU and hospital admission compared to Non-NAFLD Patients. Fatty liver disease has an association with increased healthcare admission and critical care service utilization among COVID-19 patients.

319: NONALCOHOLIC FATTY LIVER DISEASE ASSOCIATION WITH INTUBATION AND SEVERITY OF COVID-19

Introduction: Non-alcoholic fatty liver disease (NAFLD) and its hepatic manifestation, metabolic-associated fatty liver disease (MAFLD) have a rising prevalence worldwide in the background of the ongoing global pandemic. It is imperative to explore the relationship with COVID-19 to improve patient care and treatment protocols for better outcomes. This meta-analysis aims to investigate the association between NAFLD and MAFLD with the severity of COVID-19 infection and the need for mechanical ventilation. Methods: A systematic review of literature across 5 databases was conducted from January 2019 to June 2022. Observational studies or clinical trials were included. Studies that evaluated NAFLD/ MAFLD using laboratory methods, non-invasive imaging, or liver biopsy were included. The study protocol was registered in Prospero and Prisma guidelines were followed (Figure 1). Meta-analysis was performed on studies with mechanical ventilation and severity of COVID-19 infection outcomes using Revman software. The Mantel-Haenszel odds ratio was generated to describe the overall effect size using random effect models. Results: Mechanical Ventilation A total of 36,817 patients from twelve studies were included in the qualitative analysis. There were 5615 patients in the NAFLD group and 31,202 patients in the Non-NAFLD group. A total of 3148 patients with COVID-19 required mechanical ventilation; 778 (13.8%) in the NAFLD group and 782 (2.5%) in the Non-NAFLD group with high odds of need for mechanical ventilation (OR 2.03, 95%CI 1.06-3.88, p-value=0.03, I2=95%) (Figure 2). COVID-19 Severity A total of 5286 patients from fourteen studies were included in the qualitative analysis. 2716 patients were in the NAFLD group, while 2570 patients were in the Non-NAFLD group. A total of 1,623 patients had increased severity of COVID-19; 901 (33.1%) in the NAFLD group and 722 (28.9%) in the Non-NAFLD group. COVID-19 patients with NAFLD had worse COVID-19 infection outcomes compared to those without NAFLD (OR 1.59, 95%CI 1.12-2.26, p-value=0.01, I2=81%) (Figure 4). Conclusions: Our meta-analysis suggests that NAFLD patients had higher odds of needing mechanical ventilation or ICU admission and developing more severe forms of COVID-19 than Non-NAFLD patients.