The impact of mobile health applications on the outcomes of patients with chronic kidney disease: a systematic review and meta-analysis.

Chronic kidney disease is one of the main causes of mortality worldwide. It affects more than 800 million patients globally, accounting for approximately 10% of the general population. The significant burden of the disease prompts healthcare systems to implement adequate preventive and therapeutic measures. This systematic review and meta-analysis aimed to provide a concise summary of the findings published in the existing body of research about the influence that mobile health technology has on the outcomes of patients with the disease. A comprehensive systematic literature review was conducted from inception until March 1st, 2023. This systematic review and meta-analysis included all clinical trials that compared the efficacy of mobile app-based educational programs to that of more conventional educational treatment for the patients. Eleven papers were included in the current analysis, representing 759 CKD patients. 381 patients were randomly assigned to use the mobile apps, while 378 individuals were assigned to the control group. The mean systolic blood pressure was considerably lower in the mobile app group (MD -4.86; 95%-9.60, -0.13; p=0.04). Meanwhile, the mean level of satisfaction among patients who used the mobile app was considerably greater (MD 0.75; 95% CI 0.03, 1.46; p=0.04). Additionally, the mean self-management scores in the mobile app groups were significantly higher (SMD 0.534; 95% CI 0.201, 0.867; p=0.002). Mobile health applications are potentially valuable interventions for patients. This technology improved the self-management of the disease, reducing the mean levels of systolic blood pressure with a high degree of patient satisfaction.

Impact of Complete or Incomplete Revascularization for Left Main Coronary Disease: The Extended PRECOMBAT Study.

Background: Whether complete revascularization (CR) or incomplete revascularization (IR) may affect long-term outcomes after PCI) and coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease is unclear. Objectives: The authors sought to assess the impact of CR or IR on 10-year outcomes after PCI or CABG for LMCA disease. Methods: In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) 10-year extended study, the authors evaluated the effect of PCI and CABG on long-term outcomes according to completeness of revascularization. The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (MACCE) (composite of mortality from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization). Results: Among 600 randomized patients (PCI, n = 300 and CABG, n = 300), 416 patients (69.3%) had CR and 184 (30.7%) had IR; 68.3% of PCI patients and 70.3% of CABG patients underwent CR, respectively. The 10-year MACCE rates were not significantly different between PCI and CABG among patients with CR (27.8% vs 25.1%, respectively; adjusted HR: 1.19; 95% CI: 0.81-1.73) and among those with IR (31.6% vs 21.3%, respectively; adjusted HR: 1.64; 95% CI: 0.92-2.92) (P for interaction = 0.35). There was also no significant interaction between the status of CR and the relative effect of PCI and CABG on all-cause mortality, serious composite of death, myocardial infarction, or stroke, and repeat revascularization. Conclusions: In this 10-year follow-up of PRECOMBAT, the authors found no significant difference between PCI and CABG in the rates of MACCE and all-cause mortality according to CR or IR status. (Ten-Year Outcomes of PRE-COMBAT Trial [PRECOMBAT], NCT03871127; PREmier of Randomized COMparison of Bypass Surgery Versus AngioplasTy Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT], NCT00422968).

The efficacy of flexor tenotomy to prevent recurrent diabetic foot ulcers (DIAFLEX trial): Study protocol for a randomized controlled trial.

Foot ulcers are a frequent and costly problem in people with diabetes mellitus and can lead to amputations. Prevention of these ulcers is therefore of paramount importance. Claw/hammer toe deformities are commonly seen in people with diabetes. These deformities increase the risk of ulcer development specifically at the (tip of) the toe. Percutaneous needle tenotomy of the tendon of the m. flexor digitorum longus (tendon tenotomy) can be used to reduce the severity of claw/hammer toe deformity with the goal to prevent ulcer recurrence. The main objective of this randomized controlled trial is to assess the efficacy of flexor tenotomy to prevent recurrence of toe ulcers in people with diabetes and a history of toe (pre-)ulcers. Additionally, we aim to assess interphalangeal joints (IPJ) and metatarsophalangeal joint (MTPJ) angles in a weight-bearing and non-weight-bearing position, barefoot plantar pressure during walking, cost-effectiveness and quality of life before and after the intervention and compare intervention and control study groups. Sixty-six subjects with diabetes and claw/hammer toe deformity and a recent history of (pre-)ulceration on the tip of the toe will be included and randomized between flexor tenotomy of claw/hammer toes (intervention) versus standard of care including orthosis and shoe offloading (controls) in a mono-center randomized controlled trial. Clinicaltrialsgov registration: NCT05228340.

The cholesterol-lowering effect of statins is modified by LILRB5 intolerance genotype: Results from a recruit-by-genotype clinical trial.

Background/Aims: Statin intolerance leads to poor adherence to statin therapy, resulting in a failure to achieve desired cholesterol reduction and adverse outcomes. The LILRB5 Asp247Gly genotype has been identified as being associated with statin intolerance and statin-induced myalgia. We conducted a randomized clinical trial to examine its role in immune response through T regulatory cell aggregation and in achieving cholesterol reduction targets. Methods: A double-blind, cross-over, recruit-by-genotype trial was undertaken. A total of 18 participants who had either the Asp247Asp (T/T) genotype or the Gly247Gly (C/C) genotype were recruited to the study. Participants were randomised to receive placebo or atorvastatin 80 mg daily for 28 days. Following a washout period of 3 weeks, they were then switched to the opposite treatment. Biochemical and immunological measurements as well as interviews were performed prior to and after both treatment periods. Within genotype group comparisons were performed using repeated measures Wilcoxon tests. Two-way repeated measures ANOVA with genotype and treatment as factors were used to compare changes in biochemical parameters between groups during placebo and atorvastatin periods. Results: Individuals with the Asp247Asp genotype had a greater increase in creatine kinase (CK) compared to those with Gly247Gly genotype in response to atorvastatin (p = 0.03). Those with Gly247Gly genotype had a mean non-HDL cholesterol reduction of 2.44 (95% CI:1.59 - 3.29) mmol/L while in Asp247Asp genotype group the mean reduction was 1.28 (95%CI: 0.48 - 2.07) mmol/L. The interaction between the genotype and atorvastatin treatment for total cholesterol (p = 0.007) and non-HDL cholesterol response was significant (p = 0.025). Immunological assessment showed no significant changes in aggregation of T regulatory cells by genotype. Conclusion: The Asp247Gly variant in LILRB5, previously associated with statin intolerance, was associated with differential increases in creatine kinase and total cholesterol and non-HDL cholesterol-lowering response to atorvastatin. Taken together, these results suggest that this variant could have utility in precision cardiovascular therapy.

Effect of exercise on renal function in diabetic nephropathy-a systematic review and meta-analysis.

Diabetic nephropathy causes cardiovascular complications among individuals with diabetes which results in decreased kidney function and overall physical decline. The objective of this systematic review was to determine effects of exercise on various renal function parameters amond individuals with type 2 diabetes and nephropathy. It was registered with PROSPERO (CRD42020198754). Total 6 databases (PubMed/Medline, Scopus, Web of Science, CINAHL, ProQuest, and Cochrane) were searched. Among 1734 records, only four randomized controlled trials were included. The review included a total of 203 participants (103 in the intervention group and 100 in the control/standard group) with type 2 diabetic nephropathy or stage 2,3, or 4 of chronic kidney disease. The meta-analysis showed no effects of exercise on serum creatinine, serum cystatin c and varied eGFR equations. However, exercise decreased urinary albumin to creatinine ratio, urinary protein to creatinine ratio, serum urea nitrogen, creatinine clearance, and urinary protein excretion while increasing urea clearance. Limited evidence on the reno-protective role of exercise demands future research in this direction.

Emerging Pharmacotherapies in Alcohol-Associated Hepatitis.

The incidence of alcoholic-associated hepatitis (AH) is increasing. The treatment options for severe AH (sAH) are scarce and limited to corticosteroid therapy which showed limited mortality benefit in short-term use only. Therefore, there is a dire need for developing safe and effective therapies for patients with sAH and to improve their high mortality rates.This review article focuses on the current novel therapeutics targeting various mechanisms in the pathogenesis of alcohol-related hepatitis. Anti-inflammatory agents such as IL-1 inhibitor, Pan-caspase inhibitor, Apoptosis signal-regulating kinase-1, and CCL2 inhibitors are under investigation. Other group of agents include gut-liver axis modulators, hepatic regeneration, antioxidants, and Epigenic modulators. We describe the ongoing clinical trials of some of the new agents for alcohol-related hepatitis. Conclusion: A combination of therapies was investigated, possibly providing a synergistic effect of drugs with different mechanisms. Multiple clinical trials of novel therapies in AH remain ongoing. Their result could potentially make a difference in the clinical course of the disease. DUR-928 and granulocyte colony-stimulating factor had promising results and further trials are ongoing to evaluate their efficacy in the large patient sample.

Long-term results of carbidopa/levodopa enteral suspension across the day in advanced Parkinson's disease: Post-hoc analyses from a large 54-week trial.

Introduction: Carbidopa/levodopa enteral suspension (CLES) previously demonstrated reduction in total daily OFF from baseline by over 4 hours in advanced Parkinson's disease patients across 54 weeks. Evidence on CLES's long-term effectiveness on patterns of motor-symptom control throughout the day remains limited. Methods: We present post-hoc analyses of a large, open-label study of CLES monotherapy (N = 289). Diary data recorded patients' motor states at 30-minute intervals over 3 days at baseline and weeks 4, 12, 24, 36, and 54. Adjusted generalized linear mixed models assessed changes from baseline at each timepoint for four outcome measures: time to ON without troublesome dyskinesia (ON-woTD) after waking, motor-symptom control as measured by motor states' durations throughout the day, number of motor-state transitions, and presence of extreme fluctuations (OFF to ON with TD). Results: Patients demonstrated short-term (wk4) and sustained (wk54) improvement in all outcomes compared to baseline. At weeks 4 and 54, patients were more likely to reach ON-woTD over the course of their day (HR: 1.86 and 2.51, both P < 0.0001). Across 4-hour intervals throughout the day, patients also experienced increases in ON-woTD (wk4: 58-65 min; wk54: 60-78 min; all P < 0.0001) and reductions in OFF (wk4: 50-61 min; wk54: 56-68 min; all P < 0.0001). At weeks 4 and 54, patients' motor-state transitions were reduced by about half (IRR: 0.53 and 0.49, both P < 0.0001), and fewer patients experienced extreme fluctuations (OR: 0.22 and 0.15, both P < 0.0001). Conclusion: CLES monotherapy was associated with significant long-term reductions in motor-state fluctuations, faster time to ON-woTD upon awakening, and increased symptom control throughout the day.

PPAR agonists for the treatment of primary biliary cholangitis: Old and new tales.

Introduction: Primary biliary cholangitis (PBC) is an autoimmune liver disease involving the small intrahepatic bile ducts; when untreated or undertreated, it may evolve to liver fibrosis and cirrhosis. Ursodeoxycholic Acid (UDCA) is the standard of care treatment, Obeticholic Acid (OCA) has been approved as second-line therapy for those non responder or intolerant to UDCA. However, due to moderate rate of UDCA-non responders and to warnings recently issued against OCA use in patients with cirrhosis, further therapies are needed.Areas covered. Deep investigations into the pathogenesis of PBC is leading to proposal of new therapeutic agents, among which peroxisome proliferator-activated receptor (PPAR) ligands seem to be highly promising given the preliminary, positive results in Phase 2 and 3 trials. Bezafibrate, the most evaluated, is currently used in clinical practice in combination with UDCA in referral centers. We herein describe completed and ongoing trials involving PPAR agonists use in PBC, analyzing pits and falls. Expert opinion: Testing new therapeutic opportunities in PBC is challenging due to its low prevalence and slow progression. However, new drugs including PPAR agonists, are currently under investigation and should be considered for at-risk PBC patients.

Real-world comparison of in-hospital complications after catheter ablation for atrial fibrillation between non-antivitamin K anticoagulants and warfarin: A propensity-matched analysis using nation-wide database.

Background: Few large-scale, real-world studies have compared the efficacy and safety of non-antivitamin K anticoagulants (NOACs) with that of warfarin in catheter ablation (CA) for atrial fibrillation (AF). Methods: This retrospective, cross-sectional study used a nationwide administrative claims database, to compare complication-incidence rates following CA for AF between NOAC-treated patients and warfarin-treated matched cohorts in the real-world. Among the 32,797,540 records between June 2011 and August 2020 from 426 hospitals, 41,347 patients (38,065 on NOACs and 3,282 on Warfarin) were considered eligible. After performing propensity matching, 6,564 patients (3,282 per group) were analyzed. Results: The overall complication incidence was significantly lower in the NOACs group than in the warfarin group (2.3 % vs. 4.0 %; P < 0.001, odds ratio [OR]: 0.55, 95 % confidence interval [CI]: 0.41-0.74). Although no significant differences in the incidence of cardiac tamponade (1.0 % vs. 1.1 %; P = 0.90, OR: 0.97, 95 % CI: 0.60-1.56) and major bleeding (0.6 % vs. 0.7 %; P = 0.54, OR: 0.83, 95 % CI: 0.44-1.52) were noted, blood transfusion requirements (0.6 % vs. 1.2 %; P = 0.02, OR: 0.52, 95 % CI: 0.30-0.88) and vascular complications (0.2 % vs. 0.5 %; P = 0.02, OR: 0.33, 95 % CI: 0.12-0.79) were significantly lower in the NOACs group than in the warfarin group. Furthermore, the thromboembolic event incidence was significantly lower in the NOACs group than in the warfarin group (0.5 % vs. 1.2 %; P < 0.001, OR: 0.36, 95 % CI: 0.19-0.64). Conclusions: NOACs should be considered as a first-line therapy for periprocedural anticoagulation in patients undergoing CA for AF.

Local Field Potentials in Deep Brain Stimulation: Investigation of the Most Cited Articles.

Objective: Deep brain stimulation (DBS) allows for direct electrical stimulation of neural circuitry and recording of local field potentials (LFPs). A bibliometric analysis can be implemented to identify studies that have shaped a research field and influenced future study; however, no such analysis investigating the implementation of LFPs in DBS has been performed. The objective of the present study was to identify the most highly cited articles pertaining to DBS LFPs to identify and evaluate the research that has contributed the most to this growing field. Methods: The Science Citation Index of the Web of Science was implemented to identify the top 84 most cited articles pertaining to DBS LFPs. Information regarding the publication, including author information and study aims, was extracted. Results: The most highly cited articles had had a mean of 109 citations and had been published between 2002 and 2019, with a mode in 2016. The articles had predominantly investigated the subthalamic nucleus (68% of clinical studies) in humans (83.8% of clinical studies). The studies of humans had recruited a mean of 12.5 subjects. Most of the identified articles (56.0%) had reported class III clinical evidence. Conclusions: The implementation of DBS LFPs is a novel field that is rapidly growing. However, a need exists for more studies with larger patient cohorts and more randomized controlled trials to further elucidate the benefits of this technology. These results will allow for the identification and recognition of the most influential studies pertaining to DBS LFPs, appreciation of the current and future research trends, and inform us regarding areas warranting further investigation.

Feasibility of the SOAR (Stop OsteoARthritis) program.

Objective: Assess the feasibility of a virtually-delivered, physiotherapist-guided knee health program (SOAR) that targets self-management of knee health and osteoarthritis risk after an activity-related knee injury. Design: In this quasi-experimental feasibility study, individuals with varied lived experience of knee trauma completed a 4-week SOAR program. This included: 1) Knee Camp (group education, 1:1 exercise and activity goal-setting); 2) weekly home-based exercise and activity program with tracking, and; 3) weekly 1:1 physiotherapy-guided action-planning. SOAR program feasibility was assessed with implementation (attrition, adherence, intervention fidelity), practicality (adverse events, goal completion), acceptability and efficacy (change in Knee injury and Osteoarthritis Outcome Score subscales, Patient Specific Functional Scale (PSFS), Godin Leisure-Time Exercise Questionnaire (GLTEQ), Partner in Health Scale (PHS)) outcomes. Descriptive statistics, disaggregated by gender, were calculated. Results: Thirty participants (60% women, median (min-max) age 30 years (19-50), time from injury 5.6 years (1.2-25.2)) were enrolled. No participant attrition or adverse events were reported, and 90% of mandatory program components were completed. Participants rated their adherence at 80%, and 96% of exercise-therapy and 95% of activity goals were fully or partially achieved. Both women and men reported significant group mean (95%CI) improvements in GLTEQ scores (women: 22 METS (6,37), men: 31 METS (8,54)), while women alone reported improvements in PHS (-7 (-11,-3) and PSFS (1.7 (0.6,2.8) scores. Conclusion: The SOAR program is feasible for persons at various timepoints post-knee trauma, and gender may be an important consideration for SOAR implementation and assessment. A randomized controlled trial to assess intervention efficacy is warranted.

Prognosis and Medical Cost of Measuring Fractional Flow Reserve in Percutaneous Coronary Intervention.

Background: There are limited data regarding comparative prognosis and medical cost between fractional flow reserve (FFR)-based and angiography-based percutaneous coronary intervention (PCI) among revascularized patients. Objectives: This study evaluates prognosis and medical cost of FFR use in revascularized patients by PCI. Methods: Using the National Health Insurance Service database, stable or unstable angina patients who underwent PCI from 2011 to 2017 were evaluated. Eligible patients were divided into 2 groups according to use of FFR in PCI. Primary outcome was a composite of all-cause death or spontaneous myocardial infarction (MI). Secondary outcomes included individual components of the primary outcome, unplanned revascularization, and medical costs. Results: Among 134,613 eligible patients, PCI was performed based on angiography (n = 129,497) and FFR (n = 5,116). During the study period, both the annual number and proportion of use of FFR in PCI increased (all P for trend <0.001). The FFR group showed significantly lower risk of the primary outcome (7.0% vs 9.5%; P < 0.001), all-cause death (5.8% vs 7.7%; P = 0.001), and spontaneous MI (1.6% vs 2.2%; P = 0.022) than the angiography group. Although the FFR group showed higher medical cost during index admission than angiography group (median: $6,265.10 vs $5,385.60; P < 0.001), cumulative medical cost after index admission was significantly lower ($2,696.50 vs. $3,142.10; P < 0.001). Conclusions: Use of FFR in PCI in stable or unstable angina patients showed significantly lower risk of all-cause death and spontaneous MI compared to angiography-based PCI. Although the FFR group had higher initial medical cost than the angiography group, cumulative medical cost after index admission was significantly lower.

Antithrombotic Therapy After Acute Coronary Syndromes or Percutaneous Coronary Interventions in East Asian Populations.

Because guidelines and recommendations in response to multiple randomized clinical trials (RCTs) of new therapies undergo rapid changes, antithrombotic therapies for patients after acute coronary syndrome, or percutaneous coronary intervention, are becoming more complex in daily clinical practice. The proportion of Asian populations enrolled in landmark RCTs is substantially low, which limits the direct application of trial findings into clinical practice in Asian countries. Moreover, compared with Caucasian patients, East Asian patients are considered to have a different ischemia/bleeding propensity in response to antithrombotic therapy, known as the "East Asian paradox" (ie, more bleeding events but fewer thromboembolic events). Coincident with consecutive RCTs in Western populations to optimize antithrombotic strategies, several such studies have now been conducted in East Asian cohorts. Herein, we provide a comprehensive summary of the key RCTs in this regard and propose future directions and perspectives for optimal antithrombotic therapies in East Asian patients.

Prognostic Value of Sex After Revascularization for Left Main Coronary Disease: Extended PRECOMBAT Study.

Background: Female subjects have poorer outcomes in left main coronary artery (LMCA) disease compared with male subjects. However, limited information is available on the long-term prognostic impact of sex and sex-treatment interactions in patients with LMCA disease undergoing coronary revascularization. Objectives: The goal of this study was to investigate the long-term effects of sex and related differential outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in LMCA disease. Methods: The extended PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) trial evaluated the >10-year clinical outcomes in patients with LMCA disease randomized to undergo PCI with drug-eluting stents (n = 300) or CABG (n = 300). The primary outcome was major adverse cardiac or cerebrovascular events (MACCE) (composite of death, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) at 10 years. Results: Of the 600 patients, 459 (76.5%) were male. The 10-year rates of MACCE were similar between male and female subjects in the overall cohort (27.3% vs 27.0%; adjusted hazard ratio [aHR]: 1.06; 95% confidence interval [CI]: 0.70-1.59), the PCI arm (30.6% vs 27.1%; aHR: 1.19; 95% CI: 0.69-2.05), and the CABG arm (24.0% vs 26.9%; aHR: 0.93; 95% CI: 0.53-1.62). The 10-year risks for MACCE did not significantly differ between PCI and CABG in both male (aHR: 1.37; 95% CI: 0.95-1.97) and female (aHR: 1.07; 95% CI: 0.56-2.07) subjects. There was no significant sex-treatment interaction regarding the adjusted risk of MACCE at 10 years (P for interaction = 0.52). Conclusions: In this 10-year follow-up of the PRECOMBAT trial, there was no sex-related impact on the long-term risk of MACCE after PCI and CABG for LMCA disease. (Ten-Year Outcomes of PRECOMBAT Trial; NCT03871127).

Ticagrelor Versus Clopidogrel in East Asian Patients With Acute Coronary Syndrome and Diabetes Mellitus.

Background: It is still unknown whether diabetes mellitus (DM) affects the relative safety and efficacy of ticagrelor vs clopidogrel in East Asian patients with acute coronary syndrome (ACS). Objectives: The authors sought to assess the safety and efficacy of ticagrelor vs clopidogrel according to the diabetic status of East Asian patients with ACS undergoing invasive management. Methods: This prespecified analysis of the TICA KOREA (Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management) trial included 800 Korean patients. The primary safety endpoint was clinically significant bleeding (PLATO [Platelet Inhibition and Clinical Outcomes] major or minor bleeding) at 12 months; the efficacy endpoint was major adverse cardiovascular events (cardiovascular death, myocardial infarction, and stroke). Results: Of 800 patients, 216 (27.0%) had DM. The incidence of clinically significant bleeding within 12 months was significantly higher with ticagrelor than clopidogrel in the nondiabetic group (10.2% vs 4.3%; HR: 2.45; 95% CI: 1.27-4.70; P = 0.007) and tended to be higher in the diabetic group (13.8% vs 8.0%; HR: 1.87; 95% CI: 0.54-4.36; P = 0.15); there was no significant interaction between treatment-arm and DM (P for interaction = 0.64). The incidences of major adverse cardiovascular events were not significantly different after ticagrelor or clopidogrel both in the diabetic group (10.8% vs 6.0%; HR: 1.90; 95% CI: 0.71-5.07; P = 0.20) and in the nondiabetic group (8.5% vs 5.7%; HR: 1.51; 95% CI: 0.81-2.81; P = 0.19) without significant interaction (P-for-interaction = 0.71). Conclusions: In Korean ACS patients undergoing early invasive management, diabetes status did not affect the relative safety and efficacy of ticagrelor and clopidogrel. (Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/Korean Patients With Acute Coronary Syndromes Intended for Invasive Management [TICA KOREA]; NCT02094963).

Continuous positive airway pressure for term and ≥34+0 weeks' gestation newborns at birth: A systematic review.

Background: Respiratory distress is common during transition after birth, but the effect of continuous positive airway pressure applied in the delivery room has not been systematically evaluated in spontaneously breathing term and ≥34+0 weeks' gestation infants.We aimed to compare delivery room continuous positive airway pressure with no delivery room continuous positive airway pressure for term and ≥34+0 weeks' gestation newborn infants at birth. Methods: Information sources: Medline, Embase, Cochrane Databases, Database of Abstracts of Reviews of Effects, and Cumulative Index to Nursing and Allied Health Literature. The Databases were last searched in October 2021.Eligibility criteria: Randomized, quasi-randomized, interrupted time series, controlled before-after, and cohort studies with English abstracts.Synthesis of results: Two authors independently extracted data, assessed risk of bias, and certainty of evidence. The main outcome was admission to the neonatal intensive care unit (NICU) or higher level of care receiving any positive pressure support. Data were pooled using fixed effects models.Risk of bias: Was assessed using the Cochrane Risk of Bias Tool for randomized trials and the Non-Randomized Studies of Interventions Tool (ROBINS-I) for observational studies. Results: In this meta-analysis, two randomized control trials (323 newborns delivered by cesarean section) showed that delivery room continuous positive airway pressure decreased the likelihood of NICU admission (risk ratio (RR) 95% confidence interval (CI) 0.27 (0.11-0.66), p < 0.005) and NICU respiratory support (RR (95% CI) 0.18 (0.05-0.60), p = 0.005) when compared with no delivery room continuous positive airway pressure. However, in two before-after studies (8,476 newborns), delivery room continuous positive airway pressure use was associated with an increased risk of air leak syndrome when compared with no delivery room continuous positive airway pressure. Discussion: Certainty of evidence was very low for all outcomes. Among term and ≥34+0 weeks' gestation infants having or at risk of having respiratory distress, there is insufficient evidence to suggest for or against routine use of continuous positive airway pressure in the delivery room.Funding: No Funding has been received to conduct this study.Clinical Trial Registration: This systematic review has been registered with the International Prospective Register of Systematic Reviews (http://www.crd.york.ac.uk/prospero/) [identifier: CRD42021225812].

Modifiers of the Risk of Diabetes for Long-Term Outcomes After Coronary Revascularization: CREDO-Kyoto PCI/CABG Registry.

Background: Diabetes is a well-known risk factor for adverse outcomes after coronary revascularization. Objectives: This study sought to determine high-risk subgroups in whom the excess risks of diabetes relative to nondiabetes are particularly prominent and thus may benefit from more aggressive interventions. Methods: The study population consisted of 39,427 patients (diabetes: n = 15,561; nondiabetes: n = 23,866) who underwent first percutaneous coronary intervention (n = 33,144) or coronary artery bypass graft (n = 6,283) in the pooled CREDO-Kyoto PCI/CABG (Coronary Revascularization Demonstrating Outcome Study in Kyoto Percutaneous Coronary Intervention/Coronary Artery Bypass Graft) registry. The primary outcome measure was major adverse cardiovascular and cerebral endpoints (MACCE), which was defined as a composite of all-cause death, myocardial infarction, and stroke. Results: With median follow-up of 5.6 years, diabetes was associated with significantly higher adjusted risks for MACCE. The excess adjusted risks of diabetes relative to nondiabetes for MACCE increased with younger age (≤64 years: adjusted HR: 1.30; 95% CI: 1.19-1.41; P < 0.001; 64-73 years: adjusted HR: 1.24; 95% CI: 1.16-1.33; P < 0.001; >73 years: adjusted HR: 1.17; 95% CI: 1.10-1.23; P < 0.001; P interaction < 0.001), mainly driven by greater excess adjusted mortality risk of diabetes relative to nondiabetes in younger tertile. No significant interaction was observed between adjusted risk of diabetes relative to nondiabetes for MACCE and other subgroups such as sex, mode of revascularization, and clinical presentation of acute myocardial infarction. Conclusions: The excess risk of diabetes relative to nondiabetes for MACCE was profound in the younger population. This observation suggests more aggressive interventions for secondary prevention in patients with diabetes might be particularly relevant in younger patients.

Associations of serum 25-hydroxyvitamin D and subjective sleep measures in an arctic population: Insights from the population-based Tromsø Study.

Objective: To investigate the relation between serum 25-hydroxyvitamin D (s-25(OH)D) and subjective sleep measures in an Arctic population (69°N). Methods: Cross-sectional data was collected from 21,083 individuals (aged ≥40 years) participating in the population based Tromsø Study: Tromsø7 (2015-2016). The present study included 20,438 participants, after having excluded respondents missing data on s-25(OH)D (n = 161) and/or subjective sleep measures (including sleep duration, insomnia, and daytime sleepiness)(n = 490). Based on s-25(OH)D (assessed using LC-MS/MS), participants were grouped as deficient (<30 nmol/L), insufficient (30-49.9 nmol/L), sufficient (50-75 nmol/L), or high (>75 nmol/L). Sleep duration was grouped as inadequate (ISD) if < 7 or ≥9 h. Linear and logistic regression were used to calculate unstandardized ß-values and odds ratios [95% confidence intervals]. The analyses were adjusted for season, age, BMI, lifestyle factors and relevant comorbidities. Results: In both men and women, s-25(OH)D was positively associated with sleep duration, and compared to the sufficient s-25(OH)D group, the insufficient s-25(OH)D group reported significantly shorter sleep duration in both sexes. There was an increased odds of ISD in both men and women but adjusted for confounding factors this was only significant in women (1.16 [1.03, 1.32], p = .017). In men, there were no significant associations between s-25(OH)D and the remaining sleep measures. Women in the high s-25(OH)D group had lower ESS-scores (-0.28 [-0.47, -0.08], p = .006), but higher odds of insomnia (1.16 [1.01, 1.33], p = .036) compared to women in the sufficient group. Conclusions: In this Arctic population, a tenuous association was found between s-25(OH)D and subjective sleep measures, predominantly in women.

Stereotactic radiotherapy or metastasectomy for oligometastatic esophagogastric cancer: A nationwide population-based cohort study.

Background and purpose: This nationwide population-based study analyzed the outcomes of local treatment (i.e. stereotactic body radiotherapy [SBRT] or metastasectomy) or systemic therapy for oligometastatic disease (OMD) in patients with esophagogastric cancer in The Netherlands. Materials and methods: Between 2015 and 2016, all patients in The Netherlands with esophagogastric cancer and synchronous or metachronous OMD were eligible for inclusion. Patients who underwent local treatment of OMD (SBRT or metastasectomy) and/or systemic therapy were included. OMD was defined as distant metastases in 1 organ or 1 extra-regional lymph node region. The primary outcomes were overall survival (OS) and independent prognostic factors for OS. OS was calculated from diagnosis of OMD. Prognostic factors for OS were analyzed using a multivariable Cox proportional hazard model. Results: A total of 594 patients were included, of whom 83 underwent local treatment for OMD alone, 22 local treatment plus systemic therapy, and 489 systemic therapy alone. Median OS after local treatment for OMD alone was 16.0 months, local treatment plus systemic therapy 22.7 months, and after systemic therapy alone 8.5 months. Improved OS was independently associated with local treatment for OMD alone or combined with systemic therapy as compared with systemic therapy alone (hazard ratio [HR] 0.52, 95% CI: 0.31-0.90 and HR 0.42, 95% CI: 0.22-0.82, respectively) and a controlled primary tumor(HR 0.48, 95% CI: 0.27-0.86). Worse OS was independently associated with worse performance scores (HR 1.41, 95%: 1.32-1.75), poorly or undiffertumor as compared with good or moderadifferentiated tumor (HR 1.37, 95% CI: 1.06-1.76), and peritoneal as compared with lymph mode metastases (HR 1.39, 95% CI: 1.00-1.93). Conclusion: Local treatment of OMD alone or combined with systemic therapy was independently associated with improved OS as compared with systemic therapy alone in this population-based cohort study in The Netherlands. Randomized controlled trials are warranted to confirm these results.

Corticosteroid use with extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest: A nationwide observational study.

Aim: Several studies have reported that corticosteroid administration for cardiac arrest patients may improve outcomes. However, these previous studies have not examined the effect of corticosteroid use in out-of-hospital cardiac arrest (OHCA) patients administered extracorporeal cardiopulmonary resuscitation (ECPR). Therefore, we aimed to examine the effectiveness of corticosteroids in OHCA patients administered ECPR. Methods: Using the Japanese Diagnosis Procedure Combination inpatient database, we included OHCA patients who were administered ECPR on the day of admission between July 2010 and March 2019. The patients were categorized into the corticosteroid and control groups according to whether they received corticosteroids on the day of admission or not. The primary outcome was in-hospital mortality and the secondary outcomes included percentages of neurologically favorable survival, major bleeding complications, and infection-related complications. We compared the outcomes using a propensity score matching analysis. Results: We identified 6,142 eligible patients (459 vs 5,683, the corticosteroid and control group, respectively). One-to-four propensity score matching analysis (457 vs 1,827) showed in-hospital mortality was significantly higher in the corticosteroid group compared with the control group (82.1% vs 76.6%; risk difference, 5.5%; 95% CI, 1.5 to 9.5%). Neurologically favorable outcomes did not differ between the two groups (13.6% vs 16.9%; risk difference, -3.3%; 95% CI, -6.9 to 0.3%). The percentage of major bleeding complications and infection-related complications did not significantly differ between the two groups. Conclusions: The results of this study demonstrated that administration of corticosteroids on the day of admission to OHCA patients administered ECPR was associated with increased in-hospital mortality.