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Objective The study objective was to investigate the impact of multiple arterial grafting on long-term all-cause mortality in women undergoing isolated coronary artery bypass grafting. Methods A comprehensive search was performed to identify observational studies reporting outcomes after coronary artery bypass grafting reported by sex and stratified into multiple arterial grafting versus single arterial grafting strategies. Articles were considered for inclusion if they were written in English and were propensity-matched observational studies. Included studies were then pooled in a meta-analysis performed using the generic inverse variance method. The primary outcome was long-term all-cause mortality. Secondary outcomes were operative mortality and spontaneous myocardial infarction. Meta-regression was used to explore the effects of preoperative and intraoperative variables on the primary outcome. Results A total of 6 studies with 32,793 women (25,714 single arterial grafting and 7079 multiple arterial grafting) were included. Women who received multiple arterial grafting had lower long-term mortality (incidence rate ratio, 0.86; 95% confidence interval, 0.76-0.96; P = .007) and spontaneous myocardial infarction (incidence rate ratio, 0.80; 95% confidence interval, 0.68-0.93; P = .003) compared with women who received single arterial grafting, but the difference in mortality disappeared when including only the 3 largest studies. There was no difference between groups in operative mortality (odds ratio, 0.99; 95% confidence interval, 0.84-1.17; P = .91). Meta-regression did not identify any associations with the incidence rate ratio for long-term mortality. Conclusions The use of multiple arterial grafting in women undergoing coronary artery bypass grafting is associated with lower long-term mortality, although the difference is mostly driven by small series. Further studies, including randomized trials, are needed to evaluate the efficacy of multiple arterial grafting in women undergoing coronary artery bypass grafting.

An inclusive contemporary analysis of spinal cord injury (SCI) rates in patients undergoing aneurysm repair and the factors associated with complications has not been performed.Following a systematic literature search, studies from 2008 to 2018 on repair of descending thoracic aneurysm (DTA) and thoracoabdominal aortic aneurysm (TAAA) were pooled in a meta-analysis performed using the generic inverse variance method. The primary outcome was permanent SCI. Secondary outcomes were temporary SCI, operative mortality, long-term mortality, postoperative stroke, and cerebrospinal fluid (CSF) drain-related complications.One-hundred sixty-nine studies (22,634 patients) were included. The pooled rate of permanent SCI was 4.5% (95% confidence interval [CI], 3.8-5.4); 3.5% (95% CI, 1.8-6.7) for DTA and 7.6% (96% CI, 6.2-9.3) for TAAA repair (P for subgroups = .02), 5.7% (95% CI, 4.3-7.5) for open repair and 3.9% (95% CI, 3.1-4.8) for endovascular repair (P for subgroups = .03). Rates for Crawford extents I, II, III, IV, and V aneurysms were 4.0% (95% CI, 3.0-5.0), 15.0% (95% CI, 10.0-22.0), 7.0% (95% CI, 6.0-9.0), 2.0% (95% CI, 2.0-4.0), and 7.0% (95% CI, 2.0-23.0) respectively (P for subgroups.001). The pooled rates for operative mortality, late mortality at a mean follow-up of 5.0 years, stroke, and temporary SCI were 7.4% (95% CI, 6.1-9.4), 1.0% (95% CI, 0.0-1.0), 4.2% (95% CI, 3.6-4.8), and 3.7% (95% CI, 3.0-4.6), respectively. The pooled rates for severe, moderate, and minor CSF-drain related complications were 5.1% (95% CI, 2.23-11.1), 4.1% (95% CI, 0.6-22.0), and 3.6% (95% CI, 1.2-8.0) respectively.Despite improvement, both open and endovascular aneurysm repair remain associated with a substantial risk of permanent SCI. The risk is greater for TAAA repair, especially extent II, III, and V.

Advancements in imaging techniques are key forces of progress in neurosurgery. The importance of accurate visualization of intraoperative anatomy cannot be overemphasized and is commonly delivered through traditional neuronavigation. Augmented Reality (AR) technology has been tested and applied widely in various neurosurgical subspecialties in intraoperative, clinical use and shows promise for the future. This systematic review of the literature explores the ways in which AR technology has been successfully brought into the operating room (OR) and incorporated into clinical practice. A comprehensive literature search was performed in the following databases from inception-April 2020: Ovid MEDLINE, Ovid EMBASE, and The Cochrane Library. Studies retrieved were then screened for eligibility against predefined inclusion/exclusion criteria. A total of 54 articles were included in this systematic review. The studies were sub- grouped into brain and spine subspecialties and analyzed for their incorporation of AR in the neurosurgical clinical setting. AR technology has the potential to greatly enhance intraoperative visualization and guidance in neurosurgery beyond the traditional neuronavigation systems. However, there are several key challenges to scaling the use of this technology and bringing it into standard operative practice including accurate and efficient brain segmentation of magnetic resonance imaging (MRI) scans, accounting for brain shift, reducing coregistration errors, and improving the AR device hardware. There is also an exciting potential for future work combining AR with multimodal imaging techniques and artificial intelligence to further enhance its impact in neurosurgery.

Introduction Many health providers and communicators who are concerned that patients will not understand numbers instead use verbal probabilities (e.g., terms such as “rare” or “common”) to convey the gist of a health message. Objective To assess patient interpretation of and preferences for verbal probability information in health contexts. Methods We conducted a systematic review of literature published through September 2020. Original studies conducted in English with samples representative of lay populations were included if they assessed health-related information and elicited either (a) numerical estimates of verbal probability terms or (b) preferences for verbal vs. quantitative risk information. Results We identified 33 original studies that referenced 145 verbal probability terms, 45 of which were included in at least two studies and 19 in three or more. Numerical interpretations of each verbal term were extremely variable. For example, average interpretations of the term “rare” ranged from 7 to 21%, and for “common,” the range was 34 to 71%. In a subset of 9 studies, lay estimates of verbal probability terms were far higher than the standard interpretations established by the European Commission for drug labels. In 10 of 12 samples where preferences were elicited, most participants preferred numerical information, alone or in combination with verbal labels. Conclusion Numerical interpretation of verbal probabilities is extremely variable and does not correspond well to the numerical probabilities established by expert panels. Most patients appear to prefer quantitative risk information, alone or in combination with verbal labels. Health professionals should be aware that avoiding numeric information to describe risks may not match patient preferences, and that patients interpret verbal risk terms in a highly variable way.

In the era of evidence-based medicine, systematic reviews and meta-analyses are considered at the top of evidence hierarchy. Despite the almost exponential increase in the number of published meta-analyses over the course of the last decades, only a small minority of them are of high quality, with major flaws involving every aspect of the meta-analytic process. The strength of a meta-analysis is closely linked to the quality of the included studies. Once preliminary phases are completed, it is vital that selected papers undergo a thorough quality assessment, using the most appropriate tools among those available. Analytical approaches must be tailored to the nature of the extracted data and the specific purpose of the meta-analysis. Appraisal of heterogeneity is a key step to inform subgroup or meta-regression analyses. The solidity of the results of the main analysis (especially in meta-analyses of observational studies or studies with high heterogeneity) should be tested by means of pertinent sensitivity analyses. Finally, the investigators should be aware of the possibility of publication bias and make efforts to assess it using qualitative and quantitative methods. The aim of the second part of this expert review is to provide guidance on how to appropriately perform trial level meta-analyses, with particular focus on the quality assessment of the included studies, the choice of the appropriate statistical approach, the methods to deal with heterogeneity (including subgroup, meta-regression, and sensitivity analyses), and the appraisal of publication bias.

Background Aortic valve area (AVA) is commonly determined from 2-dimensional transthoracic echocardiography (2D TTE) by the continuity equation; however, this method relies on geometric assumptions of the left ventricular outflow tract which may not hold true. This study compared mean differences and correlations for AVA by planimetric (2-dimensional transesophageal echocardiography [2D TEE], 3-dimensional transesophageal echocardiography [3D TEE], 3-dimensional transthoracic echocardiography [3D TTE], multi-detector computed tomography [MDCT], and magnetic resonance imaging [MRI]) with hemodynamic methods (2D TTE and catheterization) using pairwise meta-analysis. Method Ovid MEDLINE®, Ovid EMBASE, and The Cochrane Library (Wiley) were queried for studies comparing AVA measurements assessed by planimetric and hemodynamic techniques. Pairwise meta-analysis for mean differences (using random effect model) and for correlation coefficients (r) were performed. Results Forty-five studies (3014 patients) were included. Mean differences between planimetric and hemodynamic techniques were 0.12 cm2 (95%CI 0.10–0.15) for AVA (pooled r = 0.84; 95%CI 0.76–0.90); 1.36cm2 (95%CI 1.03–1.69) for left ventricular outflow tract area; and 0.13 cm (95%CI 0.07–0.20) for annular diameter (pooled r = 0.76; 95% CI 0.64–0.94); 0.67 cm2 (95%CI 0.59–0.76) for annular area (pooled r = 0.74; 95%CI 0.55–0.86). Conclusions Planimetric techniques slightly, but significantly, overestimate AVA when compared to hemodynamic techniques.

Objectives/hypothesis This scoping review aims to map out existing disparities research within the subspecialty of laryngology in order to highlight gaps in knowledge and guide future research. Study design Scoping Review. Methods We completed a scoping review of PubMed, Ovid Embase, and the Cochrane Library for primary research focused on evaluating the existence and impact of disparities in race/ethnicity, sex/gender, insurance status, education level, income, geography, and LGBTQ identity in the context of various laryngological conditions. Publications of any design and date, performed in the United States, and focusing on the adult population exclusively were included. Results Of the 4,999 unique abstracts identified, 51 articles were ultimately included. The most frequently examined condition in relation to disparities was laryngeal cancer (27 of 51), followed by voice disorders (15 of 51), deglutitive disorders (eight of 51), and airway disorders (one of 51). Sources of inequity evaluated from most common to least common were race/ethnicity (43 of 51), sex/gender (39 of 51), insurance status (23 of 51), geography (23 of 51), income (21 of 51), and education level (16 of 51). No study examined the association of LGBTQ identity with inequity. Conclusions This scoping review highlights the limited extent of disparities research in laryngology and establishes the need for further scholarship on the impact of disparities in laryngology care. The pathologies studied were, in decreasing order of frequency: laryngeal cancer, voice disorders, deglutitive disorders, and airway disorders. Race/ethnicity and sex/gender were the most common disparities examined, with no evaluation of LGBTQ-related care inequity. Level of evidence NA Laryngoscope, 2020.

Background Contemporary outcomes of open repair of thoracoabdominal aortic aneurysms (TAAAs) and descending thoracic aortic aneurysms (DTAs) have not been analyzed in an inclusive meta-analysis. Methods After a systematic literature search, studies from 2008 to 2018 reporting outcomes of open repair of DTAs or TAAAs were pooled in a single-arm meta-analysis performed using the generic inverse variance method. Primary outcome was operative mortality. Secondary outcomes were late mortality, postoperative stroke, permanent and temporary spinal cord injury, renal failure, respiratory failure, and myocardial infarction. Results Fifty-four studies with 12,245 patients were included. Pooled operative mortality for open repair was 10.4% (95% confidence interval [CI], 8.3-12.8): 6.6% (95% CI, 3.7-11.6) for DTA and 10.5% (95% CI, 7.5-14.5) for TAAA. Pooled incidence rate of late mortality was 0.6% (95% CI, 0.5-0.8) per person-year. Pooled rates for postoperative outcomes were 4.9% (95% CI, 3.9-6.1) for stroke; 5.7% (95% CI, 4.3-7.5) and 3.0% (95% CI, 2.1-4.2) for permanent and temporary spinal cord injury, respectively; 13.2% (95% CI, 9.9-17.3) for renal failure; 23.3% (95% CI, 17.5-30.4) for respiratory failure; and 2.7% (95% CI, 1.8-4.1) for myocardial infarction. At metaregression, year of publication, use of the clamp-and-sew technique, and use of the cerebrospinal fluid drain were associated with lower operative mortality. Ruptured aneurysms were associated with higher operative mortality. Conclusions Despite improvement, open repair of DTAs and TAAAs continues to be associated with a considerable risk for operative death and perioperative complications. Use of the cerebrospinal fluid drain is associated with better outcomes.

Introduction The impact of sex on the outcomes after coronary artery bypass grafting (CABG) is controversial. The majority of CABG studies are retrospectively collected clinical or registry data, women comprise only a minority, and the reported findings represent the male predominated cohort. This individual patient meta-analysis is aimed at evaluating sex-related differences in outcomes after CABG using high quality data from randomized controlled trials (RCTs). Methods and analysis A systematic literature search will be performed to identify all CABG RCTs (minimum follow-up: 5 years). Detailed specification for the minimum deidentified patient records' data requirements will be provided to RCT primary contact to request their deidentified data for pooling. The pooled analysis will follow the prospective register of systematic reviews (PROSPERO) and the preferred reporting items for systematic reviews and meta-analyses for individual patient data systematic reviews (PRISMA-IPD) recommendations and will compare sex-related outcomes after CABG. The main hypothesis is that outcomes after CABG are worse in women than in men. We will also test whether treatment effects for off-pump and the use of multiple arterial grafts are present within each sex, and also, whether there are differential treatment effects between sexes. The primary endpoint will be a composite of all-cause mortality, myocardial infarction, stroke, and repeat revascularization at long-term follow up. Ethics and dissemination Ethics approval and participant consent for the study will be obtained locally by each study team if needed. Data will be disseminated and submitted to peer-reviewed scientific journals and meetings irrespective of study outcome.

Background The objective of this study was to assess the overall quality of study-level meta-analyses in high-ranking journals using commonly employed guidelines and standards for systematic reviews and meta-analyses. Methods 100 randomly selected study-level meta-analyses published in ten highest-ranking clinical journals in 2016–2017 were evaluated by medical librarians against 4 assessments using a scale of 0–100: the Peer Review of Electronic Search Strategies (PRESS), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Institute of Medicine’s (IOM) Standards for Systematic Reviews, and quality items from the Cochrane Handbook. Multiple regression was performed to assess meta-analyses characteristics’ associated with quality scores. Results The overall median (interquartile range) scores were: PRESS 62.5(45.8–75.0), PRISMA 92.6(88.9–96.3), IOM 81.3(76.6–85.9), and Cochrane 66.7(50.0–83.3). Involvement of librarians was associated with higher PRESS and IOM scores on multiple regression. Compliance with journal guidelines was associated with higher PRISMA and IOM scores. Conclusion This study raises concerns regarding the reporting and methodological quality of published MAs in high impact journals Early involvement of information specialists, stipulation of detailed author guidelines, and strict adherence to them may improve quality of published meta-analyses.

Whether hemodiafiltration (HDF) is better than conventional hemodialysis (HD) in improving left ventricular hypertrophy (LVH), defined as reduction of the left ventricular mass index (LVMi) and increasing the ejection fraction (EF), is unclear. A systematic literature search was performed. Primary outcome was the mean difference between pre- and post-procedural LVMi. Secondary outcome was the mean difference in EF. Seven studies with a total of 845 patients were included. The pooled mean difference between pre-and post-procedural LVMi was -8.0 g/m2 (95% confidence interval [CI] -13.1, -2.8). On subgroup analysis, the mean differences between pre- and post-procedural LVMi for HD and HDF were -6.7 g/m2 (95% CI -14.5, 1.1) and -9.3 g/m2 (95% CI -16.3, -2.3), respectively (P for subgroups = .62). Pooled mean difference between pre- and post-procedural EF was 2.4% (95% CI -1.8, 6.5). On subgroup analysis, the mean differences between pre- and post-procedural EF for HD and HDF were 3.6% (95% CI -2.7, 9.8) and 2.0% (95% CI 2.9, 6.8), respectively (P for subgroups = .68). On meta-regression, age (Beta -0.35 ± 0.05, P

Objectives The evidence supporting the use of the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) score for risk stratification is controversial. We performed a systematic review and meta-analysis of all the randomized controlled trials comparing percutaneous coronary intervention versus coronary artery bypass grafting that reported their outcomes stratified by SYNTAX score, focusing on between-strata comparisons. Methods A systematic review of MEDLINE, EMBASE, Cochrane Library databases was performed. Incidence rate ratios were pooled with a random effect model. Between-group statistical heterogeneity according to accepted SYNTAX score tertiles was computed in the main analysis. Ratios of incidence rate ratios were computed to appraise between-strata effect, as sensitivity analysis. Primary and secondary outcomes were major adverse cardiac and cerebrovascular events and all-cause mortality, respectively. Separate sub-analyses were performed for left main and multivessel disease. Results From 425 citations, 6 trials were eventually included (8269 patients [4134 percutaneous coronary interventions, 4135 coronary artery bypass graftings]; mean follow-up: 6.2 years [range: 3.8-10]). Overall, percutaneous coronary intervention was associated with a significant increase in major adverse cardiac and cerebrovascular events (incidence rate ratio, 1.39, 95% confidence interval, 1.27-1.51) and nonsignificant increase in all-cause mortality (incidence rate ratio, 1.17, 95% confidence interval, 0.98-1.40). There was no significant statistical heterogeneity of treatment effect by SYNTAX score for major adverse cardiac and cerebrovascular events or mortality (P = .40 and P = .34, respectively). Results were consistent also for patients with left main and multivessel disease (major adverse cardiac and cerebrovascular events: P = .85 in left main, P = .78 in multivessel disease 0.78; mortality: P = .12 in left main; P = .34 in multivessel disease). Results of analysis based on ratios of incidence rate ratios were consistent with the main analysis. Conclusions No significant association was found between SYNTAX score and the comparative effectiveness of percutaneous coronary intervention and coronary artery bypass grafting. These findings have implications for clinical practice, future guidelines, and the design of percutaneous coronary intervention versus coronary artery bypass grafting trials.

Objectives It has been hypothesized that the survival benefit of coronary artery bypass (CABG) compared with percutaneous interventions (PCI) may be associated with the reduction in spontaneous myocardial infarction (SMI) achieved by surgery. This, however, has not been formally investigated. The present meta-analysis aims to evaluate the association between the difference in SMI and in survival in PCI versus CABG randomized controlled trials (RCTs). Methods A systematic search was performed to identify all RCTs comparing PCI with CABG for the treatment of coronary artery disease and reporting SMI outcomes. Generic inverse variance method was used to pool outcomes as natural logarithms of the incident rate ratios across studies. Subgroup analysis and interaction test were used to compare the difference of the primary outcome among trials that did and did not report a significant reduction in SMI- in the patients treated by CABG. Primary outcome was all-cause mortality; secondary outcome was SMI. Results Twenty RCTs were included in the meta-analysis. A statistically significant difference in SMI in favor of CABG was found in 7 of the included trials (35%). Overall, PCI was associated with significantly greater all-cause mortality (incident rate ratio, 1.13; 95% confidence interval, 1.01-1.28). At subgroup analysis, a significant difference in survival in favor of CABG was seen only in trials that reported a significant reduction in SMI in the surgical arm (P for interaction 0.02). Conclusions In the published PCI versus CABG trials, the reduction in all-cause mortality in the surgical arm is associated with the protective effect of CABG against SMI.

Background Differences in long-term outcomes of single-fraction stereotactic radiosurgery (SRS) between gamma knife (GK) and linear accelerator (LINAC) systems for vestibular schwannoma (VS) management remain unclear. To investigate differences in safety and efficacy between modalities, we conducted a meta-analysis of studies over the past decade. Methods MEDLINE, EMBASE, and Cochrane databases were queried for studies with the following inclusion criteria: English language, published between January 2010 and April 2020, cohort size ≥30, and mean/median follow-up ≥5 years. Odds ratios (OR) compared rates of tumor control, hearing preservation, and cranial nerve toxicities before and after SRS. Results Thirty-nine studies were included (29 GK, 10 LINAC) with 6516 total patients. Tumor control rates were 93% (95% CI 91-94%) and 94% (95% CI 91-97%) for GK and LINAC, respectively. Both GK (OR 0.06, 95% CI 0.02-0.13) and LINAC (OR 0.47, 95% CI 0.29-0.76) reduced odds of serviceable hearing. Neither GK (OR 0.71, 95% CI 0.41-1.22) nor LINAC (OR 1.13, 95% CI 0.64-2.00) impacted facial nerve function. GK decreased odds of trigeminal nerve (TN) impairment (OR 0.55, 95% CI 0.32-0.94) while LINAC did not impact TN function (OR 1.45, 95% CI 0.81-2.61). Lastly, LINAC offered decreased odds of tinnitus (OR 0.15, 95% CI 0.03-0.87) not observed with GK (OR 0.70, 95% CI 0.48-1.01). Conclusions VS tumor control and hearing preservation rates are comparable between GK and LINAC SRS. GK may better preserve TN function, while LINAC decreases tinnitus rates. Future studies are warranted to investigate the efficacy of GK and LINAC SRS more directly.

Aims We conducted a systematic review and meta-analysis to evaluate temporal trends in quality of life (QoL) after coronary artery bypass grafting (CABG) surgery in randomized clinical trials, and a quantitative comparison from before surgery to up to 5 years after surgery. Methods and results We searched MEDLINE, CINAHL, EMBASE, Cochrane Library, and PsycINFO from 2010 to 2020 to identify studies that included the measurement of QoL in patients undergoing CABG. The primary outcome was the Seattle Angina Questionnaire (SAQ), and secondary outcomes were the 36-item Short Form Health Survey (SF-36) and EuroQol Questionnaire (EQ-5D). We pooled the means and the weighted mean differences over the follow-up period. In the meta-analysis, 2586 studies were screened and 18 full-text studies were included. There was a significant trend towards higher QoL scores from before surgery to 1 year post-operatively for the SAQ angina frequency (AF), SAQ QoL, SF-36 physical component (PC), and EQ-5D, whereas the SF-36 mental component (MC) did not improve significantly. The weighted mean differences from before surgery to 1 year after was 24 [95% confidence interval (CI): 21.6–26.4] for the SAQ AF, 31 (95% CI: 27.5–34.6) for the SAQ QoL, 9.8 (95% CI: 7.1–12.8) for the SF-36 PC, 7.1 (95% CI: 4.2–10.0) for the SF-36 MC, and 0.1 (95% CI: 0.06–0.14) for the EQ-5D. There was no evidence of publication bias or small-study effect. Conclusion CABG had both short- and long-term improvements in disease-specific QoL and generic QoL, with the largest improvement in angina frequency.

Objectives: Non-ST-elevation acute coronary syndrome (NSTE-ACS) affects millions of patients. Although an invasive strategy can improve survival, the optimal treatment (i.e., percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) is not clear. We performed a meta-analysis of studies reporting outcomes between PCI and CABG in patients with NSTE-ACS.Methods: MEDLINE, EMBASE and Cochrane Library were assessed. The primary outcome was long-term mortality. Inverse variance method and random model were performed.Results: We identified 13 observational studies (48,891 patients). No significant difference was found in the primary endpoint (CABG vs. PCI, incidence rate ratio [IRR]= 0.93, 95% confidence interval [CI] 0.70; 1.23). CABG was associated with lower long-term major adverse cardiovascular events (MACE) (IRR= 0.64, 95% CI 0.54; 0.76) and lower long-term re-revascularization (IRR= 0.37, 95% CI 0.30; 0.47). There was no significant difference in long-term myocardial infarction (CABG vs. PCI, IRR= 0.96, 95% CI 0.50; 1.84) and peri-operative mortality (CABG vs. PCI, odds ratio [OR]= 1.36, 95% CI 0.94; 1.95).Conclusion: For the treatment of NSTE-ACS, CABG and PCI are associated with similar rates of long-term mortality and myocardial infarction. CABG is associated with lower rates of long-term MACE and re-revascularization. Randomized comparisons in this setting are necessary.

ObjectiveThe objective of this systematic review was to evaluate the effectiveness and safety of pasireotide, cabergoline, ketoconazole, levoketoconazole, metyrapone, osilodrostat, and temozolomide for the treatment of Cushing’s disease (CD).MethodsThe primary outcomes were the proportion of CD control, adverse events (AE), and reduction of urinary free cortisol. Search strategies were applied to Embase, Medline, and CENTRAL. Independent reviewers assessed the study eligibility, extracted data, and evaluated risk of bias. Standardized mean difference was calculated with 95% confidence interval (CI) for continuous data (i.e., pre- and post-intervention). Random meta-analyses for the proportion of CD control and AE were conducted.ResultsTwenty-nine controlled and non-controlled studies were included. No study with temozolomide and levoketoconazole and one study with osilodrostat fulfilled the inclusion criteria. The meta-analyses of proportion of CD control was 35% for cabergoline (95% CI: 27–43%, six studies, 141 participants), 44% for pasireotide (95% CI: 25–35%, eight studies, 522 participants), 41% for ketoconazole (95% CI: 36–46%, six studies, 450 participants), 66% for metyrapone (95% CI: 46–87%, four studies, 66 participants), and of 66.4% for osilodrostat (95% CI: 57.9, 74.3, 97 participants, one study). One study compared two different treatments (cabergoline vs. ketoconazole), and no statistical difference was observed in CD control (RR: 0.53, 95% CI: 0.15 to 1.87, 14 participants, very low certainty of evidence). The most frequent AE associated with pasireotide was hyperglycemia, dizziness and nausea with cabergoline and metyrapone, and elevated transaminases with ketoconazole.ConclusionThe superiority of one drug over another could not be determined due to lack of controlled studies, but the proportion of disease control identified in our meta-analysis may support clinical decision. New therapeutic options should be investigated due to the limited efficacy and tolerability of the currently available medical treatment for patients with Cushing’s disease.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020205567, identifier CRD42020205567.

Objective Cerebral protection for aortic arch surgery has been widely studied, but comparisons of all the available strategies have rarely been performed. We performed direct and indirect comparisons of antegrade cerebral perfusion, retrograde cerebral perfusion, and deep hypothermic circulatory arrest in a network meta-analysis. Methods After a systematic literature search, studies comparing any combination of antegrade cerebral perfusion, retrograde cerebral perfusion, and deep hypothermic circulatory arrest were included, and a frequentist network meta-analysis was performed using the generic inverse variance method. The primary outcomes were postoperative stroke and operative mortality. Secondary outcomes were postoperative transient neurologic deficits, myocardial infarction, respiratory complications, and renal failure. Results A total of 68 studies were included with a total of 26,968 patients. Compared with deep hypothermic circulatory arrest, both antegrade cerebral perfusion and retrograde cerebral perfusion were associated with significantly lower postoperative stroke and operative mortality rates: antegrade cerebral perfusion (odds ratio [OR], 0.62; 95% confidence interval [CI], 0.51-0.75; and OR, 0.63, 95% CI, 0.51-0.76, respectively) and retrograde cerebral perfusion (OR, 0.66; 95% CI, 0.54-0.82; and OR, 0.57; 95% CI, 0.45-0.71, respectively). Antegrade cerebral perfusion and retrograde cerebral perfusion were associated with similar incidence of primary outcomes. No difference among the 3 techniques was found in secondary outcomes. At meta-regression, circulatory arrest duration correlated with the neuroprotective effect of antegrade cerebral perfusion and retrograde cerebral perfusion compared with deep hypothermic circulatory arrest. Unilateral or bilateral antegrade cerebral perfusion and arrest temperature did not influence the results. Conclusions Antegrade cerebral perfusion and retrograde cerebral perfusion are associated with better postoperative outcomes compared with deep hypothermic circulatory arrest, and the relative benefit increases with the duration of the circulatory arrest. No differences between antegrade cerebral perfusion and retrograde cerebral perfusion were found for all the explored outcomes.

Background This study reports the re-operation and symptom resolution rates of different techniques used in surgical excision of genitourinary mesh erosions. Methods A comprehensive systematic review was completed after searching electronic databases for studies involving outcomes of mesh erosion in humans that were managed surgically using a transvaginal, cystoscopic, or abdominal approach. Surgical outcomes were reported in percentages, ranges, and simple pooling to generate trends in management techniques. Results There were 177 cases that met our inclusion criteria. Forty-one patients underwent cystoscopic removal of eroded urethral mesh while 40 cases underwent transvaginal removal of urethral mesh. Conclusions For mesh eroded into the urethra, a transvaginal vs. cystoscopic approach showed a trend toward resolution of symptoms and fewer interventions. For mesh eroded into the bladder, abdominal and cystoscopic approaches had similar symptom resolution, but abdominal approach required fewer interventions.

Background and Purpose— The clinical utility of positron emission tomography (PET) imaging in evaluating carotid artery plaque vulnerability remains unclear. Two tracers of recent interest for carotid plaque imaging are 18 F-fluorodeoxyglucose ( 18 F-FDG) and 18 F-sodium fluoride ( 18 F-NaF). We performed a systematic review and meta-analysis evaluating the association between carotid artery 18 F-FDG or 18 F-NaF uptake and recent or future cerebral ischemic events. Methods— A systematic review of Ovid MEDLINE, Ovid EMBASE, and the Cochrane library was conducted from inception to December 2017 for articles evaluating PET tracer uptake in recently symptomatic versus asymptomatic carotid arteries, and articles evaluating carotid uptake in relation to future ischemic events. Cerebral ischemic events were defined as ipsilateral strokes, transient ischemic attacks, or amaurosis fugax. We quantitatively pooled studies by a random-effects model when 3 or more studies were amenable for analysis. We assessed the standardized mean difference between tracer uptake in the symptomatic versus asymptomatic carotid artery using Cohen’s d metric. Results— After screening 4144 unique articles, 13 prospective cohort studies assessing carotid artery 18 F-FDG uptake in patients with recent cerebral ischemia were eligible for review. Eleven cohorts of 290 subjects scanned with 18 F-FDG were eligible for meta-analysis. We found that carotid arteries ipsilateral to recent ischemic events had significantly higher 18 F-FDG uptake than asymptomatic arteries (Cohen’s d =0.492; CI=0.130–0.855; P =0.008) as well as significant heterogeneity (Cochran’s Q =31.5; P =0.0005; I 2 =68.3%). Meta-regression was not performed due to the limited number of studies in the analysis. Only 2 studies investigating 18 F-NaF PET imaging, and another 2 articles investigating ischemic event recurrence were found. Conclusions— Recent ipsilateral cerebral ischemia may be associated with increased carotid 18 F-FDG uptake on PET imaging regardless of degree of carotid stenosis, although significant heterogeneity was found, and these results should be interpreted with caution. Emerging evidence suggests a similar association may be present with 18 F-NaF plaque uptake. More studies are warranted to provide definitive conclusions on the utility of 18 F-FDG or 18 F-NaF in carotid plaque evaluation before investigating carotid PET as a diagnostic tool for cerebral ischemic events.

Importance Randomized clinical trials (RCTs) provide the highest level of evidence to evaluate 2 or more surgical interventions. Surgical RCTs, however, face unique challenges in design and implementation. Objective To evaluate the design, conduct, and reporting of contemporary surgical RCTs. Evidence review A literature search performed in the 2 journals with the highest impact factor in general medicine as well as 6 key surgical specialties was conducted to identify RCTs published between 2008 and 2020. All RCTs describing a surgical intervention in both experimental and control arms were included. The quality of included data was assessed by establishing an a priori protocol containing all the details to extract. Trial characteristics, fragility index, risk of bias (Cochrane Risk of Bias 2 Tool), pragmatism (Pragmatic Explanatory Continuum Indicator Summary 2 [PRECIS-2]), and reporting bias were assessed. Findings A total of 388 trials were identified. Of them, 242 (62.4%) were registered; discrepancies with the published protocol were identified in 81 (33.5%). Most trials used superiority design (329 [84.8%]), and intention-to-treat as primary analysis (221 [56.9%]) and were designed to detect a large treatment effect (50.0%; interquartile range [IQR], 24.7%-63.3%). Only 123 trials (31.7%) used major clinical events as the primary outcome. Most trials (303 [78.1%]) did not control for surgeon experience; only 17 trials (4.4%) assessed the quality of the intervention. The median sample size was 122 patients (IQR, 70-245 patients). The median follow-up was 24 months (IQR, 12.0-32.0 months). Most trials (211 [54.4%]) had some concern of bias and 91 (23.5%) had high risk of bias. The mean (SD) PRECIS-2 score was 3.52 (0.65) and increased significantly over the study period. Most trials (212 [54.6%]) reported a neutral result; reporting bias was identified in 109 of 211 (51.7%). The median fragility index was 3.0 (IQR, 1.0-6.0). Multiplicity was detected in 175 trials (45.1%), and only 35 (20.0%) adjusted for multiple comparisons. Conclusions and relevance In this systematic review, the size of contemporary surgical trials was small and the focus was on minor clinical events. Trial registration remained suboptimal and discrepancies with the published protocol and reporting bias were frequent. Few trials controlled for surgeon experience or assessed the quality of the intervention.

Aims Data suggest that women have worse outcomes than men after coronary artery bypass grafting (CABG), but results have been inconsistent across studies. Due to the large differences in baseline characteristics between sexes, suboptimal risk adjustment due to low-quality data may be the reason for the observed differences. To overcome this limitation, we undertook a systematic review and pooled analysis of high-quality individual patient data from large CABG trials to compare the adjusted outcomes of women and men. Methods and results The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), stroke, and repeat revascularization (major adverse cardiac and cerebrovascular events, MACCE). The secondary outcome was all-cause mortality. Multivariable mixed-effect Cox regression was used. Four trials involving 13 193 patients (10 479 males; 2714 females) were included. Over 5 years of follow-up, women had a significantly higher risk of MACCE [adjusted hazard ratio (HR) 1.12, 95% confidence interval (CI) 1.04–1.21; P = 0.004] but similar mortality (adjusted HR 1.03, 95% CI 0.94–1.14; P = 0.51) compared to men. Women had higher incidence of MI (adjusted HR 1.30, 95% CI 1.11–1.52) and repeat revascularization (adjusted HR 1.22, 95% CI 1.04–1.43) but not stroke (adjusted HR 1.17, 95% CI 0.90–1.52). The difference in MACCE between sexes was not significant in patients 75 years and older. The use of off-pump surgery and multiple arterial grafting did not modify the difference between sexes. Conclusions Women have worse outcomes than men in the first 5 years after CABG. This difference is not significant in patients aged over 75 years and is not affected by the surgical technique.

Background and aim Thoracotomy approaches to left ventricular assist device (LVAD) implantation may reduce surgical morbidity and, through preservation of the pericardial restraint over the right heart, may reduce the incidence of right ventricular failure (RVF). Methods A meta-analysis of all original studies describing the effect of the surgical approach on postoperative outcomes after LVAD implantation was performed. Postoperative outcomes analyzed. Results Thirteen studies were included with 692 patients undergoing a sternotomy and 373 a thoracotomy approach. Patients undergoing a thoracotomy approach had a higher comorbid status (INTERMACS 1-2: 56% vs. 44%; p = .0004), but were less likely to undergo a concomitant procedure (4% vs. 15%; p = .0002) than patients undergoing a sternotomy approach. Patients undergoing a thoracotomy approach demonstrated a reduced incidence of RVF (OR, .47; CI, .23-.97; p = .04), reexploration for bleeding (OR, .55; CI, .32-.94; p = .03), perioperative blood transfusion (SMD, -.30; CI, -.49 to -.11; p = .002), LOS (-5.57; -10.56 to -.59; p = .03), and mortality (OR, .57; CI, .33-.98; p = .04), but no difference in RVAD requirement or stroke were noted. Metaregression demonstrated that the performance of a concomitant procedure did not modify the effect of the surgical approach on the primary endpoints of RVF or RVAD requirement. Conclusions In the current meta-analysis including over 1000 patients undergoing LVAD implantation, a thoracotomy approach was associated with a reduced incidence of RVF (but not RVAD requirement), bleeding, LOS, and mortality. No difference in stroke rates was noted. These findings not only offer additional support as to the feasibility of a thoracotomy approach for LVAD implantation but also suggest a potential superiority over a sternotomy approach.

Background Among boys with X-Linked adrenoleukodystrophy, a subset will develop childhood cerebral adrenoleukodystrophy (CCALD). CCALD is typically lethal without hematopoietic stem cell transplant before or soon after symptom onset. We sought to establish evidence-based guidelines detailing the neuroimaging surveillance of boys with neurologically asymptomatic adrenoleukodystrophy. Methods To establish the most frequent age and diagnostic neuroimaging modality for CCALD, we completed a meta-analysis of relevant studies published between January 1, 1970 and September 10, 2019. We used the consensus development conference method to incorporate the resulting data into guidelines to inform the timing and techniques for neuroimaging surveillance. Final guideline agreement was defined as >80% consensus. Results One hundred twenty-three studies met inclusion criteria yielding 1285 patients. The overall mean age of CCALD diagnosis is 7.91 years old. The median age of CCALD diagnosis calculated from individual patient data is 7.0 years old (IQR: 6.0-9.5, n = 349). Ninety percent of patients were diagnosed between 3 and 12. Conventional MRI was most frequently reported, comprised most often of T2-weighted and contrast-enhanced T1-weighted MRI. The expert panel achieved 95.7% consensus on the following surveillance parameters: (a) Obtain an MRI between 12 and 18 months old. (b) Obtain a second MRI 1 year after baseline. (c) Between 3 and 12 years old, obtain a contrast-enhanced MRI every 6 months. (d) After 12 years, obtain an annual MRI. Conclusion Boys with adrenoleukodystrophy identified early in life should be monitored with serial brain MRIs during the period of highest risk for conversion to CCALD.

Background Quality of the peer‐review process has been tested only in small studies. We describe and summarize the randomized trials that investigated interventions aimed at improving peer‐review process of biomedical manuscripts. Methods and Results All randomized trials comparing different peer‐review interventions at author‐, reviewer‐, and/or editor‐level were included. Differences between traditional and intervention‐modified peer‐review processes were pooled as standardized mean difference (SMD) in quality based on the definitions used in the individual studies. Main outcomes assessed were quality and duration of the peer‐review process. Five‐hundred and seventy‐five studies were retrieved, eventually yielding 24 randomized trials. Eight studies evaluated the effect of interventions at author‐level, 16 at reviewer‐level, and 3 at editor‐level. Three studies investigated interventions at multiple levels. The effects of the interventions were reported as mean change in review quality, duration of the peer‐review process, acceptance/rejection rate, manuscript quality, and number of errors detected in 13, 11, 5, 4, and 3 studies, respectively. At network meta‐analysis, reviewer‐level interventions were associated with a significant improvement in review quality (SMD, 0.20 [0.06 to 0.33]), at the cost of increased duration of the review process (SMD, 0.15 [0.01 to 0.29]), except for reviewer blinding. Author‐ and editor‐level interventions did not significantly impact peer‐review quality and duration (respectively, SMD, 0.17 [−0.16 to 0.51] and SMD, 0.19 [−0.40 to 0.79] for quality, and SMD, 0.17 [−0.16 to 0.51] and SMD, 0.19 [−0.40 to 0.79] for duration). Conclusions Modifications of the traditional peer‐review process at reviewer‐level are associated with improved quality, at the price of longer duration. Further studies are needed. Registration URL: https://www.crd.york.ac.uk/prospero ; Unique identifier: CRD42020187910.

Background Several randomized trials have compared the patency of coronary artery bypass conduits. All of the published studies, however, have performed pairwise comparisons and a comprehensive evaluation of the patency rates of all conduits has yet to be published. We set out to investigate the angiographic patency rates of all conduits used in coronary bypass surgery by performing a network meta‐analysis of the current available randomized evidence. Methods and Results A systematic literature search was conducted for randomized controlled trials comparing the angiographic patency rate of the conventionally harvested saphenous vein, the no‐touch saphenous vein, the radial artery (RA), the right internal thoracic artery, or the gastroepiploic artery. The primary outcome was graft occlusion. A total of 4160 studies were retrieved of which 14 were included with 3651 grafts analyzed. The weighted mean angiographic follow‐up was 5.1 years. Compared with the conventionally harvested saphenous vein, both the RA (incidence rate ratio [IRR] 0.54; 95% CI, 0.35–0.82) and the no‐touch saphenous vein (IRR 0.55; 95% CI, 0.39–0.78) were associated with lower graft occlusion. The RA ranked as the best conduit (rank score for RA 0.87 versus 0.85 for no‐touch saphenous vein, 0.23 for right internal thoracic artery, 0.29 for gastroepiploic artery, and 0.25 for the conventionally harvested saphenous vein). Conclusions Compared with the conventionally harvested saphenous vein, only the RA and no‐touch saphenous vein grafts are associated with significantly lower graft occlusion rates. The RA ranks as the best conduit. Registration URL: https://www.crd.york.ac.uk/prospero ; Unique identifier: CRD42020164492.

Objective New-onset postoperative atrial fibrillation (POAF) after cardiac surgery is common, with rates up to 60%. POAF has been associated with early and late stroke, but its association with other cardiovascular outcomes is less known. The objective was to perform a meta-analysis of the studies reporting the association of POAF with perioperative and long-term outcomes in patients with cardiac surgery. Methods We performed a systematic review and a meta-analysis of studies that presented outcomes for cardiac surgery on the basis of the presence or absence of POAF. MEDLINE, EMBASE, and the Cochrane Library were assessed; 57 studies (246,340 patients) were selected. Perioperative mortality was the primary outcome. Inverse variance method and random model were performed. Leave-one-out analysis, subgroup analyses, and metaregression were conducted. Results POAF was associated with perioperative mortality (odds ratio [OR], 1.92; 95% confidence interval [CI], 1.58-2.33), perioperative stroke (OR, 2.17; 95% CI, 1.90-2.49), perioperative myocardial infarction (OR, 1.28; 95% CI, 1.06-1.54), perioperative acute renal failure (OR, 2.74; 95% CI, 2.42-3.11), hospital (standardized mean difference, 0.80; 95% CI, 0.53-1.07) and intensive care unit stay (standardized mean difference, 0.55; 95% CI, 0.24-0.86), long-term mortality (incidence rate ratio [IRR], 1.54; 95% CI, 1.40-1.69), long-term stroke (IRR, 1.33; 95% CI, 1.21-1.46), and longstanding persistent atrial fibrillation (IRR, 4.73; 95% CI, 3.36-6.66). Conclusions The results suggest that POAF after cardiac surgery is associated with an increased occurrence of most short- and long-term cardiovascular adverse events. However, the causality of this association remains to be established.

Summary OBJECTIVES The optimal revascularization strategy for patients with ischaemic left ventricular systolic dysfunction (iLVSD) remains controversial. We aimed to compare percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) and medical therapy (MT) in a network meta-analysis. METHODS All randomized controlled trials and observational studies comparing any combination of PCI, CABG and MT in patients with iLVSD were analysed in a frequentist network meta-analysis (generic inverse variance method). Primary outcome was mortality at longest available follow-up. Secondary outcomes were cardiac death, stroke, myocardial infarction (MI) and repeat revascularization (RR). RESULTS Twenty-three studies were included (n = 23 633; 4 randomized controlled trials). Compared to CABG, PCI was associated with higher mortality [incidence rate ratio (IRR) 1.32, 95% confidence interval (CI) 1.13–1.53], cardiac death (IRR 1.65, 95% CI 1.18–2.33), MI (IRR 2.18, 95% CI 1.70–2.80) and RR (IRR 3.75, 95% CI 2.89–4.85). Compared to CABG, MT was associated with higher mortality (IRR 1.52, 95% CI 1.26–1.84), cardiac death (IRR 3.83, 95% CI 2.12–6.91), MI (IRR 3.22, 95% CI 1.52–6.79) and RR (IRR 3.37, 95% CI 1.67–6.79). Compared to MT, PCI was associated with lower cardiac death (IRR 0.43, 95% CI 0.24–0.78). CABG ranked as the best revascularization strategy for mortality, cardiac death, MI and RR; MT ranked as the strategy associated with the lowest incidence of stroke. Left ventricular ejection fraction, year of study, use of drug-eluting stents did not affect relative treatment effects. CONCLUSIONS CABG appears to be the best therapy for iLVSD, although mainly based on observational data. Definitive randomized controlled trials comparing CABG and PCI in iLVSD are required. PROSPERO registration ID 132414.

The aim was to estimate risk of aortic re-operation, and re-operative morbidity and mortality, following replacement of the proximal aorta for aneurysm or dissection.A meta-analysis was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and the Meta-Analysis of Observational Studies in Epidemiology guidelines. A comprehensive literature review was performed to identify all articles reporting aortic re-operation after proximal aortic replacement. The proximal aorta was defined as extending to the origin of the brachiocephalic trunk. The incidence rate for aortic re-operation (IRAR) was calculated, and stratified based on presence/absence of connective tissue disorders, as well as initial surgical indication. Pooled in hospital mortality and post-operative complication rates were estimated.In total, 7821 patients who underwent proximal aortic replacement from 47 studies were included: 8.3% (n = 649) had Marfan syndrome (MS). During a weighted mean follow up of 4.7 ± 0.3 years, 11.5% (n = 903) underwent aortic re-operation. Mean weighted time between initial surgery and re-operation was 5.2 ± 0.2 years. IRAR was 2.4% per person-year (PPY) (confidence interval [CI] 2.1-2.8%). Patients with MFS had a threefold higher IRAR (6.0% PPY, CI 4.1-8.8%) than did patients without a connective tissue disorders (2.3% PPY, CI 1.9-2.7%; p .001). IRAR was 2.5% PPY (CI 2.1-3.0%) after operation for dissection and 1.3% PPY (CI 0.9-2.0%) after operation for aneurysm (p = .004 for subgroup differences). IRAR proximal and distal to the left subclavian artery was 1.2% PPY (CI 1.0-1.5%) and 1.3% PPY (CI 1.1-1.6%), respectively. The pooled in hospital mortality and complication rates after re-operation were 14.31% (CI 11.28-17.99%) and 18.08% (CI 10.54-29.25%), respectively. On meta-regression, initial operation for dissection was the only significant predictor of aortic re-operation (beta = .030, p = .001).Aortic re-operation occurs at a mean rate of 2.4% per person-year in the five years after proximal aortic replacement and is strongly associated with initial operation for dissection.

Lenalidomide is associated with increased risk of thromboembolism (VTE) in patients with multiple myeloma. This risk has not previously been defined in B-cell non-Hodgkin lymphoma (NHL), for which lenalidomide is also an active agent. We conducted a systematic literature search in Ovid MEDLINE (1946 to February 2017), Ovid EMBASE (1974 to February 2017), The Cochrane Library (Wiley), and Web of Science Core Collection for prospective studies evaluating lenalidomide-containing regimens in B-cell NHL with adequate reporting of patient characteristics, total cycles received, and safety data including VTE rates. The primary outcome was VTE events per 100 patient-cycles by meta-analysis using random-effects models. Our literature search identified 1719 citations; 28 articles were included. For all patients with B-cell NHL receiving lenalidomide, the rate of VTE per 100 patient-cycles was 0.77 (95% confidence interval [CI], 0.48-1.12; I 2 , 67%). The rate for single-agent lenalidomide was 1.09 events per 100 patient-cycles (95% CI, 0.49-1.94; I 2 , 76%), the rate for lenalidomide plus biologics was 0.49 (95% CI, 0.17-0.97; I 2 , 59%), and the rate for lenalidomide plus chemotherapy was 0.89 (95% CI, 0.39-1.60; I 2 , 57%). Rate of VTE events in B-cell NHL patients treated with lenalidomide in clinical trials is similar to the rate in multiple myeloma. The VTE rate appears to be lowest for lenalidomide combined with a biologic compared with single-agent lenalidomide or its combination with chemotherapy. This protocol was registered at www.crd.york.ac.uk/prospero/ as #CRD42017056042.

Background Totally endoscopic coronary artery bypass (TECAB) has emerged as an alternative to other minimally invasive techniques. However, limited TECAB results are available to date. The purpose of this systematic review is to examine the existing literature to give an objective estimate of the outcomes of TECAB using a meta-analytical approach. Methods A comprehensive online review was performed in Ovid MEDLINE®, Ovid EMBASE and The Cochrane Library from 2000 to July 2017. Eligible studies included single arm TECAB studies as well as comparative studies (TECAB vs minimally invasive direct coronary artery bypass (MIDCAB)). Pooled event rates and odds ratios (ORs) for operative mortality, perioperative myocardial infarction (MI), perioperative stroke, graft patency and repeat revascularization were estimated. Single arm and pairwise comparisons were performed. Results Seventeen single arm TECAB articles (3721 patients, weighted mean follow-up 3.3years) were included. The pooled event rate was 0.80% (95%CI: 0.60–1.2%) for operative mortality, 2.28% (95%CI: 1.7–3%) for perioperative MI, 1.50% (95%CI: 1.1–2.0%) for perioperative stroke, 2.99% (95%CI: 1.6–5.4%) for repeat revascularization and 94.8% (95%CI: 89.3–97.5%) for early graft patency (weighted mean follow-up 10.1months). On pairwise meta-analysis 376 patients (263 TECAB and 113 MIDCAB) were included. No difference in operative mortality (OR=0.25, 95%CI: 0.02–2.83), perioperative MI (OR=3.09, 95%CI: 0.37–26.12) or perioperative stroke (OR=1.33, 95%CI: 0.17–10.26) was found between the two techniques. Conclusions TECAB has an acceptably low operative risk and a good early patency rate. The incidence of perioperative MI requires further investigation. The dearth of data comparing TECAB to open approaches compels the need for future comparative trials.

To evaluate the inflammatory response following transvaginal implantation of polypropylene (PP) mesh. A comprehensive literature search was performed in the following databases from inception in April 2017: Ovid MEDLINE, Ovid EMBASE, and The Cochrane Library (Wiley). The studies retrieved were screened for eligibility against predefined inclusion and exclusion criteria. Twenty-three articles were included in this review. Following the implantation of PP mesh, there are immediate and local inflammatory responses. PP mesh elicits an inflammatory response that decreases over time; however, no studies documented a complete resolution. Further studies are needed to determine if there is a complete resolution of inflammation or if it persists.

Background Immigrants in the United States (US) today are facing a dynamic policy landscape. The Trump administration has threatened or curtailed access to basic services for 10.5 million undocumented immigrants currently in the US. We sought to examine the historical effects that punitive laws have had on health outcomes in US immigrant communities. Methods In this systematic review, we searched the following databases from inception–May 2020 for original research articles with no language restrictions: Ovid MEDLINE, Ovid EMBASE, Cochrane Library (Wiley), Web of Science Core Collection (Clarivate), CINAHL (EBSCO), and Social Work Abstracts (Ovid). This study is registered with PROSPERO, CRD42019138817. Articles with cohort sizes >10 that directly evaluated the health-related effects of a punitive immigrant law or policy within the US were included. Findings 6,357 studies were screened for eligibility. Of these, 32 studies were selected for inclusion and qualitatively synthesized based upon four themes that appeared throughout our analysis: (1) impact on healthcare utilization, (2) impact on women’s and children’s health, (3) impact on mental health services, and (4) impact on public health. The impact of each law, policy, mandate, and directive since 1990 is briefly discussed, as are the limitations and risk of bias of each study. Interpretation Many punitive immigrant policies have decreased immigrant access to and utilization of basic healthcare services, while instilling fear, confusion, and anxiety in these communities. The federal government should preserve and expand access for undocumented individuals without threat of deportation to improve health outcomes for US citizens and noncitizens.

Importance Changes in evidence-based practice and guideline recommendations depend on high-quality randomized clinical trials (RCTs). Commercial device and pharmaceutical manufacturers are frequently involved in the funding, design, conduct, and reporting of trials, the implications of which have not been recently analyzed. Objective To evaluate the design, outcomes, and reporting of contemporary randomized clinical trials of invasive cardiovascular interventions and their association with the funding source. Design, Setting, and Participants This cross-sectional study analyzed published RCTs between January 1, 2008, to May 31, 2019. The trials included those involving coronary, vascular and structural interventional cardiology, and vascular and cardiac surgical procedures. Main Outcomes and Measures We assessed (1) trial characteristics, (2) finding of a statistically significant difference in the primary end point favoring the experimental intervention, (3) reporting of implied treatment advantage in trials without significant differences in primary end point, (4) existence of major discrepancies between registered and published primary outcomes, (5) number of patients whose outcomes would need to switch from a nonevent to an event to convert a significant difference in primary end point to nonsignificant, and (6) association with funding source. Results Of the 216 RCTs analyzed, 115 (53.2%) reported having commercial sponsorship. Most trials had 80% power to detect an estimated treatment effect of 30%, and 128 trials (59.3%) used composite primary end points. The median (interquartile range [IQR]) sample size was 502 (204-1702) patients, and the median (IQR) follow-up duration was 12 (1.0-14.4) months. Overall, 123 trials (57.0%) reported a statistically significant difference in the primary outcome favoring the experimental intervention; reporting strategies that implied an advantage were identified in 55 (65.5%) of 84 trials that reported nonsignificant differences. Commercial sponsorship was associated with a statistically significantly greater likelihood of favorable outcomes reporting (exponent of regression coefficient β, 2.80; 95% CI, 1.09-7.18;P = .03) and with the reporting of findings that are inconsistent with the trial results. Discrepancies between the registered and published primary outcomes were found in 82 trials (38.0%), without differences in trial sponsorship. A median (IQR) number of 5 (2.8-12.5) patients experiencing a different outcome would have change statistically significant results to nonsignificant. Commercial sponsorship was associated with a greater number of patients (exponent of regression coefficient β, 1.29; 95% CI, 1.00-1.66;P = .04). Conclusions and Relevance These results suggest that contemporary RCTs of invasive cardiovascular interventions are relatively small and fragile, have short follow-up, and have limited power to detect large treatment effects. Commercial support appeared to be associated with differences in trial design, results, and reporting.

BackgroundAlthough it is traditionally regarded as a single entity, perioperative stroke comprises 2 separate phenomena (early/intraoperative and delayed/postoperative stroke). We aimed to systematically evaluate incidence, risk factors, and clinical outcome of early and delayed stroke after cardiac surgery.Methods and ResultsA systematic review (MEDLINE,EMBASE, Cochrane Library) was performed to identify all articles reporting early (on awakening from anesthesia) and delayed (after normal awakening from anesthesia) stroke after cardiac surgery. End points were pooled event rates of stroke and operative mortality and incident rate of late mortality. Thirty‐six articles were included (174 969 patients). The pooled event rate for early stroke was 0.98% (95%CI0.79% to 1.23%) and was 0.93% for delayed stoke (95%CI0.77% to 1.11%;P=0.68). The pooled event rate of operative mortality was 28.8% (95%CI17.6% to 43.4%) for early and 17.9% (95%CI14.0% to 22.7%) for delayed stroke, compared with 2.4% (95%CI1.9% to 3.1%) for patients without stroke (PCI7.5% to 18.3%) for early and 9.4% (95%CI5.9% to 14.9%) for delayed stroke, compared with 3.4% (95%CI2.4% to 4.8%) in patients with no stroke. Meta‐regression demonstrated that off‐pump was inversely associated with early stroke (β=−0.009,P=0.01), whereas previous stroke (β=0.02,PConclusionsEarly and delayed stroke after cardiac surgery have different risk factors and impacts on operative mortality as well as on long‐term survival.

A rise in antimicrobial resistance, seen especially since 2000, is in part caused by indiscriminate antimicrobial use. Varied types of persuasive interventions aimed to optimize antimicrobial use have been tried with varying success. Our review seeks to identify and assess factors associated with the successful implementation of persuasive interventions. We searched five databases (MEDLINE, EMBASE, The Cochrane Library, PsycINFO, and ERIC) to identify critical studies published between 2000 and December 2018 of interventions employing audit and feedback, education through meetings, academic detailing, reminders, and patient, family, or public education. Outcome measures of interest were any means to measure antimicrobial use. We included 26 articles in our analysis. Seventeen examined multimodal interventions and the most common was audit and feedback and meeting (four studies). Nine examined single interventions and the most common was audit and feedback (five studies). Our findings inform four evidence-based strategies to enable healthcare administrators, clinicians, and researchers to make informed choices when planning and designing an antimicrobial stewardship program: (1) implement a combination of persuasive interventions from both groups: audit and feedback, academic detailing, or patient, family, or provider education; and meeting or reminders, (2) design interventions that last one year or longer; post-intervention, assess the intervention’s long-term effects for at least another one year, (3) conduct quality improvement projects examining persuasive interventions if the prescribing database provides adequate diagnosis information, and most importantly, (4) make patient, family, or provider education an integral component of multimodal intervention.

INTRODUCTION AND OBJECTIVES:The risk of prostate needle biopsy (PNBx) infections and sepsis is increasing, with recent estimates of 7% and 3%, respectively. Each post-PNBx infection costs an estima...

Background Hydroxychloroquine is widely used for the treatment of cutaneous lupus erythematosus (CLE). Although new recommendations exist for hydroxychloroquine dosing, there is still uncertainty about the dosage that will elicit a satisfactory response in CLE while limiting adverse effects, specifically retinopathy. Objective To summarize hydroxychloroquine dosages, outcomes, and adverse effects in the treatment of CLE, focusing on retinopathy. Methods A comprehensive literature search from inception to December 2018 was performed in Ovid MEDLINE, Ovid Embase, and The Cochrane Library (Wiley). Studies were screened against predefined inclusion and exclusion criteria. Results Twelve studies were selected and included 5 retrospective studies, 3 prospective studies, 2 case series, and 2 randomized controlled trials. These studies show that a hydroxychloroquine dosage up to 400 mg/d is effective for most CLE patients (range of effectiveness, 50%-97%), with few adverse effects. One incidence of retinopathy, after a very high cumulative dose, was reported across all 12 studies (852 total patients). Limitations Because retinopathy and other serious adverse effects may not appear until much later, many of these studies are limited by short follow-up time. Conclusions This evidence suggests that hydroxychloroquine for CLE is effective at 400 mg/d, with an exceedingly low incidence of retinopathy and other adverse effects.

BACKGROUND Elder mistreatment is common and has serious social and medical consequences for victims. Though programs to combat this mistreatment have been developed and implemented for more than three decades, previous systematic literature reviews have found few successful ones. OBJECTIVE To conduct a more comprehensive examination of programs to improve elder mistreatment identification, intervention, or prevention, including those that had not undergone evaluation. DESIGN Systematic review. SETTING Ovid MEDLINE, Ovid EMBASE, Cochrane Library, PsycINFO Elton B. Stephens Co. (EBSCO), AgeLine, CINAHL. MEASUREMENTS We abstracted key information about each program and categorized programs into 14 types and 9 subtypes. For programs that reported an impact evaluation, we systematically assessed the study quality. We also systematically examined the potential for programs to be successfully implemented in environments with limited resources available. RESULTS We found 116 articles describing 115 elder mistreatment programs. Of these articles, 43% focused on improving prevention, 50% focused on identification, and 95% focused on intervention, with 66% having multiple foci. The most common types of program were: educational (53%), multidisciplinary team (MDT) (21%), psychoeducation/therapy/counseling (15%), and legal services/support (8%). Of the programs, 13% integrated an acute-care hospital, 43% had high potential to work in low-resource environments, and 57% reported an attempt to evaluate program impact, but only 2% used a high-quality study design. CONCLUSION Many programs to combat elder mistreatment have been developed and implemented, with the majority focusing on education and MDT development. Though more than half reported evaluation of program impact, few used high-quality study design. Many have the potential to work in low-resource environments. Acute-care hospitals were infrequently integrated into programs.

Background:Black people are less likely to undergo total joint arthroplasties, despite reporting more severe symptoms. (1) While racial disparities exist in treatment utilization for osteoarthritis, comprehensive studies of the treatment preferences of Black people have not been conducted.Objectives:The purpose of this manuscript is to systematically review the literature and identify Black osteoarthritis patients’ treatment preferences to understand how they may contribute to racial differences in the utilization of different treatment options.Methods:Searches ran on April 8, 2019 and April 7, 2020 in the following databases: Ovid MEDLINE (ALL - 1946 to Present); Ovid EMBASE (1974 to present); and The Cochrane Library (Wiley). Using the Patient/Population-Intervention-Comparison/Comparator-Outcome (PICO) format, our population of interest was Black people with hip and/or knee osteoarthritis, our intervention was preferences and opinions about treatment options for osteoarthritis, our comparator was white people with hip and/or knee osteoarthritis, and our outcome was preferences of osteoarthritis therapies. The protocol was registered under the PROSPERO international register, and the Preferred Reporting Items of Systematic reviews and Meta-Analyses (PRISMA) guidelines were followed.Results:Searches across the chosen databases retrieved 10,894 studies after de-duplication, 182 full text, and 31 selected for inclusion in this review. Black people were less likely to use NSAIDs or narcotic analgesics compared to white people. (Figure 1) Black people were more likely than white people to use spirituality and prayer, as well as topical treatments. Utilization of meditation, supplement/vitamin use, and hot/cold treatments was not significantly different between groups. Black people were less willing than white people to consider or undergo joint replacements, even if the procedure was needed and recommended by a physician.Conclusion:Racial differences persist in OA care across the spectrum of options. Future interventions should focus on providing accessible information surrounding treatment options and targeting perceptions of the importance of joint health.References:[1]Suarez-Almazor ME, Souchek J, Kelly PA, et al. Ethnic Variation in Knee Replacement: Patient Preferences or Uninformed Disparity? Arch Intern Med. 2005;165(10):1117-1124. doi:10.1001/archinte.165.10.1117Figure 1.Meta-analysis describing the odds ratios of Black people using NSAIDs and Narcotic Analgesics compared to white peopleDisclosure of Interests:Collin Brantner: None declared, Diyu Pearce-Fisher: None declared, Carine Moezinia: None declared, Haley Tornberg: None declared, John FitzGerald: None declared, Michael Parks Consultant of: Zimmer Biomet, Peter Sculco Consultant of: EOS Imaging, Intellijoint Surgical, DePuy Synthes, Lima Corporate, Cynthia Kahlenberg: None declared, Curtis Mensah: None declared, Ajay Premkuar: None declared, Nicholas Williams: None declared, Michelle Demetres: None declared, Susan Goodman Consultant of: UCB, Grant/research support from: Novartis, Horizon Therapeutics.

Study Objective. We performed a systematic comparison of high-dose and low-dose opioid anesthesia in cardiac surgery. Design Systematic review and meta-analysis of randomized controlled trials (RCTs). Setting Operating room. Patients 1400 adult patients undergoing cardiac surgery using general anesthesia. Interventions All RCTs comparing the effects of various doses of intravenous opioids (morphine, fentanyl, sufentanil, and remifentanil) during adult cardiac surgery using general anesthesia published until May 2018 (full-text English articles reporting data from human subjects) were included. Measurements Primary outcome was intensive care unit (ICU) length of stay (LOS). Secondary outcomes were ventilation time, use of vasopressors, perioperative myocardial infarction, perioperative stroke, and hospital LOS. Main results Eighteen articles were included (1400 patients). There was no difference in ICU LOS between studies using high or low dose of opioids (both short-acting and long-acting) (standard mean difference [SMD]−0.02, 95%CI: −0.15–0.11, P = 0.74). Similarly, there was no difference in secondary outcomes of ventilation time (SMD−0.27, 95%CI: −0.63–0.09, P = 0.14), use of vasopressors (OR 0.61, 95%CI: 0.29–1.30, P = 0.20), myocardial infarction (risk difference 0.00, 95% CI: −0.02–0.03, P = 0.70), stroke (RD 0.00, 95% CI: −0.01–0.01, P = 0.92) and hospital LOS (SMD 0.03, 95% CI: −0.26–0.33, P = 0.84). At meta-regression, there was no effect of age, gender, or type of opioid on the difference between groups. Conclusions Our data suggest that low-dose opioids, both short acting and long acting, are safe and effective to use in adult cardiac surgery patients, independent of the clinical characteristics of the patients and the type of opioid used. In view of the current opioid epidemic, low-dose opioid anesthesia should be considered for cardiac surgery patients.

Accurate measurement of aortic valve area (AVA) is crucial for timing of treatment of aortic stenosis. AVA is widely assessed by 2-dimensional transthoracic echocardiography (2D TTE), as recommended by current guidelines. However, 2D TTE Doppler-derived AVA relies on geometric assumptions that may

Background Patients with inflammatory arthritis (IA) are at increased risk of prosthetic joint infections (PJI), yet differentiating between septic and aseptic failure is a challenge. The aim of our systematic review is to evaluate synovial biomarkers and their efficacy at diagnosing PJI in patients with IA. Methods A comprehensive literature search was performed in the following databases from inception to January 2018: Ovid MEDLINE, Ovid EMBASE, and the Cochrane Library. Searches across the databases retrieved 367 results. Two of 5 reviewers independently screened a total of 298 citations. Discrepancies were resolved by a third reviewer. Twenty articles fit our criteria, but due to methodological differences findings could not be pooled for meta-analysis. For 5 studies, raw data were provided, pooled, and used to derive optimal diagnostic cut points. Results Our final analysis included 1861 non-IA patients, including 426 patients with PJI, and 90 IA patients of whom 26 had PJI. There was a significant difference among the 4 groups for serum C-reactive protein (CRP), erythrocyte sedimentation rate, and synovial CRP, polymorphonuclear neutrophil percent, white blood cells, interleukin (IL)-6, IL-8, and IL-1b. Polymorphonuclear neutrophil percent had the highest sensitivity (95.2%) and specificity (85.0%) to detect infections with an optimum threshold of 78%. Conclusion While levels of synovial white blood cells, IL-6, IL-8, and serum CRP appear higher in patients with IA, there is overlap with those who are not infected. Further studies are needed to explore diagnostic tests that will better detect PJI in patients with IA.

This chapter introduces scholarly publication and the informationst's role in supporting researchers embarking on this journey. It breaks down the scholarly communications lifecycle into three sections and illustrates techniques on how the informationist may assist in each stage. The Pre-Pre-Publishing section covers establishing a good research project, focusing the question, appropriate format for topic, reaching the target audience, authorship, and filing for patents. Pre-Publishing covers topics such as literature review, trustworthiness, determining publisher/sponsor longevity, pros and cons of impact factors, visibility/reach, open access considerations, and acceptance rate/time to publication. The Publishing: Navigating the submission process section, focuses on assisting the researcher with the “Instructions for authors,” choosing Keywords/subject headings, Copyright, and Open researcher and contributor ID (ORCID). The last section is a case study where assistance by an informationist is provided to a researcher whose manuscript has been returned by reviewers with a request for extensive edits.

EndNote for iPad is the tablet companion to the EndNote citation manager from Clarivate Analytics (formerly produced by Thomson Reuters).

Background: Lenalidomide is an immunomodulatory agent FDA approved for the treatment of multiple myeloma (MM) and relapsed/refractory mantle cell lymphoma (MCL). More recently, lenalidomide has been shown to enhance the activity of rituximab and has shown activity in first-line and refractory MCL, diffuse large B-Cell lymphoma (DLBCL), and indolent NHL, both as a single agent and in combination with rituximab. In patients with MM treated with lenalidomide, there is a well-documented risk of venous thromboembolism (VTE), cited as 0.7-0.8 events per 100 patient-cycles. However, this risk has never been well-defined in patients with B-cell NHL treated with lenalidomide and remains an important clinical question. We present preliminary findings of a systematic review and meta-analysis determining rates of venous thrombosis in patients with B-cell NHL treated with lenalidomide. We also present subgroup analyses comparing those patients treated with single-agent lenalidomide and those treated with lenalidomide in combination with chemotherapy or biologic agents. Aims: Study aims were to assess rates of VTE in B-cell NHL patients treated with lenalidomide Methods: We conducted a systematic literature search to identify studies in the MEDLINE (1946 to January 2017), EMBASE (1980 to January 2017), and Web of Science Core Collection using the OVID engine, and reviewed the footnotes of all included studies for additional potential studies. We reviewed all abstracts using a structured format and reviewed candidate articles to ensure that they included prospective enrollment of patients with newly diagnosed or relapsed/refractory B-cell NHL, treatment with lenalidomide, and that the number of cycles of lenalidomide given, as well as safety data including rates of VTE, were reported. Two reviewers independently assessed articles for eligibility and extracted data. A VTE event was prospectively defined as Grade II or greater venous thrombosis, and primary outcome defined as VTE events per patient cycle. This was subsequently converted to VTE events per 100 patient cycles for ease of use. The authors were contacted directly if the study would otherwise have met eligibility criteria but did not report all outcomes. Results: 1719 citations were identified in our initial literature search. Of these, 24 articles were deemed eligible. In total, our review identified 8270 cycles of lenalidomide received by patients with B-cell NHL with 65 VTE events, with an event rate of 0.78 per 100 patient-cycles, a rate very consistent with that of lenalidomide in the treatment of MM. In subgroup analyses, the rate of VTE in patients treated with single-agent lenalidomide was 1.56 per 100 patient/cycles versus 0.41 in patients treated with lenalidomide + biologics with a relative risk (RR) of 3.78 (95% CI: 2.04-7.02, p There was no significant difference in rates of VTE between patients treated with lenalidomide + chemotherapy or lenalidomide + biologics. In addition, there was no statistically significant difference between patients treated for DLBCL, MCL, or indolent lymphoma, although our analysis was inadequately powered to detect such a difference. Further risk stratification by disease and patient characteristics, as well as pooled estimates and forest plot creation, is ongoing and will be included in our final report. Conclusion: Rates of thrombosis in patients with B-cell lymphoma treated with lenalidomide are significantly greater in patients treated with single-agent lenalidomide vs those treated with lenalidomide in combination with either chemotherapy or biologic agents. This is consistent with the findings of a phase II trial by Leonard et al. comparing single-agent lenalidomide and lenalidomide + rituximab in follicular lymphoma that showed a differential risk of thrombosis, although statistical significance was not reached in that study. Rates of thrombosis in patients treated with lenalidomide for B-cell NHL are comparable to rates of VTE in MM. These data inform the consideration of strategies for monitoring and prophylaxis in specific clinical settings. Disclosures Leonard: Celgene: Consultancy, Research Funding; Roche: Consultancy. Ruan: Cell Medica: Research Funding; Pharmacyclics: Research Funding; Seattle Genetics: Consultancy, Research Funding; Celgene: Consultancy, Research Funding.