Prospective Registry Data Research Articles

Robotic liver surgery: literature review and future perspectives.

Minimally invasive liver resections (MILR) have been gaining popularity over the last decades. MILR provides superior peri-operative outcome. Despite these advantages, the penetrance of MILR in the clinical setting has been limited, and it was slowed down, among other factors, also by the laparoscopic technological limitations. A literature review has been carried out (Pubmed, Embase and Scopus platforms) focusing on the role of robotic surgery in MILR. The literature review results are presented and our additional remarks on the topic are discussed. Robotic MILR has been helping to expand the penetrance of MIS in liver surgery by making possible increasingly more challenging procedures. Minor resections still represent most of the robotic liver surgery data currently available. Robotic liver surgery is safe and effective, and it shows perioperative outcomes comparable with laparoscopic and open surgery. The oncological efficacy, within the limitations of the current level of evidence (mostly retrospective studies and literature heterogeneity), seems to show promising result. High quality prospective randomized studies, the use of prospective registry data, and multi-institutional efforts are needed.

Fondaparinux versus enoxaparin in the contemporary management of non-ST-elevation acute coronary syndromes. Insights from a multicenter registry

BackgroundFondaparinux is thought to have the most favorable risk–benefit profile among all anticoagulants in non-ST-elevation acute coronary syndrome (NSTE-ACS). However, conflicting findings exist whether this holds true in current clinical practice. We aimed to assess the net clinical benefit of fondaparinux versus enoxaparin in the contemporary management of NSTE-ACS. MethodsAnalysis of prospective multicenter registry data of NSTE-ACS patients who received fondaparinux or enoxaparin from February 2015, through December 2017. Survival models within a competing risks framework including site-specific random effects, were used to assess the composite of clinically relevant bleedings and major adverse cardiovascular events at 30 days. ResultsOf 2094 patients, 1724 (82%) received enoxaparin and 370 (18%) fondaparinux. Both groups were comparable except for a lower prevalence of diabetes and renal impairment, and greater use of transradial approach in the fondaparinux group. Multivariate analysis revealed a net clinical benefit in favour of fondaparinux versus enoxaparin (Subhazard Ratio [SHR] 0.59; 95%CI 0.37–0.92), mainly driven by a reduction in bleeding (SHR 0.57; 95%CI 0.37–0.89). Exploratory analysis suggested greater reductions in bleeding with fondaparinux among patients undergoing transradial approach, revealing a significant interaction between treatment and vascular access on the multiplicative scale (Pinteraction = 0.0056), but not on an additive scale (P = 0.457). Propensity-score-matching analysis yielded similar results. ConclusionsIn contemporary management of NSTE-ACS, fondaparinux seems to provide a favorable net clinical benefit compared with enoxaparin, primarily driven by a bleeding reduction. Effect modification on the safety profile of fondaparinux by the vascular access approach warrants further investigation.

The 5 Pillars in Tourette Syndrome Deep Brain Stimulation Patient Selection: Present and Future.

The selection of patients with Tourette syndrome (TS) for deep brain stimulation (DBS) surgery rests on 5 fundamental pillars. However, the operationalization of the multidisciplinary screening process to evaluate these pillars remains highly diverse, especially across sites. High tic severity and tic-related impact on quality of life (first 2 pillars) require confirmation from objective, validated measures, but malignant features of TS should per se suffice to fulfill this pillar. Failure of behavioral and pharmacologic therapies (third pillar) should be assessed taking into account refractoriness through objective and subjective measures supporting lack of efficacy of all interventions of proven efficacy, as well as true lack of tolerability, adherence, or access. Educational interventions and use of remote delivery formats (for behavioral therapies) play a role in preventing misjudgment of treatment failure. Stability of comorbid psychiatric disorders for 6 months (fourth pillar) is needed to confirm the predominant impact of tics on quality of life, to prevent pseudo-refractoriness, and to maximize the future DBS response. The 18-year age limit (fifth pillar) is currently under reappraisal, considering the potential impact of severe tics in adolescence and the predictive effect of tic severity in childhood on tic severity when transitioning into adulthood. Future advances should aim at a consensus-based definition of failure of specific, noninvasive treatment strategies for tics and of the minimum clinical observation period before considering DBS treatment, the stability of behavioral comorbidities, and the use of a prospective international registry data to identify predictors of positive response to DBS, especially in younger patients.

Esssential thrombocythaemia and pregnancy—A need for prospective study and a consensus on its management

MPN are rare diseases, however young women with ET are increasingly being recognised. Management during pregnancy is often a recognised issue with no clear guidelines for management. Pregnancy is associated with considerable risk of complications and therefore warrants a multidisciplinary approach and early identification of high-risk pregnancies. Robust data is limited and therefore we advocate for more prospective (cohort and registry), multicentre, collaborative efforts to gather meaningful information about risk, and risk-adapted therapy, to guide management.The commentary reviews the study by How et al and compares the observations to other studies around the world. It recognises that previous pregnancies with complications increase the risk of further complications during future pregnancies. It is important to recognise the high-risk pregnancies and have a risk adapted approach to the same. The use of low dose aspirin is recommended throughout the pregnancy. The use of LMWH prophylaxis antepartum should be individualised to the thrombotic risk status and applied post-partum for at least 6 weeks. Interferon a remains the safest and effective approach for cytoreductive therapy. Collaborative expert efforts world-wide, as well as larger prospective trials and registry data, will enhance our knowledge to formulate standard guidelines for these group of patients.

Evaluating abusive head trauma in children < 5 years old: Risk factors and the importance of the social history

BackgroundAbusive head trauma (AHT) is the leading cause traumatic death in children ≤5 years of age. AHT remains seriously under-surveilled, increasing the risk of subsequent injury and death. This study assesses the clinical and social risks associated with fatal and non-fatal AHT. MethodsA single-institution, retrospective review of suspected AHT patients ≤5 years of age between 2010 and 2016 using a prospective hospital forensic registry data yielded demographic, clinical, family, psycho-social and other follow-up information. Descriptive statistics were used to look for differences between patients with AHT and accidental head trauma. Logistic regression estimated the adjusted odds ratios (AOR) for AHT. A receiver operating characteristic (ROC) curve was created to calculate model sensitivity and specificity. ResultsForensic evaluations of 783 children age ≤5 years with head trauma met the inclusion criteria; 25 were fatal with median[IQR] age 23[4.5–39.0] months. Of 758 non-fatal patients, age was 7[3.0–11.0] months; 59.5% male; 435 patients (57.4%) presented with a skull fracture, 403 (53.2%) with intracranial hemorrhage. Ultimately 242 (31.9%) were adjudicated AHT, 335(44.2%) were accidental, 181 (23.9%) were undetermined. Clinical factors increasing the risk of AHT included multiple fractures (Exp(β) = 9.9[p = 0.001]), bruising (Expβ = 5.7[p < 0.001]), subdural blood (Exp(β) = 5.3[p = 0.001]), seizures (Exp(β) = 4.9[p = 0.02]), lethargy/unresponsiveness (Exp(β) = 2.24[p = 0.02]), loss of consciousness (Exp(β) = 4.69[p = 0.001]), and unknown mechanism of injury (Exp(β) = 3.9[p = 0.001]); skull fracture reduced the risk of AHT by half (Exp(β) = 0.5[p = 0.011]). Social risks factors included prior police involvement (Exp(β) = 5.9[p = 0.001]), substance abuse (Exp(β) = 5.7[p = .001]), unknown number of adults in the home (Exp(β) = 4.1[p = 0.001]) and intimate partner violence (Exp(β) = 2.3[p = 0.02]). ROC area under the curve (AUC) = 0.90([95% CI = 0.86–0.93] p = .001) provides 73% sensitivity; 91% specificity. ConclusionsTo improve surveillance of AHT, interviews should include and consider social factors including caregiver/household substance abuse, intimate partner violence, prior police involvement and household size. An unknown number of adults in home is associated with an increased risk of AHT. Study Type/Level of EvidencePrognostic, Level III.

Ten-Year Experience in Implementing Single-Fraction Lung SBRT for Medically Inoperable Early Stage Lung Cancer

PURPOSE To review ten years of employing single-fraction lung SBRT (SF-SBRT) for medically inoperable peripheral early stage lung cancer. METHODS An IRB-approved prospective lung SBRT data registry was surveyed until the end of December 2019 for all patients receiving SF-SBRT with minimum 6-month follow up. Doses employed were either 34 Gy or 30 Gy. Outcomes of interest included rates of local failure (LF) and overall survival (OS), as well as treatment-related toxicity graded per CTCAE version 3.0. RESULTS 229 patients met study criteria. Patient characteristics included: female (55%); median age 74.6 years (range 47-94); median KPS 80 (range 50-100). Tumor characteristics included: median diameter 1.6 cm (range 0.7-4.1); median PET SUVmax 6.1 (range 0.8-24.3); 63.6% of patients biopsied. SF-SBRT dose was 34 Gy in 72.1% cases and 30 Gy in 27.9%, with patient and tumor characteristics balanced between cohorts. Overall median follow up times for 30 Gy and 34 Gy were 36.7 and 17.2 months, respectively (p <0.0001). At analysis, 55.9% patients were alive. Two (0.9%) patients developed grade 3 toxicities and none grade 4/5 toxicities. Grades 1-2 pneumonitis and chest wall toxicity were seen in 7% and 12.7% patients, respectively. Median overall survival was 44.1 months. Rates (in %) of 2-year local, nodal and distant failure were 7.3, 9.4 and 12.2, respectively. There were no significant differences in outcomes by dose. CONCLUSIONS This is the largest institutional series to date reporting on SF-SBRT outcomes for medically inoperable peripheral early stage lung cancer and the first to report on a decade's experience in implementing this schedule. Outcomes from this analysis are comparable to published results from two randomized trials and validate the utilization of this schedule in routine practice. In the absence of phase III trials, this study should encourage increased utilization of SF-SBRT for inoperable tumors.

The burden of trauma in Tanzania: Analysis of prospective trauma registry data at regional hospitals in Tanzania

BackgroundTrauma contributes significantly to the burden of disease and mortality in sub-Saharan Africa (SSA). Like most of SSA, Tanzania lacks prospective trauma registries (TRs), resulting in poor and inconsistent availability of injury data. A model TR was implemented at five representative regional hospitals in Tanzania; the TR incorporates the variables recommended by the World Health Organisation (WHO) Data Set for Injury. This study characterises the burden of trauma seen at five regional hospital Emergency Units (EUs) in Tanzania using data from this new TR. MethodsThis prospective descriptive study used TR data from EUs of five regional Hospitals in Tanzania between February 2019 to September 2019. Descriptive statistics were calculated for mechanism of injury, injury severity, disposition and mortality. Injury severity scores were calculated. We determined relative risk for mortality by injury type. ResultsOver a seven-month period, 6,302 (9.6%) patients presented to these EUs with trauma-related complaints. They had a median age of 27 (IQR: 19–37) years and 71.3% were male. Most patients (76.6%) were self-referred and presented to EU on motorized (two or three-wheeler) vehicle (55.9%). Road traffic accidents (RTAs) 3786 (60.3%) were the most common mechanism of injury. Most patients (63.3%) presented with injuries to the upper and lower extremities, while few (2.0%) had injuries to the chest. The overall mean Injury Severity Score (ISS) was 9 (Interquartile Range (IQR): 4–13], and varied by hospital. Total 24-hour mortality was 3.3% and 126 (2.1%) patients died while receiving care at the EU. Among those who died, 156 (81.7%) had an intracranial injury; relative risk of death was [13.3 (CI95%: 9.3 -19.1), p<0.0001] for intracranial injuries compared to other injury patterns. ConclusionsTR from these five Tanzanian regional hospitals has provided an opportunity to more accurately describe the country's burden of injury. Having sufficient data for ISS and other key trauma variables allows us to compare the burden and outcomes of trauma in Tanzania with other countries, which will help to quantify an accurate burden of injury, inform quality improvement initiatives, and suggest where to focus preventative measures.

Prevalence and clinical significance of totally occluded infarct-related arteries in patients with non-ST-segment elevation acute coronary syndromes

Background Seemingly conflicting findings exist regarding the prognostic impact of totally occluded infarct-related arteries (oIRA) in non-ST elevation acute coronary syndromes (NSTE-ACS).Methods Retrospective analysis of prospective multicenter registry data comprising a single-center NSTE-ACS cohort, aimed at assessing the impact of occluded (TIMI flow 0/1) versus patent culprit vessels (pIRA, TIMI flow 2/3) on the composite endpoint of all-cause death and cardiogenic shock events at 30 days.Results Of 568 patients, 183 (32.5%) had oIRA. Male sex, refractory angina, ECG suggestive of multivessel or left main disease, and larger infarct sizes with inferior/posterolateral wall involvement, were identified as highly specific markers of oIRA. Successful culprit-lesion revascularization occurred more frequently in patent than in oIRA (90% vs. 96%; P = 0.013). Conversely, patients with oIRA more frequently achieved successful revascularization of concurrent non-IRAs including chronic total occlusions than did those with pIRA (28% vs. 3%; P = 0.0005). Multivariate analysis revealed neutral effects of oIRA on outcomes and identified incomplete revascularization as a powerful predictor of mortality. Moderation analysis revealed a significant interaction between completeness of revascularization and IRA patency, whereby among the incompletely revascularized patients, those with oIRA enjoyed a significant survival advantage over their counterparts with pIRA (11.8% vs. 28%, adjusted OR 0.34; 95% CI 0.10–0.73; Pinteraction = 0.012).Conclusions Approximately one third of NSTE-ACS patients in this cohort had oIRA. However, compared with pIRA, the occurrence of oIRA did not portend poor outcomes, likely resulting from the higher rate of incomplete revascularization and increased risk of subsequent mortality in patients with pIRA. These exploratory findings warrant further investigation.

Impact of prior (neo)adjuvant trastuzumab (NAT) exposure on the efficacy of HER2-targeted therapy for metastatic breast cancer

Trastuzumab, pertuzumab, and docetaxel are the standard first-line therapy for HER2-positive (HER2+) metastatic breast cancer (MBC). However, only 10% of patients received neoadjuvant and/or adjuvant trastuzumab (NAT) in the registration trial (NCT00567190). In contemporary practice, the majority of recurrent HER2+ MBC patients had prior NAT. We explore any impact of prior therapy on the efficacy of dual HER2-targeted antibody with taxane therapy for metastatic disease. Utilising a prospective national registry, clinico-pathological, treatment, and outcome data for HER2+ MBC patients diagnosed between October 2006 and January 2019 were collected. Survival was estimated by the Kaplan-Meier method and compared among groups by log-rank test. Of 287 HER2+ MBC patients, 222 (77%) received first-line trastuzumab, pertuzumab, and taxane therapy. There were 130 (45%) with de novo MBC. Of the recurrent MBC patients 107/157 (68%) had received NAT. The median progression-free survival (PFS) among patients who received NAT was 15.8months compared with 24.3months without prior NAT (hazard ratio [HR] 1.45, 95% CI 1.05-2.03, p = 0.03). The median overall survival (OS) was 42.7months in patients who had NAT, and was not reached in those who did not (HR 1.80, 95% CI 1.12-2.90, p = 0.02). However, when excluding de novo MBC patients, prior NAT exposure was no longer significantly associated with survival (p = 0.11). De novo MBC patients had the longest median PFS (25.2months) and OS (91.2months). Prior receipt of NAT was associated with inferior median PFS following first-line HER2-based therapy in the metastatic setting. However, prior NAT exposure did not significantly impact OS, supporting the efficacy of taxane, trastuzumab, pertuzumab combination for first-line HER2+ MBC regardless of prior NAT exposure. Patients with de novo MBC had the longest survival, suggesting stratification for synchronous versus metachronous disease in prospective clinical trials of MBC should be considered.

Hydroxychloroquine use in hospitalised patients with COVID-19: An observational matched cohort study

AimTo assess the efficacy and safety of hydroxychloroquine with or without azithromycin) in hospitalized adult patients with COVID-19. MethodsWe utilized a hospital based prospective data registry. The primary end point was to assess the impact of hydroxychloroquine with or without azithromycin, on outcome, length of hospitalization, and time to clinical improvement. We utilized treatment effects with inverse-probability-weighting and Cox proportional hazards models. All analyses accounted for age, gender, race, severity on admission, days from symptoms onset and chronic comorbidities. Results36 patients received hydroxychloroquine and were age- and sex-matched to 72 patients with COVID-19 who received supportive care. Compared to supportive care, the use of HCQ did not shorten the time to clinical improvement (+0.23 days; 95% CI: −1.8–2.3 days) nor did it shorten the duration of hospital stay (+0.91 days; 95% CI: −1.1–2.9 days). Additionally, HCQ did not decrease the risk of COVID-19 in-hospital death (aHR 1.67; 95% CI: 0.29–9.36). Finally, we observed a slight QTc prolongation from a baseline of 444 ± 26 ms to 464 ± 32 ms (mean±SD) among patients receiving hydroxychloroquine with or without azithromycin. ConclusionThis study did not yield benefits from hydroxychloroquine use in patients with COVID-19 and monitoring for adverse events is warranted. Nevertheless, the treatment was safely studied under the guidance of an antimicrobial stewardship program.

Long-term efficacy of vasodilating β-blocker in patients with acute myocardial infarction: nationwide multicenter prospective registry

Background/AimsLong-term benefit of vasodilating β-blockers is unknown. This study aimed to investigate the long-term benefit of vasodilating β-blockers over conventional β-blockers in patients with acute myocardial infarction (AMI).MethodsUsing nationwide prospective multicenter Korean Acute Myocardial Infarction Registry data, we analyzed 3-year clinical outcomes of 7,269 patients with AMI who received percutaneous coronary intervention (PCI) and β-blocker therapy. Patients were classified according to treatment strategy (vasodilating β-blockers vs. conventional β-blockers). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), and hospitalization for heart failure (HF) at 3 years. Secondary outcomes were each component of the primary outcome. Propensity score matching was performed to adjust for differences of baseline characteristics.ResultsIn 3,079 pairs (6,158 patients) of propensity score-matched patients, the primary outcome occurred significantly less in the vasodilating β-blockers group compared with the conventional β-blockers group (7.6% vs. 9.8%, p = 0.003). Among the secondary outcomes, cardiac death occurred significantly less in the vasodilating β-blockers group than in the conventional group (3.5% vs. 4.8%, p = 0.015). The incidence rates of MI (2.4% vs. 3.0%, p = 0.160) or hospitalization for HF (2.6% vs. 3.2%, p = 0.192) were not significantly different between the two groups.ConclusionsVasodilating β-blocker therapy was associated with better clinical outcomes compared with conventional β-blocker therapy in AMI patients undergoing PCI during 3 years follow-up. Vasodilating β-blockers could be recommended preferentially for these patients.

Prognostic factors for lymphedema in patients with locally advanced head and neck cancer after combined radio(chemo)therapy- results of a longitudinal study.

Treatment-associated lymphedema is a common side effect after multimodal therapy for locally advanced head and neck cancer (LAHNC). This study aims to evaluate potential prognostic factors for head and neck lymphedema (HNL) and its potential impact on clinical outcome. This is a prospective data registry analysis on 280 patients treated for locally advanced head and neck cancer (LAHNC). All patients received surgery and risk-adapted platinum-based adjuvant intensity modulated radio(chemo)therapy (R(C)T, IMRT). Treatment- related toxicity was prospectively registered in a data base in regular intervals (baseline 3months after R(C)T, every 3months for 3years, and every 6months thereafter) and documented according to RTOG/EORTC toxicity criteria. Predictive for any grade HNL 3months after R(C)T were age, BMI, number of removed nodes and RT modality. Multivariable logistic regression analysis showed that in the acute toxicity phase (3months after R(C)T) higher body mass index (BMI), extracapsular spread (ECE), linac-based IMRT, bilateral treatment to the neck (surgery and RT), and the addition of chemotherapy increase the risk for grade 2 HNL. For chronic HNL, higher BMI, linac-based IMRT and ECE were predictive for grade 2 HNL. Higher BMI is associated with better local control rates. Advanced age and ECE had a negative impact on OS. HNL is a common acute and late side effect after multimodal therapy for LAHNC. Knowing risk factors for HNL prior to therapy enables caregivers and patients to take measures prior to treatment to prevent or limit the effects of HNL.

Impact of complete recanalization on clinical recovery in cardioembolic stroke patients with M2 occlusion

Background and purposeWe investigated the impact of complete recanalization beyond partial recanalization in distal (M2) middle cerebral artery (MCA) occlusion. MethodsData regarding M2 occlusion patients treated with endovascular thrombectomy (EVT) and/or intravenous thrombolysis (tPA) were reviewed from our prospective EVT registry and multicenter tPA (YAMATO study) data bank. Complete recanalization was modified thrombolysis with cerebral infarction score (TICI) of 3 at the end of EVT or similar appearances of both MCAs on magnetic resonance angiography (MRA) within 1.5 h after tPA. Partial recanalization was defined as TICI ≥2b or > 50% recanalization on MRA. At 3 months, favorable outcome was defined as a modified Rankin Scale score ≤ 2. ResultData on 121 patients were analyzed. EVT-alone was in 38 patients; combined EVT and tPA in 28; and tPA-alone in 55. Complete recanalization was achieved in 27 (22%), partial recanalization in 48 (40%), and no-to-limited recanalization in 46 (38%). At 3 months, 51% of patients had favorable outcomes, and this rate was significantly higher in the complete recanalization group than in the partial and no-to-limited recanalization groups (75% vs. 41% vs. 49%, p = .043). Multivariate regression analysis showed that complete recanalization was an independent parameter related to favorable outcomes (odds ratio 4.78, 95% CI: 1.16–19.73, p = .030). However, combined complete and partial recanalization was not associated with favorable outcomes (odds ratio 1.49, 95% CI 0.53–4.22, p = .449). ConclusionComplete recanalization, but not partial recanalization, at the end of EVT and tPA therapy is associated with favorable outcomes in patients with M2 occlusion.

Prevalence of Deep Endometriosis and Rectouterine Pouch Obliteration in the Presence of Normal Ovaries.

It is well-established that there is a strong association between ovarian endometriomas (OE) and deep endometriosis (DE) and rectouterine pouch (RP) obliteration. We aimed to determine the prevalence of DE and RP obliteration in the presence of normal ovaries. We conducted a multicentre retrospective cohort study from January 2009 to December 2017 using a prospective multicentre data registry. Participants included patients with signs and/or symptoms of endometriosis who underwent excisional laparoscopic surgery at one of eight hospitals. The primary outcome was the prevalence of DE and RP obliteration, which was compared between women with normal ovaries (i.e., no OE) and women with ovaries containing OE. Secondary outcomes evaluated included rates of DE by anatomic site between women with and without OE. The ovaries did not contain an OE in 319 of 410 patients (77.8%). The prevalence of DE and RP obliteration in this cohort was 25.4% and 9.7% (81 and 31 patients), respectively; whereas, in patients with OE, DE and RP obliteration prevalence was 68.1% and 60.4% (62 and 55 patients), respectively (P < 0.001 for both DE and RP obliteration). The uterosacral ligaments were the most common site for DE (right: 47/319 [14.7%]; left: 42/319 [13.2%]). In patients who visited a tertiary care centre with endometriosis without ovarian involvement, 1 in 4 had DE and 1 in 10 had RP obliteration. These prevalence rates should encourage knowledge and skills dissemination to improve non-invasive imaging diagnosis overall. In patients with symptoms or signs suggestive of endometriosis, a basic pelvic ultrasound that ends at evaluation for OE should not be regarded as reassuring.

Establishing and Coordinating a Nationwide Multidisciplinary Study Group: Lessons Learned by the Dutch Pancreatic Cancer Group.

Establishing and Coordinating a Nationwide Multidisciplinary Study Group: Lessons Learned by the Dutch Pancreatic Cancer Group.

Acute Cardiovascular Care Association position statement for the diagnosis and treatment of patients with acute myocardial infarction complicated by cardiogenic shock: A document of the Acute Cardiovascular Care Association of the European Society of Cardiology.

Most of the guideline-recommended treatment strategies for patients with acute coronary syndromes have been tested in large randomised clinical trials. Still, a major challenge is represented by patients with acute myocardial infarction admitted with impending or established cardiogenic shock. Despite early revascularization the mortality of cardiogenic shock remains high and roughly half of patients do not survive until hospital discharge or 30-day follow-up. However, there is only limited evidence-based scientific knowledge in the cardiogenic shock setting. Therefore, recommendations and actual treatments are often based on retrospective or prospective registry data and extrapolations from randomised clinical trials in acute myocardial infarction patients without cardiogenic shock. This position statement will summarise the current consensus of the diagnosis and treatment of patients with acute myocardial infarction complicated by cardiogenic shock based on current evidence and will provide advice for clinical practice.

Impact of Modifiable Bleeding Risk Factors on Major Bleeding in Patients With Atrial Fibrillation Anticoagulated With Rivaroxaban.

BackgroundReducing major bleeding events is a challenge when managing anticoagulation in patients with atrial fibrillation. This study evaluated the impact of modifiable and nonmodifiable bleeding risk factors in patients with atrial fibrillation receiving rivaroxaban and estimated the impact of risk factor modification on major bleeding events.Methods and ResultsModifiable and nonmodifiable risk factors associated with major bleeding events were identified from the XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation) prospective registry data set (6784 rivaroxaban‐treated patients). Parameters showing univariate association with bleeding were used to construct a multivariable model identifying independent risk factors. Modeling was used to estimate attributed weights to risk factors. Heavy alcohol use (hazard ratio [HR]=2.37; 95% CI 1.24–4.53); uncontrolled hypertension (HR after parameter‐wise shrinkage=1.79; 95% CI 1.05–3.05); and concomitant treatment with antiplatelets, nonsteroidal anti‐inflammatory drugs, or paracetamol (HR=1.80; 95% CI 1.24–2.61) were identified as modifiable, independent bleeding risk factors. Increasing age (HR=1.25 [per 5‐year increment]; 95% CI 1.12–1.38); heart failure (HR=1.97; 95% CI 1.36–2.86); and vascular disease (HR=1.91; 95% CI 1.32–2.77) were identified as nonmodifiable bleeding risk factors. Overall, 128 (1.9%) patients experienced major bleeding events; of these, 11% had no identified bleeding risk factors, 50% had nonmodifiable bleeding risk factors only, and 39% had modifiable bleeding risk factors (with or without nonmodifiable risk factors). The presence of 1 modifiable bleeding risk factor doubled the risk of major bleeding.ConclusionsElimination of modifiable bleeding risk factors is a potentially effective strategy to reduce bleeding risk in atrial fibrillation patients receiving rivaroxaban.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01606995.

Big Data vs. Clinical Trials in HPB Surgery

Randomized controlled clinical trials (RCTs) are at the heart of “evidence-based” medicine. However, in surgical practice, RCTs remain uncommon. Conducting well-designed RCTs for surgical procedures is often challenged by inadequate recruitment accrual, blinding, or standardization of the surgical procedure, as well as lack of funding and evolution of the treatment strategy during the many years over which such trials are conducted. In addition, most clinical trials are performed in academic high-volume centers in highly selected patients, which may not necessarily reflect a “real-world” practice setting. Over the past decades, surgical outcomes research using nationwide administrative and registry databases has become increasingly common. Large databases provide easy and inexpensive access to data on a large and diverse patient population at a variety of treatment centers. Furthermore, large database studies provide the opportunity to answer questions that would be impossible or very arduous to answer using RCTs, including questions regarding health policy efficacy, trends in surgical practice, access to health care, impact of hospital volume, and adherence to practice guidelines, as well as research questions regarding rare disease, infrequent surgical outcomes, and specific subpopulation. Prospective data registries may also allow for quality benchmarking and auditing. This review outlines the role, advantages, and limitations of RCTs and large database studies in answering important research questions in surgery.

Development of a prospective data registry system for retrograde intrarenal surgery in renal stones: Turkish Academy of Urology Prospective Study Group (ACUP study)

We aimed to report the development of a prospective data registry by generating a retrograde intrarenal surgery (RIRS)-specific electronic case report form (eCRF), which can be used by multiple centers in Turkey. The Stone Disease Study Group of Turkish Urology Academy developed a template for the necessary data to be collected, which was then implemented within a dedicated server. Urologists from different universities, research and training centers, and private hospitals were invited to participate in this data registry. Each urologist was provided with a unique username and password after they agreed to participate in the study. In March 2015, the development of the eCRF was completed, and the server was opened for data input in April 2015. We started a prospective clinical data registry for all patients undergoing RIRS for renal stone(s) in 15 participating hospitals. Until the end of June 2016, 1112 RIRSs on 1264 patients have been included in the dataset. The easy-to-use eCRF specifically developed for RIRS was first of its kind in Turkey. This prospective data registry harvests important data that will be used to identify real-world demographic, clinical and operative data of patients with renal stone who undergo RIRS in various urology departments throughout Turkey. The results of this dataset will be presented in various papers.

The Experience of Land and Water Birth Within the American Association of Birth Centers Perinatal Data Registry, 2012-2017.

Consumer demand for water birth has grown within an environment of professional controversy. Access to nonpharmacologic pain relief through water immersion is limited within hospital settings across the United States due to concerns over safety. The study is a secondary analysis of prospective observational Perinatal Data Registry (PDR) used by American Association of Birth Center members (AABC PDR). All births occurring between 2012 and 2017 in the community setting (home and birth center) were included in the analysis. Descriptive, correlational, and relative risk statistics were used to compare maternal and neonatal outcomes. Of 26 684 women, those giving birth in water had more favorable outcomes including fewer prolonged first- or second-stage labors, fetal heart rate abnormalities, shoulder dystocias, genital lacerations, episiotomies, hemorrhage, or postpartum transfers. Cord avulsion occurred rarely, but it was more common among water births. Newborns born in water were less likely to require transfer to a higher level of care, be admitted to a neonatal intensive care unit, or experience respiratory complication. Among childbearing women of low medical risk, personal preference should drive utilization of nonpharmacologic care practices including water birth. Both land and water births have similar good outcomes within the community setting.