Early technology review: towards an expedited pathway.

Objectives: Evidence development for medical devices is often focused on satisfying regulatory requirements with the result that health professional and payer expectations may not be met, despite considerable investment in clinical trials. Early engagement with payers and health professionals could allow companies to understand these expectations and reflect them in clinical study design, increasing chances of positive coverage determination and adoption into clinical practice.

Methods: An example of early engagement through the EXCITE International model using an early technology review (ETR) is described which includes engagement with payers and health professionals to better inform companies to develop data that meet their expectations.

Overview and experience of the YODA Project with clinical trial data sharing after 5 years.

The Yale University Open Data Access (YODA) Project has facilitated access to clinical trial data since 2013. The purpose of this article is to provide an overview of the Project, describe key decisions that were made when establishing data sharing policies, and suggest how our experience and the experiences of our first two data generator partners, Medtronic, Inc. and Johnson & Johnson, can be used to enhance other ongoing or future initiatives.

Advancing the Science of Healthcare Service Delivery: The NHLBI Corporate Healthcare Leaders' Panel.

There is a growing gap between available science and evidence and the ability of service providers to deliver high-quality care in a cost-effective way to the entire population. We believe that the chasm between knowledge and action is due to a lack of concerted effort among all organizations that deliver health care services across the life span of patients. Broad participation is needed and necessitates a far more explicit and concerted public-private partnership focused on large-scale transformation.

Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.

Purpose: To estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice.

Methods: We conducted repeated sample size estimates to calculate the medical device utilization needed, systematically varying device-specific safety event rate ratios and significance levels while maintaining 80% power, testing 3 average adverse event rates (3.9, 6.

Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators.

Background: Machine learning methods may complement traditional analytic methods for medical device surveillance.

Methods And Results: Using data from the National Cardiovascular Data Registry for implantable cardioverter-defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection).

Transcatheter valve therapy registry is a model for medical device innovation and surveillance.

Heart valve diseases are increasingly prevalent, especially in people older than age seventy. Many of these elderly people have other comorbid conditions, making them poor candidates for surgical treatment of heart valve diseases. Since 2011 such patients have been eligible to receive new nonsurgical heart valve treatments approved by the Food and Drug Administration (FDA) and covered by Medicare.

Network news: powering clinical research.

The Patient-Centered Outcomes Research Institute announces bold plans to build a National Patient-Centered Clinical Research Network that will unite millions of patients through a coordinated collaboration with researchers and health care delivery organizations.

The reporting of blinding in physical medicine and rehabilitation randomized controlled trials: a systematic review.

Objective: To conduct a systematic review evaluating the reporting of blinding in randomized controlled trials published in the field of Physical Medicine and Rehabilitation over two time periods.

Data Sources: We searched MEDLINE via PubMed for all randomized controlled trials published in American Journal of Physical Medicine and Rehabilitation, Archives of Physical Medicine and Rehabilitation, Clinical Rehabilitation, Disability and Rehabilitation and (Scandinavian) Journal of Rehabilitation Medicine in the years 2000 and 2010.

Study Selection: We initially identified 222 articles, and 139 (62.

Transurethral holmium laser enucleation versus transurethral resection of the prostate and simple open prostatectomy--which procedure is faster?

Purpose: The longer operative time of holmium laser enucleation of the prostate compared to transurethral resection of the prostate or simple open prostatectomy reported in the literature might have been biased by the unavailability of a soft tissue morcellator, limited surgical experience with holmium laser prostate enucleation or the fact that significantly more tissue was removed by enucleation than by resection. We objectively compared the resection speed of contemporary holmium laser enucleation vs transurethral resection of the prostate and of holmium laser enucleation vs simple open prostatectomy.

Materials And Methods: The study cohort consisted of 100 cases of transurethral prostate resection and 60 of simple open prostatectomy from our previous randomized, controlled trials.

Rationale and design of the MASS COMM trial: A randomized trial to compare percutaneous coronary intervention between MASSachusetts hospitals with cardiac surgery on-site and COMMunity hospitals without cardiac surgery on-site.

Background: Emergency surgery has become an increasingly rare event after percutaneous coronary intervention (PCI). There have been no randomized trials evaluating whether cardiac surgery services on-site are essential for patient safety and optimal outcomes during and after PCI.

Study Design: The MASS COMM trial (ClinicalTrials.

Clostridium perfringens bacteriophages ΦCP39O and ΦCP26F: genomic organization and proteomic analysis of the virions.

Poultry intestinal material, sewage and poultry processing drainage water were screened for virulent Clostridium perfringens bacteriophages. Viruses isolated from broiler chicken offal washes (O) and poultry feces (F), designated ΦCP39O and ΦCP26F, respectively, produced clear plaques on host strains. Both bacteriophages had isometric heads of 57 nm in diameter with 100-nm non-contractile tails characteristic of members of the family Siphoviridae in the order Caudovirales.

Meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement.

Context: There is a continuous decline in the number of transurethral resections of the prostate (TURP) and an increase use of minimally invasive surgical therapy (MIST) for lower urinary tract symptoms resulting from benign prostatic enlargement. Current results from randomised controlled trials (RCT) and methodologically sound prospective studies suggest that some of the proposed procedures have the potential to replace TURP.

Objective: To determine the contemporary status of TURP and of the currently most commonly applied transurethral MISTs: (1) bipolar TURP, (2) bipolar transurethral vaporisation of the prostate (bipolar TUVP), (3) holmium laser enucleation of the prostate (HoLEP), and (4) potassium-titanyl-phosphate (KTP) laser vaporisation of the prostate.

Relative spatial distributions of coronary artery bypass graft insertion and acute thrombosis: a model for protection from acute myocardial infarction.

Background: Randomized trials have demonstrated coronary artery bypass surgery (CABG) to be superior to percutaneous coronary intervention with respect to long-term mortality and morbidity from myocardial infarction within specific high-risk cohorts. The purpose of this study was to analyze the spatial distribution of coronary artery bypass graft anastomoses relative to acute thromboses in native coronary arteries. We hypothesized that insertion sites of bypass grafts are located distal to sites of acute thrombosis and consequently decrease cardiac morbidity and mortality associated with plaque rupture.

Lack of association between migraine headache and patent foramen ovale: results of a case-control study.

Background: Clinical observations of migraine headache symptoms in patients with a patent foramen ovale (PFO), both of which conditions are highly prevalent, have raised the question of a possible pathophysiological relationship. We sought to evaluate the assumption of an association between migraine headaches and the presence of PFO by use of a large case-control study.

Methods And Results: We conducted a case-control study to assess the prevalence of PFO in subjects with and without migraine.

A review of the recent evidence (2006-2008) for 532-nm photoselective laser vaporisation and holmium laser enucleation of the prostate.

Context: Holmium laser enucleation of the prostate (HoLEP) and 532-nm laser vaporisation of the prostate (with potassium titanyl phosphate [KTP] or lithium borate [LBO]) are promising alternatives to transurethral resection of the prostate (TURP) and open prostatectomy (OP).

Objective: To assess safety, efficacy, and durability by analysing the most recent evidence of both techniques, aiming to identify advantages, pitfalls, and unresolved issues.

Evidence Acquisition: A Medline search of recently published data (2006-2008) regarding both techniques over the last 2 yr (January 2006 to September 2008) was performed using evidence obtained from randomised trials (level of evidence: 1b), well-designed controlled studies without randomisation (level of evidence: 2a), individual cohort studies (level of evidence: 2b), individual case control studies (level of evidence: 3), and case series (level of evidence: 4).

Location of acute coronary artery thromboses in patients with and without chronic kidney disease.

Patients with chronic kidney disease have high rates of myocardial infarction and death following an initial attack. Proximal location of coronary atherosclerotic lesions has been linked to the risk of acute myocardial infarction and to infarction-associated mortality. To examine if the spatial distribution of lesions differs in patients with and without chronic kidney disease, we used quantitative coronary angiography to measure this in patients with acute coronary thromboses who were having angiography following acute myocardial infarction.

Genomic differences between Campylobacter jejuni isolates identify surface membrane and flagellar function gene products potentially important for colonizing the chicken intestine.

Campylobacter spp. are one of the leading bacterial etiologic agents of acute human gastroenteritis among industrialized countries. Poultry are implicated as a major source of the organism for human illness; however, the factors involved with colonization of poultry gastrointestinal systems remain unclear.

Saphenous vein graft stenting and major adverse cardiac events: a predictive model derived from a pooled analysis of 3958 patients.

Background: Treatment of saphenous vein graft (SVG) stenosis with percutaneous coronary intervention has a 15% to 20% incidence of major adverse cardiac events (MACE) within 30 days. Although MACE rates are reduced significantly by the use of embolic protection devices (EPDs), neither the level of baseline risk nor the benefit provided by EPDs has been well characterized.

Methods And Results: Data from 5 randomized controlled trials and 1 registry evaluating EPDs in SVG percutaneous coronary intervention (n=3958 patients) were pooled for analysis.