MDEpiNet’s Scientific Oversight Committee begins its work

MDEpiNet’s Scientific Oversight Committee recently conducted its introductory meeting, and is now beginning to review the first round of proposals that have been submitted to it.

The committee is the convening, oversight, and facilitation body for MDEpiNet’s Working Groups. It includes a broad range of individuals, representing the scientific community (from academia and industry) and regulatory agencies (from the United States and other countries). The committee’s charter directs it to consider key aspects of the Working Group implementation plans, the alignment of objectives with the MDEpiNet mission; the practicality of any implementation plans, including access to resources, leadership, expertise and timelines for deliverables; and the impact of specific proposed deliverables.

Chaired by Jesse Berlin of Johnson and Johnson, and Gregory Pappas of the U.S. Food and Drug Administration, the committee is currently evaluating the proposals generated by the Predictable and Sustainable Implementation of National Cardiovascular Registries (PASSION) and Specific, Measurable, Achievable, Results-Oriented, Time Bound Collaboration (SMART) INFORMATICS Think Tank meetings held earlier this year. At present, there are nine projects under consideration by the Scientific Oversight Committee.

“Our intent is to take on a collaborative role and provide helpful advice to investigators on study design, implementation, and desired outcomes,” Berlin said. “The goal is to improve investigators’ chances for obtaining ongoing external funding and provide an objective scientific perspective to ensure that the proposals are aligned with MDEpiNet’s goals.

“We are not, at least for now, aiming at any kind of evaluation or approval role, in part because we’re not a funding body,” he said.

Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: population based cohort study

Journal BMJ
Authors Chughtai, Bilal; Mao, Jialin; Buck, Jessica; Kaplan, Steven; Sedrakyan, Art
Year Published 2015
Link to article

Abstract

OBJECTIVE: To assess the use of mesh in pelvic organ prolapse surgery, and compare short term outcomes between procedures using and not using mesh.

DESIGN: All inclusive, population based cohort study.

SETTING: Statewide surgical care captured in the New York Statewide Planning and Research Cooperative System.

PARTICIPANTS: Women who underwent prolapse repair procedures in New York state from 2008 to 2011.

MAIN OUTCOMES MEASURES: 90 day safety events and reinterventions within one year, after propensity score matching. Categorical, time to event, and subgroup analyses (<65 and ≥65 year age groups) were conducted.

RESULTS: Of 27 991 patients in total, 7338 and 20 653 underwent prolapse repair procedures with and without mesh, respectively. Mesh use increased by 44.7%, from 1461 procedures in 2008 to 2114 procedures in 2011. Most patients in the cohort were younger than 65 years (62.3% (n=17 424/27 991)). However, more patients were aged 65 years and older in the mesh group than in the non-mesh group (44.3% (n=3249) v 35.4% (n=7318)). Complications after surgery were not common, irrespective of the use or non-use of mesh. After propensity score matching, patients who received the surgery with mesh had a higher chance of having a reintervention within one year (mesh 3.3% v no mesh 2.2%, hazard ratio 1.47 (95% confidence interval 1.21 to 1.79)) and were more likely to have urinary retention within 90 days (mesh 7.5% v no mesh 5.6%, risk ratio 1.33 (95% confidence interval 1.18 to 1.51)), compared with those who received surgery without mesh. In subgroup analyses based on age, mesh use was associated with an increased risk of reintervention within one year in patients under age 65 years, and increased risk of urinary retention in patients aged 65 years and over.

CONCLUSIONS: Despite multiple warnings released by the US Food and Drug Administration since 2008, use of mesh in pelvic organ prolapse surgery continues to grow. In this statewide comprehensive study, mesh procedures were associated with an increased risk of reinterventions within one year and urinary retention after surgery.

Mesh use in surgery for pelvic organ prolapse

Journal BMJ
Authors Barber, Matthew D
Year Published 2015
Link to article

Introduction

By age 80 years, one in eight women will undergo surgery for pelvic organ prolapse (POP), a condition where the pelvic organs descend into or through the vaginal canal. In the United States, about 80% of procedures are performed transvaginally. Building on the experience of general surgeons and the treatment of abdominal hernias, pelvic surgeons began using synthetic mesh to augment prolapse repairs to reduce prolapse recurrence seen frequently after native tissue (non-mesh) repairs. However, use of synthetic mesh also results in increased adverse events, in some cases with serious consequences

Combining randomized trial data to estimate heterogeneous treatment effects

Authors  Hatfield, Laura; Kramer, Daniel;  Normand, Sharon-Lise
Year Published 2015
Link to white paper

Abstract

Heart failure arises, progresses, and responds to therapy differently in different people. Yet clinical trials often lack power to estimate treatment effects for subgroups, or enforce eligibility criteria that exclude some patients entirely. Combining information across trials increases power for subgroup estimates and expands generalizibility. However, naively pooling patient-level data sacrifices the benefits of randomization, and pooling study-level estimates must consider trial heterogeneity.We develop and illustrate approaches for combining information across trials to estimate effects in men and women with heart failure who are treated with implantable cardioverter-defibrilliator (ICD) alone or in combination with cardiac resynchronization therapy (CRT-D). We consider individual- and trial-level factors that may confound or mediate subgroup treatment effects. For example, ischemic disease is more common in men; could this explain why women appear to benefit more from CRT-D than men?Our Bayesian models estimate sex-specific treatment effects across trials, accounting for uncertainty, confounding, and mediation. We find that with a very small number of heterogeneous studies, hierarchical modeling offers few benefits over conventional effect pooling,producing wider credible intervals but little shrinkage. We also find little evidence for residual confounding within subgroups, but some evidence of interactions between left bundle branch blockage and ischemic etiology in the sex-specific treatment effects, suggesting further study.

Acknowledgments

LAH and SLN are supported by contract DHHS/FDA-223201110172C and grant 1U01FD004493-01 from the Center for Devices and Radiological Health, US Food and Drug Administration.DBK is supported by a Paul B. Beeson Career Development Award (NIA K23AG045963).

HHS announces proposed rules to support the path to nationwide interoperability – Open for public comment

The U.S. Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) today announced the release of the Stage 3 notice of proposed rulemaking for the Medicare and Medicaid Electronic Health Records (EHRs) Incentive Programs and 2015 Edition Health IT Certification Criteria to improve the way electronic health information is shared and ultimately improve the way care is delivered and experienced.

The Stage 3 proposed rule may be viewed at here and the comment period ends on May 29, 2015. The 2015 Edition proposed rule may be viewed at here and the comment period ends on May 29, 2015. The Draft 2015 Edition Certification Test Procedures may be viewed at HealthIT.gov, and the comment period ends on June 30, 2015.

Read more on about the proposed rule on the HHS website.