Additional Protections for Children Who Participate in Clinical Research

Blogs.fda.gov: August 27, 2012 Parents and guardians of seriously ill children often face difficult decisions about their child’s medical care. As a physician practicing for about 20 years in a pediatric intensive care unit, I knew that many of the interventions I used, while potentially life-saving, had no guarantee of success and carried a risk of […]

Adaptive trial designs: a review of barriers and opportunities

Trialsjournal.com: 8/23/12 Adaptive designs allow planned modifications based on data accumulating within a study. The promise of greater flexibility and efficiency stimulates increasing interest in adaptive designs from clinical, academic, and regulatory parties. When adaptive designs are used properly, efficiencies can include a smaller sample size, a more efficient treatment development process, and an increased chance […]

Potential explanations for control group benefit

http://ctj.sagepub.com: 8/23/12 Estimating effectiveness of clinical interventions depends on detecting differences between the responses of intervention and control groups. The outcome, intervention, and moderating factors all may influence the between group change. The absence of a clinically or statistically meaningful difference may also result from control group improvement due to nonspecific factors such as participants’ perception […]

Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study

bmj.com: 8/21/12 Objectives To investigate the degree to which Cochrane reviews of drug interventions published in 2010 reported conflicts of interest from included trials and, among reviews that reported this information, where it was located in the review documents. Design Cross sectional study. Data sources Cochrane Database of Systematic Reviews. Selection criteria Systematic reviews of drug interventions published in 2010 […]

A method for utilizing co-primary efficacy outcome measures to screen regimens for activity in two-stage Phase II clinical trials

ctj.sagepub.com: 7/18/12 Background Most Phase II clinical trials utilize a single primary end point to determine the promise of a regimen for future study. However, many disorders manifest themselves in complex ways. For example, migraine headaches can cause pain, auras, photophobia, and emesis. Investigators may believe that a drug is effective at reducing migraine pain and the […]

Recessions and seniors’ health, health behaviors, and healthcare use: Analysis of the Medicare Current Beneficiary Survey

Sciencedirect.com: 8/28/12 A number of studies report that U.S. state mortality rates, particularly for the elderly, decline during economic downturns. Further, several prior studies use microdata to show that as state unemployment rates rise, physical health improves, unhealthy behaviors decrease, and medical care use declines. We use data on elderly mortality rates and data from the […]

Stage 2

cms.gov: 8/28/12 CMS recently published a final rule that specifies the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to continue to participate in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. All providers must achieve meaningful use under the Stage 1 criteria before […]

Hospitals Tally Likely Costs From New Readmissions Penalties

kaiserhealthnews.org: By Jordan Rau. AUGUST 24TH, 2012, 8:32 AM Across the country, hospitals are estimating how much money they are going to forfeit when Medicare’s new penalties for excess readmissions kick in. Hospitals are also issuing divergent verdicts on whether they think the program is a good idea or not. Starting in October, 2,211 hospitals will lose a portion […]

HHS announces next steps to promote use of electronic health records and health information exchange

hhs.gov: August 23, 2012 Today, Health and Human Services (HHS) Secretary Kathleen Sebelius announced the next steps in the Obama administration’s work to help doctors and hospitals use electronic health records. “The changes we’re announcing today will lead to more coordination of patient care, reduced medical errors, elimination of duplicate screenings and tests and greater patient […]

CBO Says Medicare Spending Growth Slower Than Expected

Kaiserhealthnews.org: By Sarah Barr, AUGUST 22ND, 2012, 3:31 PM Amid its grim projections for the economy overall, the Congressional Budget Office on Wednesday said that Medicare spending growth is slowing, although the program will take up a larger share of the economy in a decade than it does now. In an update to its January report on the nation’s budget and […]

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