December 17, 2018: NIH Collaboratory Advances Knowledge in Peer-Reviewed Literature in 2018

The NIH Collaboratory program contributed knowledge from pragmatic clinical research with 12 peer-reviewed publications in 2018, including several reports of findings from Demonstration Projects and more:

NIH Collaboratory Coordinating Center

Identifying and supporting nonpharmacological dementia interventions ready for pragmatic trials: results from an expert workshop. J Am Med Dir Assoc. 2018;19(7):560-562.

NIH Collaboratory Distributed Research Network

Cancer screening results and follow-up using routinely collected electronic health data: estimates for breast, colon, and cervical cancer screenings. J Gen Intern Med. 2018 Oct 22. doi: 10.1007/s11606-018-4697-y. [Epub ahead of print]

STOP CRC Demonstration Project

Effect of reminding patients to complete fecal immunochemical testing: a comparative effectiveness study of automated and live approaches. J Gen Intern Med. 2018;33(1):72-78.

Predictors of colorectal cancer screening prior to implementation of a large pragmatic trial in Federally Qualified Health Centers. J Community Health. 2018;43(1):128-136.

Effectiveness of a mailed colorectal cancer screening outreach program in community health clinics: the STOP CRC cluster randomized clinical trial. JAMA Intern Med. 2018;178(9):1174-1181.

Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial. Cancer Med. 2018;7(9):4781-4790.

Effectiveness of automated and live phone reminders after mailed-FIT outreach in a pilot randomized trialPrev Med Rep. 2018;12:210-213.

LIRE Demonstration Project

Comparison of natural language processing rules-based and machine-learning systems to identify lumbar spine imaging findings related to low back pain. Acad Radiol. 2018;25(11):1422-1432.

PROVEN Demonstration Project

Representation in the care planning process for nursing home residents with dementia. J Am Med Dir Assoc. 2018;19(5):415-421.

A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems. Trials. 2018;19(1):453.

PPACT Demonstration Project

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) – protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. 2018;67:91-99.

Automating collection of pain-related patient-reported outcomes to enhance clinical care and research. J Gen Intern Med. 2018;33(Suppl 1):31-37.

December 14, 2018: New Alzheimer Trial to Be Planned Using the NIH Collaboratory Distributed Research Network

A new pragmatic trial planning grant supported by the National Institute on Aging will use the NIH Collaboratory’s Distributed Research Network (DRN) to characterize eligible patients and develop an intervention that tests the value of engaging health plan members and their caregivers, in addition to prescribers, to reduce potentially harmful medication use in patients with Alzheimer disease and related dementias (ADRD).

Patients with Alzheimer disease are at high risk for “prescribing cascades,” in which patients receive multiple, potentially unnecessary drug prescriptions to address side effects of their other medications. The Controlling and Stopping Cascades Leading to Adverse Drug Effects Study in Alzheimer’s Disease (CASCADES-AD) will be an embedded pragmatic clinical trial in 2 large healthcare systems. It would be the first evaluation of a large-scale, health plan–based educational intervention to improve medication safety and reduce the occurrence of preventable medication-related complications among patients with ADRD.

The study will characterize more than 22,500 patients with ADRD who will be identified through the DRN’s distributed data resources. The NIH Collaboratory DRN enables researchers to send queries to data partners and receive aggregate data without confidential information. Through its multiple data partners, the DRN has access to data for more than 90 million lives.

View an NIH Collaboratory Grand Rounds presentation about the status of the DRN, and learn more about the DRN in the Living Textbook.

December 13, 2018: New Living Textbook Chapter: Developing a Compelling Grant Application

A new chapter in the Living Textbook provides expert advice for investigators submitting an application for a pragmatic clinical trial to the NIH. The chapter covers finding the right Program Official and opportunity announcement, writing a strong proposal, addressing review criteria, and award status.

“First and foremost, develop and clearly define a clinical research question with a testable hypothesis and then select an experimental design best suited to answering the research question. The study question drives the research design.” —From Developing a Compelling Grant Application

Dr. Wendy Weber, the Program Officer for the NIH Collaboratory Coordinating Center, and Dr. Marcel Salive, a Program Officer from the National Institute on Aging, contributed to this chapter.

December 11, 2018: Two New NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis

The NIH has announced two new funding opportunity announcements (FOAs) for 7 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become part of the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research.

The two announcements are:

The announcements are part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

Podcast December 5, 2018: Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome?

At least once a month, we will release interviews with Grand Rounds speakers that delve into their topic of interest and give listeners bonus time with these featured experts.

Please let us know what you think by providing your feedback through the podcast page. We also encourage you to listen and share the recordings with your colleagues!

December 3, 2018: FDA Calls for Comments on Proposed Rule to Allow Exceptions to the Requirement for Informed Consent in Minimal-Risk Research

The Food and Drug Administration (FDA) is proposing a rule to allow for a waiver or alteration of informed consent for clinical investigations posing no more than minimal risk to human participants. This rule would align FDA regulations with the Common Rule, reduce burden and costs for Institutional Review Boards, and be expected to lead to advances in healthcare.

“We expect benefits in the form of healthcare advances from minimal risk clinical investigations and from harmonization of FDA’s informed consent regulations with the Common Rule’s provision for waiver of informed consent for certain minimal risk research.” —  Federal Register /Vol. 83, No. 221

Currently, FDA allows a waiver or alteration of consent only in life-threatening situations. If aligned with the Common Rule, a waiver or alteration would be allowed if the IRB finds and documents that 1) the research involves no more than minimal risk, 2) the rights and welfare of subjects will not be adversely affected, 3) the research could not practicably be carried out without a waiver, and 4) the participants will be provided with additional pertinent information after completion of the trial.

Comments on the proposed rule are due by January 14, 2019.

Podcast November 20, 2018: Data Linkage Within, Across, and Beyond PCORnet

Listen to the episode here:

At least once a month, we will release interviews with Grand Rounds speakers that delve into their topic of interest and give listeners bonus time with these featured experts.

Please let us know what you think by providing your feedback through the podcast page. We also encourage you to listen and share the recordings with your colleagues!

November 20, 2018: Upcoming NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis

The NIH has announced an intent to publish new funding opportunity announcements (FOAs) for 5 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become part of the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research. Both FOAs will be published in early December with applications due as early as February 2019.

The two notices are:

The announcements are part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

November 16, 2018: New Living Textbook Chapter on Team Composition for Pragmatic Trials

Embedded pragmatic clinical trials (ePCTs) are conducted by gathering data during the course of routine care. Accordingly, health care system personnel—not research personnel—will be collecting data and delivering the intervention. A new Living Textbook chapter describes the considerations for team composition to help ensure the success of an ePCT.

“Many different people are involved in the conduct of an ePCT, and when designing a trial, an investigator will need to carefully consider the roles of potential team members, including which roles are essential, and who will fill the roles.”

—Dr. Lesley Curtis in ePCT Team Composition

November 13, 2018: Summary of Workshop on Pragmatic Trials of Therapeutic A vs B Interventions Now Available

The NIH Collaboratory recently convened a workshop to explore embedded pragmatic clinical trials comparing two or more therapeutic medical interventions. These “A vs B” trials are meant to test existing, viable treatment alternatives where there is uncertainty about which treatment is best in which populations. There are unique barriers that make these types of pragmatic trials especially challenging to implement. For the workshop, a panel of experts gathered to discuss challenges and solutions regarding partnering with healthcare systems to conduct the trials, unique legal and ethical issues, and design and operational considerations. The summary of the workshop is now available: Workshop Summary: Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions

 

Additional Resources:

Embedded pragmatic clinical trials of therapeutic A vs. B interventions workshop videocast.