NIH Collaboratory

October 3, 2017: New Collaboratory Article Explores Data Sharing and Embedded Research

Posted on by Karen Staman

In an article published in Annals of Internal Medicine, authors from the NIH Collaboratory describe concerns and solutions regarding data sharing and embedded research. Pragmatic research embedded in health systems uses data from the electronic health record and comes from a fundamentally different context than explanatory trials, which collect research-specific data. Data from embedded research have the potential to do harm if taken out of context or used for comparisons. Therefore, while the authors enthusiastically support data sharing, they also recognize that mandating data sharing may discourage health systems from volunteering to participate in embedded research.

“In an ideal world of transparency regarding healthcare processes and outcomes, health systems would have no expectation of or need for privacy regarding quality of health care delivery.  But the current world is not perfect, and unintentional disclosures from participation in embedded research could be far greater than that required for public quality measures. Health systems volunteering to participate in research to improve public health may not be willing to bear the additional risk of misuse of sensitive information.” — Simon et al. Ann Intern Med

The authors use examples from the NIH Collaboratory Trials to illustrate potential solutions, and emphasize that data sharing plans for embedded research should be developed in partnership with health system leaders in ways that maximize the amount of data that can be shared while protecting patient privacy and healthcare system interests.

STOP CRC Trial: Analytic Challenges and Pragmatic Solutions

Posted on by Gina Uhlenbrauck

Investigators from the STOP CRC pragmatic trial, an NIH Collaboratory Trial, have recently published an article in the journal eGEMs describing solutions to issues that arose in the trial’s implementation phase. STOP CRC tests a program to improve colorectal cancer screening rates in a collaborative network of Federally Qualified Health Centers by mailing fecal immunochemical testing (FIT) kits to screen-eligible patients at clinics in the intervention arm. Clinics in the control arm provided opportunistic colorectal-cancer screening to patients at clinic visits in Year 1 and implemented the intervention in Year 2. In this cluster-randomized trial, clinics are the unit of analysis, rather than individual patients, with the primary outcome being the proportion of screen-eligible patients at each clinic who complete a FIT.

The team dealt with various challenges that threatened the validity of their primary analysis, one of which related to potential contamination of the primary outcome due to the timing of the intervention rollout: for control participants, the Year 2 intervention actively overlapped with the Year 1 control measurements. The other challenge was due to a lack of synchronization between the measurement and accrual windows. To deal with these issues, the team had to slightly modify the study design in addition to developing a few sensitivity analyses to better estimate the true impact of the intervention.

“While the nature of the challenges we encountered are not unique to pragmatic trials, we believe they are likely to be more common in such trials due to both the types of designs commonly used in such studies and the challenges of implementing system-based interventions within freestanding health clinics.” (Vollmer et al. eGEMs 2015)

The Publish EDM Forum Community publishes eGEMs (generating evidence & methods to improve patient outcomes) and provides free and open access to this methods case study. Readers can access the article here.

New Lessons Learned Document Draws on Experiences of NIH Collaboratory Trials

Posted on by Karen Staman

The NIH Collaboratory’s Health Care Systems Interactions Core has published a document entitled Lessons Learned from the NIH Health Care Systems Research Collaboratory Trials. The Principal Investigators of each of the NIH Collaboratory Trials shared their trial-specific experience with the Core to develop the document, which presents problems and solutions for initiation and implementation of pragmatic clinical trials (PCTs). Lessons learned are divided into the following categories: build partnerships, define clinically important questions, assess feasibility, involve stakeholders in study design, consider institutional review board and regulatory issues, and assess potential issues with biostatistics and the analytic plan.

Other tools available from the Health Care Systems Interactions Core include a guidance document entitled Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures and an introduction to PCTs slide set.

New Living Textbook Chapter on Acquiring and Using Electronic Health Record Data for Research

Posted on by Karen Staman

Topic ChaptersMeredith Nahm Zozus and colleagues from the NIH Collaboratory’s Phenotypes, Data Standards, and Data Quality Core (now the Electronic Health Records Core) have published a new Living Textbook chapter about key considerations for secondary use of electronic health record (EHR) data for clinical research.

In contrast to traditional randomized controlled clinical trials where data are prospectively collected, many pragmatic clinical trials use data that were primarily collected for clinical purposes and are secondarily used for research. The chapter describes the steps a prospective researcher will take to acquire and use EHR data:

  • Gain permission to use the data. When a prospective researcher wishes to use data, a data use agreement (DUA) is usually required that describes the purpose of the research and the proposed use of the data. This section also describes use of de-identified data and limited data sets.
  • Understand fundamental differences in context. Data collected in routine care settings reflect standard procedures at an individual’s healthcare facility, and are not collected in a standard, structured manner.
  • Assess the availability of health record data. Few assumptions can be made about what is available from an organization’s healthcare records; up-front, detailed discussions about data element collection over time at each facility is required.
  • Understand the available data. A secondary data user must understand both the data meaning and the data quality; both can vary greatly across organizations and affect a study’s ability to support research conclusions.
  • Identify populations and outcomes of interest. Because healthcare facilities are obligated to provide only the minimum necessary data to answer a research question, investigators must identify the needed patients and data elements with specificity and sensitivity to answer the research question given the available data.
  • Consider record linkage. Studies using data from multiple records and sources will require matching data to ensure they refer to the correct patient.
  • Manage the data. The investigator is responsible for receiving, managing, and processing data and must demonstrate that the data are reproducible and support research conclusions.
  • Archive and share the data after the study. Data may be archived and shared to ensure reproducibility, enable auditing for quality assurance and regulatory compliance, or to answer other questions about the research.

Lessons Learned from NIH Collaboratory Pragmatic Trials

Posted on by Gina Uhlenbrauck

Earlier this year, the NIH Collaboratory conducted a series of interviews with the principal investigators of its first round of pragmatic clinical trial NIH Collaboratory Trials. These projects completed a pilot phase before scaling up to full implementation in 2014-2015. The purpose of the interviews was to share challenges and lessons learned that may help future pragmatic trials. The interviews have now been archived on the Living Textbook:

NIH Collaboratory Trial Interviews

The NIH Collaboratory will continue to share information learned as these trials progress. Regular updates are also provided during weekly Grand Rounds webinars. For more information on these trials, visit the NIH Collaboratory Trial websites.

Minimizing the Burden of Practical Research: Case Studies from the NIH Collaboratory

Posted on by Gina Uhlenbrauck

In a forthcoming article in Healthcare, Dr. Eric Larson and colleagues present practical advice based on case studies from the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Physician–scientists, health services researchers, and delivery system leaders provide insight from their experience launching a pragmatic clinical trial (PCT) as part of the Collaboratory.

The authors make 5 recommendations:

  • Establish a partnership from the get-go
  • Do a pilot project
  • Take advantage of existing hospital and health system infrastructure
  • Minimize the impact on clinical workflow
  • Remember that even high-priority research questions must be balanced with the systems’ greatest priority: providing good healthcare to patients.

The authors note that researchers need to be flexible and prepared to adjust the study design to the workflow and culture of the system.

Reference: Larson E, Tachibana C, Thompson E, et al. Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems. Healthcare. 2015; in press. doi:10.1016/j.hjdsi.2015.07.005

Watch Dr. Larson’s Grand Rounds Presentation from June 2013: Trials, Not Tribulations: Minimizing the Burden of Research on Health Care Systems

Groundbreaking Suicide Prevention Trial has Enrolled Initial Patients

Posted on by Karen Staman

March 5, 2015

Dr. Greg Simon and the Suicide Prevention Team have enrolled the first participants in the Pragmatic Trial of Population-Based Programs to Prevent Suicide Attempt. This groundbreaking study was developed by researchers at Group Health Cooperative in Seattle, Washington, Health Partners Medical Group in Minnesota, and Kaiser Permanente of Colorado, in collaboration with patients who have experienced suicidal thoughts or survived suicide attempts themselves.

Over 9 million adults in the United States experience suicidal thoughts, and more than 1 million adults attempt suicide each year. However, patients at risk for suicidal behavior are not routinely identified, and successful interventions for depression and suicide are not routinely implemented. New evidence suggests that patients who report frequent thoughts of death or self-harm on a commonly-used depression questionnaire are at higher risk for suicide attempt and death over the following year.

This study aims to address the significant problem of suicide by identifying patients who are at risk for suicidal behavior and testing two suicide prevention strategies. Patients at participating institutions will complete a standard depression severity questionnaire during routine clinical care, and the results will be stored in their electronic health records (EHR). Investigators will use the responses in the EHR to identify at-risk individuals, and once identified, the patients will be randomly assigned to either usual care or to two treatment programs. The first is a collaborative care-management approach; the second is an online skills training program called “Now Matters Now,” which is designed to help people manage painful emotions and stressful situations.

Over the next 5 years, the team plans to enroll 19,500 adult patients. The study is an NIH Collaboratory Trial being overseen by the National Institute of Mental Health (NIMH).

Congratulations to Dr. Simon and his team for their achievement!

 

Collaboratory Phenotypes, Data Standards, and Data Quality Core Releases Data Quality Assessment White Paper

Posted on by Gina Uhlenbrauck

The NIH Collaboratory’s Phenotypes, Data Standards, and Data Quality Core (now the Electronic Health Records Core) has released a new white paper on data quality assessment in the setting of pragmatic research. The white paper, titled Assessing Data Quality for Healthcare Systems Data Used in Clinical Research (V1.0) provides guidance, based on the best available evidence and practice, for assessing data quality in pragmatic clinical trials (PCTs) conducted through the Collaboratory. Topics covered include an overview of data quality issues in clinical research settings, data quality assessment dimensions (completeness, accuracy, and consistency), and a series of recommendations for assessing data quality. Also included as appendices are a set of data quality definitions and review criteria, as well as a data quality assessment plan inventory.

The full text of the document can be accessed through the “Tools for Research” tab on the Living Textbook or can be downloaded directly here (PDF).

Dr. Califf to Speak Today at NIH Common Fund 10-Year Commemoration Symposium

Posted on by Gina Uhlenbrauck

On June 19, 2014, the NIH Common Fund is celebrating 10 years of achievement with a symposium, A Decade of Discovery, featuring its far-reaching research. Dr. Robert Califf, principal investigator of the NIH Collaboratory Coordinating Center, will speak during the 2:15-3:15 pm session “Reengineering the Clinical Research Enterprise.” Proceedings will be streamed live throughout the day.

View the agenda, live videocast, and commemorative book

Winners from the video and song contest will also be recognized.

NIH Common Fund Video Competition Goes Live

Posted on by Gina Uhlenbrauck

As part of its 10-year commemoration activities, the NIH Common Fund is holding a video and song competition to showcase Common Fund–supported activities in a fun and creative way. Grantees and program staff were encouraged to submit brief, original works that would be accessible and engaging to the public.

The video entries have been posted, and voting will be open until May 9. View the videos on YouTube and “like” your favorites to vote. Videos from NIH Collaboratory investigators and committee members include:

Song entries are still being screened.

Winners will receive recognition at the Common Fund 10-Year Commemoration Symposium in June 2014, where NIH Director Dr. Francis Collins will perform the winning song.