November 9, 2018: Data Linkage Within, Across, and Beyond PCORnet (Thomas W. Carton, PhD, MS, Keith Marsolo, PhD)

Speakers

Thomas W. Carton, PhD, MS
Chief Data Officer, Louisiana Public Health Institute
PI, REACHnet

Keith Marsolo, PhD
Instructor
Department of Population Health Sciences
Duke University School of Medicine

Topic

Data Linkage Within, Across, and Beyond PCORnet

Keywords

PCORnet; Data linkage; Hashed linkage; Clinical Data Research Networks (CDRNs); Health Plan Research Networks; DataMarts; Salt; Electronic health records; Common Data Model

Key Points

  • The PCORnet network provides opportunities for data linkage within the network, across the network, and beyond the network. The formation of PCORnet 2.0 provides additional opportunities for linkage.
  • PCORnet 2.0’s structure includes 9 Clinical Data Research Networks and 2 Health Plan Research Networks.
  • The patient overlap between CDRNs and HPRNs is unknown but expected to be high. The patient overlap between CDRN and HPRN DataMarts is unknown but expected to be low in most cases (expect select markets).

Discussion Themes

Hash codes are not considered private health information because they are an encrypted identifier that cannot be linked back to the patient.

The primary challenges of the hashed data linkage system lie in the differences of opinion in how data are best interpreted. Working through the governance and regulatory components have been the most difficult.

Contending with differences in data coding that are present among systems can create different hash codes. However, there are ways to make the process consistent so that parameters can be established around the program.

Tags

@Collaboratory1, @PCORnetwork, @REACHnetCDRN, @DukeMedSchool, #medicare, #datalinkage, #pctGR

November 2, 2018: EMBED Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (Ted Melnick, MD, Gail D’Onofrio, MD)

Speakers

Ted Melnick, MD, MHS
Assistant Professor of Emergency Medicine
Program Director, ACGME Clinical Informatics Fellowship
Yale School of Medicine

Gail D’Onofrio, MD
Professor and Chair of Emergency Medicine, Yale School of Medicine
Physician-in-Chief of Emergency Services Yale-New Haven Hospital

Topic

EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder

Keywords

EMBED; Embedded PCT; Pragmatic clinical trial; Opioid use disorder; Clinical decision support; Emergency department; Buprenorphine

Key Points

  • The EMBED pragmatic trial is evaluating a clinical decision support tool designed to automatically identify and facilitate management of eligible patients with opioid use disorder in the emergency department (ED).
  • From July 2016 to Sep 2017, there was a 30% increase in visits to the ED for opioid overdose (Morbidity and Mortality Weekly Report, March 9, 2018).
  • With medication-assisted treatment, patients are 2 times more likely to be engaged in addiction treatment at 30 days.
  • EMBED’s user-centered design aims to streamline workflows, address barriers to adoption, embed ED-initiated buprenorphine into routine ED care, and optimize adoption, dissemination, implementation, and scalability.

Discussion Themes

Poor usability of health information technology (HIT) is major source of frustration for clinicians. Electronic health record usability is a fundamental barrier to implementation of evidence-based medicine.

The science of usability in healthcare is still in the early stages. The EMBED study wants to improve the HIT experience.

How much does the study rely on EHR data for outcomes, and how detailed are the pilot outcomes data requested from each system? How do you plan to verify the accuracy of those data?

For more information on treatment of opioid use disorder in the emergency department, visit the National Institute on Drug Abuse (NIDA) website’s Initiating Buprenorphine Treatment in the Emergency Department.

Tags

@Ted_Melnick, @DonofrioGail, @yaleem2, @YaleMed, @Collaboratory1, #pctGR, #EmergencyMedicine

October 26, 2018: Making Measurements Meaningful (Brian J. Zikmund-Fisher, PhD)

Speaker

Brian J. Zikmund-Fisher, PhD
Associate Professor of Health Behavior and Health Education
University of Michigan
Associate Director of the UM Center for Bioethics and Social Sciences in Medicine

Topic

Making Measurements Meaningful

Keywords

Health data; Return of results; Health measurements; Health communication

Key Points

  • Patients receive a variety of health measurements when visiting with their physicians; however, they may find it difficult to determine what the measurements mean. Incorporating objective numbers with clear graphics can be helpful.
  • “Out of range” test results can sometimes be difficult to depict for patients reviewing their health records. The online tool Icon Array was developed by the presenter to aid in the process.
  • When thinking about how to communicate health data effectively to patients, remember to “design for the way people are, not the way we wish they were.” (source: Holly Witteman)

Discussion Themes

Action thresholds are actively used in environmental communication, such as the Environmental Protection Agency (EPA). The challenge in incorporating a similar system in a clinical setting is that patients are buried in their situations, and clinical judgement can be objective. The problem this creates is that many patients are left to interpret numbers that they don’t understand.

Communicating research results in an impactful and clear way can help in understanding how to do the same thing in a clinical setting.

Professional consensus and practical implementation are two main challenges of adopting new ways of communicating health measurements.

Tags

#healthdata, #pctGR, @PCTGrandRounds, @Collaboratory1, @bzikmundfisher, @UM_IHPI, @umichsph

October 19, 2018: A New Path Forward for Using Decentralized Clinical Trials (Jeffry Florian, PhD, Annemarie Forrest, Penny Randall, MD, MBA)

Speakers

Jeffry Florian, PhD
Clinical Analyst, Office of New Drugs
FDA Center for Drug Evaluation and Research (CDER)

Annemarie Forrest
Clinical Trials Transformation Initiative (CTTI)

Penny Randall, MD, MBA
VP and Global Therapeutic Head, CNS
IQVIA

Topic

A New Path Forward for Using Decentralized Clinical Trials

Keywords

Decentralized clinical trials; Telemedicine; Mobile health; Clinical Trials Transformation Initiative; FDA

Key Points

  • Decentralized clinical trials (DCTs) are defined as those executed through telemedicine, mobile, or local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model; for example, shipping investigational medical product directly to the trial participant.
  • DCTs are not “all or nothing.” They exist in a broad continuum and can expand the reach of traditional clinical trial sites.
  • Potential benefits of DCTs apply to all trials in all disease areas but may offer particular advantages in rare diseases, where patients are generally limited in number or are highly geographically dispersed.
  • Mobile HCP training is similar to that required for standard investigative sites: Good clinical practice, protocol-specific training, human subject protections, data protection, and clinical trial billing.

Discussion Themes

Will a decentralized trial lead to less diverse patient populations as participants will need to be technology literate and have access to technology?

Decentralized clinical trial safety monitoring plans should not be held to a higher standard than with traditional trials unless merited by a particular circumstance. It is important to develop protocol-specific safety monitoring and communication escalation plans.

Download CTTI’s recommendations for decentralized clinical trials.

Tags

#telemedicine #pctGR, @PCTGrandRounds, @Collaboratory1, @CTTI_Trials @IQVIA_global @US_FDA

October 12, 2018: MDEpiNet RAPID and SPEED Projects: Leveraging Real World Evidence to Get Better, Faster, Cheaper Medical Devices for Physicians and Patients (Renee Mitchell, MT, CLS, Terrie Reed, MSIE, Roseann White, MA)

Speakers

Renee Mitchell, MT(ASCP), CLS(NCA)
Regulatory Affairs
Boston Scientific Corporation, Inc.

Terrie Reed, MSIE
Senior Advisor for UDI Adoption
U.S. Food and Drug Administration (FDA)

Roseann White, MA
Director of Innovative Clinical Trial Statistics
Duke Clinical Research Institute

Topic

MDEpiNet RAPID and SPEED Projects: Leveraging Real World Evidence to Get Better, Faster, Cheaper Medical Devices for Physicians and Patients

Keywords

Medical devices; Real-world evidence; Medical Device Epidemiology Network; MDEpiNet; Unique device identifier; UDI

Key Points

  • In partnership, clinicians, device developers, and FDA can benefit from the use of real-world evidence on medical devices:
    •  Clinicians can contribute to the generation of real-world evidence.
    •  Device manufacturers can use real-world evidence to evaluate and release new devices and expand indications.
    •  Regulatory bodies can increase the use of patient-level data for device approval.
  • Unique device identifiers (UDIs) make it possible to follow medical devices longitudinally, advancing the quality of real-world evidence and allowing more sophisticated analyses.

Discussion Themes

The vision for the future is that registries will transform into big data solutions using multiple sources and will be more robustly integrated with electronic health records (EHRs). Both EHRs and registries will play a role.

More organizations as partners brings greater diversity, advancing better data and results. When stakeholders work together, learning curves can be accelerated toward a transformational approach to real-world evidence.

Tags

#MedicalDevices, #pctGR, @PCTGrandRounds, @Collaboratory1, @MDEpiNet_ppp

September 28, 2018: Assessing and Reducing Risk of Re-identification When Sharing Sensitive Research Datasets (Greg Simon, MD, MPH, Deven McGraw, JD, MPH, Khaled El Emam, PhD)

Speakers

Gregory Simon MD, MPH
Investigator, Kaiser Permanente Washington Health Research Institute

Deven McGraw, JD, MPH, LLM
General Counsel & Chief Regulatory Officer, Ciitizen

Khaled El Emam, PhD
Department of Pediatrics, University of Ottawa
Children’s Hospital of Eastern Ontario Research Institute

Topic

Assessing and Reducing Risk of Re-identification When Sharing Sensitive Research Datasets

Keywords

Clinical trials; Research ethics; Data security; Data sharing; Sensitive research data; De-identified data

Key Points

  • The cycle of risk de-identification involves setting a risk threshold, measuring the risk, evaluating the risk, and applying transformations to reduce the risk.
  • The Safe Harbor method of de-identification (removal of 18 categories of data) is a legal minimum standard that does not take context into account, and may not be sufficient when sharing sensitive data publicly.
  • A higher standard for de-identification is the “Expert Determination” method, whereby an expert with contextual knowledge of the broader data ecosystem can determine whether the risk is “not greater than very small.”
  • With increasing concern about the risks of sensitive data sharing, it is important to be transparent with data participants and continue to build trust for data uses.

Discussion Themes

When is a dataset safe for sharing? What is the risk of re-identification, and how can we reduce the risk? Consider who you are releasing the data to and what other kinds of data might they have access to that could potentially lead to re-identification.

For more information on the de-identification of protected health information, visit the U.S. Department of Health and Human Services’s Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.

The Health Information Trust Alliance de-identification framework identifies 12 criteria for a successful de-identification program and methodology.

Tags

#pctGR, #PragmaticTrials, #HealthData, @HealthPrivacy @Collaboratory1, @PCTGrandRounds

September 21, 2018: Returning Individual Research Results to Participants: Guidance for a New Research Paradigm (Jeffrey Botkin, MD, MPH, Consuelo Wilkins, MD, MSCI)

Speakers

Jeffrey R. Botkin, MD, MPH
Associate Vice President for Research
Professor of Pediatrics
University of Utah School of Medicine

Consuelo H. Wilkins, MD, MSCI
Associate Professor of Medicine
Vanderbilt University Medical Center and Meharry Medical College

Topic

Returning Individual Research Results to Participants: Guidance for a New Research Paradigm

Keywords

Return of results; Health data; Data sharing; Research ethics

Key Points

  • Historically, returning individual research results to study participants has not been a standard or common practice.
  • The National Academies of Sciences, Engineering, and Medicine (NASEM) recently spearheaded a committee charged with determining if and when it is appropriate to return individual research results to research participants.

Discussion Themes

Guidelines have not yet been established for Centers for Medicare and Medicaid Services (CMS) or other payers with regard to how research results can be used to support further clinical testing.

There are challenges in communicating results to participants. Determining a “15-second takeaway” message is a practical step and best practice for alleviating some of the challenges and can help guide the communication process.

More conversations are needed to determine how to return results for cluster-randomized trials.

For more information, view the NASEM consensus report.

 

Tags

@DrCHWilkins, @NASEM_Health #returnofresults, #healthdata, #pctGR,

September 14, 2018: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials (John Hubbard, PhD, Barry Peterson, PhD, Cheryl Grandinetti, PharmD)

Speakers

John Hubbard, PhD
Healthcare Strategic Advisory Board
Genstar Capital

Barry Peterson, PhD
Independent Consultant

Cheryl Grandinetti, PharmD
Office of Compliance, Office of Scientific Investigations, Division of Clinical Compliance Evaluation
Center for Drug Evaluation and Research
Food and Drug Administration

Topic

Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials

Keywords

Clinical trials; Mobile health technologies; Clinical Trials Transformation Initiative; CTTI; FDA; Data integrity

Key Points

  • The goal of CTTI’s Mobile Clinical Trials program is to develop evidence-based recommendations that affect the widespread adoption and use of mobile technology in clinical trials for regulatory submission.
  • Potential benefits of using mobile technology include higher quality, patient-centric endpoints and fewer barriers to participation in clinical trials.
  • Data access issues to consider before selecting a mobile technology include:
    • How will the data generated by the mobile technology be accessed and used by the manufacturer?
    • What data will be provided by the manufacturer to the sponsor?
  • The mobile era creates new data security demands.

Discussion Themes

CTTI’s recommendations aim to help sponsors determine the right device to use, how to write the protocol for remote data capture, and how to protect and analyze the data.

Know what you want to measure before selecting the mobile technology. The appropriateness of the selection should be justified through verification and validation processes.

Ensure the authenticity, integrity, and confidentiality of data over its entire lifecycle.

To reduce risk in large trials, conduct feasibility studies before full implementation.

Visit CTTI for more recommendations and resources for mobile clinical trials.

 

Tags

@CTTI_Trials, @PCTGrandRounds, #MobileTech, #pctGR

September 7, 2018: NIH Collaboratory: Research Transformation in Progress (Adrian Hernandez MD, MHS, Kevin Weinfurt, PhD, Lesley Curtis, PhD)

Speakers

Adrian F. Hernandez, MD, MHS
Professor of Medicine
Vice Dean for Clinical Research
Duke University School of Medicine

Kevin Weinfurt, PhD
Professor and Vice Chair for Research
Department of Population Health Sciences
Duke University School of Medicine

Lesley H. Curtis, PhD
Chair and Professor
Department of Population Health Sciences
Duke University School of Medicine
Interim Executive Director, Duke Clinical Research Institute

Topic

NIH Collaboratory: Research Transformation in Progress

Keywords

Clinical trials; Research studies; Healthcare delivery; Clinical care; embedded pragmatic clinical trials; ePCTs; Peer-reviewed journals; Demonstration projects; NIH funding

Key Points

  • The goal of the NIH Collaboratory is to strengthen the national capacity to implement cost-effective large-scale research studies that engage healthcare delivery organizations as research partners.
  • Embedded pragmatic clinical trials bridge research into clinical care.
  • The NIH Collaboratory has contributed to 80 publications about embedded pragmatic trials in peer-reviewed journals.
  • Six new demonstration projects were recently added to the NIH Collaboratory portfolio:
    • Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training (ACP PEACE)
    • Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo)
    • Pragmatic Trial of Parent-Focused Prevention in Pediatric Primary Care: Implementation and Adolescent Health Outcomes in Three Health Systems (GGC4H: Guiding Good Choices for Health)
    • Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (EMBED)
    • Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge)
      Primary Palliative Care for Emergency Medicine (PRIM-ER)

Discussion Themes

The NIH Collaboratory is addressing many of the challenges and logistical barriers to conducting pragmatic clinical trials embedded in healthcare systems. There is still progress to be made in explaining the value and benefit of embedded PCTs (ePCTs) to healthcare leadership.

The NIH Collaboratory workshops have had a positive impact and have increased NIH’s interest in supporting the conduct of ePCTs.

Determining how pragmatic clinical trials can be conducted more routinely will be critical to their impact.

 

Tags

@texhern, @lmhcurtis, @PCTGrandRounds, #pctGR #ClinicalResearch, #researchstudies, #clinicaltrials, #clinicalcare, #peerreviewed

August 24, 2018: FoodSwitch USA: A Mobile Platform for Packaged Food Surveillance and Behavioral Research (Mark Huffman, MD, MPH)

Speaker

Mark Huffman, MD, MPH
Associate Professor of Preventive Medicine and Medicine-Cardiology
Northwestern University Feinberg School of Medicine

Topic

FoodSwitch USA: A Mobile Platform for Packaged Food Surveillance and Behavioral Research

Keywords

FoodSwitch app; Mobile platform; Behavioral research; Packaged food surveillance; Crowdsourcing; Food supply; One Brave Idea; Community engagement; Health research; Food labeling

Key Points

  • FoodSwitch USA is a mobile platform that uses crowdsourcing for packaged food surveillance and can be used for behavioral research.
  • Crowdsourcing can be used to generate ideas, improve data collection, and enhance community engagement in health research.
  • The Global Food Monitoring Group brings together data on nutritional information for processed foods and can be used to drive national and international improvements in the food supply. There are 31 countries involved, with two-thirds representing lower to middle income countries.

Discussion Themes

There are hopes that FoodSwitch USA will eventually be classified as a mobile medical app by the FDA because the goal is to prove that if the application is used, it can help people lower their blood pressure by reducing their salt intake.

The FoodSwitch USA project is in the early stages of community engagement. There are current efforts to increase media exposure so that more are aware of the application and its benefits. The benefits include an easier sign up process, no “up-selling” to a premium model, and no linkage to any profit-driven interests.

 Crowdsourcing data “noise” can be reduced at the Label Insight level. Learn more about Food Switch USA and Label Insight.

 

Tags

@Mark_Huffman, @NUFeinbergMed, #MobilePlatform, #pctGR, #OneBraveIdea, #processedfoods, #communityengagement, #healthresearch, #crowdsourcing