Meeting Summary
First Meeting of the EHR Clinical Research Value Case Workgroup
Monday November 10, 2008
Attendees: Jonathan Andrus, Robert Annechiarico, Michael Cantor, Christopher Chute, Perry Cohen, Kevin Coonan, Elaine Collier, Timothy Cromwell, Jeffrey David, Leonard Davolio, Peggy Devine, Gregory Downing, Jennifer Garvin, Gene Ginther, John Glaser, John Halamka, Paul Harris, Steven Hirschfeld, Charles Jaffe, Michael Kahn, Linda King, Judith Kramer, Rebecca Kush, John Loonsk, Jessica Nadler, Armando Oliva, Rachel Richesson, Kristen Schneeman, Francis Schrotter, John Speakman
Purpose of this Meeting: The Electronic Health Record/Clinical Research Value Case Workgroup met for the first time to discuss the charge and vision for the workgroup, as well as select a priority area for development as a Value Case and later submission to HITSP.
SUMMARY
Key Outcomes:
The workgroup voted and decided to move forward with identification of a core dataset as a value case for submission for the February 2009 HITSP cycle.
Action Items:
Comments were solicited for draft vision document and charge.
Ideas were requested for funding opportunities.
Consider scope of core data set, relevant existing standards and aspects of implementation of this Value Case for discussion on December conference call.
Issues:
None identified
KEY TOPICS:
WELCOME
Gregory Downing welcomed the group to the first Workgroup meeting and highlighted the key roles that a number of the attendees played for this development opportunity. He emphasized the fact that HHS participates in a convening role, rather than the role it had during the AHIC initiatives. He mentioned that several participants had had previous leadership roles within AHIC workgroups and thanked them for their guidance. Finally, he introduced John Halamka, Chair of HITSP.
John Halamka emphasized that HITSP standardizes and harmonizes data flow based on the Use Cases given and that the quality of the product is a direct reflection of the quality of the priorities provided. As implementation is based on business need there is a demand for clinical Value Cases. For example, Harvard is developing standards for the exchange of data about clinical trials. In short, individual research communities are developing their own creative solutions for data exchange and it would be ideal if the existence of proprietary standards would be replaced by a ‘crisp’ interoperability standard serving a wide community. HITSP offers help with respect to harmonizing/standardizing, if required.
Next, John Glaser, co-chair of PHC Workgroup, CIO Harvard Partners, thanked people for devoting their time to this Value Case. Representing an organization that conducts patient care as well as clinical research, Glaser points out how this Value Case would support his organization’s task as well as improve efficiency of work done within the research community.
Glaser mentioned his involvement with AHIC and now ASI (AHIC 2) and highlighted that a critical element within ASI is the notion of Value Case. The idea is to take a Use Case and improve them as a Value Case by having members from academia and industry involved in the development. The aim is to prevent the piling up of standards without having a clear defined use. The question for the stakeholders is what standards and why. There has to be a clear understanding of the factors important for the adoption of standards.
John Loonsk, Director ONCHIT, thanked members of the workgroup for their participation and stated his enthusiasm to get the Clinical Research Value Case moving as a priority. He further asked workgroup members to consider the implementation aspect as well as the importance of standardization. Further, health information exchange and certification of systems should be considered in moving forward. In short, harmonization is the first step but it is also important to think about HIE and certification.
Finally, Loonsk thanked Becky, Fran and Greg for their work.
SETTING GOALS
The goals for this meeting were:
1.Look for new perspectives
2.Learn to work together
3.Help to understand utilities of clinical research.
4.Develop a summary of workgroup activities that will be posted on HITSP website
The final work products emerging from this meeting will be:
- Vision document.
- Evaluation of priorities for Value Cases and decision about priority selection
A voting exercise took place at the end of the meeting.
INTRODUCTION OF WORKGROUP MEMBERS
-see Participant List attached
OVERVIEW OF CLINICAL RESEARCH VALUE CASE (Frances Schrotter)
The workgroup was formed under the auspices of ANSI. Standards for the area of clinical research were considered a priority area for development. Previously other AHIC priorities prevented clinical research from rising to the top of the list. As ASI (AHIC 2) is currently trying to get policy and procedures into place and is not ready yet to take on tasks, ANSI will fill the gap and maintain the momentum.
AHIC will be brought to closure on Wednesday 12th November 2008.
John Loonsk was asked to bring together a group to jump start clinical research in order to maintain momentum for the development of standards interoperability procedures.
Schrotter attended this meeting in the role of an administrator of ANSI therefore providing an ANSI perspective. Schrotter did not attend as a HITSP representative - emphasis on the clear demarcation.
Previous Use Cases were supported under contract by Dept. of Health and Human Services (HHS). In contrast, this is a new public and private sector group, looking for financial backing for Value Cases. Becky Kush and Frances Schrotter will establish funding for these Value Cases, for the year-long HITSP process to take place.
Question and Answer:
Armando Oliva asked for a definition of thedifference between a Use Case and a Value Case.
John Halamka answered that Use Cases were developed by AHIC based on what interoperability would look like. A Value Case is a work product designed with a perspective towards implementation by business groups. Use Cases signify a more ideal state but interoperability lags. Value Cases can potentially provide huge cost savings.
DISCUSSION OF THE DRAFT VISION STATEMENT
Gregory Downing: Turn attention to vision statement and charge of the workgroup. In June/July an exploratory interest group was formed that presented to AHIC the importance of clinical research interoperability. How can this be used to aid clinical research? The ultimate aim is to help enterprises move quickly and effectively towards clinical research interoperability.
The goal regarding the vision statement is to discuss the use and phrasing of the document.
“Make recommendations to the Health Information Technology Standards Panel (HITSP) for a process to foster a broad, community-based approach facilitating the use of interoperable, standards-based electronic health records to support clinical research activities. Provide context that demonstrates the benefits to be achieved by facilitating health information exchange in settings of health care delivery to a broad range of health research information stakeholders.”
Input was sought whether this is a good starting point as a charge for this workgroup. What perspectives are important for capturing the importance of clinical research.
Chris Chute found the philosophy of the charge right but the wording too vague. A question to be answered is whether it is the goal of this workgroup to recommend (or a similar word) Use Cases to HITSP leading to interoperability of standards or foster community-based approaches.
Charles Jaffe found the statement to be uni-directional. The electronic health record supports clinical research because clinical research information can support the EHR. It could be the other way round as well. Bi-directionality would be the end game to clinical research and patient care.
Gregory Downing mentioned that there will be discussion about the central roles of the actors – especially patients. For example, the differences between case report versus patient summary. The role of the patient is uniquely similar in all scenarios but there will be more talk about roles that different actors will play. For now people should focus on the broad overall goal and then consider the specifics at a later stage.
John Speakman criticized the use of the word ‘to’ within the second sentence as he questioned whether the charge was trying to demonstrate the goal to researchers. In fact, research should know the benefit.
Greg Downing iterates the conscious effort to define threads of what contributes to value overall. Help with wording in charge would be appreciated.
Jeffrey David raised the fact that usually workgroups have a more homogeneous make-up. This time there are two separate industries: clinical research/science and the HIT people. Therefore it is important to make sure this is a bi-directional effort as the value needs to be marketed to both industries. It is necessary to demonstrate the value of creating a bridge between the two.
Perry Cohen emphasized the point that clinical research as the knowledge base has to be driving this effort. Experience shows that working with computer programmers leads to arbitrary decisions on how to create data elements and ultimately causes errors. The process needs to start with the knowledge base and be based on an interactive process for development of the data element.
Gregory Downing highlighted the importance of all the above comments and sees the potential for standards and broader needs of health care that may not necessarily fall in line to support clinical research. As an example other work groups have been looking at EHR and how to support quality of care needs. Next item on the agenda is a discussion about the scope and type of research activities. A definition for clinical research is provided on page 2 of the vision statement.
Definition of Clinical Research:
Patient-oriented research, including epidemiologic and behavioral studies, outcomes research, and health services research. Patient-oriented research is research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) in which a researcher directly interacts with human subjects. It includes research on mechanisms of human disease, therapeutic interventions, clinical trials, and development of new technologies, but does not include in vitro studies using human tissues not linked to a living individual.
Question and Answer:
What is the origin of this definition? National Institutes of Health
Michael Kahn: Within pediatric oncology, every child contributes to research in one way or another. In the same way every consumer/patient has something to contribute to clinical research. The wording of the definition implies that but more emphasis should be placed on ‘each consumer/patient having something to contribute to clinical research’.
Peggy Devine believes that translational research is implied in the definition but not clearly stated. An example is bio-markers, and it is important to capture that.
Chris Chute found the definition to be excellent. There are ways to conduct clinical research without interacting with patients – for example, clinical record research.
Steve Hirschfeld added that the Office of Human Research Protections (OHRP) does not define this as human subject research. Questions to be asked are whether the source of the data can be identified and linked to the patient? There exist various definitions within NIH because diverse parts of NIH cannot agree.
John Speakman mentioned the BRIDG model as an example for protocol driven clinical research (must go to IRB) but an immediate objection was voiced as this approach being too narrow.
Judith Kramer highlighted the fact that the first sentence of the definition does not address clinical trials.
Gregory Downing voiced the fact that some types of research can be conducted in ways that is not protocol driven.
Michael Cantor mentioned that asimple observational/retrospective study without actively engaging patients could be viewed as an example for non-protocol-driven studies. Chris Chutecountered that a protocol is still involved in retrospective studies.
Gregory Downing suggested that Use Cases may require delving into technical aspects. Further, consumer groups are an important aspect of a study. The landscape needs to be set for where information is exchanged and who utilizes the information. What is the appropriate scope for need in HIT in 5-10 years? The discussion about the future is ongoing and the vision statement only defines the current state of Clinical Research in HIT. The broad scope of landscape - if you came from other country at one point in time, you would get a snapshot of on the state EHR use to support clinical research and can describe it when returning home. The harder part is to describe the state as it might be in 10 years. The vision statement is designed to communicate the feasibility of tasks and should provide help determining areas of work and standardization for HITSP. Another important issue is the perspectives which appear only in draft today with the patient being central, but providers and others performing healthcare delivery need also be considered. Another perspective deals with research organizations, organizations that represent patient interests, and vendors’ health IT perspective.
Page 6 in the vision statement refers to the building blocks for change. These include some important policy issues as well as technical ones –defined as Health Information Exchange; Confidentiality, Privacy and Security; Knowledge Development, amongst others.
The tasks for the workgroup are to look at the current state, define the future state, define actors and their roles, as well as address the building blocks for change. Any comments from Workgroup members are appreciated and materials were provided to collect the comments (see doc #4).
Discussion and Questions About Process:
The issue ofvalue propositions for Value Cases was mentioned. As the expanse of clinical research is too broad just having one Value Case would not be advisable. Instead, an area of value to everybody has to be found – this, however, may lead to additional areas of value. The intent is to produce a companion document highlighting these.
A question asked whether comments about possible additional stakeholders and barriers are welcome? The answer was: Yes.
One question addressed the current U.S. focus and asked whether there are any thoughts about reaching out for collaboration – to Europe, Asia or other international elements? The answer to this question may become clearer once a priority area has been selected and the importance with respect to the international realm might be defined once a selection of a priority has occurred. An additional comment pointed out that the specific needs are constrained by the U.S. healthcare delivery system and although the clinical research community is very much international, this is an effort within the U.S. realm. International constraints should not, however, be ignored.
A matrix may be developed that illustrates the points of contact between U.S. and international efforts within the clinical research Value Case.
The workgroup should be mindful of the charge and focus on HITSP. What is the scope of HITSP and how does it work in an international perspective? So far HITSP has focused on the U.S. realm.
Another approach would be to create a number ofcheckpoints that will address any impact on international work. HITSP has contemplated international work. The priorities are focusing on U.S. standards but an international perspective should be considered along the way and points should be recognized where U.S. focus will translate to international work. The ultimate goal is to have the standards harmonized by HITSP implemented commercially. Finally, it is important to think about executive order for federal progress and certification powers.
In short, there is no attempt to look outside of the country for solutions but to look at standards, U.S.- based or otherwise.
A concern raised was that the U.S. might not be competitive if it does not look at international work. If HITSP work is passed on to international organizations, it will certainly benefit the U.S.
Presentation of “Description of Value Case for clinical research”
See attachment for presentation. The slides of the presentation address:
-Description of Use Cases
-Use Cases do not develop a specific system but focus on information exchange.
Becky Kush highlighted thatValue Cases combine the best aspects of a Use Case and a business case. Are there any other criteria for prioritization of Value Cases?
The scope and priority area for the Value Case should not be too broad.
John Loonsk highlighted 2 considerations to be taken into account with respect to the Value Case:
- During the AHIC process there was a heavy emphasis on interchange, in particular the exchange of data among organizations. However, it is difficult for organizations to exchange information internally as there is no internal standardization. Therefore information can be exchanged in a standardized format even if it is not stored in a standardized format within an organization.
- Further, much of the work has been centered on EHRs. Uptake of EHR for clinical purposes focuses on hospitals but it is necessary to consider what types of EHRs are to be considered and what the requirements for end use and storage will be.
Concern was raised about the hierarchical specification e.g. general vs. disease specific standards.