```

[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Notices]
[Pages 51567-51569]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20425]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Scientific Information Request on Health Information Exchange

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Scientific Information Submissions.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review of Health 
Information Exchange, which is currently being conducted by the 
Evidence-based Practice Centers for the AHRQ Effective Health Care 
Program. Access to published and unpublished pertinent scientific 
information will improve the quality of this review. AHRQ is conducting 
this systematic review pursuant to Section 1013 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003, Public 
Law 108-173, and Section 902(a) of the Public Health Service Act, 42 
U.S.C. 299a(a).

DATES: Submission Deadline on or before September 29, 2014.

ADDRESSES: Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the 
study for which you are submitting information from the list to upload 
your documents. Email submissions: /src.org">src.org">SIPS@epc-src.org.

Print Submissions

    Mailing Address: Portland VA Research Foundation, Scientific 
Resource Center, ATTN: Scientific Information Packet Coordinator, P.O. 
Box 69539, Portland, OR 97239.
    Shipping Address (FedEx, UPS, etc.): Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 
71, Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 58653 or Email: /src.org">src.org">SIPS@epc-src.org.

[[Page 51568]]

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Effective Health Care (EHC) Program 
Evidence-based Practice Centers to complete a review of the evidence 
for Health Information Exchange.
    The EHC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Health Information Exchange, including those that 
describe adverse events. The entire research protocol, including the 
key questions, is also available online at: http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1943.
    This notice is to notify the public that the EHC Program would find 
the following information on Health Information Exchange helpful:
     A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
     For completed studies that do not have results on 
ClinicalTrials.gov, please provide a summary, including the following 
elements: Study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
     A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
     Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EHC Program. The 
contents of all submissions will be made available to the public upon 
request. Materials submitted must be publicly available or can be made 
public. Materials that are considered confidential; marketing 
materials; study types not included in the review; or information on 
indications not included in the review cannot be used by the EHC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EHC Program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/ioin-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions. The entire research 
protocol, is also available online at: http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1943.

The Key Questions

    The draft Key Questions (KQs) developed during Topic Refinement 
were available for public comment from February 6 to February 26, 2014. 
The comments did not lead to significant changes but were helpful in 
identifying additional factors of interest in KQ 4 and KQ 5, and for 
clarifying the wording of the questions.
    Based on the public comments and subsequent discussions with AHRQ, 
the following changes of note were made to the KQs:
     KQ 4: Added ``provider type'' to KQ 4b. Added an 
additional sub question of ``Do level of use and primary uses vary by 
data source?''
     KQ 5: Added an additional sub question of ``How does 
usability vary by health care settings or systems?''
    The revised KQs are as follows:

KQ 1: Is health information exchange (HIE) effective in improving 
clinical (e.g. mortality and morbidity), economic (e.g., costs and 
resource use, the value proposition for HIE) and population (e.g., 
syndromic surveillance) outcomes?

     Does effectiveness vary by type of HIE?
     Does effectiveness vary by health care settings and 
systems?
     Does effectiveness vary by IT system characteristics?
     What evidence exists that the lack of HIE leads to poorer 
outcomes?

KQ 2: What harms have resulted from HIE? (e.g., violations of privacy, 
errors in diagnosis or treatment from too much, too little or 
inaccurate information, or patient or provider concerns about HIE)?

     Do harms vary by type of HIE?
     Do harms vary by health care settings and systems?
     Do harms vary by the IT system characteristics?

KQ 3: Is HIE effective in improving intermediate outcomes such as 
patient and provider experience, perceptions or behavior; health care 
processes; or the availability, completeness, or accuracy of 
information?

     Does effectiveness in improving intermediate outcomes vary 
by type of HIE?
     Does effectiveness in improving intermediate outcomes vary 
by health care settings and systems?
     Does effectiveness in improving intermediate outcomes vary 
by IT system characteristics?
     What evidence exists that the lack of HIE leads to poorer 
intermediate outcomes?

KQ 4: What is the current level of use and primary uses of HIE?

     Do level of use and primary uses vary by type of HIE?
     Do level of use and primary uses vary by health care 
settings and systems, or provider type?
     Do level of use and primary uses vary by IT system 
characteristics?
     Do level of use and primary uses vary by data source?

KQ 5: How does the usability of HIE impact effectiveness or harms for 
individuals and organizations?

     How usable are various types of HIE?
     What specific usability factors impact the effectiveness 
or harms from HIE?
     How does usability vary by health care settings or 
systems?

KQ 6: What facilitators and barriers impact implementation of HIE?

     Do facilitators and barriers that impact implementation 
vary by type of HIE?
     Do facilitators and barriers that impact implementation 
vary by health care settings and systems?
     Do facilitators and barriers that impact implementation 
vary by IT system characteristics?

KQ 7: What facilitators and barriers impact use of HIE?

     Do facilitators and barriers that impact use vary by type 
of HIE?

[[Page 51569]]

     Do facilitators and barriers that impact use vary by 
health care settings and systems?
     Do facilitators and barriers that impact use vary by IT 
system characteristics?

KQ 8: What factors influence sustainability of HIE?

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, 
Setting)

Populations

    Any individual or group of health care providers, patients, 
managers, health care institutions, or regional organizations.

Intervention

    Heath Information Exchange (HIE). HIE is defined as the electronic 
sharing of clinical information among users such as health care 
providers, patients, administrators or policy makers across the 
boundaries of health care institutions, health data repositories, 
States and others, typically not within a single organization or among 
affiliated providers, while protecting the integrity, privacy, and 
security of the information.

Comparators

     Time period prior to HIE implementation
     Locations (geographic or organizational without HIE)
     Situations in which HIE is not available, akin to ``usual 
care'' in a clinical study
     Comparisons across types of HIE
     Comparisons of the characteristics of the different 
settings, health care system, and IT systems in which HIE is used

Outcomes (specified for each Key Question)

    KQ 1: Effectiveness is defined in terms of clinical outcomes (e.g., 
mortality and morbidity), economic outcomes (e.g., costs and resource 
use, the value proposition for HIE) and population outcomes (e.g., 
syndromic surveillance for the identification of trends or clusters).
    KQ 2: Harms include unintended negative consequence or adverse 
events experienced by individuals, institutions, or organizations. 
Harms from HIE may include negative outcomes or the risk of negative 
outcomes resulting from information that is wrong, not provided in a 
timely manner, or in formats that inhibit its identification, 
comprehension, and use. Harms also may result from too much information 
as well as lack of information. Harms can also include negative impacts 
on attitudes (e.g., patients not trusting the privacy will be 
protected, clinicians' concerns about legal liability).
    KQ 3: Intermediate outcomes include outcomes such as provider and 
patient experience and perceptions; changes in provider behavior and 
health care processes; and changes in the availability, completeness, 
or accuracy of information.
    KQ 4: Level of use is the rate of HIE use by individuals, health 
care institutions, or regional organizations.
    KQ 5: Usability focuses on the function of the HIE in terms of the 
interaction between users and HIE and their ability to navigate and 
accomplish tasks.
    KQ 6: Implementation of HIE is defined as the realization of an HIE 
project such that the exchange of data is operational.
    KQ 7: Use is the incorporation of the HIE into the workflow and 
decisions of patients, providers or organizations.
    KQ 8: Sustainability is long-term maintenance, and improvement or 
expansion of HIE, after the implementation period.

Timing

    No minimum duration of time lapsed from implementation of HIE to 
the measurement of outcomes.

Settings

    Any aspect of the setting in which health information is exchanged 
for the purpose of improving health or health care decisions that is 
hypothesized to impact effectiveness, use, usability or sustainability. 
This may include the type(s) of clinical environments (e.g., ambulatory 
care, hospital, nursing home, etc.), payment/reimbursement model(s) 
(e.g., fee-for-service, managed care setting, risk/value-based model 
such as an accountable care organization, etc.), and legislative 
requirements (e.g., participation in HIE required to participate in 
Medicaid).

    Dated: August 20, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-20425 Filed 8-28-14; 8:45 am]
BILLING CODE 4160-90-M
```