Request for Scientific Information Submissions.
Citation: "79 FR 51567"
Page Number: "51567"
DATES: Submission Deadline on or before
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: SIPS@epc-src.org.
Shipping Address (
FOR FURTHER INFORMATION CONTACT:
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and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.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
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?
* 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)
Any individual or group of health care providers, patients, managers, health care institutions, or regional organizations.
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.
* 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.
No minimum duration of time lapsed from implementation of HIE to the measurement of outcomes.
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
[FR Doc. 2014-20425 Filed 8-28-14;
BILLING CODE 4160-90-M
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