SUPPORTING STATEMENT
Part A
American Recovery and Reinvestment Act
“Developing a Registry of Registries”
Contract No. HHSA290200500351
Version: 23 January 2017
Agency of Healthcare Research and Quality (AHRQ)
Table of contents
A. Justification 3
1. Circumstances that make the collection of information necessary 3
2. Purpose and Use of Information 5
3. Use of Improved Information Technology 5
4. Efforts to Identify Duplication 6
5. Involvement of Small Entities 6
6. Consequences if Information Collected Less Frequently 6
7. Special Circumstances 7
8. Federal Register Notice and Outside Consultations 7
8.b. Outside Consultations 7
9. Payments/Gifts to Respondents 8
10. Assurance of Confidentiality 8
11. Questions of a Sensitive Nature 9
12. Estimates of Annualized Burden Hours and Costs 9
13. Estimates of Annualized Respondent Capital and Maintenance Costs 11
14. Estimates of Total and Annualized Cost to the Government 11
15. Changes in Hour Burden 12
16. Time Schedule, Publication and Analysis Plans 12
17. Exemption for Display of Expiration Date 12
List of Attachments
The mission of the Agency for Healthcare Research and Quality (AHRQ) set out in its authorizing legislation, The Healthcare Research and Quality Act of 1999 (see http://www.ahrq.gov/hrqa99.pdf), is to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health systems practices, including the prevention of diseases and other health conditions. AHRQ shall promote health care quality improvement by conducting and supporting:
1. Research that develops and presents scientific evidence regarding all aspects of health care; and
2. The synthesis and dissemination of available scientific evidence for use by patients, consumers, practitioners, providers, purchasers, policy makers, and educators; and
3. Initiatives to advance private and public efforts to improve health care quality.
Also, AHRQ shall conduct and support research and evaluations, and support demonstration projects, with respect to (A) the delivery of health care in inner-city areas, and in rural areas (including frontier areas); and (B) health care for priority populations, which shall include (1) low-income groups, (2) minority groups, (3) women, (4) children, (5) the elderly, and (6) individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.
The US Food and Drug Administration (FDA) Modernization Act of 1997 provided for the creation of the ClinicalTrials.gov system to improve transparency in clinical research.
Since its launch in 2000, the ClinicalTrials.gov system has registered over 90,500 trials. The large volume of studies currently listed in ClinicalTrials.gov and the high usage numbers suggest that the system has been successful at improving access to information about clinical studies. Current mandates, however, only require the registration of controlled, experimental studies in ClinicalTrials.gov. Observational studies, such as patient registries, are not required to be listed in ClinicalTrials.gov.
Patient registries have received significant attention and funding in recent years. Similar to controlled studies, patient registries represent some burden to patients (e.g., time to complete patient reported outcome measures, risk of loss of privacy), who often participate voluntarily in hopes of improving knowledge about a disease or condition. Patient registries also represent a substantial investment of health research resources. Despite these factors, patient registries are not required to be registered in ClinicalTrials.gov, presenting the potential for duplication of efforts and insufficient dissemination of findings that are not published in the peer-reviewed literature. To fulfill the obligation to patients and to ensure that resources are used in the most efficient manner, registries need to be listed in a manner similar to that of trials in ClinicalTrials.gov.
By providing a centralized point of collection for information about all patient registries in the United States, the Registry of Patient Registries (RoPR) furthers AHRQ’s goals by enhancing patient registry information, extracted from ClinicalTrials.gov or modeled based on the ClinicalTrials.gov data elements, to further describe the quality, appropriateness, and effectiveness of health services (and patient registries in particular) in a more readily available, central location.
The RoPR database system aims to achieve the following objectives:
Provide a searchable database of patient registries in the United States (to promote collaboration, reduce redundancy, and improve transparency);
Facilitate the use of common data fields and definitions in similar health conditions (to improve opportunities for sharing, comparing, and linkage);
Provide a public repository of searchable summary results (including results from registries that have not yet been published in the peer-reviewed literature);
Offer a search tool to locate existing data that researchers can request for use in new studies; and
Serve as a recruitment tool for researchers and patients interested in participating in patient registries.
To achieve the objectives of this project, the following data collections will be implemented:
Collect information on registries from users who populate the RoPR database system, which will achieve all of the above goals.
AHRQ is proposing to add a self-registration option to the RoPR database so that registry owners do not need a National Library of Medicine Protocol Registration System (PRS) account to contribute. The current OMB-approved RoPR system requires users to have a PRS account. In the current data entry process, registry owners enter most of the registry information using the ClinicalTrials.gov PRS. If a user defines the ClinicalTrials.gov record as a patient registry, that user will have the option of following a link to the RoPR submission page to input additional information about the registry. Patient registry data entered in the PRS is uploaded to the RoPR system daily and is accessible (along with information entered directly into RoPR) to the public via the RoPR search function.
Under the AHRQ proposal, these users can complete a simple registration on the RoPR site, which would be less burdensome than the PRS registration process, and then enter all registry information directly on RoPR. The rationale behind this alternative registration pathway is that many registries are created for quality reporting, outcome tracking, and quality improvement purposes, rather than for research purposes. Registering in ClinicalTrials.gov implies a research purpose, so it is not necessarily appropriate for non-research registries to register in ClinicalTrials.gov, and many have expressed that they do not wish to do so. AHRQ anticipates that more than 75 percent of registries will still register through the ClinicalTrials.com. However, the remaining registries are extremely important for health policy, and providing them with a registration pathway furthers the goal of creating a central place where stakeholders can find information on research and non-research registries pertinent to a specific clinical topic.
The new self-registration pathway updates to the RoPR site is being developed by AHRQ through its contractor, L&M Policy Research and subcontractor Truven Health Analytics, an IBM Company, pursuant to AHRQ’s statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).
AHRQ, in collaboration with the Centers for Medicare & Medicaid Services (CMS), is also proposing to add three fields to the self-registration pathway related to the CMS initiative to create a Centralized Repository for Public Health Agencies and Clinical Data Registry Reporting. The purpose of the repository is to assist eligible professionals, eligible hospitals, and critical access hospitals in finding entities that accept electronic public health data. By adding these fields to the existing RoPR database, AHRQ will further the goal of creating a central place where stakeholders can find all pertinent information on registries.
The purpose and the use of the RoPR is to provide a readily available public resource strictly for patient registries, following the model of ClinicalTrials.gov, allowing for the increased availability and efficacy of patient registries. The information being collected in the RoPR Record is visible to the public visiting the RoPR website, and is readily available for public use.
The RoPR is an ongoing data collection initiative.
The RoPR is web-based, and does not require users to submit any type of paper forms.
The existing RoPR system allows for the collection of data in two (2) ways: users are able to enter information into the web-based system manually, or use an automated upload feature. The manual data entry system utilizes an intuitive and logical step-by-step data entry process. The automated uploader feature allows users to pre-populate information into an XML file, thereby eliminating the time burden involved in manual data entry. The XML files are created from existing databases, using a provided template/ schema.
When using the new self-registration pathway to enter all registry information in RoPR, users will enter information into the web-based system manually.
Additionally, the RoPR system sends an automated e-mail notification to registry holders if no change has been made to their RoPR record in the past year, reminding them to ensure that their registry information is up-to-date. This automated reminder system helps to ensure the timeliness of the information entered in the RoPR, while reducing the burden on registry holders to remember to update information they entered in the RoPR.
As mentioned in Section 1, patient registries are currently registered in ClinicalTrials.gov. These patient registries may appear in RoPR information searches. However, because registration in ClinicalTrials.gov is not currently mandated for registries and observational studies, the information that ClinicalTrials.gov collects is not completely sufficient for the needs of users registering information about existing patient registries. As such, users who enter patient registry information in ClinicalTrials.gov are asked to enter supplemental information in RoPR that is not already collected from patient registry users on ClinicalTrials.gov
As specified in Section 1, users seeking to register non-research patient registries will now have the option of self-registering on the RoPR site and entering all registry information in RoPR instead of registering through the PRS and entering data in ClinicalTrials.gov. Overall, this process will require less time and effort than the process of obtaining a PRS account and completing data entry in both ClinicalTrials.gov and RoPR.
While small businesses and other small entities may use the RoPR to enter information, participation is not compulsory. The information being requested by the RoPR is held to the absolute minimum required for the intended use, as described in Section 4. It is not expected that small businesses need to provide less information than any other business or entity registering a registry in the RoPR. The burden is voluntary and minimal, and therefore should not be taken into consideration.
If the RoPR ceases to collect the registry information it is intended to collect, then information about registries will continue to be stored and accessed as it is currently: in a fragmented and inconsistent way which does not facilitate collaboration among researchers; reduced redundancy in research, and improved transparency in registry practice.
If RoPR does not implement a self-registration pathway for non-research registry owners, non-research registries who do not wish to create a PRS account will be excluded from the database, decreasing its value as a central repository where stakeholders can find information on all registries pertinent to specific clinical topic.
Because participation in the RoPR is not obligatory, it is possible that collection from a given entity may only occur once, or less frequently than recommended. Registry holders may choose to only post information regarding their registry one time, expecting users to seek them out for updated data.
The RoPR system provides notification to registry holders informing them on a regular, or annual, basis of the need to update basic statistics and contact information, but it is the responsibility of the registry holder to update the information.
If a Registry Profile has not been reviewed and updated to the RoPR search site within four (4) years, it is considered to be archived.
Archived Registry Profiles are displayed by default on the RoPR search site. However, a selection option on the Search Web site allows for archived records to be hidden from search results.
This request is consistent with the general information collection guidelines of 5 CFR 1320.5(d)(2). No special circumstances apply.
8.a. Federal Register Notice
As required by 5 CFR 1320.8(d), notice was published in the Federal Register on Page 19723 of Federal Register, April 28, 2017 for 60 days (see Attachment A).
No comments were received.
In development of the existing RoPR database, AHRQ and its contractor, Quintiles, consulted with representatives from varied backgrounds (including the pharmaceutical industry, government agencies, academia, patient/consumer advocates, Federal funding agencies, provider/physician associations, and others) to garner their perspectives on the expected scope and policies and procedures of the RoPR. The views and opinions of these stakeholders were taken into consideration during the design and development of the RoPR.
AHRQ and Quintiles also worked closely with the team at ClinicalTrials.gov and the National Library of Medicine (NLM) to determine the technical infrastructure of the RoPR and the nature of its relationship to ClinicalTrials.gov.
Participation in the RoPR is voluntary. As such, there is no payment or remuneration offered to users for registering a registry in the RoPR.
Individuals and organizations are to be assured of the confidentiality of their replies under Section 934(c) of the Public Health Service Act, 42 USC 299c-3(c), which requires that information that is obtained in the course of AHRQ-supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it.
For the self-registration pathway, users are required to enter an email address associated with the account. This information is mandatory and is not made public. It is only used for administrative purposes such as communicating information about password updates and resets. First name, last name, and organization fields are optional.
For each registry, the RoPR interface collects the e-mail address of the RoPR record owner. This information is mandatory and is not made public. It is used only for periodic auto-generation of e-mail reminders pertaining to the maintenance of RoPR patient registry data. There is no human administrator that is pulling this information for the purpose of sending out e-mails. Therefore, individuals registering patient registries via the RoPR are told the purposes for which this information (e.g., e-mail) is collected, in accordance with the Privacy Act, not to be used, or disclosed for any other purpose than for the RoPR. To this effect, a disclaimer statement is clearly stated within the RoPR system: “This email will only be used by RoPR and will not be distributed.”
The RoPR record owner has the option to select “Do not contact” on the RoPR. This selected option does not exempt the RoPR user from having to complete these “mandatory” fields: Reasons for being contacted; Organization; E-mail and Phone.
PII (First/Last Name) and Title fields are non - mandatory entries, which are indicated as optional fields as a user completes the RoPR profile. This information is available publically for intended uses as identified by the accompanying categories detailing the sponsor’s reasons for being contacted. In this case, the Privacy Act is not applicable, however the collection of PII is deemed necessary for collection on the RoPR, for the following reasons:
The RoPR is an information repository which connects patient registries with individuals interested in learning more about them and how they advance healthcare. Many patient registries find it mutually beneficial to provide primary contact information to facilitate dialogue between them and interested parties. Patient registries comprise a highly specialized field. Only a subset of the general public would be interested in pursuing dialogue with a particular patient registry, motivated by interest in specific medical conditions being examined. Extra security measures have been taken so that PII is not searchable on the RoPR, in the live or administrative environments.
Registration burden is reduced by clearly indicating that the submission of PII, First Name/Last Name, of the primary contact person purely voluntary, for the purpose of knowledge exchange between the patient registry and concerned members of the public. ( See Attachment C: Privacy Impact Assessment For The Registry of Patient Registries, )
The RoPR does not collect any information of a sensitive nature, or information that can directly identify the respondent, such as a social security number or Medicare/Medicaid number.
Exhibit 1 shows the estimated annualized burden hours for the respondent’s time to participate in the RoPR. In 2016, 65 respondents manually entered a new RoPR record. It is expected that more than 75% of patient registries are research-focused and will continue to use the original ClinicalTrials.gov pathway described above. Thus, it is estimated that once the self-registration pathway is available, approximately 65 respondents will enter RoPR records through the ClinicalTrials.gov link annually, and an additional 16 respondents (roughly 25% of 65), representing non-research registries, will enter RoPR records through the new self-registration pathway.
Each respondent need enter his or her new RoPR record only once. The RoPR system sends an automated reminder to any registry owner who has not updated his or her RoPR record in the past year. In 2016, 132 RoPR entries were updated and released. Using the same logic as above, it is estimated that an additional 33 entries (25% of 132) might be updated annually once the self-registration pathway is available.
In January 2017, Truven Health Analytics used a sample of existing ClinicalTrials.gov registry entries to estimate the time needed to enter all additional fields added through the self-registration process. The sample included records representing a range of depth and complexity. For example, one registry record contained only one primary outcome measure. Another record contained three more detailed outcome measures (one primary, one secondary, and one other.)
As a result of the knowledge gained during these processes, it is estimated that it will take users 10 minutes, on average, to manually enter the additional fields added through the self-registration process. Adding this time to the estimated burden of completing the original RoPR fields (45 minutes), it is estimated that it will take users 55 minutes to complete all fields through the self-registration pathway.
It is estimated that it will take users 5 minutes to review and update the fields added through the self-registration pathway. Adding this time to the estimated burden of reviewing and updating the original RoPR fields (15 minutes), it is estimated that it will take 20 minutes for a user to review and make updates to an existing RoPR record created through the self-registration pathway.
Exhibit 1. Estimated annualized burden hours
Form Name |
Number of respondents |
Number of responses per respondent |
Minutes per response |
Total burden hours |
New RoPR Record entered manually through self-registration process |
16 |
1 |
55/60 |
14.67 |
New RoPR Record entered through ClinicalTrials.gov pathway |
65 |
1 |
45/60 |
48.75 |
Review/update existing RoPR Record created through self-registration process |
33 |
1 |
20/60 |
11 |
Review/update existing RoPR Record created through ClinicalTrials.gov pathway |
132 |
1 |
15/60 |
33 |
Total |
246 |
|
|
107.42 |
Exhibit 2 shows the estimated cost burden associated with the respondent’s time to participate in the RoPR. The total cost burden to respondents is estimated at an average of $4,017.51 annually.
Exhibit 2. Estimated annualized cost burden
Form Name |
Number of respondents |
Total burden hours |
Average hourly wage rate† |
Total cost burden |
New RoPR Record entered manually through self-registration process |
16 |
14.67 |
$37.40 |
$548.66 |
New RoPR Record entered through ClinicalTrials.gov pathway |
65 |
48.75 |
$37.40 |
$1,823.25 |
Review/update existing RoPR Record created through self-registration process |
33 |
11 |
$37.40 |
$411.40 |
Review/update existing RoPR Record created through ClinicalTrials.gov pathway |
132 |
33 |
$37.40 |
$1,234.20 |
Total |
246 |
107.42 |
$37.40 |
$4,017.51 |
|
|
|
|
|
* Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29-0000. National Compensation Survey: Occupational wages in the United States May 2015, “U.S. Department of Labor, Bureau of Labor Statistics.” Available at: https://www.bls.gov/oes/current/oes290000.htm
There are no direct costs to respondents other than their time to participate in the study.
The RoPR project is in the fourth phase, where ongoing RoPR user support is provided, along with the need for occasional system maintenance and performing necessary system upgrades as necessary by AHRQ’s contractor, L&M Policy Research; and L&M’s sub-contractor, Truven Health Analytics, an IBM Company.
Per Exhibit 3a, the estimated total annual cost of Project Management and system maintenance/updates is $199,897.33.
Exhibit 3a. Estimated Total and Annualized Cost
Cost Component |
Total Cost |
Annualized Cost |
Project Management |
$142,044.00 |
$47,348.00 |
Maintain & update the system |
$457,648.00 |
$152,549.33 |
Total |
$599,692.00 |
$199,897.33 |
Per exhibit 3b, the Federal Government Personnel Cost (at approximately 5%, or 104 hours, of an FTE Project Officer, GS 15, Step 5) is estimated at $7,258.10 on an annual basis.
Exhibit 3b. Federal Government Personnel Cost
Activity |
Federal Personnel* |
Annual Rate |
Estimated Hours |
Annual Cost |
Project Oversight |
Project Officer, GS 15, Step 5 |
$145,162 |
104 |
$7,258.10 |
Total |
$7,258.10 |
|||
Annual salaries based on 2015 OPM Pay Schedule for Washington/DC area: http://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/20152016/DCB.pdf
This is an ongoing collection of information. While user participation burden remains voluntary and minimal, with continued marketing of the RoPR as knowledge repository for patient registries, it is anticipated that the number of respondents will increase over time.
The estimated burden reported above reflects an increase from the burden per response reported in the previous PRA submission. The new estimates reflect updated system-generated counts of annual responses/updates, as of January 2017. The new estimates also reflect an additional group of respondents representing stewards of non-research registries. These respondents were unlikely to use the existing ClinicalTrials.gov pathway to RoPR. The estimated time burden for this set of respondents reflects the time it takes an average user to complete a registry submission using the self-registration pathway or update an entry created through the self-registration pathway. The self-registration process is expected to take more time than the original registration pathway through ClinicalTrials.gov because it involves the user entering all registry information within RoPR (see screen shots in Attachment B displaying all data entry fields), as opposed to entering most information in ClinicalTrials.gov and only supplemental information in RoPR. The process of updating these records in RoPR is also expected to take more time than it would with other records because more fields are involved.
There are no plans to publish or analyze the information collected in the RoPR Record.
AHRQ does not seek this exemption.
List of Attachments:
Attachment A: Federal Register Notice
Attachment B: New RoPR Record
Attachment C: Privacy Impact Assessment
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | OMB Clearance Application |
| Author | hamlin-ben |
| File Modified | 0000-00-00 |
| File Created | 2021-01-22 |