SUPPORTING STATEMENT
Part B
American Recovery and Reinvestment Act
“Developing a Registry of Registries”
Contract No. HHSA290200500351
Version [2 December 2011]
Agency for Healthcare Research and Quality (AHRQ)
Table of contents
B. Collections of Information Employing Statistical Methods 3
1. Respondent universe and sampling methods 3
2. Information Collection Procedures 3
3. Methods to Maximize Response Rates 4
Additional Incentives for Consideration 6
Potential Outreach Activities 6
Participation in the RoPR will be voluntary, and will be available to any entity conducting a patient registry. Therefore, it is not possible to determine with certainty the size of the respondent universe.
We do know that over 3,800 newly registered records designated as “observational studies” were entered into ClinicalTrials.gov in 2010. Only a subset of this number (which we will estimate at a maximum of 40%) would qualify as patient registries and would likely be registered in the RoPR. Therefore, we can provide a very rough, but high, estimate of 1,520 (3,800*0.40) potential respondents who will enter registries into the RoPR during its first year of operation. The actual number of respondents will depend on a variety of factors and could vary widely.
There will be no sampling or respondent selection method employed by the RoPR, aside from the self-selection that respondents will exercise when deciding to enter an eligible study in the RoPR.
Based on stakeholder feedback, the RoPR will integrate with ClinicalTrials.gov to present a seamless user interface and as low a response burden as possible. Users who register a record as a “Patient Registry” under the Study Type data element at ClinicalTrials.gov will be provided with an option to complete a blank RoPR record at the RoPR website. The RoPR record is comprised of 11 required data elements and 34 optional data elements (of which 11 may be required conditionally). Respondents will not be able to submit their record until all required data elements are completed. Once a respondent has completed and released a RoPR record, that record is available for the public to view through the RoPR search.
Describe any QC methods
RoPR records which are either missing required data elements or have invalid entries (e.g. an email address in a non-standard format), will not be able to be released for view on the RoPR search site. The RoPR will clearly display errors for any such missing or invalid data elements. Additional prompts for incomplete records will display for the respondent on attempting to release a record with errors.
Respondents who register a study in the RoPR will be contacted via email if their registry record has not been updated for one year. The RoPR system will send them an automated email message informing them that it has been one year since their registry record was updated, and prompting them to return to the RoPR website, review their registry record, and update it if necessary. The text of this email follows. It is estimated that the time burden for reviewing and updating a registry record will be about 15 minutes.
Automated email message text:
To: [Registry Holder]
From: [RoPR@tbd]
Subject: RoPR Record [Registry Title]
Body:
To Whom It May Concern:
The record [Registry Title], currently posted on RoPR (The Registry of Patient Registries] has not been updated in one year.
Please log into PRS at https://register.clinicaltrials.gov/ to make any updates to the ClinicalTrials.gov record as necessary. From the links present on either the Study Design section or the Release page of PRS, please navigate to the RoPR Registration System and make any updates to your RoPR record.
If no updates are made to the record after four years, it will be set to an Archived status. Archived records will still be available on the RoPR search site, but the public may choose to filter them out of search results.
Thank you for your support,
The RoPR team
The RoPR will not impute any missing data for any optional data elements that are not completed.
Because of the nature of the RoPR – it will be an optional, publicly-available, central point of collection for information about patient registries in the United States – there is no need to reach a particular “sample size” of respondents that would power analysis around answering a particular research question.
As described above, the RoPR will not be a data collection effort aimed at answering a specific research question. Therefore, there is no need for a particular sample size of respondents to power analysis of respondent data. Nonetheless, AHRQ is committed to maximizing response rates by lowering respondent burden and raising awareness of RoPR as a resource for registry holders and seekers of information about registries. AHRQ’s efforts to lower the response burden have been discussed in Part A of this supporting statement. AHRQ has attempted to raise public awareness of the RoPR by affiliating it with ClinicalTrials.gov, which will have a similar (although not identical) user base as the RoPR. The National Library of Medicine will add new data elements to ClinicalTrials.gov to support Patient Registry records and their data element definitions will serve as means to make their community aware of the RoPR. Additional awareness may be achieved via actions described below under Potential Outreach Activities.
Beyond inclusion and exclusion criteria, a key question is which registries (if any) will be required to be listed in the RoPR. For this question, there are several important perspectives.
First, from a regulatory and legal perspective, the RoPR does not currently have the authority to require any registry to be listed in the RoPR system. However, other groups could require listing of registries in the RoPR system. For example, it is recommended that certain funding sources, such as government agencies, strongly consider requiring the listing of registries that they fund in the RoPR through their contract terms. Such a requirement would benefit the funding agency by increasing the transparency of the registries that they fund.
Second, the issue can also be considered from a health care journal perspective, since the decision by the International Committee of Medical Journal Editors to require ClinicalTrials.gov listing of interventional studies for publication as part of their Uniform Requirements for Manuscripts policy was critical to the rapid growth of ClinicalTrials.gov as a trials registry. 1,2 While it is a clear advantage to both reviewers and publishers of peer-reviewed journals to have patient registries listed in the RoPR, the predominant view of the editors participating in the development of these the RoPR policies and procedures is that the compelling moral rationale that justified requiring registration of interventional trials does not exist for observational studies.
Despite the lack of requirements, there are very strong motivations for registry holders to list their registries.
Some of the specific motivations cited by stakeholders include:
To contribute to the common good;
To increase general awareness about the existence of the registry, which may support the registry’s goals or the goals of the sponsoring organizations;
To increase awareness of the registry in order to improve investigator and, in some cases, participant enrollment, which could reduce time to completion for time-sensitive registries;
To find other groups with whom to collaborate;
To facilitate research; and
To meet requirements that may exist as a condition of funding.
Stakeholders also noted that, as more patient registries are listed over time, the RoPR will likely become the key source for identifying registries for systematic reviews and meta analyses. Therefore, listing will be increasingly important for a registry to have an impact on evidence development.
In discussions with stakeholders, it became clear that there are several explicit incentives that could be established to motivate registry holders to list their registries in the RoPR. For example, the RoPR could provide tools that give direct benefit to listed registries, such as notifications when the listed registry is included in a publication posted on PubMed; updates about other similar registries as they are posted on the RoPR; or tools that enable and facilitate collaboration opportunities between interested organizations and the listed registries. The RoPR could also offer a ‘community of practice’ program (e.g., a learning network) to support registry holders in improving the registries listed in the RoPR and/or developing new registries. As described earlier, funding organizations, both public and private, might require registration as part of their funding agreements. This might be justified by the likelihood that visibility in the RoPR may improve the overall evidentiary impact of the funded registry. Negative incentives might also be established by journals, institutional review boards, Congress, or others. Such negative incentives are viewed as less likely to be enacted.
The RoPR would benefit from a targeted campaign after launch to generate awareness of the system and urgency to register. The utility of the system for registry seekers will depend on the number of registries that are listed. Therefore, the initial campaign would need to reach a broad set of current and future registry holders and secondarily, likely users of the RoPR system. Stakeholders suggested a number of activities that could be undertaken, such as:
Soliciting organizations with likely registry holders as members, including the Council of Medical Specialty Societies; International Society for Pharmacoeconomics and Outcomes Research (ISPOR); International Society for Pharmacoepidemiology (ISPE); manufacturer trade associations (e.g., Pharmaceutical Research and Manufacturers of America (PhRMA), AdvaMed, Drug Information Association (DIA)); associations of patient organizations; academic institutions; public health agencies; and government agencies (e.g., National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC)).
Performing research on existing registries through standard sources and soliciting those registry holders to participate.
Presenting the RoPR at conferences attended by registry developers and sponsors and researchers who may be interested in using the RoPR.
Adding a section on the RoPR to the AHRQ publication, “Registries for Evaluating Patient Outcomes: A User’s Guide”, since it is already widely used in the community of registry developers and owners.
As part of the RoPR development process, usability testing was conducted on a prototype of the data collection system. Nine individuals took part in 8 separate sessions that were a minimum of 1 hour long. Based on feedback obtained from these sessions, changes were made to the RoPR system to improve navigation and ease of use. Several changes were made to the wording of the data elements, to clarify intent and improve user understanding. All development on the RoPR system as it moves beyond the prototype is subject to software quality assurance testing, load testing, performance testing, and additional user acceptance testing. The user acceptance testing will include a minimum of 12 sessions of 5-8 stakeholders representing various actor roles to review different sections of the system. Their feedback will be incorporated in an additional round of revisions to ensure ease of use, and to decrease user burden. The documentation associated with these testing efforts will be shared with AHRQ.
The RoPR was designed and will be built by the Outcome DEcIDE Center under contract to the Agency for Healthcare Research and Quality (AHRQ). Outcome is contracted to maintain the RoPR system through 29 September 2013. It is not yet known who will be the entity maintaining the RoPR system past that date. The Outcome DEcIDE Center’s point of contact for the RoPR system will be the Chief Technology Officer, currently Dan Levy.
1 Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors, (September 2004); http://www.icmje.org/clin_trial.pdf.
2 Update on Trials Registration: Clinical Trial Registration: Looking Back and Moving Ahead, (June 2007); http://www.icmje.org/update_june07.html.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Supporting Statement Part B |
| Subject | <p>(Supporting Statement Template and Instructions; instructions are in italics) SUPPORTING STATEMENT Part B |
| Author | Heather Nalls |
| File Modified | 0000-00-00 |
| File Created | 2021-01-30 |