Public Comment Submissions

Submitted

11/1/16 15:12

Name and/or Organization

Ryan Carnahan, The University of Iowa

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

I support the idea of data sharing and transparency of analyses. This is particularly relevant for clinical trials that may produce data useful for ancillary analyses. There are some issues that may arise when considering secondary analyses of administrative data. The most significant issue related to my work has to do with the data use agreement (DUA) with CMS, which requires data destruction after the study is complete and the DUA expires. It's possible that they might allow continued holding of data for a requirement like this, but I'm not sure. CMS has become somewhat more restrictive with durations of DUAs, now requiring them to be renewed on a yearly basis. This adds personnel time to the cost of holding data for 7 years, in addition to data storage costs . Holding data may also require an IRB approved project, which means additional administrative costs for maintaining IRB approval and IRB oversight. I'm also all for reusing data that has been purchased for new studies, or even replications, but these require data reuse agreements which have a cost. The bottom line of these comments is to ensure that CMS regulations or contract arrangements relating to the use of other administrative claims data providers (e.g. large insurers) are considered when thinking about this requirement. I suspect the cost of maintaining copies of these large data sets is also somewhat higher than more typical smaller data sets, just given the size, though I don't think our data storage costs are particularly prohibitive. From a practical standpoint, I also want to note that the processing of raw CMS data to produce an analytic file isn't typically completed in one concise analytic program. Our core set of programs to complete our primary study numbers a dozen or more, and it may require significant orientation to the data and programs for someone to try to interpret what they're doing. Even the source files being used in each program may not be obvious, depending on the naming conventions used when reading the raw data into SAS or another program's format. Beyond that, we have a large number of exploratory analyses that led us to choose the methods we chose. Assumedly these would not be required to be shared. The main point of this is just to consider the additional complexity introduced when there are multiple programs in different places on a server that all combine to produce an analysis. We have organized and documented these in such a way that they could be shared, and are open to sharing these with other investigators looking to reproduce our methods, but it does add layers of effort and complexity beyond sharing the typical analytic program for an analysis-ready data set. In summary, I support the idea of data sharing, but am hopeful that the complexities of doing this for studies using large administrative data sets such as CMS data sources are considered when shaping the requirements.


Submitted

11/2/16 7:15

Name and/or Organization

Lynne Gauthier

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

What should be the retention period for how long PCORI research awardees must retain the full data package for sharing? Indefinitely What restrictions on use of PCORI research awardee data are important to include in the data use agreement executed by third parties requesting access to the data (e.g., data will not be re-identified, data will be used only for research and not commercial purposes, data will be used only for research in the same therapeutic area as the original research project through which the data were collected)? No restrictions on use, but PCORI awardees should be given ample time to publish their data first or be allowed to "claim" the topics of their publications, such that others would be restricted to publishing novel analyses (or metaanalyses) using the data (their own intellectual ideas). It would be unfair for awardees to conduct the project and then have a different team publish the results while their submission was under review. What qualifications/credentials should be required for a third party requesting access to PCORI research awardee data (e.g., education level, specific scientific expertise)? None. I think the American people are funding it, so should have open access to utilize the data for their own intellectual ideas. What documentation should a third party requester be required to provide when applying to access PCORI research awardee data (e.g., research question and lay protocol summary, full protocol and statistical analysis plan, institutional review board approval)? Research question and Aims. Less regulation is better as it would allow folks to use the data for meta-analyses. Should PCORI establish data repository standards (e.g. security, curation standards)? If so, what should the minimum standards be for a repository to qualify as a PCORI suggested repository for PCORI research awardee data? I feel like formatting for a particular repository structure would be an undue administrative burden on investigators. Perhaps a repository of links to the PIs data repository. What is the appropriate model for informed consent that should be included in the policy? Not sure, but sample IRB language or anything that could lighten administrative burden on investigators would be much appreciated. Do you have any other comments? Specifically, we seek comment about any of the following sections: (I) Purpose, (II) Applicability, (III) Definitions, and (IV) Policy.


Submitted

11/2/16 8:46

Name and/or Organization

Dr. Christopher Forrest - The Children's Hospital of Philadelphia

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

Definitions Analyzable Date Set: What about other types of studies such as observational research?


Submitted

11/2/16 11:45

Name and/or Organization

Christophe Lambert, University of New Mexico Health Sciences Center

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

The draft policy does not address commercial and private administrative claims and electronic health record (EHR) patient databases, used in observational research for comparative safety and effectiveness of treatments (including PCORI-funded CER research). The license restrictions of most administrative claims and electronic health records data providers prevent dissemination of individual level patient data (despite these data sources being deidentified). This is in part to protect patients from determined attempts at reidentification by those who have not signed legal documents promising not to do so, and in part to protect commercial interests in proprietary data that was collected at great expense. It should be stated that access to such data sources may be acquired by qualified researchers through their institutions with appropriate license fees, allowing reproducibility of findings, particularly if researchers make available all of their scripts for extraction of cohorts and variables from these datasets, and their scripts for performance of analysis (e.g. R code, SAS code, etc.). We propose that in the case of EHR and administrative claims research that researchers be required to make available their code for performing the study that would enable reproducibility by someone with access to the source data from the data provider, but that they not be required to post the individual level data. In addition, it is reasonable for the researcher to archive the individual level data and analysis scripts required to reproduce the study. However, because researchers do not own the commercial/private data, they are not in a position to bargain about the license terms, nor how they may share the commercial/private individual level data. If the requirement was made that all individual level data had to be open, this would kill large-scale observational research on EHR and administrative claims data. Only institutions who owned their own data could potentially participate in research that required disclosure of individual patient data, limiting sample size and generalizability. Even then, high quality research requires very specific patient data to be characterized and included in models (for example the information in doctors’ notes), whereby a conflict would arise between model quality and patient privacy if very fine-grain covariates were used in the models and had to be openly released. We are developing methods (not funded by PCORI) to enable release of cluster level data that would both protect individual identity and enable reproducibility of research, but these technologies are still too new to set policy around. I would draw attention to the Observational Health Data Sciences and Informatics (http://www.ohdsi.org) effort to create a framework for representing a study in both human readable, and machine-readable form, where the source code for a study can be used not only to reproduce a study on the original source data, but also be used to enable replication of a study on additional data sources that have been mapped to the OMOP common data model. Currently over 630 million patients’ records worldwide exist in various repositories in the OMOP common data model, and multi-country studies are beginning to be run over a distributed research network. For example, see: Hripcsak G, et al. (2016) Characterizing treatment pathways at scale using the OHDSI network, Proceedings of the National Academy of Sciences, doi:10.1073/pnas.1510502113. In that article, 250 million patients’ data were analyzed across global databases from the USA, Japan, South Korea, and elsewhere. Each organization runs the same analysis protocol, and serves up summary results, without the requirement of distribution of individual level patient data. We are on the cusp of enabling global reproducible comparative effectiveness research on over a half billion patients' data -- without the need for disclosure of individual level patient data. The requirement that hundreds of millions of patients' individual level data be deidentified and posted somewhere would be unreasonable given current concerns about patient privacy and the interests of private data holders.


Submitted

11/2/16 16:09

Name and/or Organization

Alex Hartzman

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

This document would be improved with greater specificity. 1. No opinion. 2. I am not sure how some of the suggested requirements would work in cases where a commercial entity (such as a consulting firm or independent research group that serves commercial clients (e.g. Urban Institute, RTI, NORC, etc) wishes to use the data. Data will also prove highly valuable to third party groups whose intent is advocacy - any number of specialty societies and associations would likely be interested in using data to produce findings of benefit to their membership directly or through legislative advocacy. 3. CMS has fairly solid requirements for data use agreements and differing levels of access depending on the type of entity requesting data. It may be useful to go to ResDAC for templates and advice. 4. Access to patient identifiable data should be restricted to researchers who have an IRB. However, documentation seriousness could be on a sliding scale depending on what sort of data someone requests. For example, CMS has some datasets where they only allow users to extract data that contains no PHI - GDIT is the vendor for at least one such project (VRDC) and may have useful information to take into consideration as well as useful specifications for the vendor RFP. 5. PCORI should establish data repository security standards. I would start with reviewing CMS requirements for using claims data (storage on encrypted survers, HIPAA training of all people who may come into contact with the data, etc). 6. That's very tricky, especially for studies that are complete or underway. Some project's informed consent documents may not allow for this further use (regardless of what the PCORI contract requirements may be). 7. Other: -Minimum standards for data security and housing of PHI must be spelled out. -A "full protocol" is not inherently meaningful. I recommend specifying the up-to-date IRB-approved protocol. -It seems that the policy implies that, for PCS and targeted studies, data must be kept for 7 years, but PCORI will pay for this only if a suggested vendor is selected. While this increases flexibility, it means that PCORI must have at least one vendor in place and ready to accept and store data by the time the first contract requirement comes due. Additionally, there may be a need for alternatives in the instance a suggested vendors are not able to complete the request. -How does PCORI plan to address issues of IP? This policy may become a deterrent for applicants who wish to mine datasets for a results following completion of the primary publications. -PCORI needs to flesh out standards around appropriate costs for maintaining data and access to data.


Submitted

11/3/16 15:27

Name and/or Organization

Clarissa Hoover, Family Voices Inc.

Community

Patient

Patient Group

Caregiver/Family member of patient

Public Comments

I would like to recommend two exemptions to the data sharing agreement. 1. This agreement does not apply where compliance with the agreement would violate national or tribal sovereignty. 2. The "Analyzable Data Set" should exclude any variables for which participants might face prosecution, deportation, or other punitive action (for example, current drug use, immigration status). Thanks for making the policy short and to-the-point. The Definitions section should be fleshed out to make sure non-researchers understand exactly what will be made available, including addressing the topic of de-identification.


Submitted

11/3/16 18:47

Name and/or Organization

Michael Rice, University of Colorado Anschutz Medical center

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

I am a clinician also. The statement on "Maintenance of the Full Data Package for Data Sharing for a period of at least seven (7) years" seems excessive and most data is out of date at 5 years.... 2. Does this meet the federal OPRS guideleins? 3. Many, (the majority) of researchers will have university affiliations and are used to data sharing. However, in order to ease the transition through IRB lease not that 1. the data will be deidentified, and 2 the consent forms include full disclosure of the data banks, use and access as the local IRBs will force us to include it or refuse to approve our involvement in the study.... ;


Submitted

11/5/16 19:21

Name and/or Organization

Daniel Mietchen

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

I annotated a copy of the draft, which sits at https://via.hypothes.is/http://www.pcori.org/sites/default/files/PCORI-Data-Access-Data-Sharing-DRAFT-for-Public-Comment-October-2016.pdf .


Submitted

11/8/16 6:46

Name and/or Organization

Duke University

Community

Stakeholder

Stakeholder Community

Clinician

Public Comments

1. Data should be completely de-identified for sharing, particularly if it consists of electronic health records. 2. Data users should demonstrate qualifications to analyze complex data for health care research; should have research protocols available and posted for public access 3. Informed consents should be obtained and include provisions for this possible sharing 4. Data obtained passively through EHRs should not require informed consent but should be verified as completely de-identified before sharing by a third party.


Submitted

11/10/16 6:34

Name and/or Organization

Andrew Vickers, Memorial Sloan-Kettering Cancer Center

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

Two quick comments. First off, guidelines for sharing of trial data started to be developed long ago and have been published in the peer review literature. See https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-7-15. Some points of note include a distinction as to whether the data are for publication are not (e.g. a statistics teacher wanting an example data set vs. a researcher wanting to test a secondary hypothesis) and the importance of offering someone from the original study team an opportunity to comment on the latter, on the grounds that there are often subtleties of trial design or data collection that may otherwise be missed. Second, I don't understand the 7 year rule. I can't say that my interest in medical research is restricted to papers published after 2009 there is a lot of earlier and important literature.


Submitted

11/11/16 15:40

Name and/or Organization

Donna Evon University of North Carolina at Chapel Hill

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

Thank you for the opportunity to comment on this draft of PCORI’s Data Access and Sharing Policy. We fully support the spirit of sharing data with outside researchers to answer additional and important research questions. Below we provide several comments that we hope PCORI will consider in drafting their final policy. 1. Ensure that the original PCORI awardees and their investigative team have ample time to submit additional scholarly works from the dataset before availing it to the public. For large multi-site studies with many co-investigators and large databases, a keen interest will remain after the PCORI contract ends to continue to produce other scholarly works. Scholarly works are an important part of academic productivity and promotion and adequate time should be given to the investigative team to continue to work on publications after the contract ends. Having a reasonable timeline in place will also avoid potential issues of competition with outside investigators and duplicity of scholarly works. A two-year deferment from the end of the contract to the time of deposit in the public repository is recommended. 2. Develop specific processes to allow PCORI and the original awardees to review and approve requests for limited datasets. Including the original investigators in the review process will ensure that the data are being used for well-intended scientific purposes that will not intentionally or unintentionally lead to harm or discrimination against certain patient subgroups contained in the dataset (e.g., patients who use drugs, those uninsured). 3. Investigators wishing to obtain a limited dataset can be asked to submit an application to be reviewed and approved by PCORI and the original awardees which would include the name and institution of the primary responsible investigator, a summary abstract of the study protocol, specific aims, analytic plan, investigative team, and plans for scholarly output. PCORI should ensure that the research group has the collective scientific and statistical expertise to conduct the study being proposed. 4. A time limit of 12 months should be placed on use of the limited dataset so that other interested parties can use the dataset for similar purposes. 5. All scholarly work based upon the study should include acknowledgement of the original investigators, research staff, and patient partners who conducted the study. 6. Consider inviting the original investigators to participate as authors on subsequent scholarly works produced from the dataset, as long as there is willingness on their part to fulfill the authorship responsibilities described by the International Committee of Medical Journal Editors (ICMJE). Having an original investigator contribute to the work will likely enhance the accuracy, validity, and interpretation of the results. 7. We agree that 7 years is an appropriate retention period for how long PCORI research awardees must retain the full data package for sharing. 8. With regard to restrictions on use of PCORI limited datasets, we agree that the datasets shared should contain no PHI or HIPPA identifiers or capacity to re-link data to identifiers. 9. The agreement should include a policy that the data are used solely for the purpose of scientific and public policy research, and not for any commercial, administrative, proprietary, or law enforcement purposes. 10. The limited dataset are only used to generate statistical summary information and are not used for any purpose that may allow any individual to be identified and no attempts will be made to identify individuals. 11. One primary investigator and institution is identified as the responsible for the safety and security of the limited dataset. No additional copies of the dataset will be made by the researcher and shared with others outside of the immediate investigative team. 12. Recommend sharing of limited datasets with pre-defined variables and purposes and not access to an entire dataset, which could be used for data mining and shared with other investigators without proper policies in place.


Submitted

11/13/16 21:13

Name and/or Organization

Cara Nikolajski - UPMC Center for High-Value Health Care

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

Here are some comments from our team to be considered: Per an investigator: I usually ask requesters to submit a brief description of the goals of data sharing (e.g., pooling with other studies for the performance of a meta-analysis), the specific data they need, and how they will use the data. (The data are of course anonymized to protect privileged health information.) This information is reviewed by my research team and by me personally for scientific, technical, and ethical merit. If the request passes muster (which it almost always does), then I instruct my database administrator to release the requested data to the requester. Another consideration may (or may not) be co-authorship on manuscripts reporting additional analyses of the shared data. Per data analytics expert: It is really important that we create a data dictionary that matches the fields included in the final cleaned dataset. It will be even more important to someone outside of the study to have a data dictionary that is complete and thorough. We currently have a data dictionary for the PCORI OH study but it should be edited to include all of the calculated fields we used in the analyses and it should describe how we defined those measures. In their document PCORI discusses the final cleaned dataset but never really explicitly mentions its data dictionary companion file.


Submitted

11/22/16 22:07

Name and/or Organization

Renee Shellhaas, University of Michigan

Community

Stakeholder

Stakeholder Community

Health Researcher

File Upload

https://www.pcori.org/sites/default/files/webform/PCORI data sharing policy response 112816.docx


Submitted

11/25/16 7:22

Name and/or Organization

Kathy Helzlsouer

Community

Stakeholder

Stakeholder Community

Stakeholder - Other

Public Comments

The policy seems to be written only for clinical trials - but it should also include large observational studies (case-control and cohort studies.) - In that case then the timeline for depositing data (e.g. in an ongoing cohort study should be further defined - since the study may not end). The data access should be as open as possible - and not limited to a specific therapeutic area since individuals from other scientific fields may add innovation for analyzing the data. Requiring registration of the data user with declaration of their qualification is good - but this should not be too restrictive. Those requiring access to use the data should not be require to provide a full grant application (as outline above) - to have access to de-identified public data sets. The process should not be over burdensome, otherwise the data will not be used. One should require that results from secondary analyses be deposited -and a report of the methods and findings included - Stipulation for not being used for commercial interests is important. Consent forms should clearly note that de-identified data will be shared. Clarify the 7 years retention - some data may become more valuable for other analyses later than 7 years - if sent to a central repository this timeline could be expanded. There should be minimal data repository standards - data manual; how the data were collected (e.g. self-admin questionnaire, medical records/chart abstraction, interview etc.); date of collection; variable label definitions; etc.; original cleaned data and derived data should be included; assays done. In addition, the consent form with any restrictions noted should be part of the file. There are basic data management standards that all should already be following and outlining this for all grantees would help facilitate the data sharing process and also make sure that minimum data management standards are followed. Genomic Data Base and BioLincc - could be resources to examine and have lessons learned when setting up a central repository - which should be done.


Submitted

11/28/16 10:53

Name and/or Organization

Rick Tivis, Idaho State University

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

Seven years seems appropriate for retention. I agree with other comments about some kind of demonstration of the analytic skills to ensure that the data are used properly is important. Who makes the decision that they are qualified enough is a tougher question what will be the qualification for this group. The group should include both statistician and clinical. There should also be a repository for the outcomes. The data dictionary is a critical component of what should be clear. Perhaps a standard for the formatting data dictionary.


Submitted

11/30/16 16:36

Name and/or Organization

Renee Pekmezaris, PhD

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

• A detailed description of comparators, (in addition to standard data dictionary) should be provided for the dataset. For example, standard outpatient care should specify what payor group(s) (including uninsured) are being enrolled, whether these patients are receiving home care, primary care, specialty care, etc. • To avoid unfair advantage to non-PCORI awardees, PCORI awardees should have a reasonable time period to submit publications and other scholarly work from the dataset before allowing the data to be accessible to others. Two years is reasonable. • Only (one) principal investigator should be the responsible for the limited dataset.


Submitted

12/9/16 19:50

Name and/or Organization

ADVANCE CDRN

Community

Stakeholder

Stakeholder Community

Stakeholder - Other

File Upload

https://www.pcori.org/sites/default/files/webform/ADVANCE_PCORI Data Access and Data Sharing Policy.pdf


Submitted

12/13/16 23:37

Name and/or Organization

Health Care Systems Research Network

Community

Stakeholder

Stakeholder Community

Hospitals and Health Systems

Public Comments

Comments are submitted on behalf of the Health Care Systems Research Network, a coalition of research centers embedded in care delivery and insurance organizations. Please see the associated PDF for our complete submission.

File Upload

https://www.pcori.org/sites/default/files/webform/HCSRN Comments on PCORI Data Sharing Policy_12132016-Final.pdf


Submitted

12/14/16 12:01

Name and/or Organization

Association of American Medical Colleges

Community

Stakeholder

Stakeholder Community

Stakeholder - Other

Public Comments

Please find the AAMC's comments on the PCORI draft policy for data sharing attached. Thank you.

File Upload

https://www.pcori.org/sites/default/files/webform/AAMC Comment to PCORI on Data Sharing 12-14-16.docx


Submitted

12/15/16 16:09

Name and/or Organization

Kaiser Permanente

Community

Stakeholder

Stakeholder Community

Hospitals and Health Systems

File Upload

https://www.pcori.org/sites/default/files/webform/KP Comments on PCORI Data Sharing & Data Access Policy_Dec2016.pdf


Submitted

12/16/16 14:10

Name and/or Organization

Group Health Research Institute

Community

Stakeholder

Stakeholder Community

Hospitals and Health Systems

Public Comments

Please find attached our comments.

File Upload

https://www.pcori.org/sites/default/files/webform/PCORIs Draft Data Sharing Policy from Group Health Research Institute dec 13_2016.docx


Submitted

12/27/16 14:22

Name and/or Organization

Howard Techau

Community

Patient

Patient Group

Patient/Caregiver Advocate or Advocacy Organization

Public Comments

I believe the retention period should be no longer than 18 months. Qualifications to receive information by third parties should include what their intentions are for the info, do they they have ongoing research regarding the same subject, and are they willing to sign an agreement to withhold information for commercial development until adequate research has been done and a patent has been filed by the original research group or person?


Submitted

12/27/16 16:08

Name and/or Organization

David Andrews

Community

Patient

Patient Group

Patient

Public Comments

1. Seven years for the researcher is fine; however, the data should be permanently available in the selected repositories. 2. Other than protecting individual subject identity, all data should be fully publically available. This is publically funded research which is founded on the premise of full patient engagement in the process; thus, patients (and by extension the public in general) should have full and free access. 3. None – there are abundant examples of patients, journalists or citizens in general with no special qualifications finding important uses for data and errors in those data. There should be no restrictions! 4. None – see above. 5. Other than that data should be “read only” to prevent users altering the original data, there should be no limitations. 6. Nothing more than the usual, plus something that says that upon completion of the study all data from the study will be publically available and all participant identities will be fully protected. 7. I think the above makes my values and recommendations clear.


Submitted

12/31/16 12:04

Name and/or Organization

Ken Martin

Community

Patient

Patient Group

Patient/Consumer

Public Comments

All PCORI grant recipients should be required to map their measures to LOINC codes. This will help to identify missing LOINC codes for clinical measures, LOINC codes in need of expansion, and existing LOINC codes not being utilized for interoperability by the grant recipients. An example is attached. LOINC codes are basic building blocks toward interoperability. LOINC: https://loinc.org/


Submitted

1/3/17 14:27

Name and/or Organization

University of North Carolina at Chapel Hill

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

Thank you for the opportunity to comment on this draft policy. I am a clinical and health services researcher at UNC Chapel Hill, and am PI of our CTSA hub. I certainly agree with the overall principles of open science and the need to ensure reproducibility in clinical and health services research. Implementing this policy will involve a lot of detail work regarding just how the 'repositories' will function; which databases will need uploading, and how the de-identification process will function. Investigators will need more detail to implement the policy. Critical will be harmonizing the PCORI procedures with NIH procedures as closely as possible to avoid confusion. For example, PCORI wants registration prior to the first patient enrolled, whereas NIH requires registration within 21 days of first patient signing a consent. While the differences are not great, the burden to investigators and regulators of keeping track of slightly different rules can be difficult. Whenever possible, please harmonize such regulations, including data format etc. When guidance is harmonized, compliance is likely to increase. There is some ambiguity regarding which study datasets would go through the documentation and posting process. For large pragmatic trials or cohort studies such posting should be the norm. The gain may not be worth the effort for smaller studies, but if findings are surprising or very high impact there may be interest in secondary analyses. PCORI should be able to determine post-doc that a study's data should be posted, as long as there was not too much a gap between finding and realization that the level of interest is high. For example, I would not want to hear from a funder 3 years after I had closed out a study that I needed to post data. The cost is then much greater since the PI may need to engage a new statistician or analyst since the original team may have moved on. Thank you.


Submitted

1/6/17 11:54

Name and/or Organization

Breast Cancer Surveillance Consortium

Community

Stakeholder

Stakeholder Community

Health Researcher

File Upload

https://www.pcori.org/sites/default/files/webform/PCORI_datasharing_response_2017_01_06.pdf


Submitted

1/10/17 2:23

Name and/or Organization

Robert A Wymer, MD, cdr/mc/usn(ret)

Community

Stakeholder

Stakeholder Community

Clinician

Public Comments

I am a physician, formerly in a solo private practice, followed by service as a physician in the U.S. Navy. I retired from the service and now working as an Urgent Care physician. Over the years I have observed the gradual deterioration of both the quality and quantity of medical care provided patients. In addition the cost of care has skyrocketed to ridiculous levels. As a primary care physician I have witnessed this deterioration and I am in a position to not only comment on the nature of the problems but to make some suggestions regarding solutions. The following is the beginnings of some of my thoughts on these issues. My plan is to write more extensively concerning these matters. ++++++++++++++++++++++++++ Problems observed in care of patients as an Urgent Care Physician that have an important bearing of the cost and quality of care. A. No records available Solution: Medical Record possessed by patient on portable electronic storage device with the following elements: 1. An imbedded application that includes a menu 2. Data chronologically organized. 3. Major categories of data: • Primary care encounters • ER encounters • Urgent care encounters • Laboratory data • Imaging reports • Ancillary testing reports such as spiromitry, ECG, EMG • Specialist’s reports • Surgeon’s report of operative procedures • Attending physician Hospital discharge summaries (not the patient discharge instructions) 4. The device and its data secure from alteration or addition by unauthorized persons or entities. Note: Encounter information above should include, at a minimum: Diagnosis, Medications prescribed, and recommended follow-up. Detailed records of history and physical exam are generally maintained at the encounter locations, but not essential for this type of record. For the past 10 years I have queried and begged IT professionals and others to create a medical record system that will allow for better more efficient care of our patients. No one will attempt or participate in this endeavor due to inhibitions imposed by HIPAA laws and threatened massive fines. I am personally very angry with my physician colleagues who will not fight for reform of these laws. B. Critical shortage of Primary Care Physicians: Solutions to Implement: 1. Advance or facilitate a conclusion of the longstanding debate over physician payment schemes – Fee-for-Service, Capitation, or Salary. Note: Common sense and evidence from past experience dictates that adequate fees for services, in an environment where there are adequate numbers of physicians, will facilitate market competitive forces that will offer patients maximal choice and superior cost effective services. Maximizing quality and quantity of service at lowest cost will follow adequate competition in free and fair markets. This result is impaired when government or insurance providers impose fixed fees and mandates on physician service providers. Such policies have caused the decades long decline in numbers of primary care physicians. A number of medical schools have shut down their Family Practice residency programs as greater numbers choose to avoid this specialty. Robert A Wymer, MD, cdr/mc/usn(ret) [email protected] Employed by TexasMed Clinic, San Antonio, Texas


Submitted

1/20/17 11:11

Name and/or Organization

The Yale University Open Data Access (YODA) Project

Community

Stakeholder

Stakeholder Community

Health Researcher

File Upload

https://www.pcori.org/sites/default/files/webform/Public Comment for PCORI Data Access and Data Sharing Policy 17-01-20.docx


Submitted

1/21/17 10:46

Name and/or Organization

Amédé Gogovor, McGill University

Community

Stakeholder

Stakeholder Community

Health Researcher

Public Comments

I like the succinctness of the document. I would like to highlight the following points: -The provision of a protocol and an institutional review board approval letter should be required from the requester; -At section III, Full data package, I would not include the analytic code; -At section IV, Data Access and availability, I think that ‘completion of the study’ should be clarify: should the Awardees make the data available at the end of their data analysis, or after the submission of their manuscript, etc.? -As the qualitative research alongside clinical trials is gaining importance for its ability to add a layer of understanding from participants’ experiences and perspectives, this aspect is not mentioned in the document. The document should specify whether the data sharing policy is limited to quantitative data. The preparation of qualitative research data requires much more time, skills, and resources based on my experience at the Irish Qualitative Data Archive.


Submitted

1/23/17 8:48

Name and/or Organization

American Medical Informatics Association (AMIA)

Community

Stakeholder

Stakeholder Community

Stakeholder - Other

Public Comments

Please see the attached file.

File Upload

https://www.pcori.org/sites/default/files/webform/AMIA Response to PCORI Data Sharing Plan_Final.pdf


Submitted

1/23/17 16:58

Name and/or Organization

National MS Society

Community

Patient

Patient Group

Patient/Caregiver Advocate or Advocacy Organization

Public Comments

See attached comments

File Upload

https://www.pcori.org/sites/default/files/webform/PCORI Data Access and Data Sharing Policy Final.pdf


Submitted

1/24/17 10:12

Name and/or Organization

Geisinger Health System

Community

Stakeholder

Stakeholder Community

Hospitals and Health Systems

File Upload

https://www.pcori.org/sites/default/files/webform/GHS Comment Letter 170124.pdf


 

What's Happening at PCORI?

The Patient-Centered Outcomes Research Institute sends weekly emails highlighting results of our funded studies, newly funded research and engagement awards, opportunities to apply for funding, stakeholder workshops, and original feature stories about our funded projects.

Sign Up for Updates

Image

Hand pointing to email icon