Presentation on theme: "Study population Demographics Age Children vs. adults Older adults? Sex: In the Medicaid database, for example, women may be over- represented. Race:"— Presentation transcript:
Demographics Age Children vs. adults Older adults? Sex: In the Medicaid database, for example, women may be over- represented. Race: Does your study require an over-representation of racial minorities? If so, does the source that you are considering over-samples minorities? Does the coding allow you to have a more granular classification of race?
Geographical representation Does your study require for you to have adequate representation of individuals residing in underserved areas Rural areas Appalachian areas Specific states, or regions of the country?
Consider the eligibility criteria to be included in a given data source Medicare database Age (older adults) Disability End-stage Renal Disease For example, if your study involves the analysis of data for pregnant women and children, the Medicare database may not be suitable. Medicaid database Income threshold (low income) Disability Dual Medicare-Medicaid enrollment
Consider the services covered (or not covered) in a given database What is covered by a given program, and what does that database offer? If you are interested in looking at medication use by older adults, then you can’t use Medicare data in the pre- Part D era.
Inclusion/exclusion criteria Whose data are included in your database? Consider the fact that claims data are not available for Medicare beneficiaries who are enrolled in managed care. data will be representative of fee-for-service beneficiaries only.
Gaps in enrollment (Medicaid) How do you account for gaps in enrollment in Medicaid on/off enrollment do you limit your study population to those with Continuous enrollment? Enrollment for 80% / 60% of the time in a given study period?
Considerations in longitudinal studies Individuals willing to participate in longitudinal studies different from those unwilling to participate (?) Consider mortal and non-mortal attrition If you limit your study population only to those who are alive an extended period of time, then you’re excluding the sicker ones (those more likely to die) Are those dropping out of the study for reasons other than death different from those who stay in the study?
Generalizability Will the inclusion/exclusion criteria affect your study Biases introduced? Managed care population healthier than the fee-for-service population? Medicaid beneficiaries enrolled in Medicaid full time Sicker than those enrolled part time? Better navigators of the system? Greater awareness of the eligibility rules / enrollment or re- enrollment procedures? Connected to a case manager?
Are the measures that you’re looking for available in the database? For example, Functional / cognitive status is not available in Medicare or Medicaid data Readmissions may be derived from HCUP data only with certain databases
How are the measures derived? How good are they? Consider comorbid conditions derived from claims data What does the presence or absence of certain conditions mean? Consider other measures Individual’s race (is it truly self-reported??) prenatal visits vs. birthweight Cause of death
Requesting data from the Center for Medicare and Medicaid Services DO IT THROUGH THE RESEARCH DATA ASSISTANCE CENTER: RESDAC (resdac.umn.edu) Contact ResDAC representatives as you are planning for your study/writing grant application Representative to offer guidance and data expertise, and provide cost estimate for your data Cost estimate to be included in grant application (shows that you’ve done your homework) Cost estimate will make it possible for you to make an educated estimate of the cost associated with your data needs
Steps in data request, as outlined by RESDAC http://www.resdac.umn.edu/Medicare/r equesting_data.asp
1) Written request letter The purpose for which the data are needed A brief description of the methodology in which the data will be used Delineation of the data requirements Criteria for data selection or searches
2) Study plan or protocol (typically includes grant application and notice of award (NOA) The study requires individually identifiable records The study is of sufficient importance to warrant effect, or risk, on beneficiary privacy There is reasonable probability that use of data will accomplish purpose, i.e., project is soundly designed and properly financed
3) Data users’ agreement Ensure the data will be used only for the specific purpose stated in the agreement Develop and implement the appropriate procedural, technical, and physical safeguards to prevent unauthorized use Not release any files without prior CMS approval Return or destroy file(s) by the date specified Not publish or release information that would permit the identification of a beneficiary
4) IRB documentation IRB: date on which the alteration or waiver of authorization was approved; HIPAA requires a potential research subject to sign a HIPAA authorization in order to use their protected health information in a research study. In circumstances where obtaining individual authorization is not practicable, researchers may seek a full or partial waiver of the authorization requirement from an IRB. A statement that the IRB has determined that the alteration or waiver of authorization, in whole or in part, satisfies the three criteria in the Rule;satisfies the three criteria in the Rule; A brief description of the protected health information for which use or access has been determined to be necessary by the IRB; A statement that the alteration or waiver of authorization has been reviewed and approved under either normal or expedited review procedures; and The signature of the chair or other member, as designated by the chair, of the IRB, as applicable.
The waiver criteria are: (A) The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements; An adequate plan to protect the identifiers from improper use and disclosure; An adequate plan to destroy then identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and (3) Adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of protected health information would be permitted by this subpart; (B) The research could not practicably be conducted without the waiver or alteration; and (C) The research could not practicably be conducted without access to and use of the protected health information.
5) Evidence of funding 6) CMS data request form 7) Privacy Board Review Summary Sheet 8) Request letter of support from the project officer
What do you do when you receive the data? The data arrive on CDs/DVDs (they used to come on cartridges or reel tapes) Go over the documentation, and prepare an INVENTORY of the data Have they sent you everything that you had requested? Does their documentation of the data and the data match?
What to do, con’td Start reading the tapes/files Record layout through ResDAC Are the files in good shape? Any “corrupt” materials? Does the number of records in each file correspond to the number of records documented in the letter by CMS (or contractor)
VERY IMPORTANT!!!!!!!!! NOTIFY CMS IMMEDIATELY of any inconsistencies between what has been requested and what has been sent NOTIFY CMS IMMEDIATELY of any files that you are unable to read (even after assistance from ResDAC or others)
Requesting data from (Ohio) Medicaid Data user’s agreement required to conduct studies examining specific research questions Study protocol to be shared with the Ohio Department of Job and Family Services (ODJFS), which administers the Medicaid program ODJFS then to issue a $0 contract with the university
Requesting data from the Ohio Department of Health (ODH) Prepare study protocol justifying your need to use patient identifiers Protocol to be reviewed by the ODH Institutional Review Board (IRB) Attendance of the Investigator at the IRB meeting desirable
Your Institution’s IRB Obtain their approval prospectively Data management protocol Qualification of personnel handling the data
Obtaining permission to link data: Logistics and other issues to consider Agencies’ perspective: TRUST Users’ knowledge of the data; proficiency; hypotheses to test Measures to protect patient confidentiality
Obtaining permission to link data: Logistics and other issues to consider, cont’d Users’ perspective: Underestimation of what it takes agencies to release data Underestimation of the agencies’ concerns on how the data should be used and protected
Proposed approach DIALOGUE Agencies to explain their concerns to potential users Users to explain The benefits of the proposed studies Measures to protect patient confidentiality
Agencies’ perspective Assess the benefits of the studies proposed Assess the ability of researchers to carry out the proposed studies to abide by rules of protecting patient confidentiality Assess the willingness of researchers to establish a collaborative relationship with the agency Guide the researchers through the agency’s process of IRB review Engage the researchers in the process
Users’ perspective Explain the proposed study: Protocol benefits relative to public health Provide details on the measures you and your staff will be taking to protect patient confidentiality Participate in the process of IRB review. Agency staff like to see documents prepared in a format that’s ready to be presented to the IRB. Some would like to see the researcher present at the IRB meeting.
Users’ perspective, cont’d Dialogue between agency and user(s) does not end upon gaining access to the data. It should be ongoing Regular meetings Definition of study cohorts and variables Findings/ interpretation of results Dissemination of results – share abstract/manuscript drafts Authorship/ acknowledgments Inform the agency staff on study progress Respect and benefit for the staff’s knowledge of the data -- They use the data on a daily basis; the user may be new to the data
How to protect patient confidentiality Restricted access to data All individuals accessing the data to understand the seriousness of the measures adopted to protect the data All individuals to sign data users’ agreement Protocol in place on: Electronic access of the data (password protected) How to protect data tapes and printed materials Locked, fireproof cabinets Use of online data only through secure internet connections (e.g., firewalls) No contact to be initiated with patients or providers identified through the study (as it is in our study) NO DOWNLOADING OF THE DATA TO YOUR COMPUTERS
CULTIVATE A RELATIONSHIP BASED ON - TRUST - MUTUAL RESPECT - COLLABORATION - MUTUAL BENEFIT
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