Learning Goal: I’m working on a public health question and need an explanation and answer to help me learn.
You are to create a video abstract (3–5 minutes) recipe explaining the current best practices and applications for dealing with data governance challenges while building and deploying a data governance plan. Please make sure to cater your video abstract towards a newly hired individual working as a consultant for a medical center. The project is to build is a patient satisfaction tool that will be used by hospitals and families about inpatient stays. This tool will use clinical data from the hospital EHR and well as self reported data from the patients and their families. The relevant parties include the hospital, clinical providers providing care, and the patients in the healthcare delivery system.
Avoid general approaches and drill down to specifics for this project’s recipe for success. Be clear about the steps in the data governance process, including which steps correlate to which parties involved, and methods to overcome common challenges related to data governance issues. The objective is to develop a “how to” guide for someone entering the world of data governance.
Please use the information you gathered from your readings, PowerPoints, podcasts, videos, and whatever useful information you are able to find performing your own investigation.
Story Time with Real Life Events!
There is an inherent tension between different stakeholders’ concepts of data ownership in healthcare research because of the multiple roles that patients, providers, and payers hold. The history of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a very large clinical trial that ran between 1998 and 2002, demonstrates these tensions well. The study included more than 43,000 men and women of all races/ethnicity’s, over the age of 55 who were randomized to receive one of four standard treatments for hypertension at their regular primary care clinic (a total of 623 community clinics). The study started recruiting patients in 1994 and completed the last round of follow-up visits with patients in 2002. With so many patients participating at so many clinics, the clinical trial had to be coordinated by a team of researchers at location, the Coordinating Center for Clinical Trials as the University of Texas School of Public Health. Although the clinical trial was designed to be a relatively simple trial design, conducted in the real world of community-based primary care providers, using limited funding, vast quantities of data were collected, in addition to blood serum samples. The study concluded that the cheap generic diuretic that had been used for more than 50 years was in fact the best first-line treatment for patients with hypertension compared to the three other patented drugs.
Patients understandably believe that information about their health, or blood samples drawn for their treatment, belong to them. However, although patients have a right to see their medical records and to dispute the content of the medical record if they believe it is incorrect, patients in ALLHAT, like all other patients, do not actually own medical information about themselves; the physician who provided the clinical treatment owns the regular medical record that the physician generated in caring for the patient. See HIPAA for Professionals (Links to an external site.). However, in a community-based research trial, those physicians were also serving as members of the research team by collecting data about patient outcomes, which they reported to the biostatisticians and program managers at the Coordinating Center for Clinical Trials. Although the analysts at the Coordinating Center collected and analyzed all the data, and controlled access to the data, the data itself belonged to the National Heart, Lung, and Blood Institute, which provided funding for the clinical trial and data analyses over the 17 years.
The blood serum samples posed a different ownership issue, as biological samples deteriorate over time and require deep freezers, lab space, and the funds to maintain the labs. The samples are finite and every test consumes a quantity of the sample, thus limiting the possibility that another investigator can use the sample in a later study. Some of the challenging questions that the ALLHAT team faced was what to do with the serum samples when there was no funding available to do additional testing for genetic markers, and the researcher who had stored all the samples at his university was retiring, thus leaving the samples orphaned. The ALLHAT funding agency decided to fund no further research after supporting the study for 17 years; that left no funds for keeping the samples frozen for potential future research. New investigators at many other institutions requested access to the samples for research projects. However there was only sufficient material left of each sample to be used once; no consensus was ever reached among the leadership of the study. The NHLBI finally officially abandoned the samples, essentially mandating that no one could use the samples for any research. The “orphaned” samples were then acquired by a genetics research lab that had the freezer space, technical capabilities, and interest in doing further analyses. But patients who first agreed to participate in the ALLHAT study gave informed consent at the time for their blood samples to be used in ALLHAT, never contemplating that the samples would decades later in an entirely new lab conducting new research and ostensible belong to the funding agency that is now paying for the new research protocol.
In such a large and lengthy clinical trial as ALLHAT, the issues of data ownership and control carry through from the conduct of the research to the analyses and dissemination of the study results. Although the biostatistical analyses were done by professional academic biostatisticians at the Coordinating Center, there was inevitably dissent amongst the many coauthors for each publication that came out of the study about the interpretation of those analyses, the proper emphasis in presenting results, and the clinical implications of their conclusions. Although a standard process had been established by the ALLHAT Steering Committee and Executive Board for prioritizing analyses, and publishing the results, some papers stalled for years because the medical experts and biostatisticians could not reach consensus on how to complete the analyses and present the information to the biomedical community so it could be translated into clinical practice.
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