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Indigenous People Grill NIH on All of Us Protections
Attempting to reassure an indigenous community that has been abused in past research, the NIH All of Us precision medicine initiative is holding a series of meetings and webinars with the National Congress of American Indians. A key part of the dialogue is letting American Indian/Alaska Native Tribal Nations ask questions and express concerns about the project.
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Identifiable Data Are Not What They Used to Be
IRBs and researchers should change their old habits when it comes to assessing studies for privacy and confidentiality. Researchers recently showed that de-identified data could be used to find a specific person. Using a mathematical model in databases of more than 200 populations, researchers found they could correctly re-identify 99.98% of Americans, using 15 demographic attributes.
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Tips for IRBs Reviewing Pragmatic Trials
Flexibility is needed when reviewing pragmatic clinical trials, which typically enroll a broader population of patients and might need more adaptable informed consent than traditional clinical trials. Researchers have raised questions about how pragmatic trials should be regulated and what IRBs should do to protect participants, but not discourage this type of research.
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Pragmatic Trials on the Rise as Data Collection Pushes Trend
Several recent changes are driving the pragmatic trial trend nationally, including acceptance from regulators and the growth of big data. Pragmatic clinical trials measure effectiveness of a study drug, device, or intervention on a wider range of people. Unlike clinical trials that exclude people based on health conditions and other criteria, pragmatic trials study a treatment’s effect on a group of people who are more representative of patients in clinical practice and the real world.
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Calls for IRB Transparency in a Closed-Door System
It is a common critical observation in human research that IRBs operate in a sort of “black box,” making decisions that could greatly affect a general public that remains largely oblivious of their role and function. This default ought to change toward transparency, both for the good of the research community and to be in line with the increasing calls for publishing research results, reporting all clinical trial data, and sharing consent forms, experts say.
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Work With Community Partners to Develop Solutions for Opioid Use Disorder Patients
While many emergency physicians are reluctant to tackle the issue of addiction, there is growing recognition that EDs offer a huge opportunity to identify patients with opioid use disorders and link them to meaningful care. The obstacles are many, but forward-thinking emergency medicine leaders in regions hit hard by the opioid epidemic are finding paths to success, often in partnership with other agencies or community groups.
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Collaborations Between Health Advocates and Case Managers, Others Can Make a Difference
Case managers and other healthcare providers increasingly are finding that their work includes collaboration and communication with providers and health advocates across the care continuum. For health advocates, these interactions are necessary to help the patient achieve optimal health and function.
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How Health Advocates Work With Patients, Case Managers, and Other Resources
A health advocate’s role varies, depending on the patient populations and goals. Health advocates collaborate with the patient’s healthcare team and help everyone reach an agreement on the care transition or any necessary changes.
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Privately Paid Case Managers Serve as Patient Health Advocates
Case managers work with patients across the care continuum, and their roles and titles vary. But one of the lesser-known models for case management is in private pay, where they are known as health advocates or patient advocates. It is a growing field, as patients and families often find it difficult to navigate the complex healthcare continuum. Health advocates provide case management-type services with their chief goals related to patients’ needs.
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Quantifying the Occupational Risk of Tuberculosis
The CDC published data on the level of tuberculosis in healthcare workers, which was used in part to support the recent recommendations to drop routine annual TB testing in the absence of an exposure or ongoing transmission. The epidemiology has shifted, with workers coming from countries endemic for TB much more likely to manifest later symptoms. Although it must be underscored that there still is TB in the United States, healthcare workers are not at the risk they once were.