Evolving patient rights in the research and delivery of health care

Just a few years ago, even though “patient engagement” was the watchword of health care reform and patient access to records (as promoted by organizations like OpenNotes) was considered a nice thing for providers to do, I sensed that people talking about real patient empowerment were out on the fringe of health care and research. As the idea reached the proscenium this month at the Health Datapalooza, a conference founded by the US Department of Health and Human Services and now attracting more than 2,000 people, patient empowerment marks its entry into the mainstream.

Greg Biggers, whom I interviewed 3 years ago, was one of the early pioneers of citizen science in clinical research. Regina Holliday and E-patient Dave DeBronkart expressed concerns for more patient involvement in care and cost containment. All were respected, but I think they were rarely heeded.

Real patient empowerment doesn’t mean downloading one’s lab results from a web portal put up by one’s doctor or getting a second opinion. Rather, it means collecting observations of daily living, getting them into the doctor’s record, and discussing them with the doctor in conjunction with conventional diagnostic tools. More broadly, it’s choosing one’s lifestyle with thoughtful, understanding input from professional clinical staff. And it means choosing the goals and procedures used to conduct trials. Pharma companies have been experimenting with patient engagement for such trials, and it has become a national initiative with PCORI’s PCORnet project, which is trying to create a kind of super-network of groups representing patients for research.

At the Datapalooza, patient empowerment took the stage along with keynoter Adriana Lukas, founder of London Quantified Self. She criticized current consumer devices and health apps for collecting our data and selling it to companies that use it for marketing or streamlining operations. Although such activities can turn up new treatments and improve care, she found it unethical to turn us into “data cows” whose main role is to “replenish the data milk bucket.”

Even more disturbing is the potential of data analysis for introducing errors and bias into the ways institutions handle us, a theme found in many places nowadays, such as the long-awaited report from the White House on big data and the the federal PCAST report on big data privacy. Lukas called for a discipline examining “algorithmic ethics” so we can articulate values and determine the consequences of applying data analysis.

But most challenging of all, I believe, in Lukas’s keynote was her suggestion that each patient apply all data to himself or herself, sharing “aggregate meanings” instead of raw data. This would rip away the lifeblood of the analytics firms–for both beneficial and manipulative purposes–but allow patients to connect purposefully with each other. We could learn things such as that adequate hydration helps one patient control his anxiety, a finding that might help others.

Lukas was not alone in her vision. Stephen Friend of Sage Bionetworks , in a session discussing the use of patient data, claimed that “the conversation has been hijacked by data sharing” and said we should consider sharing “insights’ instead. Friend, having spent many years working for the pharmaceutical industry before launching into his grand plan for reforming clinical and pharmaceutical research, was making an enormous, conscious leap away from the way individuals are conventionally treated in these fields.

At the same session Friend spoke, patient advocate Andrew Downing asked how data could be made relevant to the patient. At the other extreme of the data spectrum, high-tech venture capitalist Vinod Khosla talked in a keynote about replacing the system of clinical trials with big data analysis.

His call from the proscenium was much less shocking than it might have been a few years ago, which double-blind clinical trials were still seen as the alpha and omega of medical research and Dr. Otis Webb Brawley’s impassioned, angry book How We Do Harm listed a refusal to accept the results of such trials as the main cause of medical errors. Now we all know that few scientific controlled experiments can be replicated and that bias enters research results in multiple ways.

How can Downing’s plee for respecting the patient and Khosla’s paeon to data analysis be reconciled? They actually fit together quite well, but Khosla wants to put data and the results of research directly into the hands of patients, bypassing the professional caregivers. Khosla notoriously wants to replace doctors with machine learning–but that’s no so far from the agenda Lukas provided.

Patient empowerment was even a stronger theme at next day’s Health Privacy Summit, where panelists decried the sharing of patient information (even supposedly deidentified information) without patient consent.

There are several reasons the patient is now becoming the center of attention. Foremost is the “epidemiological transition” by which all countries see chronic illnesses become the drivers of health costs as incomes rise–illnesses that respond more behavior change than drugs or surgeries. The availability of data, electronic records, and tracking devices makes a revolution in behavioral care possible. Heightened concerns of privacy in the post-Snowden era also play a role.

But Quantified Self has yet to prove its efficacy. Many people swear it has improved their lives, but it’s hard to judge whether these self-aware, highly educated, highly disciplined individuals would lead less healthy lives if they threw away their monitors. What we really need is tools for the worst of the worst, which also cost us the most money. As Atul Gawande said in his keynote, the sickest patients get the worst care. Will they respond to beeps and text messages telling them to put down that cigarette and eat some blueberries?

The debate over patient empowerment parallels larger discussions about the source of current epidemics such as obesity. Is it the large food conglomerates, along with governments through their subsidies and school lunch programs, that make us sick, as narrators tell us in the movie “Fed Up”? Or are choices firmly in people’s own hands, as the stories of fat’s victims in that movie suggest? We need a concerted efforts by educated patients, forward-thinking doctors, and payers to get over the hump of indifference.

Andy Oram is an editor at O’Reilly Media. Reach him on Twitter using @praxagora.

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