Prepare for NEJM’s major web event on sharing research data next week

In November we posted about an extraordinary development: NEJM Data Analysis Challenge: can others create value by seeing researchers’ data? The project has come to fruition, and the big event (free) is next Monday-Tuesday. The question for us: What’s the impact on patients?


If you’re at all interested in issues of research, open data, and the collaborative future of health and care, you don’t want to miss this. Something’s happening that I believe is unprecedented, and the results so far are pretty mind-bending.

Register (free) at events.nejm.org, and follow the hashtag #NEJMDataSummit. I’ll be in the audience live at the event, and you can fully participate online.

This post gives a little background and my own prep notes, with links to the winning submissions and more.

Background

Our November post opened:

You may have heard that back in January the New England Journal of Medicine created a firestorm by noting that some said “parasites” about people who want to see a researcher’s original data. Many (including Vice President Biden, at Health Datapalooza (video)) have objected strongly, saying that data from one project might be useful to other researchers, which could accelerate cures (as in his son Beau’s brain cancer death) and improve payback from public research funding (aka government grants).

In what I think is an amazing development, NEJM has responded by saying “Game on: we will release the entire dataset from a well known study (“SPRINT”) – let’s see if anyone else can find new value.”

What’s extraordinary is that while academic medicine and its journals are often said to live behind castle walls, this journal – the highest ranked in the world – has listened. The results are in, and they’re pretty astounding.

Equally great, to me, is that the big two-day event next week is 100% free, open to the public. That means you.

Links and prep notes

  • Home page: https://challenge.nejm.org
  • About: https://challenge.nejm.org/pages/about.  Note:
    • “Thoughtful, transparent systems for the responsible sharing of data are important in maximizing the contribution of the patients who put themselves at risk by participating in clinical trials.”
      • Note in particular the acknowledgement of patients’ role in research. So often this is overlooked in discussions of trials and their data.
    • The SPRINT trial whose data is used in this project: “A Randomized Trial of Intensive versus Standard Blood-Pressure Control (N Engl J Med 373: 2103-2116). Conclusion from the abstract: (edited for lay-friendliness; emphasis added)
      • Among patients at high risk for cardiovascular events
        [heart attack, stroke, and more]
        (but without diabetes),
        treating to keep blood pressure under 120 instead of 140
        resulted in lower rates of major cardiovascular events and death.
        (But there were significantly higher rates of some adverse events.)

So, that was the original study, based on following 9,361 patients for several years. Lots of data. The question was, could other researchers look at all that data and find additional valuable, high quality conclusions?

This speaks directly to the issue raised by Biden and others. Is there real value to be had, or are people who ask to see that data (as some have suggested) merely “parasites”?

Results:

They received 143 submissions. Each has a comment page for crowdsourced feedback. Look at the winners – seems to me some new value was derived from that data:

  • To Treat Intensively or Not — Individualized Decision Making Support Tool
    • “In the era of personalized medicine, population-based treatment efficacy measures are not sufficient. Treatment decisions should be personalized by considering the individual’s specific characteristics, taking multiple outcomes into account, and not overlooking adverse events. We created a personalized tool to support clinicians when deciding on intensive hypertension treatment. This tool considers predicted benefits and harms, weighted by the perceived severity of the events they represent, thus allowing for an efficient, personalized, and evidence-based decision.”
    • We analyzed findings from the largest trial of intensive blood pressure management in patients with chronic kidney disease [CKD].
      • “First, BP is harder to manage intensively in this population.
      • “Second, primary outcomes are not improved by intensive as compared with standard BP management in CKD patients.
      • “Third, in CKD patients, intensive management is associated with a higher risk of therapy-related adverse events.
      • “Therefore, our study cautions physicians against applying the SPRINT-recommended intensive systolic BP target of <120 mm Hg to CKD patients.”
    • “Intensive blood pressure treatment can reduce the chance of having a heart attack, stroke, or other major cardiovascular illness, but it may increase the risk of a serious adverse event, such as kidney failure. We developed and validated a clinical decision score to identify patients likely to experience benefits and unlikely to experience harms when undergoing intensive treatment. The score was developed from SPRINT trial data and tested using both SPRINT and ACCORD-BP trial data.”

Is there real patient value in this? Are the findings useful?

A huge question in our era is increasingly, what’s the impact on patients? Clearly, new knowledge came out of this extraordinary project. Is it useful to patients – the people who have the problem? Let’s bring that thinking to this event. Comment, and let’s get as many of us to participate real-time as we can:

  • Register (free) at events.nejm.org
  • Plan to be online live, if you can. Test your system.
  • Look through the submissions, not just the winners. Do you see anything else important that’s not in the top three?
  • Follow the hashtag #NEJMDataSummit

There will also be live discussion room during the event.

 

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Posted in: policy issues | positive patterns | research issues

 

 

Comments

One Response to “Prepare for NEJM’s major web event on sharing research data next week”

  1. I am thrilled to see the general support for sharing of data, as the data that is hidden/not shared or so old as to be incredibly difficult to retrieve is of value to many patients.

    Quite recent trials of newly approved targeted agents against kidney cancer and others will typically have been analyzed in regard to patients’ ages, their general health, gender, previous treatments and so on. From there the response to the agents can be stratified, and raw data can guide treatment. But in even more recent years, the tumors of the patients can be further defined by their molecular characteristics. Thus, with access to that data and noting the responses with the newly refined tumor/patient, we may well be able to decided–as happens in breast cancer–that one type of properly characterized tumor should be treated with the targeted agent.

    Right now this is a guessing game, with patients given drugs nearly randomly. The defining characteristics are likely there. Letting others use the data, when the data comes from public funds, should be mandatory. “Nothing about me (and my tumor) without me,” say I.

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