Over 10K participants sign up for Stanford medical trial after ResearchKit debut

Posted:
in iPhone edited March 2015
The number of participants in a Stanford University cardiovascular study conducted using Apple's new ResearchKit medical research platform ballooned to more than 10,000 overnight, researchers say, after the trial was featured on stage during Apple's "Spring Forward" event earlier this week.




"To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country," Alan Yeung, medical director of Stanford Cardiovascular Health, told Bloomberg. "That's the power of the phone."

Apple unveiled ResearchKit, a new open-source platform designed to help medical researchers expand their study candidate pools and collect more accurate data, on Monday. ResearchKit allows participants to enroll in trials directly from an iPhone and submit data automatically, whether entered by hand or collated from the iPhone's on-board sensors and third-party HealthKit-compatible devices.

Stanford's study, a joint effort with the University of Oxford, is one of five live in the App Store. Others include an asthma self-management program from Mount Sinai, Weill Cornell Medical College, and LifeMap; a Parkinson's study from the University of Rochester and Sage Bionetworks; a diabetes analysis tool from Massachusetts General Hospital; and a breast cancer study from the Dana-Farber Cancer Institute, UCLA Fielding School of Public Health, Penn Medicine, and Sage Bionetworks.

Despite the advantages, some researchers remain skeptical of Apple's new program. The relatively close demographic grouping of iPhone users could skew data, some suggest, while others worry that they may not be able to collect the same types of candid responses in an app that they may be able to in a face-to-face conversation.

"Just collecting lots of information about people -- who may or may not have a particular disease, and may or may not represent the typical patient -- could just add noise and distraction," Dartmouth Institute for Health Policy and Clinical Practice professor Lisa Schwartz told the publication. "Bias times a million is still bias."

Still, ResearchKit is seen as a step in the right direction that is likely to augment existing research methods.

"I don't think we want to give the perception that this type of research will replace the more standard, physician-based, direct interaction with the patient, added Todd Sherer, CEO of the Michael J. Fox Foundation for Parkinson's Research. "But I do think this provides a complementary type of research in a different way. Any kind of tool that will make it easier to engage more people in research is really important."

Comments

  • Reply 1 of 14
    Quote:

     The relatively close demographic grouping of iPhone users could skew data,


    Unless you wanted a lot of dorks for your research, I don't think this would be a bad thing. iPhone owners come in all different types.

  • Reply 2 of 14
    ajmasajmas Posts: 601member
    One of the challenges, like any survey opened up to a large group of people, is ensuring data quality. There are going to be those that will want to game the system and therefore skew data. For this reason, an extra step will be needed in any analysis to ensure the extra noise is filtered out, where possible. Don't get me wrong, I like the concept and anything that increases coverage is good, but it shouldn't be taken as a magic bullet - there will still be some curating to do.

    As for the demographic, hopefully the "open source" aspect of [url=https://developer.apple.com/researchkit/]ResearchKit[/url] will mean it will appear on Android and further extend the demographic.
  • Reply 3 of 14
    jfc1138jfc1138 Posts: 3,090member
    And in medical clinical research quantity has a quality all it's own. And big quantities of participants normally cost big fortunes...

    When this leaks into patient monitoring for prescription compatibility AFTER the prescription is written this will be big. Catch those unwanted side effects before they reach crisis perhaps allowing more aggressive use of some pharmaceuticals that have a small number of at risk people in the general population but overall are potentially very valuable for treatment.
  • Reply 4 of 14

    The Verge is running a hitpiece this morning trying to slam this. As several commenters possessing actual brains have pointed out, it's baseless.

     

    Quote:



    Looks like many of those tweeters didn’t bother to read Apple’s information on Research Kit and even the article is a bit thin on that reading it would seem. I work in a medical research facility and have already sent the information for our lead researcher to look into.

    https://developer.apple.com/researchkit/

    Researchkit tehnical overview

    It is a 5 page document with 1 page being a title only, doesn’t take much effort to read and was available (when I looked for it) the same day as the announcement. It even came up at the first entry in Bing search.

    Informed Consent

    Participants in medical research studies are often asked to share sensitive health information as part of their enrollment in a study. That’s why it’s critical to clarify exactly what they need to provide and who will have access to their information. ResearchKit provides visual consent templates that you can customize to explain the details of your study and obtain participant signatures.

    Since different studies require varying degrees of informed consent, ResearchKit is flexible.

    • If your study has obtained a waiver for informed consent, you can still show a visual consent flow to provide detailed information without requiring a signature.

    • If your study requires informed consent, you can customize the consent module with language from your ethics review board and utilize the ResearchKit signature module to obtain informed consent.

    You also have the option to generate a PDF of the signed form and provide it to the participant. For example, your app can upload it to a server, email it to the participant, or display it within the app.

    • If you want to make sure that participants understand the content in the informed consent flow, you can insert comprehension tests before allowing enrollment into your study.

    We encourage you to contribute your IRB-approved consent modules to the ResearchKit community for others to use.

    AND

    Current Limitations

    The ResearchKit feature list will continue to grow as useful modules are contributed by the community. Keep in mind that ResearchKit currently doesn’t include:

    (other points removed for clarity)

    Automatic compliance with international research regulations and HIPAA guidelines. These are the researcher’s responsibility.

    AND

    Talk to your organization about international research regulations and HIPAA guidelines that your

    app needs to follow.

     

     

    And:

     

    Quote:



    There’s also one extra thing. It’s ok false subjects will be included. One of the primary tasks of these studies is to teach big data algorithms to distinguish actual data from irrelevant noise as humans will always make mistakes and sensors are not perfect. It is expected to have a reasonable amount of false data as input, and system should learn to recognise said data.

    So I don’t think any balls were dropped. It’s just a design of the research. Data shouldn’t be clean, as they are never clean in real life.


     


     

    Quote:


     

    Ethical or not, this is a single most important feature of Apple Watch that justifies its existence. Wearables should pave the way to personalised 24-hr healthcare, and this is the first step in the right direction.

    That’s the ultimate usecase that explains why wearables are needed. To monitor health around the clock. Not for fitness, but actually for difficult chronic conditions. To provide better healthcare, to warn the user of the problem, to timely contact physician.



  • Reply 5 of 14
    The Verge is running a hitpiece this morning trying to slam this. As several commenters possessing actual brains have pointed out, it's baseless.

    I saw that. The poster you quoted sure understands what's going on, and made a fool of The Verge and all the commenters.
  • Reply 6 of 14
    rob53rob53 Posts: 3,251member
    Quote:

    Originally Posted by ajmas View Post



    One of the challenges, like any survey opened up to a large group of people, is ensuring data quality. There are going to be those that will want to game the system and therefore skew data. For this reason, an extra step will be needed in any analysis to ensure the extra noise is filtered out, where possible. Don't get me wrong, I like the concept and anything that increases coverage is good, but it shouldn't be taken as a magic bullet - there will still be some curating to do.



    As for the demographic, hopefully the "open source" aspect of ResearchKit will mean it will appear on Android and further extend the demographic.



    I agree but how often do researchers cherry-pick their participants to ensure the results they seek? How often do they skew the results so they get FDA approval? I'm not saying having a lot of totally random participants is necessarily better but isn't it better to have more "normal" people participating than supposedly affected ones to really be able to compare what's going on? What if some of these extra participants were found to have the disease they were trying to fix and didn't know it? I see many benefits with a larger participant population, especially one where the researcher is only having to pay someone to look through the results instead of trying to find participants.

  • Reply 7 of 14
    cambocambo Posts: 38member
    It's open source, so it's available to Android users as well, and anyone else who wants to port it over. The 'demographic grouping' is pretty much the entire planet.
  • Reply 8 of 14
    lostkiwilostkiwi Posts: 639member
    I saw that. The poster you quoted sure understands what's going on, and made a fool of The Verge and all the commenters.

    That is the reason I never go to that site anymore. Just one hit piece too many for me.
  • Reply 9 of 14
    SpamSandwichSpamSandwich Posts: 33,407member
    lostkiwi wrote: »
    That is the reason I never go to that site anymore. Just one hit piece too many for me.

    I recently removed The Verge from my bookmarks. So many sites have evolved into pure garbage, obviously because that's what drives traffic.
  • Reply 10 of 14
    slurpyslurpy Posts: 5,384member
    Quote:
    Originally Posted by SpamSandwich View Post





    I recently removed The Verge from my bookmarks. So many sites have evolved into pure garbage, obviously because that's what drives traffic.

     

    It's sad. It actually sued to be an honest, quality publication with little sensationalism. Now, pretty much every fucking headline is a click magnet, with a focus on Anti-Apple sensationalism. Frankly disgusting. 

  • Reply 11 of 14
    solipsismysolipsismy Posts: 5,099member
    I recently removed The Verge from my bookmarks. So many sites have evolved into pure garbage, obviously because that's what drives traffic.
    slurpy wrote: »
    It's sad. It actually sued to be an honest, quality publication with little sensationalism. Now, pretty much every fucking headline is a click magnet, with a focus on Anti-Apple sensationalism. Frankly disgusting. 

    Just the other day I commented one of their sensationalist headlines...
  • Reply 12 of 14
    calicali Posts: 3,494member
    cambo wrote: »
    It's open source, so it's available to Android users as well, and anyone else who wants to port it over. The 'demographic grouping' is pretty much the entire planet.

    Big mistake in my opinion. This Apple feature should stay with Apple. I don't see why giggle would want it on android if it wont share data with them though.
  • Reply 13 of 14
    ecatsecats Posts: 272member

    I think some might be missing the point - researchkit isn't a tool to gain more participants(although it does make it easier to get them). Rather it's to make conducting research easier and more accurate. Certainly the requirement of an iphone can skew the demographic, but all research has skews that you document and allow for, there is never a perfect study.

     

    Researchkit provides tools so researchers can more easily create and deploy apps that utilise the sensors inside of an iPhone for a standardised and convenient data capture. Additionally the convenience of having the phone nearby allows accurate record keeping by participants. Other benefits such as reminders, ensure that the patient is compliant to the study guidelines.

    Researchkit simplifies using the iphone as another tool to capture data, it is not a replacement for current data capture.

  • Reply 14 of 14
    dasanman69dasanman69 Posts: 13,002member
    cambo wrote: »
    It's open source, so it's available to Android users as well, and anyone else who wants to port it over. The 'demographic grouping' is pretty much the entire planet.

    You mean like FaceTime?
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