Sage Bionetworks and PPACMAN release Psorcast app to support patients with psoriatic disease and health researchers

First-of-its kind non-profit psoriatic disease study app launches, allowing patients to monitor their skin and joint health

 

SEATTLE, Jan. 4, 2022 –The Psorcast app launches today, allowing patients with psoriasis and psoriatic arthritis to measure and monitor changes in their skin and joints over time.

Developed by Sage Bionetworks and the Psoriasis and Psoriatic Arthritis Clinics Multi-center Advancement Network (PPACMAN), Psorcast is a new non-profit research study that aims to learn more about the progress of psoriatic disease outside of clinical visits. This study is the result of the pre-competitive public/private partnership known as the Psorcast Digital Biomarker Consortium, consisting of Sage Bionetworks, PPACMAN, Novartis, UCB, Pfizer and Janssen.

Eight million Americans live with psoriasis, and roughly a third of them will go on to develop psoriatic arthritis, an immune system disease that can damage bones and joints. Researchers and clinicians hope that improving early detection and intervention while optimizing disease management over time can reduce the impact of psoriatic disease on patients and assist their doctors in diagnosing and treating them.

Anyone in the U.S. living with psoriatic disease can download the first-of-its-kind Psorcast app, developed by Sage Bionetworks, which allows patients to monitor and measure skin and joint health through their smartphone. Photo and motion data collected through the app is turned into images and short movies that help patients visualize their symptoms and how they change over time.

Data collected through the app is also anonymized (disconnected from personally identifiable information) and shared openly with researchers studying the disease.

“The Psorcast app and associated research study is the result of our cross-disciplinary team working together in an open and collaborative approach,” said Dan Webster, PhD, Principal Investigator of the study at Sage Bionetworks. “We’re hoping our research will improve health outcomes for people living with psoriatic disease, and demonstrate that participant-involved research using innovative digital tools can speed the translation of science into medicine.”

“Psorcast is the foundation of a long-term, observational study that we hope will put more information in the hands of patients and their doctors, while simultaneously helping researchers forecast outcomes like which drugs might work best for certain people, who is at greatest risk of developing psoriatic arthritis, and when flare/remission cycles may occur,” said Principal Investigators Jose Scher, MD, NYU Langone Medical Center and Joseph F. Merola, MD, MMSc, Brigham and Women’s Hospital & Harvard Medical School, both founding board members of PPACMAN.

Digital health research via remote device monitoring, with the direct participation of patients, is an important and growing area of biomedicine. The ability to measure symptom changes that take place between clinical visits can provide key insights into the mechanisms that drive psoriatic disease and other immune-mediated diseases.  

“Researchers are using remote device monitoring in ways that will revolutionize our understanding of disease and treatments. Reliable science depends on access to trustworthy digital tools and methods, as well as direct integration of patients in the research lifecycle” said Lara Mangravite, PhD, President of Sage Bionetworks. “Sage aims to be a trusted partner to researchers by developing innovative technology like the Psorcast app and, even more importantly, working collaboratively with the research community to benchmark reliable methods for collecting and interpreting data.”

The Psorcast app is available to download at the Apple Store and more information about the project is available at Psorcast.org.

ABOUT THE PSORCAST STUDY AND APP
The Psorcast Study (psorcast.org) is a remote, nationwide observational study to collect multidimensional, high-resolution time-series data from psoriasis patients’ smartphone sensors. The Psorcast app measures symptoms, disease-influencing factors, and outcomes as a foundational dataset for creating personalized forecasts of disease activity.

ABOUT SAGE BIONETWORKS
Sage Bionetworks (sagebionetworks.org) is a non-profit health research organization based in Seattle, Washington. Sage uses open practices that increase the reliability of scientific claims to speed the translation of science to medicine. Through its work, Sage supports responsible data sharing, objective evaluation of methods and results across researchers, and the empowerment of participants to be active partners in research.

ABOUT PPACMAN
The Psoriasis and Psoriatic Arthritis Clinics Multi-center Advancement Network (ppacman.org) is a network of clinics dedicated to optimizing the clinical care of patients with psoriatic disease through multidisciplinary collaboration, education, and innovative research.

Third edition of IRB reference manual released with new chapter on mHealth

Cover of IRB Management and Function textbook. The background image of the cover resembles a cross section of a colorful stone.The field of mHealth and wearables research is constantly evolving. How can IRBs keep up? In the latest edition of Internal Review Board Management and Function, Sage Bionetworks’ Meg Doerr and Sara Meeder, of Maimonides Medical Center, share their expertise in a new chapter called “mHealth, Mobile Technologies, and Apps.” Highlights in the chapter include:

  • Introduction and background to support reviewers new to the field of mHealth research
  • Guidance for reviewers evaluating mHealth studies on topics such as reliability of data, data breach procedures, third-party access and use of data, and considerations for enrollment of vulnerable populations.
  • Accessible discussion of the importance and impact of technical documentation, including privacy policies and terms of service, on regulatory compliance.

Internal Review Board Management and Function from PRIM&R (release date Feb. 22, 2021) is now available.

The Global Mental Health Databank – Practicing Better Science Together

At Sage, we build responsible practices for data sharing in health research. By combining policy and technology, we work to ensure data can be safely used across institutes. We do this because broad data resources and interdisciplinary teams are necessary to understand the complexities of human health, and we need to use this kind of information to improve people’s experiences in the health system.

We have been successful in stimulating collaborative science across teams of researchers. But we recognize that our approaches to data sharing haven’t included everyone who should be part of the conversation. Patient advocates and community-based organizations have asked us for many years why we don’t prioritize participant involvement. Indeed, there are a wide range of research opportunities that are only possible with direct involvement of the individuals contributing the data. We haven’t had a good answer.

Researchers simply can’t keep excluding those who provide the data. While we at Sage are partial to the ethical arguments for this, there are plainly scientific arguments as well. As data collection creeps out of the lab and into our homes, researchers will not recruit and engage diverse cohorts if the people in the study are treated as subjects, not partners.

In our own work we focus on “real-world evidence” – how to collect, govern, and analyze a wide range of extremely personal data about our everyday lives, including medical care, daily habits, self-management practices and lived experience. What is the value proposition that would convince anyone to contribute these kinds of data to research? How broadly are people willing distribute data collected about their daily lives? How do these tradeoffs look to people who aren’t traditionally asked their opinion about tradeoffs?

The challenge then is to create a data governance system that empowers people to be active partners in managing the way that their data is collected, shared, or used in research.

This is why I am so excited about the new partnership we’ve just formed with Miranda Wolpert and the Mental Health Priority Area at Wellcome Trust. We’re going to build – and test – that data governance system.

The Global Mental Health Databank project seeks to research strategies – active ingredients – that youth around the world can use to self-manage anxiety and depression, to develop a system that guides youth to those strategies that they are most likely to find useful. To be clear, our project is to design the governance for this kind of databank. We’ll be testing out the ways that participants want to govern such a databank – we are not conducting the research on mental health!

To be clear, our project is to design the governance for this kind of databank.

Doing this will require active partnership with both researchers and youth to help collect the data needed to answer the question of “what works for whom and why” for mental health management. A data sharing system designed for these purposes must meet the needs both of youth with lived experience in mental health and of mental health researchers. Participants and researchers are often interested in different questions – both of which have value. Just as researcher-led programs have often overlooked participant needs and interests, participant-led programs may miss subtleties of statistics and biology that are important to researchers.

Over the next two years, we will work together with youth and researchers to evaluate the feasibility of successfully implementing a participant-led databank for global mental health research that enables the collection, sharing and use of data from youth across three countries – South Africa, India, and the United Kingdom. We will run this study as an experiment in participant-led data governance designed to address several key questions: What value do youth find in participating in this kind of databank and how does that vary across individuals? Is youth involvement in research impacted by their control over how their data is collected, shared, and used? What levels of oversight do they wish to have? Do these considerations have an impact on what types of data they are willing to contribute? What do they wish to do with these data and what support do they need to achieve their goals? How do the preferences of youth and the preferences of researchers intersect?

I am thankful to be collaborating with a team of amazing researchers with deep expertise in youth mental health: Drs. Zuki Zingela and Melvyn Freeman in South Africa, Dr. Soumitra Pathare in India, and Dr. Tamsin Ford and Dr. Mina Fazel in the UK. These individuals work directly with school-based youth on the management of mental health. Together, we will evaluate the interests of youth in engaging with a databank program of this sort. We are also joined by two research teams from the University of Washington, Drs. Pamela Collins and Pat Areán who have expertise in global mental health collaboratives and in digital mental health assessment, respectively.

Our team is committed to embarking on this journey in partnership with youth. To build a system that meets the needs of youth and researchers, we need both perspectives to be involved right from the beginning. To this end, our first action has been to hire young adults onto the team to co-develop this work with these researchers. They will be supported by a series of panels of youth with lived experience of mental health in each country who can provide a diverse set of perspectives to inform the project.

Stay tuned!

‘The Playbook’ Is Essential Guide for Developing & Deploying Digital Clinical Measures

The Digital Medicine Society introduced today the first draft of the Digital Measures Playbook – the essential guide for developing & deploying digital clinical measures across clinical research, clinical care, and population health surveillance.

Experts from Sage, the FDA, Myokardia, Genentech, Scripps Research, Koneksa, Elektra Labs and the Digital Medicine Society collaborated on The Playbook and encourage the community to continue to advance this unprecedented, action-oriented guide. The Playbook will synthesize best practices into one comprehensive how-to for anyone interested in remote health monitoring.

DOWNLOAD PLAYBOOK

READ THE PRESS RELEASE

 

dHealth Digital Health Knowledge Portal Launched

Logo for dHealth Digital Health Knowledge Portal.

Sage Bionetworks is proud to announce the launch the dHealth Digital Health Knowledge Portal. The portal is a resource to catalyze digital and mobile health research by providing data, analysis tools, benchmarked outcomes, and digital biomarkers. Currently, there are five studies, 67 data files, and an R package to extract features out of mobile and wearable data, plus two reference implementation projects in Parkinson’s disease and mobile health participant retention.

EXPLORE PORTAL

 

Sage Joins Open Wearables Initiative

“We are excited to partner with OWEAR and look forward to bring together OWEARs open initiative with Sage Bionetworks efforts for open and collaborative benchmarking. Open wearables first benchmarking project is focusing on the use of wearable sensors to measure gait,” said Dr. Larsson Omberg, vice president, systems biology at Sage Bionetworks.

Shimmer Research announced today that Sage Bionetworks has joined the OWEAR Working Group. OWEAR is a collaboration designed to promote the effective use of high-quality, sensor-generated measures of health in clinical research through the open sharing and benchmarking of algorithms and datasets.

Read the press release…


Related media:

Feb. 14, 2020 – https://mhealthintelligence.com/news/new-project-eyes-an-open-platform-for-data-from-mhealth-wearables

New Papers: Remote Retention in Digital Health Studies, Machine Learning, Reproducible Benchmarking

Detecting the impact of subject characteristics on machine learning-based diagnostic applications

Journal: NPJ Digital Medicine

Authors: Elias Chaibub Neto, Abhishek Pratap, Thanneer M. Perumal, Meghasyam Tummalacherla, Phil Snyder, Brian M. Bot, Andrew D. Trister, Stephen H. Friend, Lara Mangravite and Larsson Omberg

Read the paper…


Indicators of retention in remote digital health studies: A cross-study evaluation of 100,000 participants

Preprint: arXiv:1910.01165 [stat.AP]

Authors: Abhishek Pratap, Elias Chaibub Neto, Phil Snyder, Carl Stepnowsky, Noémie Elhadad, Daniel Grant, Matthew H. Mohebbi, Sean Mooney, Christine Suver, John Wilbanks, Lara Mangravite, Patrick Heagerty, Pat Arean, Larsson Omberg

Read the paper…


Reproducible biomedical benchmarking in the cloud: lessons from crowd-sourced data challenges

Journal: Genome Biology

Authors: Kyle Ellrott, Alex Buchanan, Allison Creason, Michael Mason, Thomas Schaffter, Bruce Hoff, James Eddy, John M. Chilton, Thomas Yu, Joshua M. Stuart, Julio Saez-Rodriguez, Gustavo Stolovitzky, Paul C. Boutros, Justin Guinney

Read the paper…

VIDEOS: Watch Talks from Sage’s mHealth App Developers Workshop

The Mobile Health App Developer Workshop took place at the New York Genome Center on Sept. 12, 2019. Sage Bionetworks hosted the workshop, which featured a keynote from Andy Coravos, CEO of Elektra Labs. Workshop sessions were presented by Sage staff, including Meg Doerr, Vanessa Barone, Woody MacDuffie, and Abhishek Pratap.

Watch full playlist

 

BLOG: Reflections from the Mobile Health App Developer Workshop

Editor’s note: This post originally appeared on Medium.com on Sept. 16, 2019.

By Kimberly Milla
Elektra Labs

Sage Bionetworks co-hosted their first Mobile Research App Developer Workshop on Sept. 12 at the New York Genome Center. The event, supported by a NIH grant for ethical, legal, and social implications (ELSI) in health research using mobile technologies, sought to engage stakeholders (app developers, patient advocate groups, and security researchers) to begin conversation on governance, reliability, and privacy of data collected from connected digital tools (i.e. digital specimens). In this post, I’ll share a summary of the workshop proceedings along with reflections and resources (e.g., developer toolkits and legal resources).

John Wilbanks, CCO at Sage, and Mark Rothstein, Founding Director of the Institute for Bioethics, Health Policy, and Law at the University of Louisville School of Medicine introduced the workshop by highlighting that current practices are not regulating apps collecting data for research through governing bodies such as an Institutional Review Board (IRB). This lack of governance can lead to detriments by relying on incorrect information as well as privacy risks, such as apps selling information to third parties.

Andy Coravos gave a keynote talk that addressed the gap in overseeing digital products and regulating data governance & rights, discussing how governing organizations such as the FDA regulate based on what a company claims their products do, not necessarily based on what the products actually do (slides).

The Sage Bionetworks team then held a series of talks addressing consent, privacy, design, and engagement & enrollment. Megan Doerr talked about consent and the importance of using accessible vocabulary to inform people as well as the ethical imperative to utilize the consent to inform rather than as a pseudo-contract. This lead to the creation of Sage’s consent toolkit geared to guide researchers, app developers, and designers.

Vanessa Barone reviewed a study done in data privacy that identified people’s perception on agency in data sharing. The results showed that people’s perceptions fall in 3 groups where they feel they have no other options than providing their data (no agency), or like their data is already out there and there is nothing they can do about it (apathy), or that they have an active role in deciding what data and how it is shared (agency). Based on this study, Sage created another toolkit to help biomedical researchers, app developers, and designers improve data privacy practices in digital studies. Check it out! Thursday marked the public launch of the Sage Privacy Toolkit — it’s an excellent resource for both start-ups and big companies.

Source: Sage’s Privacy Toolkit

Likewise, Woody MacDuffie presented on digital systems for mobile research, where the Sage design team standardized their app design systems to have the same way to execute an action, such as clicking “next”, and utilize animations rather than lengthy text to consent participants and explain procedures in digital studies. Abhi Pratap then presented preliminary data from his research work on engagement & enrollment in digital health studies, which will be publicly shared later this month — be on the lookout for the report!

Woody MacDuffie presenting on digital systems for mobile health.

An expert panel featuring Deborah Estrin, JP Pollak, Adrian Gropper, and Maria Ebling, discussed privacy considerations in app development. The conversation focused on challenges such as accessible end-user license agreements, separation of concerns, selective sharing of data, and agency vs. paternalism. Cindy Geoghegan highlighted the important point of helping people understand what role is played by each entity that has access to their data, for example some organizations might only be responsible for storing data rather than using such data.

Panelist discuss current issues in data privacy. Left to right: JP Pollack, Deborah Estrin, Adrian Gropper, Maria Ebling, and John Wilbanks.

Next up were four lightning talks from workshop participants. Talks covered difficulties accessing pre-processed data from commercial connected tools, adapting current wearable devices to specific populations, and Miso Technologies’s work developing the “first research AI assistant”. Elektra Labs team member, Christine Manta, covered the current landscape of health IT standards for the digital medicine community, sparking conversation on whether popular standards such as FHIR are appropriate for the format and exchange of data collected on digital tools. In particular, FHIR may not (yet) be capable of storing data sampled at greater than 1Hz (1 sample per second), which is critical for remote monitoring (h/t Jameson Rogers and Mark Shervey).

Christine Manta discusses the current standards in health IT. To learn more, check out Digital Medicine Standards 101.

Lastly, closing remarks by John Wilbanks and Mark Rothstein emphasized the importance of education and collaboration between security and biomedical researchers, app developers, and designers to protect the privacy of people’s data and uphold ethical practices in collecting and using such data. As someone new to the field of digital medicine, I was left with the urgency to shift our paradigm towards being data stewards, not data owners, particularly while the gap in regulation from governing organizations continues.

Elektra Labs and Sage Bionetworks team members: Left to right: Megan Doerr, Mark Shervey, Andrea Coravos, Christine Manta, John Wilbanks, Kimberly Milla.

 

LAUNCH: Privacy Design Toolkit for Mobile Health

A screenshot of the home page of the Privacy Toolkit. There's a faded out background image of a handshake between two people. Below the image are icons and text that describe what's in the toolkit.Sage Bionetworks announces our Privacy Design Toolkit for mobile health research. The project was led by Vanessa Barone, a research scientist on the governance team, and Woody MacDuffie, director of design.

This toolkit is aimed at designers who need to represent a privacy policy in an app. But it’s also intended to help nudge developers and designers to do the right thing. The toolkit contains a curated collection of established interface patterns and cases to provide biomedical researchers with clear examples of when and where these patterns should be used in an app.

The tools are available for use in Google Forms, GitHub, and Figma.