Reducing friction in patient engagement: an (unconventional) case study

Participate_SCDM_SurveyOur quest for frictionless, electronic patient reported outcomes (ePRO) data capture has us looking for novel ways to engage patients and streamline process. I’d like to share a fun and interesting example of this work, in which we used Participate (the OpenClinica ePRO solution) to engage study subjects at the recent SCDM annual conference.

Our goal at the SCDM conference was to get as many attendees to try OpenClinica Participate as possible. With the vast array of vendors, eye candy, and giveaways, it’s a big challenge to cut through the noise and offer a simple, fun way to engage an audience. The same holds true when engaging patients. With the enormous number of daily distractions, ensuring that your patients can quickly access, fill out and submit well-constructed, simple forms is key to compliance and ultimately, better data.

I built the form, shown here, in OpenClinica and enabled access to it via a custom URL, a new feature in our latest release.

Attendees filled out the form, sprinkled with fun health habit questions, then captured information to allow us to draw their names to win Fitbits and other giveaways. We were able to use this data and update our graphs to give the participant a view of how they stacked up with their peers—cool!

Imagine if patients could view a visual representation of the study they are enrolled in – see the parallels and possibilities?

Graphs_SCDM

Who says ePRO and patient engagement can’t be fun?

OC15 in Review

Two weeks ago, members of the OpenClinica community converged on the Lloyd Hotel in Amsterdam for the 2015 OpenClinica Global Conference. The event was highlighted by a keynote from John Wilbanks, who inspired us with a great talk on how mobile technology and open source can help break new ground in understanding disease. Smartphone-based engagement tools, used in real world settings, can enable greater participation in research, cut costs, and make new research designs and insights possible. It’s not just theoretical, as his company, Sage BioNetworks, is walking the walk by open-sourcing its e-consent toolkit and working with Apple on studies using ResearchKit.

Our community demonstrated it is also a powerful driver of innovation. Through innovative applications, by integrating with other powerful tools, or augmenting the OpenClinica core with custom built extensions, OpenClinica is playing a role in patient engagement, big data, and translational science. TraIT shared its work integrating OpenClinica into a Translational Molecular Medicine infrastructure (ppt), Aachen University presented its integration of medical imaging applications, and University of Cambridge’s RDCIT team unveiled its integration sophisticated pedigree and phenotyping capabilities to support clinical genomics research (pdf). We got to take deep dives into powerful GUIs for data import, client libraries for OC’s web services API, and data marts/reporting. That’s just a few. Many of these efforts are open source and are being shared freely–a phenomenon unique in the field of clinical research.

https://twitter.com/RRittberg/status/604983558562820096/photo/1

https://twitter.com/benbaumann/status/604925177584087040/photo/1

We have become a community that rapidly disseminates ideas and code while holding each other to rigorous standards of quality. We are building on a shared foundation of strong data provenance, audit trails, privacy protections, and GCP compliance. OC15 was a reminder of how openly and effectively our community collaborates, and how great we are at welcoming new participants. I left OC15 inspired and motivated by the participants’ passion and creativity.

Engineering OpenClinica’s Future

We recently introduced OpenClinica Participate™.

We believe all research participants—patients, clinicians, researchers, should have technology that meets the ‘anytime, anywhere’ expectations of a mobile, smartphone enabled world. Based on conversations with the OpenClinica community, many of you share this view as well. We are committed to making sure, at minimum, that OpenClinica’s patient engagement technology ‘just works’ in mobile, real world environments. Wherever possible, we will go beyond that and work to make the participant experience engaging, fun, and inspiring.

As transformational as these patient engagement capabilities can be, what we’ve been working on is about more than that. This is about a foundation for the future of the OpenClinica project.

EnketoAs I briefly pointed out in an earlier post, OpenClinica Participate forms are powered by the new enketo-express app that was built around the widely used enketo-core form engine (both available on GitHub).

OpenROSA_LogoOpenClinica will soon natively support the OpenRosa API, which will let you run Enketo, ODK Collect, or any of a number of OpenRosa-compliant data capture clients. Eventually, we envision the Enketo forms engine will replace the current CRF engine in the OpenClinica code base.

odk_medium_squareIf you’re not familiar with Enketo, ODK, or OpenRosa, here’s a primer. Most important is understanding there is a rich global ecosystem of technology, developers and users around the OpenRosa Xform standard. The resultant solutions have been battle tested in diverse health care and field-based data collection settings over many years. In keeping with the open source principles of flexibility and choice, aligning the OpenClinica ecosystem with this community will provide new features and options that you can use.

As my 5 year-old son has taught me when we watch Spider-Man cartoons, with great power comes great responsibility. So it is with open source software. Tapping in to the richness and variety of the OpenRosa community creates new possibilities, but it can add complexity too by expanding the options you have to choose from. OpenClinica is released under an open source license so that many developers can improve, combine, and share their code in a way that enhances quality, usability, and features, and we believe that this richness will drive the next cycle of innovation.

With this goal of better encouraging code contributions, the focus of the repositories and downloads will be easy-to-use open-source libraries: building blocks for developers to create their own OpenClinica-powered apps and modules.

If you are developing on the OpenClinica code base to add features or build custom solutions, you’ll have a greater ability to mix and match just the pieces you need, and to share back your improvements in a modular fashion. It will be much easier for developers to use the libraries and share their experience and contributions back with the community. We will gladly help out if you experience issues. Our own engineers will be able to focus more of their time on improving quality, usability, and functionality, rather than on packaging, testing, and supporting so many different environments. We hope to build a strong collaboration with the Enketo and OpenRosa communities that spawns new ideas and developments.

So try it out! Check out OpenClinica Participate or get started by hooking up OpenClinica with Enketo.

And need I say, you’ll certainly be able to learn more about these OpenClinica innovations at the upcoming OC15 conference in Amsterdam, May 31-June 1.

A Look at the 2014 OpenClinica Conference Program – An Ecosystem of Innovation

The program for OC14 (the 2014 OpenClinica Global Conference) has been posted–what a line-up! Having been involved in each of the past 5 OC conferences, I can say that this one has a lot new and useful things to offer.  Many in the OpenClinica community are not aware of all the useful innovations produced by our community scattered throughout the globe. The theme of the conference is “An Ecosystem of Innovation,” and OC14 will help to communicate a number of the innovations available to you and show you how you can take advantage of them for your own work.

OC14 is a unique opportunity to enhance your capabilities and skills with OpenClinica in an information-packed 2 days, June 22-23 in Boston. Early bird deadline registration is May 2nd.

Here are some of the things you can do at OC14:

Interactive demonstrations:

  • OpenClinica Monitoring Platform
  • Converting OpenClinica Datasets to SDTM
  • DynaOCreports: A web-based reporting tool for OpenClinica
  • Medical Coding for OpenClinica EDC
  • OpenClinica-CTMS Integration with Clinical Conductor
  • New Features Playground
  • OpenClinica ePRO Mobile & OpenClinica ePRO Web
  • A Tour of Developer Resources
  • elluminate: Aggregate and Standardize Your Clinical Data
  • OpenClinica Enterprise Edition
  • Randomization in OpenClinica with RANDI2

Informative sessions, featuring innovative OC extensions, case studies, best practices, and more:

  • Lessons Learned from Integrating OpenClinica with Other IT Systems
  • Using OpenClinica for Risk-Based Monitoring and Monitoring Reports
  • Developer Meet-Up Report
  • Data Preparation, Delivery and Analysis: The Emerging Value of CDISC Data Standards in the New Era of Data Transparency
  • OpenClinica Extensions: From Nano to Macro
  • Importing Lab Normal Values: A Case Study
  • Risk-Based Monitoring with OpenClinica, add-ons and REST
  • con•nec•tiv•i•ty: Using Open Source APIs to Redefine the eClinical Ecosystem
  • OpenClinica in an Integrated Translational Environment
  • Maximizing your OpenClinica ROI with Community Engagement
  • EDC Methods in Studies Conducted in Western Kenya
  • Simplifying ODM with JSON
  • Expanding OC the Ecosystem

Workshops (in-depth, hands-on instruction in focused areas):

  • Rules for Advanced Users (includes new Rules-based calendaring features)
  • Best Practices for Building Studies
  • Meeting GCP and 21 CFR Part 11 Requirements with OpenClinica
  • Internationalizing OpenClinica
  • IT Primer for Setting-up and Running OpenClinica

In addition to the above, you can:

  • Connect with the developer community at a special OpenClinica Developers Meet-up.
  • Roll up your sleeves, relax, and enjoy the summer sun at a classic New England clam bake.
  • Get certified with 4-day OpenClinica Central User Training course while you are in Boston.

Here is the full program. Looking forward to seeing you in June!

– Ben

Back from the OpenClinica German Users Group Meeting

Loebe_900Last month, OpenClinica users throughout Germany converged in Berlin for the very first German OpenClinica Users Group Workshop entitled: OpenClinica – an Open-Source Clinical Data Management System for Clinical and Translational Research. This was held at the TMF (Technology, Methods, and Infrastructure for Networked Medical Research) facility.

Brought about by the efforts of Matthias Löbe, the goals of the workshop were to gain experience, insight, and give back to the strong community of OpenClinica users in Germany. Löbe offered the following insight when asked about his motivations for organizing this group:

“It turns out that there are many locations throughout Germany with OpenClinica experience along with many developing adaptations or extensions. But so far, none of the 70 registered workshop participants knew of the activities carried out by others. The workshop has opened a whole new perspective.”

Goodwin_900My colleague, Alicia Goodwin, who has been working with OpenClinica since 2007, was invited to speak at the conference. I interviewed Alicia after she returned to share insight on the event. 

What were you looking forward to the most at the workshop?
I really wanted to meet the OpenClinica users and learn about how OpenClinica is used in Germany. The workshop had about 70 participants, representing seasoned users and developers to clinical site personnel looking for more information. There are several very active and brilliant OpenClinica community members in Germany, such as Mattias, Gerben Rienk, Philipp Leusmann, Henrik Dittman, Christian Hänsel, to name just a few. I was excited to hear about the wide range of work they are involved with.

Was the entire workshop spoken in German?
Yes, it was. Thankfully, I have enough of the language experience that I was able to understand most of what was being said.

You were invited to speak at the workshop. What was your talk about?
I spoke about the vital users and developers in our community and their role in OpenClinica development, innovation, and global support. I also talked about some of the development tools that are used. JIRA was a big topic as it really underscores our commitment to transparency, our rigorous SDLC, and our open source ecosystem.

What kind of technical information or issues were discussed?
A key theme was around the value that could be obtained from increasing portability and scalability extending th RESTFUL APIs and reusing study elements such as OIDs, rules, metadata across multiple systems. Essentially, looking at architecture in the future.

Was there anything that surprised you at the workshop?
One of the really cool things that I saw was a project called OpenClinica Big Data, developed by Dr. Thomas Deserno from Aachen University. OpenClinica Big Data is an OpenClinica extension specifically designed to handle some of the unique challenges associated with uploading and managing large image file sets. The system utilizes OpenClinica web services, allowing users to make calls from OpenClinica to retrieve image data from the Big Data repository. This module enriches OpenClinica with a convenient and context-related transfer of binary large objects (blobs), such as biomedical images or signals.

I was also very impressed with the overall enthusiasm and turn-out. Hopefully this initial workshop will encourage ongoing interaction among German-speaking OpenClinica users.

© TMF – Images property of TMF

OC13 Wrap Up – The Fruits of an Awesome Community

DSC02823It’s hard to believe that OpenClinica’s Global Conference, OC13 happened one week ago. What a memorable experience! Excellent sessions, great workshops, and an amazing Boston Harbor Dinner Cruise–here’s a recap:

P6210325The Highlights

Doug Bain delivered a insightful keynote presentation that challenged attendees on how to think about about patient engagement in today’s clinical trials. The discussion looked at the use of social media and the many systems and websites such as WebMD, PatientsLikeMe, etc., that are regularly referenced by patients and how this trend is setting new standards for communication.

DSC02816The multitude of OC13 sessions were delivered by an incredibly diverse background of presenters. With presenters from Africa,  Netherlands, Germany and Japan and wide representation from both industry and academia, a wide breadth of relevant, helpful and interesting topics were covered.

cruise1

Visit the conference page to view presentation slides.

I will be posting photos on Facebook highlighting the event. If you are not currently linked to our Facebook account, please “like” us and feel free to post and share your OC13 experiences.

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Thank you for attending and making OC13 a great event! Until next year!

– Rob

OC13 Boston – Less than a month to go!

Please excuse our excitement! There’s less than one month to go for OC13 — if you haven’t registered, now is the time to do it. Come learn about the world’s most widely used clinical trial software. All are welcome — whether you’re new to OpenClinica or already a seasoned expert.

  • Improve your effectiveness
  • Hone your skills at workshops
  • Hear case studies and best practices
  • Establish valuable connections

We looking forward to seeing you in Boston!

Odyssey Cruise
After a jam-packed day of presentations, tutorials, case studies and workshops, enjoy a relaxing dinner and drinks aboard the Odyssey. Explore Boston from the vantage point of this historical harbor. Sign up.Odyssey Cruise Ship

A Fresh Perspective on Upcoming OpenClinica Events

GrassGuy_KickedBackWhat a great time of year! The sun is out and the flowers, trees, and grass are blooming. There is no better time to spread the news about our fresh perspective on electronic data capture.

What are we up to?

  • We’ll be at SCT – Society for Clinical Trials 34th Annual Meeting in Boston next week, talking with over 650 professionals dedicated to the design, conduct and analysis of clinical trials.
  • Going to Shanghai! We will be holding our Central User training in Shanghai, China from May 28-31. This follows the DIA China Annual meeting, where OpenClinica was featured in numerous presentations.
  • We hope to see you at the OC13 Global Conference in Boston on June 21. We have an exciting lineup of great workshops, sessions, demos and training classes–there is something useful for everyone. We are really looking forward to the Boston Harbor Dinner Cruise for a chance to kick back after the event and visit with our OpenClinica friends. Sign up! You don’t want to miss this.
  • Capping off our spring events and immediately following OC13 is DIA 2013 in Boston, June 23-27. We are bracing ourselves for 7,000 life science professionals converging on our booth to take in our fresh perspective and enjoy some espresso, demonstrations and some very competitive games of cornhole (yes, this is a real game!). We have some great giveaways and prizes in an outdoor-themed space. Will you be there? If so, stop by Booth #122 and have some fun.

OpenClinica Next Generation

EnterpriseDo you want to boldly go where OC is going? Engage! Check out Nick Sophino’s blog on next generation OpenClinica. This is where to find information on prototype design and development for OpenClinica Next Generation. Nick is going to be showing off this work at OC13 so be sure to check out his session!

Throw a few steaks on the grill and kick back and enjoy the season. And, remember to always look for a fresh perspective.

Warm Regards,
Rob

OpenClinica to present at DIA China Annual Meeting

There are numerous opportunities to learn about OpenClinica at the upcoming 5th DIA China Annual Meeting <http://www.diahome.org/en/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=31144> . The conference, held at the Beijing International Convention Center, runs from May 12-15. The event is expected to attract over 1,200 participants and is the largest annual meeting held by DIA in the Asia and Pacific region.

OpenClinica representatives will be hosting an exhibit as well delivering three poster presentations and one lecture:

  • CDISC Standards to Enhance Clinical Trial Efficiency
  • The Importance of Validated EDC System to Ensure Quality of Data
  • Electronic Data Capture (EDC): Providing A Significant Cost-Efficient Platform In Current Clinical Research Management
  • The Adoption of Electronic Data Capture (EDC) for Clinical Trial Data Management in China – The Case of ATHENA Healthcare Consultancy

Be sure to stop by the OpenClinica booth A18 to learn about new developments with the leading open source clinical trial software.

Coming up soon, OpenClinica will be running a public, open enrollment training class in Shanghai (June 4-7). More information <https://www.openclinica.com/open-enrollment-training> .

OC13: Early Bird Registration Ends Friday, March 22!

Friday, March 22 is your last chance to get early bird registration for OC13! Take advantage of this final opportunity to obtain discounted pricing on conference admission, workshops and training.

We have a superb line-up of useful content this year, including a new series of in-depth workshops taught by subject matter experts:

  • Moving from paper to EDC
  • Advanced Edit Checks and Rules
  • Operating OpenClinica in a Regulatory Compliant Environment
  • OpenClinica Web Services & Enabling Modularity
  • Orientation of OpenClinica Code Base
  • Installing and Administering OpenClinica

OC13 also coincides with this year’s DIA annual meeting, so now you have TWO great reasons to come to Boston this June.