Introducing OpenClinica Participate

In clinical research, we all work towards better evidence-based, patient-centered health interventions. We all understand the importance of evidence. But how about patient-centered? We hear this phrase perhaps too often nowadays, but it’s more than just a buzzword. A patient-centered approach directs research toward questions that are important to patients so they can make more informed healthcare decisions. It measures the outcomes that are noticeable and important to patients, and produces results that help them weigh the value of healthcare.

At OpenClinica, we think increasing the patient-centeredness of research is vital. Industry, NIH, FDA, and the general public seem to agree, and furthermore share our view that technology can increase patient engagement. This can happen by designing highly accessible, mobile technology to:

  • Improve patient participation, motivation, and adherence
  • Increase ability to meet recruitment goals, budget, and completion timelines
  • Enable new designs that better target populations and/or more closely align with real-world use

HTCPhoneI’d like to introduce our upcoming product, OpenClinica Participate, a tool tightly integrated with OpenClinica for engaging patients and collecting data directly from study participants.

If you took our recent survey, you got a glimpse of what your forms for patient-reported outcomes could look like in OpenClinica Participate. Driven by a powerful forms engine based on proven open-source technology, the participant forms are simple, dynamic, mobile-focused, and platform-independent.

But it’s about a lot more than mobile-friendly forms. Patient expectations are rising while trial participation is shrinking. Clinical trials need to engage ‘Subjects’ as ‘Participants’ — by recruiting and retaining through real-time engagement and meeting the ‘anytime, anywhere’ expectations of a mobile, smartphone enabled world. It starts with an intuitive, action-oriented dashboard. Participants are greeted with a simple interface that motivates and focuses them on what they need to do today. The layout is responsive and knows whether you are using your phone, a tablet, or a traditional browser. Communication with the participant can occur through multiple channels — via the dashboard, through SMS, or via email, with options to help you make sure the right balance is struck between security and accessibility.

Participate_OCUILast, and perhaps most important, Participate is tightly integrated with the OpenClinica EDC platform. The Participate solution allows you to design your study and forms using the OpenClinica study build tools you already know, while seamlessly capturing all your clinical and participant-reported outcomes in a single database. You can build skip patterns, repeats, and other logic into your participant forms just as you do with traditional OpenClinica CRFs, using the same rules engine. You can use scheduling rules to identify the next time participant feedback is required. As data is submitted by study participants, their activities become part of the same audit trail that tracks what your clinical users do. The data they submit can immediately be reviewed and extracted along with CRF data from other sources.

Participate is extremely easy to adopt. As a modular add-on to your hosted OpenClinica Enterprise instance, it can be activated for any new study from within your study build screen. Forms are powered by the widely used open source enketo-express library and all editions of OpenClinica will support the widely-used OpenRosa API to let you run Enketo, ODK Collect, or any of a number of OpenRosa-compliant data capture clients. Participate utilizes a cloud-based Software-as-a-Service (SaaS) delivery model, so there is no costly and delay-inducing software deployment to worry about.

 

Visit the OpenClinica Participate Website

 

Using Tokens in OpenClinica CRFs and URLs

An important new feature in OpenClinica 3.3 is the ability to incorporate variables in your CRF display. When designing your CRF, you can embed tokens into your form design with some simple markup (such as ${studySubject} to print the Study Subject ID). When the CRF is rendered for a patient visit, the tokens are parsed and replaced with the appropriate values. So, if you now want to display the name of the study, visit name or number, or study subject ID on a particular place on the form, you merely need to insert the token in the right place. You can even display the value of an item – for instance if you want to display a value entered in section 1 on a later section of the form, just use ${item[‘item_name’]}, replacing item_name with the name of your item. (screenshot right-justified – overlay snippet of CRF w/token on top of snippet of LI text with parsed variable)

ParameterizedLink2

This feature can be used in much more powerful ways too, especially when combined with the existing ability to include HTML markup and javascript code in your CRF.

In addition, tokens can be embedded as parameters in a link to an external system, such as an imaging or genomic data store. With the use of parameters specific to the study subject and event CRF, the link can take the user directly to the relevant record in the external system. With a little bit of clever javascript, the form could even embed the image or other media directly. You’ll have to set up appropriate security rules in the external system to allow this, and ensure the two systems share the same identifiers. (screenshot of embedded image)

The design, coding, and testing of this feature has been developed in collaboration with our fantastic partners at CTMM/TraIT in the Netherlands. With them, we have been able to build a feature that will fulfill a key need of theirs (link directly to a patient image at point of data entry). With the feedback of others in the community we’ve been able to make it generalizable for a far broader set of capabilities, adding to OpenClinica’s powerful existing API and extensibility while keeping it simple and familiar.

Read more here.

OpenClinica Rule Designer Now Open Source

I’m excited to announce that the OpenClinica Rule Designer module is now freely available to all OpenClinica Community Edition users, and the source code is open to developers.

With this tool, users can more easily create powerful and advanced rules, driving productivity. With the upcoming release of rules-based event scheduling it is a great time to open up this valuable, time-tested tool. You can request access to the hosted Rule Designer for your Community Edition instance here.

Up until now, the Rule Designer has been available only to users of the OpenClinica Enterprise Edition. We are always looking to reduce hurdles to increasing the adoption, development, and innovation of OpenClinica, and being more open is almost always the best way to do this. Making the Rule Designer open source and freely available encourages feedback and contributions that make it better for everyone, and enables innovative re-use of parts of the code.

If you are an Enterprise Edition subscriber, nothing will change, and you’ll continue to have fully supported access to your Rule Designer backed by our Service Level Agreement.

OpenClinica is already a highly successful community project. Tens of thousands of community members use the technology and many share their innovations, create extensions, write documentation, help beginners, translate, and contribute code to the core software. Now developers interested in advanced study design capabilities can join the party, too!

Here are a few parts of the Rule Designer code that are worthy of note:

– Tree model of an OpenClinica study with 3 views – by CRF, by CRF Version, by Event Definition
– Drag-and-drop rule design functionality
– Use of the REST API to interact with OpenClinica core
– Use of OAuth to authenticate with OpenClinica to use the REST API

Get the source code on GitHub (LGPL license). Technical information on how Rule Designer works and interacts with OpenClinica is here.

There will be some great information about the Rule Designer and the new calendaring features at the upcoming OC14 conference. Long time OpenClinica expert Alicia Goodwin will facilitate a workshop on “Rules for Advanced Users,” providing a deep dive into OpenClinica Rules, a powerful mechanism for adding workflow, edit checks, and other capabilities to your OpenClinica study. She will also be showing the latest innovation of Rules-based calendaring features. More here.

OC14Logo250x260

The Future of Open Source

It was a privilege for OpenClinica to help with the “Future of Open Source” survey recently completed by Michael Skok of North Bridge Ventures, Black Duck and Forrester. The survey polled users and other stakeholders across the entire spectrum of OSS.

Recently published results from the survey substantiate the idea that open source is ‘eating the software world’s lunch’ (to borrow a phrase from Michael). OSS powers innovation, increases security, and enables a virtuous cycle of proliferation and participation across major sectors of our economy. This is even true in healthcare and life sciences, and we are seeing these trends within OpenClinica community. People are adopting OpenClinica and other open source research technologies because of the quality, flexibility, and security they provide, not just to save a buck or two.

What I find particularly significant in the results is the increased recognition of quality as a key driver of adopting open source. 8 out of 10 survey respondents indicate quality as a factor for increased OSS adoption. This has vaulted from the #5 factor in the 2011 survey to #1. In research, quality and integrity of data are paramount. OpenClinica’s active (and vocal!) community’s constant scrutiny of the code, and continuous improvements demonstrate the power of the open source model in producing quality software. Furthermore, working in a regulated environment means you need to do more than just have quality technology. You also must provide documented evidence of its quality and know how to implement it reliably. The transparent development practices of open source are huge contributors to achieving the quality and reliability that clinical trials platforms require. Knowing that feature requests and bug reports are all publicly reported, tracked, and commentable means nothing can hide under the rug. A public source code respository provides a history of all changes to a piece of code. And of course, it greatly helps that many of the key tools and infrastructure that power open source projects are open source themselves.

That’s just one set of factors driving us to a more open, participatory future:

“As a result of all this, Open Source is enjoying a grassroots-led proliferation that starts with a growing number of new developers and extends through the vendors and enterprises to the applications and services, industries and verticals, reaching more people and things in our everyday lives than ever before… there are now over 1 million open source projects with over 100 billion lines of code and 10 million people contributing.”

One thing I predict we’ll see a lot more of in the next year, especially for OpenClinica and life sciences as a whole, is greater interaction between projects and communities. OSS reduces traditional barriers and lets more people ‘get their hands dirty’ with tools and technologies. As OSS tools, libraries, and apps proliferate, innovation will increasingly come from the mashups of these projects.

Follow the survey findings and updates @FutureofOSS and #FutureOSS  

Responding to Heartbleed

Please change your OpenClinica passwords.

By now you’ve probably heard about the Heartbleed web security bug. At OpenClinica we take the security and integrity of our users’ data very seriously. We have been hard at work over the past 3 days responding to this vulnerability.

Our team worked into the wee hours the past two nights to respond to the problem, and I’m proud to say we have fully patched the vulnerability for all our OpenClinica Enterprise Optimized Hosting customers. If you run an OpenClinica Community instance, please check and patch your system as soon as possible. The vulnerability is at the certificate/server level, so there’s no new version of OpenClinica to install. The exact steps to update will depend on the environment you’re running on. We’ll provide some more information and references shortly. Here’s what you can do:

  • Check your site for vulnerability, using a checker such as https://lastpass.com/heartbleed/.
  • Update your server to current OS patch levels, including applying OpenSSL updates where applicable.
  • Generate a new key and SSL certificate for your domain, and deploy the new key and certificate to the server.
  • Check again via https://lastpass.com/heartbleed/ to confirm vulnerability is patched.
  • Have all users update their passwords.

 

Forum upgrades and more

OpenClinica CommunityWhen you join OpenClinica as a user or a developer, you are joining an active, collaborative community. Our community is growing and with that growth it is constantly changing. Very soon you’ll see some changes that will allow you to interact with other community members in a richer, more powerful way.

The venerable GNU Mailman list software has been at the heart of the OpenClinica community for many years. It does it’s intended job (user and developer email lists) really well, but does not offer many features beyond that. Next week we are launching a new tool to power how the community works and corresponds.

The new OpenClinica Forums, powered by Vanilla, will offer the ability to post and read via the web. They still support email-based correspondence, so if you prefer to post and read via e-mail, you won’t notice much of a difference from how you’re used to doing things. In addition, the new web interface will have numerous features for search and collaboration that are simple yet powerful.

The forums will be organized into categories by topic. Some will be end-user focused, some will be IT/system admin focused, and some will be developer focused. Others may be a hybrid. If you’re currently subscribed to either the users or developers list, upon launch of the new forums, you’ll be subscribed to receive email from all of forum categories if you wish. However, you can log in to customize your settings to only receive emails from certain categories. If you have an idea for a new category, suggest it on the forums and if there’s support for it in the community we’ll create it for you.

Like any growing community, having a few ground rules about expected behavior is good for everyone. The OpenClinica community already does a great job being respectful and helpful, but it’s good to put the basics in writing so new and old participants alike know what to expect. New Community Guidelines (to be posted next week as well) are designed to help preserve the valuable culture our community has established, and ensure that participants continue to engage in the same meaningful, respectful ways as we grow. The guidelines are modeled off other successful open source communities and should be intuitive to most… however if you have feedback that can improve them, let us know (on the forums of course)!

Last and perhaps most exciting, we’ll soon be launching a new OpenClinica Extensions site. This site will allow you to easily share useful tools, add-ons, and integrations you have built to make OpenClinica more useful. It will be a catalog of useful OpenClinica resources from around the globe. We’ll have more information in the coming weeks as this gets closer to launch.

The Open Source Way

The OpenClinica LLC team subscribes to a core set of values we do our best to live and work by in everything we do. They are primarily based around what it means to us to be open source. In the spirit of living by the first one (be radically open), here they are!

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At OpenClinica, we believe that a successful business depends on a successful and growing open source community. We aspire to be part of a community that is as accomplished as Linux, Drupal, and Apache. We want to achieve a similar level of innovation, quality, collaboration, and transparency. To travel this journey (and build a great product along the way!) we constantly strive to put in practice the following values:

  • Be radically open.
  • Release early and often. Not always production releases, but find ways to get code in the hands of users and testers.
  • With enough eyeballs, all bugs are shallow. Follows from release early and often.
  • Keep barriers low!! For distribution, evaluation, adoption, contribution. Question complexity. Some is necessary but favor simplicity where at all possible.
  • If you need it, then build it. Or find it (see next one).
  • Share and re-use other’s work. Avoid not-invented-here (NIH) syndrome. Somebody has done it before. Or, someone has done something similar but not thought of using it for what you need. Here’s where radical innovation and gigantic leaps forward happen.
  • Keep at it. There are no substitutes for persistence and perspiration.
  • Reward good ideas and good contributions. Let leadership and accountability thrive.
  • Maximize participants’ strengths.
  • Avoid community anti-patterns.
  • Make it yours. You are your personality.
  • Most of all, find your passion and let your love for what you do shine through!

There are hundreds, if not thousands of articles, presentations, and academic papers on what makes open source communities work. Here are a few that best articulate the values described above:

Eric Raymond, The Cathedral and the Bazaar. It all started here. Read the summary or the full paper.
Matthew Mascord, How to Build an Open Source Community
Joel Dietz, How to build a vibrant open source community
David Neary, Open Source community building: a guide to getting it right
Jonathan Corbet, How to destroy your community
David Nalley, Leadership in open source communities
Stephen Walli, Open Source: No one is working for free
Ben Baumann, OpenClinica Community Surpasses 10,000 Members …and oh yeah, what is this open source thing?

 

 

Using Patient-centered Technology to Improve Recruitment and Retention

Sponsors of clinical research must increasingly focus on improving patient engagement in order to meet many of today’s research challenges. Promising disruptions are already under way that could define new models for patient recruitment and retention.

In a time when drug development success is becoming scarcer and more expensive, the industry is looking everywhere it can for new, innovative approaches to improving health. Meeting recruitment goals is one of the biggest challenges for traditional clinical research. Less than one-third of people who come in for a screening end up completing a clinical trial.1 Thinking in a more patient-centric manner can help is in recruiting patients. A fundamental idea behind patient-centered research is to “amplify the patient’s role in the research process.”2 Employing new ways to engage patients and physicians while increasing their level of knowledge and trust can improve the sponsor’s ability to meet recruitment goals.

One often overlooked factor for study participation and retention is convenience. Raising the level of convenience for both the investigator and participant can eliminate a huge obstacle to non-participation or non-completion. There are many ways to incorporate increased levels of patient and physician convenience into trial design and execution, particularly using Internet-based technologies. For instance, social media can be an effective recruiting tool and an important way to build trust with targeted populations. Disease-specific online communities are becoming more and more prominent for chronic diseases. Matchmaking tools act as mediators that draw together researchers and participants. “Traditional” social media offers a less targeted, but no less effective, way to engage patients and investigators.

In general, the four key determinants of a person’s likelihood to participate in a trial are prior participation in research, existing relationships with researchers, involvement of trusted leaders, and trust in the organization. Keys to recruiting success in social media should keep these determinants in mind, and engage communities in a thoughtful, ethical way while respecting the norms of the community you are targeting.

Participant retention post-recruitment can be improved by strengthening the connections between participants and researchers, and enhancing communication structures to support these relationships.3 Capturing Patient Reported Outcomes electronically (ePRO), through the web or mobile devices, offers a way to interact with the participant in a meaningful way while also capturing critical data. For instance, offering the ePRO user risk scores and health recommendations based on their data, or using gamification techniques to increase protocol adherence, can enhance the traditional ePRO experience by offering direct, immediate value to the user. Enabling a “Bring Your Own Device” (BYOD) strategy can increase convenience for populations who already own their own smartphones or tablets. Of course, the study design and applicable regulatory considerations should drive when and how these techniques are used.

Increased focus on the patient experience is not a phenomenon unique to research, but something that is rapidly permeating healthcare systems. These rapid changes can enhance research engagement. There is enormous potential to capture far more robust data and have better follow up than ever before as widespread infrastructure is put in place for coordinated team-based care, home-based continuous monitoring, and wireless data reporting from medical devices. The (still elusive) promise of using the Electronic Health Record system in research to identify participants and capture clean, accurate trial data is more critical than ever before. As medical practices become more electronic and less paper-driven, investigators and staff should be engaged by providing them trial-specific information at the points in their workflow when they can best make use of it. Conversely, requiring them to go outside the workflows and systems they use in routine practice creates complexity and hassle that can deter research participation. A new level of integration between research and health data systems, based on standards (which exist) and open interfaces (which are coming, as part of Meaningful Use), will be necessary to make good on this potential.

As difficult research questions drive increased complexity in trial designs, many feel that the answer is to use technology in simple, scalable ways to engage more participants in research and capture more data. Dr. Russ Altman, a physician and Stanford professor recently told the New York Times, “There’s a growing sense in the field of informatics that we’ll take lots of data in exchange for perfectly controlled data. You can deal with the noise if the signal is strong enough.”4

References

1. Getz, Ken, The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial, 2007, p40.

2. Pignone, Michael, MD, MPH, Challenges to Implementing Patient-Centered Research, Ann Intern Med. 18 September 2012;157(6):450-451

3. Nicholas Anderson, Caleb Bragg, Andrea Hartzler, Kelly Edwards, Participant-centric initiatives: Tools to facilitate engagement in research, Applied & Translational Genomics, Volume 1, 1 December 2012, Pages 25-29, ISSN 2212-0661, 10.1016/j.atg.2012.07.001.

4. http://www.nytimes.com/2013/01/15/health/mining-electronic-records-for-revealing-health-data.html?ref=health?src=dayp&_r=3&

The OpenClinica Platform – Developer Round Table Discussions

OpenClinica is a clinical trial software platform that aims to provide data capture, data management, and operations management functionality to support human subjects-based research. It can be used for traditional clinical trials as well as a wide variety of other types of human subjects-based research.

Our vision for the product is to provide data capture, data management, and operations management functionality out-of-the-box, in an easily configurable, usable, and highly reliable manner. The underlying platform should be interoperable, modular, extensible, and familiar – so users can solve specific problems, in a generalizable way.

This past spring, the development team here at OpenClinica, LLC held a series of round table discussions about how this vision is reflected in the product. Our goals were to learn critical standards and information models needed for our technology to truly reflect this vision, to develop a consistent, shared vocabulary for the problem domain and the OpenClinica technology, and identify the most urgent opportunities to put these lessons into practice in the product and the community. In particular, we spent a lot of the time in these discussions about how OpenClinica’s use of the CDISC Operational Data Model helps enable this vision.

The discussions were invigorating and thought-provoking. We’ve recorded them to share with the greater community of OpenClinica developers, integrators, and others who want to better understand how the technology works, the design philosophy behind it, and where we’re going in the future. The videos are embedded below.

But before getting to the videos, here’s a bit more background on how we think about OpenClinica as a product and a platform.

First, OpenClinica functionality should be ready out-of-the-box, easily configurable and highly usable. Some of the most important features include:

  • Data definition and instrument/form design with no or minimal programming
  • Sophisticated data structures such as repeating items and item groups
  • Support for a wide variety of response types and data types (single select, multiple choice, free text, image)
  • Data management and review capabilities (including discrepancy management and clinical monitoring) with flexible workflows
  • ALCOA-compliant controls and audit history over all data and metadata, including electronic signature capabilities
  • Patient visit calendar design with management of multiple patient encounters and multi-form support
  • Reporting and data extract to a wide variety of formats (tab, SPSS, CDISC ODM)
  • Ability to combine electronic patient reported outcome (ePRO) data with clinically reported data using common form definitions (write once, run anywhere)
  • Deployment via multiple media, mobile or standard web browser

Many of these things have already been implemented, and more are under development.

The core concept around which OpenClinica is organized is the electronic case report form (CRF). In OpenClinica, a CRF is a resource that is essentially a bunch of metadata modeled in CDISC ODM with OpenClinica extensions. It doesn’t (necessarily) have to correspond to a physical or virtual form; it may represent a lab data set or something similar. An OpenClinica Event CRF is that same bunch of metadata populated with actual data about a particular study participant. Thus, it combines the metadata with the corresponding item (field) data, with references to the study subject, event definition, CRF version, and event ordinal that it pertains to. In this conceptual view of the world, CRFs (as well as CRF items, studies, study events, etc.) are resources with core, intrinsic properties and then some other metadata that has to do with how they are presented in a particular representation. Built around these core resources are all the workflow, reporting, API, security, and other mechanisms that allow OpenClinica to actually save you time and increase accuracy in your research.

Second, OpenClinica should be interoperable. The ultimate measure of interoperability is having shared, machine readable study protocol definitions, and robust, real-time, ALCOA-compliant exchange of clinical data and metadata that aligns with user’s business processes. It should be easy to plug in and pull out or mix-and-match different features, such as forms, rules, study definitions, report/export formats, and modules, to transport them across OpenClinica instances or interact with other applications. Establishing well defined methods and approaches for integration into existing health data environments is a key goal of interoperability.

Third, OpenClinica should be modular and extensible. OpenClinica already provides some of the most common data capture and data management components and aims to have a very broad selection of input types, rules, reports, data extracts, and workflows. However OpenClinica developers should also have the freedom to come up with their own twist on a workflow, module, or data review workflow and have it work easily and relatively seamlessly with the rest of OpenClinica. User identification, authentication, and authorization should be highly configurable and support commonly used general purpose technologies for user credentialing and single-sign-on (such as LDAP & OAuth).

The CRF-centric model allows us a great deal of flexibility and extensibility. We can support multiple modalities, with different representation metadata for rendering the same form, or perhaps the shared representation metadata but applied in a different way (i.e. web browser vs. mobile vs. import job). We can address any part of the CRF in an atomic, computable manner. This approach has been successfully applied in the Rule Designer, which takes the ODM study metadata and allows browsing of the study CRFs and items, with the ability to drag and drop those resources to form rule expressions. Features such as rules and report/export formats are represented as XML documents. These documents define how the features behave in standardized ways so that one rule can, say, be easily replaced with another rule without having to modify all the code that makes use of the rule.

Finally, OpenClinica aims to be familiar in the sense of allowing data managers, developers, statisticians to work in a design/configuration/programming environment that they already know. Programmers don’t all have the same experience, and it would be somewhat limiting to force OpenClinica developers to all use the same language (Java) that OpenClinica was written in. We are constantly looking at ways to make it possible (not to mention reliable and easy!) for users and developers to interact with and extend OpenClinica in a programmatic way. This can mean anything from data loading to more meaningful integrations of applications common to the clinical research environment. As proponents of open, standards-based interoperability, our starting point is always to develop interfaces for these interactions based on the most successful, open, and proven methods in the history of technology – namely the protocols that power the World Wide Web (such as HTTP, SSL, XML, OAuth 2.0). They are relatively simple, extensively documented, widely understood, and well-supported out of the box in a large number of programming and IT environments. On top of this foundation, we rely heavily on the wonderful work of CDISC and the CDISC ODM to model and represent the clinical research protocol and clinical data.

Session 1:  from 30-March-2012 (start at the 5 min 20 sec mark)

Session 2:  from 06-April-2012 (start at the 1 min 25 sec mark)

Session 2a:  from 20-April-2012

Session 3:  from 27-April-2012

Session 4:  from 11-May-2012