Participant Recruitment

Teenage Migraine Researcher Uses Mobile Technology to Enhance Study

/ melissatelli / 1 Comment

A new clinical trial for adolescent migraine is underway, and it’s harnessing the power of consumer technology to collect better data and make study participation easier. The BRAiN-M Study, which is examining whether melatonin (a natural supplement) is effective in preventing teenage migraine, uses Fitbit devices and an online “headache diary” to collect data from study participants remotely.

Besides trying to figure out how to prevent teenage migraine, the study’s lead investigator, Dr. Amy Gelfand of UCSF, is looking to make pediatric migraine clinical trials more inclusive and accessible. Continue reading →

“Am I having a stroke?” UCSF Researchers Test New Way of Connecting Physicians With Information Seekers Online

/ Katja Reuter

Five questions with UCSF neurologist and stroke researcher Anthony Kim about his new study on how the Internet can help to connect with people who are searching for information online and potentially reduce incidences of preventable diseases.

Anthony S. Kim, MD, MAS is assistant clinical professor of neurology at the University of California, San Francisco (UCSF) and Medical Director of the UCSF Stroke Center. His research focuses on improving the diagnosis and cost-effective management of stroke and transient ischemic attack (TIA, also called “mini-stroke”).  An estimated 800,000 new strokes occur each year in the U.S., making it the fourth leading cause of death in America. Anthony Kim believes that the Internet opens up new opportunities that will change the way we develop interventions and conduct research to improve health.

Q: Millions of Americans search online for health information each year. Scientists are using this type of data to better understand flu outbreaks, the seasonal variance of kidney stones, the demographic prevalence of stroke, and even to demonstrate the online effectiveness of health awareness campaigns. What did you learn in your latest study?

We were surprised to see that tens of thousands of people were regularly ‘asking’ a search engine about stroke-related symptoms in many cases shortly after the onset of symptoms. In fact, every month, about 100 people were finding our study website by entering the query: “Am I having a stroke?” directly into their Google search box.

One of the challenges with mini-stroke is that most people do not seek urgent medical attention because the symptoms are transitory by definition. So people don’t realize that it is a medical emergency. Even though the symptoms may have resolved, the risk of a subsequent stroke is very high—upwards of 11% within the next 90 days—with most of this risk concentrated in the first hours and days after the mini-stroke. So getting the message out there about urgent medical attention is key.

We started this study because we thought that if people who have had a mini-stroke are looking online for information on their symptoms, then rather than just listing static health information about the disease on a website, maybe we can engage them by making the website more interactive and asking them to enter some of their symptoms online. And we wondered whether we could use this information to assess whether or not it was a true TIA or stroke and then encourage them to get the urgent medical as appropriate.

One third of the people we identified hadn’t had a medical evaluation for mini-stroke yet, which is critical, because it is a medical emergency. Instead of calling a doctor or going to the emergency room, many people were turning to the Internet as the first source for health information.

Q: How did your approach work exactly?

When a person searched on Google for stroke-related keywords, a paid text advertisement “Possible Mini-Stroke/TIA?” appeared with a link to the study website (Image). The ad appeared on the search results page and on related websites with existing content about the topic.

When users clicked on the text ad link, they were directed to the study website. Those visitors who met all of the study’s entry criteria were asked to provide informed consent online. They then reported their demographic information and symptoms based on a risk score developed for use by clinicians.

We were notified in real-time as soon as someone enrolled, and then we arranged for two vascular neurologists to follow up with the patient by telephone.

Q: You tested the approach for about four months. What’s your verdict?

We definitely think that there is a lot of potential here. About 60% of U.S. adults say that their real-life medical decisions have been influenced by information they read online. This changes the way we think about providing medical care and conducting research.

With a modest advertising budget, we were able to attract more than 200 people to our study website each day from all 50 states. About one percent of them (251 out of 25,000) completed the online questionnaire, which allowed us to contact them for follow up. Although this seems low at first, it is comparable to conversion rates in other domains of online advertising.

Also, even though the people who joined the study were a highly selected group, the incremental costs for reaching an additional person were low and the potential for applying a targeted and cost-effective public health intervention in this group would still be very interesting to evaluate in the future.

Before we started, we thought that we might lose people throughout the enrollment process since we confirmed eligibility and asked for consent online, but we didn’t. For the most part, if people were interested in participating, they completed the entire online enrollment process.

During follow up calls, we learned that 38% of enrollees actually had a mini-stroke or stroke. But fully a third of them had not seen a doctor yet. Our approach made it possible to connect with these people fairly efficiently and early on in order to influence their behavior acutely.

Despite these potential advantages, Internet-based public health interventions that target people who are looking for health information online are still underdeveloped and understudied. There’s a lot for us to learn in this space.

Q: What online tools did you use to carry out your project?

We used Google AdWords and Google’s Display Network to target English-speaking adults in the U.S. During the four-month enrollment period, the tool automatically displayed our ads more than 4.5 million times based on criteria such as location, demographics, and search terms.

Ideally, to minimize ongoing costs you would want to build and optimize a website so that it ranks highly among the non-paid (organic) search results. Non-profits can also take advantage of Google Grants, a program that supports in-kind donations of advertising resources to help selected organizations promote their websites on Google.

Q: Do you have any tips for others who want to develop similar projects?

We quickly realized that it helped to work closely with our Institutional Review Board (IRB) given that this is a new and evolving area of research, and to ensure data security and safety mechanisms are in place to protect participants. I definitely recommend that.

It’s also important to be realistic about the goals and metrics of success, and not to over-interpret numbers that seem to reflect low engagement. We saw that most visitors (86%) immediately exited the website within a few seconds of arriving at the home page. This probably reflected people who were looking for something else and clicked away immediately. But the beauty of the Internet is that it is very efficient to reach people across a wide geographic area very quickly. So it is not unexpected that we would also screen visitors who may not be qualified for the study or are not interested in enrolling.

Groups interested in using this approach should think about selection bias, authentication, validation, and the “digital divide”. Even though there is some evidence that disparities in access and adoption of Internet technologies are narrowing in the U.S., depending on the goals and target for your study or intervention the reach of the Internet is not uniform.

But selection bias issues aside, for a public health intervention you may be most interested in other metrics such as the number of people reached per dollar spent, or the burden of disease averted per dollar spent, which the Internet is particularly suited to help optimize.

And, it’s definitely beneficial to bring different subject matter and methods experts to the table. Knowledge of search engine optimization, online accessibility, website and user interface design is not necessarily part of the core expertise of a traditional clinical researcher, but developing these skills and interacting with experts in these areas could become very important for the new cadre of clinical researchers and public health professionals coming down the pipeline.

The original article was published on CTSI at UCSF

Oh that Facebook…Can social media be used for clinical trial recruitment?

/ tracystrickroth / 3 Comments

Social Media is all a buzz right now and everyone from industry giants, mom and pop shops, non-profit community organizations, and even the U.S government are trying to figure out how to use it to their advantage. Some organizations find social media platforms wildly successful, while others can’t quite hit their mark. Just days before Facebook opened on NASDAQ, General Motors Co. decided to stop their advertising on Facebook. Were their ads ineffective, or was GM not correctly seeing the potential power of the social network to build brand loyalty? Should we care?

For many organizations that are looking for quick short-term returns on their investment dollars in the pay-per-click advertising might be disappointed with the results. As the article points out, the value of the social media user is that they become an advocate of the brand. Many are wondering if this is a sign of things to come for the advertising in the Facebook social media world; since it remains to be seen whether this virtual user engagement correlates with a return on investment (ROI). Is it possible to accurately define or measure ROI in social media?

One of the great powers of social media is creating a community and buzz through social connectedness—a virtual word of mouth system. Your social reach is indicative of a classic Wayne’s World 2 scene, “You know how these things start… one guy tells another guy something, then he tells two friends, and they tell two friends, and they tell their friends, and so on”.  If you witness a friend “like” a page or event, they are giving their social network a thumbs-up that they interested in a particular company, product, event, etc.—hey, and you might too. Conceivably your “friends” are more likely to share similar interests…or least be curious enough to check it out.

But how can this be applied to academic and clinical research realm—and should it? By creating a community around a specific disease or research area, you can create a group who has common interests and build loyalty within that group—that is if you can foster trust among your group members as a credible, reliable and useful resource. For instance, if you are a group member or follower of a specific group related to diabetes treatments and you see a fellow member of that group “likes” a diabetes clinical trial, then you might be more inclined to also check out that clinical trial.

The use of social media in clinical trial recruitment is a tricky area that still is trying to find guidance. In recent blog post by Rebar Interactive, brings this issue to light and raises  A Social Media Question IRBs Must Ask about how to appropriately use the power of social media to raise awareness of clinical trial opportunities; all the while, being mindful of patient privacy. This can be counterproductive in a virtual environment and age where absolute privacy may be disintegrating, with each allow access button we click.

The FDA still has not released official regulation on what is/isn’t allowed in recruitment via social media mediums. As a result, social media for clinical trial recruitment is such a gray area which is constantly evolving in its application. Although times are changing, IRBs shy away from encouraging the use of social media in patient recruitment because of the uncertainty in how to regulate it. In the meantime, you don’t want to be left outside the social circle, so here is a helpful resource to help navigate the unregulated waters: Patient Recruitment, Regulatory & IRB Considerations for Social Media

Are you thinking about eTrails? Andy Grove does too…

/ Katja Reuter

In his latest commentary, Andrew “Andy” Grove, former Chief Executive Officer of Intel Corporation and patient advocate at the University of California, San Francisco, envisions an eTrial system similar to Amazon.com.

….Amazon.com is a good example. A large database of customers and products form the kernel of its operation. A customer’s characteristics (like buying history and preferences) are observed and stored. Customers can be grouped and the buying behavior of any individual or group can be compared with corresponding behavior of others. Amazon can also track how a group or an individual responds to an outside action (such as advertising).

We might conceptualize an “e-trial” system along similar lines. Drug safety would continue to be ensured by the U.S. Food and Drug Administration. While safety-focused Phase I trials would continue under their jurisdiction, establishing efficacy would no longer be under their purview. Once safety is proven, patients could access the medicine in question through qualified physicians. Patients’ responses to a drug would be stored in a database, along with their medical histories. Patient identity would be protected by biometric identifiers, and the database would be open to qualified medical researchers as a “commons.” The response of any patient or group of patients to a drug or treatment would be tracked and compared to those of others in the database who were treated in a different manner or not at all. These comparisons would provide insights into the factors that determine real-life efficacy: how individuals or subgroups respond to the drug. This would liberate drugs from the tyranny of the averages that characterize trial information today. The technology would facilitate such comparisons at incredible speeds and could quickly highlight negative results. As the patient population in the database grows and time passes, analysis of the data would also provide the information needed to conduct postmarketing studies and comparative effectiveness research.

Today’s e-commerce systems started small and took nearly 20 years to develop. Adapting this kind of capability to medical information would be a monumental undertaking. Initiating and overseeing it would be an appropriate task for the professional societies. There are encouraging signs, including a call in 2004 by the American Medical Association for public registries of drugs, as well as a proposal for trials that incorporate feed-forward mechanisms. (…) Another proposal would allow patients to choose between medicines whose efficacy has been determined in different manners. There is also a suggestion to use control of pricing to encourage drug developers to move forward in a “progressive” trial design.

The full article: Science 23 September 2011, Vol. 333 no. 6050 p. 1679, DOI: 10.1126/science.1212118

Mayo Clinic Finds Social Media Valuable Tool to Recruit Study Participants for Rare Diseases

/ Katja Reuter

Recently, a researcher told me that he’d be interested in learning more about using social media and networking sites to recruit participants for research studies. Here is an example that the Mayo Clinic shared this week.

Through patient-run websites dedicated to heart conditions and women’s heart health, a team of cardiologists is reaching out to survivors of spontaneous coronary artery dissection, also known as SCAD, a poorly understood heart condition that affects just a few thousand Americans every year.

The study landed 18 participants in less than a week, six more than could participate in this pilot of 12 patients. The remaining volunteers are eligible to participate in a new, larger study based on the initial study’s success.

The new research seeks patients through conventional and social media outlets and aims to build a virtual registry and DNA biobank of up to 400 SCAD survivors and their relatives. The database will help physicians conduct more detailed analyses of treatment strategies and factors that affect prognosis and better understand the possible genetic basis of some SCAD cases.

“Patient leadership in this is huge,” says study co-author Lee Aase, director of Mayo Clinic’s Center for Social Media. “Designing research protocols to study rare diseases and then recruiting enough patients to participate is extremely difficult for busy physicians, but patients with rare diseases are highly motivated to see research happen.”

Keep reading

Pfizer Announces First U.S. “Virtual” Clinical Trial Allowing Patients to Participate Regardless Of Geography

/ Katja Reuter / 2 Comments

The randomized pilot study, called REMOTE, uses mobile phone and web-based technology (e.g. electronic diaries, online testing tools, a dedicated website) to collect the necessary data for the trial without clinic visits.

Investigators plan to enroll about 600 patients from about 10 states across the United States. Pfizer will compare results to previous clinical trials and assess whether virtual trials can save time and obtain the same results as traditional ones, or perhaps even more reliable data through increased patient compliance, lower withdrawal rates and real-time data collection.

Although not all clinical trials could be done remotely, if this pilot proves successful, it might be an interesting model for our emerging UCSF-CTSI Participant Recruitment Service.

Watch the animated video that outlines the trial’s basics to patients

More information:

How Can We Make Biomedical Studies More Inclusive?

/ Katja Reuter / 2 Comments

Even in 2011, persons with disabilities (more than 47 million Americans)
are still “ profoundly underrepresented in mainstream health research”. In their recent article, the researchers Ann Williams and Shirley Moore propose a “Universal Design of Research” (UDR), which allows “routine inclusion of persons with disabilities in studies, without the need for adaptation or specialized design.”

They offer a few guidelines and ideas to support researchers in designing materials in accessible formats. Some good food for thought as the new UCSF Participant Recruitment Service (PRS) takes shape. Here is what they propose:

… provide multisensory, flexible options for recruitment, research instruments (such as questionnaires), measurements, and responses from participants, with reasonable accommodations that invite and facilitate participation by persons with disabilities; and when you do not know how to include someone with a disability, consult someone who does (the potential research participant, another person with that disability who is knowledgeable about the range of methods people use for living fully with it, or a professional who works with persons who have that disability). 

Practical guidelines for implementing the Universal Design of Research include:

… (i) plan multiple options for people to learn about, respond to, and arrive at opportunities to participate in research; (ii) provide multiple means to communicate the information in research instruments and instructions for participants; and (iii) provide multiple means of responding to research instruments and self-management interventions.

I wonder what our PRS team thinks about these ideas. And, do we know of other successful approaches, web-based technologies or great examples we could share?  Ann Williams and Shirley Moore are looking for ideas to develop comprehensive guidelines.