Conversation about Dubious Stem Cell Clinical Trials Marketed on NIH Website

A couple of days ago, I spoke with reporter Bradley J. Fikes about an interesting, new study “ClinicalTrials.gov, stem cells and ‘pay-to-participate’ clinical studies” (by Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics). The paper describes how businesses use the public website ClinicalTrials.gov to recruit participants for unapproved stem cell interventions. This is an interesting use-case that highlights the challenges of the Internet, clinical trial recruitment and research ethics.

ClinicalTrials.gov serves as a registry and results database of publicly and privately supported clinical studies conducted around the world. The site was launched in 2000 by the National Institutes of Health (NIH) and the Department of Health and Human Services, through its National Library of Medicine. The information in the registry was intended for a wide audience, including individuals with serious or life-threatening diseases or conditions, members of the public, health care providers, and researchers. One of the main barriers to successful clinical trials and clinical study participation is the lack of awareness that trials are taking place. The problem is that the success and usefulness of ClinicalTrials.gov ultimately depends on whether investigators and sponsors submit complete, timely, accurate, and informative data about their studies. Turner describes the problem as a lack of quality control and oversight. He provides food for thought as to what steps could be taken to prevent wrongful use of the site and concludes that the database needs better screening tools, for example to identify trials with approval from the Food and Drug Administration (where required) and Institutional Review Board (IRB).

In light of limited resources, I don’t think that it is realistic to ask the NIH to step up its controls for accuracy, validity, and relevance checks. However, by restricting Clinical trials.gov to trials for which clinical research teams provide FDA and IRB approval — as Turner suggests –, the registry could help to accelerate access for patients to well-regulated and adequately funded clinical trials, and the website could exercise its influence to discourage promotion of unproven stem cell interventions outside of approved clinical trials. A technical solution that leverages natural language processing and other forms of machine learning to detect lack of approval could be interesting.

Read the full article by Bradley Fikes published in The San Diego Union-Tribune

 

What We’ve Learned About Automating the Promotion of Clinical Trials On Social Media (Part 1)

For a while, I have been thinking about ways to help research teams to better promote their clinical trials. Social media provide a great opportunity to do so. But doing it right requires time and resources. Together with a team of collaborators, we’ve asked the question whether we could automate part of the process. The result is Trial Promoter, a free, Web-based tool that automates the generation and distribution of user-friendly social media messages about research. We’re excited to share the tool with you today. Check out http://trialpromoter.org. The software code is free and accessible to technical and non-technical audiences so you can run your own experiments. We would love to hear your suggestions for future extensions to the tool.

TrialPromoter.org website

If you like to know more about our first experiment using Trial Promoter, take a look at this peer-reviewed paper in the Journal of Medical Internet Research.

We still have a lot to learn and many experiments to run. Stay tuned for more, for example, a Trial Promoter study on how well automated clinical trial messages help to recruit potential study participants through social media, and a health promotion study about the effectiveness of anti-tobacco messages – distributed on social medial and analyzed by Trial Promoter.

 

Change Is Needed: “To Be A Scholar Is, Often, To Be Irrelevant”

Don’t miss the excellent post “Professors, We Need You” by Nicholas Kristof (@NickKristof) in the New York Times. Kristof explores various reasons and examples as to why scholars are not more influential in today’s society.

I believe that academic research institutions could be key to addressing this issue if they provided the infrastructure, training, and incentives in support of scholars. We don’t do that yet in a concerted effort that makes a difference to scholars.

Here are a few statements that stood out for me in the article:

(…) it’s not just that America has marginalized some of its sharpest minds. They have also marginalized themselves.

All the disciplines have become more and more specialized and more and more quantitative, making them less and less accessible to the general public. – Anne-Marie Slaughter, former dean of the Woodrow Wilson School at Princeton, now the president of the New America Foundation.

Professors today have a growing number of tools available to educate the public, from online courses to blogs to social media. Yet academics have been slow to cast pearls through Twitter and Facebook. Likewise, it was TED Talks by nonscholars that made lectures fun to watch…

Many academics frown on public pontificating as a frivolous distraction from real research. If the sine qua non for academic success is peer-reviewed publications, then academics who ‘waste their time’ writing for the masses will be penalized. – Will McCants, Middle East specialist at the Brookings Institution.

A related problem is that academics seeking tenure must encode their insights into turgid prose. As a double protection against public consumption, this gobbledygook is then sometimes hidden in obscure journals — or published by university presses whose reputations for soporifics keep readers at a distance.

Read the full text

The World Wide Web Turns 25: It Has Been A Positive Force For Society And People

Source: Pew Research Center surveys, 1995-2014.

Susannah Fox and Lee Rainie, who spearhead the Pew Research Internet Project, remind us of how the internet and web have become an integral part of Americans’ social lives. In their latest post, they share new data on the “explosive adoption of the internet and its wide-ranging impacts” on peoples’ lives.

Among the new results:

ADOPTION

• 87% of American adults now use the internet, young adults ages 18-29 (97%), and those with college degrees (97%).
• 68% of adults connect to the internet with mobile devices like smartphones or tablet computers.

IMPACT

• 90% of internet users say the internet has been a good thing for them personally and only 6% say it has been a bad thing, while 3% volunteer that it has been some of both.
• 76% of internet users say the internet has been a good thing for society, while 15% say it has been a bad thing and 8% say it has been equally good and bad.

ONLINE SOCIAL CLIMATE

• 70% of internet users say they had been treated kindly or generously by others online. That compares with 25% who say they have been treated unkindly or been attacked.
• 56% of internet users say they have seen an online group come together to help a person or a community solve a problem. That compares with 25% who say they have left an online group because the interaction became too heated or members were unpleasant to one another.

See the full report

Kudos to Sir Tim Berners-Lee who turned “the internet into a mass-adopted technology (…) easily used by hundreds of millions around the world.”

Related report: Who’s Not Online and Why

Lessons from Twitter Prompt Scientists to Rethink Public Health Outreach

“In a collection of tweets there might be a story to tell about how people describe their health experiences, which might be hard to capture in any other way.”

Click on image to view the presentation slides (PDF): Using Twitter for Academic Research

With users worldwide currently generating more than 340 million Twitter messages (tweets) daily, and making most of them public, Twitter has become a vast database of public health information.

Researchers and clinicians are just beginning to explore this abundance of community insight. They’ve been able to track and forecast the spread of Influenza and learn more about peoples’ mood variations, their perspectives on cervical and breast cancer screening as well as about the misunderstanding and misuse of antibiotics.

At UC, San Francisco, a group of researchers conducted a study of Twitter messages to better understand how people experience pain, in particular pain from toothaches, which accounts for about 40% of an estimated $80 billion in pain-related health care costs every year.

In the following interview, Barbara Gerbert, PhD, professor emeritus and lead investigator of the study, and Natalie Heaivilin, DDS, 2013 graduate from the UCSF School of Dentistry, share what they learned and how Twitter may help health professionals to prevent dental disease in the future.

Q: Why do you think people are using the Internet, and in particular social media, to share information about their health?  And what does that mean for health professionals?

Barbara Gerbert

Barbara Gerbert, PhD, professor emeritus, UCSF School of Medicine

With the Internet people can investigate their own health online, from seeking information on how to achieve a better night’s sleep, to looking up images of lesions to determine if the one on their skin might be malignant, to checking for symptoms of a stroke. The Internet is always available and easy to access. An immediate health concern might be relieved without the hassles of making appointments, missing work or school due to pain or to seek health care, or dealing with insurance.

Additionally, Twitter and other social media provide an outlet for people to relate to others, including sharing details about their own health. That’s powerful. Of course not everyone shares such personal information, but there’s enough chatter for health care professionals to consider becoming part of the conversation. If what we read online influences what we do, then well-crafted public health messages could have a big impact.

 Natalie Heaivilin

Natalie Heaivilin, DDS, 2013 graduate, UCSF School of Dentistry

And even prominent figures, who presumably have access to regular health care, will seek health information from Twitter. For example, broadcast journalist Anderson Cooper   recently asked his 1.5 million followers on Twitter, “How do you know if you have bronchitis? Anyone know?” — Many of his followers recommended, some sarcastically, that he see a doctor; some provided personal stories about their own bouts with bronchitis, and others gave management advice based on their own experiences. Some health care professionals saw this as an opportunity to weigh in with science-based answers.

We don’t know why Cooper used Twitter to post his question and we don’t know if he acted on any advice tweeted his way, but the example shows that even a person with the means and accessibility to see a health care professional sometimes chooses to ask millions of strangers for immediate advice before seeking advice from a professional.

Q:  What makes Twitter a useful research, and even clinical, tool?

Barbara Gerbert

A colleague of mine, Jennifer Gibbs, DDS, PhD, once suggested to me that there might be a story to tell about how people describe their health experiences on Twitter, and notably, that the story found on Twitter might be one that would be difficult to capture in any other way.

Most traditional health surveillance data are captured by standardized surveys and interviews with people, long after the fact. These surveys rely on participants’ memories and are cued by categories, and multiple-choice options, predetermined by researchers.

With tweets, it’s possible for us to learn about pain-related experiences in real-time. Without prompting, people are talking about the severity and location of their pain and how upset they are about curtailing their activities.

Natalie Heaivilin

From a student’s perspective, Twitter research is interesting because it provides a window into thousands of personal health experiences that offer an invaluable learning opportunity. And as a future clinician, especially the negative impact expressed in tweets about dental pain has given me the impetus to learn all I can about how to comfort patients and alleviate dental pain.

Q: Were there any surprises or difficulties in conducting this study?

Natalie Heaivilin

Initially, we thought that tweets would be easy to interpret because they are limited to 140 characters. We were also a bit concerned that we wouldn’t find anything interesting. As it turned out, we were wrong in both assumptions. In fact, tweets often contained juicy content despite the character limitation, and we spent countless hours discovering some recurring themes and debating the meaning behind them. As a result, we designed a rigorous coding system to categorize the tweets.

A few of our findings showed that 44% of the actions taken by Twitter users indicated they sought professional help, 17% missed work or school, and 14% involved actively asking the Twitter community for advice on how to deal with dental pain. These data can be useful given the high cost of health care associated with alleviating dental pain. 

Q: Do you see any limitations to this type of research?

Barbara Gerbert

I think the most important limitation is that data from Twitter and other social media exclude people who do not use Twitter and who are likely to be the most vulnerable. However, there is a trend towards increased use of social media sites and the range of the age of users will likely expand over the next decade.

Q: What’s the potential for this type of research to improve health?

Barbara Gerbert

Click on image to view the presentation slides (PDF): Using Twitter for Academic Research

Never before has it been so easy for health care professionals to reach out to so many people and disseminate health information through a conversation.

The biggest question for us is how we can leverage Twitter and the Internet to learn what public health questions people have, and then how to disseminate science-based answers. This way we can counteract misinformation and misunderstandings about health conditions and treatment options, thereby augmenting current efforts used to prevent dental disease.

Natalie Heaivilin

That’s right. Although tweets can be helpful to people, we also need to think about the potential harm from inaccurate information and how to address this risk. For example, a UC San Francisco study from 2012 found that only 14% of Twitter-delivered smoking cessation programs provided information consistent with the U.S. Tobacco Treatment Clinical Practice Guidelines. Additionally, researchers at Columbia University in 2010 found misuse and misunderstanding of antibiotics in 6% of antibiotic-related tweets, and a 2012 study conducted in Australia showed that 8% of concussion-related tweets contained health management information that was inaccurate.

Barbara Gerbert

There is clearly a need for people to easily access information about specific health concerns online. Health care professionals need to find ways to participate in social media to answer this need. Imagine if accurate health care messages were readily available for urgent conditions such as the symptoms of stroke, which then resulted in patients seeking prompt care. Imagine that the public could receive important information about the appropriate use of antibiotics, or that patients experiencing pain would know when to seek care and how to distinguish between the need for emergency assistance or routine care. The implications could be amazing.

This Q&A is part of  a perspectives series from CTSI at UCSF.

Further reading

2013

• “5 Mins of u is better than dealing with cancer 4 a lifetime”: An exploratory qualitative analysis of cervical and breast cancer screening dialogue on Twitter (Lyles et al. 2013)

2012

• Twitter=quitter? An analysis of Twitter quit smoking social networks works (Prochaska et al., 2012)
• ‘What’s happening?’ A content analysis of concussion-related traffic on Twitter (Sullivan et al., 2012)
• Epilepsy in the Twitter era: a need to re-tweet the way we think about seizures (McNeil et al., 2012)

2011

• Public health surveillance of dental pain via Twitter (Heaivilin et al., 2011)
• The Use of Twitter to track levels of disease activity and public concern in the U.S. during the Influenza an H1N1 pandemic (Signorini et al., 2011)
• Diurnal and seasonal mood vary with work, sleep, and day length across diverse cultures (Golder & Macy, 2011)
• Using social media for research and public health surveillance (Eke PI., 2011)

2010

• Dissemination of health information through social networks: Twitter and antibiotics (Scanfeld et al., 2010)

Social Media Users Are More Willing To Support A Good Cause

This is an interesting new report that research organisations should consider. The authors looked at social networking sites and how they support social good.

…social media is being used as a force for good that leads people to action, says Denise Keyes, executive director, Georgetown University Center for Social Impact Communication. The study demonstrates that these tools can go beyond just building awareness and creating connections to compel meaningful, measurable action.

• 55% of digitally active, cause-savvy American adults were likely to do far more than simply “like” a cause.
• 68% of the respondents donate money, 52% donate personal items/food, 43% attend/participate in an event related to the particular cause, 53% of them volunteer.
• The top source of information about a cause is from social networking sites itself.

Keep reading: Shilpa Shree’s report summary

New PLOS ONE Altmetrics Collection Is Focusing On Non-Traditional Research Impact Measures

Heartening to read that PLOS ONE, in collaboration with altmetrics.org, has launched the PLOS ONE Altmetrics Collection, “a body of research that aims to provide a forum for the dissemination of innovative research on these metrics.”

Altmetrics is the study and use of non-traditional scholarly impact measures that are based on activity in web-based environments.

Altmetrics research seeks to build and track a rich, holistic image of impact on diverse audiences (general public as well as scholars) and monitors diverse types of engagement with scholarship, including viewership, discussion, bookmarking, and recommendation, along with traditional citation.

This allows researchers, funders, institutions and policy makers to create a higher resolution picture of the reach and impact of academic research and track its effects on diverse audiences.

The PLOS ONE Altmetrics Collection aims to continually cover a range of subjects including statistical analysis of altmetrics data sources; metric validation, and identification of biases in measurements; validation of models of scientific discovery or recommendation based on altmetrics; qualitative research describing the scholarly use of online tools and environments; empirically-supported theory guiding altmetrics use; and other research relating to scholarly impact in online tools and environments.

“Am I Having A Stroke?” Connecting Physicians With Online Information Seekers To Prevent Disease

Five questions with UCSF neurologist and stroke researcher Anthony Kim about his latest study that explores how the Internet can potentially help to reach people who are searching for information online and reduce the number of preventable disease incidences.

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 posted on the website of the Clinical and Translational Science Institute (CTSI) at UCSF.

Predicting Disease Prevalence In Real Time Using Twitter

Adam Sadilek from Fount.in and his co-developer from the University of Rochester created a tool that tracks diseases based on the location of Twitter messages and keywords (e.g., ‘I feel sick’, ‘I have a sore throat’ or ‘My body aches’).

According to the developers, previous methods such as Google Flu Trends and government data entail time lags from days to years.

Here is an example that looks at the health of New Yorkers with the web application at Fount.in.

You see a heatmap visualization of the prevalence of flu in New York City, as observed through public Twitter data. The more red an area is, the more people are afflicted by flu at that location.

Fount.in also tracks the movement of Twitter users, the interactions of sampled cliques of friends, and the application can help to understand the public sentiment around a topic, product, or brand.

Very interesting! There is a lot for us to learn from in this realm…

More People Look At Research If It Is Promoted Via Social Media, A Case Study

Melissa Terras from London’s Global University asked two questions: What would happen to her research work if she distributed it via social media? And, would it affect how much her research was read, known, discussed, distributed?

Here’s what she did to test it:

1. She used the institutional Open Access Repository – “Discovery“ to make the paper downloads available.
2. She wrote a blog post about each research project.
3. She talked about her work and papers on Twitter.

More people looked at those papers that she had promoted via social media. They had 10+times the number of downloads compared to the papers only added to the institutional repository.

“Upon blogging and tweeting, within 24 hours, there were, on average, 70 downloads of my papers. Now, this might not be internet meme status, but that’s a huge leap in interest.”

Melissa is not the only person producing research in her department. However, she is the only one actively promoting her work using social media. In her latest article “The impact of social media on the dissemination of research: results of an experiment” published in the Journal of Digital Humanities she summarizes the results:

What became clear to me very quickly was the correlation between talking about my research online and the spike in downloads of my papers from our institutional repository. (…) Academics need to work on their digital presence to aid in the dissemination of their research, to both their subject peers and the wider community.

Related posts:

• What happens when you tweet an Open Access Paper? – Discusses the correlation between talking about an individual paper online, and seeing its downloads increase.
• Is blogging and tweeting about research papers worth it? – Discusses the overall effect of this process on all my papers: highlighting what I think the benefits of Open Access are.
• When was the last time you asked how your published research was doing? – Talks about the link between publishers and Open Access, and how little we know about how much our research is accessed once it is published.