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Evidence-Based Oncology
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Interest in digital technologies for smoking cessation is high, among consumers, health plans, employer groups, and public health advocates. Such technologies include text messaging programs, Smartphone apps, social networking platforms, e-mail outreach, and offerings that combine several digital modalities.
If a smoker planning to quit joined a text messaging program, for example, she might receive encouragement and tips in words like these: “Over half the smokers in the United States have quit; if they did, you can too!” At any time, that smoker could text back 1- word alerts, such as “moods” or “cravings,” and instantly receive suggestions for coping.1
The smoking cessation market is massive. Although US smoking rates have been declining for decades, 18% of Americans still smoked in 2012, according to the Centers for Disease Control and Prevention (CDC). If no Americans smoked, states the CDC, 1 in 5 of all deaths in the United States in a given year would not occur.2 Worldwide, tobacco use causes more than 5 million deaths annually, more than HIV/AIDS, tuberculosis, and malaria combined. Smoking causes lung cancer, emphysema, bronchitis, and chronic airway obstruction. Smoking-related medical bills and lost productivity annually costs the United States more than $193 billion.3 For these reasons, interest runs high in effective new ways to foster success among smokers hoping to quit.
Help With a Powerful Multifaceted Addiction
Smokers trying to quit often endure cravings, mood issues, and other withdrawal symptoms. They must also redefine themselves as nonsmokers among friends and relatives with whom they once shared comfortable tobacco rituals, according to Richard Brunswick, MD, author of the guideline-inspired book Can’t Quit? Bullsh*t! You Can Stop Smoking. Aware of the many hurdles to successful cessation efforts, researchers have been trying to figure out how to put new digital technologies to work for smoking cessation.
Expert researchers are at work on digital tools for smoking cessation, as are entrepreneurs with no apparent knowledge of clinically proven approaches. Says Justin Sims, CEO of Voxiva, “New digital technologies offer potentially important advantages: 1) They can reach people without geographical limits. 2) They can promote interactivity, thus forging new connections between smokers and expert advisors. 3) They provide instant access to information and support around the clock. 4) They may offer cost savings.”
Some new efforts, especially those relying on text messages, build upon proven clinical guidelines for smoking cessation. Numerous credible studies support these interactive text messaging services.4 The text services that have held up well in the literature generally do not work, at least, not as standalones; rather, they advise smokers to also use other well-established approaches: tools such as medications and quitlines. However, other new tools, especially among applications, do not generally refer to established guidelines or advise the use of proven tools.5
Payers Seem to Be Holding Back From Coverage for Now
Jan Berger, MD, MJ, and editor-in-chief of The American Journal of Pharmacy Benefits,says that payers welcome the new digital tools for their potential to help “get and keep the attention of the consumer in this very noisy world,” modeling successful approaches taken by retailers of consumer goods and services. However, at least 2 major payers do not yet cover these approaches.
A Florida Blue spokesman said in an email response that while clinical “treatments and services are expected to be evidence based,” the organization views text and mobile app programs as “member engagement and education tools” that don’t go through the rigorous studies that medications go through for coverage.
Therefore, Florida Blue members cannot currently expect reimbursement for such digital approaches to smoking cessation. The program manager for Humana’s Chronic Care Strategies, Andrew Renda, MD, MPH, wrote that his company does not currently offer standalone text programs or mobile apps for tobacco cessation. He added that Humana will most likely build these kinds of solutions themselves or partner to create a single comprehensive cessation program, rather than deploy multiple text and mobile app interventions. Humana recently formed a Digital Center of Excellence to explore these kinds of technologies for a range of health services, including tobacco cessation. “Humana will continue to evaluate tobacco cessation technology by evaluating its clinical results and cost-effectiveness,” he stated.
Research Support for Certain Text Messaging Programs
A November 2012 Cochrane Review about digital smoking cessation tools found that when compared with control programs, some text messaging programs greatly improved long-term quit rates. The review considered 5 randomized or quasi-randomized studies of mobile phone—based interventions, involving more than 9000 people. The studies included data on continued abstinence at 6 months. Some studies incorporated interactive elements, including polls, while others provided specific messages in response to a person saying they were experiencing cravings. People in the control groups received messages less frequently or heard informational, supportive information over the phone.4
Among the 5 studies, the larger, more recent ones showed the biggest improvements in quit rates with the use of digital technologies. Overall, the Cochrane investigators estimated that mobile phone programs almost doubled a smoker’s chance of quitting. Only 4% to 5% of smokers in the control group successfully quit for at least 6 months, while 6% to 10% of those in the intervention group did so.4 Berger noted that these higher rates of sustained abstinence engagement reflected great success in quitting across the age spans—with people in their 50s and 60s embracing text messaging as eagerly as younger people.
In contrast, a 2011 study by Lorien Abroms et al found that smoking cessation apps had “low levels of adherence to key guidelines in the US Public Health Service’s 2008 Clinical Guidelines” for smoking cessation. The researchers examined the contents of 47 iPhone cessation apps for sale in the iTunes store during June 2009.5 They found that “Few, if any, apps recommended or linked the user to proven treatments such as pharmacotherapy, counseling or a quitline.” None strongly followed guidelines that advise a smoker be assessed for willingness to quit, have follow-up, and consider the use of medications and/or counseling.
The apps studied acted primarily as “calculators” (32%), tracking benefits like money saved since quitting. Second most frequent were “calendars” (28%) that tracked days until and after the quit date. Third came “rationing apps” (11%) that limited the number of cigarettes, and fourth came hypnosis apps (6%). “Other” apps (24%) included some that provided virtual cigarettes to replace actual ones. Five popular apps accounted for 68% of downloads in the study sample. The investigators noted that the most popular apps were the least likely to hold with the guidelines.5
Nonetheless, the authors stated that smartphone apps have promise to enhance straight text message offerings. They cited the apps’ potential to supplement text messages with games, multimedia such as music videos, e-mail, and social networking sites, and called for future apps to be built around established cessation guidelines.5
Evidence-Based Apps, Though Few, Are Emerging
Recognizing the problems with most of the available smoking cessation apps, researchers at the National Cancer Institute (NCI) set out to develop an app that will reflect the latest smoking cessation evidence and will also be rigorously evaluated. This effort yielded QuitPal, an evidence-based app that includes 10 functional areas such as setting a quit date and financial goals and reminders. Quit-Pal users can track their own daily smoking habits with a calendar. They receive motivational reminders and reports when they reach health milestones. QuitPal also lets users connect with social networks and see personal video messages sent by relatives and friends. On October 12, 2013, QuitPal launched for free in the App Store.6
Encouraged by the evidence supporting the use of text messaging programs, Spanish researchers have also set out to develop an app to help young adults quit, following established guidelines. They published their study protocol in 2013. Plans include recruitment of smokers from 22 primary care centers who will undergo a 6-month guideline-based program that includes the new app. This app will feature a private network for participants and staff as well as entertaining and educational “minigames.” The control group will receive “usual care.” The outcome of interest will be abstinence at 12 months.7
Disparities in smartphone adoption may affect the reach of apps, says Brunswick. He explains, “Smoking is increasingly a class-based issue,” with lower-income people predominating among smokers. The book, endorsed by New York Times personal health columnist Jane Brody, grew out of his work helping hundreds of patients stop smoking. Meanwhile, according to Pew researchers, smartphone ownership is highest among prosperous, highly educated people, those under the age of 45 years, and non-whites. The Pew survey found that by 2013, a majority of American adults (56%) owned a smartphone.
Companies Offer Varied Digital Tools; Human Coaches Still Have a Role
Agile Health, led by CEO Gary Slagle, offers a text messaging program called Kick Buts. Grounded in current smoking cessation guidelines, Kick Buts was created by University of Auckland researchers who worked with consumer marketers. The Lancet published a study strongly supporting the program in 2011.8 “We chose text because it lets us offer a simple, understandable, highly interactive dialogue with our users, so we get into the users’ heads,” says Slagle. Text messaging, he stated, offers a highly standardized, efficient, and low-cost method to reach every mobile phone.
However, Slagle cited problems with apps. Among them: apps are not accessible by all mobile phones, and each app must be engineered to work with multiple operating systems on diverse handsets through multiple carriers. Users of Kick Buts can send back either keywords or spontaneous text messages which prompt targeted replies depending on the need described by the user. Agile’s program is not available directly to consumers, but rather to clients such as health plans, employer groups, managed care organizations, hospital systems, and provider groups.
Voxiva, Inc, offers a smoking cessation program called Text2Quit, which the firm developed in partnership with Lorien Abroms of George Washington University.
It’s a 4-month program planned around a person’s quit date, with tracking for a total of 9 months. “It’s a multimedia program that combines text, Web, e-mail and mobile webs, with text playing a key role,” says CEO Justin Sims. Users find mobile web pages in the texts for more information on specific topics. Alere Inc has licensed Voxiva’s Text2Quit program and integrated it into their telephone- and Web-based smoking cessation services. Alere handles the quitlines for 32 states. “When individuals dial a quitline in many states, they are offered Text2Quit there and then,” says Sims. When a person uses Text2Quit, information they text back enters a file, and is also seen by human coaches. People needing human interaction receive it.
With regard to all the new digital approaches, Berger sounds 1 cautionary note, warning that privacy laws and regulations “remain poorly articulated.” She points to a notable “lack of clarity”
regarding the degree of privacy that must be afforded to personal health information exchanged digitally, such as through text messages.
Where the FDA Stands
In an e-mail response, Jenny Haliski at FDA Office of Media Affairs said that the FDA does not comment on specific products or whether a particular product requires their review. Still, based on content on the FDA website, smoking cessation text programs and apps do not seem to require FDA approval, because they are neither intended for use as accessories to regulated medical devices nor do they transform a mobile platform into a regulated medical device. The FDA encourages app developers to contact the FDA as early as possible with any questions about their mobile app, its level of risk, or whether a premarket application is required.9
Free Digital Tools Available to Consumers
The US government has interactive text messaging tools available free of charge at several websites, including www.smokefree.gov, www.women.smokefree.gov, and www.teen.smokefree.gov. These sites also provide smokers with no-cost apps such as QuitSTART App, which is available for iOS and Android. The sites now provide brief information on Quit-Pal, the app described above, which is now under development at the NCI and scheduled for availability in a few weeks.
Healthcare providers whose patients may be spending money on commercially available apps with no research basis behind them may want to steer those patients to the free apps offered by the government that were created with proven methods in mind.References
1. Centers for Disease Control and Prevention. http://teen.smokefree.gov/. Accessed December 2013.
2. Centers for Disease Control and Prevention. Adult cigarette smoking in the United States: current estimates. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm. Accessed November 7, 2013.
3. Centers for Disease Control and Prevention. Fast facts. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/. Accessed November 7, 2013.
4. Whittaker R, McRobbie H, Bullen C, Borland R, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. The Cochrane Library. http://onlinelibrary.wiley.com/
doi/10.1002/14651858.CD006611.pub3/abstract. Published 2012. Accessed November 6, 2013.
5. Abroms L, Padmanabhan N, Thaweethal L, Phillips T. iPhone apps for smoking cessation: a content analysis. Am J Prev Med. 2011;40(3):279-285.
6. Massett H, Atkinson N, Kraiger A, Grady M, Killam B, Barry B. NCI quitpal: an evidence based app to help people quit smoking. The 2013 Annual Meeting of the American Public Health Association. https://apha.confex.com/apha/141am/webprogram/Paper284220.html. Accessed November 12, 2013.
7. Vadivieso-Lopez E, Flores-Mateo G, Molina-Gomez J-D, et al. Efficacy of a mobile application for smoking cessation in young people: study protocol for a clustered, randomized trial. BMC Public Health. 2013,13:704.
8. Free C, Knight R, Robertson S, et al. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. Lancet. 2011;378(9785):49-55.
9. US Food and Drug Administration. Mobile devices. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/default.htm. Accessed
February 18, 2014.