Using E-Technologies in Clinical Trials Rosa 2015

CONCLI-01232; No of Pages 14
Contemporary Clinical Trials xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
Contemporary Clinical Trials
journal homepage: www.elsevier.com/locate/conclintrial
Using e-technologies in clinical trials

Carmen Rosa a,⁎, Aimee N.C. Campbell b,c, Gloria M. Miele d, Meg Brunner e, Erin L. Winstanley f
a
National Institutes of Health, National Institute on Drug Abuse, Bethesda, MD, USA
b
New York State Psychiatric Institute, Department of Psychiatry, Columbia University Medical Center, New York, NY, USA
c
Mount Sinai St. Luke's Hospital Department of Psychiatry and Behavioral Health, New York, NY, USA
d
Columbia University College of Physicians and Surgeons, Department of Psychiatry, New York, NY, USA
e
Alcohol and Drug Abuse Institute, University of Washington, Seattle, WA, USA
f
The James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA
a r t i c l e i n f o a b s t r a c t
Article history: Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile
Received 12 April 2015 devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations
Received in revised form 26 June 2015 are relying more on electronic platforms and most have incorporated such technology into their daily lives. This
Accepted 5 July 2015
paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the
Available online xxxx
last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use
Keywords:
of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are
Clinical trials provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials
E-technology research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of
Social media e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and imple-
Apps ment clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing
Smartphones costs; however, researchers should be cautious when adopting these tools given the many challenges in using
Internet new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies
can be overcome with careful planning, useful partnerships, and forethought. The role of web- and
smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the pub-
lic alike make them tools that cannot be ignored.
Published by Elsevier Inc.
1. Introduction Additional reasons for the sluggish adoption of e-technology include

the limited empirical evidence on whether e-technologies improve or
Historically, clinical trial activities, including recruitment, retention, enhance the design of clinical trials and the paucity of regulatory guid-
delivery of interventions, and data collection, have been conducted ance and policies, particularly when FDA-approval is required.
using conventional “face-to-face” approaches. For example, newspaper Study teams are, however, incorporating more e-technology into
or radio advertisements are used to recruit participants, mail or tele- their study designs, perhaps most importantly because mobile technol-
phone calls are used to conduct follow-up assessments, interventions ogies and Internet-based communication are becoming the new norm
are delivered in person, and data are collected using paper-and-pencil for patients. The culture of communication has changed as potential re-
instruments. Clinical trials have been slow to incorporate e-technology search participants integrate the Internet, smartphones, and social
(i.e., digital and electronic technology that utilizes mobile devices or media into all aspects of their lives. According to recent surveys con-
the Internet) into the design and execution of studies [6,110] and are ducted by the Pew Research Center and summarized in Table 1, approx-
challenged to keep pace with fast-moving developments in technology. imately 90% of all adults in the United States use the Internet and own a
For example, in the time it takes to design, implement, and publish find- cell phone, and 74% are on a social network site, such as Facebook, Twit-
ings from a research study (approximately 6 years), the world went ter, or Instagram [43]. While younger people are more likely to be using
from playing interactive video games (Wii) to using voice-activated e-technology, older adults are increasingly adopting it into their lives as
personal assistants (Siri) [110]. Also, during this timeframe the Apple well. For example, the percentage of adults 65 years and older going on-
“App” store added approximately 1 million apps for the iPhone. line has increased from 14% in 2000 to 59% in 2013; 77% reported having
a cell phone in 2013 [107]. Most people agree that the growth of the In-
ternet, smartphones, and tablet devices could have widespread and
⁎ Corresponding author at: Carmen Rosa, 6001 Executive Blvd, Bethesda, MD, USA.
E-mail addresses: [email protected] (C. Rosa), [email protected]
beneficial health effects.
(A.N.C. Campbell), [email protected] (G.M. Miele), [email protected] (M. Brunner), The purpose of this paper is to provide a general overview of the use
[email protected] (E.L. Winstanley). of e-technologies in clinical trials research, specifically within the last
http://dx.doi.org/10.1016/j.cct.2015.07.007
1551-7144/Published by Elsevier Inc.
Please cite this article as: C. Rosa, et al., Using e-technologies in clinical trials, Contemp Clin Trials (2015), http://dx.doi.org/10.1016/
j.cct.2015.07.007
2 C. Rosa et al. / Contemporary Clinical Trials xxx (2015) xxx–xxx
Table 1 approaches have been increasingly used to supplement traditional

Technology utilization by age of user. recruitment strategies, and such approaches appear to be effective [55,
Source: Pew Research Center, surveys conducted 2012–2014 http://www.pewresearch.org/.
60,81,140]. For example, Yuan et al. [140] used various web-based and
Internet use Social media use Own cell//smartphone social media strategies (Facebook, Twitter, LinkedIn, Craigslist, and
Teens (12–17) 95% 81% 88%//73% Tumblr) to recruit individuals living with HIV, a challenging population
Adults—all 87% 74% 90%//58% to recruit in clinical trials, in part due to the stigma associated with
Adults b30 97% 89% 98%//83% HIV. The study successfully recruited, primarily through Facebook,
Adults N65 59% 56% 77%//18%
1404 adults who had diverse socio-demographic characteristics and
represented a broad range of ages. Another study compared participant
recruitment for a smoking cessation program using Facebook advertise-
decade. The objectives are to (1) present a summary of how e- ments vs. traditional strategies (flyers, newspaper advertisements) [55].
technology is currently being integrated into clinical trial design, execu- The investigators found that approximately half (51.9%, n = 138) of the
tion and dissemination; (2) illustrate how e-technology-based inter- total sample (n = 266) were recruited via Facebook, with the only sta-
ventions are being used in the treatment of alcohol and drug abuse, as tistically significant difference between the two recruitment groups
an example; (3) present the current status of regulatory guidelines for being age; subjects recruited using Facebook were approximately
e-technology use, challenges and limitations; (4) summarize the advan- seven years younger compared to subjects recruited using print
tages and limitations of e-technologies in clinical trials research; and media. No between-group differences were observed for education, eth-
(5) highlight future directions for the use of e-technologies in clinical nicity, income, gender, or smoking characteristics.
research. Patients' preferences for e-technologies may influence the extent to
which these tools can be effective strategies. Internet-based personal
2. Integrating e-technologies into clinical trial design, registry tools are used for screening and recruitment (“23andMe”,
implementation, and dissemination “PatientsLikeMe”) [26,64]. Also numerous apps are being developed
by sponsors and academic institutions to help patients find relevant
Some clinical trial researchers have been early adopters of e- clinical trials, such as the National Library of Medicine Pharmaceutical
technology, using the Internet to recruit study participants [48] and cre- Product Development's Clinical Trials app (http://www.clinicaltrials.
ating computer- or Internet-based interventions [31,63]. Researchers com/industry/clinicaltrials_mobile.htm). Additional research is needed
have been using electronic tools for the last two decades to develop pro- to elucidate how social media and other e-technologies are effective
tocols, communicate with study personnel, randomize participants, col- for recruitment based on specific content, specific disease types, when
lect data, and analyze results [86,103,115]. Early on, communication and how to target specific demographic subgroups, and other partici-
with participants was limited to directing individuals to a website for in- pant variables.
formation about the study and providing specific contact information
for recruitment and retention purposes [118]. Later, websites were
used to distribute and collect data from online questionnaires for eligi- 2.2. Engagement and retention
bility and consent purposes. More recently, clinical trials have started
using social media (e.g., Facebook, Twitter), text messaging, and blogs Another area that commonly challenges researchers is the retention
to recruit and enhance retention of participants [61] and to meet regu- of participants in studies, especially during long follow-up periods after
latory requirements of community consultation [57,124], as well as mo- the conclusion of active intervention. Prior to the advancement of mo-
bile technologies (tablets, smartphones) to collect data (surveys, patient bile and Internet technologies, maintaining contact with participants
reported outcomes) and assess or monitor study compliance [134]. In- over months or years of research took extensive staff effort and often re-
vestigators are also starting to integrate other innovative data collection sulted in less than ideal retention rates. The ability to maintain contact
approaches, such as using apps [17], GPS (global positioning system) with subjects using mobile phones (e.g., calls, voicemail, texting), social
[47], and wearable devices [68]. media (e.g., Facebook), and websites has altered traditional retention
Electronic systems have been used for clinical trial implementation strategies. The results of recent studies, however, again suggest that par-
procedures, such as randomization and data entry, for the last two de- ticipant preference for e-technologies may influence how successful
cades [106,115]. However, overall technological advances since then different engagement and retention strategies might be. For example,
have been astronomical [6]. On March 9, 2015, Apple introduced its Rooke et al. [111] compared two studies that used telephone vs.
ResearchKit software, designed for medical and health research. As of Internet-based delivery of a treatment for cannabis use disorder
March 30, 2015, several iPhone apps have been developed for use in and found that the telephone intervention had a significantly lower
large-scale studies on asthma, breast cancer, cardiovascular disease, di- dropout rate compared with the web-based study (38% vs. 46% respec-
abetes, and Parkinson's Disease (http://www.apple.com/pr/library/ tively, p b 0.01). Age may be a factor in participant preference for reten-
2015/03/09Apple-Introduces-ResearchKit-Giving-Medical- tion strategies and modality of intervention deployment, although other
Researchers-the-Tools-to-Revolutionize-Medical-Studies.html). factors such as type and length of intervention and burden of disease
Also, Google, Inc.'s has developed a tool intended as a medical device cannot be ignored.
that could be used for clinical trials in the near future (http:// A study of African American breast cancer survivors' preferences for
hitconsultant.net/2015/06/24/google-developing-wearable-for-clinical- physical activity interventions found that there were no age differences
trial-research/). Below is an overview of how researchers are using tech- in whether the physical activity intervention was administered via
nology to assist with various aspects of clinical trials, such as recruitment, email/Internet, an in-person group, or the telephone [104]. Duncan
retention, data collection, and dissemination of results. et al. [44] studied a physical activity/healthy eating intervention using
IT- and print-based delivery modes and reported no significant differ-
2.1. Recruitment ences in outcomes among middle-aged males. Two additional studies
with younger participants also found preferences for e-technologies.
Recruitment of participants into clinical trials is crucial to ensure In a study of youth with Type 2 diabetes, Nguyen et al. [97] found that
the generalizability and validity of the study; however this is often monetary incentives and technological approaches (mobile phones
one of the more challenging aspects of clinical research. Many clinical and websites) were the most effective strategies to engage and retain
trials fail to meet initial participant recruitment goals as outlined in participants. In contrast, patients with rheumatoid arthritis, with a
the study protocol [9,19,41]. In the last few years, Internet-based mean age of 61 years, preferred to complete research surveys via regular
j.cct.2015.07.007
C. Rosa et al. / Contemporary Clinical Trials xxx (2015) xxx–xxx 3
mail, followed by telephone, with the Internet identified as their least systems with comprehensive integrated EHRs, like the Department of
preferred method [58]. Veterans Affairs (VA), are starting to use this approach to recruit, screen,
randomize, obtain consent, and collect data. A recent study by the VA
2.3. Data collection [40,52] compared two standard clinical practices of insulin manage-
ment for in-patients with diabetes on length of hospital stay. This
Most of the published research on data collection using e- “learning healthcare system” approach allows investigators to embed
technologies is about using Electronic Data Capture (EDC) data entry a clinical trial directly into clinical care settings to allow for pragmatic
systems [4] and Internet-based strategies for administering surveys studies with immediate real-world impact.
and questionnaires for behavioral or health promotion studies [3,59,
96,119,125]. A novel approach for data collection that is facilitated by
2.4.3. Health apps
e-technologies is the ecological momentary assessment (EMA), which
The development of new e-technology and mobile device
is a method designed to collect data in real time, recently extended to
applications is fast-paced, and consumers have expectations regarding
also deliver interventions for individuals with substance use disorders
usability and efficiency (see Fig. 1 for a typical app development time-
as well [47,114,121]. More recently, investigators are collecting biologi-
line). For example, as of July 2014, more than 3 million apps were avail-
cal data through wearable devices that can sync with smartphone apps.
able for download into mobile devices (http://www.statista.com/
For example, Hossain et al. [68] developed a model to detect drug
statistics/276623/number-of-apps-available-in-leading-app-stores/).
(cocaine) use events from physiological measurements using a
The Apple “App” store has 1.3 million apps, the majority of which were
wearable electrocardiogram (ECG) sensor and accelerometers. Over
added in the last 6 years (http://www.statista.com/statistics/263795/
11,000 h of data from 13 participants was collected and used to develop
number-of-available-apps-in-the-apple-app-store/), and the number
a model using physiological measures to track an individual's health sta-
continues to grow, with approximately 60,000 new apps launched per
tus. This demonstrates the way new technologies can facilitate the com-
month (https://www.adjust.com/assets/downloads/AppleAppStore_
piling and analyzing of substantial quantities of data that would have
Report2014.pdf). Of these, there are an estimated 100,000 health and fit-
been nearly impossible to collect and manage several years ago.
ness apps available, the fastest growing category. It is estimated that by
In 2014, Orri and colleagues reported on the REMOTE trial [100]. In
2018, 1.7 billion mobile device users will have downloaded a health
this study, the investigators used e-technologies to recruit (social
app (http://mhealtheconomics.com/mhealth-developer-economics-
media, Craigslist, health websites, online community forums) and man-
report/). Health-related apps include reminders, diagnostic “helpers,”
age (Internet-based consents and surveys) participants with Overactive
devices connected to hospital instruments, and tools for medication ad-
Bladder (OAB). Laboratory test results used for consenting, screening,
herence and chronic care management [16]. Although these health
and determining eligibility were also conducted online, with participant
apps have the potential to improve patient outcomes, very few enjoy
identification verified using a confidential third-party vendor. Data col-
any empirical support of their efficacy for the stated benefits.
lection occurred in real time via study-provided smartphones pre-
The Apple software, ResearchKit (see Fig. 2), is the most recent
loaded with study apps, with study medications mailed to participants.
example of a national (soon to be international) tool developed to assist
While this study was not able to reach its recruitment goal, it neverthe-
the research community in the conduct of research studies (http://
less demonstrates the feasibility of integrating e-technology into clinical
www.apple.com/pr/library/2015/03/09Apple-Introduces-ResearchKit-
trials while still achieving FDA regulatory approval.
Giving-Medical-Researchers-the-Tools-to-Revolutionize-Medical-
Resources are now available to help investigators use e-technologies
Studies.html). In one of the first tests of recruitment effectiveness, the
to collect data. For example, Coons et al. [35] offered recommendations
ResearchKit software helped to find 11,000 participants for a cardiovas-
for obtaining Patient-Reported Outcomes (PROs) data using the partic-
cular study in 24 h, a task which would have taken a year using conven-
ipants' own mobile devices, via an app or web-based portal.
tional methods in 50 medical centers [13]. However, critics question the
validity of the data acquired using this approach. They point out that po-
2.4. Using electronic platforms for recruitment, retention and data
tential issues, such as patient misrepresentation (both intentional and
collection
accidental) and demographic differences may yield misleading data
[37]. In the near future, the Google X Wristband will also be in the mar-
2.4.1. Registries
ket seeking regulatory approval as a device (http://hitconsultant.net/
Researchers are conducting registry-based randomized trials, using
2015/06/24/google-developing-wearable-for-clinical-trial-research/).
existing registries to screen, recruit, randomize, and collect data. For ex-
ample, Frobert et al. [56] and Lagerqvist et al. [79] reported a trial with
patients with myocardial infarction (TASTE study) who were recruited 2.5. Dissemination of study results
using the Internet-based Swedish Coronary Angiography and Angio-
plasty Registry. The investigators used the registry to recruit, randomize A critical component of any research study is the presentation and
and collect outcome data and reported no participants were lost to dissemination of findings. Traditionally, this has been the role of peer-
follow-up. Furthermore, Lauer & D'Agostino [80] commented that this reviewed journals or other print publications, typically accessible only
approach could lower costs of clinical trials as well as improve trial to subscribers, and conference presentations and posters, often seen
efficiency. only by fellow conference attendees. Considering that the impact of a
study's results is largely dependent on how effectively those results
2.4.2. Electronic health records are disseminated, using faster, cheaper, and more efficient means for
Another tool for recruitment and data collection increasingly be- dissemination, such as Twitter, Facebook, and blogs (regularly updated,
coming essential to clinical trials is electronic health records (EHRs) often interactive web sites that feature essay-style posts providing in-
[50]. With the recent emphasis on comparative effectiveness research formation or opinion), are promising tools [1]. These platforms can be
(CER) and precision medicine, studies are using or planning to used to disseminate study results not just to scientists and practitioners,
use EHR to facilitate recruitment and consent and collect clinical data but also to the individuals who participated in the study and to the gen-
[5,34,53,54,71,85]. EHRs can provide an automated electronic approach eral public. Not only have journal publishers begun using blogs and
to (1) identify or flag potential subjects at the point of clinical care [2,15, social media to disseminate their current contents, but research institu-
113,122]; (2) differentiate between clinical and research procedures/ tions and individual researchers are increasingly promoting their work
costs; (3) extract clinical data for import into study databases [135,69, via Twitter and other social media outlets as well. A growing number
116]; and (4) collect study clinical outcomes directly [8,101,126]. Health of platforms are available for researchers to more widely disseminate
j.cct.2015.07.007
SOURCE: http://www.accella.net/iphone-app-development-timeline/
Fig. 1. Timeline for typical “app” development.

Source: http://www.accella.net/iphone-app-development-timeline/.
findings and share with colleagues, including PubPeer, ResearchGate, use Twitter to further expand dissemination of their content [120], sug-
and Academia.edu, among others. gesting that multiple routes for sharing information are beneficial in
A recent study examined the impact of some of these newer expanding its overall reach.
Internet-based dissemination tools [1]. Sixteen PLoS ONE articles from In addition to simply disseminating study results, the Internet is in-
the clinical pain sciences were released on two randomly selected creasingly being used for post-print peer-review, as more scientists use
dates, with only the first release accompanied by blogging and simulta- social media to offer critical commentary on a study's methods or appli-
neous postings on Facebook, Twitter, LinkedIn, and ResearchBlogging.org. cation to clinical practice. Twitter is a frequent choice for post-print de-
Investigators found that the date accompanied by social media increased bates [33], and a newer platform called “PubPeer” (http://pubpeer.com)
both viewing and downloads of the article by a daily average of 12 views has also been developed with a focus specifically on this role. Users of
of the HTML page of the article and 3 downloads of the article's PDF. An- PubPeer must be published authors themselves, and, once granted an
other study reported on an analysis of the impact of social media posts account, they are able to post under their own names or anonymously
about scholarly articles, examining 4208 tweets that cited 286 Journal of to discuss specific papers, often launching debates over a study's quality
Medical Internet Research papers [49]. Frequently tweeted articles were or outcomes. The ability to remain anonymous has caused some strife in
11 times more likely to be highly cited than less-tweeted articles. Top- the science community, with one researcher even suing PubPeer
cited articles could be predicted from top-tweeted articles with 93% spec- requesting to expose the names of people who had criticized his work
ificity and 75% sensitivity [49]. on the site (Sarkar v. John and/or Jane Does, Wayne County Circuit
Blogging has also played a significant role in the dissemination Court; the verdict was in favor of PubPeer). Nevertheless, this site ap-
of new research, allowing both for the speedy translation of potentially pears to be growing in use among researchers globally and it provides
complex results into formats suitable for a wider range of audiences and a useful forum that could advance the design and quality of clinical
as a way to stimulate discussion. Aggregators like ResearchBlogging.org trials.
have helped increase access to findings both in the scientific community Numerous professional groups have begun to launch Twitter-based
and to members of the public, by collecting and organizing the wide journal clubs using a hashtag to tag tweets relevant to the club
range of blog posts on the Internet citing peer-reviewed research and (e.g., #cpjc for clinical psychology, #ebnjc for evidence-based nursing,
providing a single point of access to those posts [51]. Many of the and #twitjc for microbiology). Selected articles are shared with the jour-
bloggers whose posts are represented on ResearchBlogging.org also nal club members, typically via a blog, and then during a specified time,
Source: http://www.apple.com/pr/library/2015/03/09Apple-Introduces-ResearchKit-Giving-Medical-
Researchers-the-Tools-to-Revolutionize-Medical-Studies.html (used with permission from Apple)
Fig. 2. Apple ResearchKit: image of the iPhone 6 ResearchKit app.

Source: http://www.apple.com/pr/library/2015/03/09Apple-Introduces-ResearchKit-Giving-Medical-Researchers-the-Tools-
to-Revolutionize-Medical-Studies.html (used with permission from Apple).
j.cct.2015.07.007
members log into Twitter to discuss the article together online. A search promotion interventions. It is beyond the scope of this article to com-
of the hashtag in Twitter will retrieve the complete exchange at any prehensively review how technology has been used to deliver interven-
time, and the journal clubs are generally open to anyone interested tions in clinical trials, so this paper will focus on technology-based
from around the globe, facilitating international conversations and sci- interventions for substance use disorders (SUD) as an illustrative
ence dissemination. Twitter use is also growing among conference at- example.
tendees, allowing for real-time sharing of the latest study results prior
to their publication in journals [33,138]. Conference organizers typically
2.6.1. SUD background
prepare a hashtag for the event in advance (e.g., #APA2014 for the
E-technologies, such as computer-assisted interventions or mobile
American Psychological Association's 2014 annual convention) and dis-
phone applications, for SUDs have made exciting gains over the last de-
tribute it to attendees, encouraging a virtual discussion forum accessible
cade. Of particular importance, as the behavioral health treatment land-
to the world at large.
scape has changed with the passing and implementation of the Patient
Another expanding platform in the sciences is ResearchGate, a social
Protection and Affordable Care Act (ACA) [141] and the Mental Health
networking site specifically for researchers and scientists. Unlike
Parity and Addiction Equity Act [142], is the renewed attention on the
PubPeer, researchers on ResearchGate (http://researchgate.net) create
availability of SUD treatment options and the integration of behavioral
profiles using their real names and affiliations, filling in detailed infor-
health into non-specialty settings, such as primary care. Integration of
mation about their field of specialty, and posting links to or full-text
care aims to improve the accessibility and acceptability of behavioral
copies of their published papers. Discussion forums allow for conversa-
health care, while managing the high costs associated with mental
tion among participants. In a survey of 3000 scientists and engineers
health and addiction problems. Thus, the role of e-technologies in this
published in 2014 [133], more than half the participants reported
changing landscape has the potential to make a powerful impact, espe-
using Research Gate “regularly,” beating out every other social media
cially given that only about 10% of those who need addiction treatment
and research-profiling site except for Google Scholar. Academia.edu is
services actually receive it [90].
similar to ResearchGate, though in 2013, it was sued by Elsevier for
Although the need for e-technologies is growing, the research base is
allowing users to share post-print copies of articles from copyrighted
also still accumulating and, as noted earlier, there is a gap between ad-
Elsevier titles, highlighting some of the complexities generated by
vances in technology and the ability to conduct rigorous research trials
new e-technology platforms.
testing different e-technology interventions. The need for high quality,
A major caveat to the promise of dissemination through e-
methodologically rigorous research trials to expand the evidence base
technologies is the informal nature of these various platforms and the
for e-technology tools is essential, especially with the influx of tools
challenges for end users in seeking and verifying reliable information.
available on the Internet for which there is little or no efficacy research
Many sites may not be monitored for accuracy or quality. Misinforma-
to support their use. There is also a need to better understand ways
tion is rampant on the Internet, and it can be particularly challenging
to scale up research-based e-technologies that have a science base.
to figure out what information is legitimate when users rely on anony-
For example, greater collaboration between relevant stakeholders
mous accounts for sharing. The onus of determining what information is
(e.g., researchers, clinicians and service providers, governmental insti-
valid and what is not is primarily on the end user. With so much infor-
tutions, businesses) is needed to develop models for treatment develop-
mation available at a user's fingertips, however, the consumer's ability
ment that take into account how to make an intervention available via
to make quick, accurate determinations about the quality of information
the Internet in a sustainable way should it be shown to be efficacious.
presented becomes crucial in successful dissemination of science-
This may take the form of innovative research/business partnerships
supported information. Researchers and institutions can take some sim-
that will move e-technology tools into the real world and better keep
ple steps to assist the user in making these determinations, however. A
up with the pace of technological advances.
few suggestions include:
There is a vast array of tools already under study that cross the care
• Publish in open access peer-reviewed journals whenever possible— continuum, including e-technologies to prevent, assess, treat, and sup-
this makes research readily available to the public, via sites the user port populations affected by SUD. Although certainly electronic inter-
can quickly determine are legitimate. vention tools for assessment of substance abuse (e.g., ASI-MV, [20];
• Include your name, credentials, and institution in your profile when CHAT-Comprehensive Health Assessment Tool for Teens, [84] and pri-
using social media accounts. mary prevention of SUD are available (e.g., Web-based Substance Use
• Facilitate confirmation of sources by including a link in your tweet or Prevention for Adolescent Girls, [117]), this overview will focus on sec-
post to your original paper or another reliable source of information. ondary prevention, treatment, and recovery management tools for SUD.
• Moderate and facilitate online discussions of your work; don't let mis-
interpretations or misinformation about your research stand uncor- 2.6.2. SUD prevention
rected. E-technologies for secondary and tertiary prevention have primarily
• Create an ORCID iD (orcid.org) and include this in your user informa- targeted alcohol use among at-risk college-age populations. The major-
tion so that users can quickly and reliably identify you and your other ity of these studies have examined feasibility questions and been
works. ORCID iDs are permanent identifiers for researchers that help comprised of convenience samples (i.e., offered to large groups of
protect your unique scholarly identity and unite all your work under individuals who can opt in or out). Recent research reviews and studies
a single profile. of e-technologies for these types of prevention interventions demon-
strate that brief interventions for alcohol are superior to waitlist or
no treatment controls and roughly equivalent to alternative interven-
2.6. Technology as a platform for interventions tions for problem drinking [10,27,45,82,137]. There is evidence of
diminishing returns for electronic-based brief interventions over time,
The integration of technologies into clinical interventions varies sig- and positive shorter term, but not-longer term, outcomes [74,77,78]. Di-
nificantly across disciplines and by disease or health condition. There rect comparisons with face-to-face interventions have been completed
are many published reports of Internet and mobile device interventions less frequently, but have tended to favor face-to-face interventions on
(both prevention and treatment) for a great variety of conditions, outcome measures of quantity and consequences, especially among in-
including obesity/weight loss, cancer, diabetes, depression, stroke, ar- dividuals with higher problem severity. However, several individual
thritis and so on. Most of these interventions do not focus on pharmaco- studies found e-technology prevention interventions to be as effective
therapies, but rather behavioral, disease management, and/or health as brief therapies for problem drinking in college students [7,21].
j.cct.2015.07.007
A number of secondary or tertiary prevention interventions have stand-alone alternatives to specialty addiction care [72]. Some have
been developed with the goal of raising awareness of hazardous also integrated other co-occurring disorders into the intervention in-
substance use and encouraging change in use through a combination cluding depression [72] and posttraumatic stress disorder [14].
of assessment, normative feedback, and increasing motivation for mod- Several e-technology treatment interventions have also been tested
ifying use or seeking more intensive addiction treatment services with specific subgroups of individuals with SUDs. For example,
(e.g., [91,92]). In this way, science-based interventions that have been HealthCall [66] is a brief intervention (Motivational Interviewing plus
traditionally delivered by a clinical provider can now be deployed via interactive voice response [IVR] technology to assist with daily self-
a computer and/or through the Internet. Obvious advantages of an elec- monitoring) developed specifically to reduce problem alcohol use
tronic version of a brief assessment/feedback intervention include the among HIV-infected primary care patients. HealthCall was designed to
ability to deliver it to vastly more individuals (increasing accessibility) enhance motivational interviewing without additional burden to busy
and to individuals who are ambivalent about seeking treatment but primary care staff. It was later updated to replace IVR with smartphone
may be open to exploring a potential problem by completing an inter- technology [65] with pilot results showing enhanced patient engage-
vention online (addressing acceptability of treatment options and stig- ment. As mentioned earlier, Ondersma and colleagues also designed a
ma related to treatment attendance). Brief interventions to increase brief computer-assisted intervention targeting polysubstance use
awareness of problem substance use and enhance motivation to among postpartum women [98,99].
seek additional services include: “E-Check-up to Go” or “E-Chug” Several e-technologies have recently been developed to target prob-
(e.g., [42,70,136]); Drinker's Check-up [67]; and Check Your Drinking lem cannabis use specifically. Tossman et al. [132] tested “Quit the Shit”
[39]. Ondersma et al. [98,99] have completed two randomized (QTS), a German-language, 50-day, web-based counseling program
controlled trials of the Motivational Enhancement System, a brief 20- based on the tenets of solution-focused therapy and the principles of
minute computer-assisted intervention targeting motivation to reduce self-regulation and self-control. The intervention is comprised of online
drug use, designed specifically for postpartum women. questionnaires, an entry and exit “chat” with a psychotherapist, and a
weekly diary of cannabis use combined with feedback. Reflecting
2.6.3. SUD treatment and recovery interventions a common problem with web-based interventions, this study had
Fewer e-technology treatments have been tested among illicit sub- significant attrition and only 16% of enrolled participants took part in
stance users [10,30,36,108], although the research base is growing. Sys- the 3-month post-test. Those in QTS who were retained in treatment
tematic and meta-analytic reviews of e-technology treatments for vs. wait-list did demonstrate greater reductions in cannabis use, al-
mental health and SUDs report promising findings, but methodological though additional research is necessary to determine efficacy. Rooke
weaknesses have tempered enthusiasm [10,12,38,75,105,108,123]. Im- et al. [112] developed and tested Reduce Your Use, a 6-week, web-
portant questions also remain about the best methods of integrating based, self-guided educational program for cannabis use disorder
e-technologies into usual substance use disorder care. Litvin, Abrantes, focused on cognitive, motivational, and behavioral principles. In a
and Brown [83] report on the successful adaptation of empirically sup- randomized controlled trial, two-thirds of participants completed the
ported face-to-face treatments (e.g., cognitive behavioral therapy and 6-week post-intervention assessments, with participants in Reduce
community reinforcement approach) in computer-assisted modalities, your Use completing an average of 3.5 of 6 modules. At the end of the
but suggest that these types of interventions do not necessarily take 6-week intervention period, Reduce Your Use participants reported
full advantage of what technology has to offer (an exception to this fewer days and quantity of cannabis use. Although the intervention
may be emerging in technologies related to GPS and individualized, por- group reported fewer cannabis dependence symptoms at the 3-month
table hand-held applications). The current crop of electronic alcohol and assessment as well, there were no longer differences in quantity.
drug treatment tools can provide valuable assistance for moderate These interventions suggest the promise of e-technologies for cannabis
levels of problem use (e.g., for those that do not require detoxification use reduction but also demonstrate common challenges including attri-
or addiction medications) and for those who, for various reasons, may tion and shorter-term outcomes.
not seek face-to-face treatment [83]. Another expanding area of research is focused on telehealth technol-
For treatment seekers, e-technologies can be integrated into care in ogies, the delivery of addiction and other mental health care remotely
the following ways: (1) as an adjunct to enhance or improve standard using video conferencing and including assessment, treatment, counsel-
addiction treatment (i.e., in addition to or as a supplement once a pa- ing, medication-management, education, monitoring, and collaboration
tient leaves treatment—continuing care); (2) as a clinical extender [131]. This is particularly promising for rural populations or individuals
(i.e., as a substitution for a portion of standard treatment); or (3) as a who live in areas with limited services or where the distance to a treat-
replacement for standard care (although most of these studies have in- ment program is a significant time and transportation barrier. Impor-
cluded some brief face-to-face clinician time). Substitution and replace- tantly, reimbursement for telehealth services is becoming much more
ment models may be particularly beneficial because they have the common, expanding the potential of this tool [131]. The National Fron-
capacity to reduce the amount of time providers spend with clients, tier and Rural Addiction Technology Transfer Center (see: http://
freeing them to see additional clients or focus additional time on pa- attcnetwork.org/national-focus-areas/?rc=frontierrural), funded by
tients who might have more complicated needs. Adjunct models may the Substance Abuse and Mental Health Services Administration
enhance usual care and produce better outcomes. The following section (SAMHSA), has been leading the national effort to promote awareness
focuses on two key targets of e-technology research for SUD treatment: and implementation of telehealth technologies to deliver addiction
treatment and recovery management. treatment, prepare providers to adopt and implement telehealth tech-
The number of available products with a science base has increased nologies, and support telehealth competencies and policy recommen-
substantially in the last five years. There are now several efficacious in- dations (e.g., national license portability).
terventions for illicit drug use, including CBT4CBT [28,29], Therapeutic E-technologies are also being developed that focus on post-
Education System ([11,22–24,87,88]), SHADE [72], and Reduce Your treatment recovery. These recovery management tools include the
Use [112]. Most of the e-technology treatment interventions are smartphone delivered Addiction-Comprehensive Health Enhancement
Internet- or app-versions of manualized, face-to-face, evidence-based Support System (A-CHESS; [62]) and the web-based My Ongoing Re-
treatments. For example, cognitive behavioral therapy techniques are covery Experience (MORE; [76]). A-CHESS provides monitoring and in-
available in several web-supported treatments (e.g., CBT4CBT and Ther- formation, as well as opportunities for real-time communication
apeutic Education System). These types of interventions have been ex- and other support services to assist patients leaving residential treat-
amined as adjuncts to standard substance abuse treatment [28,29], as ment. In an efficacy study of A-CHESS [62], patients with alcohol use
replacement for a portion of standard care [22–24,32,87,88]), and as disorder (N = 349) received treatment-as-usual or A-CHESS. Those in
j.cct.2015.07.007
the A-CHESS group reported fewer risky drinking days. A-CHESS is now one study [109] is currently doing this in primary care health centers.
being tested in combination with the Therapeutic Education System Additionally, the types of infrastructure and resource support needed
(the integrated intervention is known as SEVA) among individuals when introducing addiction treatment into non-specialty settings is
with SUDs in three federally qualified health centers (estimated com- also of importance. Thus, even if a stand-alone technology-based inter-
pletion in 2017; ClinicalTrials.gov #NCT01963234) to explore imple- vention is provided to primary care patients, primary care clinicians
mentation strategies and other organizational and patient outcomes must be trained to screen patients, introduce the treatment and monitor
[109]. progress [90]. Finally, reimbursement strategies and other policy-
The web-based MORE intervention is based on motivational related changes to addiction treatment are needed to incentivize the
interviewing, cognitive behavioral therapy, and 12-step facilitation use of e-technologies in diverse clinical settings. Reimbursement and
and was tested with 1124 patients leaving residential treatment. At billing shifts, from fee-for-service to achievement of specific perfor-
one year post discharge, 84% of patients had completed one MORE mod- mance outcomes, may help in this regard.
ule, but only 5% had completed all 7. However, those that were more ad-
herent reported longer periods of continuous abstinence, and the 3. Regulatory and ethical considerations
likelihood of abstinence increased as patients completed more modules
(controlling for motivation, self-efficacy, and baseline severity). These Despite the ubiquity of social media and technology use in the gen-
types of e-technologies offer a way to extend treatment and provide ad- eral population and increasing efforts to integrate technology into re-
ditional support to patients often at high-risk of relapse. search practices, little regulatory guidance exists on using technology
Text-messaging-based interventions for addiction treatment have in clinical research [93,127,129]. In 2012, the Office for Human Research
also received some attention. Muench et al. [94] recently published a Protections (OHRP) held a series of meetings and presentations on the
study examining acceptability, messaging preferences, and behavior topic promising forthcoming guidance, but it has yet to be published.
change strategies for an interactive mobile text messaging continuing OHRP has one training webinar for institutional review boards (IRBs)
care intervention. Findings demonstrated a preference for benefit- on this subject, providing some light regarding privacy/confidentiality
driven over consequence-driven messages, although perceived benefits and implications for internet research in human subject protections
of behavior change predicted message preference. The authors call for (http://videocast.nih.gov/summary.asp?Live=13932&bhcp=1).
additional intervention development based on user preference and fur-
ther study of the effect of different types of messages, some of which are 3.1. IRB review
underway (e.g., [95]).
Several resources are now available that provide information and In the absence of explicit guidance, IRBs have had to determine their
summarize findings of e-technology research for substance use disor- own policies that are in line with 45 CFR 46 and FDA Title 21 regulations.
ders. SAMHSA and the National Institute on Drug Abuse (NIDA) collab- In the past five years, IRBs have progressed from offering virtually no
orated on a web resource for technology-assisted care for substance use guidance on the issue to recognizing the increasing number of research
disorders (http://www.SUDTECH.org) that includes training and imple- protocols being submitted that integrate e-technology and hence the
mentation materials. SAMHSA is also in the process of publishing a need to develop policies and standards. The two primary issues re-
Treatment Improvement Protocol (TIP) for Technology and Behavioral searchers must consider when using technology in clinical research
Health slated to be published in 2015. Finally, the Center for Technology are privacy and informed consent [18].
and Behavioral Health (http://www.c4tbh.org/), partially funded by The more technology is used, the more vulnerable individuals are to
NIDA and located at Dartmouth College, brings together interdisciplin- having their privacy violated. While people are worried about personal
ary teams to harness existing and emerging technologies to develop autonomy and privacy, they also voluntarily disclose a great deal of per-
and deliver evidence-based interventions for substance use and co- sonal information on social networks and in day-to-day activities con-
occurring disorders. Center staff edited a recently published book [87], ducted online, like banking and shopping. Using apps, wearable
Behavioral Health Care and Technology Using Science-based Innovations devices, or any program that automatically “pushes” data to another on-
to Transform Practice, which includes a chapter on technology-based in- line source makes people increasingly vulnerable to data leaks and
terventions for substance use problems [22]. threats of fraud. From a legal standpoint, online privacy policies consid-
er whether or not a person has a “reasonable expectation of privacy.”
2.6.4. Implementation of e-technology interventions for SUD Federal and state courts have determined that people who publicly
Of particular importance, and in great need of empirical data, is the post to Facebook do not a have a reasonable expectation of privacy for
study of implementation strategies for moving e-technologies into ad- that information [93]. The very nature of social media sites is to share;
diction care services. Although e-technologies remove a number of po- once a person knowingly makes a public post to social media, that per-
tential barriers to implementation (e.g., limited staff training, increased son loses any expectation of privacy. Researchers, then, can use that in-
accessibility, and potential for patient tailoring), there are still outstand- formation like other public records without IRB review. Similarly,
ing questions about how best to link these interventions with popula- observational research that collects information from public YouTube
tions who could benefit. Research has demonstrated that, in general, videos or Twitter feeds would have little expectation of privacy.
patients rate the acceptability of e-technologies quite highly. Additional Interactive research activities on social media may require
research should focus on which types of patients, and at what point in contacting a potential participant directly, which would require IRB ap-
their recovery, e-technologies might be most helpful. For example, in proval. There are differing opinions about the appropriateness of “fol-
a recent effectiveness trial of the Therapeutic Education System, a sec- lowing” or “friending” potential participants on social media. One
ondary outcome analysis revealed that women with active substance study of social networks found that social media is a loose social net-
use at study entry rated the intervention lower in acceptability com- work, so “friending” someone does not imply a relationship that over-
pared to women who were abstinent at study entry and to men, regard- steps the bounds of researcher and participant [46]. Others might
less of their substance use status at study entry ([22–24]). question the appropriateness of this approach and consider any
As described earlier, there are numerous ways to marry e- research-related outreach to be an interaction that requires IRB review.
technologies with traditional clinical care (e.g., as an adjunct to treat-
ment, as a replacement for a component of treatment, or as a stand- 3.2. Consent
alone intervention). Testing the ways in which clinical providers inter-
act with or integrate components of e-technologies into their treatment Most online surveys or interviews require consent. The online con-
curriculums to promote patient outcomes should be explored. At least sent process typically comprises reading through a series of questions
j.cct.2015.07.007
and indicating comprehension of procedures, risks and benefits, and 3.4. Best practices for human subjects protection
voluntary participation by checking a box. Researchers and IRBs may
be more comfortable with online consent prior to online surveys or in- As guidance continues to be developed, some best practices are com-
terviews, which can be seen as ensuring greater confidentiality than ing to light in the field. Two of the coauthors (Campbell & Miele) of this
face-to-face interviews or paper surveys, since names and location paper were investigators in a randomized, multisite clinical trial study-
data (phone number, address) may not be collected. ing the effectiveness of a web-based psychosocial intervention for SUDs.
One drawback of online consent is the lack of face-to-face contact Given that e-technology was being used as an intervention, the re-
during the consent process. As a result, the interviewer may not be searchers proposed using electronic communication tools (email,
able to ensure participant understanding of the consent form in the texting, and Facebook) for participant location and follow-up (see
same way they can in a face-to-face interaction. This is not unique to on- [22–25] for methods and primary outcomes, respectively). At the time
line consent, however, as it is also true for mailed surveys. In an argu- of the study (2010–2012), few IRBs had guidance about using social
ment in favor of obtaining online consent, Moreno et al. [93] suggest media and electronic communication in research, but use of social
that people who are accustomed to online interactions might be even media and e-technology was becoming more common among partici-
more likely to reach out to an investigator with questions than those pants. Three of 10 sites used electronic communication in this capacity.
in a face-to-face situation. While this has not been addressed systemat- Research teams developed their own procedures and recommendations
ically, it is possible that greater use of e-technology can improve interac- for review. The most important component of each policy was protec-
tions between researchers and participants. tion of human subjects, especially confidentiality. Based on these expe-
Another complication in the consent process is obtaining parental riences and emerging developments in the field, the authors provide
consent for minors. Online, there is no way to know if a minor is provid- some recommendations for using e-technology in clinical trials while
ing consent on behalf of a parent without the parent's knowledge. Sim- protecting participants (see Fig. 3).
ilarly, it is difficult to verify a person's identity online, where anonymity
is often valued and “trolls” may pose as someone else as a way to in-
criminate or discredit that person. 4. Advantages, challenges, and limitations of e-technology in
In March 2015, the FDA issued a draft guidance on “Use of Electronic clinical trials
Informed Consent in Clinical Investigations,” providing recommendations
for clinical investigators, sponsors, and IRBs on the use of electronic media 4.1. Advantages
and informed consent for FDA-regulated clinical investigations of medical
products. The plan is for OHRP to consider the language and for the two Technology is dramatically changing the ways in which clinical trials
agencies to issue a joint FDA-OHRP final document (http://www.fda. are conducted, from study development through dissemination. Thanks
gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ to advances in communication, intervention delivery, and knowledge
Guidances/UCM436811.pdf). transfer, information and outreach are no longer confined to traditional
silos, resulting in enormous potential for broadening scope and applica-
tion. Potential advantages include:
3.3. Other recent guidance
3.3.1. Health apps 4.1.1. Improving efficiency

Covered entities using medical health apps that intend to process or Technology has the potential to impact the following areas to im-
store protected health information (PHI) are subject to the federal prove the efficiency of clinical trials: (1) Communication: Technology
Health Insurance Portability Accountability Act (HIPAA) and the Heath tools improve communications not just with study staff, but with pa-
Information Technology for Economic and Clinical Health (HITECH) tients and communities. This could expedite protocol develoment, reg-
Act. Under these regulations, security breaches require notification ulatory approvals, and training, thus shortening the time from study
and could result in penalties up to $50,000 per incident. There are also concept to first randomization. (2) Recruitment: Using apps, registries,
concerns that hackers could use these apps to obtain PHI and/or steal social media, and EHR could increase the number of participants
the devices to commit crimes. However, Terry [130] argue that HIPAA that can be contacted, screened, and ultimately enrolled into a trial
rules may not apply to health data collected thru modern electronic (e.g., Apple's ResearchKit application). (3) Retention: Mobile phones/
technology. devices, apps, and social media offer the opportunity to connect
Additionally, the FDA has provided guidance on using elec- with participants more often and potentially improve their engagement
tronic source data (i.e., EHR) in clinical trials. (http://www.fda. and retention into clinical trials. (4) Delivery of intervention: E-
gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ technology-based interventions can reduce resource requirements re-
Guidances/UCM328691.pdf). lated to staff training and ongoing supervision, maintain consistent de-
livery of an intervention, increase accessibility across space and time,
and potentially increase staff time to focus on more complex treatment
3.3.2. Device regulations delivery. (5) Data collection: Use of registries and EHRs can improve
In February 2015, the Food and Drug Administration (FDA) issued targeted recruitment and make standard clinical data available in real-
an updated “Mobile Medical Applications Guidance” (http://www.fda. time for study outcome purposes. Smartphones, apps, and wearable
gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ body sensors can allow for large quantities of data to be collected auto-
GuidanceDocuments/UCM263366.pdf) which indicates the agency's matically and not require face-to-face interactions with researchers.
intent to regulate certain medical apps as medical devices. Is recom-
mended that investigators contact the FDA for questions on how this
guidance applies to clinical research. 4.1.2. Lowering cost
Using technologies for recruitment, delivery of intervention, and
data collection has the potential to enroll large numbers of patients in
3.3.3. Drug labeling a relative shorter time, or reduce the time it takes to reach target recruit-
FDA guidance provides recommendations for interactive post- ment. It also may reduce the need for personnel/staff hours to perform
marketing promotional materials (http://www.fda.gov/downloads/ these activities (delivery of intervention, data entry). Taken together,
Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ this means that e-technologies have the potential to allow clinical trials
UCM381352.pdf). to be conducted faster and with less cost per patient.
j.cct.2015.07.007
Fig. 3. Best practices for human subject research protections.
4.1.3. Fostering research and development remove some of the barriers to intervention implementation, such as
There has been an explosion of health-care data available in the past extensive staff training and fidelity monitoring.
decade [128]. This offers a great opportunity not only for researchers but
other stakeholders to make big advances in health care. This “Big Data” 4.2. Challenges and limitations
is becoming more available and accessible and can be used for research
& development of pharmaceuticals, safety surveillance, marketing, and Despite the ubiquity of technology and the numerous areas of prom-
ultimately better patient outcomes. ise, there are a variety of limitations and challenges in need of careful
consideration and additional research. These include:
4.1.4. Involving stakeholders 4.2.1. Privacy/confidentiality issues

Technology could potentially serve as an effective and efficient E-technologies bring with them a tangled knot of privacy and confi-
platform for all individuals involved in the research enterprise, dentiality issues, frequently made more confusing by complex and
from participants in research trials to the practitioners who will ulti- under- or even un-developed regulatory guidelines from IRBs, funding
mately implement evidence-based interventions in clinical practice or agencies, and other stakeholder organizations. The potential violation
to obtain community consultation for certain types of planned research. of ethical standards and patient privacy and confidentiality, as well as
Evidence-based e-technology treatments can be incorporated into the professional codes of conduct, are major contributors to institutional
treatment process along a spectrum of involvement, from an adjunct hesitancy to allow and approve the use of new technologies in clinical
or “clinical extender,” to a replacement for a component of treatment, research. Further, e-technologies, especially mobile apps, may have un-
or even as a stand-alone intervention. known or difficult to anticipate privacy and/or confidentiality problems
that are further complicated by the risk of “hacking” or other cyber at-
tacks. Researchers need to know the current federal, state, and local reg-
4.1.5. Facilitate implementation and dissemination ulations and be cognizant that these are likely to evolve and expand
The technology-based facilitation of information dissemination over time.
(e.g., to public websites in lay language) helps to expand both the re-
cruitment of participants as well as the reach of scientific discoveries 4.2.2. Keeping up with technology
to those who may not otherwise have access to it, including the very What was revolutionary when a trial started may be utterly obsolete
people research interventions aim to assist: the patients themselves. It by the time it is finished, leaving results, even when positive, of limited
encourages more participation and collaboration in the scientific com- applicability. Trying to keep up with the changes during a study may re-
munity, cuts back on duplication of efforts, and spurs new thinking sult in unpredictable costs, both in staff time and budgets, as well as an
and ideas. Technology may provide the flexibility that could help imbalance in the type of technology used by participants, as some race
j.cct.2015.07.007
to acquire the latest devices and others lag behind. It will be important those physicians still need to learn how to screen patients, introduce the
to construct research questions that focus not just on a particular way of treatment, and monitor progress, all using a medium they may be unfa-
using technology, but on more general effectiveness questions that will miliar with. Implementation science studies will be useful for develop-
continue to be meaningful with future technological advancements ing best practices on how to integrate e-technologies into healthcare
(e.g., components of Internet interventions that are effective but settings. In addition, research teams should include others, such as engi-
which could be deployed on different platforms). Baker et al. [6] provide neering, data science, and business experts who can assist with study
some strategies for addressing efficiency and quality of electronic development and implementation, as well as assist with minimizing
technologies specifically for health research, given the speed with some of the challenges and limitations of the technology tools.
which electronic-based interventions are created, updated, or become
obsolete.
4.2.5. Big data/accuracy of data
Given the sheer quantity of data available, one of the biggest chal-
4.2.3. Including a non-representative sample
lenges is identify which data to collect, how to capture it, and how to an-
A criticism of using technology in research is that participants
alyze it [102]. Once researchers figure this out, the other challenge is
recruited from social media and online sites are not a representative
data quality and consistency, given the current absence of standard
sample for most studies and that this may introduce bias. While
methodologies, such as unique identifiers for patients, physicians, and
there has been conflicting information about the “digital divide,” espe-
diseases for use across all data types [128] and varying expectations
cially in people with substance use disorders [89,139] or other disad-
and time to collect fully complete data within EHRs.
vantaged populations, general research on Internet and mobile phone
use indicates the divide is continuing to shrink by age, income, and
race (Fig. 4 represents demographics of adults using social network 4.2.6. User identification
sites) (http://www.pewinternet.org/data-trend/internet-use/latest- More challenging may be the complexities that come when users
stats/ http://www.pewinternet.org/fact-sheets/mobile-technology- online have the ability to remain anonymous or to invent characteristics
fact-sheet/) for themselves. Though the ability to be mostly or completely anony-
mous can increase the comfort required for some to participate in unfet-
4.2.4. Adequate infrastructure tered dialog, it can also make it difficult to verify identities or specified
Web- or mobile-based interventions also require the use of different demographics in a study population (e.g., age, gender). The lack of any
types of infrastructure and resource support, which can be difficult to face-to-face contact may also make informed consent harder to ensure.
navigate. For example, while app-based interventions may facilitate Anonymous accounts also make it impossible to determine how much
the movement of substance abuse treatments into primary care, lessen- trust to put in the quality of information being distributed. The Internet
ing the burden on physicians to obtain training on intervention delivery, is infamous for the propagation of inaccuracies, and if a person cannot
SOURCE: http://www.pewinternet.org/fact-sheets/social-networking-fact-sheet/
Fig. 4. Social networking site use by age group, 2005–2013. % of internet users in each age group who use the networking sites, over time.
Source: http://www.pewinternet.org/fact-sheets/social-networking-fact-sheet/.
j.cct.2015.07.007
verify the credentials of a poster on Twitter or a blog, for example, it can References
be a challenge to determine the reliability of the content.
[1] H.G. Allen, T.R. Stanton, F. Di Pietro, G.L. Moseley, Social media release increases
dissemination of original articles in the clinical pain sciences, PLoS ONE 8 (7)
4.2.7. Provider attitudes (2013) e68914, http://dx.doi.org/10.1371/journal.pone.0068914.
Time limitations for researchers and stigma about “professionalism” [2] W. Amin, et al., PaTH: towards a learning health system in the Mid-Atlantic region,
can be barriers to the use of blogs and social media as wel. In one survey J. Am. Med. Inform. Assoc. 21 (2014) 633–636, http://dx.doi.org/10.1136/amiajnl-
2014-002759.
of faculty at Johns Hopkins School of Public Health [73], a majority of [3] S.D. Anton, et al., Use of a computerized tracking system to monitor and provide
respondents were either not interested in or actively opposed to feedback on dietary goals for calorie-restricted diets: the POUNDS LOST study,
professional engagement in social media. Lack of time was frequently J. Diabetes Sci. Technol. 6 (5) (2012) 1216–1225.
[4] E. Babre, Electronic data capture—narrowing the gap between clinical and data
cited, and only 24% felt social media usage was useful for “career management, Perspect. Clin. Res. 2 (1) (2011) 1–3 (Jan–Mar).
advancement.” [5] H.J. Baer, et al., Use of a web-based risk appraisal tool for assessing family history
and lifestyle factors in primary care, J. Gen. Intern. Med. 28 (6) (2013) 817–824,
http://dx.doi.org/10.1007/s11606-013-2338-z.
5. Future directions
[6] T.B. Baker, et al., How can research keep up with eHealth? Ten strategies for in-
creasing the timeliness and usefulness of eHealth research, J. Med. Internet Res.
The advent of new technologies for clinical trials and availability of 16 (2014) e36, http://dx.doi.org/10.2196/jmir.2925.
“Big Data” provides an enormous opportunity for researchers, but [7] N.P. Barnett, J.G. Murphy, S.M. Colby, P.M. Monti, Efficacy of counselor vs.
computer-delivered intervention with mandated college students, Addict. Behav.
many challenges still remain. Investigational teams should keep in 32 (11) (2007) 2529–2548, http://dx.doi.org/10.1016/j.addbeh.2007.06.017.
mind that e-technologies are simply additional types of research [8] E. Basch, New frontiers in patient-reported outcomes: adverse event reporting,
tools not intended to completely supplant traditional methods, particu- comparative effectiveness, and quality assessment, Annu. Rev. Med. 65 (2014)
307–317, http://dx.doi.org/10.1146/annurev-med-010713-141500.
larly given the need for more empirical evidence. Newly released [9] S. Bernardez-Pereira, et al., Prevalence, characteristics, and predictors of early ter-
technologies require time to be tested and refined to overcome chal- mination of cardiovascular clinical trials due to low recruitment: insights from
lenges. Future research can expand our knowledge of the impact of e- the ClinicalTrials.gov registry, Am. Heart J. 168 (2) (2014) 213–219, http://dx.doi.
org/10.1016/j.ahj.2014.04.013.
technologies on clinical trial design and interpretation, particularly in [10] B.M. Bewick, et al., The effectiveness of web-based interventions designed to de-
respect to validity of results, randomization and blinding. When deter- crease alcohol consumption—a systematic review, Prev. Med. 47 (2008) 17–26,
mining whether to integrate e-technologies into clinical trials, one http://dx.doi.org/10.1016/j.ypmed.2008.01.005.
[11] W.K. Bickel, L.A. Marsch, A. Buchhalter, G.A. Badger, Computerized behavior thera-
may want to consider 1) the target population and their access to and py for opioid-dependent outpatients: a randomized controlled trial, Exp. Clin.
preferences for specific e-technologies, 2) how technology may change Psychopharmacol. 16 (2) (2008) 132–143, http://dx.doi.org/10.1037/1064-1297.16.2.132.
during the time it takes to conduct the trial, 3) whether methods will [12] W.K. Bickel, D.R. Christensen, L.A. Marsch, A review of computer-based interven-
tions used in the assessment, treatment, and research of drug addiction, Subst.
be compliant with regulations on the use of e-technologies, 4) the avail-
Use Misuse 46 (1) (2011) 4–9, http://dx.doi.org/10.3109/10826084.2011.521066.
able infrastructure to process large volumes of data, and 5) whether the [13] J. Bort, Thanks to Apple, 11,000 people signed up for a heart disease study in one
e-technologies introduce additional and/or unnecessary risks to sub- day, Bus. Insider (March 12 2015) (Retrieved June 23, 2015, from http://
jects' privacy or confidentiality. Investigators should partner with pro- www.businessinsider.com/apple-makes-heart-disease-study-go-nuts-2015-3).
[14] D.J. Brief, et al., Web intervention for OEF/OIF veterans with problem drinking and
fessionals from multidisciplinary knowledge areas (e.g., engineering, PTSD symptoms: a randomized clinical trial, J. Consult. Clin. Psychol. 81 (5) (2013)
information/computer science, business) and patients to address the 890–900, http://dx.doi.org/10.1037/a0033697.
variety of challenges involved in integrating e-technologies in clinical [15] D. Brieger, B. Aliprandi-Costa, Developments in procedural and disease registries: a
focus on coronary artery disease, Curr. Opin. Cardiol. 28 (4) (2013) 405–410,
trials. Careful planning will not just help with a successful implementa- http://dx.doi.org/10.1097/HCO.0b013e328361e95a.
tion of the clinical trial, but will increase the chances of the usability and [16] K.W. Bucklen, B.M. Abbott, Promise and challenges with the use of mobile applica-
sustainability of the studied technology after the end of grant funding. tions to support and improve patient care: an industry perspective, Clin.
Pharmacol. Ther. 95 (5) (2014) 469–471, http://dx.doi.org/10.1038/clpt.2014.34.
While theoretical and practical challenges definitely exist when it [17] D.B. Buller, R. Borland, E.P. Bettinghaus, J.H. Shane, D.E. Zimmerman, Randomized
comes to new e-technologies in clinical research, many of these chal- trial of a smartphone mobile application compared to text messaging to support
lenges can be overcome with careful planning, useful partnerships, smoking cessation, Telemed. J. E-Health 20 (3) (2014) 206–214, http://dx.doi.
org/10.1089/tmj.2013.0169.
and forethought. The role of web- and smartphone-based applications, [18] I. Buschel, R. Mehdi, A. Cammilleri, Y. Marzouki, B. Elger, Protecting human health
including social media, is expanding in every field and the increasing and security in digital Europe: how to deal with the “Privacy Paradox”? Sci. Eng.
use of those platforms by scientists and the public alike make them Ethics 20 (2014) 639–658, http://dx.doi.org/10.1007/s11948-013-9511-y.
[19] J. Butler, et al., Improving cardiovascular clinical trials conduct in the United States:
tools that cannot be ignored. These new mediums allow researchers to
recommendation from clinicians, researchers, sponsors, and regulators, Am. Heart
do things never before possible and have the potential to improve effi- J. 169 (3) (2015) 305–314, http://dx.doi.org/10.1016/j.ahj.2014.12.001.
ciency and lower the cost of clinical trials while radically expand both [20] S.F. Butler, S.H. Budman, R.J. Goldman, F.L. Newman, K.E. Beckley, D. Trottier, J.S.
the availability and reach of clinical interventions to those who need Cacciola, Initial validation of a computer administered addiction severity index:
the ASI–MV, Psychol. Addict. Behav. 15 (2001) 4–12.
them the most. [21] L.H. Butler, C.J. Correia, Brief alcohol intervention with college student drinkers:
face-to-face versus computerized feedback, Psychol. Addict. Behav. 23 (1) (2009)
Funding 163–167, http://dx.doi.org/10.1037/a0014892.
[22] A. Campbell, F. Muench, E.V. Nunes, Technology-based behavioral interventions for
alcohol and drug use problems, in: L. Marsch, S. Lord, J. Dallery (Eds.), Behavioral
This work was supported by grants from the National Institute on Health Care and Technology: Using Science-Based Innovations to Transform Prac-
Drug Abuse Clinical Trials Network: U10 DA013035 (PIs: Nunes, tice, Oxford University Press, New York, 2014.
[23] A.N.C. Campbell, et al., Gender-based outcomes and acceptability of a web-
Rotrosen); U10 DA013714 (PIs: Donovan, Roll). delivered psychosocial intervention for substance use disorders, J. Subst. Abus.
Treat. (2014)http://dx.doi.org/10.1016/j.jsat.2014.12.006.
Declaration of conflicting interests [24] A.N.C. Campbell, et al., Internet-delivered treatment for substance abuse: a multi-
site randomized controlled clinical trial, Am. J. Psychiatr. 171 (6) (2014)
683–690, http://dx.doi.org/10.1176/appi.ajp.2014.13081055.
The authors do not have any conflicting interests. [25] A.N.C. Campbell, et al., Design and methodological considerations of an effective-
ness trial of a computer-assisted intervention: an example from the NIDA Clinical
Trials Network, Contemp. Clin. Trials 33 (2) (2012) 386–395, http://dx.doi.org/10.
Acknowledgments
1016/j.cct.2011.11.001.
[26] D.A. Carere, et al., Design, methods, and participant characteristics of the Impact of
Portions of this manuscript were presented at SAMHSA's Technology Personal Genomics (PGen) Study, a prospective cohort study of direct-to-
Assistance Center Strategy Regional Summit, June 10, 2014, Reno, NV consumer personal genomic testing customers, Genome Med. 6 (12) (2014) 96,
http://dx.doi.org/10.1186/s13073-014-0096-0.
and the Society for Clinical Trials 35th Annual Meeting, May 18, 2014, [27] K.B. Carey, L.A.J. Scott‐Sheldon, J.C. Elliott, J.R. Bolles, M.P. Carey, Computer‐
Philadelphia, PA. delivered interventions to reduce college student drinking: a meta‐analysis,
j.cct.2015.07.007
Addiction 104 (11) (2009) 807–1819, http://dx.doi.org/10.1111/j.1360-0443. [56] O. Frobert, et al., Thrombus aspiration during ST-segment elevation myocardial in-
2009.02691.x. farction, N. Engl. J. Med. 369 (17) (2013) 1587–1597, http://dx.doi.org/10.1056/
[28] K.M. Carroll, et al., Computer-assisted delivery of cognitive-behavioral therapy for NEJMoa1308789.
addiction: a randomized trial of CBT4CBT, Am. J. Psychiatr. 165 (7) (2008) [57] K.L. Galbraith, Practical and ethical considerations for using social media in com-
881–888, http://dx.doi.org/10.1176/appi.ajp.2008.07111835. munity consultation and public disclosure activities, Acad. Emerg. Med. 21 (10)
[29] K.M. Carroll, et al., Computer-assisted delivery of cognitive-behavioral therapy: (2014) 1151–1157, http://dx.doi.org/10.1111/acem.12483.
efficacy and durability of CBT4CBT among cocaine-dependent individuals main- [58] I. Garcia, C. Portugal, L.H. Chu, A.A. Kawatkar, Response rates of three modes of sur-
tained on methadone, Am. J. Psychiatr. 171 (4) (2014) 436–444, http://dx.doi. vey administration and survey preferences of rheumatoid arthritis patients, Nico-
org/10.1176/appi.ajp.2013.13070987. tine Tob. Res. 66 (3) (2014) 364–370, http://dx.doi.org/10.1002/acr.22125.
[30] K.M. Carroll, B.J. Rounsaville, Computer-assisted therapy in psychiatry: be [59] J. Geyer, et al., Implementing a low-cost web-based clinical trial management
brave—it's a new world, Curr. Psychiatry Rep. 12 (2010) 426–432, http://dx.doi. system for community studies: a case study, Clin. Trials 8 (5) (2011) 634–644,
org/10.1007/s11920-010-0146-2. http://dx.doi.org/10.1177/1740774511416384.
[31] D. Cawthorpe, An evaluation of a computer-based psychiatric assessment: evi- [60] J.R. Gorman, et al., A diversified recruitment approach incorporating social media
dence for expanded use, Cyberpsychol. Behav. 4 (4) (2001) 503–510. leads to research participation among young adult-aged female cancer survivors,
[32] M. Chaple, et al., Feasibility of a computerized intervention for offenders with sub- J. Adolesc. Young Adult. Oncol. 3 (2) (2014) 59–65.
stance use disorders: a research note, J. Exp. Criminol. 10 (1) (2014) 105–127, [61] I. Gurol-Urganci, et al., Mobile phone messaging reminders for attendance at
http://dx.doi.org/10.1007/s11292-013-9187-y. healthcare appointments, Cochrane Database Syst. Rev. 12 (2013) CD007458,
[33] E.K. Choo, et al., Twitter as a tool for communication and knowledge http://dx.doi.org/10.1002/14651858.CD007458.pub3.
exchange in academic medicine: a guide for skeptics and novices, Med. Teach. [62] D.H. Gustafson, et al., A smartphone application to support recovery from alcohol-
(2014)http://dx.doi.org/10.3109/0142159x.2014.993371 (in press). ism: a randomized clinical trial, JAMA Psychiatry 71 (5) (2014) 566–572, http://dx.
[34] F.S. Collins, H. Varmus, A new initiative on precision medicine, N. Engl. J. Med. 372 doi.org/10.1001/jamapsychiatry.2013.4642.
(9) (2015) 793–795, http://dx.doi.org/10.1056/NEJMp1500523. [63] D. Gustafson, et al., Development and pilot evaluation of a computer-based support
[35] S.J. Coons, et al., Capturing Patient-Reported Outcome (PRO) data electronically: system for women with breast cancer, J. Psychosoc. Oncol. 11 (4) (1994) 69–93,
the past, present, and promise of ePRO measurement in clinical trials, Patient http://dx.doi.org/10.1300/J077V11N04_05.
(2014) (in press). [64] E. Hafen, et al., Health data cooperatives—citizen empowerment, Methods Inf. Med.
[36] J. Copeland, G. Martin, Web-based interventions for substance use disorders: a 53 (2) (2014) 82–86, http://dx.doi.org/10.3414/ME13-02-0051.
qualitative review, J. Subst. Abus. Treat. 26 (2004) 109–116. [65] D.S. Hasin, E. Aharaonovich, E. Greenstein, HealthCall for the smartphone: technol-
[37] M. Cortez, C. Chen, Thousands have already signed up for Apple's ResearchKit, ogy enhancement of brief intervention HIV alcohol dependent patients, Addict. Sci.
BloombergBusinessMarch 1 2015. (Retrieved June 23, 2015, from http:// Clin. Pract. 9 (5) (2014)http://dx.doi.org/10.1186/1940-0640-9-5.
www.bloomberg.com/news/articles/2015-03-11/apple-researchkit-sees-thou- [66] D.S. Hasin, et al., Reducing heavy drinking in HIV primary care: a randomized trial
sands-sign-up-amid-bias-criticism). of brief intervention, with and without technological enhancement, Addiction 108
[38] P. Cuijpers, et al., Computer-aided psychotherapy for anxiety disorders: a meta- (7) (2013) 1230–1240, http://dx.doi.org/10.1111/add.12127.
analytic review, Cogn. Behav. Ther. 38 (2009) 66–82, http://dx.doi.org/10.1080/ [67] R.K. Hester, H.D. Delaney, W. Campbell, The college drinker's check-up: outcomes
16506070802694776. of two randomized clinical trials of a computer-delivered intervention, Psychol.
[39] J.A. Cunningham, T.C. Wild, J. Cordingley, T. Van Mierlo, K. Humphreys, A random- Addict. Behav. 26 (1) (2012) 1–12, http://dx.doi.org/10.1037/a0024753.
ized controlled trial of an Internet‐based intervention for alcohol abusers, Addic- [68] S.M. Hossain, et al., Identifying drug (cocaine) intake events from acute physiolog-
tion 104 (12) (2009) 2023–2032, http://dx.doi.org/10.1111/j.1360-0443.2009. ical response in the presence of free-living physical activity, IPSN (2014) 71–82.
02726.x. [69] E.M. Hunkeler, et al., A web-delivered care management and patient self-
[40] L. D'Avolio, et al., Implementation of the Department of Veterans Affairs' first management program for recurrent depression: a randomized trial, Psychiatr.
point-of-care clinical trial, J. Am. Med. Inform. Assoc. 19 (e1) (2012) e170–e176. Serv. 63 (11) (2012) 1063–1071, http://dx.doi.org/10.1176/appi.ps.005332011.
[41] J.M. Davis, et al., Optimizing clinical trial enrollment methods through “goal pro- [70] J.T.P. Hustad, N.P. Barnett, B. Borsari, K.M. Jackson, Web-based alcohol prevention
gramming”, Appl. Clin. Trials 23 (6–7) (2014) 46–50. for incoming students: a randomized controlled trial, Addict. Behav. 35 (3)
[42] D.M. Doumas, C.M. Kane, T.B. Navarro, J. Roman, Decreasing heavy drinking in first- (2010) 183–189, http://dx.doi.org/10.1016/j.addbeh.2009.10.012.
year students: evaluation of a web-based personalized feedback program adminis- [71] D.C. Kaelber, W. Foster, J. Gilder, T.E. Love, A.K. Jain, Patient characteristics associat-
tered during orientation, J. Coll. Couns. 14 (1) (2011) 5–20. ed with venous thromboembolic events: a cohort study using pooled electronic
[43] M. Duggan, N.B. Ellison, C. Lampe, A. Lenhart, M. Madden, Social Media Up- health record data, J. Am. Med. Inform. Assoc. 19 (6) (2012) 965–972, http://dx.
date 2014, Pew Research Center, 2015, Jan.. (Retrieved from: http://www. doi.org/10.1136/amiajnl-2001-00782.
pewInternet.org/2015/01/09/social-media-update-2014/). [72] F.J. Kay-Lambkin, et al., Study protocol: a dissemination trial of computerized psy-
[44] M. Duncan, et al., Effectiveness of a web- and mobile phone-based intervention to chological treatment for depression and alcohol/other drug use comorbidity in an
promote physical activity and healthy eating in middle-aged males: randomized Australian clinical service, BMC Psychiatry 12 (77) (2012)http://dx.doi.org/10.
controlled trial of the ManUp study, J. Med. Internet Res. 16 (6) (2014) e136. 1186/1471-244X-12-77.
[45] J.C. Elliott, K.B. Carey, J.R. Bolles, Computer-based interventions for college drink- [73] B. Keller, A. Labrique, K.M. Jain, A. Pekosz, O. Levine, Mind the gap: Social media en-
ing: a qualitative review, Addict. Behav. 33 (2008) 994–1005, http://dx.doi.org/ gagement by public health researchers, J. Med. Internet Res. 16 (1) (2014) 38,
10.1016/j.addbeh.2008.03.006. http://dx.doi.org/10.2196/jmir.2982.
[46] N.B. Ellison, C. Steinfield, C. Lampe, The benefits of Facebook “Friends:” social cap- [74] Z. Khadjesari, E. Murray, C. Hewitt, S. Hartley, C. Godfrey, Can stand-alone
ital and college students' use of online social network sites, J. Comput.-Mediat. computer-based interventions reduce alcohol consumption? A systematic review,
Commun. 12 (2007) 1143–1168, http://dx.doi.org/10.1111/j.1083-6101.2007. Addiction 106 (2011) 267–282, http://dx.doi.org/10.1111/j.1360-0443.2010.03214.x.
00367.x. [75] B.D. Kiluk, et al., A methodological analysis of randomized clinical trials of
[47] D.H. Epstein, et al., Real-time tracking of neighborhood surroundings and mood in computer-assisted therapies for psychiatric disorders: towards improved stan-
urban drug misusers: application of a new method to study behavior in its geo- dards for an emerging field, Am. J. Psychiatr. 168 (8) (2011) 790–799, http://dx.
graphical context, Drug Alcohol Depend. 134 (2014) 22–29, http://dx.doi.org/10. doi.org/10.1176/appi.ajp.2011.10101443.
1016/j.drugalcdep.2013.09.007. [76] A.A. Klein, V.J. Slaymaker, K.L. Dugosh, J.R. McKay, Computerized continuing care
[48] J.F. Etter, T.V. Perneger, A comparison of cigarette smokers recruited through the support for alcohol and drug dependence: a preliminary analysis of usage and out-
Internet or by mail, Int. J. Epidemiol. 30 (3) (2001) 521–525. comes, J. Subst. Abus. Treat. 42 (2012) 25–34, http://dx.doi.org/10.1016/j.jsat.2011.
[49] G. Eysenbach, Can tweets predict citations? Metrics of social impact based on Twit- 07.002.
ter and correlation with traditional metrics of scientific impact, J. Med. Internet [77] K. Kypri, et al., Web‐based screening and brief intervention for hazardous drinking:
Res. 13 (4) (2011) e123, http://dx.doi.org/10.2196/jmir.2012. a double‐blind randomized controlled trial, Addiction 99 (11) (2004) 1410–1417,
[50] G. De Moor, et al., Using electronic health records for clinical research: the case of http://dx.doi.org/10.1111/j.1360-0443.2012.04067.x.
the EHR4CR project, J. Biomed. Inform. 53 (2014) 162–173, http://dx.doi.org/10. [78] K. Kypri, J.D. Langley, J.B. Saunders, M.L. Cashell-Smith, P. Herbison, Randomized
1016/j.jbi.2014.10.006. controlled trial of web-based alcohol screening and brief intervention in
[51] S. Fausto, et al., Research blogging: indexing and registering the change in science primary care, Arch. Intern. Med. 168 (5) (2008) 530, http://dx.doi.org/10.1001/
2.0, PLoS ONE 7 (12) (2012) e50109, http://dx.doi.org/10.1371/journal.pone. archinternmed.2007.109.
0050109. [79] B. Lagerqvist, et al., Outcomes 1 year after thrombus aspiration for myocardial in-
[52] L.D. Fiore, et al., A point-of-care clinical trial comparing insulin administered using farction, N. Engl. J. Med. 371 (12) (2014) 1111–1120, http://dx.doi.org/10.1056/
a sliding scale versus a weight-based regimen, Clin. Trials 8 (2) (2011) 183–195, NEJMoa1405707.
http://dx.doi.org/10.1177/1740774510395635. [80] M.S. Lauer, R.B. D'Agostino Sr., The randomized registry trial—the next disruptive
[53] R.L. Fleurence, et al., Patient-powered research networks aim to improve patient technology in clinical research? N. Engl. J. Med. 369 (17) (2013) 1579–1581,
care and health research, Health Aff. 33 (7) (2014) 1212–1219, http://dx.doi.org/ http://dx.doi.org/10.1056/NEJMp1310102.
10.1377/hlthaff.2014.0113. [81] A. Leonard, et al., Recruitment and retention of young women into nutrition re-
[54] R.L. Fleurence, et al., Launching PCORnet, a national patient-centered clinical research studies: practical considerations, Trials 15 (2014) 23, http://dx.doi.org/10.
search network, J. Am. Med. Inform. Assoc. 21 (4) (2014) 578–582, http://dx.doi. 1186/1745-6215-15-23.
org/10.1136/amiajnl-2014-002747. [82] M.A. Lewis, C. Neighbors, Optimizing personalized normative feedback: the use of
[55] M. Frandsen, J. Walters, S.G. Ferguson, Exploring the viability of using online gender-specific referents, J. Stud. Alcohol Drugs 68 (2) (2007) 228.
social media advertising as a recruitment method for smoking cessation clinical [83] E.B. Litvin, A.M. Abrantes, R.A. Brown, Computer and mobile technology-based in-
trials, Nicotine Tob. Res. 16 (2) (2014) 247–251, http://dx.doi.org/10.1093/ntr/ terventions for substance use disorders: an organizing framework, Addict. Behav.
ntt157. 38 (2013) 1747–1756, http://dx.doi.org/10.1016/j.addbeh.2012.09.003.
j.cct.2015.07.007
[84] S. Lord, K. Trudeau, R. Black, et al., Comprehensive Health Assessment Tool for [109] A.R. Quanbeck, et al., Integrating addiction treatment into primary care using mo-
Teens (CHAT): development and validation of a computer-delivered, self-report bile health technology: protocol for an implementation research study, Implement.
substance use assessment for adolescents, Subst. Use Misuse 46 (6) (2011) Sci. 9 (2014) 65, http://dx.doi.org/10.1186/1748-5908-9-65.
781–794. [110] W.T. Riley, et al., Rapid, responsive, relevant (R3) research: a call for a rapid learn-
[85] M. Lu, et al., Improving efficiency and reducing costs: design of an adaptive, seam- ing health research enterprise, Clin. Transl. Med. 2 (1) (2013) 10, http://dx.doi.org/
less, and enriched pragmatic efficacy trial of an online asthma management pro- 10.1186/2001-1326-2-10.
gram, Contemp. Clin. Trials 38 (1) (2014) 19–27, http://dx.doi.org/10.1016/j.cct. [111] S.E. Rooke, et al., Applying technology to the treatment of cannabis use disorder: com-
2014.02.008. paring telephone versus Internet delivery using data from two completed trials, J.
[86] R.G. Marks, et al., Paradigm shifts in clinical trials enabled by information technol- Subst. Abus. Treat. 46 (1) (2014) 78–84, http://dx.doi.org/10.1016/j.jsat.2013.08.007.
ogy, Stat. Med. 20 (17–18) (2001) 2683–2696. [112] S. Rooke, J. Copeland, M. Norberg, D. Hine, J. McCambridge, Effectiveness of a self-
[87] L.A. Marsch, S.E. Lord, J. Dallery (Eds.), Behavioral Health Care and Technology: guided web-based cannabis treatment program, J. Med. Internet Res. 15 (2) (2013)
Using Science-based Innovations to Transform Practice, Oxford University Press, e26, http://dx.doi.org/10.2196/jmir.2256.
New York, 2014. [113] M.T. Ruffin 4th, D.E. Nease Jr., Using patient monetary incentives and electronically
[88] L.A. Marsch, et al., Web-based behavioral treatment for substance use disorders as derived patient lists to recruit patients to a clinical trial, J. Am. Board Fam. Med. 24
a partial replacement of standard methadone maintenance treatment, J. Subst. (5) (2011) 569–575, http://dx.doi.org/10.3122/jabfm.2011.05.100169.
Abus. Treat. 46 (2014) 43–51, http://dx.doi.org/10.1016/j.jsat.2013.08.012. [114] J.D. Runyan, T.A. Steenbergh, C. Bainbridge, D.A. Daugherty, L. Oke, et al., A
[89] E.A. McClure, S.P. Acquavita, E. Harding, M.L. Stitzer, Utilization of communication smartphone ecological momentary assessment/intervention “app” for collecting
technology by patients enrolled in substance abuse treatment, Drug Alcohol De- real-time data and promoting self-awareness, PLoS ONE 8 (8) (2013) e71325,
pend. 129 (1–2) (2013) 145–150, http://dx.doi.org/10.1016/j.drugalcdep.2012.10. http://dx.doi.org/10.1371/journal.pone.0071325.
003. [115] E. Santoro, et al., Internet for clinical trials: past, present, and future, Control. Clin.
[90] A.T. McLellan, A.M. Woodworth, The Affordable Care Act and treatment for Trials 20 (2) (1999) 194–201.
“substance use disorders:” implications of ending segregated behavioral [116] A. Sargious, S.J. Lee, Remote collection of questionnaires, Clin. Exp. Rheumatol. 32
healthcare, J. Subst. Abus. Treat. 46 (5) (2014) 541–545, http://dx.doi.org/10. (5 Suppl. 85) (2014) S-168-172.
1016/j.jsat.2014.02.001. [117] S.P. Schinke, L. Fang, K.C. Cole, Preventing substance use among adolescent girls: 1-
[91] W.R. Miller, R.G. Sovereign, B. Krege, Motivational interviewing with problem year outcomes of a computerized, mother–daughter program, Addict. Behav. 34
drinkers: II. The Drinker's Check-up as a preventive intervention, Behav. Psychother. (12) (2009) 1060–1064, http://dx.doi.org/10.1016/j.addbeh.2009.06.007.
16 (4) (1988) 251–268, http://dx.doi.org/10.1017/S0141347300014129. [118] S.H. Scholle, et al., Effect of different recruitment sources on the composition of a
[92] W.R. Miller, A. Zweben, C.C. DiClemente, R.G. Rychtarik, Motivational Enhancement bipolar disorder case registry, Soc. Psychiatry Psychiatr. Epidemiol. 35 (5) (2000)
Therapy Manual: A Clinical Research Guide for Therapists Treating Individuals with 220–227.
Alcohol Abuse and Dependence, Project MATCH Monograph Series. Volume 2, Na- [119] T.M. Schwinn, S. Schinke, L. Fang, S. Kandasamy, A web-based, health promotion
tional Institute on Alcohol Abuse and Alcoholism, Rockville, MD, 1992. program for adolescent girls and their mothers who reside in public housing,
[93] M.A. Moreno, N. Goniu, P.S. Moreno, D. Diekema, Ethics and social media research: Addict. Behav. 39 (4) (2014) 757–760, http://dx.doi.org/10.1016/j.addbeh.2013.
common concerns and practical considerations, Cyberpsychol. Behav. Soc. Netw. 11.029.
16 (9) (2013) 708–713, http://dx.doi.org/10.1089/cyber.2012.0334. [120] H. Shema, J. Bar-Ilan, M. Thelwall, Research blogs and the discussion of scholarly
[94] F. Muench, R.A. Weiss, A. Kuerbis, J. Morgenstern, Developing a theory driven text information, PLoS ONE 7 (5) (2012) e35869, http://dx.doi.org/10.1371/journal.
messaging intervention for addiction care with user driven content, Psychol. Ad- pone.0035869.
dict. Behav. 27 (1) (2013) 315–321, http://dx.doi.org/10.1037/a0029963. [121] S. Shiffman, Ecological momentary assessment (EMA) in studies of substance use,
[95] F. Muench, K. van Stolk-Cooke, J. Morgenstern, A.N. Kuerbis, K. Markle, Under- Psychol. Assess. 21 (4) (2009) 486–497, http://dx.doi.org/10.1037/a0017074.
standing messaging preferences to inform development of mobile goal-directed [122] K.S. Smith, et al., Using web-based screening to enhance efficiency of HMO clinical
behavioral interventions, J. Med. Internet Res. 16 (2) (2014) e14, http://dx.doi. trial recruitment in women aged forty and older, Clin. Trials 4 (1) (2007) 102–105.
org/10.2196/jmir.2945. [123] V. Spek, et al., Internet-based cognitive-behaviour therapy for symptoms of de-
[96] H. Muzaffar, K. Chapman-Novakofski, D.M. Castelli, J.A. Scherer, The HOT (Healthy pression and anxiety: a meta-analysis, Psychol. Med. 37 (2007) 319–338.
Outcome for Teens) project. Using a web-based medium to influence attitude, sub- [124] S.W. Stephens, et al., Preliminary experience with social media for community con-
jective norm, perceived behavioral control and intention for obesity and type 2 di- sultation and public disclosure in exception from informed consent trials, Circula-
abetes prevention, Appetite 72 (2014) 82–89, http://dx.doi.org/10.1016/j.appet. tion 3 (2013) 267–270, http://dx.doi.org/10.1161/CIRCULATIONAHA.113.002.390.
2013.09.024. [125] A.A. Stone, et al., Patient compliance with paper and electronic diaries, Control.
[97] T.T. Nguyen, et al., Challenging recruitment of youth with type 2 diabetes into clin- Clin. Trials 24 (2) (2003) 182–199.
ical trials, J. Adolesc. Health 54 (3) (2014) 247–254, http://dx.doi.org/10.1016/j. [126] M.D. Stilman, et al., Health care utilization and barriers experienced by
jadohealth.2013.08.017. individuals with spinal cord injury, Arch. Phys. Med. Rehabil. 95 (6) (2014)
[98] S.J. Ondersma, D.S. Svikis, C.R. Schuster, Computer-based brief intervention: a 1114–1126, http://dx.doi.org/10.1016/j.apmr.2014.02.005.
randomized trial with postpartum women, Am. J. Prev. Med. 32 (3) (2007) [127] E.S. Swirsky, J.G. Hoop, S. Labott, Using social media in research: new ethics for a
231–238. new meme? Am. J. Bioeth. 14 (10) (2014) 60–61, http://dx.doi.org/10.1080/
[99] S.J. Ondersma, D.S. Svikis, L.R. Thacker, J.R. Beatty, R.N. Lockhart, Computer- 15265161.2014.948302.
delivered screening and brief intervention (e-SBI) for postpartum drug use: a ran- [128] N. Szlezak, M. Evers, J. Wang, L. Perez, The role of big data and advanced analytics
domized trial, J. Subst. Abus. Treat. 46 (2014) 52–59, http://dx.doi.org/10.1016/j. in drug discovery, development, and commercialization, Clin. Pharmacol. Ther. 95
jsat.2013.07.013. (5) (2014) 492–495, http://dx.doi.org/10.1038/clpt.2014.29.
[100] M. Orri, C.H. Lipset, B.P. Jacobs, A.J. Costello, S.R. Cummings, Web-based trial to [129] H.A. Taylor, E. Kuwana, B.S. Wilfond, Ethical implications of social media in health
evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overac- care research, Am. J. Bioeth. 14 (10) (2014) 58–59, http://dx.doi.org/10.1080/
tive bladder: REMOTE trial, Contemp. Clin. Trials 38 (2) (2014) 190–197, http://dx. 15265161.2014.947820.
doi.org/10.1016/j.cct.2014.04.009. [130] N. Terry, Health privacy is difficult but not impossible in a post-HIPAA data-driven
[101] S.H. Otsuka, et al., Improving herpes zoster vaccination rates through use of a clin- world, Chest 146 (3) (2014) 835–840, http://dx.doi.org/10.1378/chest.13-2909.
ical pharmacist and a personal health record, Am. J. Med. 126 (9) (2013)http://dx. [131] L. Thomas, G. Capistrant, 50 State Telemedicine Gaps Analysis: Coverage and
doi.org/10.1016/j.amjmed.2013.02.018 (832.e831–836). Reimbursement, American Telemedicine Association, 2014. (Retrieved from:
[102] M. Panahaizar, V. Taslimitehrani, A. Jadhav, J. Pathak, Empowering personalized http://www.americantelemed.org/docs/default-source/policy/50-state-telemedi-
medicine with big data and semantic web technology: promises, challenges, and cine-gaps-analysis—coverage-and-reimbursement.pdf?sfvrsn=6).
use cases, Proceedings of the IEEE International Conference on Big Data 2014, [132] H.P. Tossman, B. Jonas, M.D. Tensil, P. Lang, E. Struber, A controlled trial of an
pp. 790–795. Internet-based intervention program for cannabis users, Cyberpsychol. Behav.
[103] J. Paul, et al., The Internet and clinical trials: background, online resources, exam- Soc. Netw. 14 (11) (2011) e26, http://dx.doi.org/10.1089/cyber.2010.0506.
ples and issues, J. Med. Internet Res. 7 (1) (2005) e5. [133] R. Van Noorden, Scientists and the social network: giant academic social networks
[104] R.J. Paxton, et al., African-American breast cancer survivors' preferences for have taken off to a degree that no one expected even a few years ago. A Nature sur-
various types of physical activity interventions: a Sisters Network Inc. web-based vey explains why, Nature 512 (7513) (2014) 126–129, http://dx.doi.org/10.1038/
survey, J. Cancer Surviv. 8 (1) (2014) 31–38, http://dx.doi.org/10.1007/s11764- 512126a.
013-0308-5. [134] B. Wagner, et al., Internet-based versus face-to-face cognitive-behavioral interven-
[105] H.E. Payne, C. Lister, J.H. West, J.M. Bernhardt, Behavioral functionalilty of mobile tion for depression: a randomized controlled non-inferiority trial, J. Affect. Disord.
apps in health interventions: a systematic review of the literature, J. Med. Internet 152–154 (2014) 113–121, http://dx.doi.org/10.1016/j.jad.2013.06.032.
Res. 3 (1) (2015) e20, http://dx.doi.org/10.2196/mhealth.3335. [135] L.R. Waitman, et al., The Greater Plains Collaborative: a PCORnet clinical research
[106] C.J. Pepine, et al., Rationale and design of the International Verapamil SR/ data network, J. Am. Med. Inform. Assoc. 21 (4) (2014) 637–641, http://dx.doi.
Trandolapril Study (INVEST): an Internet-based randomized trial in coronary org/10.1136/amiajnl-2014-002756.
artery disease patients with hypertension, J. Am. Coll. Cardiol. 32 (5) (1998) [136] S.T. Walters, A.M. Vader, T.R. Harris, A controlled trial of web-based feedback for
1228–1237. heavy drinking college students, Prev. Sci. 8 (2) (2007) 83–88.
[107] Pew Research Center, Older Adults and Technology UseRetrieved from: http:// [137] R.E. White, Health information technology will shift the medical care paradigm, J. Gen.
www.pewinternet.org/2014/04/03/older-adults-and-technology-use/Apr. 2014. Intern. Med. 23 (4) (2008) 495–499, http://dx.doi.org/10.1007/s11606-007-0394-y.
[108] D.B. Portnoy, L.A.J. Scott-Sheldon, B.T. Johnson, M.P. Carey, Computer-delivered [138] S.E. Wilkinson, M.Y. Basto, G. Perovic, N. Lawrentschuk, D.G. Murphy, The social
interventions for health promotion and behavioral risk reduction: a meta- media revolution is changing the conference experience: analytics and trends
analysis of 75 randomized controlled trials, 1988–2007, Prev. Med. 47 (2008) from eight international meetings, BJU Int. (2014)http://dx.doi.org/10.1111/bju.
3–16, http://dx.doi.org/10.1016/j.ypmed.2008.02.014. 12910 (in press).
j.cct.2015.07.007
[139] M. Wolf-Branigan, New media and social networks: considerations from clients in [141] United States, Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-
addictions treatment, J. Technol. Hum. Serv. 27 (4) (2009) 339–345. 148, 124 Stat 119 (2010).
[140] P. Yuan, et al., Using online social media for recruitment of human immunodefi- [142] United States, Mental Health Parity and Addiction Equity Act of 2008, Pub. L. No.
ciency virus-positive participants: a cross-sectional survey, J. Med. Internet Res. 110-343, 112 Stat. 3765, H.R. 1424, 110th Cong (2008).
16 (5) (2014) e117, http://dx.doi.org/10.2196/jmir.3229.
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Using E-Technologies in Clinical Trials Rosa 2015

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CONCLI-01232; No of Pages 14

Contemporary Clinical Trials xxx (2015) xxx–xxx

Contents lists available at ScienceDirect

Contemporary Clinical Trials

journal homepage: www.elsevier.com/locate/conclintrial

Using e-technologies in clinical trials

1. Introduction Additional reasons for the sluggish adoption of e-technology include

Table 1 approaches have been increasingly used to supplement traditional

Fig. 1. Timeline for typical “app” development.

Fig. 2. Apple ResearchKit: image of the iPhone 6 ResearchKit app.

3.3.1. Health apps 4.1.1. Improving efﬁciency

Fig. 3. Best practices for human subject research protections.

4.1.4. Involving stakeholders 4.2.1. Privacy/conﬁdentiality issues

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