Faculty Bibliography

BACKGROUND:The development of mobile health (mHealth) technologies is progressing at a faster pace than that of the science to evaluate their validity and efficacy. Under the International Committee of Journal Medical Editors (ICMJE) guidelines, clinical trials that prospectively assign people to interventions should be registered with a database before the initiation of the study. OBJECTIVE:The aim of this study was to better understand the smartphone mHealth trials for high-burden neuropsychiatric conditions registered on ClinicalTrials.gov through November 2018, including the number, types, and characteristics of the studies being conducted; the frequency and timing of any outcome changes; and the reporting of results. METHODS:We conducted a systematic search of ClinicalTrials.gov for the top 10 most disabling neuropsychiatric conditions and prespecified terms related to mHealth. According to the 2016 World Health Organization Global Burden of Disease Study, the top 10 most disabling neuropsychiatric conditions are (1) stroke, (2) migraine, (3) major depressive disorder, (4) Alzheimer disease and other dementias, (5) anxiety disorders, (6) alcohol use disorders, (7) opioid use disorders, (8) epilepsy, (9) schizophrenia, and (10) other mental and substance use disorders. There were no date, location, or status restrictions. RESULTS:Our search identified 135 studies. A total of 28.9% (39/135) of studies evaluated interventions for major depressive disorder, 14.1% (19/135) of studies evaluated interventions for alcohol use disorders, 12.6% (17/135) of studies evaluated interventions for stroke, 11.1% (15/135) of studies evaluated interventions for schizophrenia, 8.1% (11/135) of studies evaluated interventions for anxiety disorders, 8.1% (11/135) of studies evaluated interventions for other mental and substance use disorders, 7.4% (10/135) of studies evaluated interventions for opioid use disorders, 3.7% (5/135) of studies evaluated interventions for Alzheimer disease or other dementias, 3.0% (4/135) of studies evaluated interventions for epilepsy, and 3.0% (4/135) of studies evaluated interventions for migraine. The studies were first registered in 2008; more than half of the studies were registered from 2016 to 2018. A total of 18.5% (25/135) of trials had results reported in some publicly accessible location. Across all the studies, the mean estimated enrollment (reported by the study) was 1078, although the median was only 100. In addition, across all the studies, the actual reported enrollment was lower, with a mean of 249 and a median of 80. Only about a quarter of the studies (35/135, 25.9%) were funded by the National Institutes of Health. CONCLUSIONS:Despite the increasing use of health-based technologies, this analysis of ClinicalTrials.gov suggests that only a few apps for high-burden neuropsychiatric conditions are being clinically evaluated in trials.

OBJECTIVE/UNASSIGNED:There are more than 325,000 health-related smartphone applications (apps) on the market. To better understand the apps currently on the market for the five most disabling neuropsychiatric conditions, the authors conducted a study investigating their intended uses (target population and intervention), the data collected, and any privacy policies. METHODS/UNASSIGNED:This was a cross-sectional study of apps for the five most disabling neuropsychiatric conditions per the World Health Organization: stroke, migraine, depression, Alzheimer's disease and dementia, and anxiety. Up to 15 apps in the U.S. Google Play and Apple app stores were selected based on the following prespecified inclusion criteria: the app appeared in the top 50 search results, offered intervention or tracking capabilities, and listed the condition in the app title or description. Exclusion criteria were <$5.00 to purchase, solely motor versus cognitive-based intervention, or designed for use by caregivers or health care providers. Data abstracted included function, behavior change rewards, and information about intervention, privacy policy, and payment. RESULTS/UNASSIGNED:Eighty-three apps were reviewed (stroke, N=8; migraine, N=25; Alzheimer's disease and dementia, N=8; depression, N=7; anxiety, N=14; apps targeting depression and anxiety, N=21). Sixty-nine percent of apps had an intervention component, 18% were deemed evidence based, 77% had a privacy policy, 70% required payment for access to all features, and 19% rewarded user behavior changes. CONCLUSIONS/UNASSIGNED:Most apps on the market targeted migraine, depression, and anxiety and contained interventions, although most of the interventions did not appear to be evidence based. Additionally, although most apps had privacy policies, lay people may have difficulty understanding these policies due to their complexities.

BACKGROUND:Headache mobile health (mHealth) applications (apps) have gained popularity in use but there is little research into what people with migraine find important to track. This information is important for helping with adherence and determining meaningful data to patients. We conducted several clinical trials using a headache research app (RELAXaHEAD). The app contains a "notes" feature (a free-text input section) where patients could record notes related to their headache. OBJECTIVE:To identify what patients view as important when tracking migraine/headaches within a headache tracking mHealth app. METHODS:This was a retrospective study where smartphone diary notes inputted by people with migraine were qualitatively analyzed; notes were extracted, a preliminary codebook was developed and used to code each note. Using grounded theory, themes and subthemes emerged. RESULTS:About 288 subjects in the trials used the notes function. There were 5364 total notes with an average of 18.6 ± 39.2 notes/user. The qualitative analysis yielded 759 unique codes and the emergence of 4 major themes. The first theme was "Utility in free-text tracking of headache characteristics, medications, and sleep" which emerged as a space for users to elaborate on data that could have been inputted into other sections of the app. The second theme was "Monitoring coexisting conditions both related to and distinct from headache." The third theme was "Personal records of behavioral therapy adherence," which included a range of concepts from behavioral therapy session frequency/adherence to subjects' thoughts or emotions regarding the behavioral therapy. The fourth theme was "Migraine trigger, prevention, and relief patterns deciphered through consistent data tracking." CONCLUSION/CONCLUSIONS:We found that the majority of patients choose to expand on information beyond what can be inputted into specific icons in a headache app. Moreover, they want to be able to monitor not only headache-related symptoms but symptoms they experience from other conditions. In addition to tracking their pharmacologic treatment, they may choose to track their nonpharmacologic, that is, behavioral therapy use, and they also use a smartphone diary app to assess what triggers versus relieves a migraine. While the RELAXaHEAD app was designed with features to extract data that would be useful to physicians and patients in treating migraine, our study results indicated that users also prefer a range of tracking capabilities that may or may not be useful to physicians but may be important for headache smartphone user engagement.

BACKGROUND:Many headache smartphone applications (apps) are commercially available. A Modified Delphi Study aimed to determine specialists' expectations of what a headache app should entail but consumer expectations of headache apps have not been evaluated extensively. OBJECTIVE:To evaluate publicly available reviews of headache apps to understand app features that motivate the consumers to use apps. METHODS:The Google Play and Apple App Stores were systematically searched for headache/migraine diary apps with 10+ consumer reviews. A maximum of 300 "Most Helpful" reviews for each app were extracted. Four coders coded reviews and resolved discrepancies. Themes and subthemes were created based on codes used 5+ times. RESULTS:About 15 apps met the study criteria (9 Android, 6 IOS). 945 reviews were coded. Four themes emerged: (1) App allows users to track headache characteristics, potential triggers, and treatments; (2) App usability; (3) Personalization and features to assess trends in data are key motivators for app use; (4) Ease with exportation and viewing data is critical. DISCUSSION/CONCLUSIONS:A user-centered design with the ability to (1) customize key features including headache characteristics, potential triggers, and treatments, (2) assess trends in data, and (3) view and export data would best optimize headache smartphone applications based on consumer preference.

BACKGROUND:There are safe and well-tolerated level A evidence-based behavioral therapies for the prevention of migraine. They are biofeedback, cognitive behavioral therapy, and relaxation. However, the behavioral therapies for the prevention of migraine are underutilized. OBJECTIVES/OBJECTIVE:We sought to examine whether people with migraine with 4 or more headache days a month had preferences regarding the type of delivery of the behavioral therapy (in-person, smartphone based, telephone) and whether they would be willing to pay for in-person behavioral therapy. We also sought to determine the predictors of likelihood to pursue the behavioral therapy. METHODS:Using a cross-sectional study design, we developed an online survey using TurkPrime, an online survey platform, to assess how likely TurkPrime participants who screened positive for migraine using the American Migraine Prevalence and Prevention screen were to pursue different delivery methods of the behavioral therapy. We report descriptive statistics and quantitative analyses. RESULTS:There were 401 participants. Median age was 34 [IQR: 29, 41] years. More than two thirds of participants (70.3%, 282/401) were women. Median number of headache days/ month was 5 [IQR: 2.83, 8.5]. Some (12.5%, 50/401) used evidence-based behavioral therapy for migraine. The participants reported that they were "somewhat likely" to pursue in-person or smartphone behavioral therapy and behavioral therapy covered by insurance but were neutral about pursuing the telephone-based behavioral therapy. Participants were "not very likely" to pay out of pocket for the behavioral therapy. Migraine-related disability as measured by the MIDAS grading score was associated with likelihood to pursue the behavioral therapy in-person (P = .004), via telephone (P = .015), and via smart phone (P < .001), and covered by insurance (P = .001). However, migraine-related disability was not associated with likelihood to pursue out of pocket (P = .769) behavioral therapy. Pain intensity was predictive of likelihood of pursuing the behavioral therapy for migraine when covered by insurance. Other factors including education, employment, and headache days were not predictors. CONCLUSION/CONCLUSIONS:People with migraine prefer in-person and smartphone-based behavioral therapy to telephone-based behavioral therapy. Migraine-related disability is associated with likelihood to pursue the behavioral therapy (independent of type of delivery of the behavioral therapy-in-person, telephone based or smartphone based). However, participants were not very likely to pay for the behavioral therapy.

Background: Headache diaries are a mainstay of headache treatment. Various headache smartphone applications (apps) are commercially available. While a Modified Delphi Study aimed to determine specialists' expectations of what a headache app should entail, consumer expectations of these apps have not been evaluated extensively. The aim of this study was to evaluate publicly available reviews of headache apps in the Google Play Store and Apple store to understand app features that motivate consumers to use apps.
Method(s): Using pre-specified criteria, the Google and Apple Play Stores were systematically searched for headache/migraine diary apps with at least 10 consumer reviews. A maximum of 300 'Most Helpful' reviews for each app were extracted into Google Sheets. Four coders qualitatively reviewed and coded reviews until discrepancies were resolved. Codes were counted, and 4 themes with sub-themes were created based on codes used 5+ times.
Result(s): 15 apps met study criteria (9 Android, 6 IOS). The four main themes with sub-themes were: (1) Apps allows user to track headache characteristics, potential triggers, and treatments: track triggers; track treatments; track headache information; users suggest features to log relevant information. (2) App usability: apps allow viewing/editing of existing records; design features for migraine patients are appreciated; technical difficulties limit app usage; developer services satisfy customers. (3) Personalization and features to assess trends in data are key motivators for app use: apps point out trends in data; customization by collection of user's personal information; app provides relief. (4) Ease with exportation and viewing data is critical: app generates data reports; app assists doctors in better treating user's headaches.
Conclusion(s): A user-centered design with the ability to customize key features including headache characteristics, potential triggers and treatments, assess trends in data and view and export the data would best optimize headache smartphone applications based on consumer preference

OBJECTIVE:To outline strategies for the treatment of migraine which do not require in-person visits to clinic or the emergency department, and to describe ways that health insurance companies can remove barriers to quality care for migraine. BACKGROUND:COVID-19 is a global pandemic causing widespread infections and death. To control the spread of infection we are called to observe "social distancing" and we have been asked to postpone any procedures which are not essential. Since procedural therapies are a mainstay of headache care, the inability to do procedures could negatively affect our patients with migraine. In this manuscript we review alternative therapies, with particular attention to those which may be contra-indicated in the setting of COVID-19 infection. DESIGN/RESULTS/UNASSIGNED:The manuscript reviews the use of telemedicine visits and acute, bridge, and preventive therapies for migraine. We focus on evidence-based treatment where possible, but also describe "real world" strategies which may be tried. In each section we call out areas where changes to rules from commercial health insurance companies would facilitate better migraine care. CONCLUSIONS:Our common goal as health care providers is to maximize the health and safety of our patients. Successful management of migraine with avoidance of in-person clinic and emergency department visits further benefits the current urgent societal goal of maintaining social distance to contain the COVID-19 pandemic.