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Migraine Radar - A Novel Approach Collecting Migraine Attack Data Using Smartphone Apps and Web Forms

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Abstract

About 10% of the population suffers from migraine. Nevertheless, despite this large number of affected persons, most of the traditional epidemiological studies, analyzing triggers of migraine, are based only on small groups of patients – usually up to 200 participants. Furthermore, these studies are often limited in relation to regional extensions as well as to the time periods of the surveys. These limitations become a disadvantage when analyzing migraine triggers which affect only a small group of patients, e.g., different levels of stress between full-time workers and unemployed people. In this work we introduce a newly developed system for the collection of migraine attack data. Migraine patients – the migraine type is diagnosed by a standard questionnaire or a qualified doctor – have to register and afterwards submit information about their migraine attacks using a smartphone or a PC. In order to cluster patients later on, we collect demographic information as well as spatial data for each migraine attack. To respect the patients’ privacy, all data are saved in pseudonymized form – only information necessary for our analyses are requested. This new approach helped us to recruit about 3,000 (April 2016) migraine patients, within Germany, Austria and Switzerland, participating in our project. After a period of only 10 months the participants reported nearly 20,000 migraine attacks. With this large quantity of data, we will be able to identify and evaluate groups of patients with very specific triggers causing their migraine attacks, e.g., certain weather conditions, geomagnetic activity or other environmental impacts.
Introduction
QMigraine affects 10-15% of the population.
QPatients are dealing with different trigger factors
(food, smells, ect.) and try to manage or avoid them.
However, most of the studies, analyzing triggers of
migraine, are based only on small groups of patients.
QIn a preliminary project we have already shown that
a study using a web platform for data collection pro-
duces reliable results with the advantage of reach-
ing considerably more patients participating [1].
QObjective: Obtain trigger factors and distribu-
tions of headaches during the week with special fo-
cus on weekends and correlate findings with gender
and profession.
Methods
Data Acquisition
QMigraine patients register using a smartphone app
(see figure 1) or web platform and afterwards regu-
larly submit information about their migraine attacks.
MIGRAINE RADAR
A NOVEL APPROACH COLLECTING MIGRAINE ATTACK DATA USING SMARTPHONE
APPS AND WEB FORMS
WOGENSTEIN F1, DRESCHER J1, RILL S1, SCHEIDT J1, GAUL C2, KROPP P3
1INSTITUTE OF INFORMATION SYSTEMS, UNIVERSITY OF APPLIED SCIENCES HOF, ALFONS-GOPPEL-PLATZ 1, 95028 HOF, GERMANY
2MIGRAINE AND HEADACHE CLINIC KÖNIGSTEIN, ÖLMÜHLWEG 31, 61462 KÖNIGSTEIN, GERMANY
3INSTITUTE OF MEDICAL PSYCHOLOGY AND MEDICAL SOCIOLOGY, UNIVERSITY OF ROSTOCK, GEHLSHEIMER STR. 20, 18147 ROSTOCK, GERMANY
Statistics
QTo examine the thesis of an increase of migraine at-
tacks over the weekends, attack data for full-time
and part-time workers as well as for pupils and stu-
dents within a time period of 64 full weeks (1st of
June 2015 until 21st of August 2016) were analyzed.
QSince the participants are not as close guided as in
clinical studies, data cleaning is necessary before
further analyses. Especially, according to [3] two at-
tacks have to fulfill the condition that they are sepa-
rated by a 24 hours period without headache.
QTo decide if the distribution of the migraine attacks
over the weekdays significantly differs from a uni-
form distribution, chi-square tests were performed.
Results
Q3,200 migraine patients were recruited (Germany,
Austria and Switzerland). Since the participation is
not limited to specific areas, the places of residence
of the registered migraineurs are well distributed
within the three countries (see figure 2).
Conclusion
QThe hypothesis of weekend migraine can not gener-
ally be confirmed.
QOur study shows a reduced migraine frequency on
Sundays and Mondays for working people and from
Fridays to Sundays for female pupils and students.
This supports the results of [4], were a decreased
migraine frequency on Sundays was found. Only for
male full-time workers an increased migraine attack
rate on Saturdays is visible. Torelli et al. concluded
to similar results in [5].
QThe present project shows that reliable results are
achievable using data acquired using web platforms
or smartphone apps. The large quantity of data will
later on enable us to investigate sub-groups of pa-
tients with very specific triggers, including certain
weather conditions, geomagnetic activity or other
environmental impacts. As more data is collected
it will enable us to examine more granular groups,
e.g., in age or location.
QNevertheless, the design of this study still has some
shortcomings in comparison to traditional epidemi-
ological studies. First of all, the participants are not
as closely introduced and medically guided as in
clinical studies. Furthermore, the fact that it is pos-
sible to join and leave the project at any time may
create some bias.
Figure 2: Spatial distribution of all participants within Germany,
Austria and Switzerland.
References
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Figure 3: Distribution of migraine attacks by day of the week for
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QThe migraine type is diagnosed by a validated ques-
tionnaire [2]. For each migraine attack necessary
information is collected, e.g., pain intensity and lo-
cation, associated symptoms, medication and the
disturbance of activities or work. In order to cluster
participants later on, we also collect demographic
information as well as spatial data for each migraine
attack.
QTo respect the patients’ privacy, all data are saved
pseudonymized.
QIn order to motivate migraineurs to take part in the
project, participants have the ability to use the plat-
form as an online migraine diary. They can review
their attack data, get a better overview about their
attacks using the provided statistics and create
printable reports for their treating doctor.
Figure 1: Android App showing the migraine calendar (sample
data).
QWithin 64 weeks nearly 30,000 migraine attacks
were reported, about 20,000 remained after the fil-
tering step.
QThe attack frequencies of each day of the week are
shown in figure 3 (a) to (f). Uniform distributions are
indicated by dashed lines in each of the plots. Four
of the plots – (a), (b), (c) and (e) – show a curve shape
being significantly different from a uniform distribu-
tion.
QFemale and male full-time workers as well as fe-
male part-time workers have a reduced or average
presence of migraine attacks between Sundays
and Tuesdays and an excess of attacks between
Wednesdays and Saturdays. For female pupils and
students, the number of migraine attacks decreases
significantly over the week. The other two distribu-
tions – (d) and (f) – do not show a significant devia-
tion from a uniform distribution.
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Article
Full-text available
In 1991 the Clinical Trials Subcommittee of the International Headache Society (IHS) published its first edition of the Guidelines on controlled trials of drugs in migraine (1). The Guidelines’ overarching goal was to improve ‘the quality of controlled clinical trials in migraine’, which could be achieved by using scientifically robust methods of clinical research. The report highlighted the complex nature of migraine clinical trial methodologies and offered a road map to clinical investigators who were interested in the field. The Migraine Guidelines were adopted widely (2–7), although – for a variety of reasons, including regulatory restrictions – not universally (8–11), and this was the impetus for the development of similar guidelines for tension-type headache (12,13) and for cluster headache (14). The second edition of the guidelines was published in 2000 (15) and, based on the second edition, the European Medicines Agency published in 2007 ‘Guidelines on Clinical Investigation of Medicinal Products for the Treatment of Migraine’ (16). Have investigators then followed the recommendations in these guidelines for randomized controlled trials (RCTs)? Unlike the case of RCTs for migraine prevention where the recommended primary efficacy measure of migraine attack frequency was used in 72% of 52 RCTs (17), adherence to the recommendations in the guidelines for acute migraine treatment has not been overwhelming. Indeed, the recommended measure of freedom from pain after 2 h was the primary efficacy measure in 31% of 145 acute RCTs between 2002 and 2008 (17). Instead, headache relief after 2 h (a decrease from moderate or severe to none or mild) was used in 39% of such trials. Notwithstanding, the proportion of RCTs using pain freedom as the primary efficacy measure has continued to increase over time (17), and is even used in recent large clinical trials (18–21). Following the publication of the IHS Clinical Trials Guidelines, several clinical drug development programmes emerged, notably for acute migraine (e.g. 5- HT1B/D agonists, triptans) and for prevention (e.g. topiramate). The majority of these RCTs were performed mainly for registration purposes (16). This exponential increase in migraine clinical research, the accumulating experience of clinical researchers and the pharmaceutical industry alike, and the trend towards large multi-centre and multi-national studies, call for a timely revisit and a refresh of the original guidelines and their second edition. 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Guideline on clinical investigation of medicinal products for the treatment of migraine. Vol 2011. London, 2007. 17. Hougaard A and Tfelt-Hansen P. Are the current IHS guidelines for migraine drug trials being followed? J Headache Pain 2010; 11: 457–468. 18. Ho TW, Mannix LK, Fan X, et al. Randomized controlled trial of an oral CGRP receptor antagonist, MK- 0974, in acute treatment of migraine. Neurology 2008; 70: 1304–1312. 19. Ho TW, Ferrari MD, Dodick DW, et al. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial. Lancet 2008; 372: 2115–2123. 20. Connor KM, Shapiro RE, Diener HC, et al. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology 2009; 73: 970–977. 21. Tfelt-Hansen P. Pain freedom at 2 hours in migraine after telcagepant 300 mg. CNS Drugs 2011; 25: 269–270. 22. 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