International Journal of Psychiatry in Clinical Practice

ISSN: 1365-1501 (Print) 1471-1788 (Online) Journal homepage: https://www.tandfonline.com/loi/ijpc20

A unique database for gathering data from a

mobile app and medical prescription software: a
useful data source to collect and analyse patient-
reported outcomes of depression and anxiety
symptoms

Yoshinori Watanabe, Yoko Hirano, Yuko Asami, Maki Okada & Kazuya Fujita

To cite this article: Yoshinori Watanabe, Yoko Hirano, Yuko Asami, Maki Okada & Kazuya Fujita
(2017) A unique database for gathering data from a mobile app and medical prescription
software: a useful data source to collect and analyse patient-reported outcomes of depression
and anxiety symptoms, International Journal of Psychiatry in Clinical Practice, 21:4, 318-321,
DOI: 10.1080/13651501.2017.1315139

To link to this article: https://doi.org/10.1080/13651501.2017.1315139

© 2017 The Author(s). Published by Informa Published online: 21 Apr 2017.

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INTERNATIONAL JOURNAL OF PSYCHIATRY IN CLINICAL PRACTICE, 2017
VOL. 21, NO. 4, 318–321
http://dx.doi.org/10.1080/13651501.2017.1315139

COMMENTARY

A unique database for gathering data from a mobile app and medical prescription
software: a useful data source to collect and analyse patient-reported outcomes of
depression and anxiety symptoms
Yoshinori Watanabea, Yoko Hiranob, Yuko Asamib, Maki Okadac and Kazuya Fujitac
a
Himorogi Psychiatric Institute, Tokyo, Japan; bMedical Affairs, Pfizer Essential Health, Pfizer Japan Inc, Tokyo, Japan; cJapan Clinical Informatics
& Innovation, Pfizer Japan Inc, Tokyo, Japan

ABSTRACT ARTICLE HISTORY

A unique database named ‘AN-SAPO’ was developed by Iwato Corp. and Japan Brain Corp. in collabor- Received 31 January 2017
ation with the psychiatric clinics run by Himorogi Group in Japan. The AN-SAPO database includes Revised 17 March 2017
patients’ depression/anxiety score data from a mobile app named AN-SAPO and medical records from Accepted 29 March 2017
medical prescription software named ‘ORCA’. On the mobile app, depression/anxiety severity can be eval-
KEYWORDS
uated by answering 20 brief questions and the scores are transferred to the AN-SAPO database together Patient-reported outcome;
with the patients’ medical records on ORCA. Currently, this database is used at the Himorogi Group’s psy- app; post-marketing
chiatric clinics and has over 2000 patients’ records accumulated since November 2013. Since the database surveillance; database;
covers patients’ demographic data, prescribed drugs, and the efficacy and safety information, it could be pharmacovigilance
a useful supporting tool for decision-making in clinical practice. We expect it to be utilised in wider areas
of medical fields and for future pharmacovigilance and pharmacoepidemiological studies.

Introduction the Sheehan Patient-Rated Anxiety Scale (SPRAS) (Sheehan &

The number of patients with depression is rapidly increasing world-
wide, with an estimated 350 million people affected. Especially in
case of depression that is chronic and of moderate or severe inten-
sity, it may become a serious health condition (World Health
Organization 2016). The majority of patients with major depressive
disorder (MDD) present with typical anxiety symptoms.
Approximately 95% of MDD patients have psychological anxiety
symptoms and 85% have somatic anxiety symptoms (Hamilton
1983). Joffe et al. (1993) reported that MDD patients with high levels
of anxiety had greater severity of depressive illness and functional
impairment, and the Sequenced Treatment Alternatives to Relieve
Depression (STAR
D) study found that MDD with anxiety symptoms
had poorer acute outcomes than MDD without anxiety symptoms
following antidepressant treatment (Fava et al. 2008). In addition,
the presence of comorbid psychiatric conditions appears to have a
detrimental effect on the prognosis and outcome of medical ill-
nesses (Lecrubier 2001); hence, total care and total management of
these disorders or symptoms are essential to restore patients’ qual-
ity of life and alleviate the burden on the health services.
Scales of depression and anxiety symptoms
The 17-item Hamilton Rating Scale for Depression (HAM-D17)
(Hamilton 1960) and the Montgomery-Asberg Depression Rating
Scale (MADRS) (Montgomery & Asberg 1979) are the most widely
used instruments to measure the level of depression in clinical tri-
als. Anxiety scales that are used throughout the world include the
Hamilton Rating Scale for Anxiety (HAM-A) (Hamilton 1969) and
Harnett-Sheehan 1990). Since it takes considerable time to evalu-
ate depression/anxiety symptoms using these scales, however,
they are rarely used in clinical practice. To resolve this problem,
Himorogi Psychiatric Institute developed brief self-rating depres-
sion/anxiety scales (10 items for each scale) making the evaluation
of items in depression and anxiety scales that had been devel-
oped for Western culture applicable to Japanese culture (Himorogi
Self-Rating Depression Scale [HSDS]) (Mimura et al. 2011a) and
(Himorogi Self-Rating Anxiety Scale [HSAS]) (Mimura et al. 2011b).
Since the two scales provide patient-reported outcomes, they can
contribute to eliminating possible bias that can be caused by
observer-rated reports. In addition, the 10 items in each scale are
easy to answer, which makes them appropriate to be used in daily
clinical practice. High correlation was demonstrated between the
HSDS and the Japanese version of the HAM-D17, and between the
HSAS and the Japanese versions of the Hamilton Rating Scale for
the Anxiety Scale Interview Guide (HAMA-IG) (Bruss et al. 1994) as
well as the SPRAS. Cronbach’s alpha coefficients for the HSDS and
the HSAS were 0.85 (95% confidence interval [CI]: 0.82–0.88) and
0.87 (95% CI: 0.85–0.90), respectively, which showed sufficient reli-
ability (Mimura et al. 2011a, 2011b).
Unique database for gathering data from a mobile app,
named AN-SAPO and medical prescription software,
named ‘ORCA’
In 2013, Iwato Corp. and Japan Brain Corp. developed a unique
mobile app named ‘AN-SAPO mobile app’ (Iwato Corp. and Japan
Brain Corp. 2013), which is an abbreviation for ‘Anshin Sapo-to’ in

CONTACT Yoshinori Watanabe watanabe@himorogi.org Himorogi Psychiatric Institute, Ichigaya-Asukara Bldg. 1F-2F, 2-31-3 Ichigayatamachi, Shinjuku-ku,
Tokyo 162-0843, Japan.
ß 2017 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/Licenses/by-nc-nd/4.0/),
which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.

Figure 1. Image of AN-SAPO database. DB: database; ORCA: Online Receipt
Computer Advantage.
Japanese, meaning ‘relief support’ in English, on the basis of an
idea of one of the authors, Yoshinori Watanabe (head director of
Himorogi Psychiatric Institute) in response to needs in the after-
math of the 2011 Great East Japan Earthquake (Watanabe 2013).
With this app, users can evaluate their severity of depression/anx-
iety by answering the brief questions of HSDS/HSAS wherever
they are at any time, and their HSDS/HSAS scores are recorded on
the app. Users can also record the details of their medications
such as drug names and set alarms on their smartphones to
remind themselves of the time to take medications. It is also pos-
sible to follow sequential changes in the HSDS and HSAS scores
as well as changes in the number of medicines in graphs, and
compare these data with the averages of the total AN-SAPO users.
There are more than 20,000 users of this app in Japan (as of
January 2017). Iwato Corp. and Japan Brain Corp. also developed
a unique database named ‘AN-SAPO database’ (Figure 1), which
includes patients’ HSDS and HSAS scores collected with the AN-
SAPO mobile app (Iwato Corp. and Japan Brain Corp. 2013;
Watanabe 2013) and patient data collected from medical prescrip-
tion software named ‘ORCA’ (Online Receipt Computer
Advantage) (Japan Medical Association 2016), which is also used
as medical practitioners’ receipt for health insurance claim. ORCA,
which is used at 16,122 hospitals/clinics in Japan (as of 15
February 2017) (Japan Medical Association 2017), was launched by
Japan Medical Association in 2002 in the view to promoting
Information Technology in medical paperwork processing. Patient
information in ORCA such as prescription records can be collected
and anonymised to be used as data if patients’ consent and
approval by an institutional review board are obtained. As of
January 2017, the AN-SAPO database is used at the psychiatric
clinics run by Himorogi Group. More than 2000 patients’ data
have been accumulated since November 2013. This database cov-
ers patients’ demographic data, information on prescribed drugs,
efficacy (HSDS and HSAS) and safety data (adverse events).
Therefore, we expect that the database can be a useful data
source to collect and analyse patient-reported outcomes in com-
bination with receipt records. For this study, we obtained all
patients’ consent for secondary use of their data and our study
was approved by the internal Institutional Review Board. A total
of 1301 patients (female: 672; male: 629) who continued to visit
Himorogi Group’s psychiatric clinics for longer than 2 years with-
out an absence of more than 3 months were included (data
extraction date: 14 November 2015). The mean age (standard
deviation) was 48.56 (17.35) years. The number of patients (%) are
28 (2.2%) aged under 18 years, 573 (44.0%) aged 18–44 years, 464
(35.7%) aged 45–64 years and 236 (18.1%) aged 65 years and
older as of 31 October 2015.
INTERNATIONAL JOURNAL OF PSYCHIATRY IN CLINICAL PRACTICE 319
Examples of the utilisation of AN-SAPO database
The sequential changes in the HSDS and HSAS scores and infor-
mation on diagnoses, adverse events and prescribed drugs over
time collected in the AN-SAPO database can easily be visualised
using a JavaScript library for manipulating documents on the basis
of data (Data Driven Documents JavaScript [D3.js]) (D3.js 2015).
The classification of drugs (antidepressants, anti-anxiety drugs,
hypnotics and antipsychotics) was that defined by the MHLW
(Ministry of Health, Labour and Welfare in Japan 2016) of Japan.
Figure 2 is a sample graphic. Symptom changes (HSDS and HSAS
scores), prescribed drugs and the occurrence of adverse events
can be visually determined for each patient. The monitoring data
are useful as a supporting decision-making tool for prescribing
doctors.
Database research and conventional post-marketing
surveillance
Pharmacoepidemiological studies using various types of database
(e.g., claims database and medical record database) have recently
attracted attention as a means of evaluating the safety and effi-
cacy of drugs in Western countries (Japan Pharmaceutical
Manufacturers Association 2009). In Japan, however, the conven-
tional methodology of uncontrolled, prospective and observa-
tional research is still standard for pharmaceutical company-
sponsored post-marketing surveillance (PMS) to collect safety and
efficacy information on new drugs, regardless of the individual
research question, because the Ministry of Health, Labour and
Welfare (MHLW) of Japan mandates the conduct of PMS of new
drugs. Most PMS research has been conducted on thousands of
subjects, even after the Guideline on Pharmacovigilance Planning
(International Conference on Harmonisation [ICH]-E2E) (ICH
Steering Committee 2004) based on international consensus was
officially released in 2004 (Narukawa 2014). Conventional PMS is
not cost-effective at all, because it requires huge expenses and
human resources, and puts an enormous burden on healthcare
providers and pharmaceutical companies compared to the benefit
obtained from the results. Furthermore, with conventional PMS,
‘selection bias’ is an unavoidable matter because investigational
sites are selected by the sponsor and enrolled patients are
selected by physicians contracted by the sponsor. In addition,
data obtained from clinical trials for drug development are limited
because clinical trials involve limitations known as ‘Five Toos’, that
is, (1) too few, (2) too simple, (3) too median-aged, (4) too narrow
and (5) too brief (Rogers 1987). Therefore, a system of collecting
prescription, safety and efficacy information of drugs in actual
clinical practice after launch and providing appropriate feedback
to patients is essential to evaluate the actual value of new drugs
and promote their proper use.
Considering such background, the AN-SAPO database may also
be useful as a pharmacovigilance tool for pharmaceutical compa-
nies since efficacy and safety data can be collected simultaneously
and the effect of drug switching and augmentation can be exam-
ined. Comparison of the efficacy and safety of the target and
other similar drugs also becomes possible.
Limitations
Limitations of the AN-SAPO database include the presence of
unstructured data and narrative fields that have not been
extracted, the lack of information on the prescribed dose of each
drug, which makes it impossible to examine the effect of dose
increases or decreases visually, and the absence of efficient
320 Y. WATANABE ET AL.

2014 Apr. Jul. Oct. 2015 Apr. Jul. Oct.

40
HSDS 30
HSAS
20

10

0
Depressive state
Panic disorder
Spasm
Dizziness
Suspect of malignant syndrome
Suspect of Hashimoto's disease
Dysmenorrhea
Hypothyroidism
Headache
Insomnia
Chronic gastris
Sensivity to cold
Sertraline 25 mg
Andepressants
An-anxiety drugs Alprazolam 0.4 mg
Anemecs Lorazepam 0.5 mg
Other drugs Mosapride 5 mg
Tsumura-Kampo Kamishoyosan
Tsumura-Kampo Kanbakutaisoto
Tsumura-Kampo Goreisan
Tsumura-Kampo Gosyuyuto
Tsumura-Kampo Saikokeishikankyoto
Tsumura-Kampo Hangekobokuto

Figure 2. A sample graphic of changes in the HSDS and HSAS scores with information on diagnoses, adverse events and prescribed drugs over time. Diagnoses are
depressive state and panic disorder. HSDS: Himorogi Self-Rating Depression Scale; HSAS: Himorogi Self-Rating Anxiety Scale.

information such as the duration of the underlying diseases and for future pharmacovigilance and pharmacoepidemiological
the course of adverse events. These points need to be improved studies.
to use this database more efficiently for pharmacovigilance and
pharmacoepidemiological studies in the future.
Geolocation information

Future perspective This study was conducted in Japan.

This is the first report introducing AN-SAPO, a unique database

that collects data from both a mobile app and medical prescrip-
tion software. Despite the above-mentioned limitations, the AN-
SAPO database could become not only a supporting tool for deci-
sion-making in clinical practice but also a potentially useful data
source as a pharmacovigilance tool for pharmaceutical companies.
Moreover, the use of modern technology such as mobile apps
and database software in clinical practice may play an important
role in the psychiatric field as well as in other areas of medical
treatment. For example, depressive symptoms that might be
caused by somatic diseases such as cancer, diabetes or heart dis-
ease (Polsky et al. 2005; Patten et al. 2016) could be detected/
treated more easily when patient data become available as a com-
mon tool between psychiatrists and physicians in other medical
fields through the utilisation of modern technology. So far, this
database has been used only at limited psychiatric clinics, but we
expect it to be used in wider areas of medical fields for preven-
tion and treatment of psychiatric diseases such as depression and
Acknowledgements
We would like to thank Mr. Yasutaka Yamamoto of Megumi Inc.
and Mr. Kazutaka Onodera of Japan Brain Corp. for extracting and
cleaning of data.
Disclosure statement
Yoshinori Watanabe is the originator of the AN-SAPO mobile app
as well as AN-SAPO database, and the head director of Himorogi
Group. Yoshinori Watanabe has received speaker’s honoraria from
Pfizer Japan Inc., GlaxoSmithKline K.K., Otsuka Pharmaceutical Co.,
Ltd., Janssen Pharmaceutical K.K., Meiji Seika Pharma Co., Ltd., Eli
Lilly Japan K.K., MSD K.K., a subsidiary of Merck & Co., Inc., Takeda
Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd.,
Mitsubishi Tanabe Pharma Corp. and Sumitomo Dainippon
Pharma Co., Ltd. within the past 5 years. Yoko Hirano, Yuko

Asami, Maki Okada and Kazuya Fujita are employees of Pfizer
Japan Inc., which funded the study.
Funding
This work was supported by Pfizer Japan Inc.
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