![RESEARCH ARTICLE
A pilot study to determine the feasibility of
enhancing cognitive abilities in children with
sensory processing dysfunction
Joaquin A. Anguera1,2☯
*, Anne N. Brandes-Aitken1☯
, Ashley D. Antovich1
, Camarin
E. Rolle1
, Shivani S. Desai1
, Elysa J. Marco1,2,3
1 Department of Neurology, University of California, San Francisco, United States of America, 2 Department
of Psychiatry, University of California, San Francisco, United States of America, 3 Department of Pediatrics,
University of California, San Francisco, United States of America
☯ These authors contributed equally to this work.
* joaquin.anguera@ucsf.edu
Abstract
Children with Sensory Processing Dysfunction (SPD) experience incoming information in
atypical, distracting ways. Qualitative challenges with attention have been reported in these
children, but such difficulties have not been quantified using either behavioral or functional
neuroimaging methods. Furthermore, the efficacy of evidence-based cognitive control inter-
ventions aimed at enhancing attention in this group has not been tested. Here we present
work aimed at characterizing and enhancing attentional abilities for children with SPD. A
sample of 38 SPD and 25 typically developing children were tested on behavioral, neural,
and parental measures of attention before and after a 4-week iPad-based at-home cognitive
remediation program. At baseline, 54% of children with SPD met or exceeded criteria on a
parent report measure for inattention/hyperactivity. Significant deficits involving sustained
attention, selective attention and goal management were observed only in the subset of
SPD children with parent-reported inattention. This subset of children also showed reduced
midline frontal theta activity, an electroencephalographic measure of attention. Following
the cognitive intervention, only the SPD children with inattention/hyperactivity showed both
improvements in midline frontal theta activity and on a parental report of inattention. Notably,
33% of these individuals no longer met the clinical cut-off for inattention, with the parent-
reported improvements persisting for 9 months. These findings support the benefit of a
targeted attention intervention for a subset of children with SPD, while simultaneously
highlighting the importance of having a multifaceted assessment for individuals with neuro-
developmental conditions to optimally personalize treatment.
Introduction
Five percent of all children suffer from Sensory Processing Dysfunction (SPD)[1], with these
individuals exhibiting exaggerated aversive, withdrawal, or seeking behaviors associated with
sensory inputs [2]. These sensory processing differences can have significant and lifelong con-
sequences for learning and social abilities, and are often shared by children who meet
PLOS ONE | https://doi.org/10.1371/journal.pone.0172616 April 5, 2017 1 / 19
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OPEN ACCESS
Citation: Anguera JA, Brandes-Aitken AN, Antovich
AD, Rolle CE, Desai SS, Marco EJ (2017) A pilot
study to determine the feasibility of enhancing
cognitive abilities in children with sensory
processing dysfunction. PLoS ONE 12(4):
e0172616. https://doi.org/10.1371/journal.
pone.0172616
Editor: Jacobus P. van Wouwe, TNO,
NETHERLANDS
Received: October 5, 2016
Accepted: February 1, 2017
Published: April 5, 2017
Copyright: © 2017 Anguera et al. This is an open
access article distributed under the terms of the
Creative Commons Attribution License, which
permits unrestricted use, distribution, and
reproduction in any medium, provided the original
author and source are credited.
Data Availability Statement: All relevant data are
within the paper and its Supporting Information
files.
Funding: This work was supported by the
Mickelson-Brody Family Foundation, the Wallace
Research Foundation, the James Gates Family
Foundation, the Kawaja-Holcombe Family
Foundation (EJM), and the SNAP 2015 Crowd
funding effort.
•감각처리장애(SPD)를 가진 소아 환자 중 ADHD를 가진 20명에 대해서 실험
•4주 동안 (주당 5일, 25분)Project EVO 게임을 하게 한 결과,
•20명 중 7명이 큰 개선을 보여서 더 이상 ADHD의 범주에 들지 않게 됨
•사용 후 적어도 9개월 동안 효과가 지속되었음
Fig 4. Transfer effect on behavioral and parent report measures. Pre and post (A) response time (B) and respo
revealing within group change. Error bars indicate standard error of the mean. Within group main effects of session
= p .05, ** =.p .01. Sun symbols indicate statistically significant instances where SPD+IA post-training performa
TDC group prior to training. (C) Vanderbilt parent report inattention change bar plot (calculated by pre-post margina
significant group x session interaction. Error bars indicate standard error of the mean. All group x session interactio
stars (* = p .05, ** =.p .01) on bar graph.
https://doi.org/10.1371/journal.pone.0172616.g004
PLOS ONE | https://doi.org/10.1371/journal.pone.0172616 April 5, 2017](https://image.slidesharecdn.com/digitalthearapeuticsunchartedterritory181120-181122143829/85/slide-68-320.jpg)
![The Effect of a Smartphone-Based,
Patient-Centered Diabetes Care
System in Patients With Type 2
Diabetes: A Randomized,
Controlled Trial for 24 Weeks
https://doi.org/10.2337/dc17-2197
OBJECTIVE
Thisstudyevaluatedtheefficacyofasmartphone-based,patient-centered diabetes
care system (mDiabetes) for type 2 diabetes that contains comprehensive modules
forglucosemonitoring,diet,physicalactivity,andaclinicaldecisionsupportsystem.
RESEARCH DESIGN AND METHODS
We conducted a 24-week, multicenter, randomized controlled trial with adult
patients with inadequately controlled type 2 diabetes. The patients were randomly
assigned to the mDiabetes group or the paper logbook (pLogbook) group. The
primary end point was the difference of the change in HbA1c from baseline between
the two groups.
RESULTS
HbA1c reductionfrombaselinewasgreaterinthemDiabetesgroup(20.4060.09%,
n = 90) than in the pLogbook group (20.06 6 0.10%, n = 82). The difference of
adjusted mean changes was 0.35% (95% CI 0.14–0.55, P = 0.001). The proportion
of patients whose HbA1c fell below 7.0% (53 mmol/mol) was 41.1% for the mDia-
betes group and 20.7% for the pLogbook group (odds ratio [OR] 2.01, 95% CI 1.24–
3.25, P = 0.003). The percentage of patients who attained HbA1c levels below 7.0%
(53 mmol/mol) without hypoglycemia was 31.1% in the mDiabetes group and
17.1% in the pLogbook group (OR 1.82, 95% CI 1.03–3.21, P = 0.024). There was no
difference in the event numbers of severe hyperglycemia and hypoglycemia be-
tween the two groups.
CONCLUSIONS
The implementation of the mDiabetes for patients with inadequately controlled
type 2 diabetes resulted in a significant reduction in HbA1c levels, with tolerable
safety profiles.
Diabetes is a chronic disease requiring lifelong management with lifestyle modifi-
cation, medication, or both; therefore, diabetes self-management education and
adherence to the treatment plans are considered key components in the manage-
ment of diabetes (1). As information technology (IT) advances, medical services us-
ing IT devices, such as mobile health care (mHealth) systems, have been developed
to aid chronic disease management. Currently, ;259,000 mHealth applications are
1
International Healthcare Center, Seoul National
University Hospital, Seoul, Korea
2
Department of Internal Medicine, Seoul Na-
tional University College of Medicine, Seoul,
Korea
3
Department of Internal Medicine, Boramae
Medical Center, Seoul, Korea
4
Department of Internal Medicine, Seoul Na-
tional University Bundang Hospital, Seongnam,
Korea
Correspondingauthor:YoungMinCho,ymchomd@
snu.ac.kr.
Received 19 October 2017 and accepted 1
October 2019.
Clinical trial reg. no. NCT02451631, clinicaltrials
.gov.
This article contains Supplementary Data online
at http://care.diabetesjournals.org/lookup/suppl/
doi:10.2337/dc17-2197/-/DC1.
© 2018 by the American Diabetes Association.
Readers may use this article as long as the work
is properly cited, the use is educational and not
for profit, and the work is not altered. More infor-
mation is available at http://www.diabetesjournals
.org/content/license.
Eun Ky Kim,1,2
Soo Heon Kwak,2
Hye Seung Jung,2
Bo Kyung Koo,2,3
Min Kyong Moon,2,3
Soo Lim,2,4
Hak Chul Jang,2,4
Kyong Soo Park,2
and
Young Min Cho2
Diabetes Care 1
CLINCARE/EDUCATION/NUTRITION/PSYCHOSOCIAL
Diabetes Care Publish Ahead of Print, published online October 30, 2018
• 헬스커넥트의 당뇨 관리 앱이 2형 당뇨의 관리에 효과가 있음을 증명
• 총 환자 172명 (실험군: 대조군=90:82), 24주, multi-center, RCT](https://image.slidesharecdn.com/digitalthearapeuticsunchartedterritory181120-181122143829/85/slide-102-320.jpg)
![ORIGINAL ARTICLE
Virtual Reality as an Adjunctive Non-pharmacologic
Analgesic for Acute Burn Pain During Medical Procedures
Hunter G. Hoffman, PhD & Gloria T. Chambers, RN & Walter J. Meyer III, MD, PhD &
Lisa L. Arceneaux, PhD & William J. Russell, MS & Eric J. Seibel, PhD &
Todd L. Richards, PhD & Sam R. Sharar, MD & David R. Patterson, PhD
Published online: 25 January 2011
# The Society of Behavioral Medicine 2011
Abstract
Introduction Excessive pain during medical procedures
is a widespread problem but is especially problematic
during daily wound care of patients with severe burn
injuries.
Methods Burn patients report 35–50% reductions in pro-
cedural pain while in a distracting immersive virtual reality,
and fMRI brain scans show associated reductions in pain-
related brain activity during VR. VR distraction appears to
be most effective for patients with the highest pain intensity
levels. VR is thought to reduce pain by directing patients’
attention into the virtual world, leaving less attention
available to process incoming neural signals from pain
receptors.
Conclusions We review evidence from clinical and labora-
tory research studies exploring Virtual Reality analgesia,
concentrating primarily on the work ongoing within our
group. We briefly describe how VR pain distraction systems
have been tailored to the unique needs of burn patients to
date, and speculate about how VR systems could be tailored
to the needs of other patient populations in the future.
Keywords Virtual reality. Pain distraction . Analgesia
Introduction
The Problem: Uncontrolled Pain
The treatment of severely burn-injured patients is one of the
most painful processes in medicine. Few injuries involve
more painful and numerous procedures than severe burns.
In the USA, each year, an estimated 700,000 people visit
the emergency room for treatment of burns. Of these,
45,000 have burns significant enough to require inpatient
hospitalization [1]. In order to prevent infection and
promote healing, patients with severe burns typically must
have their bandages removed and have their wounds
cleaned daily for weeks or even months. During cleaning/
debridement, foreign materials and dead tissue are removed
from the open wound, antiseptic ointments are applied, and
the wound is re-dressed/re-bandaged. These wound care
sessions allow caregivers to look at the wound and monitor
healing progress. Surgeons may need to surgically remove
damaged skin and transplant fresh skin from another part of
the body, e.g., the patient’s own unburned thigh to their
burned hands, or in some cases, with donated skin from a
cadaver. Once the graft takes hold on the burn site, staples
or other adhesive devices that have been temporarily
Electronic supplementary material The online version of this article
(doi:10.1007/s12160-010-9248-7) contains supplementary material,
which is available to authorized users.
H. G. Hoffman :G. T. Chambers :E. J. Seibel :T. L. Richards :
S. R. Sharar :D. R. Patterson
University of Washington,
Seattle, WA, USA
W. J. Meyer III :L. L. Arceneaux :W. J. Russell
University of Texas Medical Branch and Shriners Children’s
Hospital Galveston TX,
Galveston, TX, USA
H. G. Hoffman (*)
Human Interface Technology Laboratory, Human Photonics Lab,
and Department of Mechanical Engineering,
University of Washington,
Seattle, WA, USA
e-mail: hunter@hitL.washington.edu
H. G. Hoffman
e-mail: hunthoff@uw.edu
URL: www.vrpain.com
ann. behav. med. (2011) 41:183–191
DOI 10.1007/s12160-010-9248-7
• 화상 환자에서 VR의 진통 효과는 여러 연구로 입증되고 있음
• 30-50%의 진통 경감 효과가 보고
• fMRI 결과 VR로 통증과 관련된 brain activity가 낮아짐
• 특히, VR은 highest pain intensity level 의 환자에게 효과적](https://image.slidesharecdn.com/digitalthearapeuticsunchartedterritory181120-181122143829/85/slide-125-320.jpg)
![ORIGINAL ARTICLE
Virtual Reality as an Adjunctive Non-pharmacologic
Analgesic for Acute Burn Pain During Medical Procedures
Hunter G. Hoffman, PhD & Gloria T. Chambers, RN & Walter J. Meyer III, MD, PhD &
Lisa L. Arceneaux, PhD & William J. Russell, MS & Eric J. Seibel, PhD &
Todd L. Richards, PhD & Sam R. Sharar, MD & David R. Patterson, PhD
Published online: 25 January 2011
# The Society of Behavioral Medicine 2011
Abstract
Introduction Excessive pain during medical procedures
is a widespread problem but is especially problematic
during daily wound care of patients with severe burn
injuries.
Methods Burn patients report 35–50% reductions in pro-
cedural pain while in a distracting immersive virtual reality,
and fMRI brain scans show associated reductions in pain-
related brain activity during VR. VR distraction appears to
be most effective for patients with the highest pain intensity
levels. VR is thought to reduce pain by directing patients’
attention into the virtual world, leaving less attention
available to process incoming neural signals from pain
receptors.
Conclusions We review evidence from clinical and labora-
tory research studies exploring Virtual Reality analgesia,
concentrating primarily on the work ongoing within our
group. We briefly describe how VR pain distraction systems
have been tailored to the unique needs of burn patients to
date, and speculate about how VR systems could be tailored
to the needs of other patient populations in the future.
Keywords Virtual reality. Pain distraction . Analgesia
Introduction
The Problem: Uncontrolled Pain
The treatment of severely burn-injured patients is one of the
most painful processes in medicine. Few injuries involve
more painful and numerous procedures than severe burns.
In the USA, each year, an estimated 700,000 people visit
the emergency room for treatment of burns. Of these,
45,000 have burns significant enough to require inpatient
hospitalization [1]. In order to prevent infection and
promote healing, patients with severe burns typically must
have their bandages removed and have their wounds
cleaned daily for weeks or even months. During cleaning/
debridement, foreign materials and dead tissue are removed
from the open wound, antiseptic ointments are applied, and
the wound is re-dressed/re-bandaged. These wound care
sessions allow caregivers to look at the wound and monitor
healing progress. Surgeons may need to surgically remove
damaged skin and transplant fresh skin from another part of
the body, e.g., the patient’s own unburned thigh to their
burned hands, or in some cases, with donated skin from a
cadaver. Once the graft takes hold on the burn site, staples
or other adhesive devices that have been temporarily
Electronic supplementary material The online version of this article
(doi:10.1007/s12160-010-9248-7) contains supplementary material,
which is available to authorized users.
H. G. Hoffman :G. T. Chambers :E. J. Seibel :T. L. Richards :
S. R. Sharar :D. R. Patterson
University of Washington,
Seattle, WA, USA
W. J. Meyer III :L. L. Arceneaux :W. J. Russell
University of Texas Medical Branch and Shriners Children’s
Hospital Galveston TX,
Galveston, TX, USA
H. G. Hoffman (*)
Human Interface Technology Laboratory, Human Photonics Lab,
and Department of Mechanical Engineering,
University of Washington,
Seattle, WA, USA
e-mail: hunter@hitL.washington.edu
H. G. Hoffman
e-mail: hunthoff@uw.edu
URL: www.vrpain.com
ann. behav. med. (2011) 41:183–191
DOI 10.1007/s12160-010-9248-7
dental/periodontal procedures in patients with dental fears
[47, 48], and VR reduced fear/anxiety in a claustrophobic
patient during a brain scan [49]. VR has reduced pain
during a urological procedure in an older man receiving
endoscopic transurethral microwave thermotherapy ablation
of the prostate [50], and in pediatric cerebral palsy patients
during painful physical therapy rehabilitation after single
event multilevel surgery to increase ambulation [51]. VR
has reduced discomfort during subcutaneous vascular port
access and venipuncture in children and adolescents with
cancer [52, 53], and VR reduced pain in children getting
venipuncture in general [54]. A growing number of
researchers using a variety of distraction software have
TBSA, were studied for 10 days each. Occupational and
physical therapists orchestrated passive range of motion
exercises with each patient for 5 days during VR compared
with similar treatment for 5 days without VR. Treatment order
was randomized. Some patients received 5 days of physical
therapy with VR vs. 5 days with no VR, and others received
5 days of no VR followed by 5 days of VR. Results showed
large reductions in worst pain intensity (approximately 45%
reduction in worst pain), pain unpleasantness, and time spent
thinking about pain, and more fun during VR compared with
no VR during the 25-min VR treatments per day, for 5 days in
a row per patient [61]. There was no diminishment in
analgesic effectiveness over the 5 day period (see Fig. 4),
Fig. 4 Pediatric burn patient in
virtual reality during passive
range of motion exercises. The
VR helmet shown has high-
technology 80° diagonal field of
view goggle views of the virtual
world, as seen by the patient.
(Photo credit—left photo by
Hunter Hoffman, www.vrpain.
com)
• 소아 화상 환자 7명에 대한 파일럿 (TBSA: 45%-82%)
• 5일 동안의 w/ VR 과, 5일 동안의 w/o VR을 비교 (순서는 랜덤)
• 결과: worst pain intensity에 큰 경감 (평균 45%)
• 5일 동안에 진통 효과에 큰 변화 없음
• 다만, 더 장기적이고 더 큰 규모의 임상 연구가 필요 (2011년 기준..)
• 또한, 기존의 마약성 진통제와 비교임상을 한 정도의 근거는 아직 없는듯](https://image.slidesharecdn.com/digitalthearapeuticsunchartedterritory181120-181122143829/85/slide-126-320.jpg)
Uploaded byYoon Sup Choi
디지털 신약, 누구도 가보지 않은 길
Professor Yoon Sup Choi summarizes digital therapeutics as an uncharted territory. He discusses how artificial intelligence is revolutionizing the traditionally conservative medical system. Digital therapeutics, also known as digital drugs or digiceuticals, have the potential to either replace or augment traditional pharmaceuticals. Major pharmaceutical companies are increasingly investing in digital health startups developing digital therapeutics. If approved by regulators, digital therapeutics could become a third category of treatment alongside chemicals and proteins.
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디지털 신약, 누구도 가보지 않은 길
- 1. Professor, SAHIST, SungkyunkwanUniversity Director, Digital Healthcare Institute Yoon Sup Choi, Ph.D. Digital Therapeutics, the Uncharted Territory 디지털 신약, 누구도 가보지 않은 길
- 2. “It's in Apple'sDNA that technology alone is not enough. It's technology married with liberal arts.”
- 3. The Convergence ofIT, BT and Medicine
- 5. 최윤섭 지음 의료인공지능 표지디자인•최승협 컴퓨터 털 헬 치를만드는 것을 화두로 기업가, 엔젤투자가, 에반 의 대표적인 전문가로, 활 이 분야를 처음 소개한 장 포항공과대학교에서 컴 동 대학원 시스템생명공 취득하였다. 스탠퍼드대 조교수, KT 종합기술원 컨 구원 연구조교수 등을 거 저널에 10여 편의 논문을 국내 최초로 디지털 헬스 윤섭 디지털 헬스케어 연 국내 유일의 헬스케어 스 어 파트너스’의 공동 창업 스타트업을 의료 전문가 관대학교 디지털헬스학과 뷰노, 직토, 3billion, 서지 소울링, 메디히어, 모바일 자문을 맡아 한국에서도 고 있다. 국내 최초의 디 케어 이노베이션』에 활발 을 연재하고 있다. 저서로 와 『그렇게 나는 스스로 •블로그_ http://www •페이스북_ https://w •이메일_ yoonsup.c 최윤섭 의료 인공지능은 보수적인 의료 시스템을 재편할 혁신을 일으키고 있다. 의료 인공지능의 빠른 발전과 광범위한 영향은 전문화, 세분화되며 발전해 온 현대 의료 전문가들이 이해하기가 어려우며, 어디서부 터 공부해야 할지도 막연하다. 이런 상황에서 의료 인공지능의 개념과 적용, 그리고 의사와의 관계를 쉽 게 풀어내는 이 책은 좋은 길라잡이가 될 것이다. 특히 미래의 주역이 될 의학도와 젊은 의료인에게 유용 한 소개서이다. ━ 서준범, 서울아산병원 영상의학과 교수, 의료영상인공지능사업단장 인공지능이 의료의 패러다임을 크게 바꿀 것이라는 것에 동의하지 않는 사람은 거의 없다. 하지만 인공 지능이 처리해야 할 의료의 난제는 많으며 그 해결 방안도 천차만별이다. 흔히 생각하는 만병통치약 같 은 의료 인공지능은 존재하지 않는다. 이 책은 다양한 의료 인공지능의 개발, 활용 및 가능성을 균형 있 게 분석하고 있다. 인공지능을 도입하려는 의료인, 생소한 의료 영역에 도전할 인공지능 연구자 모두에 게 일독을 권한다. ━ 정지훈, 경희사이버대 미디어커뮤니케이션학과 선임강의교수, 의사 서울의대 기초의학교육을 책임지고 있는 교수의 입장에서, 산업화 이후 변하지 않은 현재의 의학 교육 으로는 격변하는 인공지능 시대에 의대생을 대비시키지 못한다는 한계를 절실히 느낀다. 저와 함께 의 대 인공지능 교육을 개척하고 있는 최윤섭 소장의 전문적 분석과 미래 지향적 안목이 담긴 책이다. 인공 지능이라는 미래를 대비할 의대생과 교수, 그리고 의대 진학을 고민하는 학생과 학부모에게 추천한다. ━ 최형진, 서울대학교 의과대학 해부학교실 교수, 내과 전문의 최근 의료 인공지능의 도입에 대해서 극단적인 시각과 태도가 공존하고 있다. 이 책은 다양한 사례와 깊 은 통찰을 통해 의료 인공지능의 현황과 미래에 대해 균형적인 시각을 제공하여, 인공지능이 의료에 본 격적으로 도입되기 위한 토론의 장을 마련한다. 의료 인공지능이 일상화된 10년 후 돌아보았을 때, 이 책 이 그런 시대를 이끄는 길라잡이 역할을 하였음을 확인할 수 있기를 기대한다. ━ 정규환, 뷰노 CTO 의료 인공지능은 다른 분야 인공지능보다 더 본질적인 이해가 필요하다. 단순히 인간의 일을 대신하는 수준을 넘어 의학의 패러다임을 데이터 기반으로 변화시키기 때문이다. 따라서 인공지능을 균형있게 이 해하고, 어떻게 의사와 환자에게 도움을 줄 수 있을지 깊은 고민이 필요하다. 세계적으로 일어나고 있는 이러한 노력의 결과물을 집대성한 이 책이 반가운 이유다. ━ 백승욱, 루닛 대표 의료 인공지능의 최신 동향뿐만 아니라, 의의와 한계, 전망, 그리고 다양한 생각거리까지 주는 책이다. 논쟁이 되는 여러 이슈에 대해서도 저자는 자신의 시각을 명확한 근거에 기반하여 설득력 있게 제시하 고 있다. 개인적으로는 이 책을 대학원 수업 교재로 활용하려 한다. ━ 신수용, 성균관대학교 디지털헬스학과 교수 최윤섭지음 의료인공지능 값 20,000원 ISBN 979-11-86269-99-2 최초의 책! 계 안팎에서 제기 고 있다. 현재 의 분 커버했다고 자 것인가, 어느 진료 제하고 효용과 안 누가 지는가, 의학 쉬운 언어로 깊이 들이 의료 인공지 적인 용어를 최대 서 다른 곳에서 접 를 접하게 될 것 너무나 빨리 발전 책에서 제시하는 술을 공부하며, 앞 란다. 의사 면허를 취득 저가 도움되면 좋 를 불러일으킬 것 화를 일으킬 수도 슈에 제대로 대응 분은 의학 교육의 예비 의사들은 샌 지능과 함께하는 레이닝 방식도 이 전에 진료실과 수 겠지만, 여러분들 도생하는 수밖에 미래의료학자 최윤섭 박사가 제시하는 의료 인공지능의 현재와 미래 의료 딥러닝과 IBM 왓슨의 현주소 인공지능은 의사를 대체하는가 값 20,000원 ISBN 979-11-86269-99-2 레이닝 방식도 이 전에 진료실과 수 겠지만, 여러분들 도생하는 수밖에 소울링, 메디히어, 모바일 자문을 맡아 한국에서도 고 있다. 국내 최초의 디 케어 이노베이션』에 활발 을 연재하고 있다. 저서로 와 『그렇게 나는 스스로 •블로그_ http://www •페이스북_ https://w •이메일_ yoonsup.c
- 7. Inevitable Tsunami ofChange
- 8.
- 9. • "2018년 3Q는역대 최고로 투자 받기 좋은 시기였다” • 2018년 3Q에서 이미 2017년 투자 규모를 능가 • 모든 라운드에서 더 높은 빈도로, 더 큰 금액이 투자되는 entrepreneurs’ market
- 10.
- 11. •최근 3년 동안Merck, J&J, GSK 등의 제약사들의 디지털 헬스케어 분야 투자 급증 •2015-2016년 총 22건의 deal (=2010-2014년의 5년간 투자 건수와 동일) •Merck 가 가장 활발: 2009년부터 Global Health Innovation Fund 를 통해 24건 투자 ($5-7M) •GSK 의 경우 2014년부터 6건 (via VC arm, SR One): including Propeller Health
- 12. AnalysisTarget Discovery AnalysisLeadDiscovery Clinical Trial Post Market Surveillance Digital Healthcare in Drug Development
- 13. AnalysisTarget Discovery AnalysisLeadDiscovery Clinical Trial Post Market Surveillance Digital Healthcare in Drug Development •개인 유전 정보 분석 •블록체인 기반 유전체 분석 •딥러닝 기반 후보 물질 •인공지능+제약사 •환자 모집 •데이터 측정: 웨어러블 •디지털 표현형 •복약 순응도 •SNS 기반의 PMS •블록체인 기반의 PMS
- 14. AnalysisTarget Discovery AnalysisLeadDiscovery Clinical Trial Post Market Surveillance Digital Healthcare in Drug Development •개인 유전 정보 분석 •블록체인 기반 유전체 분석 •딥러닝 기반 후보 물질 •인공지능+제약사 •환자 모집 •데이터 측정: 웨어러블 •디지털 표현형 •복약 순응도 •SNS 기반의 PMS •블록체인 기반의 PMS + Digital Therapeutics
- 15. • Pear Therapeutics •노바티스는 시리즈A (2016.2)이어, 시리즈B (2018.1) 펀딩에도 참여 • 테마섹에서 리드 (테마섹은 Akili 시리즈B도 리드)
- 16. • Pear Therapeutics •노바티스와 schizophrenia 및 MS 관련 digital therapeutics 개발 협력 (2018.3) • 산도스 (노바티스 제네릭 부서)와는 reSET, reSET-O 의 개발/사업화 협력 (2018.4)
- 17. • Pear Therapeutics •2018년 11월 20일, 노바티스와 산도스를 통해서 reSET 을 시장 출시 • 현재, 인허가 및 시장 출시된 유일한 digital therapeutics • 12-week (90-day) prescription digital therapeutic to be used in conjunction with outpatient clinician-delivered care.
- 18. •Akili Interactive •2016년 7월,$42.4m 규모의 Series B 펀딩 (암젠, 머크 등이 참여) •2018년 5월, $55m 규모의 Series C 펀딩 (암젠, 머크 등이 참여) •2018년 연내로 FDA 승인을 받는 것이 목표였으나, 2019년에 결정될 것으로 예상 •2018년 11월 기준, FDA 리뷰 중
- 19. • Click Therapeutics •사노피 벤처스에서 $17M 규모의 Venture Round 를 리드 (2018.7) • depression, insomnia, acute coronary syndrome, and chronic pain.
- 20.
- 21. •Digiceutical = digital+ pharmaceutical •"chemical 과 protein에 이어서 digital drug 이 세번째 종류의 신약이 될 것이다” •digital drug 은 크게 두 가지 종류 •기존의 약을 아예 대체 •기존 약을 강화(augment)
- 22. "The Birth ofPrescription Digital Therapeutics," Pear Therapeutics and InCrowd, IIeX 2018”
- 23. DTxDM East (2018.10at Boston)
- 24. “치료 효과가 있는‘게임’이 아니라, ‘치료제’가 (어쩌다보니) 게임의 형식을 가진 것이다” by Eddie Martucci, CEO of Akili Interactive, at DTxDM East 2018
- 25. Digital Therapeutics, 약인가 치료기기인가? •DigitalTherapeutics는 새로운 종류의 ‘약’으로 보는 것이 맞다. •이미 업계의 consensus가 그러하며, 모든 논의가 이 개념을 기반. •그래서 국문으로는 ‘디지털 신약’으로 번역하는 것이 좋다고 생각함.
- 26.
- 27. Day 1. Tuesday,September 25th 2018 8:00 Registration, Breakfast & Networking Defining the Commercial Opportunities for Digital Therapeutics & Digital Medicine 9:00 Chair’s Opening Remarks & Setting the Scene ● How has the industry progressed since DTxDM West? ● What should we expect to have learnt by the end of DTxDM East? Edward Cox, Chief Executive Officer, Dthera Sciences 9:15 Fireside Chat: Pear Therapeutics and Novartis An exclusive look into the partnership on everyone's minds. This is an unprecedented opportunity to discover more about this groundbreaking collaboration, by hearing a first hand account from the leading executives on both sides of the partnership. This fireside chat will be shaped around key themes, including: ● Understand how the Pear-Novartis collaboration came to be ● What are the unique challenges facing Novartis when trying to integrate digital therapy methodologies? ● Once a partnership is established, how is this operationalized as a commercial product to sell - is there a need for a new division within Pharma to be created? ● How do Pear currently view the day-to-day working relationship with Novartis? ● Do we expect to see more Pharmaceutical companies following Novartis’ lead? Yuri Maricich, Chief Medical Officer & Head of Clinical Development, Pear Therapeutics Joris van Dam, Executive Director, Head of Digital Therapeutics, Novartis 9:45 Opportunities and Challenges in using the Specialty Pharmacy Model to Increase Adherence, Outcomes, and Produce RWE for Digital Therapeutics ● The number of precision medicines and specialty type therapies currently in development has risen dramatically, as is the development of companion digital therapeutics to clinical treatments. ● On the commercial side of the house the number of specialty therapy brand teams who are looking to implement solutions to better assess new patients for risk and deploy personalized digital care is rising. In Defining How to Achieve Commercial and Patient Success with Digital Therapeutics San Mateo, CA | February 26th-28th, 2019 Workshop 1, Tuesday February 26th 2019 Workshop 1: Digital Therapeutics 101 As the digital therapeutics industry continues to swell with its growing pioneers, the next wave of innovators and new sectors entering into the space, there is a need for newcomers to have their fundamental questions answered. Led by pioneers of the industry, this deep-dive workshop will provide newcomers to the digital therapeutics industry the opportunity to be fully clued up on the basics and primed for the main conference. Workshop Leaders: Jeffrey Abraham, Vice President, Market Access & Trade, Akili Interactive Anil Jina, Senior Vice President, Head of Medical Affairs, Akili Interactive Agenda: 9:00 Presentation: What is the Current State of Play with the Digital Therapeutics Industry? ● How has the digital therapeutics industry got to this point in its history? ● What are the current definitions and main sectors involved in digital therapeutic development and adoption? 9:30 Breakout Discussions: Splitting into smaller working groups, each group will discuss their current views on digital therapeutics as a concept and their views on the different facets of the industry. - Are we comfortable with the definition of a digital therapeutic? - Generally speaking, how do payers, pharma and regulatory authorities view digital therapeutics? - What lessons can we draw on from working with other related industries? - What are our thoughts on the other similar digital medicine approaches out there? - What remaining questions do we have about digital therapeutics? 하드웨어 패널/발표자는 거의 없음
- 28. Bakul Patel, AssociateCentre Director for Digital Health, FDA DTxDM at Boston, Oct 2018
- 29. www.dtxalliance.org Digital Therapeutics: Combining Technologyand Evidence-based Medicine to Transform Personalized Patient Care Nov 2018
- 30. 5www.dtxalliance.org Defining Digital Therapeutics Thoughtleaders across the digital therapeutics industry, supported by the Digital Therapeutics Alliance, collaborated to develop the following comprehensive definition: Digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. DTx products incorporate advanced technology best practices relating to design, clinical validation, usability, and data security. They are reviewed and cleared or approved by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use. Digital therapeutics empower patients, healthcare providers, and payers with intelligent and accessible tools for addressing a wide range of conditions through high quality, safe, and effective data-driven interventions. Digital therapeutics present the market with evidence-based technologies that have the ability to elevate medical best practices, address unmet medical needs, expand healthcare access, and improve clinical and health economic outcomes. • 질병을 예방, 관리, 혹은 치료하는 고도의 소프트웨어 프로그램 • 독립적으로 사용될 수도 있고, 약제/기기/다른 치료제와 함께 사용될 수 있음 • 효능, 목적, 위험도 등의 주장과 관련해서는 규제기관의 인허가를 거침
- 31. 8 www.dtxalliance.org Developing IndustryStandards The direct delivery of personalized treatment interventions to patients places digital therapeutics in a unique position, one full of additional responsibility and promise. Given the diversity of interventions being delivered by digital therapeutics and the types of disease states addressed, it is important for all products to adhere to industry-adopted core principles and best practices. Core principles all digital therapeutics must adhere to: Prevent, manage, or treat a medical disorder or disease Produce a medical intervention that is driven by software, and delivered via software or complementary hardware, medical device, service, or medication Incorporate design, manufacture, and quality best practices Engage end users in product development and usability processes Incorporate patient privacy and security protections Apply product deployment, management, and maintenance best practices Publish trial results inclusive of clinically-meaningful outcomes in peer-reviewed journals Be reviewed and cleared or approved by regulatory bodies as required to support product claims of risk, efficacy, and intended use Make claims appropriate to clinical validation and regulatory status Collect, analyze, and apply real world evidence and product performance data Digital therapeutics are designed to integrate into patient lifestyles and provider workflows to deliver a fully integrated healthcare experience with improved outcomes. • 모든 digital therapeutics 가 따라야 하는 Core Principle: • 이 medical intervention은 소프트웨어에 의해서 주도(driven by)되고, • 또한 소프트웨어, 혹은 보완적인 하드웨어나 의료기기, 약을 통해 전달(delivered) 된다.
- 32. Digital Therapeutic Products Thetypes of interventions being delivered by digital therapeutic products across the industry are as diverse as the disease states being addressed. As the DTx field grows, patients, providers, and payers can expect to see an increasingly comprehensive network of therapy options for physical, mental, and behavioral disease states. Examples of digital therapeutics on the market or under development include: Digital therapeutic utilizing adaptive sensory stimulus software for the treatment of ADHD delivered through an engaging video game experience Digital sleep improvement program featuring Cognitive Behavioral Therapy (CBT) techniques AI-based digital diagnostics and personalized therapeutics for pediatric behavioral healthcare Digital delivery of physical exercises, behavioral therapy, and education for chronic back pain patients Basal insulin dose calculator for adults with Type 2 diabetes Intervention tool to train cognition in concussion patients Personalized digital program to help people prevent the onset of diabetes and other chronic diseases Digital therapeutic engaging individuals with Type 2 diabetes, hypertension, and obesity, and their providers, to improve self-management and outcomes Digital therapeutic used as an adjunct to standard, outpatient treatment for Substance Use Disorder (SUD) Combined software and hardware program to improve asthma and COPD control and optimize healthcare utilization Neurologic Music Therapy to address motor, speech, and cognitive dysfunction caused by neurologic disease or injury
- 33. Digital Therapeutic Products Thetypes of interventions being delivered by digital therapeutic products across the industry are as diverse as the disease states being addressed. As the DTx field grows, patients, providers, and payers can expect to see an increasingly comprehensive network of therapy options for physical, mental, and behavioral disease states. Examples of digital therapeutics on the market or under development include: Digital therapeutic utilizing adaptive sensory stimulus software for the treatment of ADHD delivered through an engaging video game experience Digital sleep improvement program featuring Cognitive Behavioral Therapy (CBT) techniques AI-based digital diagnostics and personalized therapeutics for pediatric behavioral healthcare Digital delivery of physical exercises, behavioral therapy, and education for chronic back pain patients Basal insulin dose calculator for adults with Type 2 diabetes Intervention tool to train cognition in concussion patients Personalized digital program to help people prevent the onset of diabetes and other chronic diseases Digital therapeutic engaging individuals with Type 2 diabetes, hypertension, and obesity, and their providers, to improve self-management and outcomes Digital therapeutic used as an adjunct to standard, outpatient treatment for Substance Use Disorder (SUD) Combined software and hardware program to improve asthma and COPD control and optimize healthcare utilization Neurologic Music Therapy to address motor, speech, and cognitive dysfunction caused by neurologic disease or injury Propeller Health Pear Therapeutics Akili Interactive Omada Health, Noom etc WellDoc Big Health (Sleepio) Cognoa KAIA MedRhythms
- 34.
- 35. Digital Therapeutics는 소프트웨어인가, 하드웨어인가? •DigitalTherapeutics는 소프트웨어: 앱, AI, VR, 챗봇, 게임 •소프트웨어를 중심으로, 보조적 하드웨어, 기기, 약과 전달 가능 •업계의 consensus가 그러하며, DTxDM에 하드웨어는 거의 없음
- 36. 대표적인 Digital Therapeutics의사례연구 • Pear Therapeutics • Akili Interactive • Click Therapeutics • Dthera Science • Noom, Omada Health • Hurray Positive, SK Health Connect • Virtual Vietnam • AppliedVR • Woebot • Cognoa • Propeller Health • Neofect
- 37. 대표적인 Digital Therapeutics의사례연구 • Pear Therapeutics • Akili Interactive • Click Therapeutics • Dthera Science • Noom, Omada Health • Hurray Positive, SK Health Connect • Virtual Vietnam • AppliedVR • Woebot • Cognoa • Propeller Health • Neofect
- 38.
- 39. Pear Therapeutics •Pear Therapeutics의reSET •의사의 ‘처방’을 받아, 12주에 걸쳐 알콜, 코카인, 대마 등의 중독과 의존성을 치료 •스마트폰 앱 만으로 치료용 FDA 인허가 (De Novo)를 받은 것은 최초 (2017년 9월) •업계에서는 digital therapeutics의 시초로 이 Pear Therapeutics를 꼽음
- 40. •reSET 의 Indicationfor Use •18세 이상의, Substance Use Disorder(SUD)으로, 외래 진료를 받는 환자에게 •의사의 감독 하에, 기존의 contingency management system 에 더하여 (adjunctive to) •CBT(Cognitive Behavioral Therapy)를 12주 동안 제공하여, •SUD에 대한 abstinence와 치료 프로그램의 retention을 증가시키는 것이 목적
- 41. •reSET의 구성 •(미국에서 처방을받아야만 사용가능하므로, 내부 구조를 들여다보기 쉽지 않음 (from FDA letter) •다양한 therapy lesson (모듈)제공; 각 모듈은 CBT로 구성됨 •약물 사용과 관련한 상황/요인 파악; 관련된 생각에 대한 대처법; 사고방식 변화 •CBT는 텍스트, 비디오, 애니메이션, 그래픽 등의 다양한 컨텐츠로 구성 •각 therapy lesson에서 배운 것을 환자가 fluency learning으로 문제 풀이; 자가 데이터 입력; 리뷰
- 42. RCT of reSET DENOVO CLASSIFICATION REQUEST FOR RESET logistic Generalized Estimating Equations (GEE) model with factors for treatment, time and treatment X time (“treatment times time”) interaction. Missing data were treated as failures. The analysis results of abstinence for cohort 1 and 2 are presented below, additionally compared by abstinence at baseline. The abstinence analyses were completed in the context of a GEE model that incorporates within-subject variability across the observation window and estimates abstinence at specified time points based on the model the analyses yields percentages rather than absolute numbers. The number of patients reported in the table below represents the number of patients in that entire group (e.g., N=252 patients in Cohort 1 were in the TAU group overall; N=139 patients were abstinent at baseline in the Cohort 1 TAU group). Table 3: Abstinence rates in Cohorts 1 (N=507) and 2 (N=399) Patients who received rTAU + reSET had statistically significant increased odds of remaining abstinent at the end of treatment: Cohort 1: Odds ratio=2.22, 95% CI (1.24, 3.99); p=0.0076 Cohort 2: Odds ratio=3.17, 95% CI (1.68, 5.99); p=0.0004. Cohort 3 (all opioids excluded, N=153 TAU, N=152 rTAU+reSET) had similar abstinence to cohorts 1 and 2, with abstinence rates in the rTAU + reSET arm of 38.5% compared to 17.5% in the TAU arm (Odds Ratio=2.95, 95% CI=1.43, 6.09, p=0.0034). Abstinence: patients who were abstinent at baseline: Patients who were abstinent at baseline were significantly more likely to remain abstinent throughout the study than patients who were not abstinent at baseline for both patients who received TAU and patients who received rTAU + reSET. • TAU(Treatment As Usual)과 rTAU(reduced TAU)+reSET을 RCT • Primary Opioid를 포함/제외하여 따로 분석 • Baseline에서 Abstinent/non-abstinent를 별개로 분석
- 43. RCT of reSET DENOVO CLASSIFICATION REQUEST FOR RESET logistic Generalized Estimating Equations (GEE) model with factors for treatment, time and treatment X time (“treatment times time”) interaction. Missing data were treated as failures. The analysis results of abstinence for cohort 1 and 2 are presented below, additionally compared by abstinence at baseline. The abstinence analyses were completed in the context of a GEE model that incorporates within-subject variability across the observation window and estimates abstinence at specified time points based on the model the analyses yields percentages rather than absolute numbers. The number of patients reported in the table below represents the number of patients in that entire group (e.g., N=252 patients in Cohort 1 were in the TAU group overall; N=139 patients were abstinent at baseline in the Cohort 1 TAU group). Table 3: Abstinence rates in Cohorts 1 (N=507) and 2 (N=399) Patients who received rTAU + reSET had statistically significant increased odds of remaining abstinent at the end of treatment: Cohort 1: Odds ratio=2.22, 95% CI (1.24, 3.99); p=0.0076 Cohort 2: Odds ratio=3.17, 95% CI (1.68, 5.99); p=0.0004. Cohort 3 (all opioids excluded, N=153 TAU, N=152 rTAU+reSET) had similar abstinence to cohorts 1 and 2, with abstinence rates in the rTAU + reSET arm of 38.5% compared to 17.5% in the TAU arm (Odds Ratio=2.95, 95% CI=1.43, 6.09, p=0.0034). Abstinence: patients who were abstinent at baseline: Patients who were abstinent at baseline were significantly more likely to remain abstinent throughout the study than patients who were not abstinent at baseline for both patients who received TAU and patients who received rTAU + reSET. • Cohort 2 (Excluding Primary Opioid) 의, • Overall 과 Non-abstinent at baseline 그룹에서 통계적으로 유의한 차이
- 44. RCT of reSET DENOVO CLASSIFICATION REQUEST FOR RESET The Kaplan-Meier curve for cohort 1 is shown below: Figure 2: Kaplan-Meier curve for Cohort 1 (all comers) Adverse events In the entire clinical study, the number of patients with any adverse event was 13% (n=66). The number of patients with any event was 29 (11.5%) in TAU and 37 (14.5%) in reSET + rTAU (p = 0.3563). None of the adverse events in the reSET arm were adjudicated by the study investigators to be device-related. The events evaluated were typical of patients with SUD, including cardiovascular disease, gastrointestinal events, depression, mania, suicidal behavior, • Cohort1에서 TAU와 rTAU+reSET의 12주 이후 retention을 비교 • Retention에도 통계적으로 유의미한 차이 확인
- 46. • Pear Therapeutics •노바티스와 schizophrenia 및 MS 관련 digital therapeutics 개발 협력 (2018.3) • 산도스 (노바티스 제네릭 부서)와는 reSET, reSET-O 의 개발/사업화 협력 (2018.4)
- 47. • Pear Therapeutics •2018년 11월 20일, 노바티스와 산도스를 통해서 reSET 을 시장 출시 • 현재, 인허가 및 시장 출시된 유일한 digital therapeutics • 12-week (90-day) prescription digital therapeutic to be used in conjunction with outpatient clinician-delivered care.
- 48.
- 49. Reimagining digital healthproduct oversight 무엇을 규제할 것인가? 기기
- 50. 무엇을 규제할 것인가? 기기제조사 Reimagining digital health product oversight
- 51. •디지털 헬스케어 제품(product)가아닌, 제조사(developer) 기반 규제 • 적절한 자격 요건을 갖춘 회사에 “자격(pre-certify)”을 부여 • 이 제조사의 디지털 헬스케어 제품은 pre-market submission을 면제받거나, 인허가 과정을 간소화, 빠른 속도의 review 가능 •제조사와 환자의 win-win • 자격 요건을 갖춘 제조사들은 보다 큰 자율권을 가지고 자신의 기술을 제품으로 만들어, 시장에 더욱 빠르게 출시 가능 • 환자들은 혁신의 결과물을 적시에 수혜 가능 Reimagining digital health product oversight
- 52. •디지털 헬스케어 제품(product)가아닌, 제조사(developer) 기반 규제 • 적절한 자격 요건을 갖춘 회사에 “자격(pre-certify)”을 부여 • 이 제조사의 디지털 헬스케어 제품은 pre-market submission을 면제받거나, 인허가 과정을 간소화, 빠른 속도의 review 가능 •제조사와 환자의 win-win • 자격 요건을 갖춘 제조사들은 보다 큰 자율권을 가지고 자신의 기술을 제품으로 만들어, 시장에 더욱 빠르게 출시 가능 • 환자들은 혁신의 결과물을 적시에 수혜 가능 Reimagining digital health product oversight
- 53. Pre-Cert 파일럿 참여기업 9개 선정 (2017.9.26) • Apple • Samsung • Verily (Google) • Johnson & Johnson • Roche • Fitbit • Pear Therapeutics • Phosphorus • Tidepool 대형 IT 기업 의료기기/제약사 헬스케어 스타트업 비영리 (1형 당뇨) 총 103개의 지원 기업 중에, 다양한 규모의 조직 다양한 위험도의 의료기기 포괄
- 54. 대표적인 Digital Therapeutics의사례연구 • Pear Therapeutics • Akili Interactive • Click Therapeutics • Dthera Science • Noom, Omada Health • Hurray Positive, SK Health Connect • Virtual Vietnam • AppliedVR • Woebot • Cognoa • Propeller Health • Neofect
- 55. • Puretech Health •‘새로운 개념의 제약회사’를 추구하는 회사 • 기존의 신약 뿐만 아니라, 게임, 앱 등을 이용한 Digital Therapeutics 를 개발 • Digital Therapeutics는 최근 미국 FDA의 de novo 승인을 받기도 함
- 58. • Puretech Health •신약 파이프라인 중에는 일반적인 small molecule 등도 있지만, • Akili: ADHD, 우울증, 알츠하이머 등을 위한 인지 능력 개선 목적의 게임 (Project EVO) • Sonde: Voice biomarker 를 이용한 우울증 등 mental health의 진단 및 모니터링 목적
- 59. • Puretech Health •신약 파이프라인 중에는 일반적인 small molecule 등도 있지만, • Akili: ADHD, 우울증, 알츠하이머 등을 위한 인지 능력 개선 목적의 게임 (Project EVO) • Sonde: Voice biomarker 를 이용한 우울증 등 mental health의 진단 및 모니터링 목적
- 60. • Puretech Health •신약 파이프라인 중에는 일반적인 small molecule 등도 있지만, • Akili: ADHD, 우울증, 알츠하이머 등을 위한 인지 능력 개선 목적의 게임 (Project EVO) • Sonde: Voice biomarker 를 이용한 우울증 등 mental health의 진단 및 모니터링 목적
- 62. ADHD 치료용 아이패드기반의 게임
- 63. LETTER doi:10.1038/nature12486 Video gametraining enhances cognitive control in older adults J. A. Anguera1,2,3 , J. Boccanfuso1,3 , J. L. Rintoul1,3 , O. Al-Hashimi1,2,3 , F. Faraji1,3 , J. Janowich1,3 , E. Kong1,3 , Y. Larraburo1,3 , C. Rolle1,3 , E. Johnston1 & A. Gazzaley1,2,3,4 Cognitivecontrolisdefinedbyasetofneuralprocessesthatallowusto interact with our complex environment in a goal-directed manner1 . Humans regularly challenge these control processes when attempting to simultaneously accomplish multiple goals (multitasking), generat- ing interference as the result of fundamental information processing limitations2 . It is clear that multitasking behaviour has become ubi- quitous in today’s technologically dense world3 , and substantial evid- ence has accrued regarding multitasking difficulties and cognitive control deficits in our ageing population4 . Here we show that multi- tasking performance, as assessed with a custom-designed three- dimensional video game (NeuroRacer), exhibits a linear age-related decline from 20 to 79 years of age. By playing an adaptive version of NeuroRacer in multitasking training mode, older adults (60 to 85 years old) reduced multitasking costs compared to both an active control group and a no-contact control group, attaining levels beyond those achieved by untrained 20-year-old participants, with gains persisting for 6 months. Furthermore, age-related deficits in neural signatures of cognitive control, as measured with electroencephalo- graphy,wereremediated by multitasking training (enhanced midline frontal theta power and frontal–posterior theta coherence). Critically, thistrainingresultedinperformancebenefitsthatextendedtountrained cognitive control abilities (enhanced sustained attention and working memory), with an increase in midline frontal theta power predicting the training-induced boost in sustained attention and preservation of multitasking improvement 6 months later. These findings high- light the robust plasticity of the prefrontal cognitive control system inthe ageing brain, and provide the first evidence, to our knowledge, ofhowacustom-designedvideogamecanbeusedtoassesscognitive abilities across the lifespan, evaluate underlying neural mechanisms, and serve as a powerful tool for cognitive enhancement. In a first experiment, we evaluated multitasking performance across the adult lifespan. A total of 174 participants spanning six decades of life (ages 20–79; ,30 individuals per decade) played a diagnostic version of NeuroRacertomeasuretheirperceptualdiscriminationability(‘signtask’) withandwithoutaconcurrentvisuomotortrackingtask(‘drivingtask’;see Supplementary Information for details of NeuroRacer). Performance was evaluated using two distinct game conditions: ‘sign only’ (respond as rapidly as possible to the appearance of a sign only when a green circle was present); and ‘sign and drive’ (simultaneously perform the sign task while maintaining a car in the centre of a winding road using a joystick (that is, ‘drive’; see Fig. 1a)). Perceptual discrimination performance was evaluatedusingthesignaldetectionmetricofdiscriminability(d9).A‘cost’ index was used to assess multitasking performance by calculating the percentage change in d9 from ‘sign only’ to ‘sign and drive’, such that greater cost (that is, a more negative percentage cost) indicates increased interference when simultaneously engaging in the two tasks (see Methods Summary). Prior to the assessment of multitasking costs, an adaptive staircase algorithm was used to determine the difficulty levels of the game at which each participant performed the perceptual discrimination and visuomotor tracking tasks in isolation at ,80% accuracy. These levels were then used to set the parameters of the component tasks in the multitasking condition, so that each individual played the game at a customizedchallengelevel.Thisensuredthatcomparisonswouldinform differences in the ability to multitask, and not merely reflect disparities in component skills (see Methods, Supplementary Figs 1 and 2, and Sup- plementary Information for more details). Multitasking performance diminished significantly across the adult lifespan in a linear fashion (that is, increasing cost, see Fig. 2a and Sup- plementaryTable1),withtheonlysignificantdifferenceincostbetween adjacent decades being the increase from the twenties (226.7% cost) to the thirties (238.6% cost). This deterioration in multitasking perform- ance is consistent with the pattern of performance decline across the lifespan observed for fluid cognitive abilities, such as reasoning5 and working memory6 . Thus, using NeuroRacer as a performance assess- ment tool, we replicated previously evidenced age-related multitasking deficits7,8 , and revealed that multitasking performance declines linearly as we advance in age beyond our twenties. In a second experiment, we explored whether older adults who trained by playing NeuroRacer in multitasking mode would exhibit improve- mentsintheirmultitaskingperformanceonthegame9,10 (thatis,diminished NeuroRacer costs). Critically, we also assessed whether this training 1 Department of Neurology, University of California, San Francisco, California 94158, USA. 2 Department of Physiology, University of California, San Francisco, California 94158, USA. 3 Center for Integrative Neuroscience, University of California, San Francisco, California 94158, USA. 4 Department of Psychiatry, University of California, San Francisco, California 94158, USA. 1 month MultitaskingSingle taskNo-contact control Initial visit NeuroRacer EEG and cognitive testing Drive only Sign only Sign and drive and 1 hour × 3 times per week × 1 month or Single task Multitask 6+ months Training intervention NeuroRacer or a b + + Figure 1 | NeuroRacer experimental conditions and training design. a, Screen shot captured during each experimental condition. b, Visualization of training design and measures collected at each time point. 5 S E P T E M B E R 2 0 1 3 | V O L 5 0 1 | N A T U R E | 9 7 Macmillan Publishers Limited. All rights reserved©2013
- 64. Video game trainingenhances cognitive control in older adults https://www.youtube.com/watch?v=1xPX8F_wl0c
- 65. transferred to enhancementsin their cognitive control abilities11 beyond those attained by participants who trained on the component tasks in isolation. In designing the multitasking training version of NeuroRacer, during game play as a key mechanistic feature of the tr In addition, although cost reduction was observed o group, equivalent improvement in component task sk byboth STTandMTT(seeSupplementary Figs 4 and that enhancedmultitaskingabilitywas notsolelythere component skills, but a function of learning to reso generated by the two tasks when performed concurr the d9 cost improvement following training was not th trade-off, as driving performance costs also diminish group from pre- to post-training (see Supplementa Notably in the MTT group, the multitasking per remained stable 6 months after training without boo 6 months, 221.9% cost). Interestingly, the MTT grou cost improved significantly beyond the cost level attain 20 year olds who played a single session of NeuroRac experiment 3; P , 0.001). Next, we assessed if training with NeuroRacer le enhancementsofcognitivecontrolabilitiesthatareknow in ageing (for example, sustained attention, divided at memory; see Supplementary Table 2)12 . We hypothe immersed in a challenging, adaptive, high-interferen for a prolonged period of time (that is, MTT) would cognitive performance on untrained tasks that also dem control. Consistent with our hypothesis, significant interactions and subsequent follow-up analyses eviden training improvements in both working memory (del task with and without distraction7 ; Fig. 3a, b) and su † –100% –90% –80% –70% –60% –50% –40% –30% –20% –10% Multitaskingcost(d′) † * ba 1 month later 6 months later Experiment 1: lifespan Experiment 2: training Single task training No-contact control Multitasking training 0% 20s 30s 40s 50s 60s 70s Initial Figure 2 | NeuroRacer multitasking costs. a, Costs across the lifespan (n 5 174) increased (that is, a more negative percentage) in a linear fashion when participants were grouped by decade (F(1,5) 5 135.7, P , 0.00001) or analysed individually (F(1,173) 5 42.8, r 5 0.45, P , 0.00001; see Supplementary Fig. 3), with significant increases in cost observed for all age groups versus the 20-year-old group (P , 0.05 for each decade comparison). b, Costs before training, 1 month post-training, and 6 months post-training showed a session X group interaction (F(4,72) 5 7.17, P , 0.0001, Cohen’s d 5 1.10), with follow-up analyses supporting a differential benefit for the MTT group (Cohen’s d for MTT vs STT 5 1.02; MTT vs NCC5 1.20). {P , 0.05 within group improvement from pre to post, *P , 0.05 between groups (n 5 46). Error bars represent s.e.m. –100 0 100 200 Pre–post WM task with distractions (RT) RTdifference(ms) † * a –100 0 100 200 Pre–po without d RTdifference(ms) † b RESEARCH LETTER Video game training enhances cognitive control in older adults z • 게임을 통한 고령층의 인지 능력 (멀티태스킹 능력) 개선 효과가 있음을 증명 • 60-85세 참가자 46명을 4주간 뉴로레이서를 통해서 훈련 • 그 결과 훈련 받지 않은 20대보다 더 잘 하게 되었으며, • 연습을 하지 않고 6개월이 지나도, 능력은 그대로 남아 있었다. Nature 501, 97–101 (2013)
- 66. Video game trainingenhances cognitive control in older adults (vigilance; test of variables of attention (T group (Fig. 3c; see Supplementary Table several statistical trendssuggestive of impr ance on other cognitive controltasks (dual and changedetectiontask;see analysisofco in Supplementary Table 2). Note that alth and sustained attention improvements w rapid responses to test probes, neither im alternative version of the TOVA) nor accu cant group differences, revealing that traini of a speed/accuracy trade-off. Importantl ments were specific to working memory a cesses, and not theresult ofgeneralized incr as no group X session interactions were fou tasks (a stimulus detection task and the dig see Supplementary Table 2). Finally, only significant correlation between multitaski withNeuroRacer)andimprovementsonan task (delayed-recognition with distraction (Fig. 3d). These important ‘transfer of benefits’ sug lying mechanism of cognitive control was c MTT with NeuroRacer. To assess this furth basis of training effects by quantifying even tions (ERSP) and long-range phase cohere of each sign presented during NeuroRacer Wespecificallyassessedmidlinefrontalthe EEG measure of cognitive control (for exam tained attention15 and interference resolutio prefrontal cortex. In addition, we analysed between frontal and posterior brain region measure also associated with cognitive co memory14 and sustained attention15 ). Se power and coherence each revealed signifi b Long-range theta coherence Older adult post-training PLV (% coherence) 1 5 10 * ) Initial Older adults Younger adults † Midline frontal theta Power(dB) Initial * a Older adults Younger adults Older adult post-training Single task training Multitasking training No-contact control 3.40 3.05 2.70 2.35 1.65 1.30 0.95 0.60 0.25 –0.10 –0.45 –0.80 –1.15 –1.50 2.00 Nature 501, 97–101 (2013) • 인지 능력의 개선은 brain activity 로도 동일하게 관찰되었다. • 노년층 실험군에서 기술이 향상될수록 cognitive control을 관장하는 prefrontal cortex 의 activity가 높아지는 것이 관찰되었다.
- 67. OPEN ORIGINAL ARTICLE Characterizing cognitivecontrol abilities in children with 16p11.2 deletion using adaptive ‘video game’ technology: a pilot study JA Anguera1,2 , AN Brandes-Aitken1 , CE Rolle1 , SN Skinner1 , SS Desai1 , JD Bower3 , WE Martucci3 , WK Chung4 , EH Sherr1,5 and EJ Marco1,2,5 Assessing cognitive abilities in children is challenging for two primary reasons: lack of testing engagement can lead to low testing sensitivity and inherent performance variability. Here we sought to explore whether an engaging, adaptive digital cognitive platform built to look and feel like a video game would reliably measure attention-based abilities in children with and without neurodevelopmental disabilities related to a known genetic condition, 16p11.2 deletion. We assessed 20 children with 16p11.2 deletion, a genetic variation implicated in attention deficit/hyperactivity disorder and autism, as well as 16 siblings without the deletion and 75 neurotypical age-matched children. Deletion carriers showed significantly slower response times and greater response variability when compared with all non-carriers; by comparison, traditional non-adaptive selective attention assessments were unable to discriminate group differences. This phenotypic characterization highlights the potential power of administering tools that integrate adaptive psychophysical mechanics into video-game-style mechanics to achieve robust, reliable measurements. Translational Psychiatry (2016) 6, e893; doi:10.1038/tp.2016.178; published online 20 September 2016 INTRODUCTION Cognition is typically associated with measures of intelligence (for example, intellectual quotient (IQ)1 ), and is a reflection of one’s ability to perform higher-level processes by engaging specific mechanisms associated with learning, memory and reasoning. Such acts require the engagement of a specific subset of cognitive resources called cognitive control abilities,2–5 which engage the underlying neural mechanisms associated with atten- tion, working memory and goal-management faculties.6 These abilities are often assessed with validated pencil-and-paper approaches or, now more commonly with these same paradigms deployed on either desktop or laptop computers. These approaches are often less than ideal when assessing pediatric populations, as children have highly varied degree of testing engagement, leading to low test sensitivity.7–9 This is especially concerning when characterizing clinical populations, as increased performance variability in these groups often exceeds the range of testing sensitivity,7–9 limiting the ability to characterize cognitive deficits in certain populations. A proper assessment of cognitive control abilities in children is especially important, as these abilities allow children to interact with their complex environment in a goal-directed manner,10 are predictive of academic performance11 and are correlated with overall quality of life.12 For pediatric clinical populations, this characterization is especially critical as they are often assessed in an indirect fashion through intelligence quotients, parent report questionnaires13 and/or behavioral challenges,14 each of which fail to properly characterize these abilities in a direct manner. One approach to make testing more robust and user-friendly is to present material in an optimally engaging manner, a strategy particularly beneficial when assessing children. The rise of digital health technologies facilitates the ability to administer these types of tests on tablet-based technologies (that is, iPad) in a game-like manner.15 For instance, Dundar and Akcayir16 assessed tablet- based reading compared with book reading in school-aged children, and discovered that students preferred tablet-based reading, reporting it to be more enjoyable. Another approach used to optimize the testing experience involves the integration of adaptive staircase algorithms, as the incorporation of such appro- aches lead to more reliable assessments that can be completed in a timely manner. This approach, rooted in psychophysical research,17 has been a powerful way to ensure that individuals perform at their ability level on a given task, mitigating the possi- bility of floor/ceiling effects. With respect to assessing individual abilities, the incorporation of adaptive mechanics acts as a normalizing agent for each individual in accordance with their underlying cognitive abilities,18 facilitating fair comparisons between groups (for example, neurotypical and study populations). Adaptive mechanics in a consumer-style video game experi- ence could potentially assist in the challenge of interrogating cognitive abilities in a pediatric patient population. This synergistic approach would seemingly raise one’s level of engagement by making the testing experience more enjoyable and with greater sensitivity to individual differences, a key aspect typically missing in both clinical and research settings when testing these populations. Video game approaches have previously been utilized in clinical adult populations (for example, stroke,19,20 1 Department of Neurology, University of California, San Francisco, San Francisco, CA, USA; 2 Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA; 3 Akili Interactive Labs, Boston, MA, USA; 4 Department of Pediatrics, Columbia University Medical Center, New York, NY, USA and 5 Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA. Correspondence: JA Anguera or EJ Marco, University of California, San Francisco, Mission Bay – Sandler Neurosciences Center, UCSF MC 0444, 675 Nelson Rising Lane, Room 502, San Francisco, CA 94158, USA. E-mail: joaquin.anguera@ucsf.edu or elysa.marco@ucsf.edu Received 6 March 2016; revised 13 July 2016; accepted 18 July 2016 Citation: Transl Psychiatry (2016) 6, e893; doi:10.1038/tp.2016.178 www.nature.com/tp Figure 2. Project: EVO selective attention performance. (a) EVO single- and multi-tasking response time performance f non-affected siblings and non-affected control groups). (b) EVO multi-tasking RT. (c) Visual search task performance Characterizing cognitive control abilities in child JA Anguera et al •Project EVO (게임)을 통해서, •아동 집중력 장애(attention disorder) 관련 특정 유전형 carrier 를 골라낼 수 있음 •게임에서의 Response Time을 기준으로 carrier vs. non-carrier 간 유의미한 차이
- 68. RESEARCH ARTICLE A pilotstudy to determine the feasibility of enhancing cognitive abilities in children with sensory processing dysfunction Joaquin A. Anguera1,2☯ *, Anne N. Brandes-Aitken1☯ , Ashley D. Antovich1 , Camarin E. Rolle1 , Shivani S. Desai1 , Elysa J. Marco1,2,3 1 Department of Neurology, University of California, San Francisco, United States of America, 2 Department of Psychiatry, University of California, San Francisco, United States of America, 3 Department of Pediatrics, University of California, San Francisco, United States of America ☯ These authors contributed equally to this work. * joaquin.anguera@ucsf.edu Abstract Children with Sensory Processing Dysfunction (SPD) experience incoming information in atypical, distracting ways. Qualitative challenges with attention have been reported in these children, but such difficulties have not been quantified using either behavioral or functional neuroimaging methods. Furthermore, the efficacy of evidence-based cognitive control inter- ventions aimed at enhancing attention in this group has not been tested. Here we present work aimed at characterizing and enhancing attentional abilities for children with SPD. A sample of 38 SPD and 25 typically developing children were tested on behavioral, neural, and parental measures of attention before and after a 4-week iPad-based at-home cognitive remediation program. At baseline, 54% of children with SPD met or exceeded criteria on a parent report measure for inattention/hyperactivity. Significant deficits involving sustained attention, selective attention and goal management were observed only in the subset of SPD children with parent-reported inattention. This subset of children also showed reduced midline frontal theta activity, an electroencephalographic measure of attention. Following the cognitive intervention, only the SPD children with inattention/hyperactivity showed both improvements in midline frontal theta activity and on a parental report of inattention. Notably, 33% of these individuals no longer met the clinical cut-off for inattention, with the parent- reported improvements persisting for 9 months. These findings support the benefit of a targeted attention intervention for a subset of children with SPD, while simultaneously highlighting the importance of having a multifaceted assessment for individuals with neuro- developmental conditions to optimally personalize treatment. Introduction Five percent of all children suffer from Sensory Processing Dysfunction (SPD)[1], with these individuals exhibiting exaggerated aversive, withdrawal, or seeking behaviors associated with sensory inputs [2]. These sensory processing differences can have significant and lifelong con- sequences for learning and social abilities, and are often shared by children who meet PLOS ONE | https://doi.org/10.1371/journal.pone.0172616 April 5, 2017 1 / 19 a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 OPEN ACCESS Citation: Anguera JA, Brandes-Aitken AN, Antovich AD, Rolle CE, Desai SS, Marco EJ (2017) A pilot study to determine the feasibility of enhancing cognitive abilities in children with sensory processing dysfunction. PLoS ONE 12(4): e0172616. https://doi.org/10.1371/journal. pone.0172616 Editor: Jacobus P. van Wouwe, TNO, NETHERLANDS Received: October 5, 2016 Accepted: February 1, 2017 Published: April 5, 2017 Copyright: © 2017 Anguera et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All relevant data are within the paper and its Supporting Information files. Funding: This work was supported by the Mickelson-Brody Family Foundation, the Wallace Research Foundation, the James Gates Family Foundation, the Kawaja-Holcombe Family Foundation (EJM), and the SNAP 2015 Crowd funding effort. •감각처리장애(SPD)를 가진 소아 환자 중 ADHD를 가진 20명에 대해서 실험 •4주 동안 (주당 5일, 25분)Project EVO 게임을 하게 한 결과, •20명 중 7명이 큰 개선을 보여서 더 이상 ADHD의 범주에 들지 않게 됨 •사용 후 적어도 9개월 동안 효과가 지속되었음 Fig 4. Transfer effect on behavioral and parent report measures. Pre and post (A) response time (B) and respo revealing within group change. Error bars indicate standard error of the mean. Within group main effects of session = p .05, ** =.p .01. Sun symbols indicate statistically significant instances where SPD+IA post-training performa TDC group prior to training. (C) Vanderbilt parent report inattention change bar plot (calculated by pre-post margina significant group x session interaction. Error bars indicate standard error of the mean. All group x session interactio stars (* = p .05, ** =.p .01) on bar graph. https://doi.org/10.1371/journal.pone.0172616.g004 PLOS ONE | https://doi.org/10.1371/journal.pone.0172616 April 5, 2017
- 69. •ADHD에 대해서는 대규모RCT phase III 임상 시험 진행 중이며, FDA 의료기기 인허가 목표 •8-12살 환자(n=330), 치료 효과 없는 비디오게임을 control group으로 •primary endpoint: TOVA •의사의 처방을 받는 ADHD 치료용 게임 + 보험사의 커버 목표
- 70. •2017년 12월, pivotaltrial 의 임상 결과가 긍정적으로 나옴 •348 명의 소아 환자, 4주간의 사용 •ADHD와 집중력이 대조군 대비 유의미하게 개선됨 (Attention Performance Index) •그러나, secondary outcome에 대해서는 대조군 대비 유의미한 개선을 보여주지 못함 •심각한 부작용은 없었음
- 73. 두브레인 AI는 개인화된인지치료 프로그램을 제공합니다
- 76. 대표적인 Digital Therapeutics의사례연구 • Pear Therapeutics • Akili Interactive • Click Therapeutics • Dthera Science • Noom, Omada Health • Hurray Positive, SK Health Connect • Virtual Vietnam • AppliedVR • Woebot • Cognoa • Propeller Health • Neofect
- 79. Weight loss efficacyof a novel mobile Diabetes Prevention Program delivery platform with human coaching Andreas Michaelides, Christine Raby, Meghan Wood, Kit Farr, Tatiana Toro-Ramos To cite: Michaelides A, Raby C, Wood M, et al. Weight loss efficacy of a novel mobile Diabetes Prevention Program delivery platform with human coaching. BMJ Open Diabetes Research and Care 2016;4:e000264. doi:10.1136/bmjdrc-2016- 000264 Received 4 May 2016 Revised 19 July 2016 Accepted 11 August 2016 Noom, Inc., New York, New York, USA Correspondence to Dr Andreas Michaelides; andreas@noom.com ABSTRACT Objective: To evaluate the weight loss efficacy of a novel mobile platform delivering the Diabetes Prevention Program. Research Design and Methods: 43 overweight or obese adult participants with a diagnosis of prediabetes signed-up to receive a 24-week virtual Diabetes Prevention Program with human coaching, through a mobile platform. Weight loss and engagement were the main outcomes, evaluated by repeated measures analysis of variance, backward regression, and mediation regression. Results: Weight loss at 16 and 24 weeks was significant, with 56% of starters and 64% of completers losing over 5% body weight. Mean weight loss at 24 weeks was 6.58% in starters and 7.5% in completers. Participants were highly engaged, with 84% of the sample completing 9 lessons or more. In-app actions related to self-monitoring significantly predicted weight loss. Conclusions: Our findings support the effectiveness of a uniquely mobile prediabetes intervention, producing weight loss comparable to studies with high engagement, with potential for scalable population health management. INTRODUCTION Lifestyle interventions,1 including the National Diabetes Prevention Program (NDPP) have proven effective in preventing type 2 diabetes.2 3 Online delivery of an adapted NDPP has resulted in high levels of engagement, weight loss, and improvements in glycated hemoglobin (HbA1c).4 5 Prechronic and chronic care efforts delivered by other means (text and emails,6 nurse support,7 DVDs,8 community care9 ) have also been successful in promoting behavior change, weight loss, and glycemic control. One study10 adapted the NDPP to deliver the first part of the curriculum in-person and the remaining sessions through a mobile app, and found 6.8% weight loss at 5 months. Mobile health poses a promising means of delivering prechronic and chronic care,11 12 and provides a scalable, convenient, and accessible method to deliver the NDPP. The weight loss efficacy of a completely mobile delivery of a structured NDPP has not been tested. The main aim of this pilot study was to evaluate the weight loss efficacy of Noom’s smartphone-based NDPP-based cur- ricula with human coaching in a group of overweight and obese hyperglycemic adults receiving 16 weeks of core, plus postcore cur- riculum. In this study, it was hypothesized that the mobile DPP could produce trans- formative weight loss over time. RESEARCH DESIGN AND METHODS A large Northeast-based insurance company offered its employees free access to Noom Health, a mobile-based application that deli- vers structured curricula with human coaches. An email or regular mail invitation with information describing the study was sent to potential participants based on an elevated HbA1c status found in their medical records, reflecting a diagnosis of prediabetes. Interested participants were assigned to a virtual Centers for Disease Control and Prevention (CDC)-recognized NDPP master’s level coach. Key messages ▪ To the best of our knowledge, this study is the first fully mobile translation of the Diabetes Prevention Program. ▪ A National Diabetes Prevention Program (NDPP) intervention delivered entirely through a smart- phone platform showed high engagement and 6-month transformative weight loss, comparable to the original NDPP and comparable to trad- itional in-person programmes. ▪ This pilot shows that a novel mobile NDPP inter- vention has the potential for scalability, and can address the major barriers facing the widespread translation of the NDPP into the community setting, such as a high fixed overhead, fixed locations, and lower levels of engagement and weight loss. BMJ Open Diabetes Research and Care 2016;4:e000264. doi:10.1136/bmjdrc-2016-000264 1 Open Access Research group.bmj.comon April 27, 2017 - Published byhttp://drc.bmj.com/Downloaded from •Noom Coach 앱이 체중 감량을 위해서 효과적임을 증명 •완전히 모바일로 이뤄진 최초의 당뇨병 예방 연구 •43명의 전당뇨단계에 있는 과체중이나 비만 환자를 대상 •24주간 Noom Coach의 앱과 모바일 코칭을 제공 •그 결과 64% 의 참가자들이 5-7% 의 체중 감량 효과 •84%에 달하는 사람들이 마지막까지 이 6개월 간의 프로그램에 참여
- 80. www.nature.com/scientificreports Successful weight reduction andmaintenance by using a smartphone application in those with overweight and obesity SangOukChin1,* ,Changwon Keum2,* , JunghoonWoo3 , Jehwan Park2 , Hyung JinChoi4 , Jeong-taekWoo5 & SangYoul Rhee5 A discrepancy exists with regard to the effect of smartphone applications (apps) on weight reduction due to the several limitations of previous studies.This is a retrospective cohort study, aimed to investigate the effectiveness of a smartphone app on weight reduction in obese or overweight individuals, based on the complete enumeration study that utilized the clinical and logging data entered by NoomCoach app users betweenOctober 2012 andApril 2014.A total of 35,921 participants were included in the analysis, of whom 77.9% reported a decrease in body weight while they were using the app (median 267 days; interquartile range=182). Dinner input frequency was the most important factor for successful weight loss (OR=10.69; 95%CI=6.20–19.53; p<0.001), and more frequent input of weight significantly decreased the possibility of experiencing the yo-yo effect (OR=0.59, 95%CI=0.39–0.89; p<0.001).This study demonstrated the clinical utility of an app for successful weight reduction in the majority of the app users; the effects were more significant for individuals who monitored their weight and diet more frequently. Obesity is a global epidemic with a rapidly increasing prevalence worldwide1,2 . As obese individuals experience significantly higher mortality when compared with the non-obese population3,4 , this phenomenon poses a sig- nificant socioeconomic burden, necessitating strategies to manage overweight and prevent obesity5 . Although numerous interventions such as life style modification including exercise6–10 , and pharmacotherapy11–13 have been shown effective for both the prevention and treatment of obesity, some of these methods were found to have a limitation which required substantial financial inputs and repeated time-consuming processes14,15 . Recently, as the number of smartphone users is increasing dramatically, many investigators have attempted to implement smartphone applications (app) for health promotion16–19 . Consequently, many smartphone apps have demonstrated at least partial efficacy in promoting successful weight reduction according to the number of previous studies20–24 . However, due to the limitations associated with study design such as small-scale studies and short investigation periods, a discrepancy exists with regard to the effect of apps on weight reduction20,21,23 . Even systemic reviews which investigated the efficacy of mobile apps for weight reduction reported more or less inconsistent results; Flores Mateo et al. reported a significant weight loss by mobile phone app intervention when compared with control groups25 whereas Semper et al. reported that four of the six studies included in the analysis showed no significant difference of weight reduction between comparison groups26 . Thus, the aim of this study was to investigate the effectiveness of a smartphone app on weight reduction in obese or overweight individuals Recei e : 0 pri 016 Accepte : 15 eptem er 016 Pu is e : 0 o em er 016 OPEN •스마트폰 앱이 체중 감량에 도움을 줄 수 있는가? •2012년부터 2014년 까지 최소 6개월 이상 애플리케이션을 사용 •80여 국가(미국, 독일, 한국, 영국, 일본 등)에서 모집된 35,921명의 데이터 •애플리케이션 평균 사용기간은 267일 Chin et al. Sci Rep 2016
- 81. www.nature.com/scientificreports/ Figure 1. Distributionof weight loss among app users. Percentages (and 95% CIs) of participants achieving <5%, 5–10%, 10–15%, 15–20% and >20% weight loss relative to baseline at the end of the 6-month trial period. Data are reported as the mean±SD. Univariate Linear Regression p-value Multivariate Linear Regression p-valueβ (95% CI) β (95% CI) Gender (male) 0.60 (0.54, 0.66) <0.001 0.71 (0.65, 0.77) <0.001 Age 0.01 (0.008, 0.013) <0.001 −0.026 (−0.03, −0.02) <0.001 Follow-up Days −0.001 (−0.001, −0.001) <0.001 0.00 (0.00, 0.00) 0.886 Baseline BMI 0.146 (0.143, 0.150) <0.001 0.165 (0.161, 0.168) <0.001 Successful weight reduction and maintenance by using a smartphone application in those with overweight and obesity Chin et al. Sci Rep 2016 •대상자의 약 77.9%에서 성공적인 체중감량 효과를 확인 •이 중 23%는 본인 체중의 10% 이상 감량에 성공 •앱의 사용이 약물 치료 등 다른 비만 관리 기법에 비해 체중 감량 효과가 뒤쳐지지 않음
- 82. Successful weight reduction and maintenance by using a smartphone application in those with overweight and obesity Chin et al.Sci Rep 2016 •체중을 자주 기록하고 저녁식사를 자주 입력한 사용자의 체중감량 효과가 가장 높았음 •비만 관리에서 강조되던 생활 습관의 중요성을 글로벌 스케일의 데이터로 증명 nature.com/scientificreports/ Diabetes Prevention Program (DPP)-intensive lifestyle intervention is one such method, designed to produce clinically significant weight reduction in adults with prediabetes, proving its effectiveness for both weight loss and cardiometabolic outcomes8 . In addition, life style modification has been shown to be effective for reducing body weight and cardiovascular risk6–10 ; however, each of these studies had important limitations, particularly in that some of them were resource intensive, expensive, and time-consuming14,15 . Frequent group and individual Univariate Logistic Regression Wald Test p-value Multivariate Logistic Regression Wald Test p-valueOR (95% CI) OR (95% CI) Gender (male) 1.44 (1.29, 1.60) <0.001 2.05 (1.79, 2.36) <0.001 Age 0.99 (0.99, 1.00) 0.002 0.97 (0.95, 0.97) <0.001 Follow-up Days 1.00 (1.000, 1.00) 0.627 — — Baseline BMI 1.10 (1.09, 1.11) <0.001 1.13 (1.12, 1.14) <0.001 Weight input frequency (n/person-day) 2.85 (2.20, 3.70) <0.001 3.0 (2.21, 4.08) <0.001 Breakfast input frequency (n/person-day) 3.15 (2.72, 3.66) <0.001 0.36 (0.22, 0.57) <0.001 Lunch input frequency (n/person-day) 3.98 (3.42, 4.64) <0.001 1.14 (0.57, 2.28) 0.718 Dinner input frequency (n/person-day) 4.86 (4.16, 5.68) <0.001 10.69 (6.20, 18.53) <0.001 Breakfast calories (kcal/person-day) 1.00 (1.00, 1.00) <0.001 1.00 (1.00, 1.00) <0.001 Lunch calories (kcal/person-day) 1.00 (1.00, 1.00) <0.001 1.00 (1.00, 1.00) <0.001 Dinner calories (kcal/person-day) 1.00 (1.00, 1.00) 0.105 1.00 (1.00, 1.00) <0.001 Exercise input frequency (n/person-day) 4.02 (3.30, 4.90) <0.001 2.49 (1.96, 3.17) <0.001 Exercise calories expenditure (kcal/person-day) 1.00 (1.00, 1.00) <0.001 1.00 (1.00, 1.00) 0.085 Table 4. Factors contributing to being a success or a partial success against stationary subgroup. Abbreviations: BMI, body mass index; OR, odds ratio; CI, confidence interval.
- 83. •미국 CDC의 당뇨병예방 프로그램(DPP)으로 공식 인증 •CDC에서 fully recognised 된 첫번째 ‘virtual provider’ •2018년 1월부터 CMS(Centers for Medicare&Medicaid Services)의 보험 수가를 적용 •메디케어 1인당 2년에 성취도에 따라 $630 까지 지급 •B2B 사업으로도 확대 예정 "눔은 OEM(주문자상표부착생산) 업체로서 라이선스를 사간 기업에 모바일 플랫폼과 건강관리 코치들, 교육프로그램 등을 종합적으로 제공한다"
- 86. •Omada Health는 당뇨병예방 프로그램(DPP)에 대한 최대 규모 임상 시작 •The Preventing Diabetes With Digital Health and Coaching (PREDICTS) •2019년 9월까지 성인 484명을 대상 •Randomized, controlled trial •실험군: Omada + 코칭 •대조군: 병원의 표준치료 •Outcome •Primary: HbA1c •Secondary: 체중감량, CVD의 위험도 감소 •추가적으로: QoL, healthcare utilization, 의료진의 인식
- 88. 대표적인 Digital Therapeutics의사례연구 • Pear Therapeutics • Akili Interactive • Click Therapeutics • Dthera Science • Noom, Omada Health • Hurray Positive, SK Health Connect • Virtual Vietnam • AppliedVR • Woebot • Cognoa • Propeller Health • Neofect
- 91. 14© 2017 byHURAYPOSITIVE INC., a Digital Healthcare Service Provider. This information is strictly privileged and confidential. All rights reserved. 제2형 당뇨병 환자 95% 임신성 당뇨병 환자 2% 기타 1% 정상인 당뇨병 전단계 환자 당뇨병 환자 경증합병증 동반 당뇨병 환자 중증합병증 동반 당뇨병 환자 제1형 당뇨병 환자 2% 보건복지부/건강보험공단 (국민건강증진 및 관리) 병원/제약사/보험사 (비용절감 및 고객만족) 차기 위험단계로의 적극적인 진입 억제를 위한 헬스케어 솔루션 휴레이포지티브 헬스케어 솔루션 $ key facts Products & Services 서비스 대상 & 역할
- 92. 15© 2017 byHURAYPOSITIVE INC., a Digital Healthcare Service Provider. This information is strictly privileged and confidential. All rights reserved. Products & Services 서비스 흐름 & 솔루션 구성 건강상태 데이터 실시간 데이터 분석을 통한 의료 통찰력 제공 즉각적인 알림 및 중재 경험 및 데이터 (EMR/PHR) 개인별 고객 맞춤형 중재 서비스 사용자 헬스케어 제공자 Switch Band 신체에 접촉되어 실시간 생활습관 관리를 위한 알림 및 적극적 동기부여 Health Switch 혈당, 혈압, 식사, 복약, 운동, 체중 등 생활습관 관리를 위한 모바일 앱 Switch Station 가정 내에서 효과적인 알림 및 동기부여를 통한 생활습관 관리 기기(특히, 노령환자 대상) 혈당 측정기 혈당 측정에 관한 기술적 개발 및 상용화 프로젝트 Health Switch PRO 헬스케어 제공자가 더욱 정밀하고 정확한 진단과 진료를 할 수 있도록 의료 통찰력을 제공하는 관리 소프트웨어 key facts 하드웨어와 소프트웨어 모든 분야에서의 풍부한 기술적 경험 Advanced Database Big Data/ Analytics Machine Learning Lifestyle Intervention
- 93. 16© 2017 byHURAYPOSITIVE INC., a Digital Healthcare Service Provider. This information is strictly privileged and confidential. All rights reserved. 7 7.2 7.4 7.6 7.8 8 8.2 3M 6M 9M 12M0M ▼0.63%p. ▼0.64%p. 당화혈색소(HbA1c,%) & Products & Services 의학적 유효성(Health Switch를 활용한 임상실험) 기간 • 1차 실험(0M-6M) 실험군: 중재 O ( ) 대조군: 중재 X ( ) • 2차 실험: 실험군과 대조군 교차(6M-12M) 대조군: 중재 X ( ) 실험군: 중재 O ( ) 당화혈색소 0.63%p. 감소 무의미한 변화 당화혈색소 수준 유지 당화혈색소 0.64%p. 감소 ▼0.04%p. • N = 148명 • 평균 연령: 52.2세 결과 임상 대상자 1 모바일 중재 서비스의 의미 있는 혈당 감소 효과 2 약 6개월의 서비스 후 생활습관 유지 가능성 3 고령 환자들도 사용할 수 있는 간편한 서비스 임상실험을 통해 검증된 Health Switch의 효과 key facts • 특징: 제2형 당뇨병 유병자 • 기간: 2014.10 ~ 2015.12
- 94. 1SCIENTIFIC REPORTS |(2018) 8:3642 | DOI:10.1038/s41598-018-22034-0 www.nature.com/scientificreports The effectiveness, reproducibility, and durability of tailored mobile coaching on diabetes management in policyholders:A randomized, controlled, open-label study DaYoung Lee1,2 , Jeongwoon Park3 , DooahChoi3 , Hong-YupAhn4 , Sung-Woo Park1 & Cheol-Young Park 1 This randomized, controlled, open-label study conducted in Kangbuk Samsung Hospital evaluated the effectiveness, reproducibility, and durability of tailored mobile coaching (TMC) on diabetes management.The participants included 148 Korean adult policyholders with type 2 diabetes divided into the Intervention-Maintenance (I-M) group (n=74) andControl-Intervention (C-I) group (n=74). Intervention was the addition ofTMC to typical diabetes care. In the 6-month phase 1, the I-M group receivedTMC, and theC-I group received their usual diabetes care. During the second 6-month phase 2, theC-I group receivedTMC, and the I-M group received only regular information messages.After the 6-month phase 1, a significant decrease (0.6%) in HbA1c levels compared with baseline values was observed in only the I-M group (from 8.1±1.4% to 7.5±1.1%, P<0.001 based on a paired t-test). At the end of phase 2, HbA1c levels in theC-I group decreased by 0.6% compared with the value at 6 months (from 7.9±1.5 to 7.3±1.0, P<0.001 based on a paired t-test). In the I-M group, no changes were observed. Both groups showed significant improvements in frequency of blood-glucose testing and exercise. In conclusion, addition ofTMC to conventional treatment for diabetes improved glycemic control, and this effect was maintained without individualized message feedback. The incidence and prevalence of type 2 diabetes are increasing rapidly worldwide, and the disease is expected to affect 439 million adults by 20301 . Previous large clinical trials indicated that adequate glycemic control con- tributed to a reduction in both microvascular and macrovascular complications as well as mortality rates due to diabetes2,3 . Complications from diabetes result in greater expenditure and reduced productivity. Therefore, it is a socioeconomic concern4,5 . Adequate glycemic control is important not only as an individual health problem, but also as a challenge to healthcare systems worldwide. However, approximately 40% of subjects with diabetes in the United States do not meet the recommended target for glycemic control, low-density lipoprotein cholesterol (LDL-C) level, or blood pressure (BP)6 . In Korea, glycated hemoglobin (HbA1c) levels for nearly half of diabetic patients were above 7.0%7 . Although successful diabetes care requires therapeutic lifestyle modification in addition to proper medica- tion8–10 , only 55% of individuals with type 2 diabetes receive diabetes education from healthcare professionals11 , and 16% report adhering to recommended self-management activities9 . Multifaceted professional inter- ventions are needed to support patient efforts for behavior change including healthy lifestyle choices, disease self-management, and prevention of diabetes complications10 . 1 Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, SungkyunkwanUniversitySchool of Medicine,Seoul, Republic of Korea.2 Division of Endocrinology and Metabolism, Department of Internal Medicine, KoreaUniversityCollege of Medicine,Seoul, Republic of Korea.3 Huraypositive Inc. Sinsa-dong, Gangnam-gu, Seoul, Republic of Korea. 4 Department of Statistics, Dongguk University-Seoul, Seoul, Republic of Korea. Correspondence and requests for materials should be addressed to C.-Y.P. (email: cydoctor@ chol.com) Received: 29 November 2017 Accepted: 15 February 2018 Published: xx xx xxxx OPEN
- 95. 1SCIENTIFIC REPORTS |(2018) 8:3642 | DOI:10.1038/s41598-018-22034-0 www.nature.com/scientificreports The effectiveness, reproducibility, and durability of tailored mobile coaching on diabetes management in policyholders:A randomized, controlled, open-label study DaYoung Lee1,2 , Jeongwoon Park3 , DooahChoi3 , Hong-YupAhn4 , Sung-Woo Park1 & Cheol-Young Park 1 This randomized, controlled, open-label study conducted in Kangbuk Samsung Hospital evaluated the effectiveness, reproducibility, and durability of tailored mobile coaching (TMC) on diabetes management.The participants included 148 Korean adult policyholders with type 2 diabetes divided into the Intervention-Maintenance (I-M) group (n=74) andControl-Intervention (C-I) group (n=74). Intervention was the addition ofTMC to typical diabetes care. In the 6-month phase 1, the I-M group receivedTMC, and theC-I group received their usual diabetes care. During the second 6-month phase 2, theC-I group receivedTMC, and the I-M group received only regular information messages.After the 6-month phase 1, a significant decrease (0.6%) in HbA1c levels compared with baseline values was observed in only the I-M group (from 8.1±1.4% to 7.5±1.1%, P<0.001 based on a paired t-test). At the end of phase 2, HbA1c levels in theC-I group decreased by 0.6% compared with the value at 6 months (from 7.9±1.5 to 7.3±1.0, P<0.001 based on a paired t-test). In the I-M group, no changes were observed. Both groups showed significant improvements in frequency of blood-glucose testing and exercise. In conclusion, addition ofTMC to conventional treatment for diabetes improved glycemic control, and this effect was maintained without individualized message feedback. The incidence and prevalence of type 2 diabetes are increasing rapidly worldwide, and the disease is expected to affect 439 million adults by 20301 . Previous large clinical trials indicated that adequate glycemic control con- tributed to a reduction in both microvascular and macrovascular complications as well as mortality rates due to diabetes2,3 . Complications from diabetes result in greater expenditure and reduced productivity. Therefore, it is a socioeconomic concern4,5 . Adequate glycemic control is important not only as an individual health problem, but also as a challenge to healthcare systems worldwide. However, approximately 40% of subjects with diabetes in the United States do not meet the recommended target for glycemic control, low-density lipoprotein cholesterol (LDL-C) level, or blood pressure (BP)6 . In Korea, glycated hemoglobin (HbA1c) levels for nearly half of diabetic patients were above 7.0%7 . Although successful diabetes care requires therapeutic lifestyle modification in addition to proper medica- tion8–10 , only 55% of individuals with type 2 diabetes receive diabetes education from healthcare professionals11 , and 16% report adhering to recommended self-management activities9 . Multifaceted professional inter- ventions are needed to support patient efforts for behavior change including healthy lifestyle choices, disease self-management, and prevention of diabetes complications10 . 1 Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, SungkyunkwanUniversitySchool of Medicine,Seoul, Republic of Korea.2 Division of Endocrinology and Metabolism, Department of Internal Medicine, KoreaUniversityCollege of Medicine,Seoul, Republic of Korea.3 Huraypositive Inc. Sinsa-dong, Gangnam-gu, Seoul, Republic of Korea. 4 Department of Statistics, Dongguk University-Seoul, Seoul, Republic of Korea. Correspondence and requests for materials should be addressed to C.-Y.P. (email: cydoctor@ chol.com) Received: 29 November 2017 Accepted: 15 February 2018 Published: xx xx xxxx OPEN e.com/scientificreports/ Figure 3. Changes in means and standard errors of glycated hemoglobin (H study period. HbA1c levels of the C-I group who received TMC during phase 2 of the study decreased by 0.6% compared to phase 1 levels. In the I-M group, initial improvement in HbA1c levels at 3 months continued until 12 months. Consequently, HbA1c levels in both the C-I and I-M groups decreased significantly compared to baseline values over the 12-month study period.
- 101. 보험사 환자 사용료 스타트업 보험료 데이터 질병 관리 서비스 “사업적수익” “보험금 지급 감소” “질병 관리”
- 102. The Effect ofa Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks https://doi.org/10.2337/dc17-2197 OBJECTIVE Thisstudyevaluatedtheefficacyofasmartphone-based,patient-centered diabetes care system (mDiabetes) for type 2 diabetes that contains comprehensive modules forglucosemonitoring,diet,physicalactivity,andaclinicaldecisionsupportsystem. RESEARCH DESIGN AND METHODS We conducted a 24-week, multicenter, randomized controlled trial with adult patients with inadequately controlled type 2 diabetes. The patients were randomly assigned to the mDiabetes group or the paper logbook (pLogbook) group. The primary end point was the difference of the change in HbA1c from baseline between the two groups. RESULTS HbA1c reductionfrombaselinewasgreaterinthemDiabetesgroup(20.4060.09%, n = 90) than in the pLogbook group (20.06 6 0.10%, n = 82). The difference of adjusted mean changes was 0.35% (95% CI 0.14–0.55, P = 0.001). The proportion of patients whose HbA1c fell below 7.0% (53 mmol/mol) was 41.1% for the mDia- betes group and 20.7% for the pLogbook group (odds ratio [OR] 2.01, 95% CI 1.24– 3.25, P = 0.003). The percentage of patients who attained HbA1c levels below 7.0% (53 mmol/mol) without hypoglycemia was 31.1% in the mDiabetes group and 17.1% in the pLogbook group (OR 1.82, 95% CI 1.03–3.21, P = 0.024). There was no difference in the event numbers of severe hyperglycemia and hypoglycemia be- tween the two groups. CONCLUSIONS The implementation of the mDiabetes for patients with inadequately controlled type 2 diabetes resulted in a significant reduction in HbA1c levels, with tolerable safety profiles. Diabetes is a chronic disease requiring lifelong management with lifestyle modifi- cation, medication, or both; therefore, diabetes self-management education and adherence to the treatment plans are considered key components in the manage- ment of diabetes (1). As information technology (IT) advances, medical services us- ing IT devices, such as mobile health care (mHealth) systems, have been developed to aid chronic disease management. Currently, ;259,000 mHealth applications are 1 International Healthcare Center, Seoul National University Hospital, Seoul, Korea 2 Department of Internal Medicine, Seoul Na- tional University College of Medicine, Seoul, Korea 3 Department of Internal Medicine, Boramae Medical Center, Seoul, Korea 4 Department of Internal Medicine, Seoul Na- tional University Bundang Hospital, Seongnam, Korea Correspondingauthor:YoungMinCho,ymchomd@ snu.ac.kr. Received 19 October 2017 and accepted 1 October 2019. Clinical trial reg. no. NCT02451631, clinicaltrials .gov. This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/ doi:10.2337/dc17-2197/-/DC1. © 2018 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More infor- mation is available at http://www.diabetesjournals .org/content/license. Eun Ky Kim,1,2 Soo Heon Kwak,2 Hye Seung Jung,2 Bo Kyung Koo,2,3 Min Kyong Moon,2,3 Soo Lim,2,4 Hak Chul Jang,2,4 Kyong Soo Park,2 and Young Min Cho2 Diabetes Care 1 CLINCARE/EDUCATION/NUTRITION/PSYCHOSOCIAL Diabetes Care Publish Ahead of Print, published online October 30, 2018 • 헬스커넥트의 당뇨 관리 앱이 2형 당뇨의 관리에 효과가 있음을 증명 • 총 환자 172명 (실험군: 대조군=90:82), 24주, multi-center, RCT
- 103. changes was 0.35%(95% CI 0.14–0.55, P = 0.001). In the per protocol analysis, the change in HbA1c level was 20.40 6 0.09% patients in groups C+D (Fig. 1E). The proportion of patients with HbA1c lev- els ,7.0% (,53 mmol/mol) was 41.1% proportion of patients with HbA1c #6.5% (#48 mmol/mol) without hypoglycemia was 11.1% in the mDiabetes group and 2.4% in the pLogbook group (OR 4.56, 95% CI 1.03–20.18, P = 0.050). A total of 136 patients (68 patients in each group) completed the 7-point SMBG with no missing entries. There was no difference between the mDia- betes group and the pLogbook group at baseline (Supplementary Fig. 4A). Af- ter 24 weeks, the glucose levels of the mDiabetes group at the prebreakfast, prelunch, and postdinner times were lower compared with those of the pLog- book group (Supplementary Fig. 4B). Other secondary outcomes, including blood pressure, body composition, fast- ing plasma glucose, and lipid profile are provided in Supplementary Table 5. Body weight modestly decreased in the mDia- betes group from 67.7 6 11.8 to 67.1 6 11.6 kg (P = 0.005) and in the pLogbook group from 68.4 6 13.0 to 68.0 6 12.7 kg (P = 0.041), which, however, were not different between the two groups (P = 0.531). At week 24, the mDiabetes group showed a greater reduction in the per- centage of body fat than the pLogbook group did (20.93 6 0.29% vs. 20.25 6 0.31%, P = 0.038). Fasting plasma glucose in the mDiabetes group decreased from 7.8 6 2.1 mmol/L to 7.7 6 2.2 mmol/L, whereas that in the pLogbook group increased from 7.3 6 1.8 mmol/L to 8.0 6 1.6 mmol/L. The mean changes of fasting glucose between the groups were statistically significant (P = 0.026). Blood pressure and lipid profile were not significantly changed after 24 weeks of intervention compared with baseline in both groups. Baseline scores of all SDSCA domains taken after 2 weeks of the run-in period and the glucose monitoring scores were similar between the mDiabetes group (6.4 6 1.5) and the pLogbook group Figure 1—Changes in HbA1c levels after intervention. A: After 24 weeks, HbA1c levels were significantly decreased in the mDiabetes group compared with the pLogbook group. B: Per protocol analysis showed a more remarkable difference in the change of HbA1c between the two groups. C and D: There was a more remarkable reduction in HbA1c levels among the patients with baseline HbA1c levels $8.0% ($64 mmol/mol) and insulin users. E: The reduction in HbA1c was significant among patients in groups C+D but not in groups A+B. The data were analyzed by ANCOVA (A and B) or Wilcoxon rank sum test (C–E). *P , 0.05, **P , 0.01, ***P , 0.001. • 헬스커넥트의 앱 mDiabetes를 사용한 그룹이, 수기로 혈당 노트를 작성한 그룹보다 HbA1c가 유의미하게 감소 (A,B) • per protocol analysis 에서는 차이가 더 유의미함 (B) • 치료 받는 유형이나 베이스라인 대비 HbA1c의 감소폭도 분석 • HbA1c가 원래 높았던 사람일 수록(C) • 인슐린을 사용했던 환자가, 하지 않던 환자보다 (D) • mDiabetes의 효과 좋음
- 104. changes was 0.35%(95% CI 0.14–0.55, P = 0.001). In the per protocol analysis, the change in HbA1c level was 20.40 6 0.09% patients in groups C+D (Fig. 1E). The proportion of patients with HbA1c lev- els ,7.0% (,53 mmol/mol) was 41.1% proportion of patients with HbA1c #6.5% (#48 mmol/mol) without hypoglycemia was 11.1% in the mDiabetes group and 2.4% in the pLogbook group (OR 4.56, 95% CI 1.03–20.18, P = 0.050). A total of 136 patients (68 patients in each group) completed the 7-point SMBG with no missing entries. There was no difference between the mDia- betes group and the pLogbook group at baseline (Supplementary Fig. 4A). Af- ter 24 weeks, the glucose levels of the mDiabetes group at the prebreakfast, prelunch, and postdinner times were lower compared with those of the pLog- book group (Supplementary Fig. 4B). Other secondary outcomes, including blood pressure, body composition, fast- ing plasma glucose, and lipid profile are provided in Supplementary Table 5. Body weight modestly decreased in the mDia- betes group from 67.7 6 11.8 to 67.1 6 11.6 kg (P = 0.005) and in the pLogbook group from 68.4 6 13.0 to 68.0 6 12.7 kg (P = 0.041), which, however, were not different between the two groups (P = 0.531). At week 24, the mDiabetes group showed a greater reduction in the per- centage of body fat than the pLogbook group did (20.93 6 0.29% vs. 20.25 6 0.31%, P = 0.038). Fasting plasma glucose in the mDiabetes group decreased from 7.8 6 2.1 mmol/L to 7.7 6 2.2 mmol/L, whereas that in the pLogbook group increased from 7.3 6 1.8 mmol/L to 8.0 6 1.6 mmol/L. The mean changes of fasting glucose between the groups were statistically significant (P = 0.026). Blood pressure and lipid profile were not significantly changed after 24 weeks of intervention compared with baseline in both groups. Baseline scores of all SDSCA domains taken after 2 weeks of the run-in period and the glucose monitoring scores were similar between the mDiabetes group (6.4 6 1.5) and the pLogbook group Figure 1—Changes in HbA1c levels after intervention. A: After 24 weeks, HbA1c levels were significantly decreased in the mDiabetes group compared with the pLogbook group. B: Per protocol analysis showed a more remarkable difference in the change of HbA1c between the two groups. C and D: There was a more remarkable reduction in HbA1c levels among the patients with baseline HbA1c levels $8.0% ($64 mmol/mol) and insulin users. E: The reduction in HbA1c was significant among patients in groups C+D but not in groups A+B. The data were analyzed by ANCOVA (A and B) or Wilcoxon rank sum test (C–E). *P , 0.05, **P , 0.01, ***P , 0.001. • 환자를 4가지 세부 그룹으로 구분 • A: 생활 습관으로만 관리하는 그룹 • B: hypoglycemia 가능성이 낮아서 메트포민을 복용하는 그룹 • C: hypoglycemia 가능성으로 sulfonylurea와 meglitinide를 복용하는 그룹 • D: 인슐린을 사용하는 그룹 • ABCD 전체와, CD 그룹은 HbA1c의 감소가 유의미 • AB 그룹은 유의미하지 않음
- 105. 대표적인 Digital Therapeutics의사례연구 • Pear Therapeutics • Akili Interactive • Click Therapeutics • Dthera Science • Noom, Omada Health • Hurray Positive, SK Health Connect • Virtual Vietnam • AppliedVR • Woebot • Cognoa • Propeller Health • Neofect
- 106. PTSD (외상 후스트레스 장애)
- 107. • PTSD는 전쟁,고문, 자연재해, 범죄, 테러 등의 심각한 사건을 경험한 후, 사 건 이후에도 그 사건에 공포감을 느끼고 트라우마를 느끼는 질환 • 환자들은 악몽을 꾸거나, 특정 장면이 영화의 회상 장면(Flashback)처 럼 재현되는 등의 증상을 가지게 되며, 사고와 연관된 자극을 회피 • 이러한 변화에 따라서 일상 사회 생활에도 어려움을 겪거나, 우울증, 분 노 장애 등을 동반하는 경우 많음 • 이라크전 참전 군인의 15.6-17.1%, 아프가니스탄 전에 참전 군인의 11.2% 가 PTSD 를 겪음 (NEJM, 2004) PTSD (외상 후 스트레스 장애)
- 108.
- 109. •PTSD 치료를 위해가장 효과적인 치료로 증명된 원리 •환자가 트라우마를 갖고 있는 상황과 기억에 지속적으로 노출시켜 스트레스와 회피 행동을 감소시키는 치료 방식 •트라우마에 대한 기억을 반복해서 떠올리게 되는데, 이러한 과정을 거치며 특정 기억과 반응의 연결고리를 약화 시킴 Prolonged Exposure Therapy (지속 노출 치료)
- 111. 지속 노출 치료의한계 • 환자들이 트라우마를 떠올리는 것에 거부감을 느끼거나, 효과적으로 상상하지 못함 • 사실 그 자체가 PTSD 의 증상의 하나 • 환자가 트라우마에 대한 기억을 생생하게 시각화하지 못하면 치료 효과 감소 어떻게 환자에게 실감나는 상황을 시각화 해줄 것인가
- 112.
- 113. VirtualVietnam •VR은 PTSD의 치료를위해 1990년대부터 활용 •최초의 시도: 버추얼 베트남 (1997) • 정글을 헤치고 나가는 시나리오 / 군용 헬리곱터가 날아가는 시나리오 • 그래픽 수준, 구현 효과 및 시나리오 등이 제한적 • 전통적 심리 치료에 효과 없던 환자 전원이 유의미한 개선 효과 “영상 속에서 베트남 사람들과 탱크를 보았어요”
- 114.
- 115.
- 116.
- 118. scores at baseline,post treatment and 3-month follow-up are in Fig group, mean Beck Anxiety Inventory scores significantly decrea (9.5) to 11.9 (13.6), (t=3.37, df=19, p < .003) and mean PHQ-9 decreased 49% from 13.3 (5.4) to 7.1 (6.7), (t=3.68, df=19, p < 0.00 Figure 4. PTSD Checklist scores across treatment Figure 5. BAI and PH The average number of sessions for this sample was just under successful treatment completers had documented mild and mode injuries, which suggest that this form of exposure can be useful PTSD Checklist scores across treatment • 연구 결과 20명의 환자들은 전반적으로 유의미한 개선을 보임 • 환자들 전체의 PCL-M 수치가 평균 54.4에서 35.6으로 감소 • 20명 중 16명은 치료 직후에 더 이상 PTSD 를 가지지 않은 것으로 나타남 • 치료가 끝난지 3개월 후에 환자들의 상태는 유지 http://www.ncbi.nlm.nih.gov/pubmed/19377167
- 119. reatment and 3-monthfollow-up are in Figure 4. For this same iety Inventory scores significantly decreased 33% from 18.6 =3.37, df=19, p < .003) and mean PHQ-9 (depression) scores 3 (5.4) to 7.1 (6.7), (t=3.68, df=19, p < 0.002) (see Figure 5). ores across treatment Figure 5. BAI and PHQ-Depression scores r of sessions for this sample was just under 11. Also, two of the mpleters had documented mild and moderate traumatic brain that this form of exposure can be usefully applied with this BAI and PHQ-Depression scores • 벡 불안 지수는 평균 18.6에서 11.9로 33% 감소 • PHQ-9 우울증 지수 역시 13.3에서 7.1로 49% 감소 • 경미한 외상성 뇌손상 (traumatic brain injury) 환자 2명에도 유의미한 효과 http://www.ncbi.nlm.nih.gov/pubmed/19377167
- 120. 대표적인 Digital Therapeutics의사례연구 • Pear Therapeutics • Akili Interactive • Click Therapeutics • Dthera Science • Noom, Omada Health • Hurray Positive, SK Health Connect • Virtual Vietnam • AppliedVR • Woebot • Cognoa • Propeller Health • Neofect
- 122. Snow World,VR forburn patients
- 123. Clinical note Virtual realityas an adjunctive pain control during burn wound care in adolescent patients Hunter G. Hoffmana, c , Jason N. Doctorb , David R. Pattersonb,*, Gretchen J. Carrougherb , Thomas A. Furness IIIc a Department of Psychology, University of Washington, Seattle, WA, USA b Department of Rehabilitation Medicine, University of Washington School of Medicine, P.O. Box 359740, Seattle, WA 98104, USA c Human Interface Technology Laboratory, P.O. Box 352142, University of Washington, Seattle, WA 98195-2142, USA Received 6 September 1999; accepted 16 November 1999 Abstract For daily burn wound care procedures, opioid analgesics alone are often inadequate. Since most burn patients experience severe to excruciating pain during wound care, analgesics that can be used in addition to opioids are needed. This case report provides the ®rst evidence that entering an immersive virtual environment can serve as a powerful adjunctive, nonpharmacologic analgesic. Two patients received virtual reality (VR) to distract them from high levels of pain during wound care. The ®rst was a 16-year-old male with a deep ¯ash burn on his right leg requiring surgery and staple placement. On two occasions, the patient spent some of his wound care in VR, and some playing a video game. On a 100 mm scale, he provided sensory and affective pain ratings, anxiety and subjective estimates of time spent thinking about his pain during the procedure. For the ®rst session of wound care, these scores decreased 80 mm, 80 mm, 58 mm, and 93 mm, respectively, during VR treatment compared with the video game control condition. For the second session involving staple removal, scores also decreased. The second patient was a 17-year-old male with 33.5% total body surface area deep ¯ash burns on his face, neck, back, arms, hands and legs. He had dif®culty tolerating wound care pain with traditional opioids alone and showed dramatic drops in pain ratings during VR compared to the video game (e.g. a 47 mm drop in pain intensity during wound care). We contend that VR is a uniquely attention- capturing medium capable of maximizing the amount of attention drawn away from the `real world', allowing patients to tolerate painful procedures. These preliminary results suggest that immersive VR merits more attention as a potentially viable form of treatment for acute pain. q 2000 International Association for the Study of Pain. Published by Elsevier Science B.V. All rights reserved. Keywords: Burn pain; Virtual reality; Presence; Analgesia; Distraction; Attention 1. Introduction Burns of a severity requiring hospitalization cause severe pain during wound care (e.g. dressing changes), despite treatment with potent opioid analgesics (Perry, 1981; Choi- niere et al., 1989; Everett et al., 1990). Unfortunately, severe burns prompt changes in body chemistry that make control- ling pain with pharmacologic therapies more dif®cult (Cooper and Pavlin, 1990). Perry et al. (1981) indicated that 84% of their patients given a typical dose of morphine still rated wound care pain as severe to excruciating. Since the degree of pain reported during hospitalization is asso- ciated with the degree of postdischarge mental and physical dysfunction (Ptacek et al., 1995), improved burn wound pain management may have practical as well as humane purposes. While opioid analgesics should be the cornerstone of nearly any burn wound care pain treatment plan, psycholo- gical or other pharmacologic interventions should be considered as an adjunct treatment (Patterson, 1992,1995). For example, benzodiazopines have been used to decrease anxiety and pain associated with medical procedures (Patterson et al., 1997). Cognitive-behavioral techniques offer another promising intervention. In essence, such inter- ventions treat internal thoughts as modi®able behaviors and can alter the patient's attention to, and interpretation of, pain signals. Typical applications of cognitive-behavioral inter- ventions for acute pain include avoidance or distraction strategies such as hypnosis (Patterson et al., 1992), mental imagery (e.g. picturing oneself without pain on a tropical island), mental effort (solving math problems during a pain- ful procedure), engaging the patient in conversation, listen- Pain 85 (2000) 305±309 0304-3959/00/$20.00 q 2000 International Association for the Study of Pain. Published by Elsevier Science B.V. All rights reserved. PII: S0304-3959(99)00275-4 www.elsevier.nl/locate/pain * Corresponding author. Tel.: 11-206-731-3418; fax: 11-206-731- 8580.
- 124. Clinical note Virtual realityas an adjunctive pain control during burn wound care in adolescent patients Hunter G. Hoffmana, c , Jason N. Doctorb , David R. Pattersonb,*, Gretchen J. Carrougherb , Thomas A. Furness IIIc a Department of Psychology, University of Washington, Seattle, WA, USA b Department of Rehabilitation Medicine, University of Washington School of Medicine, P.O. Box 359740, Seattle, WA 98104, USA c Human Interface Technology Laboratory, P.O. Box 352142, University of Washington, Seattle, WA 98195-2142, USA Received 6 September 1999; accepted 16 November 1999 Abstract For daily burn wound care procedures, opioid analgesics alone are often inadequate. Since most burn patients experience severe to excruciating pain during wound care, analgesics that can be used in addition to opioids are needed. This case report provides the ®rst evidence that entering an immersive virtual environment can serve as a powerful adjunctive, nonpharmacologic analgesic. Two patients received virtual reality (VR) to distract them from high levels of pain during wound care. The ®rst was a 16-year-old male with a deep ¯ash burn on his right leg requiring surgery and staple placement. On two occasions, the patient spent some of his wound care in VR, and some playing a video game. On a 100 mm scale, he provided sensory and affective pain ratings, anxiety and subjective estimates of time spent thinking about his pain during the procedure. For the ®rst session of wound care, these scores decreased 80 mm, 80 mm, 58 mm, and 93 mm, respectively, during VR treatment compared with the video game control condition. For the second session involving staple removal, scores also decreased. The second patient was a 17-year-old male with 33.5% total body surface area deep ¯ash burns on his face, neck, back, arms, hands and legs. He had dif®culty tolerating wound care pain with traditional opioids alone and showed dramatic drops in pain ratings during VR compared to the video game (e.g. a 47 mm drop in pain intensity during wound care). We contend that VR is a uniquely attention- capturing medium capable of maximizing the amount of attention drawn away from the `real world', allowing patients to tolerate painful procedures. These preliminary results suggest that immersive VR merits more attention as a potentially viable form of treatment for acute pain. q 2000 International Association for the Study of Pain. Published by Elsevier Science B.V. All rights reserved. Keywords: Burn pain; Virtual reality; Presence; Analgesia; Distraction; Attention 1. Introduction Burns of a severity requiring hospitalization cause severe pain during wound care (e.g. dressing changes), despite treatment with potent opioid analgesics (Perry, 1981; Choi- niere et al., 1989; Everett et al., 1990). Unfortunately, severe burns prompt changes in body chemistry that make control- ling pain with pharmacologic therapies more dif®cult (Cooper and Pavlin, 1990). Perry et al. (1981) indicated that 84% of their patients given a typical dose of morphine still rated wound care pain as severe to excruciating. Since the degree of pain reported during hospitalization is asso- ciated with the degree of postdischarge mental and physical dysfunction (Ptacek et al., 1995), improved burn wound pain management may have practical as well as humane purposes. While opioid analgesics should be the cornerstone of nearly any burn wound care pain treatment plan, psycholo- gical or other pharmacologic interventions should be considered as an adjunct treatment (Patterson, 1992,1995). For example, benzodiazopines have been used to decrease anxiety and pain associated with medical procedures (Patterson et al., 1997). Cognitive-behavioral techniques offer another promising intervention. In essence, such inter- ventions treat internal thoughts as modi®able behaviors and can alter the patient's attention to, and interpretation of, pain signals. Typical applications of cognitive-behavioral inter- ventions for acute pain include avoidance or distraction strategies such as hypnosis (Patterson et al., 1992), mental imagery (e.g. picturing oneself without pain on a tropical island), mental effort (solving math problems during a pain- ful procedure), engaging the patient in conversation, listen- Pain 85 (2000) 305±309 0304-3959/00/$20.00 q 2000 International Association for the Study of Pain. Published by Elsevier Science B.V. All rights reserved. PII: S0304-3959(99)00275-4 www.elsevier.nl/locate/pain * Corresponding author. Tel.: 11-206-731-3418; fax: 11-206-731- 8580. wound care. The ®rst patient's pain ratings showed consid- erable reduction while in VR relative to a video game control condition. While in VR, the patient's pain scores decreased dramatically for sensory pain, affective pain, anxiety, and he showed a large reduction in the amount of time spent thinking about his pain during wound care. VR and the video game control condition differed with respect to the patient's ability to physically look at his burn wound. In VR this was not possible; in the video game, this was possible for patient one, and nurses informally observed that he looked over at his wound brie¯y several times during the video game condition. The patient's inability to see the burn wound while in VR may have contributed to the reduction in the patient's pain. Simulator sickness was not a problem in this study but should be monitored closely in any medical quate pain management (Melza higher doses of morphine-based hood of side effects like respirat phalopathy and constipation. Hea may worry (albeit unnecessarily) addicted (Melzack, 1990) and mu the often large number of medica patient. (Patient 2 experienced o dures at the time of this writing). of VR to pediatric populations since children are severely under anxiety (Melzack, 1990). Worsen often develop strong conditioned ciated with burn pain wound ca 1995). Visual cues associated w the appearance of the nurse who create anxiety that exacerbates th use of classical conditioning prin caregivers can minimize the imp ing. Anxiety-inducing sights and hospital environment (e.g. surgic blood, dis®gured wounds typica dures) are blocked out by the VR Both patients in this study repo awareness of pain. They appeare VR task that they did not think of in VR. Unlike opioid analgesics consciously re¯ect upon the ef with distraction patients appear has been reduced until after the would appear to be a different r opioid based pharmacologies, the to rely on the physiological effeFig. 1. Drops in pain ratings in VR compared to Nintendo64 (for patient 2).
- 125. ORIGINAL ARTICLE Virtual Realityas an Adjunctive Non-pharmacologic Analgesic for Acute Burn Pain During Medical Procedures Hunter G. Hoffman, PhD & Gloria T. Chambers, RN & Walter J. Meyer III, MD, PhD & Lisa L. Arceneaux, PhD & William J. Russell, MS & Eric J. Seibel, PhD & Todd L. Richards, PhD & Sam R. Sharar, MD & David R. Patterson, PhD Published online: 25 January 2011 # The Society of Behavioral Medicine 2011 Abstract Introduction Excessive pain during medical procedures is a widespread problem but is especially problematic during daily wound care of patients with severe burn injuries. Methods Burn patients report 35–50% reductions in pro- cedural pain while in a distracting immersive virtual reality, and fMRI brain scans show associated reductions in pain- related brain activity during VR. VR distraction appears to be most effective for patients with the highest pain intensity levels. VR is thought to reduce pain by directing patients’ attention into the virtual world, leaving less attention available to process incoming neural signals from pain receptors. Conclusions We review evidence from clinical and labora- tory research studies exploring Virtual Reality analgesia, concentrating primarily on the work ongoing within our group. We briefly describe how VR pain distraction systems have been tailored to the unique needs of burn patients to date, and speculate about how VR systems could be tailored to the needs of other patient populations in the future. Keywords Virtual reality. Pain distraction . Analgesia Introduction The Problem: Uncontrolled Pain The treatment of severely burn-injured patients is one of the most painful processes in medicine. Few injuries involve more painful and numerous procedures than severe burns. In the USA, each year, an estimated 700,000 people visit the emergency room for treatment of burns. Of these, 45,000 have burns significant enough to require inpatient hospitalization [1]. In order to prevent infection and promote healing, patients with severe burns typically must have their bandages removed and have their wounds cleaned daily for weeks or even months. During cleaning/ debridement, foreign materials and dead tissue are removed from the open wound, antiseptic ointments are applied, and the wound is re-dressed/re-bandaged. These wound care sessions allow caregivers to look at the wound and monitor healing progress. Surgeons may need to surgically remove damaged skin and transplant fresh skin from another part of the body, e.g., the patient’s own unburned thigh to their burned hands, or in some cases, with donated skin from a cadaver. Once the graft takes hold on the burn site, staples or other adhesive devices that have been temporarily Electronic supplementary material The online version of this article (doi:10.1007/s12160-010-9248-7) contains supplementary material, which is available to authorized users. H. G. Hoffman :G. T. Chambers :E. J. Seibel :T. L. Richards : S. R. Sharar :D. R. Patterson University of Washington, Seattle, WA, USA W. J. Meyer III :L. L. Arceneaux :W. J. Russell University of Texas Medical Branch and Shriners Children’s Hospital Galveston TX, Galveston, TX, USA H. G. Hoffman (*) Human Interface Technology Laboratory, Human Photonics Lab, and Department of Mechanical Engineering, University of Washington, Seattle, WA, USA e-mail: hunter@hitL.washington.edu H. G. Hoffman e-mail: hunthoff@uw.edu URL: www.vrpain.com ann. behav. med. (2011) 41:183–191 DOI 10.1007/s12160-010-9248-7 • 화상 환자에서 VR의 진통 효과는 여러 연구로 입증되고 있음 • 30-50%의 진통 경감 효과가 보고 • fMRI 결과 VR로 통증과 관련된 brain activity가 낮아짐 • 특히, VR은 highest pain intensity level 의 환자에게 효과적
- 126. ORIGINAL ARTICLE Virtual Realityas an Adjunctive Non-pharmacologic Analgesic for Acute Burn Pain During Medical Procedures Hunter G. Hoffman, PhD & Gloria T. Chambers, RN & Walter J. Meyer III, MD, PhD & Lisa L. Arceneaux, PhD & William J. Russell, MS & Eric J. Seibel, PhD & Todd L. Richards, PhD & Sam R. Sharar, MD & David R. Patterson, PhD Published online: 25 January 2011 # The Society of Behavioral Medicine 2011 Abstract Introduction Excessive pain during medical procedures is a widespread problem but is especially problematic during daily wound care of patients with severe burn injuries. Methods Burn patients report 35–50% reductions in pro- cedural pain while in a distracting immersive virtual reality, and fMRI brain scans show associated reductions in pain- related brain activity during VR. VR distraction appears to be most effective for patients with the highest pain intensity levels. VR is thought to reduce pain by directing patients’ attention into the virtual world, leaving less attention available to process incoming neural signals from pain receptors. Conclusions We review evidence from clinical and labora- tory research studies exploring Virtual Reality analgesia, concentrating primarily on the work ongoing within our group. We briefly describe how VR pain distraction systems have been tailored to the unique needs of burn patients to date, and speculate about how VR systems could be tailored to the needs of other patient populations in the future. Keywords Virtual reality. Pain distraction . Analgesia Introduction The Problem: Uncontrolled Pain The treatment of severely burn-injured patients is one of the most painful processes in medicine. Few injuries involve more painful and numerous procedures than severe burns. In the USA, each year, an estimated 700,000 people visit the emergency room for treatment of burns. Of these, 45,000 have burns significant enough to require inpatient hospitalization [1]. In order to prevent infection and promote healing, patients with severe burns typically must have their bandages removed and have their wounds cleaned daily for weeks or even months. During cleaning/ debridement, foreign materials and dead tissue are removed from the open wound, antiseptic ointments are applied, and the wound is re-dressed/re-bandaged. These wound care sessions allow caregivers to look at the wound and monitor healing progress. Surgeons may need to surgically remove damaged skin and transplant fresh skin from another part of the body, e.g., the patient’s own unburned thigh to their burned hands, or in some cases, with donated skin from a cadaver. Once the graft takes hold on the burn site, staples or other adhesive devices that have been temporarily Electronic supplementary material The online version of this article (doi:10.1007/s12160-010-9248-7) contains supplementary material, which is available to authorized users. H. G. Hoffman :G. T. Chambers :E. J. Seibel :T. L. Richards : S. R. Sharar :D. R. Patterson University of Washington, Seattle, WA, USA W. J. Meyer III :L. L. Arceneaux :W. J. Russell University of Texas Medical Branch and Shriners Children’s Hospital Galveston TX, Galveston, TX, USA H. G. Hoffman (*) Human Interface Technology Laboratory, Human Photonics Lab, and Department of Mechanical Engineering, University of Washington, Seattle, WA, USA e-mail: hunter@hitL.washington.edu H. G. Hoffman e-mail: hunthoff@uw.edu URL: www.vrpain.com ann. behav. med. (2011) 41:183–191 DOI 10.1007/s12160-010-9248-7 dental/periodontal procedures in patients with dental fears [47, 48], and VR reduced fear/anxiety in a claustrophobic patient during a brain scan [49]. VR has reduced pain during a urological procedure in an older man receiving endoscopic transurethral microwave thermotherapy ablation of the prostate [50], and in pediatric cerebral palsy patients during painful physical therapy rehabilitation after single event multilevel surgery to increase ambulation [51]. VR has reduced discomfort during subcutaneous vascular port access and venipuncture in children and adolescents with cancer [52, 53], and VR reduced pain in children getting venipuncture in general [54]. A growing number of researchers using a variety of distraction software have TBSA, were studied for 10 days each. Occupational and physical therapists orchestrated passive range of motion exercises with each patient for 5 days during VR compared with similar treatment for 5 days without VR. Treatment order was randomized. Some patients received 5 days of physical therapy with VR vs. 5 days with no VR, and others received 5 days of no VR followed by 5 days of VR. Results showed large reductions in worst pain intensity (approximately 45% reduction in worst pain), pain unpleasantness, and time spent thinking about pain, and more fun during VR compared with no VR during the 25-min VR treatments per day, for 5 days in a row per patient [61]. There was no diminishment in analgesic effectiveness over the 5 day period (see Fig. 4), Fig. 4 Pediatric burn patient in virtual reality during passive range of motion exercises. The VR helmet shown has high- technology 80° diagonal field of view goggle views of the virtual world, as seen by the patient. (Photo credit—left photo by Hunter Hoffman, www.vrpain. com) • 소아 화상 환자 7명에 대한 파일럿 (TBSA: 45%-82%) • 5일 동안의 w/ VR 과, 5일 동안의 w/o VR을 비교 (순서는 랜덤) • 결과: worst pain intensity에 큰 경감 (평균 45%) • 5일 동안에 진통 효과에 큰 변화 없음 • 다만, 더 장기적이고 더 큰 규모의 임상 연구가 필요 (2011년 기준..) • 또한, 기존의 마약성 진통제와 비교임상을 한 정도의 근거는 아직 없는듯
- 127.
- 128. AppliedVR:TherapeuticVirtual Reality for HealthcareProviders https://youtu.be/XsGgNfYYetk
- 129. Coping Skills, Relaxation,Distraction, Escape 등 다양한 시나리오
- 130. Coping Skills, Relaxation,Distraction, Escape 등 다양한 시나리오
- 131. Coping Skills, Relaxation,Distraction, Escape 등 다양한 시나리오
- 132.
- 133. DTxDM West 2018 마약성진통제를 장기 복용할 수록 중독의 가능성이 높아짐
- 134. DTxDM West 2018 현재미국의 Opioid Epidemic은 아주 심각한 상태
- 135. DTxDM West 2018 VR로painkiller를 대체하거나 사용을 줄일 수 있는가?
- 136. DTxDM West 2018 AppliedVR은이미 미국 내 많은 주와 국가에서 사용되고 있음
- 137. DTxDM West 2018 RCT결과가 도출되었다고 이야기 하였으나, 아직 publish 되지는 않은 듯 VR이 실제 painkiller 만큼의 효능, 혹은 시너지를 보여줄 수 있는가?
- 138. DTxDM West 2018 다양한진료과의 병원 내 환경과 일상 모두에서 현재 활용 중
- 139. DTxDM West 2018 VR의컨텐츠와 인터렉션을 위해서 심박 센서 및 호흡 센서를 함께 사용하기도
- 140. 대표적인 Digital Therapeutics의사례연구 • Pear Therapeutics • Akili Interactive • Click Therapeutics • Dthera Science • Noom, Omada Health • Hurray Positive, SK Health Connect • Virtual Vietnam • AppliedVR • Woebot • Cognoa • Propeller Health • Neofect
- 141. • Woebot, 정신상담 챗봇 스타트업 • 스탠퍼드의 mental health 전문가들이 시작한 우울증 치료 (인지행동치료) 목적의 챗봇 • Andrew Ng 교수는 이사회장으로 참여
- 142. • Woebot, 정신상담 챗봇 • 실제 상담사들이 하듯이, 대화형으로 설명하고 사용자의 정신 건강 상태를 체크 • 대부분 설문과 다를 것이 없지만 (정해진 답 중에 하나 선택), UI 상의 혁신이라고 볼 수 있음 • 아직까지는 아주 정교한 NLP를 사용하고 있지는 않음 (세션 당 한 번 정도)
- 143. • Woebot, 정신상담 챗봇 • 실제 상담사들이 하듯이, 대화형으로 설명하고 사용자의 정신 건강 상태를 체크 • 대부분 설문과 다를 것이 없지만 (정해진 답 중에 하나 선택), UI 상의 혁신이라고 볼 수 있음 • 아직까지는 아주 정교한 NLP를 사용하고 있지는 않음 (세션 당 한 번 정도)
- 144. • Woebot, 정신상담 챗봇 • 실제 상담사들이 하듯이, 대화형으로 설명하고 사용자의 정신 건강 상태를 체크 • 대부분 설문과 다를 것이 없지만 (정해진 답 중에 하나 선택), UI 상의 혁신이라고 볼 수 있음 • 아직까지는 아주 정교한 NLP를 사용하고 있지는 않음 (세션 당 한 번 정도)
- 145. Original Paper Delivering CognitiveBehavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial Kathleen Kara Fitzpatrick1* , PhD; Alison Darcy2* , PhD; Molly Vierhile1 , BA 1 Stanford School of Medicine, Department of Psychiatry and Behavioral Sciences, Stanford, CA, United States 2 Woebot Labs Inc., San Francisco, CA, United States * these authors contributed equally Corresponding Author: Alison Darcy, PhD Woebot Labs Inc. 55 Fair Avenue San Francisco, CA, 94110 United States Email: alison@woebot.io Abstract Background: Web-based cognitive-behavioral therapeutic (CBT) apps have demonstrated efficacy but are characterized by poor adherence. Conversational agents may offer a convenient, engaging way of getting support at any time. Objective: The objective of the study was to determine the feasibility, acceptability, and preliminary efficacy of a fully automated conversational agent to deliver a self-help program for college students who self-identify as having symptoms of anxiety and depression. Methods: In an unblinded trial, 70 individuals age 18-28 years were recruited online from a university community social media site and were randomized to receive either 2 weeks (up to 20 sessions) of self-help content derived from CBT principles in a conversational format with a text-based conversational agent (Woebot) (n=34) or were directed to the National Institute of Mental Health ebook, “Depression in College Students,” as an information-only control group (n=36). All participants completed Web-based versions of the 9-item Patient Health Questionnaire (PHQ-9), the 7-item Generalized Anxiety Disorder scale (GAD-7), and the Positive and Negative Affect Scale at baseline and 2-3 weeks later (T2). Results: Participants were on average 22.2 years old (SD 2.33), 67% female (47/70), mostly non-Hispanic (93%, 54/58), and Caucasian (79%, 46/58). Participants in the Woebot group engaged with the conversational agent an average of 12.14 (SD 2.23) times over the study period. No significant differences existed between the groups at baseline, and 83% (58/70) of participants provided data at T2 (17% attrition). Intent-to-treat univariate analysis of covariance revealed a significant group difference on depression such that those in the Woebot group significantly reduced their symptoms of depression over the study period as measured by the PHQ-9 (F=6.47; P=.01) while those in the information control group did not. In an analysis of completers, participants in both groups significantly reduced anxiety as measured by the GAD-7 (F1,54= 9.24; P=.004). Participants’ comments suggest that process factors were more influential on their acceptability of the program than content factors mirroring traditional therapy. Conclusions: Conversational agents appear to be a feasible, engaging, and effective way to deliver CBT. (JMIR Ment Health 2017;4(2):e19) doi:10.2196/mental.7785 KEYWORDS conversational agents; mobile mental health; mental health; chatbots; depression; anxiety; college students; digital health Introduction Up to 74% of mental health diagnoses have their first onset particularly common among college students, with more than half reporting symptoms of anxiety and depression in the previous year that were so severe they had difficulty functioning Fitzpatrick et alJMIR MENTAL HEALTH
- 146. depression at baselineas measured by the PHQ-9, while three-quarters (74%, 52/70) were in the severe range for anxiety as measured by the GAD-7. Figure 1. Participant recruitment flow. Table 1. Demographic and clinical variables of participants at baseline. WoebotInformation control Scale, mean (SD) 14.30 (6.65)13.25 (5.17)Depression (PHQ-9) 18.05 (5.89)19.02 (4.27)Anxiety (GAD-7) 25.54 (9.58)26.19 (8.37)Positive affect 24.87 (8.13)28.74 (8.92)Negative affect 22.58 (2.38)21.83 (2.24)Age, mean (SD) Gender, n (%) 7 (21)4 (7)Male 27 (79)20 (55)Female Ethnicity, n (%) 2 (6)2 (8)Latino/Hispanic 32 (94)22 (92)Non-Latino/Hispanic 28 (82)18 (75)Caucasian Fitzpatrick et alJMIR MENTAL HEALTH Delivering Cognitive Behavior Therapy toYoung Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot):A Randomized Controlled Trial •분노장애와 우울증이 있다고 스스로 생각하는 대학생들이 사용하는 self-help 챗봇 •목적: 챗봇의 feasibility, acceptability, preliminary efficacy 를 보기 위함 •대학생 총 70명을 대상으로 2주 동안 진행 •실험군 (Woebot): 34명 •대조군 (information-only): 31명 •Oucome: PHQ-9, GAD-7
- 147. d cPFWoebotInformation-only control 95%CIb T2a 95% CIb T2a 0.44.0176.039.74-12.3211.14 (0.71)12.07-15.2713.67 (.81)PHQ-9 0.14.5810.3816.16-18.1317.35 (0.60)15.52-18.5616.84 (.67)GAD-7 0.02.7070.1724.35-29.4126.88 (1.29)23.17-28.8626.02 (1.45)PANAS positive affect 0.344.9120.9123.54-28.4225.98 (1.24)24.73-30.3227.53 (1.42)PANAS nega- tive affect a Baseline=pooled mean (standard error) b 95% confidence interval. c Cohen d shown for between-subjects effects using means and standard errors at Time 2. Figure 2. Change in mean depression (PHQ-9) score by group over the study period. Error bars represent standard error. Preliminary Efficacy Table 2 shows the results of the primary ITT analyses conducted on the entire sample. Univariate ANCOVA revealed a significant treatment effect on depression revealing that those in the Woebot group significantly reduced PHQ-9 score while those in the information control group did not (F1,48=6.03; P=.017) (see Figure 2). This represented a moderate between-groups effect size (d=0.44). This effect is robust after Bonferroni correction for multiple comparisons (P=.04). No other significant between-group differences were observed on anxiety or affect. Completer Analysis As a secondary analysis, to explore whether any main effects existed, 2x2 repeated measures ANOVAs were conducted on the primary outcome variables (with the exception of PHQ-9) among completers only. A significant main effect was observed on GAD-7 (F1,54=9.24; P=.004) suggesting that completers experienced a significant reduction in symptoms of anxiety between baseline and T2, regardless of the group to which they were assigned with a within-subjects effect size of d=0.37. No main effects were observed for positive (F1,50=.001; P=.951; d=0.21) or negative affect (F1,50=.06; P=.80; d=0.003) as measured by the PANAS. To further elucidate the source and magnitude of change in depression, repeated measures dependent t tests were conducted and Cohen d effect sizes were calculated on individual items of the PHQ-9 among those in the Woebot condition. The analysis revealed that baseline-T2 changes were observed on the following items in order of decreasing magnitude: motoric symptoms (d=2.09), appetite (d=0.65), little interest or pleasure in things (d=0.44), feeling bad about self (d=0.40), and concentration (d=0.39), and suicidal thoughts (d=0.30), feeling down (d=0.14), sleep (d=0.12), and energy (d=0.06). JMIR Ment Health 2017 | vol. 4 | iss. 2 | e19 | p.6http://mental.jmir.org/2017/2/e19/ (page number not for citation purposes) XSL•FO RenderX Change in mean depression (PHQ-9) score by group over the study period •결과 •챗봇을 2주 동안 평균 12.14번 사용함 •우울증에 대해서는 significant group difference •Woebot 그룹에서는 우울증(PHQ-9)의 유의미한 감소가 있었음 •대조군에서는 유의미한 감소 없음 •분노 장애에 대해서는 두 그룹 모두 유의미한 감소가 있었음 (GAD-7 기준)
- 148. •2018년 3월 Woebot이 $8m의 시리즈A 투자에 성공 •New Enterprise Associates (NEA)가 리드하고 Andrew Ng 교수의 AI Fund 도 참여 •AI Fund: Andrew Ng 교수가 올해 1월 결성한 AI 스타트업에 투자하는 $175M 규모 펀드 •Woebot은 작년 많은 데이터를 수집하면서 성장 •페북 메신져로만 서비스 하였음에도 불구하고, 매달 50% 이상 성장, •주당 2m 개 이상의 메시지 축적, 130개국 이상의 사용자 확보 •2018년 초 iOS 앱 및 안드로이드 앱 출시
- 149. 대표적인 Digital Therapeutics의사례연구 • Pear Therapeutics • Akili Interactive • Click Therapeutics • Dthera Science • Noom, Omada Health • Hurray Positive, SK Health Connect • Virtual Vietnam • AppliedVR • Woebot • Cognoa • Propeller Health • Neofect
- 150. AI-based Digital PrecisionMedicine for Behavioral Health Brent Vaughan CEO
- 151. www.cognoa.comwww.cognoa.com 1 Years 2Years 3 Years 7 years6 Years Key developmental window for most effective intervention 4 Years 5 Years Speech Delay ADHD Autism No Diagnosis 3+ critical years lost • Uncertain parents • Delayed referrals • 1 year + waits for diagnosis Initial parent concern The current system is broken for children and parents
- 152. www.cognoa.com Cognoa’s precision medicineapproach begins with multi-modal patient assessment Data collected directly from parents or caregivers AI classifiers integrating data features Patient-centric video Language, motor and visual interaction data Assessment and prescribing data from clinicians
- 155. ARTICLE OPEN Exploratory studyexamining the at-home feasibility of a wearable tool for social-affective learning in children with autism Jena Daniels 1 , Jessey N. Schwartz1 , Catalin Voss2 , Nick Haber1 , Azar Fazel1 , Aaron Kline1 , Peter Washington2 , Carl Feinstein3 , Terry Winograd2 and Dennis P. Wall 1,3,4 Although standard behavioral interventions for autism spectrum disorder (ASD) are effective therapies for social deficits, they face criticism for being time-intensive and overdependent on specialists. Earlier starting age of therapy is a strong predictor of later success, but waitlists for therapies can be 18 months long. To address these complications, we developed Superpower Glass, a machine-learning-assisted software system that runs on Google Glass and an Android smartphone, designed for use during social interactions. This pilot exploratory study examines our prototype tool’s potential for social-affective learning for children with autism. We sent our tool home with 14 families and assessed changes from intake to conclusion through the Social Responsiveness Scale (SRS-2), a facial affect recognition task (EGG), and qualitative parent reports. A repeated-measures one-way ANOVA demonstrated a decrease in SRS-2 total scores by an average 7.14 points (F(1,13) = 33.20, p = <.001, higher scores indicate higher ASD severity). EGG scores also increased by an average 9.55 correct responses (F(1,10) = 11.89, p = <.01). Parents reported increased eye contact and greater social acuity. This feasibility study supports using mobile technologies for potential therapeutic purposes. npj Digital Medicine (2018)1:32 ; doi:10.1038/s41746-018-0035-3 INTRODUCTION Children with autism spectrum disorder (ASD) struggle to recognize facial expressions, make eye contact, and engage in social interactions.1,2 An estimated 1 in 68 children have an ASD, and many can have dramatic improvements if social skills are taught intensively from an early age.1–5 Children with ASD have demonstrated deficits in facial processing abilities, such as distinguishing fear from surprise and identifying subtler emo- tions.6–9 Children also struggle with facial engagement and eye contact.10,11 Teaching these skills to children with autism is important for social development and is closely linked with empathy.12–16 Today’s standard for treatment of these core ASD deficits focuses on a form of behavioral therapy known as applied behavioral analysis (ABA).17,18 Although ABA therapy is effective in increasing IQ, improving eye contact, face-to-face gaze, and emotion recognition, children who receive ABA often struggle to generalize learned behaviors to natural interactions and are dependent on prompts.17,19 Therapies called naturalistic develop- mental behavioral interventions (NDBIs) promote better general- ization of newly learned skills due to their integration into the child’s natural everyday interactions.15,20,21 However, the delivery of behavioral interventions like ABA and NDBIs is bottlenecked by an increasing imbalance between the availability of behavioral therapists and the number of children who must receive care.22,23 One of the strongest predictors of greater treatment outcomes is younger age at entry into behavioral interventions24,25 , but delays in access to therapy leave many children untreated until after sensitive periods for language and cognitive development have already passed.26,27 Additionally, waitlists for access to therapies, such as ABA and NDBIs can be up to 18 months long.23,25 Consequently, many children with autism are unable to build such core social skills and subsequently regress towards a path of isolation.24,28 These issues have compounded into an urgent need for alternative, ubiquitous mobile methods of delivery29 that can positively alter the healthcare system and scale to meet the growing population in need of early intervention. To address the complications associated with accessing the clinical setting and to expedite children’s access to therapy, we have begun development of a system to deliver therapy at home using a machine-learning-assisted software system that runs on Google Glass paired with an Android smartphone, designed for use in the child’s natural environment during social interactions with friends and family members.30–32 It recognizes eight emotions, as described in detail by Ekman et al.: happiness, sadness, anger, disgust, surprise, fear, neutral, and contempt (named “meh” in child-friendly terms), which are recognized as theoretically universal emotions.33–35 The Glass provides audio- visual feedback to the wearer that corresponds to which of the eight emotions the Glass recognizes during social interactions through its outward-facing camera. Using technology and software for children with autism may assist children struggling with social anxiety in social Received: 7 February 2018 Revised: 18 May 2018 Accepted: 25 May 2018 1 Division of Systems Medicine, Department of Pediatrics, Stanford University, Palo Alto, CA, USA; 2 Department of Computer Science, Stanford University, Palo Alto, CA, USA; 3 Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA and 4 Department of Biomedical Data Science, Stanford University, Palo Alto, CA, USA Correspondence: Dennis P. Wall (dpwall@stanford.edu) www.nature.com/npjdigitalmed Published in partnership with the Scripps Translational Science Institute
- 156. ARTICLE OPEN Exploratory studyexamining the at-home feasibility of a wearable tool for social-affective learning in children with autism Jena Daniels 1 , Jessey N. Schwartz1 , Catalin Voss2 , Nick Haber1 , Azar Fazel1 , Aaron Kline1 , Peter Washington2 , Carl Feinstein3 , Terry Winograd2 and Dennis P. Wall 1,3,4 Although standard behavioral interventions for autism spectrum disorder (ASD) are effective therapies for social deficits, they face criticism for being time-intensive and overdependent on specialists. Earlier starting age of therapy is a strong predictor of later success, but waitlists for therapies can be 18 months long. To address these complications, we developed Superpower Glass, a machine-learning-assisted software system that runs on Google Glass and an Android smartphone, designed for use during social interactions. This pilot exploratory study examines our prototype tool’s potential for social-affective learning for children with autism. We sent our tool home with 14 families and assessed changes from intake to conclusion through the Social Responsiveness Scale (SRS-2), a facial affect recognition task (EGG), and qualitative parent reports. A repeated-measures one-way ANOVA demonstrated a decrease in SRS-2 total scores by an average 7.14 points (F(1,13) = 33.20, p = <.001, higher scores indicate higher ASD severity). EGG scores also increased by an average 9.55 correct responses (F(1,10) = 11.89, p = <.01). Parents reported increased eye contact and greater social acuity. This feasibility study supports using mobile technologies for potential therapeutic purposes. npj Digital Medicine (2018)1:32 ; doi:10.1038/s41746-018-0035-3 INTRODUCTION Children with autism spectrum disorder (ASD) struggle to recognize facial expressions, make eye contact, and engage in social interactions.1,2 An estimated 1 in 68 children have an ASD, and many can have dramatic improvements if social skills are taught intensively from an early age.1–5 Children with ASD have demonstrated deficits in facial processing abilities, such as distinguishing fear from surprise and identifying subtler emo- tions.6–9 Children also struggle with facial engagement and eye contact.10,11 Teaching these skills to children with autism is important for social development and is closely linked with empathy.12–16 Today’s standard for treatment of these core ASD deficits focuses on a form of behavioral therapy known as applied behavioral analysis (ABA).17,18 Although ABA therapy is effective in increasing IQ, improving eye contact, face-to-face gaze, and emotion recognition, children who receive ABA often struggle to generalize learned behaviors to natural interactions and are dependent on prompts.17,19 Therapies called naturalistic develop- mental behavioral interventions (NDBIs) promote better general- ization of newly learned skills due to their integration into the child’s natural everyday interactions.15,20,21 However, the delivery of behavioral interventions like ABA and NDBIs is bottlenecked by an increasing imbalance between the availability of behavioral therapists and the number of children who must receive care.22,23 One of the strongest predictors of greater treatment outcomes is younger age at entry into behavioral interventions24,25 , but delays in access to therapy leave many children untreated until after sensitive periods for language and cognitive development have already passed.26,27 Additionally, waitlists for access to therapies, such as ABA and NDBIs can be up to 18 months long.23,25 Consequently, many children with autism are unable to build such core social skills and subsequently regress towards a path of isolation.24,28 These issues have compounded into an urgent need for alternative, ubiquitous mobile methods of delivery29 that can positively alter the healthcare system and scale to meet the growing population in need of early intervention. To address the complications associated with accessing the clinical setting and to expedite children’s access to therapy, we have begun development of a system to deliver therapy at home using a machine-learning-assisted software system that runs on Google Glass paired with an Android smartphone, designed for use in the child’s natural environment during social interactions with friends and family members.30–32 It recognizes eight emotions, as described in detail by Ekman et al.: happiness, sadness, anger, disgust, surprise, fear, neutral, and contempt (named “meh” in child-friendly terms), which are recognized as theoretically universal emotions.33–35 The Glass provides audio- visual feedback to the wearer that corresponds to which of the eight emotions the Glass recognizes during social interactions through its outward-facing camera. Using technology and software for children with autism may assist children struggling with social anxiety in social Received: 7 February 2018 Revised: 18 May 2018 Accepted: 25 May 2018 1 Division of Systems Medicine, Department of Pediatrics, Stanford University, Palo Alto, CA, USA; 2 Department of Computer Science, Stanford University, Palo Alto, CA, USA; 3 Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA and 4 Department of Biomedical Data Science, Stanford University, Palo Alto, CA, USA Correspondence: Dennis P. Wall (dpwall@stanford.edu) www.nature.com/npjdigitalmed Published in partnership with the Scripps Translational Science Institute • 표준 자폐증 치료 • Social deficit 에 효과적이나, 시간이 오래 걸리고/의사에 의존도 높음 • 이른 시기에 시작할 수록 좋으나, 웨이팅리스트가 18개월까지도 • Superpower Glass • 구글 글래스와 스마트폰: 상대의 감정 파악을 보조 • 총 14개의 가정에서 pilot test • Measures • Social Responsiveness Scale (SRS-2) • Facial affect recognition task (EGG, Emotion Guessing Game)
- 158. social skills thatour Glass system may encourage in children with autism. We intend to benchmark gains in social acuity over the course of 12 weeks at intake, conclusion, and follow-up to the Superpower Glass therapy program and run an intention-to-treat analysis. METHODS Participant recruitment and screening methods During this study, participants were provided game mode options and feedback selection options at the beginning of each session via the app. Each game mode is focused on an aspect of emotion recognition and social interaction, such as emotion identification, eye contact, and/or social initiation.10 Before the start of a Superpower Glass session (a period of time when the child and their family member(s) interact with the system’s modes), the parent selects the game mode on the app dashboard, and then selects the type of feedback that will be provided to the child via Google Glass. The feedback options are audio feedback labeling the recognized emotion via the bone-conducting speakers on the Google Glass, emoticons representing the recognized emotion via the heads-up Child Wearer Child wears Glass and interacts with peers and caregivers outside of clinical setting for natural emotions and interactions Happy Smartphone App Sensor processor tracks faces, recognizes action units, expressions, and Database HIPAA-compliant, encrypted server at Stanford University Social Feedback Cue Emoticon and color on heads up display; audio of expression recognized Fig. 1 Overview of the Superpower Glass System. The Android app connects to the Google Glass worn by the child participant. The app receives facial-tracked data from the Glass camera and computes the emotion expressed by the person the child is interacting with and returns the emotion as social feedback to the child, all the while recording the social interaction for parent–child review when the session is complete Wearable Social Learning Aid for Autism J Daniels et al. 6
- 159. ARTICLE OPEN Exploratory studyexamining the at-home feasibility of a wearable tool for social-affective learning in children with autism Jena Daniels 1 , Jessey N. Schwartz1 , Catalin Voss2 , Nick Haber1 , Azar Fazel1 , Aaron Kline1 , Peter Washington2 , Carl Feinstein3 , Terry Winograd2 and Dennis P. Wall 1,3,4 Although standard behavioral interventions for autism spectrum disorder (ASD) are effective therapies for social deficits, they face criticism for being time-intensive and overdependent on specialists. Earlier starting age of therapy is a strong predictor of later success, but waitlists for therapies can be 18 months long. To address these complications, we developed Superpower Glass, a machine-learning-assisted software system that runs on Google Glass and an Android smartphone, designed for use during social interactions. This pilot exploratory study examines our prototype tool’s potential for social-affective learning for children with autism. We sent our tool home with 14 families and assessed changes from intake to conclusion through the Social Responsiveness Scale (SRS-2), a facial affect recognition task (EGG), and qualitative parent reports. A repeated-measures one-way ANOVA demonstrated a decrease in SRS-2 total scores by an average 7.14 points (F(1,13) = 33.20, p = <.001, higher scores indicate higher ASD severity). EGG scores also increased by an average 9.55 correct responses (F(1,10) = 11.89, p = <.01). Parents reported increased eye contact and greater social acuity. This feasibility study supports using mobile technologies for potential therapeutic purposes. npj Digital Medicine (2018)1:32 ; doi:10.1038/s41746-018-0035-3 INTRODUCTION Children with autism spectrum disorder (ASD) struggle to recognize facial expressions, make eye contact, and engage in social interactions.1,2 An estimated 1 in 68 children have an ASD, and many can have dramatic improvements if social skills are taught intensively from an early age.1–5 Children with ASD have demonstrated deficits in facial processing abilities, such as distinguishing fear from surprise and identifying subtler emo- tions.6–9 Children also struggle with facial engagement and eye contact.10,11 Teaching these skills to children with autism is important for social development and is closely linked with empathy.12–16 Today’s standard for treatment of these core ASD deficits focuses on a form of behavioral therapy known as applied behavioral analysis (ABA).17,18 Although ABA therapy is effective in increasing IQ, improving eye contact, face-to-face gaze, and emotion recognition, children who receive ABA often struggle to generalize learned behaviors to natural interactions and are dependent on prompts.17,19 Therapies called naturalistic develop- mental behavioral interventions (NDBIs) promote better general- ization of newly learned skills due to their integration into the child’s natural everyday interactions.15,20,21 However, the delivery of behavioral interventions like ABA and NDBIs is bottlenecked by an increasing imbalance between the availability of behavioral therapists and the number of children who must receive care.22,23 One of the strongest predictors of greater treatment outcomes is younger age at entry into behavioral interventions24,25 , but delays in access to therapy leave many children untreated until after sensitive periods for language and cognitive development have already passed.26,27 Additionally, waitlists for access to therapies, such as ABA and NDBIs can be up to 18 months long.23,25 Consequently, many children with autism are unable to build such core social skills and subsequently regress towards a path of isolation.24,28 These issues have compounded into an urgent need for alternative, ubiquitous mobile methods of delivery29 that can positively alter the healthcare system and scale to meet the growing population in need of early intervention. To address the complications associated with accessing the clinical setting and to expedite children’s access to therapy, we have begun development of a system to deliver therapy at home using a machine-learning-assisted software system that runs on Google Glass paired with an Android smartphone, designed for use in the child’s natural environment during social interactions with friends and family members.30–32 It recognizes eight emotions, as described in detail by Ekman et al.: happiness, sadness, anger, disgust, surprise, fear, neutral, and contempt (named “meh” in child-friendly terms), which are recognized as theoretically universal emotions.33–35 The Glass provides audio- visual feedback to the wearer that corresponds to which of the eight emotions the Glass recognizes during social interactions through its outward-facing camera. Using technology and software for children with autism may assist children struggling with social anxiety in social Received: 7 February 2018 Revised: 18 May 2018 Accepted: 25 May 2018 1 Division of Systems Medicine, Department of Pediatrics, Stanford University, Palo Alto, CA, USA; 2 Department of Computer Science, Stanford University, Palo Alto, CA, USA; 3 Department of Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA and 4 Department of Biomedical Data Science, Stanford University, Palo Alto, CA, USA Correspondence: Dennis P. Wall (dpwall@stanford.edu) www.nature.com/npjdigitalmed Published in partnership with the Scripps Translational Science Institute • Social Responsiveness Scale (SRS-2) • decrease by average 7.14 points (p<0.001) • Facial affect recognition task (EGG) • increase by average 9.55 correct response (p<0.001)
- 161. 대표적인 Digital Therapeutics의사례연구 • Pear Therapeutics • Akili Interactive • Click Therapeutics • Dthera Science • Noom, Omada Health • Hurray Positive, SK Health Connect • Virtual Vietnam • AppliedVR • Woebot • Cognoa • Propeller Health • Neofect
- 162.
- 164. Effects of virtualreality-based rehabilitation on distal upper extremity function and health-related quality of life: a single-blinded, randomized controlled trial ments at T2 and 23 completed the follow-up assessments at T3. During the study, 5 and 8 participants from the SG and CON groups, respectively, did not complete the inter- vention programs. The sample sizes at the assessment time points are presented in Fig. 2. There were no serious ad- verse events, and only 1 participant from the CON group dropped out owing to dizziness, which was unrelated to the intervention. Thus, most of the study withdrawals were related to uncooperativeness, and the number was higher than that hypothesized in the study design. At baseline, dist: F = 4.64, df = 1.38, P = 0.024). Secondary outcomes Jebsen–Taylor hand function test The JTT scores of the SG and CON groups are presented in Table 2. There were no significant differences in the JTT-total, JTT-gross, and JTT-fine scores between the 2 groups at T0. The post-hoc test found that there were sig- nificant improvements in the JTT-total, JTT-gross, and JTT-fine scores in the SG group during the intervention Fig. 2 Flowchart of the participants through the study. Abbreviations: SG, Smart Glove; CON, conventional intervention Shin et al. Journal of NeuroEngineering and Rehabilitation (2016) 13:17 Shin et al. Journal of NeuroEngineering and Rehabilitation (2016) 13:17
- 165. Effects of virtualreality-based rehabilitation on distal upper extremity function and health-related quality of life: a single-blinded, randomized controlled trial composite SIS score (F = 5.76, df = 1.0, P = 0.021) and the overall SIS score (F = 6.408, df = 1.0, P = 0.015). Moreover, among individual domain scores, the Time × standard OT than using amount-matched conventional re- habilitation, without any adverse events, in stroke survivors. Additionally, this study noted improvements in the SIS- Fig. 3 Mean and standard errors for the FM scores in the SG and CON groups. Abbreviations: FM, Fugl–Meyer assessment, SG, Smart Glove; CON, conventional intervention Fig. 4 Mean and standard errors for the JTT scores in the SG and CON groups. Abbreviations: JTT, Jebsen–Taylor hand function test; SG, Smart Glove; CON, conventional intervention Shin et al. Journal of NeuroEngineering and Rehabilitation (2016) 13:17 Page 7 of 10 composite SIS score (F = 5.76, df = 1.0, P = 0.021) and the overall SIS score (F = 6.408, df = 1.0, P = 0.015). standard OT than using amount-matched conventional re- habilitation, without any adverse events, in stroke survivors. Fig. 3 Mean and standard errors for the FM scores in the SG and CON groups. Abbreviations: FM, Fugl–Meyer assessment, SG, Smart Glove; CON, conventional intervention Fig. 4 Mean and standard errors for the JTT scores in the SG and CON groups. Abbreviations: JTT, Jebsen–Taylor hand function test; SG, Smart Glove; CON, conventional intervention Shin et al. Journal of NeuroEngineering and Rehabilitation (2016) 13:17 Page 7 of 10 Shin et al. Journal of NeuroEngineering and Rehabilitation (2016) 13:17
- 166. Digital Therapeutics, TheUncharted Territory 디지털 신약, 누구도 가보지 않은 길
- 167. 임상-인허가-보험-의사 처방-RWE-환자 사용 •DTx에도 RCT가 필요한가 • 효용을 어떻게 증명할 것인가
- 168. 임상-인허가-보험-의사 처방-RWE-환자 사용 •의료기기 or 컨슈머BM • 어떤 방식의 regulatory pathway로 • De Novo: 완전히 새로운 • 510(k): 기존 의료기기와 동등성 • Pre-Cert: 2021년은 되어야 • DTx에도 RCT가 필요한가 • 효용을 어떻게 증명할 것인가
- 169. 임상-인허가-보험-의사 처방-RWE-환자 사용 •의료기기 or 컨슈머BM • 어떤 방식의 regulatory pathway로 • De Novo: 완전히 새로운 • 510(k): 기존 의료기기와 동등성 • Pre-Cert: 2021년은 되어야 • 보험사는 DTx를 어떻게 바라볼까 • 수가를 받을 수 있는가/받아야 하는가 • DTx에도 RCT가 필요한가 • 효용을 어떻게 증명할 것인가
- 170. 임상-인허가-보험-의사 처방-RWE-환자 사용 •의료기기 or 컨슈머BM • 어떤 방식의 regulatory pathway로 • De Novo: 완전히 새로운 • 510(k): 기존 의료기기와 동등성 • Pre-Cert: 2021년은 되어야 • 보험사는 DTx를 어떻게 바라볼까 • 수가를 받을 수 있는가/받아야 하는가 • 기존 약 대신에 의사가 처방할까 • 기존 약 대비 강점을 가지는 분야는 • DTx에도 RCT가 필요한가 • 효용을 어떻게 증명할 것인가
- 171. 임상-인허가-보험-의사 처방-RWE-환자 사용 •의료기기 or 컨슈머BM • 어떤 방식의 regulatory pathway로 • De Novo: 완전히 새로운 • 510(k): 기존 의료기기와 동등성 • Pre-Cert: 2021년은 되어야 • 보험사는 DTx를 어떻게 바라볼까 • 수가를 받을 수 있는가/받아야 하는가 • 의사들이 활용할 여건이 되는가 • EMR 속으로 어떻게 통합 • 진단/치료/관리 기준은 • DTx에도 RCT가 필요한가 • 효용을 어떻게 증명할 것인가 • 기존 약 대신에 의사가 처방할까 • 기존 약 대비 강점을 가지는 분야는
- 172. 임상-인허가-보험-의사 처방-RWE-환자 사용 •의료기기 or 컨슈머BM • 어떤 방식의 regulatory pathway로 • De Novo: 완전히 새로운 • 510(k): 기존 의료기기와 동등성 • Pre-Cert: 2021년은 되어야 • 보험사는 DTx를 어떻게 바라볼까 • 수가를 받을 수 있는가/받아야 하는가 • 의사들이 활용할 여건이 되는가 • EMR 속으로 어떻게 통합 • 진단/치료/관리 기준은 • 게임을 처방 받으면 환자는 어떻게 느낄까 • 지속사용성: 계속 사용할까 • 디지털 리터러시: 이해할 수 있을까 • 기존 약 대신에 의사가 처방할까 • 기존 약 대비 강점을 가지는 분야는 • DTx에도 RCT가 필요한가 • 효용을 어떻게 증명할 것인가
- 173. 임상-인허가-보험-의사 처방-RWE-환자 사용 •DTx에도 RCT가 필요한가 • 효용을 어떻게 증명할 것인가 • 의료기기 or 컨슈머BM • 어떤 방식의 regulatory pathway로 • De Novo: 완전히 새로운 • 510(k): 기존 의료기기와 동등성 • Pre-Cert: 2021년은 되어야 • 보험사는 DTx를 어떻게 바라볼까 • 수가를 받을 수 있는가/받아야 하는가 • 기존 약 대신에 의사가 처방할까 • 기존 약 대비 강점을 가지는 분야는 • 의사들이 활용할 여건이 되는가 • EMR 속으로 어떻게 통합 • 진단/치료/관리 기준은 • 게임을 처방 받으면 환자는 어떻게 느낄까 • 지속사용성: 계속 사용할까 • 디지털 리터러시: 이해할 수 있을까
- 175. Feedback/Questions • E-mail: yoonsup.choi@gmail.com •Blog: http://www.yoonsupchoi.com • Facebook: 최윤섭 디지털 헬스케어 연구소