Evidence map›Paper›PMID 36899073›Full record

ArticleNPJ digital medicine2023

Digital therapeutics from bench to bedside.

Changwon Wang, Chungkeun Lee, Hangsik Shin

Full text read
PubMed Full text at PMC Publisher
In one paragraph

Article in NPJ digital medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 97 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
97citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

97 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Digital Therapeutics in China: Comprehensive Review.Journal of medical Internet research · 2025
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  7. Efficacy of guided breathing virtual reality for pain management in patients with cancer undergoing percutaneous transhepatic biliary drainage.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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37 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Changwon Wang *Biomedical Engineering Research Center, Asan Medical Center, Seoul, 05505, Republic of Korea.ORCID http://orcid.org/0000-0002-8490-9494
Chungkeun Lee *Digital Health Devices Division, Medical Device Evaluation Department, National Institute of Food and Drug Evaluation, Ministry of Food and Drug Safety, Osong, 28159, Republic of Korea.ORCID http://orcid.org/0000-0002-4863-776X
Hangsik ShinDepartment of Digital Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, 05505, Republic of Korea. hangsik.shin@amc.seoul.kr.ORCID http://orcid.org/0000-0002-3353-0310

Funding

NTP INFORMATION SYSTEMS SUPPORT27305C0011 · NIEHS · Z-TECH CORPORATION · 2007 to 2009
$4.3M
PROVIDE RABBITS, RATS, MICE, HAMSTERS, GERBILS, GUINEA PIGS27307C0011 · NIEHS · PI BOLEN, WAYNE · 2007 to 2007
$500k
NIEHS NIH HHS 27305C0011NIEHS NIH HHS 27307C0011NIEHS NIH HHS 27398C0011
6 · The paper itself

Abstract

As a new therapeutic technique based on digital technology, the commercialization and clinical application of digital therapeutics (DTx) are increasing, and the demand for expansion to new clinical fields is remarkably high. However, the use of DTx as a general medical component is still ambiguous, and this ambiguity may be owing to a lack of consensus on a definition, in addition to insufficiencies in research and development, clinical trials, standardization of regulatory frameworks, and technological maturity. In this study, we conduct an in-depth investigation and analysis of definitions, clinical trials, commercial products, and the regulatory status related to DTx using published literature, ClinicalTrials.gov, and web pages of regulatory and private organizations in several countries. Subsequently, we suggest the necessity and considerations for international agreements on the definition and characteristics of DTx, focusing on the commercialization characteristics. In addition, we discuss the status and considerations of clinical research, key technology factors, and the direction of regulatory developments. In conclusion, for the successful settlement of DTx, real-world evidence-based validation should be strengthened by establishing a cooperative system between researchers, manufacturers, and governments, and there should be effective technologies and regulatory systems for overcoming engagement barriers of DTx.

Identifiers

PMID36899073
PMCPMC10006069

What Socratic holds

Textfull text, public
LicenceCC BY
measurements read37
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.