Evidence map›Paper›PMID 40206630›Full record

ReviewMayo Clinic proceedings. Digital health2023

Continuous Improvement of Digital Health Applications Linked to Real-World Performance Monitoring: Safe Moving Targets?

Stephen Gilbert, Andreia Pimenta, Ashley Stratton-Powell, Cindy Welzel, Tom Melvin

Abstract readReview
In one paragraph

Review in Mayo Clinic proceedings. Digital health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–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

17 citing papers in PubMed.

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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

5 authors.

Stephen GilbertElse Kröner Fresenius Center for Digital Health, Technische Universität Dresden, Dresden, Germany.
Andreia PimentaAda Health GmbH, Berlin, Germany.
Ashley Stratton-PowellRQM+, Blenheim Court, Nottingham, United Kingdom.
Cindy WelzelElse Kröner Fresenius Center for Digital Health, Technische Universität Dresden, Dresden, Germany.
Tom MelvinSchool of Medicine, Trinity College, University of Dublin, Dublin, Ireland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Real-time high-quality data on the performance of digital health applications is needed for feedback-led optimization and to ensure safety and performance, particularly if they will have on-market updates. Developers must verify that applications accurately and consistently fulfill their intended purpose in real-world use. In particular, new thinking from regulators recognizes the importance of monitoring real-world performance. It is acknowledged that real-world data can deliver information from wider patient populations than are generally included in controlled studies, and in certain circumstances, this can enable extensions of the application's intended purpose. Proactive postmarket surveillance surveys are an important source of real-world data that are distinct from clinical investigations but may vary in quality and, if inappropriately designed, can be subject to uncontrolled bias. We aimed to describe the practice of real-world data gathering through patient-reported and clinician-reported outcomes and high-quality surveys and identify challenges, uncertainties, and health policy gaps.

Identifiers

PMID40206630
PMCPMC11975726

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.