Evidence map›Paper›PMID 34254275›Full record

SynthesisApplied health economics and health policy2021

The Sandbox Approach and its Potential for Use in Health Technology Assessment: A Literature Review.

Emily Leckenby, Dalia Dawoud, Jacoline Bouvy, Páll Jónsson

Abstract readSystematic Review
In one paragraph

Synthesis in Applied health economics and health policy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

4 authors.

Emily LeckenbyCentre for Health Technology Evaluation, National Institute for Health and Care Excellence (NICE), Manchester, UK.
Dalia DawoudScience Policy and Research Programme, Science, Evidence and Analytics Directorate, National Institute for Health and Care Excellence (NICE), 2nd Floor, 2 Redman Place, London, E20 1JQ, UK. dalia.dawoud@nice.org.uk.ORCID 0000-0002-2105-1937
Jacoline BouvyNICE Scientific Advice, Centre for Health Technology Evaluation, National Institute for Health and Care Excellence (NICE), London, UK.
Páll JónssonData and Analytics, Science, Evidence and Analytics Directorate, National Institute for Health and Care Excellence (NICE), Manchester, UK.

Funding

Horizon 2020 82516
6 · The paper itself

Abstract

backgroundThe concept of the regulatory sandbox-a safe space for testing new regulatory processes-was first used within the financial technologies (FinTech) sector, but has since expanded into other sectors, including healthcare.

objectivesThis review aims to describe the extent of use of sandboxes in healthcare and assess the potential for the sandbox approach to be used to test and develop emerging health technology assessment (HTA) methods, policies and processes for innovative technologies.

methodsA systematic literature review was undertaken to identify published papers and reports that described and/or assessed the use of sandboxes in the healthcare sector. Searches were conducted in Medline, Embase, Econlit, Social Policy and Practice, and Health Management Information Consortium databases from inception to March 2020. Free-text Google search was also conducted to identify relevant grey literature. Only papers and reports discussing or evaluating the use of sandboxes in healthcare settings and published in English were included. Included studies were qualitatively summarised using a thematic analysis approach.

resultsOverall, 46 papers and reports were included. The topics covered were classified into 4 major themes: history of the regulatory sandbox, the sandbox as a testing environment, the sandbox as a regulatory approach, examples of using sandboxes in healthcare. Findings show that the use of regulatory sandboxes in healthcare is relatively new and primarily used in high-income countries to support the adoption of new technologies, particularly those related to digital health. Recommendations are made based on these findings to guide its use in HTA policy and methods development.

conclusionsSandboxes are increasingly used within healthcare regulation. Despite its potential, this approach has not been used in HTA policy and methodological developments to date. HTA agencies should consider this approach to facilitate developing policies, methods and processes for innovative and disruptive health technologies. Transferability to low- and middle-income countries' settings, however, should be assessed.

Indexed as

Biomedical TechnologyTechnology Assessment, BiomedicalDelivery of Health CareHumans

Identifiers

PMID34254275
PMCPMC8545721

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.