Evidence map›Paper›PMID 31337393›Full record

SynthesisBMC health services research2019

Defining the clinician's role in early health technology assessment during medical device innovation - a systematic review.

Vinayak Smith, Ritesh Warty, Amrish Nair, Sathya Krishnan, Joel Arun Sursas, Fabricio da Silva Costa, Beverley Vollenhoven, Euan Morrison Wallace

Abstract readSystematic Review
In one paragraph

Synthesis in BMC health services research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

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

17 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

8 authors.

Vinayak SmithDepartment of Obstetrics and Gynaecology, Monash University, 252 Clayton Road, Clayton, Victoria, 3168, Australia. Vinayak.smith@monash.edu.ORCID http://orcid.org/0000-0001-6099-3671
Ritesh WartyBiorithm Pte Ltd, 81 Ayer Rajah Crescent 03-53, Singapore, 139967, Singapore.
Amrish NairBiorithm Pte Ltd, 81 Ayer Rajah Crescent 03-53, Singapore, 139967, Singapore.
Sathya KrishnanDepartment of Paediatrics, Rockhampton Base Hospital, Canning Street, Rockhampton City, Queensland, 4700, Australia.
Joel Arun SursasBiorithm Pte Ltd, 81 Ayer Rajah Crescent 03-53, Singapore, 139967, Singapore.
Fabricio da Silva CostaDepartment of Obstetrics and Gynaecology, Monash University, 252 Clayton Road, Clayton, Victoria, 3168, Australia.
Beverley VollenhovenDepartment of Obstetrics and Gynaecology, Monash University, 252 Clayton Road, Clayton, Victoria, 3168, Australia.
Euan Morrison WallaceDepartment of Obstetrics and Gynaecology, Monash University, 252 Clayton Road, Clayton, Victoria, 3168, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly Health Technology Assessment (EHTA) is an evolving field in health policy which aims to provide decision support and mitigate risk during early medical device innovation. The clinician is a key stakeholder in this process and their role has traditionally been confined to assessing device efficacy and safety alone. There is however, no data exploring their role in this process and how they can contribute towards it. This motivated us to carry out a systematic review to delineate the role of the clinician in EHTA as per the PRISMA guidelines.

methodsA systematic search of peer reviewed literature was undertaken across PUBMED, OVID Medline and Web of science up till June 2018. Studies that were suitable for inclusion focused on clinician input in health technology assessment or early medical device innovation. A qualitative approach was utilised to generate themes on how clinicians could contribute in general and specific areas of EHTA. Data was manually extracted by the authors and themes were agreed in consensus using a grounded theory framework. The specific stages included: All stages of EHTA, Basic research on mechanisms, Targeting for specific product, Proof of principle and Prototype and product development. Bias was assessed utilising the NICE Qualitative checklist.

resultsA total of 33 articles met the inclusion criteria for the review. Areas identified in which the clinicians could contribute to EHTA included: i) needs driven problem solving, ii) conformity assessment of MDs, iii) economic evaluation of MDs and iv) addressing the conflicts in interest. For clinicians' input across the various specific areas of EHTA, an innovation framework was generated based on the subthemes extracted.

conclusionsThe following review has identified the various segments in which clinicians can contribute to EHTA to inform stakeholders and has also proposed an innovation framework.

Indexed as

Health PersonnelProfessional RoleTechnology Assessment, BiomedicalHumansClinical strategyClinicianEfficacyFrameworkHealth technology assessmentInnovationMedical deviceNeeds analysisSafety

Identifiers

PMID31337393
PMCPMC6651962

What Socratic 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 Socratic graph.