No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework

被引:0
作者
Bolton, William S. [1 ]
Aruparayil, Noel K. [1 ]
Cundill, Bonnie [2 ]
McCulloch, Peter [3 ]
Gnanaraj, Jesudian [4 ,5 ]
Bundu, Ibrahim [6 ]
Culmer, Peter R. [7 ]
Brown, Julia M. [2 ]
Scott, Julian [1 ]
Jayne, David G. [1 ]
机构
[1] Univ Leeds, Leeds Inst Med Res, Sch Med, Leeds, England
[2] Univ Leeds, Leeds Inst Clin Trials Res, Sch Med, Leeds, England
[3] Univ Oxford, Nuffield Dept Surg Sci, Oxford, England
[4] Rural Surg Innovat, Dimapur, Nagaland, India
[5] Karunya Inst Technol & Sci, Rural Surg Innovat Pvt Ltd, Coimbatore, India
[6] Connaught Hosp, Freetown, Sierra Leone
[7] Univ Leeds, Sch Mech Engn, Leeds, England
关键词
Device Evaluation; RANDOMIZED-TRIALS; SURGERY;
D O I
10.1136/bmjsit-2023-000248
中图分类号
R61 [外科手术学];
学科分类号
摘要
Objective The Global IDEAL Sub-Framework Study aimed to combine the intended effects of the 2009/2019 IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework recommendations on evaluating surgical innovation with the vision outlined by the 2015 Lancet Commission on Global Surgery to provide recommendations for evaluating surgical innovation in low-resource environments.Design A mixture of methods including an online global survey and semistructured interviews (SSIs). Quantitative data were summarized with descriptive statistics and qualitative data were analyzed using the Framework Method.Participants Surgeons and surgical researchers from any country.Main outcome measures Findings were used to suggest the nature of adaptations to the IDEAL Framework to address the particular problems of evaluation in low-resource settings.Results The online survey yielded 66 responses representing experience from 40 countries, and nine individual SSIs were conducted. Most respondents (n=49; 74.2%) had experience evaluating surgical technologies across a range of life cycle stages. Innovation was most frequently adopted based on colleague recommendation or clinical evaluation in other countries. Four themes emerged, centered around: frugal innovation in technological development; evaluating the same technology/innovation in different contexts; additional methodologies important in evaluation of surgical innovation in low/middle-income countries; and support for low-income country researchers along the evaluation pathway.Conclusions The Global IDEAL Sub-Framework provides suggestions for modified IDEAL recommendations aimed at dealing with the special problems found in this setting. These will require validation in a stakeholder consensus forum, and qualitative assessment in pilot studies. From assisting researchers with identification of the correct evaluation stage, to providing context-specific recommendations relevant to the whole evaluation pathway, this process will aim to develop a comprehensive and applicable set of guidance that will benefit surgical innovation and patients globally.
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页数:10
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