Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review
ObjectivesThe development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying...
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Published in | BMJ open Vol. 14; no. 5; p. e079654 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
British Medical Journal Publishing Group
24.05.2024
BMJ Publishing Group LTD BMJ Publishing Group |
Series | Original research |
Subjects | |
Online Access | Get full text |
ISSN | 2044-6055 2044-6055 |
DOI | 10.1136/bmjopen-2023-079654 |
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Abstract | ObjectivesThe development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design.DesignSecondary qualitative analysis of a systematic review.Data sourcesCitation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers.Eligibility criteriaStudies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers.Data extraction and synthesisAll relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage.Results48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes.ConclusionIdentifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors’ rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making. |
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AbstractList | ObjectivesThe development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design.DesignSecondary qualitative analysis of a systematic review.Data sourcesCitation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers.Eligibility criteriaStudies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers.Data extraction and synthesisAll relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage.Results48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes.ConclusionIdentifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors’ rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making. Objectives The development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design.Design Secondary qualitative analysis of a systematic review.Data sources Citation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers.Eligibility criteria Studies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers.Data extraction and synthesis All relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage.Results 48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes.Conclusion Identifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors’ rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making. The development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design. Secondary qualitative analysis of a systematic review. Citation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers. Studies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers. All relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage. 48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes. Identifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors' rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making. The development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design.OBJECTIVESThe development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design.Secondary qualitative analysis of a systematic review.DESIGNSecondary qualitative analysis of a systematic review.Citation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers.DATA SOURCESCitation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers.Studies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers.ELIGIBILITY CRITERIAStudies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers.All relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage.DATA EXTRACTION AND SYNTHESISAll relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage.48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes.RESULTS48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes.Identifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors' rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making.CONCLUSIONIdentifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors' rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making. |
Author | Shah, Maximilian Richards, Hollie Sarah Scroggie, Darren L Cousins, Sian Macefield, Rhiannon Blencowe, Natalie S Elliott, Daisy Blazeby, Jane Hudson, Elizabeth Alford, Natasha Mutanga, Ian Rodney |
AuthorAffiliation | National Institute for Health Research Bristol Biomedical Research Centre Surgical and Orthopaedic Innovation Theme, Bristol Centre for Surgical Research, Bristol Medical School , University of Bristol Medical School , Bristol , UK |
AuthorAffiliation_xml | – name: National Institute for Health Research Bristol Biomedical Research Centre Surgical and Orthopaedic Innovation Theme, Bristol Centre for Surgical Research, Bristol Medical School , University of Bristol Medical School , Bristol , UK |
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BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38803251$$D View this record in MEDLINE/PubMed |
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Snippet | ObjectivesThe development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term... The development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL)... Objectives The development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term... |
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SubjectTerms | Humans Innovations Intervention Qualitative Research Research Design Surgeons Surgery Surgical Procedures, Operative - standards Systematic review Systematic Reviews as Topic Terminology |
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Title | Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review |
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