Designing medical technology for resilience: integrating health economics and human factors approaches

Borsci, Simone; Uchegbu, Ijeoma F.; Buckle, Peter; Ni, Zhifang; Hanna, George B.

doi:10.1080/17434440.2018.1418661

Cited by 44 publications

(42 citation statements)

References 43 publications

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“…Clinical validity studies address the question: how well does the test perform in the clinical environment? The methods employed include human factors studies [26,27], feasibility studies, and, the focus of this section, diagnostic accuracy studies. These studies are observational by design; this means that the results of the test are evaluated, but not used in clinical practice.…”

Section: Clinical Validitymentioning

confidence: 99%

How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development

et al. 2020

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Bringing a diagnostic point of care test (POCT) to a healthcare market can be a painful experience as it requires the manufacturer to meet considerable technical, financial, managerial, and regulatory challenges. In this opinion article we propose a framework for developing the evidence needed to support product development, marketing, and adoption. We discuss each step in the evidence development pathway from the invention phase to the implementation of a new POCT in the healthcare system. We highlight the importance of articulating the value propositions and documenting the care pathway. We provide guidance on how to conduct care pathway analysis as little has been published on this. We summarize the clinical, economic and qualitative studies to be considered for developing evidence, and provide useful links to relevant software, on-line applications, websites, and give practical advice. We also provide advice on patient and public involvement and engagement (PPIE), and on product management. Our aim is to help device manufacturers to understand the concepts and terminology used in evaluation of in vitro diagnostics (IVDs) so that they can communicate effectively with evaluation methodologists, statisticians, and health economists. Manufacturers of medical tests and devices can use the proposed framework to plan their evidence development strategy in alignment with device development, applications for regulatory approval, and publication.

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Section: Clinical Validitymentioning

confidence: 99%

How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development

et al. 2020

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“…RHC is theoretically attractive and recent reviews indicate a growing interest and evidence in operationalising RHC [22,29] for example in defining models and measurements to understand the effect of trade-offs in operational activities [15]. Ellis et al (2019) however, reported an increasing shift from studying and understanding RHC to developing resilience in health care settings [16].…”

Section: Introductionmentioning

confidence: 99%

“…As observed by Ellis et al (2019), the current literature on RHC has reported factors that promote resilience. Examples include training and educating health care professionals to cope with various conditions [24][25][26]; encouraging different departments and specialities to communicate concerns pertaining to work practice [19,25,27]; repeated exposure to similar disturbances [4,26,28]; enhancing the knowledge and experience of health care professionals to respond to actual work conditions and to enact important trade-offs [4,19,28]; reducing the cognitive load on health care practitioners by simulation training to manage expected and unexpected situations [4]; and integrating human factors and health economics in the design process [29].…”

Section: Introductionmentioning

confidence: 99%

Resilient Health Care: a systematic review of conceptualisations, study methods and factors that develop resilience.

Iflaifel

Lim

Ryan

et al. 2020

Preprint

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Background Traditional approaches to safety management in health care have focused primarily on counting errors and understanding how things go wrong. Resilient Health Care (RHC) provides an alternative complementary perspective of learning from incidents and understanding how, most of the time, work is safe. The aim of this review was to identify how RHC is conceptualised, described and interpreted in the published literature, to describe the methods used to study RHC, and to identify factors that develop RHC.Methods Electronic searches of PubMed, Scopus and Cochrane databases were performed to identify relevant peer-reviewed studies, and a hand search undertaken for studies published in books that explained how RHC as a concept has been interpreted, what methods have been used to study it, and what factors have been important to its development. Studies were evaluated independently by two researchers. Data was synthesised using a thematic approach.Results Thirty-six studies were included; they shared similar descriptions of RHC which was the ability to adjust its functioning prior to, during, or following events and thereby sustain required operations under both expected and unexpected conditions. Qualitative methods were mainly used to study RHC. Two types of data sources have been used: direct (e.g. focus groups and surveys) and indirect (e.g. observations and simulations) data sources. Most of the tools for studying RHC were developed based on predefined resilient constructs and have been categorised into three categories: performance variability and Work As Done, cornerstone capabilities for resilience, and integration with other safety management paradigms. Tools for studying RHC currently exist but have yet to be fully implemented. Effective team relationships, trade-offs and health care ‘resilience’ training of health care professionals were factors used to develop RHC. Conclusions Although there was consistency in the conceptualisation of RHC, methods used to study and the factors used to develop it, several questions remain to be answered before a gold standard strategy for studying RHC can confidently be identified. These include operationalising RHC assessment methods in multi-level and diverse settings and developing, testing and evaluating interventions to address the wider safety implications of RHC amidst organisational and institutional change.

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“…The traditional approach to increasing safety has focused on counting incidents, identifying system failures, and understanding the causes of incidents in order to develop strategies to eliminate or reduce incidents [4]. This is called a Safety-I1 approach [5] which assumes that complex systems different departments and specialities to communicate about concerns pertaining to work practice [12,14], repeated exposure to similar disturbances [13,15,4], enhancing the knowledge and experience of health care professionals to respond to actual work conditions and to enact important trade-offs [15,4], reducing cognitive load on healthcare practitioners by simulation training to manage expected and unexpected situations [4] and integrating human factors and health economics in the design process [16]. Although RHC is conceptually and theoretically attractive, there is a need for more clarity around how RHC is currently conceptualised and operationalised in health care.…”

Section: Introductionmentioning

confidence: 99%

Resilient Health Care: a systematic review of conceptualisations, study methods and factors that develop resilience.

Iflaifel

Lim

Ryan

et al. 2019

Preprint

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Background Traditional approaches to safety management in health care have focused primarily on counting errors and understanding how things go wrong. Resilient Health Care (RHC) provides an alternative complementary perspective of learning from incidents and understanding how, most of the time, work is safe. The aim of this review was to identify how RHC was conceptualised, described and interpreted, to describe the methods used to study, and to identify factors that develop RHC. Methods Electronic searches of PubMed, Scopus and Cochrane databases were performed to identify relevant peer-reviewed studies, and a hand search for studies published in books that explained how RHC as a concept was interpreted, methods used to study, and factors to develop RHC. Studies were evaluated independently by two researchers. Data was synthesised using a deductive thematic approach. Results Twenty-seven studies were included; they shared similar descriptions of RHC which was the ability to adjust its functioning prior to, during, or following events and thereby sustain required operations under both expected and unexpected conditions. Qualitative methods such as observations and interviews were used to study RHC. Models for studying RHC currently exist and were in the early stages of implementation. Effective team relationships, trade-offs and healthcare ‘resilience’ training of health care professionals were factors used to develop RHC. Conclusions Although there was consistency in the conceptualisation of RHC, methods used to study and factors to develop RHC, further research should focus on operationalising RHC assessment methods and developing, testing and evaluating interventions for developing RHC.

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Designing medical technology for resilience: integrating health economics and human factors approaches

Cited by 44 publications

References 43 publications

How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development

How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development

Resilient Health Care: a systematic review of conceptualisations, study methods and factors that develop resilience.

Resilient Health Care: a systematic review of conceptualisations, study methods and factors that develop resilience.

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