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4.
BMJ Open ; 14(5): e080445, 2024 May 20.
Article in English | MEDLINE | ID: mdl-38772579

ABSTRACT

OBJECTIVE: The aim of this study is to understand stakeholder experiences of diagnosis of cardiovascular disease (CVD) to support the development of technological solutions that meet current needs. Specifically, we aimed to identify challenges in the process of diagnosing CVD, to identify discrepancies between patient and clinician experiences of CVD diagnosis, and to identify the requirements of future health technology solutions intended to improve CVD diagnosis. DESIGN: Semistructured focus groups and one-to-one interviews to generate qualitative data that were subjected to thematic analysis. PARTICIPANTS: UK-based individuals (N=32) with lived experience of diagnosis of CVD (n=23) and clinicians with experience in diagnosing CVD (n=9). RESULTS: We identified four key themes related to delayed or inaccurate diagnosis of CVD: symptom interpretation, patient characteristics, patient-clinician interactions and systemic challenges. Subthemes from each are discussed in depth. Challenges related to time and communication were greatest for both stakeholder groups; however, there were differences in other areas, for example, patient experiences highlighted difficulties with the psychological aspects of diagnosis and interpreting ambiguous symptoms, while clinicians emphasised the role of individual patient differences and the lack of rapport in contributing to delays or inaccurate diagnosis. CONCLUSIONS: Our findings highlight key considerations when developing digital technologies that seek to improve the efficiency and accuracy of diagnosis of CVD.


Subject(s)
Cardiovascular Diseases , Delayed Diagnosis , Focus Groups , Qualitative Research , Humans , Cardiovascular Diseases/diagnosis , United Kingdom , Female , Male , Middle Aged , Adult , Delayed Diagnosis/prevention & control , Aged , Digital Technology , Physician-Patient Relations , Biomedical Technology , Interviews as Topic , Communication , Diagnostic Errors/prevention & control , Stakeholder Participation , Digital Health
5.
Syst Rev ; 13(1): 133, 2024 May 15.
Article in English | MEDLINE | ID: mdl-38750593

ABSTRACT

BACKGROUND: This cross-sectional study investigated the online dissemination of Cochrane reviews on digital health technologies. METHODS: We searched the Cochrane Database of Systematic Reviews from inception up to May 2023. Cochrane reviews with any population (P), intervention or concept supported by any digital technology (I), any or no comparison (C), and any health outcome (O) were included. Data on review characteristics (bibliographic information, PICO, and evidence quality) and dissemination strategies were extracted and processed. Dissemination was assessed using review information on the Cochrane website and Altmetric data that trace the mentions of academic publications in nonacademic online channels. Data were analysed using descriptive statistics and binary logistic regression analysis. RESULTS: Out of 170 records identified in the search, 100 Cochrane reviews, published between 2005 and 2023, were included. The reviews focused on consumers (e.g. patients, n = 86), people of any age (n = 44), and clinical populations (n = 68). All reviews addressed interventions or concepts supported by digital technologies with any devices (n = 73), mobile devices (n = 17), or computers (n = 10). The outcomes focused on disease treatment (n = 56), health promotion and disease prevention (n = 27), or management of care delivery (n = 17). All reviews included 1-132 studies, and half included 1-10 studies. Meta-analysis was performed in 69 reviews, and certainty of evidence was rated as high or moderate for at least one outcome in 46 reviews. In agreement with the Cochrane guidelines, all reviews had a plain language summary (PLS) that was available in 3-14 languages. The reviews were disseminated (i.e. mentioned online) predominantly via X/Twitter (n = 99) and Facebook (n = 69). Overall, 51 reviews were mentioned in up to 25% and 49 reviews in 5% of all research outputs traced by Altmetric data. Dissemination (i.e. higher Altmetric scores) was associated with bibliographic review characteristics (i.e. earlier publication year and PLS available in more languages), but not with evidence quality (i.e. certainty of evidence rating, number of studies, or meta-analysis performed in review). CONCLUSIONS: Online attention towards Cochrane reviews on digital health technologies is high. Dissemination is higher for older reviews and reviews with more PLS translations. Measures are required to improve dissemination of Cochrane reviews based on evidence quality. SYSTEMATIC REVIEW REGISTRATION: The study was prospectively registered at the Open Science Framework ( https://osf.io/mpw8u/ ).


Subject(s)
Digital Technology , Cross-Sectional Studies , Humans , Information Dissemination/methods , Systematic Reviews as Topic , Biomedical Technology , Review Literature as Topic , Internet , Digital Health
6.
J Pak Med Assoc ; 74(4 (Supple-4)): S65-S71, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38712411

ABSTRACT

Countries that are striving to keep pace with emerging technologies in surgical practices and still not able to cope with exemplary international standards are in dire need of resources to build and strengthen their healthcare system. This review focusses on the impeding factors that hinder in adaptation of advanced technology and machinery in the health care industry. Considering the immense potential for current surgical technologies to transform the delivery of healthcare, their implementation in LMICs confronts considerable challenges due to lack of infrastructure, human capital and inadequate resources. To address these difficulties, various entities, including healthcare institutions, government and non-governmental organisations, and foreign partners, must work together. Building capacity through intended education and training initiatives, building infrastructure, and collaborative partnerships are critical for overcoming hurdles to effective deployment of surgical technology in low-income communities of the world.


Subject(s)
Developing Countries , Humans , Surgical Procedures, Operative , Delivery of Health Care/organization & administration , Biomedical Technology/trends
7.
Cad Saude Publica ; 40(4): e00117923, 2024.
Article in Spanish | MEDLINE | ID: mdl-38695457

ABSTRACT

Argentina, as other countries, showed several public policies related to the health technologies implemented to fight and treat the COVID-19 pandemic. This study sought to analyze how articulation vs. cooperation and autonomy vs. division of powers between entities occurred in Argentina, exploring asymmetries between several entities in implementing public policies related to health technologies during the pandemic and the influences of other actors. For this, a documentary research was carried out related to 2020-2021 (technical reports published by the World Health Organization, national agencies and scientific societies, laws, court decisions, press, and research and in-depth interviews with members of the Argentine Ministries of Health). The processes and results of decision-making in the Ministries of Health were analyzed, outlining the coverage and orientations of each technology and the political party in power in the province. This study found heterogeneous results and processes between Ministries and disputes within them. It also observed the poor adherence to official guidelines due to technical-political criteria (power relations, social, media, academic, judiciary, and legislative pressure). Some cases showed a strong tension between the government and its opposition over the discussion of technologies. Each province in Argentina has autonomously defined its policies on health technologies for COVID-19, and decision-making in public administration was disorderly, complex, and non-linear during the pandemic.


En pandemia, en Argentina y en otros países se observó variabilidad en las políticas públicas implementadas sobre tecnologías sanitarias para prevención y tratamiento de la COVID-19. El objetivo fue analizar cómo se procesaron en Argentina los movimientos de coordinación vs. cooperación, y de autonomía vs. reparto de autoridad entre entidades, explorando asimetrías entre diferentes entidades en la implementación de políticas públicas sobre tecnologías sanitarias en pandemia y las influencias de otros actores. Se realizó una revisión documental del período 2020-2021 (informes técnicos publicados por la Organización Mundial de la Salud, organismos nacionales y sociedades científicas, leyes, fallos judiciales, prensa, encuestas y entrevistas en profundidad a miembros de los Ministerios de Salud de Argentina). Se indagó sobre procesos y resultados de la toma de decisiones en los Ministerios de Salud, mapeando la cobertura y recomendación de cada tecnología y el partido político provincial gobernante. Hubo heterogeneidad en resultados y procesos entre los Ministerios, y disputas en el interior de los mismos. La adherencia a recomendaciones oficiales fue baja, influyendo distintos criterios técnico-políticos (relaciones de poder, presión social, de los medios, académicos, poder Judicial y Legislativo). En algunos casos se observó una fuerte tensión entre oficialismo y oposición al partido gobernante a partir de la discusión sobre tecnologías. Cada provincia argentina definió sus políticas sobre tecnologías sanitarias para COVID-19 con autonomía, y la toma de decisiones en la administración pública en pandemia fue desordenada, compleja y no lineal.


Na Argentina, assim como em outros países, houve uma variabilidade de políticas públicas relacionadas às tecnologias de saúde implementadas no combate e tratamento da COVID-19 durante a pandemia. Este estudo buscou analisar como ocorreram a articulação vs. cooperação, e a autonomia vs. divisão de poderes entre as entidades na Argentina, explorando assimetrias entre diferentes entidades na implementação de políticas públicas relacionadas a tecnologias de saúde na pandemia, bem como as influências de outros atores. Para tanto, realizou-se uma pesquisa documental para o período de 2020-2021 (relatórios técnicos publicados pela Organização Mundial da Saúde, agências nacionais e sociedades científicas, leis, decisões judiciais, imprensa, pesquisas e entrevistas em profundidade com membros dos Ministérios da Saúde da Argentina). Os processos e os resultados da tomada de decisão nos Ministérios da Saúde foram analisados, traçando a cobertura e orientações de cada tecnologia e o partido político no poder na província. Observou-se uma heterogeneidade nos resultados e processos entre os Ministérios, e disputas em seu interior. Houve uma baixa adesão às orientações oficiais, influenciada por diferentes critérios técnico-políticos (relações de poder, pressão social, midiática, acadêmica, do poder Judiciário e do Legislativo). Em alguns casos, observou-se uma forte tensão entre governo e oposição a partir da discussão das tecnologias. Cada província da Argentina definiu suas políticas sobre tecnologias de saúde para a COVID-19 de forma autônoma, e a tomada de decisões na administração pública foi desordenada, complexa e não linear durante a pandemia.


Subject(s)
COVID-19 , Health Policy , Pandemics , COVID-19/prevention & control , COVID-19/epidemiology , Argentina , Humans , Pandemics/prevention & control , Health Policy/legislation & jurisprudence , Biomedical Technology/legislation & jurisprudence , Politics , SARS-CoV-2 , Federal Government , Public Policy
8.
Methods ; 227: 60-77, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38729456

ABSTRACT

INTRODUCTION: Digital Health Technologies (DHTs) have been shown to have variable usability as measured by efficiency, effectiveness and user satisfaction despite large-scale government projects to regulate and standardise user interface (UI) design. We hypothesised that Human-Computer Interaction (HCI) modelling could improve the methodology for DHT design and regulation, and support the creation of future evidence-based UI standards and guidelines for DHTs. METHODOLOGY: Using a Design Science Research (DSR) framework, we developed novel UI components that adhered to existing standards and guidelines (combining the NHS Common User Interface (CUI) standard and the NHS Design System). We firstly evaluated the Patient Banner UI component for compliance with the two guidelines and then used HCI-modelling to evaluate the "Add New Patient" workflow to measure time to task completion and cognitive load. RESULTS: Combining the two guidelines to produce new UI elements is technically feasible for the Patient Banner and the Patient Name Input components. There are some inconsistencies between the NHS Design System and the NHS CUI when implementing the Patient Banner. HCI-modelling successfully quantified challenges adhering to the NHS CUI and the NHS Design system for the "Add New Patient" workflow. DISCUSSION: We successfully developed new design artefacts combing two major design guidelines for DHTs. By quantifying usability issues using HCI-modelling, we have demonstrated the feasibility of a methodology that combines HCI-modelling into a human-centred design (HCD) process could enable the development of standardised UI elements for DHTs that is more scientifically robust than HCD alone. CONCLUSION: Combining HCI-modelling and Human-Centred Design could improve scientific progress towards developing safer and more user-friendly DHTs.


Subject(s)
User-Computer Interface , Humans , Digital Technology/methods , Biomedical Technology/methods , Biomedical Technology/standards , Digital Health
10.
Int J Health Policy Manag ; 13: 7494, 2024.
Article in English | MEDLINE | ID: mdl-38618836

ABSTRACT

BACKGROUND: There is a lack of guidance on approaches to formulary management and funding for high-cost drugs and therapeutics by individual healthcare institutions. The objective of this review was to assess institutional approaches to resource allocation for such therapeutics, with a particular focus on paediatric and rare disease populations. METHODS: A search of Embase and MEDLINE was conducted for studies relevant to decision-making for off-formulary, high-cost drugs and therapeutics. Abstracts were evaluated for inclusion based on the Simple Multiple-Attribute Rating Techniques (SMART) criteria. A framework of 30 topics across 4 categories was used to guide data extraction and was based on findings from the initial abstract review and previous health technology assessment (HTA) publications. Reflexive thematic analysis was conducted using QSR NVivo 12 software. RESULTS: A total of 168 studies were included for analysis. Only 4 (2%) focused on paediatrics, while 21 (12%) centred on adults and the remainder (85%) did not specify. Thirty-two (19%) studies discussed the importance of high-cost therapeutics and 34 (23%) focused on rare/orphan drugs. Five themes were identified as being relevant to institutional decision-making for high-cost therapeutics: institutional strategy, substantive criteria, procedural considerations, guiding principles and frameworks, and operational activities. Each of these themes encompassed several sub-themes and was complemented by a sixth category specific to paediatrics and rare diseases. CONCLUSION: The rising cost of novel drugs and therapeutics underscores the need for robust, evidence-based, and ethically defensible decision-making processes for health technology funding, particularly at the hospital level. Our study highlights practices and themes to aid decision-makers in thinking critically about institutional, substantive, procedural, and operational considerations in support of legitimate decisions about institutional funding of high-cost drugs and therapeutics, as well as opportunities and challenges that exist for paediatric and rare disease populations.


Subject(s)
Health Facilities , Rare Diseases , Adult , Humans , Child , Rare Diseases/drug therapy , Hospitals , Biomedical Technology , Drug Costs
11.
J Health Care Poor Underserved ; 35(1): ix-xiv, 2024.
Article in English | MEDLINE | ID: mdl-38661853

ABSTRACT

Human subjects research and drug and device development currently base their findings largely on the genetic data of the non-Hispanic White population, excluding People of Color. This practice puts People of Color at a distinct and potentially deadly disadvantage in being treated for sickness, disability, and disease, as seen during the COVID-19 pandemic. Major disparities exist in all chronic health conditions, including cancer. Data show that less than 2% of genetic information being studied today originates from people of African ancestry. If genomic datasets do not adequately represent People of Color, new drugs and genetic therapies may not work as well as for people of European descent. Addressing the urgent concern that historically marginalized people may again be excluded from the next technological leap affecting human health and the benefits it will bring will requires a paradigm shift. Thus, on behalf of underserved and marginalized people, we developed the Together for CHANGE (T4C) initiative as a unique collaborative public-private partnership to address the concern. The comprehensive programs designed in the T4C initiative, governed by the Diaspora Human Genomics Institute founded by Meharry Medical College, will transform the landscape of education and health care and positively affect global Black communities for decades to come.


Subject(s)
Biomedical Technology , Black People , Cultural Diversity , Vulnerable Populations , Research Design , Evidence Gaps , Biomedical Technology/standards , Biomedical Technology/trends , Public-Private Sector Partnerships , Genomics , Ethicists , Humans
12.
JMIR Hum Factors ; 11: e50889, 2024 Apr 26.
Article in English | MEDLINE | ID: mdl-38669076

ABSTRACT

BACKGROUND: New digital technology presents new challenges to health care on multiple levels. There are calls for further research that considers the complex factors related to digital innovations in complex health care settings to bridge the gap when moving from linear, logistic research to embracing and testing the concept of complexity. The nonadoption, abandonment, scale-up, spread, and sustainability (NASSS) framework was developed to help study complexity in digital innovations. OBJECTIVE: This study aims to investigate the role of complexity in the development and deployment of innovations by retrospectively assessing challenges to 4 digital health care innovations initiated from the bottom up. METHODS: A multicase retrospective, deductive, and explorative analysis using the NASSS complexity assessment tool LONG was conducted. In total, 4 bottom-up innovations developed in Region Västra Götaland in Sweden were explored and compared to identify unique and shared complexity-related challenges. RESULTS: The analysis resulted in joint insights and individual learning. Overall, the complexity was mostly found outside the actual innovation; more specifically, it related to the organization's readiness to integrate new innovations, how to manage and maintain innovations, and how to finance them. The NASSS framework sheds light on various perspectives that can either facilitate or hinder the adoption, scale-up, and spread of technological innovations. In the domain of condition or diagnosis, a well-informed understanding of the complexity related to the condition or illness (diabetes, cancer, bipolar disorders, and schizophrenia disorders) is of great importance for the innovation. The value proposition needs to be clearly described early to enable an understanding of costs and outcomes. The questions in the NASSS complexity assessment tool LONG were sometimes difficult to comprehend, not only from a language perspective but also due to a lack of understanding of the surrounding organization's system and its setting. CONCLUSIONS: Even when bottom-up innovations arise within the same support organization, the complexity can vary based on the developmental phase and the unique characteristics of each project. Identifying, defining, and understanding complexity may not solve the issues but substantially improves the prospects for successful deployment. Successful innovation within complex organizations necessitates an adaptive leadership and structures to surmount cultural resistance and organizational impediments. A rigid, linear, and stepwise approach risks disregarding interconnected variables and dependencies, leading to suboptimal outcomes. Success lies in embracing the complexity with its uncertainty, nurturing creativity, and adopting a nonlinear methodology that accommodates the iterative nature of innovation processes within complex organizations.


Subject(s)
Diffusion of Innovation , Humans , Retrospective Studies , Sweden , Biomedical Technology
13.
Biomacromolecules ; 25(5): 2814-2822, 2024 May 13.
Article in English | MEDLINE | ID: mdl-38598701

ABSTRACT

Peptide-based hydrogels have gained considerable attention as a compelling platform for various biomedical applications in recent years. Their attractiveness stems from their ability to seamlessly integrate diverse properties, such as biocompatibility, biodegradability, easily adjustable hydrophilicity/hydrophobicity, and other functionalities. However, a significant drawback is that most of the functional self-assembling peptides cannot form robust hydrogels suitable for biological applications. In this study, we present the synthesis of novel peptide-PEG conjugates and explore their comprehensive hydrogel properties. The hydrogel comprises double networks, with the first network formed through the self-assembly of peptides to create a ß-sheet secondary structure. The second network is established through covalent bond formation via N-hydroxysuccinimide chemistry between peptides and a 4-arm PEG to form a covalently linked network. Importantly, our findings reveal that this hydrogel formation method can be applied to other peptides containing lysine-rich sequences. Upon encapsulation of the hydrogel with antimicrobial peptides, the hydrogel retained high bacterial killing efficiency while showing minimum cytotoxicity toward mammalian cells. We hope that this method opens new avenues for the development of a novel class of peptide-polymer hydrogel materials with enhanced performance in biomedical contexts, particularly in reducing the potential for infection in applications of tissue regeneration and drug delivery.


Subject(s)
Biomedical Technology , Hydrogels , Peptides , Polyethylene Glycols , Hydrogels/chemical synthesis , Hydrogels/pharmacology , Hydrogels/standards , Hydrogels/toxicity , Peptides/chemistry , Polyethylene Glycols/chemistry , Biomedical Technology/methods , Humans , Cell Line , Fibroblasts/drug effects , Rheology , Antimicrobial Peptides/chemistry , Antimicrobial Peptides/pharmacology , Cell Survival/drug effects , Escherichia coli/drug effects
14.
Med Law Rev ; 32(2): 205-228, 2024 May 28.
Article in English | MEDLINE | ID: mdl-38654475

ABSTRACT

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.


Subject(s)
Biological Specimen Banks , Intellectual Property , Humans , Biological Specimen Banks/legislation & jurisprudence , Biological Specimen Banks/ethics , Patents as Topic/legislation & jurisprudence , Biomedical Technology/legislation & jurisprudence , Biomedical Technology/ethics , Tissue Donors/legislation & jurisprudence , Bioethical Issues/legislation & jurisprudence
15.
Eur J Health Law ; 31(2): 171-186, 2024 Mar 13.
Article in English | MEDLINE | ID: mdl-38594024

ABSTRACT

The new EU Regulation on health technology assessment (HTAR) provides for joint clinical assessments (JCA) of health technologies at EU level. When Member States carry out health technology assessments (HTA) at the national level, they shall give due consideration to the results of a JCA and comply with other obligations of the Regulation. This article aims to clarify what these obligations mean for the Member States and whether JCA results have to be considered outside a national health technology assessment as well. In this context, the question of which processes qualify as 'national HTA' and which requirements need to be fulfilled to trigger the obligations under Article 13 HTAR are discussed in more detail in this paper.


Subject(s)
Biomedical Technology , Technology Assessment, Biomedical , Humans
16.
Sensors (Basel) ; 24(7)2024 Mar 22.
Article in English | MEDLINE | ID: mdl-38610255

ABSTRACT

In recent years, biomedical optics technology has developed rapidly. The current widespread use of biomedical optics was made possible by the invention of optical instruments. The advantages of being non-invasive, portable, effective, low cost, and less susceptible to system noise have led to the rapid development of functional near-infrared spectroscopy (fNIRS) technology for hemodynamics detection, especially in the field of functional brain imaging. At the same time, laboratories and companies have developed various fNIRS-based systems. The safety, stability, and efficacy of fNIRS systems are key performance indicators. However, there is still a lack of comprehensive and systematic evaluation methods for fNIRS instruments. This study uses the fNIRS system developed in our laboratory as the test object. The test method established in this study includes system validation and performance testing to comprehensively assess fNIRS systems' reliability. These methods feature low cost and high practicality. Based on this study, existing or newly developed systems can be comprehensively and easily evaluated in the laboratory or workspace.


Subject(s)
Biomedical Technology , Spectroscopy, Near-Infrared , Humans , Reproducibility of Results , Brain/diagnostic imaging , Laboratories
17.
BMC Med Inform Decis Mak ; 24(1): 76, 2024 Mar 14.
Article in English | MEDLINE | ID: mdl-38486175

ABSTRACT

BACKGROUND: Economic evaluation of emerging health technologies is mandated by agencies such as the National Institute for Health and Care Excellence (NICE) to ensure their cost is proportional to their benefit. To avoid bias, NICE stipulate that the benefit of a treatment is assessed across the lifetime of the patient population, which can be many decades. Unfortunately, follow-up from a clinical trial will not usually cover the required period and the observed follow-up will require extrapolation. For survival data this is often done by selecting a preferred model from a set of candidate parametric models. This approach is limited in that the choice of model is restricted to those originally fitted. What if none of the models are consistent with clinical prediction or external data? METHOD/RESULTS: This paper introduces SurvInt, a tool that estimates the parameters of common parametric survival models which interpolate key survival time co-ordinates specified by the user, which could come from external trials, real world data or expert clinical opinion. This is achieved by solving simultaneous equations based on the survival functions of the parametric models. The application of SurvInt is shown through two examples where traditional parametric modelling did not produce models that were consistent with external data or clinical opinion. Additional features include model averaging, mixture cure models, background mortality, piecewise modelling, restricted mean survival time estimation and probabilistic sensitivity analysis. CONCLUSIONS: SurvInt allows precise parametric survival models to be estimated and carried forward into economic models. It provides access to extrapolations that are consistent with multiple data sources such as observed data and clinical predictions, opening the door to precise exploration of regions of uncertainty/disagreement. SurvInt could avoid the need for post-hoc adjustments for complications such as treatment switching, which are often applied to obtain a plausible survival model but at the cost of introducing additional uncertainty. Phase III clinical trials are not designed with extrapolation in mind, and so it is sensible to consider alternative approaches to predict future survival that incorporate external information.


Subject(s)
Biomedical Technology , Seizures , Humans , Cost-Benefit Analysis , Uncertainty
18.
BMJ Health Care Inform ; 31(1)2024 Mar 12.
Article in English | MEDLINE | ID: mdl-38471784

ABSTRACT

OBJECTIVES: This project aimed to determine where health technology can support best-practice perioperative care for patients waiting for surgery. METHODS: An exploratory codesign process used personas and journey mapping in three interprofessional workshops to identify key challenges in perioperative care across four health districts in Sydney, Australia. Through participatory methodology, the research inquiry directly involved perioperative clinicians. In three facilitated workshops, clinician and patient participants codesigned potential digital interventions to support perioperative pathways. Workshop output was coded and thematically analysed, using design principles. RESULTS: Codesign workshops, involving 51 participants, were conducted October to November 2022. Participants designed seven patient personas, with consumer representatives confirming acceptability and diversity. Interprofessional team members and consumers mapped key clinical moments, feelings and barriers for each persona during a hypothetical perioperative journey. Six key themes were identified: 'preventative care', 'personalised care', 'integrated communication', 'shared decision-making', 'care transitions' and 'partnership'. Twenty potential solutions were proposed, with top priorities a digital dashboard and virtual care coordination. DISCUSSION: Our findings emphasise the importance of interprofessional collaboration, patient and family engagement and supporting health technology infrastructure. Through user-based codesign, participants identified potential opportunities where health technology could improve system efficiencies and enhance care quality for patients waiting for surgical procedures. The codesign approach embedded users in the development of locally-driven, contextually oriented policies to address current perioperative service challenges, such as prolonged waiting times and care fragmentation. CONCLUSION: Health technology innovation provides opportunities to improve perioperative care and integrate clinical information. Future research will prototype priority solutions for further implementation and evaluation.


Subject(s)
Communication , Waiting Lists , Humans , Biomedical Technology , Perioperative Care , Australia
19.
Ther Innov Regul Sci ; 58(3): 456-464, 2024 May.
Article in English | MEDLINE | ID: mdl-38528278

ABSTRACT

Artificial intelligence (AI)-enabled technologies in the MedTech sector hold the promise to transform healthcare delivery by improving access, quality, and outcomes. As the regulatory contours of these technologies are being defined, there is a notable lack of literature on the key stakeholders such as the organizations and interest groups that have a significant input in shaping the regulatory framework. This article explores the perspectives and contributions of these stakeholders in shaping the regulatory paradigm of AI-enabled medical technologies. The formation of an AI regulatory framework requires the convergence of ethical, regulatory, technical, societal, and practical considerations. These multiple perspectives contribute to the various dimensions of an evolving regulatory paradigm. From the global governance guidelines set by the World Health Organization (WHO) to national regulations, the article sheds light not just on these multiple perspectives but also on their interconnectedness in shaping the regulatory landscape of AI.


Subject(s)
Artificial Intelligence , Humans , Delivery of Health Care , Biomedical Technology/legislation & jurisprudence , World Health Organization
20.
Ther Innov Regul Sci ; 58(3): 567-577, 2024 May.
Article in English | MEDLINE | ID: mdl-38491262

ABSTRACT

INTRODUCTION: Integration of precision medicine (PM) competencies across the Medical Technology and Pharmaceutical industry is critical to enable industry professionals to understand and develop the skills needed to navigate the opportunities arising from rapid scientific and technological innovation in PM. Our objective was to identify the key competency domains required by industry professionals to enable them to upskill themselves in PM-related aspects of their roles. METHODS: A desktop research review of current literature, curriculum, and healthcare trends identified a core set of domains and subdomains related to PM competencies that were consistent across multiple disciplines and competency frameworks. A survey was used to confirm the applicability of these domains to the cross-functional and multi-disciplinary work practices of industry professionals. Companies were requested to trial the domains to determine their relevance in practice and feedback was obtained. RESULTS: Four PM-relevant domains were identified from the literature review: medical science and technology; translational and clinical application; governance and regulation and professional practice. Survey results refined these domains, and case studies within companies confirmed the potential for this framework to be used as an adjunct to current role specific competency frameworks to provide a specific focus on needed PM capabilities. CONCLUSION: The framework was well accepted by local industry as a supplement to role specific competency frameworks to provide a structure on how to integrate new and evolving technologies into their current workforce development planning and build a continuous learning and cross-disciplinary mindset.


Subject(s)
Drug Industry , Precision Medicine , Drug Industry/organization & administration , Humans , Biomedical Technology , Surveys and Questionnaires
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