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

Micromachines ◽  
2020 ◽  
Vol 11 (3) ◽  
pp. 291 ◽  
Author(s):  
Sara Graziadio ◽  
Amanda Winter ◽  
B. Lendrem ◽  
Jana Suklan ◽  
William Jones ◽  
...  
Keyword(s):  
Development Strategy ◽  
Public Involvement ◽  
Care Pathway ◽  
Point Of Care ◽  
Patient And Public Involvement ◽  
Product Management ◽  
Point Of Care Test ◽  
Value Propositions ◽  
On Line

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.

The challenges of patient and public involvement in medical technology and in-vitro diagnostic research

2018 ◽  
Vol 2 (2) ◽  
pp. 335-346
Author(s):  
Ijeoma Uchegbu ◽  
Momoko Sato ◽  
Alison Allam ◽  
Peter Buckle ◽  
George Hanna
Keyword(s):  
Medical Technology ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
In Vitro Diagnostic ◽  
Diagnostic Research

scholarly journals The challenges of patient and public involvement in medical technology and in-vitro diagnostic research

2018 ◽  
Vol 2 (2) ◽  
pp. 335-346
Author(s):  
Ijeoma F. Uchegbu ◽  
Momoko Sato ◽  
Alison Allam ◽  
Peter Buckle ◽  
George R. Hanna
Keyword(s):  
Medical Technology ◽  
Public Involvement ◽  
Health Care Research ◽  
Patient And Public Involvement ◽  
Technology Research ◽  
Impact Measurement ◽  
Transfer Event ◽  
Measurement Framework ◽  
In Vitro Diagnostic

Patient and public involvement (PPI) in research is defined as 'research being carried out "with" or "by" members of the public rather than "to", "about" or "for" them'. A knowledge transfer event (KTE) was planned to share the experience of organizations who carry out medical technology research. The KTE was attended by organizations with an interest in the effective application of PPI in health-care research, including organizations from academia, industry and charities. The aim was to share current PPI experience and to discuss the development of a PPI impact measurement framework to support future growth in PPI application within medical technology research.

scholarly journals Patient engagement in fertility research: bench research, ethics, and social justice

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Perry R. Fleming ◽  
Makayla M. Swygert ◽  
Coen Hasenkamp ◽  
Jessica Sterling ◽  
Ginny Cartee ◽  
...  
Keyword(s):  
Patient Engagement ◽  
Public Involvement ◽  
Science Research ◽  
Patient And Public Involvement ◽  
Main Body ◽  
Vitro Fertilization ◽  
Unique Nature ◽  
Meaningful Engagement ◽  
Verbal Agreement

Abstract Background Patient and Public Involvement (PPI) in research is increasingly being utilized to better connect patients and researchers. The Patient Engagement Studio (PES) supports PPI in research by working directly with researchers throughout various stages of their projects. Recently, two researchers presented to the PES for assistance with their project, Embryo+™. The purpose of Embryo+™ is to decrease miscarriage rates using RNA sequencing technology that screens for the most viable embryos. To date, no examples of PPI directly in the planning or implementation of bench research concerning in vitro fertilization and embryo transfer have been identified. Main body Embryo+™ researchers met in-person with the PES two times (fall 2019; each meeting had 9 PES members in attendance) for initial feedback and protocol development. After these meetings, PES leadership and Embryo+™ researchers decided that the unique nature of the project merited a PPI evaluation. Subsequent evaluation of engagement efforts occurred by reviewing the PES reports for the Embryo+™ researchers, conducting two recorded web-based discussion meetings with the PES (summer 2020; meeting 1 n = 7; meeting 2 n = 6), and a brief survey (n = 13). The discussion meetings provided an opportunity for the PES members to define engagement themes through consensus via verbal agreement to the studio director’s periodic summaries during the discussions. Combining survey results and PES themes allowed for a broad discussion for meaningful engagement. The Embryo+™ researchers established trust with the patients by changing some of their language in response to patient suggestions, allowing for unintended ethical conversations, and implementing the patient developed protocols. Overall, the patient experts thought this project was very meaningful and valuable, quantified by a mean loyalty score 89.43 (s.d. 10.29). Conclusion Bench science researchers may need additional PPI training prior to engaging with patient groups. PPI in this project was successful in large part due to this training, where the director emphasized the importance of gaining trust with the patients. The researchers applied what they learned and several examples of how to develop trust with patients are discussed. If trust is established, PPI in an ethically charged, basic science research study can be both valuable and successful.

scholarly journals Current attitudes towards HIV viral load self-testing: thematic analysis of a consultation with potential end-users

2021 ◽  
Author(s):  
Harriet D Gliddon ◽  
Rachel A McKendry ◽  
Jo Gibbs
Keyword(s):  
Viral Load ◽  
Thematic Analysis ◽  
Public Involvement ◽  
Point Of Care ◽  
Patient And Public Involvement ◽  
End Users ◽  
Hiv Care ◽  
People Living With Hiv ◽  
Hiv Viral Load ◽  
Self Testing

AbstractBackgroundHIV viral load (VL) is key to monitoring response to antiretroviral therapy. A number of point-of-care HIV VL tests are in development. These tests could be repurposed for HIV VL self-testing.MethodsWe held a patient and public involvement (PPI) consultation for people living with HIV to explore the prospect of HIV viral load self-testing. We conducted a thematic analysis on the data from this consultation.ResultsKey themes were access, convenience, usability, technical aspects, technology potential, connectivity and confidentiality. Attendees expressed significant appetite for decentralised HIV care, including HIV VL self-testing.ConclusionsThis PPI consultation can help researchers developing HIV viral load self-testing technology to better understand the needs of potential end users. Our findings will help guide the development and implementation of HIV VL self-testing.

Testing for resistance: Point-of-care testing as a communicational tool in antibiotic prescribing

2018 ◽  
Vol 14 (3) ◽  
pp. 229-240
Author(s):  
Johanna Lindell
Keyword(s):  
Point Of Care ◽  
Rapid Test ◽  
Antibiotic Use ◽  
Treatment Recommendation ◽  
Antibiotic Prescribing ◽  
Communicative Practices ◽  
Effective Strategies ◽  
Reactive Protein ◽  
Point Of Care Test ◽  
Test Result

As antibiotic resistance becomes a growing health emergency, effective strategies are needed to reduce inappropriate antibiotic use. In this article, one such strategy – communicative practices associated with the C-reactive protein point-of care test – is investigated. Building on a collection of 31 videorecorded consultations from Danish primary care, and using conversation analysis, this study finds that the rapid test can be used throughout the consultation to incrementally build the case for a nonantibiotic treatment recommendation, both when the test result is forecast and reported. The study also finds that the format of reports of elevated results differs from that of ‘normal’ results, resulting in a subtle shift of authority from doctor to test.

n. 188 (16): Dor On Line

Dor on line ◽  
2016 ◽  
Author(s):  
Paulo Barboni
Keyword(s):  
Urtica Dioica ◽  
On Line

Edição de Março de 2016 - Ano 16 - Número 188   Olá, leitores! Epigenética e dor é o tema de nosso editorial desse mês. Na seção de Divulgação Científica, trazemos alertas tratando de assuntos como o uso da pupilometria na avaliação da analgesia opioide; a relação do excesso de trabalho e a lombalgia; novas propostas de analgésicos, inclusive em serviços de música on line; e mais um artigo ligado ao “Ano de Combate à Dor Articular”. Na seção de Ciência e Tecnologia, trazemos alertas tratando da inibição da via da tetrahidrobiopterina; a identificação de um fator ligado à proliferação microglial em nervos lesionados; um alvo proteico ligado ao estresse e dor crônica e um novo tipo de priming hiperalgésico. Boa Leitura!   Editorial Participação de mecanismos epigenéticos na dor crônica: uma crescente área de investigação Andreza Urba de Quadros   Divulgação Científica Movimento da pupila pode predizer redução da dor pela administração de opioides. Pupilometria auxilia no tratamento da dor. Alexandre Hashimoto Pereira Lopes Dor nas costas aumenta em pessoas viciadas em trabalho. Você é um workaholic? Se sim, cuidado! Dênis Augusto Santana Reis Analgésicos potentes para o alívio da dor. Pesquisa mostra o efeito de análogos às endomorfinas administrados para aliviar a dor. Andressa Daiane de Carvalho Zaparolli Dorflex cria 'analgésico musical'. O uso de uma terapia musical pode funcional como um tratamento complementar ao tratamento farmacológico. Dênis Augusto Santana Reis Prescrição e efeito total da utilização de analgésicos, hipnóticos, antidepressivos e ansiolíticos. Resultado proveniente de uma população total de pacientes com artroplastia no quadril. Ana Carolina Alves M. de Moura   Ciência e Tecnologia Redução da dor inflamatória e neuropática através da inibição da via da tetrahidrobiopterina (BH4). Pesquisadores desenvolveram um inibidor da via de BH4 capaz de reduzir a dor crônica sem causar tolerância e efeitos adversos. Flávia Viana Santa-Ceclília CSF-1 derivado do nervo sensorial lesionado induz proliferação microglial e dor via dependente de DAP12. Neurônios sensoriais lesionados ativam a micróglia. Miriam das Dores Mendes Fonseca Avaliação in vivo e in vitro dos efeitos da Urtica dioica e natação em fatores do diabetes. A Urtiga é utilizada como planta medicinal para o tratamento de diversas patologias. Erika Ivanna Araya Pallarés Proteína FKBP51, envolvida na resposta do organismo ao estresse, envolvida na origem da dor crônica. Proteína FKBP51 como um possível alvo terapêutico para o tratamento da dor crônica. Sabrina Francesca de Souza Lisboa Agonista do receptor adenosina-a1 induz sensibilização hiperalgésica tipo II. Modelo de cronificação da dor. Thatiane Sandielen Lima Soares

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