Challenges and potential solutions to the evaluation, monitoring, and regulation of surgical innovations.
BMC Surg
; 19(1): 119, 2019 Aug 27.
Article
em En
| MEDLINE
| ID: mdl-31455337
ABSTRACT
BACKGROUND:
As it may be argued that many surgical interventions provide obvious patient benefits, formal, staged assessment of the efficacy and safety of surgical procedures has historically been and remains uncommon. The majority of innovative surgical procedures have therefore often been developed based on anatomical and pathophysiological principles in an attempt to better manage clinical problems. MAIN BODY In this manuscript, we sought to review and contrast the models for pharmaceutical and surgical innovation in North America, including their stages of development and methods of evaluation, monitoring, and regulation. We also aimed to review the present structure of academic surgery, the role of methodological experts and funding in conducting surgical research, and the current system of regulation of innovative surgical procedures. Finally, we highlight the influence that evidence and surgical history, education, training, and culture have on elective and emergency surgical decision-making. The above discussion is used to support the argument that the model used for assessment of innovative pharmaceuticals cannot be applied to that for evaluating surgical innovations. It is also used to support our position that although the evaluation and monitoring of innovative surgical procedures requires a rigorous, fit-for-purpose, and formal system of assessment to protect patient safety and prevent unexpected adverse health outcomes, it will only succeed if it is supported and championed by surgical practice leaders and respects surgical history, education, training, and culture.CONCLUSION:
We conclude the above debate by providing a recommended approach to the evaluation, monitoring, and regulation of surgical innovations, which we hope may be used as a guide for all stakeholders involved in interpreting and/or conducting future surgical research.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Procedimentos Cirúrgicos Operatórios
/
Tomada de Decisões
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Segurança do Paciente
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article