Evaluating clinical decision support software (CDSS): challenges for robust evidence generation.
Int J Technol Assess Health Care
; 40(1): e16, 2024 Feb 08.
Article
em En
| MEDLINE
| ID: mdl-38328905
ABSTRACT
OBJECTIVES:
Computerized clinical decision support software (CDSS) are digital health technologies that have been traditionally categorized as medical devices. However, the evaluation frameworks for traditional medical devices are not well adapted to assess the value and safety of CDSS. In this study, we identified a range of challenges associated with CDSS evaluation as a medical device and investigated whether and how CDSS are evaluated in Australia.METHODS:
Using a qualitative approach, we interviewed 11 professionals involved in the implementation and evaluation of digital health technologies at national and regional levels. Data were thematically analyzed using both data-driven (inductive) and theory-based (deductive) approaches.RESULTS:
Our results suggest that current CDSS evaluations have an overly narrow perspective on the risks and benefits of CDSS due to an inability to capture the impact of the technology on the sociotechnical environment. By adopting a static view of the CDSS, these evaluation frameworks are unable to discern how rapidly evolving technologies and a dynamic clinical environment can impact CDSS performance. After software upgrades, CDSS can transition from providing information to specifying diagnoses and treatments. Therefore, it is not clear how CDSS can be monitored continuously when changes in the software can directly affect patient safety.CONCLUSION:
Our findings emphasize the importance of taking a living health technology assessment approach to the evaluation of digital health technologies that evolve rapidly. There is a role for observational (real-world) evidence to understand the impact of changes to the technology and the sociotechnical environment on CDSS performance.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
Base de dados:
MEDLINE
Assunto principal:
Sistemas de Apoio a Decisões Clínicas
Tipo de estudo:
Prognostic_studies
Limite:
Humans
País/Região como assunto:
Oceania
Idioma:
En
Revista:
Int J Technol Assess Health Care
/
Int. j. technol. assess. health care
/
International journal of technology assessment in health care
Ano de publicação:
2024
Tipo de documento:
Article