NUR01
How to improve adherence to visits, protocols, and procedures required in clinical trials? Literature review applied to haemophilia
S. García Barcenilla1,*, L. González Rodríguez1, S. Rochas López1, I. Viera Hernández2, M. M. Martínez González2, E. Monzón Manzano1, N. Butta Coll1, P. Acuña1, I. Rivas Pollmar1,2, M. Martín Salces1,2, V. Jimenez Yuste1,2, M. T. Álvarez Román1,2
1IdiPAZ Hospital Universitario La Paz Institute for Health Research, 2Hospital Universitario La Paz, Madrid, Spain
Introduction: Maintaining compliance throughout clinical trials (CT) is challenging due to frequent visits, drug-related assessments, and long duration follow ups. However, non-compliance with visits and procedures determined by protocol leads to increased deviations, reducing data quality, increasing operational costs with impact in staff motivation. While adherence and therapeutic compliance in haemophilia have been extensively studied, there is little evidence on strategies to ensure compliance with CT procedures and visits. However, findings in other areas could provide lessons applicable to our context.
Methods: A narrative review of the literature on adherence and retention in CT was conducted, including publications on treatment adherence, retention strategies, digital tools, and patient engagement in the last 5 years. Key themes were categorised into patient-level, protocol-related, and related to the center. These were then mapped to the roles of different stakeholders in haemophilia CTs, including physicians, study coordinators, nurses, sponsors and clinical research associates (CRAs).
Results: Evidence shows that effective strategies for treatment adherence are multi-component. First, factors that have known impact in adherence in CT context were identified and shown in table 1. Secondly, taking the taxonomy of Vrijens (2012) as standard, three key phases regarding adherence were defined: initiation (moment when patient accepts and initiates trial), implementation (quality of the participation of the patient regarding compliance with protocol) and persistence (total time from beginning and end of study), also the impact that trial activities have in each timepoint was analysed in table 2. Finally, image 3 presents tasks to promote adherence clasified by role.
Discussion/Conclusion: Persistence does not depend solely on individual motivation, but on the interaction between personal, organisational and contextual factors. The patient's personality can have an influence, but the research centre and multidisciplinary team have the capacity to compensate it. Minimising the burden, flexibility, logistical support and digital technology can potentially contribute to lower dropout or deviation rates and greater compliance. Funding: Project PI22/01461 Funded by Instituto de Salud Carlos III (ISCIII), co-funded by the European Union.Catedra UAM-Roche.
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Disclosure of Interest: None declared