We sincerely thank the authors of the letter for their thoughtful and constructive comments on the ‘PSICU-ALTA protocol’1 published a few months ago. We especially appreciate the external perspective, which highlights the relevance of the topic and offers valuable suggestions to improve its translational value.
Continuing treatment with psychotropic drugs after discharge from the ICU is a complex and multifactorial problem. Our current protocol was deliberately designed as an exploratory, descriptive, observational study with pragmatic endpoints. The study was approved by the corresponding Research Ethics Committee, which granted a waiver of informed consent given that no interventions beyond usual clinical practice are performed and data are collected retrospectively and anonymized. This approach represents a necessary first step in generating national data on rates of continuation of treatment with psychotropic drugs before moving on to the intervention phases.2
We fully agree that qualitative methodologies, explicit suitability assessments, and a broader view of polypharmacy represent important dimensions that could enrich our understanding of this phenomenon. Similarly, the incorporation of intervention strategies, such as decision support tools and pharmacist-led reconciliation at all levels of care, are promising avenues that we intend to incorporate in later phases of the project, which may require formal patient consent for active intervention.
Therefore, we consider that the thoughtful comments raised by the authors are not limitations of the current protocol, but rather opportunities for the natural evolution of the PSICU-ALTA study toward more comprehensive phases.
Once again, we appreciate the interest in our work and the constructive contributions, which we are sure will help shape the future developments of the project.
Ethical considerationsThe study referenced in the letter was evaluated and approved as an observational study with medications (prospective) by the Research Ethics Committee of the Vall d'Hebron University Hospital on September 29, 2023 (promoter code PSICU-ALTA). All collaborating investigators will sign a commitment to ensure compliance with Good Clinical Practice standards and the Helsinki Declaration. Given the observational nature of the study without interventions, informed consent was waived. At all times, confidentiality and anonymity of information related to patients, professionals, and ICU participants will be guaranteed, ensuring compliance with Organic Law 3/2018 of December 5th, on Data Protection and the Guarantee of Digital Rights. The study results will not be directly binding for professionals or patients; therefore, a commitment to publish both positive and negative results is made.
FundingThe project mentioned in the letter received one of the grants awarded to working groups by the Sociedad Española de Farmacia Hospitalaria in the 2023-2024 call for proposals.
Use of Artificial Intelligence (AI) toolsThe AI tool ChatGPT was used as support for the English translation for drafting the letter.
