Hospital data can inform decision-makers with real-time evidence, yet it remains underutilised. This study aims to compare international health technology assessment (HTA) and regulatory real-world evidence (RWE) guidance, focusing on their applicability to hospital data.

We used a two-step sequential qualitative design: a scoping review and semi-structured interviews with HTA experts. We searched for RWE guidance for HTA in 12 countries: the UK, Germany, Italy, Spain, France, Finland, the Netherlands, Portugal, Denmark, Canada, the US and Australia, along with the European Medicines Agency and Food and Drug Administration. The expert interviews aimed to validate document selection and assess their applicability to hospital data. We analysed the interviews thematically.

We identified 19 guidance documents providing recommendations for RWE. Of these, four documents explicitly provided recommendations tailored to hospital data, while two others did so implicitly. The scope, definition and applications of RWE vary among guidance. Recommendations across all agencies mainly address the clinical-effectiveness domain, with limited guidance on quality-of-life and patient-reported outcomes, and none on real-world cost. The interviews identified seven themes playing a role in using hospital data: data-related, generalisability, ethical/legal, organisational, communication, governance and technology-related. Barriers included data availability, access, timeliness, quality, validation and heterogeneity. HTA experts emphasised the need for standardised policies.

There is a lack of harmonisation in assessing RWE among HTA and regulatory agencies. The available RWE guidance documents provide limited guidance on real-world hospital data. Considering their unique nature and to unlock their potential for HTA, we emphasise the need for more in-depth guidance tailored to the hospital context.

A quality management system (QMS) in healthcare organisations encompasses not only policies, processes and necessary procedures but also the quality, safety and risk management of medical technology. Tactical and operational decision-making levels should be closely interconnected. Previous studies have shown that nurses at the operational level do have good awareness of patient safety, but especially in teams with a strong degree of self-organisation, interaction with tactical levels is an issue. The tactical level is regarded as crucial for linking top-down policy with bottom-up experiences.

To explore the perspectives of homecare employees working at a tactical level regarding (1) the quality frameworks used within their organisation according to these employees, (2) the extent to which these employees are aware of the procedures for the safe use of advanced medical technologies (AMTs), such as infusion pumps, within their organisation and (3) how these employees perceive the patient safety culture related to the use of AMTs within their organisation.

A qualitative descriptive research design was employed.

15 semistructured interviews were conducted online with purposively sampled participants from homecare organisations across the Netherlands that had previously participated in related studies. The participants were employees at the tactical level within these homecare organisations, responsible for the quality and safety of AMTs.

All participating organisations possess a QMS; however, only seven indicated that there is a dedicated plan for ensuring the quality and safety of AMTs. National protocols for the use of AMTs and the supplier’s maintenance protocols are commonly followed. Although some participants say that their organisation has no formal procedure for resolving malfunctions with AMTs, all participants know pathways for solving problems. Tailored training programmes for nurses on AMTs are provided, but often without testing knowledge and skills or formal registration of nurses’ competence. Professionals report an incident on a separate form in the electronic client file or via a separate reporting system. However, there is no uniformity within organisations about handling incidents. Most interviewees state that, in any case, incidents are discussed within the team. On the dimension ‘reporting, evaluating and learning from incidents’ of the ‘Instrument for Self-Evaluation of Patient Safety Culture’, the prevailing patient safety culture is, on average, characterised as ‘proactive’.

There is a lack of uniformity regarding quality and safety procedures for the use of AMTs in homecare organisations, and structured policies for the implementation, use and maintenance of AMTs are needed. This study identified additional risk factors regarding individual competencies in the use of AMTs at home. Employees at the tactical level seem to be more positive about the patient safety culture with AMTs in their organisations than nurses at the operational level are.