Core Outcomes for Continuous Patient Monitoring on General Hospital Wards: A Mixed-Methods Study to Inform a Core Outcome Set

Continuous vital sign monitoring is increasingly used on general hospital wards to close the surveillance gap left by intermittent checks, which can miss early physiological deterioration. However, improved detection of abnormal physiology does not consistently translate into better patient outcomes; the effect depends on patient population, clinical context, and how monitoring is integrated into workflows and escalation-of-care systems. The current evidence base reports highly heterogeneous outcomes — clinical (e.g. mortality, unplanned ICU admissions, rapid response activations) and non-clinical (e.g. staff workload, alarm burden, patient acceptability, cost, and implementation outcomes) — which limits comparability across studies. This mixed-methods study aims to identify, understand, and prioritize the outcomes that matter most to stakeholders when evaluating continuous ward monitoring, drawing on Proctor's implementation outcomes framework and the Implementation Research Logic Model. It proceeds in three phases: (1) a literature review and semi-structured stakeholder interviews (nurses, physicians, decision-makers, biomedical/IT staff, quality and safety teams); (2) a Delphi survey to prioritize outcomes through iterative, anonymous rating rounds with predefined consensus thresholds; and (3) an optional consensus workshop to finalize definitions and short-list outcomes. The study will produce a comprehensive catalogue of clinical and implementation outcomes and a prioritized short-list to inform a future Core Outcome Set (COS) for research and evaluation of continuous patient monitoring on general hospital wards.

Contributors

Charité Universtiätsmedizin Berlin
Carolina Gaul; Prof. Dr. Akira-Sebastian Poncette; Begüm Kül

Further Study Information

Current Stage: Ongoing
Date: February 2026 - February 2027
Funding source(s): Funding is provided through an industry collaboration with Masimo.


Health Area

Disease Category: Other

Disease Name: N/A

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Active monitoring, Device

Stakeholders Involved

- Clinical experts
- Device manufacturers
- Researchers
- Service commissioners

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Delphi process
- Interview
- Literature review
- Semi structured discussion
- Survey

Mixed-methods design in three phases. Phase 1: literature review and semi-structured stakeholder interviews to identify relevant clinical and implementation outcomes and how they should be defined. Phase 2: online Delphi survey with iterative, anonymous rating rounds (9-point Likert scale) and predefined consensus thresholds to prioritize outcomes. Phase 3 (optional): multi-stakeholder consensus workshop to finalize definitions and short-list outcomes.

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