Search strategy and evidence selection

Search strategy and evidence selection

Search strategy

1. Databases were searched from inception to January 2015 including MEDLINE(R) In‑Process & Other Non‑Indexed Citations and MEDLINE(R) (via Ovid); Embase (via OVID); Cochrane Library; CAB Abstracts; Web of Science Science Citation Index. The keywords visensia and biosign were used for the searches.

2. The internet was searched using the above keywords.

3., WHO ICTRP, and Current Controlled Trials were also searched for ongoing trials.

4. Information provided by the manufacturer was thoroughly checked for relevant studies. Information provided by the manufacturer in supporting this briefing was checked to identify any further information.

5. The manufacturer's website was thoroughly investigated.

Evidence selection

The inclusion criteria were as follows:

Patients: adult patients in level 1 and level 2 care for whom multi‑parameter patient monitoring has been routine.

Intervention: Visensia, a physiological monitoring system for detecting early clinical patient deterioration in vital signs.

Comparator: non‑Visensia monitoring

Outcomes: any relevant efficacy and safety clinical outcomes, including but not limited to:

  • Reduction in patient instability

  • Nurse response to alert for patient attention and time to alert

  • Clinical workload change

  • Prevention of major adverse events e.g. cardiac arrest, unscheduled admission to ICU, or death

  • Acute change in treatment or care level

  • Unscheduled visit by clinical staff

  • Emergency surgical procedure

  • In‑hospital mortality

  • Length of hospital stay

  • Sensitivity

  • Specificity

  • Positive predictive value

  • Negative predictive value

Study design: for effectiveness any controlled study will be included; for safety aspect of the device, any controlled study, non‑controlled study and case report will be included. Systematic reviews and meta‑analyses will be used for identifying relevant primary studies only. Proof of concept and non‑English language studies will be excluded.