Annex 3: Common Challenge & Functional Specifications - Nightingale
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Annex 3: Common Challenge & Functional
Specifications
European Commission Horizon 2020 Pre-commercial Procurement: Project number 727534
www.nightingale-h2020.eu
Five Academic Hospitals seek innovative partners to deliver cutting edge health care solutions for wireless
monitoring and identification of high-risk patients, both in hospital and at home.
Executive Summary
Clinical need
Patients die because signs of deterioration are missed. There is a huge unfulfilled need for better monitoring
of vital signs and other data to identify high-risk patients who are on general hospital wards or at home.
Patient deterioration is often overlooked or not detected at all. One of the reasons is the intensity in nursing
and frequency of vital signs monitoring which decreases from the Intensive Care via ward towards home. Early
detection of physiological instability is crucial to prevent death and disability.
Pre-commercial Procurement (PCP)
Five leading European academic hospitals (Utrecht, the Netherlands; Stockholm, Sweden; London, United
Kingdom; Leuven, Belgium and Aachen, Germany) uses the European commission’s Pre-commercial
Procurement (PCP) funding scheme to challenge and stimulate European industry to develop a system to
connect patients and carers to wirelessly monitor patients’ vital signs and identify high risk individuals. The
available budget for the development of this innovative solution is 5.3 million euro, consisting of 3.75 million
euro in the form of innovation subsidies to the industry.
Finding a solution
The solution should consist of one or more unobtrusive wireless sensors that do not interfere with the
patient’s daily activities or rehabilitation. Intelligent analysis software is a key feature of the requested system,
as the false alarm rate must be extremely low to be acceptable to the users. It should be well-integrated into
the hospital’s electronic medical record system. The sensors should involve a mechanism that allows patients
and informal carers to communicate with their healthcare team, and allow entry of qualitative data (e.g., pain
and well-being scores).
Vital signs such as respiratory rate, pulse, blood pressure and level of consciousness are key predictors of
deterioration 1., 2., but prediction will be much enhanced with analysis of various data from the medical record.
This includes demographic data such as patient age and also biochemistry and haematology data, e.g., serum
1
creatinine (as an indicator of acute kidney injury); urea, white blood cell count, etc .
Patient inputs are critical for several reasons, not least because respiration, blood pressure and consciousness
2.
are probably the three most important parameters - and standard monitoring devices cannot measure
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consciousness. However, patients’ response(s) to questions or instructions can tell us how their brain is
working - and also allow patients to say if they are thirsty (perhaps dehydrated), light-headed or faint (altered
neurological or cardiovascular function), nauseous (neurological or gastrointestinal dysfunction), in pain, or
simply “feeling well”/”not well”.
We expect that successful implementation of such a system will empower patients and carers. It will have the
potential to transform healthcare by reducing death and disability from undetected deterioration, and can
provide a ‘safety net’ to high-risk patients after discharge home.
We invite industry to solve this huge unfilled need for better patient monitoring!
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Nightingale - Connecting Patients and Carers using wireless technology:
The Common Challenge
The Clinical Need
Despite improvements in diagnostic and therapeutic options in the last decades, there is an
increasingly important ‘Achilles heel’ in the care of patients who become acutely ill, who recently
underwent surgery, those who return to a general ward in the hospital after discharge from a Critical
Care environment, or those receiving continuing care at home.
Figure 1. Monitoring gap
Early detection of deterioration is crucial to prevent death and disability from rapidly fatal
conditions such as upper airway obstruction, internal bleeding, sepsis, and respiratory and cardiac
arrest. In Appendix A typical patient situations (patient journeys) are described where the proposed
Nightingale system could predict and detect physiological instability at an early point, allowing
treatments to prevent death and disability. Such monitoring is primarily a nursing task. However,
nurses on hospital wards must care for increasingly unwell patients and on many wards it is only
feasible to perform one set of vital sign observations once per nursing shift (every 8 hours).
3
Increasing the intensity of patient observation and vital sign monitoring by more frequent nurse
rounds is severely limited by the availability of sufficient numbers of trained nurses and budget
constraints.
Once discharged home, patients’ vital signs are no longer monitored at all. While this may seem
acceptable for patients who are stable and nearly completely recovered from their illness, the reality
today is different in many cases. A sizeable proportion of mortality occurs in the first week after
discharge; on the other hand, patients are now discharged home earlier than ever before. Note that
while enhanced early recovery after surgery is associated with better outcomes, early discharge also
means that some major complications will become first manifested in the home setting.
A system that connects the high-risk patient at home with the healthcare team, and generates alerts
when vital signs deteriorate will allow early recognition of any problems and early treatment, with
rapid rehospitalisation where needed.
Objective and Key Performance Indicators of the Nightingale solution
The objective of Nightingale is: ‘prediction and detection of physiological instability to prevent death
and disability, by wearable smart monitoring leading to safer care’.
In the end, after successful (commercial) implementation in the healthcare market, Nightingale’s
long term performance can be described in the following ‘performance indicators’:
● Safe reduction of Length of Stay (LOS) in the hospital
● Reduced number of avoidable re-admissions to Intensive Care Unit (ICU)
● Faster re-admission to ICU for patients who do need escalation of care
● Reduction of mortality
● Reduction of additional costs of care
To assess the performance of Nightingale systems clinical trials are needed with large patient
populations.
In the short term, during the research & development phase of Nightingale, system performance can
be described in the following ‘performance indicators’:
● Ease of use and acceptance by the users; both the patient as the nurses
● Technical validity of both hardware and software components
Scope
The Nightingale solution should be supportive both in the hospital and in the home setting. For in-
hospital use we are currently focussing on high risk patients admitted for both serious medical
problems and for surgery.
For the home setting, we expect Nightingale solutions to be of added value for post-surgery patients
and patients sent home after emergency room visits for acute medical problems (who would
otherwise need to be admitted ‘for observation’).
Nightingale may be used to monitor patients in three different situations:
1. to highlight and communicate information about high risk patients, based on analysis of both acute
4
physiology (primarily vital signs and blood profile) and factors related to age, chronic disease, frailty,
functional status); and to ensure that they are monitored when subject to acute insults or any
procedures.
2. to allow early detection of physiological deterioration, which then allows early treatment and
improved outcomes. In some situations monitoring and rapid treatment will prevent re-admission to
the ICU, while in others necessary (re)admission to the ICU will not be delayed by late recognition of
deterioration.
3. to provide assurance about patient status and continuing recovery when discharged from higher
levels of care in the hospital (e.g., from the ICU or operating theatre recovery area to the ward; or, in
some cases, from the Emergency Department to home).
Figure 2. Hospital and home application
Market search (as of November 15th 2016)
The consortium partners have performed an extensive search to discover possible solutions that are
currently available. We identified several ‘wearable’ devices that are designed to measure one or
more vital signs and transmit these data wirelessly to another device such as a smartphone or
network-attached ‘bridge’ (and from there to a server and the patient record).
Currently the majority of wearable sensor devices appear to be geared towards lifestyle and sports.
We identified only a handful of companies that produce a ‘medical grade’ wearable sensor that can
measure and wirelessly transmit vital signs such as heart rate, respiratory rate and temperature.
None of these companies currently has a user front end for the care giver that intelligently interprets
the various signals to avoid repeated triggering of false alarms. Most systems that present data on a
central terminal use traditional user-selectable alarm ‘threshold’ functionality. None of the currently
available systems is sufficiently developed to allow remote monitoring of patients’ vital signs in the
home situation. Moreover, there is also a need to add in information from the medical record and
from patient inputs as described above; i.e., demographic data, laboratory data, patient responses to
questions or instructions.
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Nightingale - Connecting Patients and Carers using wireless technology:
The Common Challenge
The Business Case
The business case for our requested solution is very strong. Avoidable adverse events (including
death) are extremely costly; for example, most major surgical complications result in excessive
Length of Stay and added costs for additional drugs and interventions (total cost up to more than
twice the cost of admission without complications). For example, it is estimated that if the number of
[cases of] sepsis were reduced by 10%, 20% or 30% …the potential annual cost savings to the UK NHS
would be £148 million, £296 million or £444 million respectively3..
Moreover, patients with complications have a higher likelihood of being readmitted to hospital after
discharge home. For hospitals and third-party payers, unplanned readmissions are an increasing
cause for concern. Even complications that cannot be avoided by improved patient monitoring will
benefit from rapid recognition and timely treatment.
The partners have initiated formal Health Technology Assessment (HTA) studies to help define the
business case and cost effectiveness ratio of the envisioned solution.
An example:
If Nightingale is able to reduce:
● Length of Stay with 5% (assumed costs of one day extra LoS is €600)
● Mortality by 5% (relative risk reduction) and assumed societal cost of one avoidable death is
€200.000)
● Readmission rate by 5% (assumed costs of readmission is €6.000)
The potential savings in healthcare are calculated at €7,3 million per year per hospital with a capacity
of 30.000 patients per year, based on the mentioned assumptions.
This is based on the following rationale:
- If we assume that with using Nightingale the average Length of Stay can be reduced by 5% from an
average of 6.1 days of stay per patient and assuming a hospital with 30.000 clinical admissions per
year, this results in potential annual cost savings of €5,5 million.
- If we assume that the absolute number of avoidable deaths (hospital mortality rate of 2% with a
potentially avoidable fraction of 4%) can be reduced with 0.25 by applying monitoring on vital signs
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and detecting early deterioration and assuming a hospital has 30.000 patients a year this results in
potential avoided costs of death of €1,2 million per year.
- If we assume a modest reduction of the readmission rate by 5% (from a current readmission rate of
6.2% to 5.9%) this results in potential cost savings of €560.000 per year.
In these potential cost savings we have not taken into account the costs of applying the Nightingale
solution. Assuming a cost level of €100 per patient, the net potential savings are €4,3 million per year
for this type of hospital (30.000 patients per year). Assuming a purchase price of €50 per patient, the
net potential savings are €5,8 million per year; while at a € 200 price point the savings would be €1,3
million per year.
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Nightingale - Connecting Patients and Carers using wireless technology:
The Common Challenge
Nightingale minimum technical requirements
As mentioned in the PCP Request for Tenders document (section 4.5), there are a few minimum
technical requirements for the Nightingale solution, shown below:
Nightingale system
Final solution must be at least a sophistication level 3 system (Details in common challenge document)
Final solution must be compliant with all applicable law & standards of the participating buyer hospitals
for use in a clinical environment
Final solution must correspond to at least Technology Readiness Level 1 7 at the end of Phase 3
Sensing system
The final sensor(s) must be able to perform continuous monitoring for at least 5 days
The final sensor(s) must measure at least the following parameters:
1. Heart rate
2. respiratory rate
3. temperature
4. motion and 3 axis position
Data Transmission
Data transmission of the final solution must be compliant with the HL7 standard
Data transmission of the final solution must be compliant with the Fast Healthcare Interoperability
Resources (FHIR) standard
All sensors and integrated wireless signal transmission systems must be compliant with all applicable
(National and European) safety regulations
(Wireless) data transmission must be encrypted
Please be aware that proposals for solutions that do not meet these requirement will be excluded.
All solutions that meet these minimum requirements will be evaluated for awarding to Phase 1. This
evaluation will be done by assessing the award criteria as described in the PCP Request for Tenders
document (section 4.6). The main basis for the awarding criteria are the functional specifications as
described in the pages below. These functional specifications in the pages below are not minimum
requirements, but the better a solution meets these specifications, the higher the score per criterion
will be.
1
https://en.wikipedia.org/wiki/Technology_readiness_level
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The Functional specifications for a system to wirelessly connect patients,
carers and the healthcare team
The Nightingale system is used by healthcare workers, patients, and informal caregivers.
In the low care ward the Nightingale system notifies healthcare workers in case of deterioration of
the patient’s condition when deterioration (or increased deterioration risk) is detected from the
monitored patient’s vital signs, patient-entered subjective data and updates in the patient’s medical
record and lab result data.
In the home environment the informal caregiver can also receive a notification if applicable.
Additionally, the Nightingale system provides a means of communication between healthcare
workers, patients, and informal caregivers.
Figure 3. The Nightingale system and its users both in hospital and home application
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The system will consist of five building blocks, creating all together the solution for safe patient
monitoring. Per building block the different functional specs that Nightingale is aiming for are
described. Also the link to the specific award criteria is shown.
Figure 4. Functional components of Nightingale (building blocks)
The Nightingale solution should consist of a few simple sensors (and preferably one), referred to as
the Nightingale sensor, and an Intelligent information analysis information system.
The wireless Nightingale sensor continuously monitors vital signs without interfering with the
patient’s daily activities or mobilization/rehabilitation. The Nightingale system notifies healthcare
workers of the deterioration of patient’s conditions in case deterioration (or increased deterioration
risk) is detected from the monitored patient’s vital signs, patient-entered subjective data, patient
demographic data and updates in the patient’s medical record and lab result data.
10Figure 5. The Nightingale solution consists of a sensor and an intelligent information analysis
information system
Sensing system
(linked to award criteria I1.1 & Q4.1)
● The ideal multi-parameter sensor is small, light-weight and can be worn on an area of the body
without the patient being aware of its presence
● The sensor can be continuously used for uninterrupted vital signs monitoring for at least 5 days
Please note: for practical reasons, we define ‘continuous’ here as: at least one full set of vital signs
measurements every 2 min; In the home setting this update rate may be reduced.
o this requires that it either uses very little battery power for its sensing functions and data
transmission, or:
11o that it can extract its required energy from the patient
● robustness: the sensor can withstand a daily shower. Preferably the sensor can also remain attached
during imaging studies (with MRI studies as a possible unavoidable exception)
● A sensor that can measure oxygen saturation is highly desirable
o the consortium partners are aware of the fairly high energy requirements of the current
generation pulse oximeters
o Intermittent readings of oxygen saturation to preserve battery life (at fixed intervals or triggered
by abnormalities in any continuous parameter) might be acceptable
● A sensor that gives an approximation of the patient’s current global hemodynamic status, in
particular, blood pressure or pulse pressure, is highly desirable. This does not need to be a
conventional arm or finger cuff-based ‘exact’ blood pressure measurement, but must be able to
reliably track changes over time in perfusion pressure.
● A sensor system that appraises the consciousness level of the patient is highly desirable (e.g.
evidence of spontaneous, appropriate movements or responses to verbal or tactile stimuli).
● Other sensors measuring stress, distress, relevant blood parameters (lactate, pH, other) are
potentially very valuable.
● Sustainability of the sensor (for example: is it designed for reuse?)
Current experiences with vital signs monitoring and minimal accuracy levels
The minimal accuracy levels of vital sign measurements are described in table 1, however
emphasizing that accuracy of trend measurements (ability to detect deterioration over time) is far
more important than just an accurate single measurement at one specific point in time. In addition,
experiences with current wireless sensors for vital sign monitoring within patients and the
consequences regarding false positive alarms are further explored in more detail.
The solution should be capable of recognizing vital instability and as such, able to measure vital sign
trends accurately and reliable. In the subsequent table we have tried to set minimal requirements for
measuring different vital signs. In terms of accuracy of vital sign measurements, there are two
aspects which need elaboration first:
1. Ideally, we want to measure every vital sign accurately, but this is not in every situation as important.
Normal rates of for example respiratory rate vary between 10 to 20 breaths per minute. However,
the challenge lies in the abnormal range. Measuring both high (>21/min) and lower respiratory rates
(0-10 breaths per minute) is far more important, as in those regions small measurement deviations
may have implications for treatment (e.g. reversal of opioids in case of bradypnea).
2. Secondly, it is even more important to pick up vital sign trends over time rather than the ability to
accurately measure a single parameter at one point in time only. For example, detecting a decreasing
respiratory rate over time (e.g. a slowly changing RR starting at 10 brpm to 4 brpm) could be an
important indicator of vital instability. Likewise a slowly changing trend pattern of RR measurements
from 18 to 10 brpm which is still within the normal range is important to detect.
Table 1: minimal accuracy levels of vital signs
Parameter Range Minimal accuracy Remarks
1230 - 200 beats ≤5 or 10% bpm, Heart Rate Variability (variation in time interval between
Heart Rate per minute whichever is heartbeats) is a very interesting parameter to measure as
(bpm) greater well
0 - 40 breaths
Respiration
per minute ≤5 brpm See remarks below
Rate
(brpm)
≤ 0.3 between 36.0 Cut-offs for hypothermia, normal, fever, (or hyperyrexia)
Temperature 35 °C - 41 °C
and 39.0 °C could be used as well?
A sensor that can measure oxygen saturation is highly
desirable. We are aware of the fairly high energy
Oxygen requirements of the current generation pulse oximeters.
70 - 100 % ≤ 3%
saturation Intermittent readings to preserve battery life (at fixed
intervals or triggered by abnormalities) might be acceptable.*
See remarks below
A sensor that gives an approximation of the patient’s current
Systolic: 80-220 global hemodynamic status, in particular blood pressure or
Blood mmHg. pulse pressure is highly desirable. This does not need to be a
≤ 15 mmHg
pressure Diastolic: 40- conventional arm or finger cuff-based ‘exact’ blood pressure
100 mmHg measurement, but must be able to reliably track changes
over time in perfusion pressure*
The consortium partners suggest active monitoring of patient
motion. Not only will this greatly facilitate flagging of motion
Activity rate TBD
artefacts, we also believe that motion itself (or lack thereof)
/ motion (gravity/second)
might prove to be an important vital sign that is worthy of
tracking alongside the more traditional vital signs *
Posture >70% accuracy
TBD Lying down, upright, walking (or running).
detection compared to visual
Remarks Respiration rate
• We have experienced that the current medical-grade wireless sensors for continuous respiratory rate
monitoring do not measure respiration rates lower than 4 brpm, either because it is technically too
difficult, or due to other safety issues and/ or liability restrictions. However, we want to be able to
detect life threatening conditions, such as apnea (cessation of respiratory air flow due to a morphine
overdose for example), which is probably preceded by severe bradypnea (RR < 9 brpm). If a sensor
may somehow not be able to measure RR < 4, a slowly changing RR pattern starting at 10 to 4 brpm
for example, could still be identified and used as important indicator of vital instability. In addition,
the activity level of a patient with apnea is probably (almost) zero. See also aspect nr 2 as mentioned
above.
• It is technically more difficult to accurately measure respiration continuously, especially during
spontaneous breathing in patients who are moving and talking. However, movement detection by an
accelerometer not only provides additional information about the patient’s activity level, but can
also distinguish between physiological abnormalities and movement artefacts. An elevated heart rate
while a patient is very active will be interpreted differently compared to a rapidly increasing heart
rate while the activity level is almost zero. Also, artifacts casued by active moving patients may imply
13that the patient is alive and breathing, which makes the chance of an apnea very unlikely. Using all
this information ‘smart’ could be helpful to reduce the number of false alarms.
Remarks oxygen saturation
• We have experienced that measuring continuously measuring saturation levels with a wired pulse
oximeter doesn’t always detect the level of saturation accurately when patients are moving their
fingers intensively. Distinguishing these technical artefacts from actual (accurate) saturations levels
during rest may be helpful to reduce the number of false alarms.
Data transmission protocol and interference rejection
(linked to award criteria I1.2 & Q4.2)
● the consortium expects safe and reliable data transmission with a minimum of dropouts, but does
not wish to prescribe any specific protocols for data transmission
o the transmission protocol can therefore be either an industry standard (e.g., WiFi, Bluetooth LE, etc.)
or a proprietary protocol
o however, ‘open standards’ are highly desirable from an interoperability perspective
o any sensor and integrated wireless signal transmission system must be compliant with all applicable
safety regulations, both regarding patient harm (electrical safety, EM radiation) and potentially
unsafe RF interference causing malfunction of other medical devices
● Data transmission needs to be compliant with HL7/Fast Healthcare
Interoperability Resources (FHIR) international standards for transfer of clinical data
(https://www.hl7.org/fhir/summary.html).
● The sensor (whether or not via a relay device) is able to cover an entire home; e.g., the sensor worn
by the patient can transmit from any room in the patient’s home without the necessity to be in close
vicinity of a relay device.
● Wireless data security requires the use of robust encryption, in particular while wireless vital signs
data are in transit
● patient acceptance of the system will be highly dependent on the convenience of using the entire
system.
o for example: a system using a number of fixed ‘wired’ receivers (bridges) in many rooms to connect
the patient to the health care worker over the network will have dead zones in some areas of the
hospital.
o using such a system for home monitoring means that the patient effectively has ‘house arrest’.
● when there are two wireless transmission protocols active at the same time to sequentially and
wirelessly relay the vital signs data streams (first from sensor to mobile device and then from mobile
device to a hospital server), this might theoretically increase the likelihood of data loss caused by
electromagnetic interference or other network issues.
Artefact rejection system
(linked to award criteria I1.3 & Q4.3)
● a high quality artefact rejection system is necessary to prevent false alarms, ‘alarm fatigue’ in
caregivers (from the need to check the patient repeatedly on spurious readings) and unnecessary
anxiety in patients
● many artefacts in vital signs monitoring are caused by motion artefact. In contrast to anaesthetised
patients and patients on intensive care units, most patients in the targeted groups are mobile and
14may be actively exercising several times a day.
● The consortium partners suggest active monitoring of patient motion. Not only will this greatly
facilitate flagging of motion artefacts, we also believe that in the future motion itself (or lack thereof)
might prove to be an important vital sign that is worthy of tracking alongside the more traditional
vital signs
Analysis system
(linked to award criteria I1.4 & Q4.4)
A sophisticated analysis and alarm generation system is paramount. Unlike operating rooms and
intensive care units where ‘one on one’ nursing is the rule, on general hospital wards many patients
will be simultaneously monitored. In case of abnormal signals, the nurse can immediately check the
patient to see if there is any real deterioration of vital status or that the alarm was caused by
technical problems with the sensor or data transmission. In contrast, when telemonitoring is applied
in the home care situation there is no easy way to perform such ‘cross-checks’ for sensor
dislodgment, strange movements, etc.
Therefore we request that the solution design contains:
• intelligent analysis of the incoming vital signs data streams
• analysis of trends and rates of change
• pattern analysis in multiple simultaneous data streams
• generation of probabilistic alarms
The consortium partners realize that this might require the use of machine learning and artificial
intelligence. There are several possible levels of sophistication with clinical decision support based
on such intelligent alarms (see below).
Usability
(linked to award criteria I1.5 & Q4.5)
The usability of Nightingale will be assessed based on the following functional specifications:
• The sensor is small, extremely lightweight, easy to clean/disinfect (waterproof).
• The sensor device can be worn on an area of the body without the patient being aware of its
presence.
• The sensor is externally placed, not damaging/pulling the skin and biocompatible.
• The sensor cannot interfere the patient while sleeping.
• The sensor will stay correctly in place in case of sweating.
• The sensor ideally can withstand a daily shower. Preferably the sensor can also remain
attached during imaging studies (with MRI studies as a possible unavoidable exception)
• The sensor must have characteristics such that the application of the sensor (properly
connecting it to the body of the patient) and its operation is learnable by medical
professionals (hospital situation) and is learnable by an instructed patient or instructed
informal caregiver home situation).
• The system must indicate to the user whether the sensor is properly applied.
• The sensor must identifiably be part of the Nightingale system and clearly distinguishable
15from other non-Nightingale devices, sensors or instruments applied to the patient.
• The sensor must comply to all applicable safety standards.
• The user interface shall be easy to use, intuitive and human-centered.
• The system has the option to display ‘actionable’ recommendations.
• The system can signal and deliver the notification to the user by different modalities (eg.
visually, aurally, by vibration) of its user’s choice.
Note that solution designers should carefully balance security and usability. The system must be
usable for patients with limited e-health literacy (for example, frail elderly still living independently at
home). Demanding password protection means that some device in the system needs a (virtual)
keyboard to enter passwords. However entering passwords on a disposable sensor will not make
sense. Password or biometric security should not be a problem for caregiver notification devices.
Value Sensitive Design
The use of the Nightingale solution is influenced by the needs and competencies of the (end-) users.
Lack of understanding of human factors is key to failure of innovation.
Stakeholders such as patients, informal carers, nurses and physicians have a direct relation with the
solution, but also indirect stakeholders as industry, engineers, and insurers are related to the
solution. By identifying these stakeholders we are able to translate values into benefits and risks
during the design process. The insights of the various stakeholders will support different design
choices in different phases of development.
As a methodological feature, Nightingale will involve (end-)users in the design process by using a
‘value sensitive design’ (VSD) approach. The approach involves investigation of patient values and
concerns, as well as those of caregivers and informal carers throughout the development. We will
elicit these values and concerns via focus group sessions with patients, informal carers and health
care workers. Patients who have participated in the validation studies will be explicitly asked for their
attitudes, values, concerns and experiences with the test system. The following (main) values are
distinguished and are key for the system development and the solution. During the different phase
we will test how the solution meets the requirements ao with help of the values as mentioned below
:
• Health
• Trust
• Accessibility
• Reliability
• Autonomy
See Appendix C for a detailed description of the Nightingale values per stakeholder, comparing
benefits and risks per subcategory.
16Nightingale - Connecting Patients and Carers using wireless technology:
The Common Challenge
Levels of sophistication with clinical decision support based on intelligent
alarms
Different levels of sophistication can be distinguished. Starting with the early warning systems as we
have today ending with a level based on artificial intelligence that is self-learning and self-optimizing.
Nightingale is aiming for the best solution possible, with at least level 3.
Figure 5. Levels of sophistication
17Level 0: Threshold alarm
No artificial intelligence, simple threshold alarms only
(the user must set the lower limit and the upper limit for each measured variable).
For example: IF (heart rate > 100/min OR heart rate < 40/min).
A slightly more sophisticated alternative simple alarm scenario: < ‘orange’ alarm> IF (heart rate >
90/min OR heart rate < 50/min); IF (heart rate > 110/min OR heart rate < 40/min). Or a
‘no data’ alert, when the patient moves to far from a relay device.
Such systems may also attempt to avoid triggering of false alarms by applying median filtering (or
some other method of averaging the signal over longer periods of time) to remove brief movement-
induced artefact transients or by simply delaying the alarm for a predefined time period, as currently
used in some monitor systems.
Level 1: Automated early warning score
As described above for ‘level 0’, but with simple integration of multiple data sources: for example an
‘automated early warning score’. Early warning scores (EWS) are simple sum scores calculated by
adding points for each vital sign that is ‘out of range’. For example: the National EWS (NEWS, United
Kingdom)
18Figure 3 Example of physiological parameters
Level 2: Deterioration alarm
An advanced system to track vital signs that does not only track changes in single parameters, but
also considers the relationship between changes in various vital signs. For example, a combination of
progressive tachycardia (high heart rate, increasing over time), progressive tachypnea (high
respiratory rate, increasing over time) combined with fever, suggests early sepsis which may
necessitate measurement of blood lactate and intensive care expert consultation. Alternatively: a
pattern of reduced motion, decreasing respiratory rate followed by progressive hypoxemia (low
blood oxygen saturation) in a patient who recently had surgery and is receiving opioid pain
medication suggests the possibility of opioid overdose. The latter constellation requires the nurse to
check on the patient immediately and discuss the need for an opioid antagonist such a naloxone with
the attending doctor.
19Level 3: Clinical Decision Support system – minimum requirement for the Nightingale
solution!
A clinical decision support system that incorporates more than only the intelligent analysis of vital
signs data. Such a system may also take existing or new abnormal laboratory results into account,
e.g., a new observation of hyperkalaemia (high blood potassium level), or an increase in blood
creatinine (an indicator of acute kidney injury) that becomes available in the laboratory tab of the
EMR). A level 3 system may also take environmental information and important diagnostic
information into account, including structured nursing observations such as restlessness,
sleepiness/sedation, dyspnea, sweating, etc. In the home setting, such information can be entered
directly by the patient or informal carer.
Level 4: fully-integrated hospital-wide clinical decision support system
A fully-integrated hospital-wide clinical decision support system that monitors the patient’s status in
real-time and constantly updates the risk of death and severe complications each time a new data
element becomes available. It may be even optimized to detect several specific rare but lethal
conditions. For example, a life-threatening disturbance of ventricular rhythm (‘torsade des pointes’
caused by ‘long QT-syndrome’ – please see use case ‘Henrik’) as a result of inadvertent drug-drug
interactions. Such a highly sophisticated system takes as its inputs clinical data (current diagnoses,
recent procedures, prior history, structured nurse observations (including a sense of ‘worry’
regarding the condition of the patient), doctors observations and clinical notes, data entered by the
patient or informal carer, on-line continuous vital signs data, laboratory data, new imaging results,
and updates its predictions every time a new data element reaches the system.
20Level 5: Self-learning system
an artificial intelligence integrated self-optimising system. The most obvious application of artificial
intelligence in healthcare is data management. Nightingale is collecting many data, storing it,
normalizing it, tracing its lineage – it is the first step in revolutionizing the existing healthcare system.
With artificial integrated in Nightingale it should be possible to optimise the dedicated patient
specific decision support.
The consortium partners require a solution with at least ‘level 3’ sophistication.
In appendix B of this common challenge an overview of the levels of sophistication can be found.
21Nightingale - Connecting Patients and Carers using wireless technology:
The Common Challenge
A brief introduction to Pre-commercial Procurement (PCP)
Several years ago the European Commission designed a new scheme / demand-side instrument
called ‘Pre-Commercial Procurement’ that enables the public sector to stimulate European
Innovation by engaging with innovative businesses and other interested parties to deliver cutting-
edge, innovative solutions , , in situations where there is currently no existing solution in the market.
The European Commission funded Nightingale project is an implementation of Pre-Commercial
Procurement (PCP). Rather than directly subsidizing European industry, the prospective users of the
new technology assist in guiding the development process using a ‘funnel-shaped’ procurement
model, which entails the use of competitive development in phases (as several technology vendors
will be selected to enter the first phase of the PCP), risk-benefit sharing under market conditions, and
a clear separation between the procurement of R&D services and the potential public procurements
of innovative solutions focusing on deployment of commercial volumes of end-products (Public
Procurement of Innovative Solutions - PPI). This innovative process presents an opportunity for
suppliers to develop new solutions and to introduce new, beyond state-of-the-art technologies and
products, in direct cooperation with the healthcare institutes and their employees. The PCP process
is exempted from the EU procurement directives, is flexible and allows an early dialogue between
potential suppliers and the healthcare institutes in order to optimize the solution. The
aforementioned exclusion from the application of the European public procurement framework is
also justified by the fact that the procurer does not reserve all the benefits of the R&D exclusively for
himself. Accordingly, Intellectual Property Rights (IPR) of the developed solution will be shared
between the Nightingale procurers and the supplier in the sense that each R&D provider
participating in the PCP retains the ownership of the IPRs it generates in the PCP, provided the
Nightingale procurers receive a ‘free use’ license in return, as well as a right to license or to request
the R&D provider to license the IPR to third parties on non-exclusive, fair and reasonable market-
based terms and conditions. The development work will be co-financed by Nightingale project
funding, within the Horizon 2020 programme of the European Union.
The PCP process will start with an extensive preparation phase (‘Phase zero’; below leftmost panel)
and is followed by three development phases, as visualized below:
22*This is an example of the PCP process. In Nightingale PCP, we will select a minimum of 8 suppliers for phase 1,
4 suppliers for phase 2, and 2 suppliers for phase 3.
Phase 0 - The preparation of the Nightingale PCP started with the publication of a Public Information
Notice (PIN) and then entered an Open Market Consultation, which consisted of the following
sequential components: I) Market Sounding, II) Market Sounding Review, and III) Market
Consultation. In the Market Sounding, through different channels, the Nightingale procurers widely
announced the project and raised the interest of possible developers/suppliers. All interested
companies in the EU have been invited to fill in an online questionnaire that is aimed to help the
procurers gain more insight into the market and the scope.
In the Market Sounding Review, a summary/conclusion of the questionnaires has been made.
In the Market Consultation, the Nightingale procurers invited all those interested companies for a
face to face workshop & dialogue, with the aim of further explain the Nightingale and obtain more
insight in the feasibility and technical developments & possibilities. Partly based on the results of this
Market Consultation, the Nightingale procurers further fine-tuned the scope and criteria that are
used in the PCP. The Market Consultation is followed by this formal PCP Call for Tender. Interested
companies (or consortia) are invited to submit their proposals on paper. These submitted proposals
will be further evaluated according to the criteria and the selection guidelines described in the PCP
Call for Tender. The Nightingale procurers aim to select the eight companies with the most promising
proposals which will be invited to participate in the first phase Nightingale PCP process (Phase 1). A
framework agreement and a Phase 1 contract between the Nightingale consortium and every
individual company will be signed.
The Nightingale PCP process will include three phases of solution development.
In Phase 1, which will last 3 months, the selected companies (min. of 8) will each develop their
proposal, including feasibility studies. The Nightingale consortium partners will evaluate the tenders
with respect to their technical, economical and organizational viability. Four companies will be
invited to proceed to the second phase, in which actual prototype systems will be developed and
tested.
23In Phase 2, two interim evaluations are foreseen to assist in continuously improving the prototypes
under development. After critical evaluation of these early prototypes at the end of the second
phase, two companies will be invited to develop and test a pre-production model within the
hospitals during the last, third phase of the PCP process.
Phase 3: in this phase the prototype system will be refined to a pre-production model. Three interim
evaluations and feedback sessions are foreseen, based on field tests with actual patients and care
givers using the system.
During the entire PCP process, selection of companies/consortia to enter the next phase will be
based on transparent and objective evaluation criteria. After this phased process, the PCP process
ends.
Public Procurement of Innovation (PPI)
In order to help the companies with such new highly innovative technology to overcome market
inertia, the European Commission also facilitates the uptake of innovative solutions by the intended
end-users. The EU can subsidize the purchase of large quantities of the new devices or solutions
using the Public Procurement of Innovation (PPI) model. The Nightingale Consortium intends to
conduct a PPI after the completion of the PCP if the PCP is successful (i.e., at least one ‘market-ready’
solution has been generated).
For more information about PCP, please visit the EU website by clicking on the links below:
https://ec.europa.eu/digital-single-market/en/innovation-procurement
See also:
https://ec.europa.eu/digital-single-market/en/news/frequently-asked-questions-about-pcp-and-ppi
24References
1. Churpek MM, et al. Multicenter Comparison of Machine Learning Methods and Conventional
Regression for Predicting Clinical Deterioration on the Wards. Crit Care Med. 2016 ;44(2):368-74.
doi: 10.1097/CCM.0000000000001571.
2. Singer M, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
JAMA. 2016;315(8):801-10. doi: 10.1001/jama.2016.0287.
3. York Health Economics Consortium. The Cost of Sepsis Care in the UK. 17 February 2017 (downloaded
from http://sepsistrust.org/wp-content/uploads/2017/02/YHEC-Sepsis-Report-17.02.17-FINAL.pdf).
25Appendix A Nightingale Patient journeys
Four patient journeys will be shown in this appendix. At this moment the Steering Committee is working on the final versions:
1. Just one loose stitch – at home situation
2. When a patient stops breathing – hospital situation
3. If everything starts failing – hospital situation
4. Deterioration can go slow – at home situation
5. It is all in the detail - hospital situation
2627
28
29
30
31
Appendix B Overview levels of sophistication
32Appendix C Value Sensitive Design – Stakeholder values
Table 1: Values and their interpretations for the Nightingale solution IN-HOSPITAL
Value Subcategory Benefit Risk Stakeholder
(direct/indirect)
Health Patient safety Timely detection of patient Harm caused by the system: too many false Patient
deterioration on the ward positives (alarm fatigue) Nurse
Technical failure (sensing, transmission) Physician
Adverse reaction to (sensor) solution Industry/engineer
(indirect)
Optimal care Personalized care New knowledge may generate questions Nurse
Additional information about the that cannot be answered Physician
patient’s condition and vital signs Problems with availability of healthcare Patient
professionals to respond to alarms
Health Related Survival & freedom from disability as Potential burden of (sensor) solution Patient
Quality of Life much as possible Earlier hospital discharge to own home does Informal carer
Reduced risk to suffer from avoidable not fit the patient’s needs and expectations
consequences of a severe
complication
Earlier hospital discharge to own
home (or low-care facility)
Trust Reassurance Assurance of response of caregivers in Skipping patient rounds, longer periods Patient
case of patient deterioration without direct nurse-patient contact Informal carer
Management may be tempted to reduce Nurse
nurse staffing
33Technical failure (sensing, transmission)
Confidence Healthcare professional is confident to Skipping patient rounds Nurse
be able to monitor all patients New knowledge on trend information
Availability of appropriate patient (rather than single measurements) may
(trend) information impede decision making by healthcare
professional
Quality of Life Sense of trust and relaxation Potential burden for informal carer at home Patient
Earlier hospital discharge does not fit Informal carer
patients’ needs and expectations
Accessibility Usability Ease of use Technical failure (sensing, transmission) Nurse
(Technical) support Problems with availability of trained Physician
Personalised care healthcare professionals to respond to Patient
alarms
Availability Easy access to data of patient’s Costs of solution Patient
condition Acceptance of insurance Nurse
Not all patients will be equipped with Insurer (indirect)
solution: risk of ‘missed patients’ Industry (indirect)
Reliability Accuracy Accurate vital sign measurements Unacceptable number of false positive Physician
(scientific validity) alarms Nurse
Ability to detect ‘trend’ changes Alarm fatigue Industry/engineer
Low number of false positives/false Interpretation of vital sign ‘trends’ remains (indirect)
negatives difficult
Technical Sustainability Inadequate technical support Industry/engineer
functioning Continuous, real time information Interference with other systems (indirect)
34Remote control Nurse
Physician
Autonomy Privacy More privacy in case of earlier Inadequate security: Patient identity Industry/engineer
discharge from hospital to home information (with patient data) is being used (indirect)
elsewhere Patient
Inadequate security/legal framework:
patient data is being used for other
(commercial) purposes
Responsibility More patient information to ensure Potential burden of responsibility to Nurse
more optimal conditions for healthcare professional Physician
responsible care Unclear ‘overriding authority’ leads to safety
issues
Problems with availability of trained
healthcare professionals to respond to
alarms
35Table 2: Values and their interpretations for the Nightingale solution in the HOME situation
Value Subcategory Benefit Risk Stakeholder
(direct/indirect)
Health Patient safety Timely detection of patient Alarm fatigue: having to react on a multitude Patient
deterioration at home of false positive alarms at home will make Nurse
the system unfeasible to use and Physician
unacceptable to users Industry/engineer
Unrecognized deterioration: solely (indirect)
interpreting vital signs without actively
taking into account the patient’s or informal
carer’s subjective complaints, appearance,
etc.
Technical failure (sensing, transmission)
Adverse reaction to (sensor) solution
Optimal care Providing timely & tailored treatment New knowledge may generate questions Nurse
New information about patient’s that cannot be answered Physician
condition and vital signs at home Problems with availability of healthcare
Patients who need to be readmitted professionals to timely respond to alarms
to the hospital are in a less serious remotely
state (due to early recognition of
patient deterioration)
Health related Survival & freedom from disability as Potential burden of (sensor) solution when Patient
Quality of Life much as possible no caregiver is around directly Informal carer
Reduced risk to suffer from Potential burden to informal carer to feel
consequences of a severe the need to check their relative’s condition
complication Responsibility of home caregiver to respond
36Trust Reassurance Pleasant feeling that someone is Not able to communicate with healthcare Patient
looking over their shoulder to check professional due to failure or unavailability Informal carer
their condition of healthcare professional Nurse
Pleasant feeling to be able to
communicate with the healthcare
professional if the patient feels
worried
Assurance of response of caregivers in
case of patient deterioration at home
Confidence Healthcare professional is equipped Skipping patient check-ups (remotely) Nurse
with appropriate patient (trend) Skipping communication with patient Physician
information New knowledge on trend information
Healthcare professional is confident to (rather than single measurements) may
be able to monitor patients, even impede decision making by healthcare
when they’re at home professional
Quality of Life Sense of trust and relaxation Technical failure (sensing, transmission) Patient
Potential burden for informal carer at home Informal carer
Accessibility Usability Ease of use Technical failure (sensing, transmission) Nurse
Personalized care Patients with low health literacy cannot cope Physician
(Technical) support with solution at home Patient
Allows bi-directional communication Problems with availability of trained
healthcare professionals to respond to
alarms remotely
Bi-directional communication forces
structural availability of healthcare
professional
Availability Easy access to data of patient’s Costs of solution Patient
37condition Acceptance of insurance Nurse
Not all patients will be equipped with Insurer (indirect)
solution: risk of ‘missed patients’ Industry (indirect)
Not all patients that may benefit from home
monitoring will be happy to participate
Reliability Accuracy Accurate vital sign measurements High number of false positive alarms Physician
(scientific validity) Alarm fatigue Nurse
Ability to detect ‘trend’ changes Interpretation of vital sign ‘trends’ remains Industry/engineer
Low number of false positives/false difficult (indirect)
negatives
Technical Sustainability Unseen patient deterioration due to absence Industry/engineer
functioning Continuous, real time information of technical support remotely (indirect)
Remote control Interference with other systems at home Nurse, Physician
Autonomy Privacy Patient surveillance Restriction of freedom, feeling that someone Industry/engineer
is keeping an eye on you continuously (indirect)
Transmitted patient identity information Patient
(with patient data) is being used elsewhere
Patient data is being used for other
(commercial) purposes
Self- More patient empowerment Difficult to estimate self-management skills Patient
management Self-management skills increase of a patient remotely and to rely on this Informal carer
Patient or informal carer will ‘judge’ their Nurse
feeling on measurements they follow
Responsibility More patient information ensure Unclear ‘overriding authority’ leads to Nurse
more optimal conditions for patient safety issues Physician
responsible care Potential burden of responsibility
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