REmote MOniToring usE in Suspected Cases of COVID-19 (Coronavirus): REMOTE-COVID Trial
Conditions: Coronavirus
Sponsor: Imperial College London

1 
March 16th 2020 
Design of the pilot, proof of concept REMOTE-COVID trial: 
1 
REmote MOniToring usE in suspected cases of COVID-19 
2 
(SARS-CoV 2)  
3 
A trial protocol 
4 
 
5 
Fahad Mujtaba Iqbal1*, Meera Joshi1, Gary Davies2, Sadia Khan2, Hutan Ashrafian1, Ara Darzi1 
6 
1) Division of Surgery & Cancer, 10th Floor Queen Elizabeth the Queen Mother Wing (QEQM) St 
7 
Mary’s Campus, London, W2 1NY 
8 
2) West Middlesex University Hospital, Twickenham Road, Isleworth, TW7 6AF 
9 
 
10 
 
11 
Clinical trials registration information: ClinicalTrials.gov Identifier: NCT04337489 
12 
 
13 
16 March 2020 
14 
 
 
15 

2 
March 16th 2020 
Abstract: 
16 
Background: The outbreak of SARS-CoV-2 (coronavirus, COVID-19), declared a pandemic by the 
17 
World Health Organisation (WHO) is global health problem with ever-increasing attributed deaths. 
18 
Vital sign trends are routinely used to monitor patients with changes in these parameters often 
19 
preceding an adverse event.  Wearable sensors can measure vital signs continuously (e.g. heart rate, 
20 
respiratory rate, temperature) remotely and can be utilised to recognise early clinical deterioration.   
21 
Methods: We describe the protocol for a pilot, proof-of-concept, observational study to be 
22 
conducted in an engineered hotel near London airports, United Kingdom.  The study is set to 
23 
continue for the duration of the pandemic.  Individuals arriving to London with mild symptoms 
24 
suggestive of COVID-19 or returning from high risk areas requiring quarantine, as recommended by 
25 
Public Health England, or healthcare professionals with symptoms suggestive of COVID-19 unable to 
26 
isolate at home will be eligible for a wearable patch to be applied for the duration of their stay.  
27 
Notifications will be generated should deterioration be detected through the sensor and displayed 
28 
on a central monitoring hub viewed by nursing staff, allowing for trend deterioration to be noted.  
29 
The primary objective is to determine the feasibility of remote monitoring systems in detecting 
30 
clinical deterioration for quarantined individuals in a hotel.   
31 
Discussion: This trial should prove the feasibility of a rapidly implemented model of healthcare 
32 
delivery through remote monitoring during a global pandemic at a hotel, acting as an extension to a 
33 
healthcare trust.  Potential benefits would include reducing infection risk of COVID-19 to healthcare 
34 
staff, with earlier recognition of clinical deterioration through ambulatory, continuous, remote 
35 
monitoring using a discrete wearable sensor.  We hope our results can power future, robust future 
36 
randomised trials. 
37 
Trial registration: ClinicalTrials.gov Identifier: NCT04337489 
38 
Keywords: remote sensing technology; protocol; clinical trial; patient deterioration; monitoring, 
39 
ambulatory. 
 
40 

3 
March 16th 2020 
Background: 
41 
The recent outbreak of SARS-CoV-2 (COVID-19), declared a pandemic by the World Health 
42 
Organisation (WHO) and a growing global health problem, has stretched resources, creating 
43 
pressures within the National Health Service (NHS) with implications for patient safety.1  UK Chief 
44 
Medical Officers have raised the risk to the UK to high, with ever increasing confirmed cases and 
45 
attributed deaths.1   
46 
High risk travellers with suspected or confirmed cases of COVID-19 are likely to transferred 
47 
immediately to hospital.  However, travellers with milder symptoms or returning from high risk 
48 
areas, a two-week period of observation/quarantine may be required, in accordance with Public 
49 
Health England recommendations.2  The rate of clinical deterioration for individuals suffering with 
50 
COVID-19 remains unknown; given that widespread vaccine deployment remains imminently 
51 
unforeseeable, novel strategies are required in approaching this pandemic. 
52 
Vital signs trends (heart rate, respiratory rate, blood pressure, temperature, oxygen saturations) are 
53 
routinely used for monitoring hospital patients.3  Clinical deterioration may be recognised through 
54 
changes in these parameters, and often precedes an adverse event.4,5  As such, The National 
55 
Institute for Health and Care Excellence (NICE) and the Royal College of Physicians (RCP) recommend 
56 
that all patients have their vital signs recorded every 12h as a minimum.6,7   
57 
Across the National Health Service (NHS), the use of the National Early Warning Score 2 (NEWS), a 
58 
‘track and trigger’ warning score, has been implemented in accordance with the RCP to guide on 
59 
escalation protocols and monitoring frequency of vital signs.7  Accordingly, heart rate (HR), 
60 
respiratory rate (RR), temperature, blood pressure, oxygen saturations, and level of consciousness 
61 
are assessed every 4-6 hours with more frequent monitoring for acutely unwell patients.  
62 
Progression in non-invasive digital technologies have renewed potential for remote monitoring 
63 
solutions.8,9  Wearable sensors offer an opportunity for sensor alerting systems to continuously 
64 
monitor vital parameters remotely, recognise early deterioration and support clinical decision 
65 

4 
March 16th 2020 
making, allowing people to receive monitoring outside of expensive hospital facilities; in resource 
66 
limited hospitals; and utilising alternate sites in crisis scenarios.10  
67 
Previous studies have demonstrated acceptability and practicability of continuous monitoring using 
68 
wearable sensors on general surgical and medical wards in the UK and The Netherlands.11,12  Initial 
69 
work by Downey et al. were limited by imbalanced randomisation leading to significant baseline 
70 
differences across the two trial arms and failure to adjust for these in their analyses.11  Nevertheless, 
71 
the wearable sensor seemed to demonstrate feasibility in hospital settings.  Qualitative analyses, 
72 
through semi-structured interviews for patients and healthcare staff, similarly favoured continuous 
73 
the notion of continuous vital sign monitoring in general wards.12  It should be noted that many of 
74 
the patients interviewed were admitted for malignant disease which is likely to influence qualitative 
75 
outcomes.  Delivery of healthcare outside of hospital facilities (e.g. in hotels) is theoretically possible 
76 
through continuous remote monitoring of vital signs but has yet to be studied; given the global 
77 
pandemic and fear of future waves, evaluation of its viability is justified.  
78 
Here, we describe the design of our pragmatic trial, exploring the feasibility of remote monitoring 
79 
systems in suspected cases of COVID-19 at a hotel, primarily as earlier recognition of clinical 
80 
deterioration. 
81 
Methods: 
82 
Overall design: 
83 
This pragmatically designed, pilot, proof-of-concept, observational study was reviewed and 
84 
approved by London – Queen Square Research Ethics Committee (IRAS: 281757) and this protocol 
85 
was developed in accordance with recommendations from the Standard Protocol Items: 
86 
Recommendations for Interventional Trials (SPIRIT) guidelines.13  The objective is to determine the 
87 
feasibility of remote healthcare delivery in a hotel with rapid implementation in the COVID-19 era.  
88 
Feasibility will be tested through rate of participation and number of vital alerts generated.   
89 

5 
March 16th 2020 
The SensiumVitals™ (Sensium Healthcare Ltd., United Kingdom) system can be engineered in the 
90 
building (hotel) for use with the wearable sensor.  All participants would be fitted with the sensor on 
91 
arrival and would always be worn.  A designated area within the facility would act as a central hub 
92 
allowing for remote monitoring to occur by healthcare staff.  Alerts would be generated, in 
93 
accordance with NEWS parameters (Table 1) but can be individually tailored, to identify 
94 
deteriorating participants.  Participants can be escalated to hospitals should rapid deteriorating in 
95 
vital signs be noted; ambulance services and paramedics will be present on site to facilitate this.  The 
96 
decision to escalate will come from a senior nurse, present on site, or a general practitioner 
97 
contactable at all times..  The temperature alert threshold was lowered to the lowest score in the 
98 
NEWS chart, allowing for earlier detection and improved sensitivity14; this decision was made from 
99 
previous work which demonstrated varying limits of agreement for temperature when compared to 
100 
nursing observations.15  Escalation protocols will be developed and trialled, allowing staff to address 
101 
issues as they arise (Figure 1).  
102 
Wearable sensor system 
103 
SensiumVitals™ by the Surgical Company, have produced a lightweight, waterproof, single-use, 
104 
wearable wireless ‘patch’ with a battery life of 5 days measuring vital signs every two minutes.  The 
105 
sensor attaches to an individual’s chest with two ECG electrodes, recording HR, RR, and a wire 
106 
attaches around the individual’s back, measuring axillary temperature.  The sensor is FDA approved 
107 
and CE marked.  Data are transmitted through radiofrequency and dedicated intranet hotspots.  
108 
Physiological parameters can be viewed by clinical staff on a mobile device/desktop computer, 
109 
allowing trends towards deterioration to be noted, with tailored alerts generated for deteriorating 
110 
individuals in accordance with NEWS (Figure 2).   
111 
All sensor data collected by the SensiumVitals® system will be stored on a created secured hotel 
112 
network; access to which is restricted to research personnel.  Given that the hotel acts as an 
113 

6 
March 16th 2020 
extension to a healthcare trust, the SensiumVitals® system inherits all the hospital procedures and 
114 
data backup policies, ensuring data access and servers are secured. 
115 
In line with the principles of Good Clinical Practice guidelines, data will be securely archived for a 
116 
minimum of 5 years. 
117 
Following the completion of quarantine, participants will be invited to share their experiences 
118 
through using semi-structured interviews and questionnaires.  Individual interviews allow for 
119 
anonymity and truthful perceptions/attitudes.  This method enables narratives to be elicited through 
120 
guided but open questioning. 
121 
Hypotheses: 
122 
1) 
Continuous remote monitoring with wearable sensors of vital signs will identify 
123 
deteriorating patients. 
124 
2) 
Healthcare provision in a hotel will be feasible and acceptable amongst healthcare staff 
125 
and participants. 
126 
Sequence of events: 
127 
Patching patients and using data for academic research 
128 
1. Eligible participants from the airport will be transferred to the hotel by paramedics.  
129 
2. Upon arrival to the engineered hotel, an initial assessment of all participants will be 
130 
undertaken.  A study information sheet will be provided, and informed consent taken for 
131 
wearable sensors to be applied, allowing remote monitoring of vital signs.  To ensure 
132 
appropriate quarantine. 
133 
3. In a designated area within the building, a central monitoring hub will be set up to monitor 
134 
the recorded parameters by National Health Service (NHS) healthcare staff from a local 
135 
Trust. The hub contains a site manager, porters, security staff, nurses, ambulance services, 
136 
professional cleaners, and hotel staff.   
137 

7 
March 16th 2020 
4. If a participant deteriorates, an alert should be generated on a smartphone device/desktop 
138 
computer; following this, an escalation protocol will be trialled to action the alert in an 
139 
appropriate manner; hospitalisation may be necessary.  Initially, nursing staff will gather 
140 
more information through telephone review.  Following this, a virtual GP can be contacted 
141 
for further advice.  Ambulance services and paramedics will be on-site to facilitate 
142 
hospitalisation should rapid deterioration occur.  These healthcare professionals are 
143 
independent and can provide oversight.  
144 
5. Participants will be invited for an interview and be asked to complete a survey on their 
145 
experiences following quarantine completion. 
146 
6. Participant care records will be stored on an online Care Information Exchange system 
147 
(compliant with General Data Protection Regulation) that is currently in place across the 
148 
trust.  Electronic health records and patient notes will be reviewed to determine clinically 
149 
relevant events if transfer to hospital occurs (e.g. hospital length of stay, mortality, 
150 
escalation to ITU). 
151 
7. Sensor data will be extracted from the central servers containing sensor data for appropriate 
152 
statistical analyses for associated clinical efficacy of health outcomes in COVID-19.  
153 
 
154 
Semi-structured interviews/Questionnaires (mixed methods) 
155 
1. All participants alongside healthcare staff will be invited to take part in semi-structured 
156 
interviews and be given questionnaires.  These will take place by the primary lead researcher 
157 
using prepared topic guides. 
158 
2. Written consent will be obtained from those who agree to participate.   
159 
3. An audio recording will be made of the interviews.  Notes reflecting verbal responses may be 
160 
taken.  The interviews will be conducted at the engineered hotel. 
161 
4. The recordings will be transcribed, and the data will undergo thematic analyses. 
162 

8 
March 16th 2020 
5. Validated and unvalidated questionnaires will also be given enquiring about experiences 
163 
(e.g. PHQ-916, GAD-717, satisfaction, anxiety related to the devices).   
164 
 
165 
Outcomes and progression criteria: 
166 
Feasibility outcomes: 
167 
1. Rate of participation 
168 
Using the confidence interval approach18, for a minimum sample size of 10 individuals, we 
169 
estimate a rate of participation of 90% with a 95% confidence interval of +/- 18%.   
170 
2. Generation of an alert following abnormal vital signs (e.g. raised temperature). 
171 
We aim for a minimum of 5 vital alerts to be generated to demonstrate feasibility.   
172 
3. Missing data recorded from sensor limited to less than 20% attrition will be a criterion for 
173 
progression. 
174 
4. Number of adverse events relating to the sensor system (e.g., skin reaction to sensor 
175 
preventing trial continuation) 
176 
 
177 
Exploratory clinical outcomes: 
178 
1. Actions following alert generation (e.g., phone consultation, virtual general practitioner 
179 
review, transfer to hospital). 
180 
2. Acceptability and usability of the SensiumVitals™ system by healthcare staff and participants 
181 
(mixed methods analysis)  
182 
 
183 
Participant eligibility: 
184 
The study will recruit flight arrivals returning to the UK in London.  High risk travellers are screened 
185 
at the airport and tested for COVID-19, with transfer to hospital if appropriate; this cohort would be 
186 
ineligible for the study.   
187 
Additionally, healthcare professionals who display symptoms of COVID-19 and are unable to isolate 
188 
safely at home (e.g. lodging with vulnerable persons) would be eligible to take part in the study and 
189 
invited to stay at the hotel. 
190 
Inclusion Criteria 
191 
• 
Aged 18 years or over. 
192 

9 
March 16th 2020 
• 
Able to provide written consent. 
193 
• 
Travellers returning with milder symptoms suggestive of COVID-19 or returning from high 
194 
risk areas requiring quarantine, as recommended by Public Health England. 
195 
• 
Healthcare professionals with milder symptoms suggestive of COVID-19 unable to isolate at 
196 
home. 
197 
Exclusion Criteria 
198 
• 
Any participants that withdraw their consent. 
199 
• 
A skin condition/reaction preventing wearing the wearable sensor (these can be 
200 
communicated by the participant to the researcher or healthcare staff at the hotel). 
201 
• 
The presence of a permanent pacemaker or cardiac defibrillator. 
202 
• 
Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may 
203 
hinder communication with the research team.  
204 
• 
Inability to cooperate or communicate with the research team.  
205 
 
206 
Statistical considerations: 
207 
Quantitative analysis: 
208 
Descriptive statistics will be obtained about the baseline characteristics of participants.  Continuous 
209 
variables will be presented as mean ± standard deviation or medians and ranges, depending on 
210 
distribution. Categorical variables will be reported as numbers and percentages.  The total 
211 
frequencies of alerts, proportion of actioned alerts, and resultant actions will be described.  
212 
Outcome measures (e.g. phone consultation, virtual GP review, transfer to hospital) will be reviewed 
213 
from case notes should escalation occur and described in absolute frequencies.  Questionnaire data 
214 
will be presented using frequency distributions.  Data will be analysed using SPSS, Stata, and 
215 
GraphPad.   
216 

10 
March 16th 2020 
Qualitative analyses: 
217 
Semi structured interviews will take place by the primary lead researcher using the prepared topic 
218 
guides. An audio recording will be made of all interviews. The interviewer may also take field notes 
219 
reflecting the verbal responses and reflections to be used to adapt the topic/study direction. The 
220 
audio recordings will be transcribed. The data will be analysed appropriately using thematic analysis. 
221 
To ensure confidentiality and anonymity, each interview will be allocated a pseudonym, to be 
222 
applied to the corresponding consent form, topic guide form/field notes and audio file. Their name 
223 
will not be included in the audio recording; the pseudonym will be used. 
224 
Summaries of interview field notes will be typed into a word processor.  All paper and soft copies of 
225 
field notes, audio files and consent forms will be kept securely in a locker within a locked office and 
226 
if in digital format, on a password protected computer and backed up regularly. Information will only 
227 
be shared within the study team. 
228 
Audio recordings will be professionally transcribed verbatim, and a random selection of transcripts 
229 
will be checked against recordings for accuracy. Interview transcripts will be analysed using Braun 
230 
and Clarke’s thematic analysis by two independent researchers; disagreements will be resolved 
231 
through discussion.19  Power considerations: 
232 
As a pilot study in an unknown viral pandemic, the progression of which is not well established, this 
233 
study will appraise the feasibility for hotel remote sensing under these circumstances.  Sufficient 
234 
other data do not exist to allow for power calculations.  
235 
 
236 
Patient and public involvement: 
237 
Due to the nature of the pandemic and the current climate (national lockdown advised from the 
238 
government) with COVID-19, patient and public involvement was not undertaken for this 
239 

11 
March 16th 2020 
observational trial.  All eligible participants will be approached to enter the study and all recruited 
240 
participants can provide email addresses should they wish for dissemination of results.  
241 
Discussion: 
242 
To the best of our knowledge, this is the first remote monitoring study focussing on healthcare 
243 
delivery during a global pandemic at a remote site (i.e. hotel), acting as an extension to a healthcare 
244 
trust.  Apart from reducing infection risk to healthcare staff, continuous remote monitoring using a 
245 
discrete wearable sensor has the potential to detect earlier clinical deterioration allowing for earlier 
246 
intervention and provide further insight into the clinical course of COVID-19 in regards to vital signs.   
247 
Our pilot study design will test the viability of using a remote site for healthcare delivery during 
248 
times of crisis.  Continuous vital sign monitoring should provide insight to determine whether vital 
249 
sign trends can detect clinical deterioration for COVID-19, requiring hospitalisation.  Furthermore, 
250 
questionnaires and semi-structured interviews of participants will provide insight into wider 
251 
implementation of this technology and provide feedback for improvements.  Similarly, semi-
252 
structured interviews of staff will provide a healthcare perspective, particularly thoughts on reducing 
253 
potential infection risk through remote monitoring services. 
254 
Despite the strengths of our study, the design presents inherent limitations.  Mainly, the lack of 
255 
randomisation and control arm to compare remote monitoring services to ‘standard care’.  
256 
However, to maximise capacity at the hotel given the unknown of the pandemic, a pragmatic, 
257 
observational design was favoured; randomisation was not deemed appropriate.  Government 
258 
restrictions are rapidly changing for air travel, which could significantly alter our sample size, 
259 
increasing the risk of type II errors.  The inclusion of healthcare professionals may bias the 
260 
description of favourable experiences, owing to their familiarity of continuous monitoring of 
261 
physiological parameters.  In addition, implementing remote monitoring systems entails an initial 
262 
financial cost with new logistical and legal considerations; given the early phase of work, the true 
263 
extent of these issues remains unknown.  If the trial is proven to be feasible, this work could power 
264 

12 
March 16th 2020 
future randomised trials to explore for cause-effect relationships and describe cost-
265 
utility/effectiveness of remote monitoring solutions.   
266 
In conclusion, the results of our study would have potential to demonstrate the feasibility of remote 
267 
monitoring during a pandemic and may provide insight into earlier recognition of clinical 
268 
deterioration in individuals suspected with COVID-19.  
269 
 
 
270 

13 
March 16th 2020 
Declarations 
271 
Ethics approval and consent to participate 
272 
All participants must provide consent to participate.  This study has been received ethical approval 
273 
by London – Queen Square Research Ethics Committee (IRAS: 281757).   
274 
Consent for publication 
275 
Consent will be taken for publication. 
276 
Availability of data and materials 
277 
The datasets used and/or analysed during the current study are available from the corresponding 
278 
author on reasonable request.  Only the authors have access to the dataset. 
279 
Competing interests 
280 
The authors declare that they have no competing interests 
281 
Funding 
282 
This work was supported by a grant provided through CW+ (the official charity of Chelsea and 
283 
Westminster Hospital).  The funding body will play no role in the design of the study and collection, 
284 
analysis, and interpretation of data and in writing this manuscript. 
285 
Authors’ contributions 
286 
FMI drafted the manuscript.  Amendments were made by MJ, SK, HA, GD, and AD.  Statistical 
287 
considerations were discussed with MJ, SK and HA.  The idea was conceived by MJ and SK.   
288 
Acknowledgements 
289 
Infrastructure support for this research was provided by the NIHR Imperial Biomedical Research 
290 
Centre (BRC) and the NIHR Imperial Patient Safety Translational Research Centre (PSTRC). 
291 
 
292 
References: 
293 
1.  
Department of Health and Social Care; Public Health England. Coronavirus (COVID-19): latest 
294 
information and advice - GOV.UK. https://www.gov.uk/guidance/coronavirus-covid-19-
295 
information-for-the-public. Accessed March 6, 2020. 
296 
2.  
Public Health England. Stay at home: guidance for households with possible coronavirus 
297 
(COVID-19) infection - GOV.UK. https://www.gov.uk/government/publications/covid-19-stay-
298 
at-home-guidance/stay-at-home-guidance-for-households-with-possible-coronavirus-covid-
299 
19-infection. Published 2020. Accessed May 6, 2020. 
300 
3.  
Kenzaka T, Okayama M, Kuroki S, et al. Importance of vital signs to the early diagnosis and 
301 
severity of sepsis: association between vital signs and sequential organ failure assessment 
302 
score in patients with sepsis. Intern Med. 2012;51(8):871-876. 
303 
4.  
Smith GB. In-hospital cardiac arrest: is it time for an in-hospital ‘chain of prevention’? 
304 
Resuscitation. 2010;81(9):1209-1211. 
305 
5.  
DeVita MA, Smith GB, Adam SK, et al. “Identifying the hospitalised patient in crisis”—a 
306 
consensus conference on the afferent limb of rapid response systems. Resuscitation. 
307 
2010;81(4):375-382. 
308 
6.  
National Institutes of Clinical Excellence. Acutely Ill Patients in Hospital: Recognition of and 
309 

14 
March 16th 2020 
Response to Acute Illness in Adults in Hospital. National Institute for Clinical Excellence; 2007. 
310 
7.  
Royal College of Physicians. National Early Warning Score (NEWS) 2. 
311 
https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2. 
312 
Published 2017. Accessed March 6, 2020. 
313 
8.  
Bombaci A, Abbadessa G, Trojsi F, Leocani L, Bonavita S, Lavorgna L. Telemedicine for 
314 
management of patients with amyotrophic lateral sclerosis through COVID-19 tail. Neurol Sci. 
315 
2020. doi:10.1007/s10072-020-04783-x 
316 
9.  
De Farias FACD, Dagostini CM, Bicca YDA, Falavigna VF, Falavigna A. Remote patient 
317 
monitoring: A systematic review. Telemed e-Health. 2020. doi:10.1089/tmj.2019.0066 
318 
10.  
Martirosyan M, Caliskan K, Theuns DAMJ, Szili-Torok T. Remote monitoring of heart failure: 
319 
benefits for therapeutic decision making. Expert Rev Cardiovasc Ther. 2017;15(7):503-515. 
320 
11.  
Downey C, Randell R, Brown ; Julia, Jayne DG. Continuous Versus Intermittent Vital Signs 
321 
Monitoring Using a Wearable, Wireless Patch in Patients Admitted to Surgical Wards: Pilot 
322 
Cluster Randomized Controlled Trial. J Med Internet Res. 2018;20(12). doi:10.2196/10802 
323 
12.  
Weenk M, Bredie SJ, Koeneman M, Hesselink G, van Goor H, van de Belt TH. Continuous 
324 
Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized 
325 
Controlled Trial. J Med Internet Res. 2020;22(6):e15471. doi:10.2196/15471 
326 
13.  
Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: Defining Standard Protocol 
327 
Items for Clinical Trials. Ann Intern Med. 2013;158(3):200-207. doi:10.7326/0003-4819-158-3-
328 
201302050-00583 
329 
14.  
Royal College of Physicians. National Early Warning Score (NEWS) 2 | RCP London. NEWS 2. 
330 
2017. 
331 
15.  
Downey C, Ng S, Jayne D, Wong D. Reliability of a wearable wireless patch for continuous 
332 
remote monitoring of vital signs in patients recovering from major surgery: a clinical 
333 
validation study from the TRaCINg trial. BMJ Open. 2019;9(8):e031150. 
334 
doi:10.1136/bmjopen-2019-031150 
335 
16.  
Kroenke K, Spitzer RL, Williams JBW. The PHQ‐9: validity of a brief depression severity 
336 
measure. J Gen Intern Med. 2001;16(9):606-613. 
337 
17.  
Spitzer RL, Kroenke K, Williams JBW, Löwe B. A Brief Measure for Assessing Generalized 
338 
Anxiety Disorder: The GAD-7. Arch Intern Med. 2006;166(10):1092-1097. 
339 
doi:10.1001/archinte.166.10.1092 
340 
18.  
Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: the what, why and how. BMC Med 
341 
Res Methodol. 2010;10(1):1. doi:10.1186/1471-2288-10-1 
342 
19.  
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101. 
343 
doi:10.1191/1478088706qp063oa 
344 
 
345 
Figure legends: 
346 
Figure 1: Potential escalation pathway; NEWS: National Early Warning Score; GP: general 
347 
practitioner. 
348 

15 
March 16th 2020 
Figure 2: Monitoring system for SensiumVitals™ Wearable Sensor 
349 
Table: 
350 
Table 1: Criteria for generating vitals alert 
351 
Parameter 
Alert threshold 
Respiratory rate (breaths per minute) 
>25 
Temperature (Celsius) 
>38.1 
Heart rate (beats per minute) 
>131 
 
352