How Point-of-Care Ultrasound Affects the Diagnostic Process in General Practice. A Prospective Follow-up Study.
Conditions: Ultrasound, Diagnostics, General Practice
Sponsor: Aalborg University

 
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How Point-of-Care Ultrasounds Affects the 
Diagnostic Process in General Practice. A 
prospective follow-up study. 
Protocol version:04.12.2017 
Registration:  
The study will be registered at clinicaltrials.org. 
Funding:  
The Research Unit for General Practice in Aalborg supports the study. Additionally, various foundations will 
be applied for support, but they will have no influence on the study design, analysis of data or the reporting 
of results. 
Research team:   
Principal Investigator:  
Camilla Aakjær Andersen, MD, PhD student 
Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, 
Fyrkildevej 7, 1.sal, lejl.3, 9220 Aalborg Øst, Denmark.   
Email: caakjaer@dcm.aau.dk 
Co-investigators:  
Martin Bach Jensen, Professor, PhD, GP 
Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, 
Fyrkildevej 7, 1.sal, lejl.3, 9220 Aalborg Øst, Denmark.   
E-mail: mbj@dcm.aau.dk 
 
John Brodersen, Professor, PhD, GP    
Centre of Research & Education in General Practice, Primary Health Care Research Unit, Region Zealand, 
Department of Public Health, Faculty of Health Sciences, University of Copenhagen 
Øster Farimagsgade 5, P. O. Box 2099, DK-1014 Copenhagen, Denmark 
E-mail: john.brodersen@sund.ku.dk 
 
Annette Sofie Davidsen, Associate Professor,  PhD, GP,  DMSc     
Research Unit for General Practice and Section of General Practice 
Department of Public Health, Faculty of Health Sciences, University of Copenhagen, CSS 
Øster Farimagsgade 5, DK-1014 Copenhagen,Denmark 
Email: adavid@sund.ku.dk 
 
Ole Graumann, Associate Professor, PhD, MD 

 
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Consultant - Department of Radiology, Odense University Hospital 
Aarhus University & Odense University 
CECLUS - Center of Clinical Ultrasound - Aarhus University 
E-Mail: oleg@clin.au.dk/ og@dadlnet.dk 
 
Research question: What is Point of Care Ultrasound (POC-US) used for in general practice in Denmark and 
how does it affect the diagnostic process and treatment of patients?  
Population: Patients listed with a general practice in Denmark, in whom the general practitioner (GP) uses 
POC-US. 
Intervention: None, this is an observational study. 
Comparison: None. 
Outcome: Indications and frequencies of the performed POC-US examinations, change in tentative 
diagnosis, plan, and treatment before and after the use of POC-US in relation to GP characteristics, 
confidence in the tentative diagnosis, findings and quality of the POC-US examination. 
Time: Each GP collects data for one month and there is a follow-up after six months 
Introduction:   
Background and rationale 
Traditionally ultrasound (US) examinations required large expensive devices and were performed by highly 
trained specialists to provide a full anatomical description of an organ or pathological findings. This is 
known as “Diagnostic US”. As the US devices became smaller, cheaper, and better, the use of US 
disseminated and became integrated in most medical areas as point of care ultrasound (POC-US) [1]. 
POC-US is a focused US scan for a predefined condition and it is performed by healthcare professionals 
trained to use POC-US to answer simple clinical question, typically with yes-no answers e.g., “is there a 
gallstone?” Thus POC-US is an extension of the physical examination of the patient, where positive and 
negative findings are evaluated in context with the patient’s signs and symptoms and the result is noted in 
the patient’s medical record similar to how auscultation findings are recorded when using the 
stethoscope.[2] 
 
Potentially there are great advantages of using POC-US: It may improve success in US guided procedures 
e.g. vascular access[3], it may lead to more correct diagnoses [4], and supplement or replace more 
advanced imaging[5]. It may also facilitate screening, e.g. of abdominal aorta aneurism [6] in high risk 
patients.  However, an increased use of US imaging may lead to overdiagnosis [7], spurious findings, 
incidental findings or diagnosing of clinically unimportant conditions. US is a user-dependent technology 
that requires appropriate training and quality assurance. Misinterpretations may lead to flawed diagnoses 
that could raise an unnecessary concern in patients; and even worse, it could delay proper treatment if a 
serious condition is overlooked and the scanning health care professional and patient feel confident that 
everything is fine. It may also lead to false positives including potential harmful downstream procedures. 

 
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From the Danish College of General Practitioners (DSAM) interest group in POC-US we know that only few 
Danish GPs use POC-US and among those there is a great variation in the education, experience, and 
application of the method [8]. The DSAM POC-US group has suggested a curriculum for POC-US [appendix 
1], and Bitsch et al [9] have proposed a guideline for the use of POC-US, but it is not known to what extent 
these recommendations have been adapted.  
 
There are only few articles describing the use of POC-US in general practice [5,6, 10-59]. Most of the studies 
are more than 10 years old [23-59] and the development in technology may have improved the images that 
can be obtained by present-day equipment. No randomized trials have been carried out. Most of the 
studies are descriptive reports with only a few enthusiastic GPs, who might not be representatives for GPs 
in general.  
The use of POC-US:  
The literature describes that POC-US is used on very different indications, on different organs and with a 
great difference in the level of details obtained through POC-US examinations.   Most commonly reported 
are obstetric, gynecological, and abdominal scans. In addition, POC-US was used to estimate the ejection 
fraction of the heart. Table 1 summarizes the application in the studies:  
 Table 1 
Application 
 
Number of 
studies 
Reference 
Abdomen 
14 
[5,6,18,23,30,32,34,35,36,43,44,46,58,59] 
Heart 
7 
[5,17,26,31,34,37,56] 
Lung 
3 
[55,11,46] 
Gynaecology 
7 
[18,30,34,35,36,44,58] 
Obstetric 
17 
[18,21,22,29,30,33,35,36,39,40,43,47,48,49,50,51,57] 
Sinusitis 
3 
[28,41,54] 
Musculoskeletal 
3 
[8,35,53]   
Carotid arteries 
1 
[34] 
Thyroid 
2 
[34,35] 
Neck 
1 
[35] 
Mamma 
1 
[35] 
Male pelvis 
3 
[18,23,35] 
 
In different studies the POC-US examinations were used differently and described with varying levels of 
details. A recent study described POC-US as being used to confirm or dismiss a clinical hypothesis [5], 
whereas other studies describe a full anatomical assessment of several organs [35,36,45] . We do not know 
how Danish GPs scan, which organs or positions they select or if the Danish GPs restrict themselves to scan 
within the curriculum suggested by the DSAM group.   
 
Some studies describe POC-US use for screening purposes, e.g. scanning for an aortic aneurism[6,32] or a 
general health screening.[34,44] In a German survey GPs reported finding 67 % of abdominal aortic 
aneurisms as incidental findings during other investigations [10] . We do not know the number of incidental 

 
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findings among Danish GPs who scan or if the Danish GPs extend their POC-US examination to 
opportunistic screening.  
Time consumption: 
In some studies the time consumption of POC-US was found to be no more than 10 minutes although POC-
US performed for general screening or echocardiography was more time consuming (Figure 1)   
 
Figure 1 
 
 
The effect on the diagnostic process 
Many articles describing the use of POC-US in general practice state the indication and the findings, but 
details regarding the diagnostic process are missing, e.g. whether POC-US actually changes the presumptive 
diagnosis and how much emphasis POC-US adds to the diagnostic process?  
A randomized controlled trial [4] examined patients with respiratory symptoms, who were admitted to the 
hospital. In this study, the number of correct diagnoses, increased for patients, who were examined with 
POC-US as an additional test. However, patients in a hospital setting differ from the patient population in 
general practice, with more advanced or complicated disease. 
In an American survey from 2014 [13], military family physicians were introduced to a pocket ultrasound 
device and trained in broad use of POC-US. Afterwards they were asked about their experiences. 60% felt 
that POC-US improved their ability to make an accurate diagnosis and 67% found that POC-US was 
timesaving in the diagnostic process. Furthermore a survey from rural Canada in 2013 [15] found that 78 % 

 
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of the GPs thought the result of POC-US would change their clinical decision and 72 % stated that it would 
improve patient care.   
The effect on the plan and treatment of patients  
POC-US may allow more rapid or correct diagnosis and in some cases direct referral to a relevant 
department or eliminate the need for referral. However, applying POC-US in general practice inevitably 
entails a certain amount of overdiagnosis, incidental findings and possible misdiagnoses.  
A Norwegian study [18] describes specifically how the use of POC-US in 200 patients in general practice 
changed the treatment and plan for 90 patients as 35 referrals for POC-US, 40 referrals for a specialist 
opinion, and 15 referrals for procedures were avoided.   
The number of misdiagnoses are only disclosed to a limited extent in the published studies  
[18,26,29,31,34,35,44,46,53] . In an Italian study [5], POC-US was used to rule-in or rule-out diagnostic 
hypotheses, and 4,9 % of findings in POC-US were later classified as false negative. Overdiagnosis was not 
addressed in the published studies, but incidental findings were described in several studies  
[34,35,44,46,56,58,59] .  
Future GPs will be familiar with the technology as POC-US is part of the medical education at the university 
and the postgraduate specialization to become a general practitioner. To gain the benefits and avoid 
unnecessary harm by the utilization of POC-US in general practice it is crucial that the use of POC-US in a 
general practice setting is properly evaluated.  
Objective: 
The aim of this study is to describe: How general practitioners use POC-US in their daily practice, how POC-
US influences the diagnostic process, and how POC-US affects the treatment of the patients. 
 
The Use of POC-US will be explored through indication, frequency, time consumption, modification, and 
findings in order to describe:  
- 
Which organs the GPs scan, when using POC-US? 
- 
Which tentative diagnoses entail the use of POC-US? 
- 
If GPs intend to rule-in/rule-out or explore, when using POC-US? 
- 
How often the GPs use POC-US? 
- 
How often are the GPs able to produce POC-US pictures of relevant structures?  
- 
How much time POC-US adds to the consultation? 
- 
How often a difference in what the GP intends to scan and what POC-US is actually used 
for occurs (modification of the performed POC-US)? 
- 
How often POC-US leads to a specific finding? 
 
The influences of the diagnostic process will be explored through change in the tentative diagnosis and 
change in the GP’s confidence in the tentative diagnosis. We aim to describe:  
- 
If POC-US changes the patient’s tentative diagnosis  
- 
If POC-US increases the GP’s confidence in the tentative diagnosis  

 
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- 
The relationship between the GP’s expression of confidence and change in the number 
of tentative diagnoses 
- 
The relationship between change from symptom diagnoses to disease diagnoses and the 
GP’s expression of confidence in the tentative diagnosis  
- 
The relationship between specific organs scanned and the GP’s expression of confidence 
in the tentative diagnosis  
 
The effects on the treatment of patients will be explored through changes in the plan or treatment for the 
patient. We aim to describe:  
- 
If POC-US changes the GP’s plan for the patient 
- 
If POC-US changes the treatment for the patient  
- 
The relationship between findings and change in the plan or treatment for the patient.   
Trial design:  
A prospective observational cohort study 
Study setting: 
The study will take place in 20 different general practices in Denmark where the GPs use POC-US. The study 
is coordinated from the Research Unit for General Practice in Aalborg that also has a list of the participating 
study sites (GP clinics) and hosts data assessed from the clinics and patients. 
Eligibility criteria 
Participating doctors:  
The participating GP practices will be selected purposively aiming at a difference in organisation, 
geography, and equipment. GPs will be selected to vary in experience both regarding seniority as GPs and 
experience of using POC-US. Thus we will include partnerships and solo practices, urban and rural practices 
as well as practices with variable number of probes and type of ultrasound scanner. 
The GPs must fulfil the following criteria:  
Inclusion criteria: 
1. Broad use of POC-US (minimum two anatomical areas evaluated by OSAUS at baseline)  
2. Working week of minimum four days 
3. A minimum of 1400 patients listed 
4. A minimum of two scanning probes 
5. Previous participation in formal education in the use of POC-US  
6. Minimum six months experience with POC-US in general practice.  
7. Estimated use of POC-US on a daily basis (average) 
 
Exclusion criteria: 
1. Ultrasound device more than 10 years old 

 
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2. Conflict of interest, e.g. if the GP is part of the research group or if the GP has/had direct financial 
interest in selling US devices. 
3. If less than five patients have been enrolled. 
Participating patients:  
Patients must provide written, informed consent before any study procedures occur (see Appendix 1 for 
sample Informed Consent Form). Only patients assigned to the GP’s practice can participate in the study. 
Interventions 
There is no intervention in this study since the GPs are already using POC-US in their examination of 
patients. The registration for this study will reflect the GPs’ normal daily use of POC-US not adding more 
examinations or in other ways influencing the treatment of patients.    
If patients are re-scanned on a later occasion, only the primary scan will be included in the analysis. 
However, any additional scans or procedures are part of the six months follow-up study (not described in 
detail here). 
Outcomes 
How general practitioners use POC-US in their daily practice: 
The use of POC-US will be examined through the domains indication, frequency, time consumption, 
modification, and findings.   

 
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Indication: 
The GP’s indication for using POC-US will be described through the frequencies of the GP’s intention to 
rule-in/ rule-out, or explore when using POC-US (Q1.1). This binominal distribution will tell us whether the 
GP has a predefined condition to be confirmed or dismissed by POC-US (rule-in or -out) or if POC-US is used 
to explore a symptom. The indication will also be described through frequencies of the tentative diagnoses 
(Q 1.3 and Q1.4) that entail the use of POC-US.  
Frequency:  
How frequently POC-US is used will be described as the percentage of the GP’s consultations, where POC-
US is used in the study period.  Each participant will provide information on the total number of face-to-
face consultations she or he has had during the study period, not including planned preventive 
consultations or home visits. The frequency of the different POC-US examinations will be summarized in 
relation to the organs scanned (Q 2.2). The performed POC-US examinations are defined as organs scanned 
and not as standardized procedures such as FAST, FATE or LUS since there might be differences in the 
definition and interpretation of these examinations. The organs scanned are registered on a list of organs 
in the questionnaire. The possibilities in this list originate from interviews with GPs using POC-US and from 
pilot testing. The GPs can choose to write in free text if organs are missing from the list.  
GPs use of POC-
US
Indication
Rule-in/rule-out, 
or explore
Q 1.1
Nominal  scale
Tentative 
diagnoses
Q 1.3 and Q 1.4
Nominal  scale
frequency 
Total number of 
consultations 
Registration in 
the clinic
Ratio scale
Organs scanned 
Q 2.2
Nominal  scale
Time 
consumption
registrated time 
spend on POC-
US
Q 2.1
Ratio scale
Modification
Organs intended 
to scan
Q 1.2
Nominal  scale
Organs scanned
Q 2.2 
Nominal  scale
Findings
Findings using 
POC-US
Q 2.4
Norminal  scale

 
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Time consumption:  
The GPs will measure the time used for the POC-US examination. The time registration starts when the 
scanning begins and ends when the scanning has been finished. Hence, it will only include the duration of 
the POC-US examination, not information about the scanning or other elements of the consultation. This 
time registration (Q2.1) will be described in minutes for each type of POC-US examination (Q2.2). 
Modification:  
By the before and after registration of the organs intended to scan (Q 1.2) and the organ actually scanned 
(Q 2.2), the extent of modification of POC-US to include e.g. opportunistic screening, can be estimated. The 
modification of the performed POC-US will be described in frequencies of POC-US examinations that are 
reduced, expanded or unchanged.  
Findings: 
The findings in POC-US are measured through the categorial variables certain positive findings, uncertain 
positive findings, certain negative findings, uncertain negative findings, and incidental findings (Q2.4). The 
findings will be described in frequencies and we will also describe the correlation between certain findings 
and change in treatment and plan for the patient. 
How POC-US influences the diagnostic process: 
Change in diagnose: 
The GPs are asked to declare the tentative diagnoses as one main tentative diagnosis (Q1.3) and other 
possible diagnoses (Q1.4) before the use of POC-US. After the use of POC-US the GPs will be shown their 
“Before-US” tentative diagnoses (Q1.3and Q1.4) and asked if these diagnoses have changed (Q2.5). If the 
diagnoses have changed, they will be asked to specify this (Q 2.6 and Q2.7).     
The tentative diagnoses are registered as ICPC-2 codes in the questionnaire. The ICPC-2 code system is a 
familiar tool for the GPs and an overview of all ICPC-2 codes will be provided as a pdf file. Although ICPC-2 
codes cover both symptom diagnoses and disease diagnoses [62,63], they do not cover all clinical 
conditions. Thus it is possible that the patient’s tentative diagnosis changes after POC-US, but the ICPC-2 
code remains the same. Q2.5 is designed to clarify this issue.  
Change in the tentative diagnoses is measured in the frequency of GPs’ declaration of change and in overall 
registered change in the ICPC-2 codes.  Overall registered change in the ICPC-2 codes are defined as:  
- 
Change in the ICPC-2 code of the  main tentative diagnosis after US (Q1.3 and Q 2.6) 
- 
Change in all possible ICPC-2 tentative diagnoses after (Q1.4 and Q2.7) the use of POC-
US 
- 
Change in the total number of tentative diagnoses …..(Q1.3,Q1.4, Q2.6 and Q2.7) 
- 
Change from symptom diagnosis (ICPC 2 1-29) to disease diagnosis (ICPC 2 70-99) after 
POC-US  (Q1.3,Q1.4, Q2.6 and Q2.7) 
Change in confidence:  
The GPs are asked to register any change in their confidence in the tentative diagnoses after the use of 
POC-US (Q2.8) by choosing one of the following variables on an ordinal scale: Increased confidence, more 
confident, unchanged confidence, less confident, reduced confidence.    

 
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To test the reliability of the GPs’ declaration of confidence (Q2.8), we will examine if an increased 
confidence is correlated to specific organs scanned (Q2.2), a reduction in the total number of diagnoses 
(Q1.3, Q1.4, Q2.6 and Q2.7), or a change from symptom diagnosis to disease diagnosis (Q1.3,Q1.4, Q2.6 
and Q2.7). 
How POC-US affects the treatment of the patients: 
Change in the plan for the patient 
The GPs register their plan for the patient by choosing one or more of the following categorical variables 
before (Q1.5) using POC-US: Acute admission to hospital, subacute referral to hospital, normal referral to 
hospital, subacute referral to specialist, normal referral to specialist, referral for radiology, other referral 
e.g. to physiotherapist, follow-up in the clinic, no plan for follow-up, other.  
After using POC-US the GP is shown the “before POC-US plan for the patient” and asked if this plan has 
changed (Q2.9). If the plan has changed, the GP is asked to specify (Q3.0). 
Change in the plan for the patient is defined as the frequency of declared change and elaborated on in this 
before and after registration from one possible answer to another, or change in the number of possible 
answers. 
Change in the treatment for the patient 
The GPs register their initiated treatment before POC-US (Q1.6) by choosing one or more of the following 
categorical variables: Referral for treatment in the secondary sector, medication, other treatment, no 
treatment, other. After using POC-US the GP is shown the “before POC-US planned treatment for the 
patient” and asked if this planned treatment has changed (Q3.1). If the planned treatment has changed, the 
GP is asked to specify (Q3.2) 
Change in the initiated treatment of patients is defined as the frequency of declared change and elaborated 
on in this before and after registration from one possible answer to another, or in the number of possible 
answers.   
Participant timeline 
 
Year 
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STUDY II 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Pilottest 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Rekrutting 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OSAUS and feasibility test gr. 1  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Datacollection group 1 (4 GPs) 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
OSAUS and feasibility test gr. 2  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Datacollection group 2 (3 GPs) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OSAUS and feasibility test gr. 3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Datacollection group 3 (3 GPs) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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OSAUS and feasibility test gr. 4  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Datacollection group 4 (3 GPs) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OSAUS and feasibility test gr. 5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Datacollection group 5 (4 GPs) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OSAUS and feasibility test gr. 6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Datacollection group 6 (3 GPs) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Writing article 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sample size  
The overall aim of this study is to describe how POC-US is used in Danish general practice. Based on a pilot 
questionnaire (unpublished data), we estimate that there are around 75 GPs in Denmark, who use POC-US. 
We find it realistic to include 20 GPs in this study. This sample size will enable us to have some variation 
(geographical, experience, etc) among the included GPs.  
We estimate from our own experience and from talks with GPs, who scan, that the GPs will use POC-US 2-3 
times a day, and assuming a participation rate of 80%, we will therefore have 640-960 US scan during the 
study period of one month. This number of scans is expected to be sufficient to give a valid statistical 
description of e.g. frequencies of organs scanned (see table 1) and other outcomes. Additionally, it is a 
sufficiently large number of scans to enable an evaluation of safety when we later on make the six months 
follow-up. We hope to maintain the GPs’ dedication to the project by the relative short study period (one 
month). 
Recruitment 
Participating GPs:  
GPs using POC-US will be recruited through the continuous medical education small-groups program , US 
networks, conferences, through teaching sessions, and through contacts via the Danish general practice 
research units. Interested GPs will be asked to register and answer a questionnaire including background 
information. The participating GPs will be selected randomly among these registrations after considering in-
and exclusion criteria.   
Baseline questions to describe the participating GPs (BQ): 
Question 
number  
Question  
Catagory 
BQ 1.1 
How old are you? 
Age 
BQ 1.2 
Are you a woman/man? 
Gender 
BQ 1.3 
How many years have you been a GP? 
Experience 
BQ 1.4 
Which year did you graduate as a doctor? 
Experience 
BQ 1.5 
How long have you been using ultrasound? 
Experience 
 
How often do you use ultrasound? 
Frequency 
BQ 1.6 
Would you characterize your practice as a predominantly rural, urban 
or mixed 
Location 

 
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BQ 1.7 
How is your practice organized? (solo, partnership, collaboration) 
Organization 
BQ 1.8 
How many patients are assigned to your practice? 
Organization 
 
How many days a week do you do clinical work? 
Organization 
BQ 1.9 
In which region do you practice? 
Location 
BQ 2.0 
What is the approximate distance from your practice to the nearest 
radiology department where US can be performed? 
Location 
BQ 2.1 
What kind of US device (name, model, year) and probes do you have? 
Equipment 
BQ 2.2 
What kind of ultrasound education/training did you receive? 
Experience 
BQ 2.3 
How often do you use ultrasound?  
use 
BQ 2.4 
Do you have a conflict of interest, participating in this study? 
COI 
Base-line assessment of GPs 
We will evaluate the GPs’ technical skills at baseline. After inclusion, each participating GP will be asked to 
perform POC-US in a standardized setting and reviewed by an external reviewer (radiologist) using the 
standardized protocol, OSAUS[60]. This protocol is used for the certification of GPs in POC-US at the Center 
of Clinical Ultrasound at Aarhus University Hospital  [61] . This rated evaluation will serve as background 
information on the participating GPs. It will take place at different locations and if possible on the GPs own 
US device. There will be no more than three months between evaluation and data-collection for each GP.  
The GPs will not be informed about their rated evaluation score until after the study.   
Participating Patients:  
All patients who consult the participating GP for conditions relevant for a POC-US examination will be 
offered to participate in the study. Patients are excluded if they do not wish to participate or if they are not 
able to give an informed consent.  
Data collection  
Normally a consultation in general practice takes 5-15 minutes. POC-US is expected to add another 10 
minutes. During this study the GPs will be asked to measure the time used for POC-US examination and fill 
out a questionnaire before and after the use of POC-US which adds approximately 10 minutes to the 
consultation. The GPs will be financially compensated for the time used to register data for the study. The 
GPs will also be asked to give information about the total number of consultations in the clinic in the study 
period.  
Developing the registration tool:  
We will develop a registration tool based on knowledge from the literature, dialogue with the DSAM US 
group and an interview study. The registration tool will be developed as a questionnaire to be used before 
and after the GP uses POC-US in the consultation. The questionnaire will include a time log to ensure the 
before and after registration. We will perform several pilot tests both in the research group and GPs using 
POC-US in order to ensure comprehension, feasibility and compliance.   
 
• 
Step 1: Developing a preliminary registration tool/questionnaire based on literature, discussions in 
the research group and individual interviews with GPs.  
• 
Step 2: The pilot test will consist of consecutive rounds of GPs testing the questionnaire. In each 
round five GPs who use POC-US will be asked to use the questionnaire in relation to three 

 
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consultations. They will be asked to comment and declare any difficulties on each question and 
part of the questionnaire. After each round adaptions be will made by the research team until the 
questionnaires are completed without difficulties.  
• 
Step 3: Data from step 2 will be analyzed and final adaptions will follow.     
 
Ensuring feasibility: 
In order to ensure comprehension and validity of the registration tool, the principal investigator will visit 
each participating GP 1-2weeks before the data collection starts. At this visit the GP will be asked to fill out 
the registration tool before and after using POC-US in a patient. After each registration the principal 
investigator will interview the GP asking the same questions as covered by the registration tool. The GP will 
then answer in his/her own words. The principal investigator will then answer the registration tool based 
on the GPs explanations. The two questionnaires are then compared and any miscomprehensions or 
difficulties resolved. At the same time feasibility is tested.  
 
Registration tool:  
The GPs will be asked to access a questionnaire in the online database SurveyXact each time they use their 
ultrasound device during their daily work. The data will be registered electronically in SurveyXact with a 
time log to ensure a before and after registration. 
The GPs can access the questionnaire on their mobile phone,  iPad or computer, using a unique link 
(respondent link) allocated each participating GP. A key file, connecting each participating GP with the 
respondent link in Surveyxact (link), will be safely stored at the Research Unit for General Practice in 
Aalborg.  
The GPs will give each patient a unique ID-number (PQ 1.2). A Key file connecting this ID-number and the 
patients CPR-number will be safely stored at the GP’s clinic.  
 
Questions BEFORE the use of POC-US:  
Question 
number  
Question  
Possible answers 
PQ 1.1 
 GP ID number 
GPxx 
PQ 1.2 
Patient ID number  
Pxxx 
PQ 1.3 
Date 
Dxxxxxxxx 
PQ 1.4 
Patient gender 
Male/female 
PQ 1.5 
Patient Age  
xxx years 
Q 1.1 
What is the main reason to use POC-US in this patient? 
Rule-in/Rule-out 
Explore 
Q 1.2 
Which organs/positions do you expect to scan? 
Organs on list 
Q 1.3 
What is the main tentative diagnosis for this patient? 
ICPC2 codes  
Q 1.4 
Are there any other possible tentative diagnoses in this 
case? 
ICPC2 codes  
Q 1.5 
What is your overall plan for this patient? 
Acute admission to hospital 

 
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Subacute referral to hospital 
Elective referral hospital  
Subacute referral to specialist  
Elective referral to specialist 
Referral to radiology  
Other referral e.g. 
physiotherapist 
Follow-up in the clinic 
No plan for follow-up 
Other 
Q 1.6 
Which treatment will you initiate at this stage? 
Medication 
I will refer for treatment 
I will initiate other treatment  
None 
Other 
 
Questions AFTER the use of POC-US:  
Question 
number  
Question  
Possible answers 
Q 2.1 
How much time did you use on the POC-US examination? 
Minutes 
Q 2.2 
Which organs/positions did you scan? 
Organs in drop-down menu 
Q 2.3 
Were you able to produce ultrasound images of the relevant 
structures of (inserted text) ?  
Yes 
No – why not? 
Q 2.4 
What did you find? 
Certain positive findings 
Uncertain positive findings 
Certain negative findings 
Uncertain negative findings 
Incidental findings – please 
specify in free text 
Q 2.5 
Before POC-US you registered these tentative diagnoses 
(inserted text) Have your tentative diagnoses changed? 
Yes, the diagnoses have 
changed but the ICPC2 codes 

 
15 
are the same 
Yes, the diagnoses have 
changed and the ICPC2 codes 
have also changed 
No* 
Q 2.6 
What is the tentative diagnosis for this patient now? 
ICPC2 codes  
Q 2.7 
Are there any other possible tentative diagnoses for this 
patient (please specify)? 
ICPC2 codes  
Q 2.8 
How is your confidence in your main tentative diagnosis, 
after you have used POC-US? 
 
Highly increased confidence 
More confidence 
unchanged confidence 
Less confidence 
Highly reduced confidence.    
Q 2.9 
Before POC-US you registered this plan (inserted text) for 
the patient. Has your overall plan changed? 
Yes  
No** 
Q 3.0 
What is your overall plan for this patient, now? 
Acute admission to hospital 
Subacute referral to hospital 
Elective referral hospital  
Subacute referral to specialist  
Elective referral to specialist 
Referral to radiology  
Other referral e.g. 
physiotherapist 
Follow-up in the clinic 
No plan for follow-up 
Other 
Q 3.1 
Before POC-US you registered this treatment (inserted text) 
for the patient. Has your initiated treatment for this patient 
changed? 
Yes  
No* 
Q 3.2 
Which treatment will you initiate at this stage? 
Medication 
I will refer for treatment 
I will initiate other treatment  
None 
Other 
* Move on to Q2.8  

 
16 
** Move on to Q3.1 
Time-log 
We will register date and time, when the GP accesses the questionnaire and finishes the final question. 
Furthermore, we will have a java script on a page between the ”before” and the “after” questions, this java 
script will create a variable with the exact time between “before” and “after” questions.  
If GPs use less than e.g. 1 minute on this page and the GP registers a duration of the POC-US > 1 minute, we 
will assume, that there was no “before and after” registration, but only an “after” registration.  In that case, 
we will exclude the “before” answers (Q1.1 – Q1.6).     
Patient experience: 
After the consultation, patients will be asked to complete a questionnaire about their experience with POC-
US in the consultation.  This questionnaire will be described in detail in a separate protocol.  
Retention  
Participant Retention 
Since the registration in this study is expected to add approximately extra 10 minutes to the consultation, 
the participating GPs will be asked to allocate time, in their daily time schedule, during the study period.   
 
 
 
The GPs will be asked to register the following information on patients, who were eligible for the study, but 
not included due to e.g. time pressure: age, gender, indication, organs intended to scan, tentative diagnosis 
and reason for exclusion.  
The Research group will send weekly updates to the participating GPs to maintain their interest in the 
project, to remind them of including patients, when they use POC-US, and to address any difficulties in the 
procedures. The Research group will also contact GPs who fail to register patients in SurveyXact in order to 
solve any difficulties.   
The participating GPs will only receive financial compensation for patients in whom the registration in 
SurveyXact is complete.   
Potential US patient 
Included patients 
Excluded due to:
- lack of time to scan 
- lack of time to registre ( scanned pt) 
- no consent to participate 

 
17 
Participant Withdrawal 
Participating GPs and patients may withdraw from the study for any reason and at any time. The 
investigator may also withdraw participating GPs from the study if they are unwilling or unable to comply 
with required study procedures.   
If the GP has included less than five patients (10%), the GP and the patients will be excluded from the 
study. The GPs will still receive financial compensations for the patients if the registration is complete. We 
will then try to include another GP for the study.  
Follow-up 
The GPs will be asked to save patient information on the included patients (Key file) in order to identify the 
patient for an additional follow-up after six months (described in a separate protocol). 
Data management  
Data will be saved electronically on the SurveyXact server and on a server at Aalborg University and will 
only be accessed by the research group using passwords. The patient key file and consent forms will be 
saved locked up at the GPs’ office and the research group will not have access to this information during 
the study.   
Any paper editions of the registration tool or questionnaire (in case of server breakdown) will be saved 
locked up at the Research Unit of General Practice in Aalborg and Department of Clinical Medicine, Aalborg 
University, Fyrkildevej 7,1, 9220 Aalborg Ø.   
 
The Research Unit for General Practice in Aalborg is the Data Controller. Each participating GP will be data 
processor and can only process data pursuant to an agreement with the data controller. A data processor 
agreement will be made between the Research Unit for General Practice in Aalborg and each participating 
GP, between the Research Unit for General Practice in Aalborg and Aalborg University, and between 
Aalborg University and SurveyXact according to the Danish Data Protection Agency recommendations.  
Statistics  
We will use descriptive statistics. The registration tool will mainly collect data on nominal scales. However, 
Confidence after POC-US will be measured on an ordinal scale and Time consumption and patient age on a 
ratio scale. 
 
The categorical variables will be described using absolute frequencies tables and chi-square or Fishers exact 
test to test the relationship between variables. Continuous variables will be described with median and 
interquartile range and if Time consumption is normally distributed it will be reported with means and 
either a standard deviation or a 95% confidence interval of the mean; if not normally distributed with a 
median and interquartile range. 
The relationship between Confidence after POC-US and number of possible tentative diagnoses will be 
described using a scatter plot.    
A prospective statistical analysis plan will be developed before datacollection begins.  

 
18 
Data monitoring 
During the study period the research team will follow the inclusion of patients by each GP and make 
contact to the GPs who fail to include patients in order to help with any difficulties.       
Harms  
We will register all adverse events occurring during the study and follow-up period.  
Auditing 
During the study period the principal investigator will monitor the registered data in SurveyXact in order to 
contact the GP if any difficulties occur.   
Research ethics approval 
The studies will be notified to the Danish Data Protection Agency, the Committee of Multipractice Studies 
in General Practice and will not commence before approval.  
Since the study is an observational study and does not include any intervention, approval by the Danish 
National Committee on Health Research Ethics is not considered to be needed, but we will apply to be sure.    
Protocol amendments 
Will be declared and all editions and changes of the protocol will be saved.  
Consent or assent 
Each participating GP will collect data for all POC-US examinations conducted during a one month period.  
Prior to participation patients will receive written and oral information and a written consent to participate 
will be obtained by the participating GP. The consent forms will be saved in the GP’s office.  
The participating GPs will also give an informed consent before participating in the study. 
Before analyzing the data the principal investigator will ensure that there are consent forms on all 
participating patients and GPs.  
Confidentiality 
All participating GPs have signed a confidentiality agreement.  
Declaration of interest 
All participating GPs and investigators will sign a conflict of interest form.  
Access to data 
Only the Research team will have access to data. 
The key files linking the patient ID and the CPR-number will be stored under lock in the GPs’ clinics. Only 
the participating GP will have access to the key file. The data will be saved at a server in SurveyXact or 

 
19 
Aalborg University. Only the research team (MBJ and CAA) will have access to this data using two unique 
passwords. 
Dissimination polity 
Manuscript 1: 
Title: The use of ultrasound in the examination of patients in general practice.  
Authors: Camilla Aakjær Andersen, Ole Graumann, Annette Davidsen, John Brodersen, and Martin Bach 
Jensen 
Expected Journal: International peer-reviewed journal 
Expected Time of Submission: August 2019 
 
Manuscript 2: 
Title: Point-of-Care Ultrasounds impact on the diagnostic process in general practice.  
Authors: Camilla Aakjær Andersen, Ole Graumann, Annette Davidsen, John Brodersen, and Martin Bach 
Jensen 
Expected Journal: International peer-reviewed journal 
Expected Time of Submission: Oktober 2019 
 
The knowledge of this study will be disseminated through conferences, research networks, and papers 
published in peer reviewed journals. It is expected that the audit on the patient pathway after six month 
follow-up also will be presented in an article. 
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