Patient Experiences of Use of Point-of-Care Ultrasound in General Practice: A Questionnaire Study
Conditions: Ultrasound, General Practice
Sponsor: Aalborg University

How Patients Experience the use of Point-
of-Care Ultrasounds in General Practice. 
Protocol version:  29-01-2018  
 
Registration:  
The study will be registered at clinicaltrials.org. The protocol was uploaded to clinicaltrials.gov on 08-01-
2018. No changes in the content of the protocol, have been made since.   
Part of the cohort study: How Point-of-Care Ultrasound (POC-US) Affects the Diagnostic Process in General 
Practice. A prospective follow-up study. (Clinical trials registration number: NCT03375333) 
 
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:   
Principle investigator: 
Camilla Aakjær Andersen, MD  
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:  
Torsten Rahbek Rudbæk, MD. Email: trahbek@hotmail.com 
Martin Bach Jensen, Professor, PhD, GP 
Research Unit for General Practice in Aalborg and 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 
 
 

Introduction:   
There are only few articles describing the use of POC-US in general practice.[5,6, 10-59] Most of these 
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. There are no studies describing the use of POC-US in 
Danish general practice and only a few studies describe the patient perspective. In these studies, it seems that 
the use of POC-US in general practice is in line with patient preferences, however these studies were 
performed in rural areas, where access to specialists and ultrasound examinations were hours away, which is 
never the case in Denmark. Furthermore one study described that 29%.of patients felt that the GP were 
putting to must emphasis on technology in the consultation and 19% found ultrasound disrupting for the 
patient-doctor relationship. [18]   
 
In a qualitative interview study with Danish general practitioners a range of motivating factors for using 
POC-US concerned the patient perspective. The GPs felt that they were improving patient care by using 
POC-US as part of their examination of patients and that the patients appreciated the use of POC-US. In this 
present study we wish to explore the GPs believes, about how POC-US in general practice is experienced by 
the patients, by asking the patients.      
Objective: 
 
Primarily we seek to explore to what extend:  
- 
patients feel informed about the use of  POC-USin general practice 
- 
patients experience that POC-US has an influence on the consultation with the GP.  
- 
patients experience POC-US influences the doctor-patient relationship.  
- 
patients feel diagnostic reassured after the POC-US examination? 
- 
do patients feel that POC-US is improving care? 
- 
are patients satisfied with POC-US in the GP’s office? 
 
 
 Secondary we seek to test the association between GPs declared confidence in the tentative diagnosis 
after using POC-US in the consultation and patients experiences with POC-US in the consultation.  
- 
How is GPs level of confidence in the diagnosis associated with patients’ feeling of 
reassurance (assessed immediately after the POC-US examination)?  
- 
How is GPs level of confidence in the diagnosis associated with patients’ experience of 
improvement of care? 
 
Trial design:  
Cross-sectional study 
Study setting: 
The study will take place in 20 different general practices in Denmark where the GPs use POC-US. The study 
is part of a follow-up study designed to explore how POC-US affects the diagnostic process in general 
practice.   

The participating GPs will try to include all patients were they use POC-US in the consultation. After the 
consultation patients will be asked to fill out a questionnaire about their experience with POC-US in the 
consultation.  The GPs will provide the patients with a unique ID-number and a link to an online 
questionnaire on the SurveyXact server. The patients will then access the online questionnaire using this ID-
number either through Ipads in the clinic or at home using their own computer, tablet or phone. If the 
patient feels uncomfortable using an online questionnaire, a paper edition will be in provided by the GP 
including a labelled envelope. 
Baseline information (BQGP) regarding the participating GPs will be provided through the original study. 
Baseline questions about the patients (BQP) will be part of the patient-questionnaire following the 
consultation.  
Baseline questions to describe the participating GPs (BQGP) 
Question 
number  
Question  
Catagory 
BQGP 1.1 
How old are you? 
Age 
BQGP 1.2 
Are you a woman/man? 
Gender 
BQGP 1.3 
How many years have you been a GP? 
Experience 
BQGP 1.4 
Which year did you graduate as a doctor? 
Experience 
BQGP 1.5 
How long have you been using ultrasound? 
Experience 
BQGP 1.6 
Would you characterize your practice as a predominantly rural, urban 
or mixed 
Location 
BQGP 1.7 
How is your practice organized? (solo, partnership, collaboration) 
Organization 
BQGP 1.8 
In which region do you practice? 
Location 
BQGP 1.9 
What is the approximate distance from your practice to the nearest 
radiology department where US can be performed? 
Location 
BQGP 2.0 
What kind of US device (name, model, year) and probes do you have? 
Equipment 
BQGP 2.1 
What kind of ultrasound education/training did you receive? 
Experience 
 
Baseline questions about the participating patients (BQP) 
Question 
number  
Question  
Catagory 
BQP 1.1 
Are you a woman/man? 
Gender 
BQP 1.2 
How old are you? 
Age 
BQP 1.3 
Have you been ultrasound scanned in this clinic before? 
Previous 
experience 
BQP 1.4 
Employment  
Socioeconomic 
background  
BQP 1.5 
Level of education  
Socioeconomic 
background  
BQP 1.6 
Level of higher education  
Socioeconomic 
background  
 

Eligibility criteria 
Patients must provide written, informed consent before any study procedures occur (see Appendix 1 for 
sample Informed Consent Form). Only patients assigned to the GPs 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 in this study will reflect their normal daily use of POC-US not adding more 
examinations or in other ways influence on the treatment of patients.    
Outcomes 
The items in this questionnaire are generated from a qualitative interview study with GPs working in 
general practice and using POC-US. The items are the GPs expressed believes and concerns about how POC-
US was experienced by their patients.  
Domain 
Item 
Questions 
Information 
Information on the purpose 
Were you informed about the purpose of the 
ultrasound examination? 
 
Information on the limitations 
Were you informed about the difference between 
a specialist ultrasound and a GP ultrasound? 
 
Information about the findings    
Were you informed about the result of the 
ultrasound examination? 
Consultation 
Natural part of the consultation 
Did you think the ultrasound examination was a 
natural part of the consultation? 
 
Disruptive in the consultation 
 
Did you think the ultrasound examination was 
disruptive in the consultation? 
 
Influence on the relationship 
during the examination 
Did the ultrasound examination influence the 
relationship between the GP and you? 
 
Importance  
 
Do you think ultrasound made a difference in the 
consultation? 
Reassurance 
Thoroughly examined 
Do you feel more thoroughly examined after the 
ultrasound examination? 
 
Explanation 
Do you have a better understanding of your health 
problem after the ultrasound examination? 
 
Sense of security  
 
Do you feel more at ease after the ultrasound 
examination? 
 
Sense of confidence 
Has your confidence in the GPs diagnosis changed 
after the ultrasound examination? 
 
Feeling of being taken seriously  
 
Has the ultrasound examination changed your 
feeling of being taken seriously? 
Patient 
satisfaction 
Overall evaluation 
Was your overall experience with ultrasound in 
the GP’s office positive or negative? 
 
Recommendation to others  
Would you recommend ultrasound in the GPs 
office to others? 
 
Service improvement  
 
Do you think ultrasound is a service improvement 
in the GP’s office?  
 
Quality improvement   
Do you think ultrasound is a quality improvement 

in the GP’s office? 
 
Participant timeline 
 
Year 
2017 
 
 
 
 
 
2018 
 
 
 
 
 
Month 
July 
Aug 
Sep 
Oct 
Now 
Dec 
Jan 
Feb 
Mar 
Apr 
May 
June 
Activity 
 
 
 
 
 
 
 
 
 
 
 
 
Pilot 
 
 
 
 
 
 
 
 
 
 
 
 
Data 
collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sample size  
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 include 640-960 patients during the 
study period of one month.. 
Recruitment 
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 method 
This questionnaire is developed through the following steps: 
1. A first edition of the questionnaire is developed based on the results of a qualitative interview 
study with Danish GPs on their experiences on how ultrasound can be used in general practice. This 
study included both users and non-users of POC-US and the GPs reported how they experienced 
patient attitudes and reactions to POC-US in general practice. The quotations from the interviews 
were included as items in a conceptual model with domains covering the central aspects of the 
GP’s impressions of patients’ experiences of POC-US in general practice. 
2. To test face validity, comprehension and wording, pilot tests will be done with laypeople and 
patients, who have not been ultrasound scanned, using the ”think-aloud” technique and cognitive 
interviewing. The pilot-tests are done in two geographical-separated clinics including five patients 
in each clinic. Adaptions and rephrasing will follow after comparing the results. 
3. A validation test will include presenting the rephrased questions to 5 GPs, who use POC-US, and 
asking them to compare the questions to the original items from the qualitative interviews. 
Adaptions will follow. 
4. A final pilot-test will include interviews with patients in two new clinics using the ”Think-aloud” 
technique. In this pilot-test the patients are presented to both a paper-version and an online-

version of the questionnaire, to test functionality and feasibility. Pilot-tests and adaptions will 
continue until the questionnaire is completed without difficulties. 
Retention  
Participant Retention 
We will ask the GPs to register not-included patients, in whom POC-US was used during the study period, 
on a separate form and to declare the reason for the failed inclusion of the patient.  
The Research group will send weekly updates to the participating GPs to maintain their interest in the 
project, to remind them to include patients when they use POC-US, and to address any difficulties in the 
procedures.  
Participant Withdrawal 
Participating GPs and patients may withdraw from the study for any reason at any time. The investigator also 
may withdraw participating GPs from the study if they are unwilling or unable to comply with required study 
procedures.  
Data management  
Data will be saved electronically in the SurveyXact server and on a server at Aalborg University and will 
only be accessed by the research group using passwords.  
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 
agreements 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.  
The Key files identifying the patients will be safely stored at the GPs office and the research group will not 
have access to this information during the study.   
Statistics  
The questionnaire data will be collected on an ordinal scale and reported descriptively using frequencies. To 
test if the observed frequencies are statistical significant, we will use Chi squared test or fishers exact test. A 
p-value of 0.05 will be considered statistical significant. The association between the GPs reported 
confidence in the tentative diagnosis on an ordinal scale from decreased confidence to increased confidence, 
and patients reported experience of POC-US in the consultation will tested using Goodman and Kruskal’s 
gamma.   
Data monitoring 
During the study period the research team will be able to observe if the GPs include patients in the study 
and make contact to the GPs who fail to include patients in order to help out with any difficulties.       
Harms  
We will register all adverse events occurring during the study.  

Research ethics approval 
The studies will be reported to the Danish Data Protection Agency, the Committee of Multipractice Studies 
in General Practice and will not commence before approval.  
Concent or assent 
Each participating GP will collect data for all conducted POC-US examinations in a one month period.  Prior 
to participation, patients will receive written and oral information and a written consent to participate will be 
obtained. 
If a GP or a patient wished to redraw their consent to participate in the study, the GP will contact the 
research team and the data will be deleted.  
Protocol amendments 
Will be declared and all editions and changes in the protocol will be saved.  
Confidentiality 
All participating GPs have signed a confidentiality agreement.  
Declaration of interest 
None  
Access to data 
Only the Research team will have access to data. 
The key files linking the patient ID and the social security number will be stored under lock in the GPs 
clinics. Only the participating GP will have access to the key file. The anonymized data will be saved at a 
server in SurveyXact or Aalborg University. Only the research team (MBJ and CAA) will have access to this 
data using two unique passwords. 
Dissemination polity 
Manuscript 1: 
Title: How patients experience the use of point-of-care ultrasound in general practice.   
Authors: Camilla Aakjær Andersen, Torsten Rahbek Rudbæk, John Brodersen, and Martin Bach Jensen 
Expected Journal: International peer-reviewed journal 
Expected Time of Submission: Fall 2017 
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