Evaluating Scanning Competence Following a Structured POCUS Training Program for General Practitioners - A Hybrid Effectiveness-implementation Study
Conditions: Ultrasound, General Practice, Family Medicine, Education, Competence
Sponsor: Aalborg University

 
 
 
 
  
 
Study protocol 
Evaluating scanning competence 
following a structured POCUS training 
program for general practitioners 
A hybrid effectiveness-implementation study 
Center for General Practice at Aalborg University 
02-03-2022 
 

General practitioners’ POCUS competence following structured training 
1
Study protocol according to the SPIRIT 2013 Checklist 
Administrative information ............................................................................................................. 3 
1 
Title ...................................................................................................................................... 3 
2a 
Trial registration ............................................................................................................... 3 
2b 
 The World Health Organization Trial Registration Data Set .......................................... 3 
3 
Protocol version ................................................................................................................... 4 
4 
Funding ................................................................................................................................ 4 
5 
Roles and responsibilities .................................................................................................... 5 
5a  
Names, affiliations, and roles of protocol contributors ............................................................ 5 
5b 
Name and contact information for the trial sponsor ................................................................ 5 
5c 
Role of study sponsor and funders ............................................................................................... 5 
5d 
Composition, roles, and responsibilities of the steering committee and safety committee ... 5 
Introduction ..................................................................................................................................... 7 
6 
Background and rationale .................................................................................................... 7 
7 
Specific objectives ............................................................................................................... 8 
8 
Trial design .......................................................................................................................... 9 
Methods - Participants, interventions, and outcomes ................................................................... 10 
9  Study settings ..................................................................................................................... 10 
10 
Participants ..................................................................................................................... 10 
11a 
Description of the intervention ....................................................................................... 11 
11b 
Criteria for discontinuing or modifying allocated interventions for a given trial 
participant ................................................................................................................................. 22 
11c 
Strategies to improve adherence to intervention protocols, and any procedures for 
monitoring adherence................................................................................................................ 22 
11d 
Relevant concomitant care and interventions that are permitted or prohibited during the 
trial…… .................................................................................................................................... 23 
12 
Outcome measures ......................................................................................................... 23 
13 
Time schedule ................................................................................................................ 24 
14 
Sample size ..................................................................................................................... 25 
15 
Recruitment .................................................................................................................... 25 
16a  Allocation Sequence generation ..................................................................................... 25 
16b 
Allocation concealment mechanism ............................................................................... 25 
16c 
Implementation............................................................................................................... 25 
17 
Blinding .......................................................................................................................... 25 
Data collection, management, and analysis .................................................................................. 26 

General practitioners’ POCUS competence following structured training 
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18a 
Data collection - Plans for assessment and collection of outcome, baseline, and other 
trial data .................................................................................................................................... 26 
18b 
Data collection - Plans to promote participant retention and complete follow-up......... 28 
19 
Data management ........................................................................................................... 28 
20a 
Statistical methods for analysing primary and secondary outcomes.............................. 29 
20c 
Missing data ................................................................................................................... 29 
Data monitoring ............................................................................................................................ 29 
21a 
Data monitoring committee (DMC). .............................................................................. 29 
21b 
Description of any interim analyses and stopping guidelines, including who will have 
access to these interim results and make the final decision to terminate the trial .................... 29 
22 
Harms ............................................................................................................................. 29 
23 
Auditing .......................................................................................................................... 29 
Ethics and dissemination............................................................................................................... 30 
24 
Research ethics approval ................................................................................................ 30 
25 
Protocol amendments ..................................................................................................... 30 
26a 
Consent or assent ............................................................................................................ 30 
26b 
Additional consent provisions for collection and use of participant data and biological 
specimens in ancillary studies, if applicable ............................................................................. 30 
27 
Confidentiality ................................................................................................................ 30 
28 
Declaration of interests................................................................................................... 30 
29 
Access to data ................................................................................................................. 30 
30 
Ancillary and post-trial care ........................................................................................... 30 
31a 
Dissemination policy ...................................................................................................... 30 
31b 
Authorship eligibility guidelines .................................................................................... 31 
31c 
Plans for granting public access to the full protocol, participant-level dataset, and 
statistical code ........................................................................................................................... 31 
32 
Informed consent materials ............................................................................................ 31 
References ..................................................................................................................................... 31 
 
 
 

General practitioners’ POCUS competence following structured training 
3
Administrative information 
 
1 
Title 
Evaluating scanning competence following a structured POCUS training program for general 
practitioners - A hybrid effectiveness-implementation study.   
 
2a 
Trial registration 
The trial will be registered on clinicaltrials.org 
 
2b 
 The World Health Organization Trial Registration Data Set 
 
Data category 
Information 
Primary registry and trial 
identifying number 
Clinicaltrials.gov number:  
Date of registration in 
primary registry 
Uploaded to clinical trials Marts 2nd 2022 
Secondary identifying 
numbers 
Red-CAP registration number ID-242-2. Center for General Practice at Aalborg 
University (CAM AAU) 
Source(s) of monetary or 
material support 
n/a 
Primary sponsor 
Center for General Practice at Aalborg University (CAM AAU) 
Secondary sponsor(s) 
Novo Nordisk Foundation 
The General Practice Foundation in Denmark 
Contact for public queries 
mbj@dcm.aau.dk 
Contact for scientific queries 
caakjaer@dcm.aau.dk 
Public title 
General practitioners’ POCUS competence following structured training 
Scientific title 
Evaluating scanning competence following a structured POCUS training program 
for general practitioners – A hybrid effectiveness-implementation study 
Countries of recruitment 
Denmark 
Health condition(s) or 
problem(s) studied 
The use of point-of-care ultrasonography (POCUS) in general practice 
Intervention(s) 
An educational intervention consisting of three teaching seminars over three 
months, a curriculum of 10 point-of-care ultrasound (POCUS) applications, an 
online learning platform providing educational support before, during and after 
the teaching sessions. 
Key inclusion and exclusion 
criteria 
Inclusion criteria:  
1. GP, i.e. postgraduate medical doctor with a specialization in general practice. 
2.Work in office-based general practice in Denmark 
3.Access to an ultrasound device in the practice during the study period  
Exclusion criteria:  
1. GPs with a possible conflict of interest  
2. No signed informed consent to participate. 
Study type 
A hybrid effectiveness-implementation study 
Date of first enrolment 
Expected: March 2022 
Target sample size 
Twenty general practitioners  
Recruitment status 
Not yet recruiting 
Primary outcome(s) 
Primary outcome 1 (P1): For GPs, participating in a POCUS training program 
with online support and three teaching sessions, the ultrasound competence score 
(summarized OSAUS score across ten scanning modalities) after the educational 
period (three months after baseline).  
 

General practitioners’ POCUS competence following structured training 
4
Primary outcome 2 (P2): For GPs, participating in a POCUS training program 
with online support and three teaching sessions, the ultrasound competence score 
(summarized OSAUS score across ten scanning modalities) six months after 
baseline. 
Key secondary outcomes 
Secondary outcome 1 (S1): For GPs, participating in a POCUS training program 
with online support and three teaching sessions, the OSAUS scores and the item 
scores, after the educational period (three months after baseline), for each of the 
ten scanning modalities included in the curriculum. 
 
Secondary outcome 2 (S2): The proportion of GPs, participating in a POCUS 
training program with online support and three teaching sessions, who have an 
ultrasound competence score (OSAUS score) of three or above after the 
educational period (three months after baseline), for all of the seven OSAUS 
items of each of the ten scanning modalities included in the curriculum.  
 
Secondary outcome 3 (S3): The proportion of GPs, participating in a POCUS 
training program with online support and three teaching sessions, who have an 
ultrasound competence score (OSAUS score) of three or above six months after 
baseline, for each of the ten scanning modalities included in the curriculum. 
 
Secondary outcome 4 (S4): The proportion of GPs, participating in a POCUS 
training program with online support and three teaching sessions, who rate 
themselves to be competent to perform un-supervised POCUS in general practice, 
after the educational period (three months after baseline), for each of the ten 
scanning modalities included in the curriculum. 
 
Secondary outcome 5 (S5): The proportion of GPs, participating in a POCUS 
training program with online support and three teaching sessions, who rate 
themselves to be competent to perform un-supervised POCUS in general practice, 
six months after baseline, for each of the ten scanning modalities included in the 
curriculum. 
 
Process-related outcome 1 (PR1): The number of performed POCUS 
examinations by each GP in the first six months after introducing POCUS use in 
general practice (months 1-6 after baseline). 
 
Process-related outcome 2 (PR2):  The number of adverse events and near-miss 
cases associated with the use of POCUS reported by the participating GPs in the 
first six months after introducing POCUS use in general practice (months 1-6 
after baseline).    
 
Process-related outcome 3 (PR3): The proportion of GPs, participating in a 
POCUS training program with online support and three teaching sessions, who 
have completed the different educational elements in the educational intervention 
three months after baseline.  
 
3 
Protocol version 
Version 9. Marts 2nd 2022 
 
4 
Funding  
This study will be conducted as independent research at Center for General Practice at Aalborg 
University and is financially supported by The Novo Nordisk Foundation (grant number 
0061821) and The General Practice Foundation in Denmark (grant number A3495). 

General practitioners’ POCUS competence following structured training 
5
 
5 
Roles and responsibilities 
 
5a  
Names, affiliations, and roles of protocol contributors 
Camilla Aakjær Andersen (CAA) will be the principal investigator.  
CAA and Martin Bach Jensen (MBJ) will oversee the choice of and collection of outcome 
measures 
CAA and MBJ wrote the first draft of the protocol.  
Allan Riis (AR) will draft the data handling and statistical analysis plan (SAP) 
Ulrike Mehnert (UM), Thomas Løkkegaard (TL), Troels Mengel-Jørgensen (TMJ), Liv Dyre 
(LD), Nicolai Soll (NS), Bo Stork(BS) will participate as teachers in the training program  
Ole Graumann (OG), MBJ, Louise Pihl (LP), Christian Sjernebjerg (CS) and Søren Kæseler 
Andersen (SKA) will perform the OSAUS evaluations of scanning competence  
CAA, MBJ, AR, UM, TL, TMJ, LD, NS, BS, OG, LP, CS and SKA are all expected to make 
valuable scientific additions to the draft and will be co-authors on subsequent manuscripts based 
on these data. The definition of author is defined on ICMJE´s four criteria1:  
 
Substantial contributions to the conception or design of the work; or the acquisition, analysis, or 
interpretation of data for the work; AND 
Drafting the work or revising it critically for important intellectual content; AND 
Final approval of the version to be published; AND 
Agreement to be accountable for all aspects of the work in ensuring that questions related to the 
accuracy or integrity of any part of the work are appropriately investigated and resolved. 
   
The expected author list is: Andersen CA, Riis A, ……Jensen MB. 
 
5b 
Name and contact information for the trial sponsor 
Trial sponsor: Center for General Practice at Aalborg University (CAM AAU) 
Contact name: Camilla Aakjær Andersen 
Address: Center for General Practice in Aalborg, Fyrkildevej 7, 1., 9220 Aalborg East, Denmark  
E-mail: caakjaer@dcm.aau.dk 
 
5c 
Role of study sponsor and funders 
Sponsor (CAM AAU) is part of the study design, data analyses and writing of the manuscript. 
Sponsor will ensure that the results will be submitted for publication. Sponsor is non-commercial 
and declares no conflict of interest. 
 
Other sponsors have no part in the study design, data analyses or writing of the manuscript. 
 
The authors declare no conflict of interest. 
 
5d 
Composition, roles, and responsibilities of the steering committee and safety 
committee (see Item 21a for data monitoring committee) 
 

General practitioners’ POCUS competence following structured training 
6
A steering committee affiliated with CAM AAU (TL, UM, TMJ, SKA, MBJ and CAA) will 
handle and oversee the development of the intervention, the coordination and organisation of the 
ultrasound courses, and the data collection and data management.  
 
A safety committee will be set up to handle all reports of adverse and suspected adverse events 
(AEs) and serious adverse events (SAEs). MBJ will head the committee.  
 
 
 

General practitioners’ POCUS competence following structured training 
7
Introduction 
6 
Background and rationale 
The interest in performing point-of-care ultrasound (POCUS) in general practice is increasing, 
advanced due to the development of affordable, mobile ultrasound scanners. Furthermore, 
primary care residents are commonly exposed to POCUS during their hospital-based training 
laying the foundation for its later use in an office-based setting. 
Ultrasound is a highly user-dependent image modality which requires the ability to integrate 
anatomy, image acquisition, and clinical knowledge2. A robust training program in the use of 
POCUS is mandatory to minimize adverse effects in the form of false positive and false negative 
results3 4.  
An increasing body of evidence shows that GPs can perform POCUS in a safe manner5 6. 
However, GPs are faced with unique educational challenges7. While hospital-based physicians 
have the advantage of consulting with their peers if they experience problems with interpreting 
difficult cases, GPs work alone without easy access to more experienced colleagues. 
Furthermore, GPs face a wide variety of clinical conditions which require the GP to be able to 
perform multiple scanning modalities some of which may be infrequently used8. This may lead 
to a decay in competency. Therefore, measures must be put in place to maintain the retention of 
POCUS skills after initial POCUS training. While there are multiple studies showing that GPs 
can learn different scanning modalities, evidence is more limited as to their ability to keep 
competencies over time3. 
 
An educational intervention for GPs’ POCUS education has been developed by this research 
group based on a systematic literature review of educational ultrasound programs for general 
practitioners3, a previous educational intervention8, previous studies exploring the educational 
needs of general practitioners7 9, previous studies exploring skills assessments of POCUS 
performing GPs10 11 and the research groups extensive experience in planning ultrasound 
courses. This educational intervention was built to meet the basic educational needs of GPs by 
combining focused hands-on practical training with an online educational platform that provides 
continuous support in a longitudinal learning process. Prior to this study, the educational 
intervention was pilot tested on six GPs and six GP trainees (unpublished data). Adaptions 
followed based on feedback from participants, to increase feasibility and acceptance of the 
intervention.      
 
Traditionally, ultrasound learning has focused on the number of examinations needed for 
competence12, but this may be an unreliable measure of competence because of the large 
individual variations in learning curves. The Objective Structured Assessment of Ultrasound 
Skills (OSAUS) assessment tool has been developed and validated as a generic tool for assessing 
scanning competence13. The OSAUS scale consists of seven items: ‘indication for the 
examination’, ‘applied knowledge of ultrasound equipment’, ‘image optimization’, ‘systematic 
examination’, ‘interpretation of images’, ‘documentation of the examination’ and ‘medical 
decision-making’ and each item is rated using a provided five-point Likert-scale with 
descriptions of performance ranging from very poor (score = 1) to excellent (score = 5). In a 
setting of a university department of obstetrics and fertility clinic it was shown that a cut-off 
OSAUS score of 3.0 for trans abdominal fetal biometric scans and 2.5 for a systematic pelvic 
scan would effectively discriminate between novices and intermediate/expert users14. Hence, a 

General practitioners’ POCUS competence following structured training 
8
mean score of three or more may be anticipated for users with some experience though even 
consultants at a university department may score below three in some items. 
 
 
7 
Specific objectives  
The overarching aim of this study is to investigate whether a new educational intervention 
tailored for GPs can lead to scanning competence at the end of the training program (three 
months after baseline) and if scanning competence can be maintained after additional three 
months (six months after baseline).  
 
Effectiveness related primary outcomes  
Primary outcome 1 (P1): For GPs, participating in a POCUS training program with online 
support and three teaching sessions, the ultrasound competence score (summarized OSAUS 
score across ten scanning modalities) after the educational period (three months after baseline).  
 
Primary outcome 2 (P2): For GPs, participating in a POCUS training program with online 
support and three teaching sessions, the ultrasound competence score (summarized OSAUS 
score across ten scanning modalities) six months after baseline. 
 
Effectiveness related secondary outcomes 
 
Secondary outcome 1 (S1): For GPs, participating in a POCUS training program with online 
support and three teaching sessions, the OSAUS scores and the item scores, after the educational 
period (three months after baseline), for each of the ten scanning modalities included in the 
curriculum. 
 
Secondary outcome 2 (S2): The proportion of GPs, participating in a POCUS training program 
with online support and three teaching sessions, who have an ultrasound competence score 
(OSAUS score) of three or more, after the educational period (three months after baseline), in all 
of the seven OSAUS items, for each of the ten scanning modalities included in the curriculum.  
 
Secondary outcome 3 (S3): The proportion of GPs, participating in a POCUS training program 
with online support and three teaching sessions, who have an ultrasound competence score 
(OSAUS score) of three or more, six months after baseline, in all of the seven OSAUS items, for 
each of the ten scanning modalities included in the curriculum. 
 
Secondary outcome 4 (S4): The proportion of GPs, participating in a POCUS training program 
with online support and three teaching sessions, who rate themselves to be competent to perform 
un-supervised POCUS in general practice, after the educational period (three months after 
baseline), for each of the ten scanning modalities included in the curriculum. 
 
Secondary outcome 5 (S5): The proportion of GPs, participating in a POCUS training program 
with online support and three teaching sessions, who rate themselves to be competent to perform 
un-supervised POCUS in general practice, six months after baseline, for each of the ten scanning 
modalities included in the curriculum. 
 

General practitioners’ POCUS competence following structured training 
9
Implementation process related outcomes  
 
Process-related outcome 1 (PR1): The number of performed POCUS examinations by each GP 
in the first six months after introducing POCUS use in general practice (months 1-6 after 
baseline). 
 
Process-related outcome 2 (PR2):  The number of adverse events and near-miss cases associated 
with the use of POCUS reported by the participating GPs in the first six months after introducing 
POCUS use in general practice (months 1-6 after baseline).    
 
Proces-related outcome 3 (PR3): The proportion of GPs, participating in a POCUS training 
program with online support and three teaching sessions, who have completed the different 
educational elements in the educational intervention three months after baseline.  
 
8 
Trial design  
This is a hybrid effectiveness-implementation study15. We will test the effectiveness of an 
educational intervention in a real-world setting while gathering information on its delivery and 
the implementation of the intervention.  
 
Reporting of this trial will follow STROBE guideline for reporting cohort studies16. Reporting of 
the protocol will follow the SPIRIT statement17. Before data collection starts, the trial will be 
registered on clinicaltrials.gov 18.  
 
 
 

General practitioners’ POCUS competence following structured training 
10 
Methods - Participants, interventions, and outcomes 
 
9  
Study settings  
This study will be conducted in office-based general practice in Denmark with the educational 
sessions taking place at an ultrasound educational facility (MedSim, Central Denmark Region).  
 
GPs in Denmark are self-employed and work in office-based general practice clinics. Denmark 
has a public health care system where almost all patients are listed with a GP for primary health 
care. Consultations and treatments are free-of-charge for patients. GPs act as gatekeepers for 
other primary care healthcare providers and secondary care specialists. GPs are paid through a 
combination of remuneration and fee-for-service financed through taxes. There is no fee for 
performing POCUS in primary care and GPs must cover expenses for the ultrasound device and 
their ultrasound education themselves.  
 
Continuous medical education for GPs is centrally organized under the wings of the Danish 
Medical Association for General Practitioners (Praktiserende Lægers Organsation PLO-e). PLO-
e is the practical organizer of the ultrasound course delivered in this educational intervention. 
The ultrasound course has been included in PLO-e’s course catalogue for 2022 and as such all 
GPs working in Danish general practice has had the opportunity to sign-up for the course. Hence, 
PLO-e has handled the participant recruitment and registration as well as the financial and 
practical aspects of organizing and executing the course. PLO-e had no influence on the 
scientific content or data collection in the study.       
 
The study will be coordinated from CAM AAU and data will be collected by the research team 
at the training sessions and by the participating general practitioners in their clinics. All study 
data will be stored at a secure server at Aalborg University. 
 
 10 
Participants   
Twenty GPs working in office-based general practice in Denmark, who have signed up for a 
PLO-e ultrasound course, will be invited to participate in the study. To participate a GPs must 
fulfill the inclusion criteria and not the exclusion criteria 
 
Inclusion criteria:  
1. GP, i.e., be a postgraduate medical doctor with a specialization in general practice. 
2. Work in office-based general practice in Denmark 
3. Have access to an ultrasound device in the practice during the study period 
 
Exclusion criteria:  
1. GPs with a possible conflict of interest (e.g., industry affiliation related to the use of 
ultrasound)  
2. No signed informed consent to participate. 
 
The educational intervention will be delivered by an educational team (UM, TL, BS, TMJ, NS, 
CS), who is an experienced GPs, POCUS users and teachers. The competence assessment 
(OSAUS score) will be delivered by a team of POCUS experts (SKA, OG, MBJ, CS and LP), 
who have extensive POCUS experience.   

General practitioners’ POCUS competence following structured training 
11 
 
11a 
Description of the intervention  
All participants will receive the educational intervention. The educations intervention consists of 
three teaching seminars over three months, a curriculum of 10 POCUS applications, an online 
learning platform providing educational support before, during and after the teaching sessions 
(see Figure 1).  
The online platform includes instruction videos demonstrating the performance of POCUS, 
suggestions for additional literature, flashcards training the recognition of pathology, participant 
assignments to support the development of skills, self-quizzes to focus attention of learning 
outcomes and specific actioncards for each of the 10 POCUS applications framing the 
examinations in the clinical context. In addition, the online platform gives participants access to 
webinars and communication with other participants and teachers.       
 
 
Figure 1 Point-of-care ultrasonography educational intervention for general practitioners  
 
 
 
Individual preparation (Days 1-7)  
Prior to the first seminar day, the participants are invited to access and complete the preparatory 
material on the digital platform (Microsoft Teams), which includes suggested literature and 
videos about the basics of ultrasonography, how to perform POCUS, how to use POCUS in the 

General practitioners’ POCUS competence following structured training 
12 
examination of patients, and how to integrate POCUS in the general practice consultation. To 
prime the participant prior to the first seminar the preparation includes a pre-self-quiz outlining 
the specific learning outcomes of the first seminar day.    
The participants also have to respond to an individual assignment where they in words will 
declare their motivation for participating in the course, their expectations for the course, their 
individual learning goals, their previous experiences with POCUS and other prerequisites. They 
will also be asked to identify possible barriers towards their learning process and pose three 
questions that they want answered during the first teaching seminar. This allows for the 
participants to reflect on their own motivation and capability and any difficulties and questions 
they may have. The participants are encouraged to enter the first training session with a focus on 
their individual learning goals and to make sure that difficulties and questions are addressed 
during the seminar. The POCUS teachers will comment on the participants’ assignments. The 
assignment and comments will be saved in the online platform.  
The teachers will address and integrate topics from the assignments during the first teaching 
seminar.   
The pre-course assignment will also include a baseline questionnaire for participants, where they 
will be asked to declare the following information: Age (years), gender (M, F, other), previous 
use of ultrasound (number of months with regular use), previous ultrasound courses of minimum 
1 day duration (yes/no), scanner type (low range, mid-range, high end) and type of transducers 
on the device (categories).  
  
The participants must require an ultrasound device prior to the first teaching seminar and become 
familiar with basic functions. The participants are asked to register questions and difficulties 
related to the use of their ultrasound device and bring these to the first teaching seminar.    
 
Introductory webinar  
Early in the preparation phase, the participants will be invited to attend an introduction webinar, 
where the course leader will introduce the online platform and the course contend to the 
participants. The purpose of the introduction webinar is to stimulate commitment, create 
awareness about course content and requirements, and introduce and facilitate use of the online 
platform. The participants will also be encouraged to plan for the implementation of POCUS 
training during daily routines, to allocate time for practice each week, and to discuss possible 
barriers for this with colleagues.    
 
Curriculum 
From a previous qualitative study, we know that GPs select and perform POCUS examinations 
that are focused on a specific clinical problem, relevant in the clinical context, within the GPs 
area of interest, not too time consuming, and not too difficult to perform19. For this education 
intervention 10 POCUS scanning modalities have been selected. 
This selection is based on: (1) a previous systematic needs assessment9 assessing the relevance of 
different scanning modalities, (2) previous studies measuring the frequency of different POCUS 
modalities used in general practice8 10, (3) a national survey in Denmark exploring which 
POCUS examinations were performed by GP20, and (4) evidence of the diagnostic accuracy of 
different scanning modalities performed in the hands of non-imaging specialists (Table 1).  
Hence, the selected curriculum for this study include ten POCUS scanning modalities that are 
frequently encountered in general practice, relevant in the clinical setting in terms of POCUS 

General practitioners’ POCUS competence following structured training 
13 
examinations with an impact on diagnostic security or clinical pathway and manageable in terms 
of performance and competence.     
To prevent cognitive overload21 22 and because previous studies have shown that GPs often start 
scanning just a few application7 19, the ten scanning modalities in the curriculum will be 
introduced stepwise. Five scanning modalities will be introduced on the first teaching seminar, 
while the remaining five applications will be introduced on the second teaching seminar.   
 
Table 1 Diagnostic accuracy of curriculum for the educational intervention  
Curriculum 
Diagnostic accuracy* 
% of current 
users who 
perform the 
examination 
(National survey)20 
% of users who 
found the 
examination 
relevant  
(Delphi study)9 
 
sensitivity specificity 
First teaching seminar  
 
 
 
 
 
Residual urine (bladder)23 
69.0 
99.0 
72% 
100% 
 
Hydronephrosis (kidney)24 
70.2  
75.4 
46% 
95% 
 
Viable intrauterine pregnancy (uterus)25 
97.0 
98.0 
87% 
93% 
 
Joint effusion (knee)26 
0.84 
0.93 
46% 
73% 
 
Gallstone (Gall bladder)27 
89.8 
88.0 
64% 
98% 
Second teaching seminar  
 
 
 
 
 
Ascites (abdominal FAST)28 
100.0 
100.0 
37% 
85% 
 
Intrauterine device location (uterus)** 
 
 
86% 
95% 
 
Constipation (Rectum diameter)*** 29 
95.5 
94.1 
19% 
46% 
 
Subcutaneous abscess (skin)30 
96.2 
82.9 
42% 
98% 
 
Pleural effusion (lung)31 
88.0 
90.0 
28% 
76% 
*Diagnostic accuracy of POCUS reported in studies using the same scanning protocol as we intend to use in this intervention.  
** No studies have been identified, where ultrasound is compared to a gold standard e.g. MRI or CT scan  
*** Using POCUS for measuring rectal diameters as part of the ROM-IV criteria for diagnosing constipation in children is a relative new 
scanning modality and as such the GPs participating in the above-mentioned studies, have not been trained to perform the examination. However, 
the examination has been included in the NICE guidelines and the patient category is common in general practice.  
 
Actioncards 
A basis of the educational intervention are actioncards designed for each POCUS scanning 
modality. The actioncards are 1-page instructions specifying the indication for performing the 
POCUS examinations, the transducer and specific equipment settings needed to perform the 
examination, the POCUS procedure including transducer placement, image acquisition and 
optimization, the interpretation of the examination, possible pitfalls to be aware off and 
integration of findings into a clinical context.  
The actioncards are used as résumés of the preparation literature, to structure the examination 
during the teaching seminars and as supporting guidelines that can be used or consulted during 
the examination if needed.      
 
 
 
 
 

General practitioners’ POCUS competence following structured training 
14 
Figure 2 Actioncards describing a specific scanning modality 
 
 
Instruction videos  
An instruction video is developed for each of scanning modalities included in the curriculum. All 
instruction videos are built with a structure similar to the structure of the actioncards: (1) 
Description of the indication for the examination, (2) Description of the needed equipment and 
equipment settings, and (3) demonstration of the conduction of the POCUS examination 
including tips and tricks regarding transducer placement, patient cooperation, image optimization 
etc.  
The video demonstration of the performance of the POCUS scan will be divided into three 
pictures that are displayed simultaneously. One picture illustrating the ultrasound image on the 
monitor, one picture illustrating the hand on the transducer and thereby the transducer 
manipulation and one picture illustrating the anatomy.  
 
Self-tests 
Participants have access to self-tests before (pre-self-test) and after (post-self-test) each teaching 
seminar. These self-tests include 10-15 questions covering the learning outcomes of each 
teaching seminar and the pre- and post-tests for each seminar are largely similar. Some questions 
will concern ultrasound physics and basic scanning knowledge, others will be more application 
specific. Hence, the pre-self-test is designed to prime participants and create awareness about the 
learning outcomes of the following teaching seminar, whereas the post-self-test is designed as 
individual feed-back for participants and to create awareness about certain difficulties or missed 
information. The POCUS-teachers will monitor the results of these tests as part of their 
assessment of the participants learning progress.    
Indication for 
using POCUS 
Equipment 
needed 
Procedure 
description 
and image 
illustration 
Possible 
pitfalls  
Interpretation in 
a clinical context  

General practitioners’ POCUS competence following structured training 
15 
 
Assignments  
Throughout the learning process, participants will be invited to complete online assignments. 
The first assignment will be a questionnaire concerning the individual participants’ capability, 
opportunity and motivation for using POCUS. These factors are known key-elements driving the 
behavior of healthcare providers32. Hence, we aim to identify previous experience with POCUS 
in order to assemble groups of participants with similar background for the hands-on sessions, 
identify possible barriers for the learning process in order to remove these or minimize the 
influence of these in the learning process and identify motivational factors to create awareness 
about these among participants and to use these in the learning process and mentoring.  
In between teaching seminars, a number of assignments will include uploading of POCUS scans 
for review and feed-back from the POCUS teachers. Before the second and third seminar day, an 
assignment will be sent to participants including a questionnaire where participants are asked to 
specify learning goals and questions for the coming teaching seminar in order to create 
awareness about these. Participants are encouraged to brings these to the teaching seminar to 
ensure that questions are covered or addressed during the seminar.   
 
Webinars  
In between teaching seminars, participants will be invited to participate in short webinars 
addressing obstacles and difficulties encountered in the learning process. The course director and 
the teachers will have gathered topics for the webinar from monitoring the individual 
participants’ learning processes registered in logbooks, self-tests results, uploaded assignments 
or questions posed in the chat forum. Webinars will be approximately 30 minutes and 
participants will have the opportunity to ask questions during the sessions.       
 
Online groupware platform (from day 1) 
The educational intervention includes an online groupware platform, which all participants in the 
course and the teachers have access to.  
 
Figure 3 Online platform to support the longitudinal learning process  
 
 

General practitioners’ POCUS competence following structured training 
16 
 
Through the online platform participants will have access to:  
1. Course information including timelines, course material, general and practical information.  
2. Folders where actioncards, documents, instruction videos and other education material are uploaded.  
3. A wall for sharing information between all participants. Here there is a group chat function, where 
participants may share experiences and reflections with each other the learning process. The teachers may 
also engage in this ongoing debate. Videos, documents, links etc. may be uploaded or posted and shared 
here and all participants will have the opportunity to comment on uploads and posts. Notifications for the 
participants are also posted here.  
4. Invitations to webinars with the teachers, where tips and tricks are shared based on the participants 
uploaded or returned comments, feed-back, uploads and logbook registrations. 
5. A document where notes can be shared between the participants during webinars or teaching seminars. 
6. Link to the individual assignments to be completed by participants during the learning process. The 
teachers on the course have the opportunity to comment and respond in the assignment.  
7. A logbook where the individual participant can note conducted POCUS examination during the learning 
process (date, type of POCUS, focus during the examination, reflections afterwards). A template specifies 
the number of examinations recommended at each phase in the educational intervention.  
8. A direct chat opportunity with the teachers, where participants can have access to guidance and support 
from the course teachers. It is also possible to upload scanning images or videos for review by the teachers.  
9. The individual structured feedback for all scanning modalities collected at teaching seminar 2 and 3.   
10. Access to Pre/post self-quizzes before and after each training seminar and access to the results.  
 
Participants will receive a notification by email or on their phones, when there is activity on the 
online platform. The overall purpose of this online platform is to support the participant in the 
continuous learning process. We aim to create awareness about the learning process, individual 
focus points and goals, the importance of training and gaining experience, and to make guidance 
available when difficulties/problems are encountered.   
 
Teaching seminars (day 7, 30 and 90) 
The educational intervention includes three teaching seminars on days 7, 30 and 90. All seminar 
days have a similar overall structure with a focus on hands-on training and the individual 
participant’s development of scanning competences. However, the teaching aims are different on 
each seminar which means different focus in the teaching and different activities between 
seminar days.    
 
Teaching seminar 1 
The aim of the first teaching seminar is to give participants first-hand experiences with 
performing POCUS scans and to create a foundation of knowledge and experience which is to be 
further developed in the coming months. Furthermore, the participants will learn to perform five 
of the POCUS scans in the selected curriculum.  
The teaching seminar will start off with a short lecture summarizing the theoretical foundation 
for using POCUS and the participants preparation. The teachers will summarize the results of the 
first assignment and address questions, barriers and concerns raised by participants. Afterwards, 
a short lecture will follow introducing basic transducer manipulation and image optimization. 
The participants are then introduced to the five selected POCUS modalities in a short lecture 
summarizing the fundamentals of the five scans. The participants are then divided into small 
groups of four participants based on their POCUS experience as declared in the prior assignment. 
Participants working in the same practice, will be separated into different group to ensure a good 

General practitioners’ POCUS competence following structured training 
17 
group dynamic. The small groups will now circulate between hands-on workshops (Figure 4). 
Each hands-on workshop will focus on one scanning modality. At the workshop, a teacher 
demonstrates the scanning modality according to the specific actioncard. The participants then 
take turns explaining the performance of the scan and practice performing the POCUS 
examination on healthy volunteers (or phantoms for pelvic ultrasound).  The teacher will assist 
and provide guidance. During this first teaching seminar, the participants attend five workshops 
and thereby get their first experiences with conducting five of the POCUS examinations 
according to the actioncards. The participants attend the five workshops twice – first with a focus 
of getting the view and optimizing the view and second with a focus on optimizing the image. 
Hence, the workshops are constructed in order to (1) conceptualize the POCUS scan, (2) 
visualize the POCUS scan, (3) verbalize the POCUS scan and finally (4) practice the POCUS 
scan33. The overall aim with the workshops is to enable participants to perform the five POCUS 
examination with assistance.   
 
Figure 4. Structure of hands-on workshops on the first teaching seminar  
 
 
The participants will be asked to bring their own ultrasound device for the teaching seminar in 
order to learn to master their own device. The small groups are composed to match members 
with similar equipment, prior knowledge and similar competence.   
At the beginning of the day, the participants will be asked to share their learning goals and 
specific challenges with their small group and at the end of the day, they will have time to 
discuss the learning outcomes of the day and consult the teachers with unanswered questions.    
After the teaching seminar a post-self-quiz is available (a replication of the pre-self-quiz) for the 
participants to create awareness about learning process and to illustrate to which extend the 
learning objectives of the first teaching seminar made been reached. The teachers will reach-out 
and offer extra support to participants where the test scores or performance during the hands-on 
workshops reveal problems or difficulties.    
 

General practitioners’ POCUS competence following structured training 
18 
In-between teaching seminar 1 and 2 (practice phase) 
After the first teaching seminar participant are encouraged to start practicing POCUS 
examinations. This phase in the learning process is considered and articulated as a training phase, 
where participants are to conduct as many POCUS examinations as possible with a primary aim 
of training without having to draw conclusions based on their scans. As such, participants are in 
this phase encouraged to treat patients as usual without taking scan results into account. 
Participants are also encouraged to train examinations on volunteers e.g. family members, as the 
goal in this phase is to perform as many examinations as possible.  
During the three weeks between the two teaching seminars, participants are encouraged to 
register all POCUS examinations in their individual logbook and note reflections and questions 
that occur during this process.  It is recommended that participants aim to perform a minimum of 
three POCUS examinations of each scanning modality in the curriculum and upload one POCUS 
examination of each scanning modality for review by the teachers (assignments 2, 3, 4, 5, and 6).  
Midway in the practice phase (day 20), participants will be invited to participate in a half-an-
hour webinar. In this webinar, one of the teachers will go though some of the encountered 
problems and difficulties uploaded or posted on the online platform. Participants will also have 
the opportunity to ask questions.  
Prior to the second teaching seminar, assignment 7 is send to the participants. In this assignment 
participants have to register their specific focus points and individual learning goals for the 
second seminar as well as any questions they may have to the teachers. 
A specific pre-self-quiz will be available before teaching seminar 2. This self-test will access 
basic knowledge of the five POCUS scans introduced at the first teaching seminar and prime the 
participants for the learning objective of the second teaching seminar.   
 
Teaching seminar 2 
From evaluation of previous POCUS training sessions, we know that GPs usually start off 
practicing their scanning skills by selecting a few scanning modalities in the curriculum. Thereby 
they develop a comfort zone of scanning modalities before they move on to include more 
scanning modalities in their portfolio. Therefore, the aim of the second training seminar is to (1) 
validate the scanning modalities that the participating GPs have been practicing in order to adjust 
and improve their performance, (2) to repeat and refresh the scanning modalities in the 
curriculum, that the participants have not been practicing in-between the teaching seminars to 
make the participant comfortable to move on to train these or even include these in their 
portfolio, (3) to provide feedback on performance and allow for guidance and support on 
encountered problems or difficulties and (4) to introduce five new POCUS modalities.  
The teaching seminar starts off with a plenum session where encountered experiences, problems 
or difficulties are shared and discussed. The teachers will address registrations and reflections 
from the logbooks, assignment 7 and common difficulties identifies in the uploaded scans. The 
participants are invited to openly share and discuss. Afterwards, the participants are divided into 
small groups of four participants and they then circulate between hands-on workshop stations, as 
they did in teaching seminar 1. The first five workshop stations will include the five scanning 
modalities taught at the first teaching seminar. Here, the teacher will not demonstrate the scan or 
lecture, instead the participants will take turns demonstrating the scan for the teacher. The 
teacher will then assess the participants’ individual scanning competences using an adapted 
version of the OSAUS score including only items 2-5 which focus solely on the technical and 
practical ability to produce ultrasound images. It has been the intention from the beginning, that 

General practitioners’ POCUS competence following structured training 
19 
items 1 and 6 should only be used if applicable13. The teachers will give feedback on ways to 
improve performance and help the participants to set new learning goals and focus points for the 
continuous learning process. The feedback and teacher suggestions are uploaded to the 
participants individual channels on the online platform, allowing participants to consult these at a 
later stage in the learning process. While one participant is demonstrating the scan for the teacher 
using one of the scanners at the workshop, the remaining three participants will practice 
performing the scan and give each other feedback using the other ultrasound device.      
Following the first five workshops, there will be a short lecture for all participants, where the 
five new scanning modalities are explained and elaborated. After this the participants return to 
the workshops.   
The next five workshop stations will introduce five new scanning modalities from the selected 
curriculum. At the workshop, a teacher will demonstrate the scanning modality according to the 
specific actioncard. The participants will then take turns explaining the performance of the scan 
and practice performing the POCUS examination on healthy volunteers (or phantoms for pelvic 
ultrasound).  The teacher will assist and provide guidance.  
 
After the second teaching seminar a post-self-quiz is available (a replication of the pre-self-quiz 
for teaching seminar 2) for the participants to create awareness about learning process and to 
illustrate to which extend the learning objectives of the first teaching seminar made been 
reached. The teachers will reach-out to participants, where the test scores reveal problems or 
difficulties, as well as participants, where the OSAUS score revealed specific difficulties. These 
participants will be offered additional support if needed.   
 
In-between teaching seminar 2 and 3 (developing phase) 
This phase in the learning process is considered and articulated as a developing phase, where 
participants continue to develop their scanning skills and routines. The participants are 
encouraged to use POCUS examinations on all patients with relevant clinical conditions suited 
for POCUS and to work with the integration of POCUS into their clinical practice and medical 
decision making. It is important in this phase that the participants develop routines and become 
comfortable performing POCUS examinations.  During the eight weeks between the teaching 
seminars 2 and 3, participants are encouraged to register all POCUS examinations in their 
individual logbook in the online platform and note reflections and questions that occur during 
this process. The participants will still have the opportunity to consult the teachers during this 
phase by uploading questions, images or videos to the online platform. It is again recommended 
that participants perform a minimum of three POCUS examinations on patients within each 
scanning modalities during the eight weeks and that participants upload at least one POCUS 
examination of each of the five new scanning modalities for review and feed-back (assignments 
8-12).    
During the eight weeks, participants will be invited to participate in two half-an-hour webinars 
(on day 50 and 75). At these webinars, one of the teachers will go though some of the 
encountered problems and difficulties uploaded or posted on the online platform and present 
images and videos of common pathologies with the 10 selected POCUS modalities. Participants 
will also have the opportunity to ask questions and the teacher will have an ultrasound device 
and a volunteer available for live POCUS demonstration.  

General practitioners’ POCUS competence following structured training 
20 
Before the third and final teaching seminar, the participants will be asked to complete a pre-self-
quiz and to send in a list of questions or topics that they want included in the final teaching 
seminar (assignment 13).  
 
Teaching seminar 3 
Before the final teaching seminar, the teachers will prepare feedback for each participant based 
on the information gathered about each participant, i.e., from notes in the logbook, the uploaded 
scans, impressions from teaching seminars, the correspondence in the chat function, etc. 
The structure of this final teaching seminar is similar to previous seminars. However, besides 
validating, adjusting and improving the participants’ POCUS examinations, the goal is also to 
evaluate the participants’ learning process, scanning competence and to offer guidance for future 
development.  
Like the second seminar, this teaching seminar starts off with a plenum session where 
encountered experiences, problems or difficulties are shared and discussed. The teachers will 
address questions raised on the online platform and common difficulties identifies in the 
uploaded scans. The participants are invited to openly share and discuss. Afterwards, the 
participants are divided into small groups of 4 participants and they then circulate between 
hands-on workshop stations, as they did on the previous seminars. At the workshop stations, the 
participants will take turns demonstrating the POCUS scan for the teacher (figure 5). The teacher 
will then assess the participants’ individual scanning competences using item 2-5 on the OSAUS 
score, give feedback on ways to improve performance and help the participants to set new 
learning goals and focus points for the continuous learning process. The participants will also 
receive suggestions for improvement from fellow participants, as the instructor invites to a 
discussion about the use of the scanning modality in general practice. The feedbacks and teacher 
suggestions are uploaded to the online platform, so participants may consult these at a later stage.   
 
Figure 5. Structure of hands-on workshops on the third teaching seminar  
 
 
At the end of the teaching seminar, participants will be asked to evaluate the educational 
intervention, their own learning outcome and to identify unanswered questions in the small 
groups. Afterwards, these a discussed in a final plenary session for all participants and teachers. 

General practitioners’ POCUS competence following structured training 
21 
If needed, the teachers will upload additional information to the online platform to support the 
participants’ further learning.            
After the teaching seminar a final post-self-test is available (a replication of the pre-self-test for 
teaching seminar 3) for the participants to create awareness about continuous learning process 
and to illustrate to what extend the learning objectives of the teaching seminar have been 
reached. The teachers will reach out to participants, where the test scores reveal problems or 
difficulties, as well as participants, where the demonstration of the scan revealed specific 
difficulties. These participants will be offered additional support.  
 
Competence assessment by experts  
On the third teaching seminar, participants will have their scanning competence assessed by 
external experts. These experts are blinded to the participants previous experience and learning 
process. During the workshop rotation, each participant will step-a-side to have their competence 
assessed by a POCUS expert. This assessment will be staggered from the scanning modality 
being the topic of the workshop. Hence, the participants will first have the workshop with a 
specific scanning modality and then immediately after, during the next workshop, they will take 
turns, stepping-a-side for 10 minutes to have their scanning competence for the modality 
assessed.  
The experts will assess the participants by asking the following questions: 
- 
In which clinical scenarios would you perform this POCUS examination (Item 1 in the OSAUS) 
The experts will ask participants to demonstrate the POCUS examination (for maximum five 
minutes) to assess the following:  
- 
Applied knowledge of the ultrasound equipment (Item 2 in the OSAUS)  
- 
Image optimation (Item 3 in the OSAUS)  
- 
Systematic examination (Item 4 in the OSAUS)  
- 
Interpretation of images (Item 5 in the OSAUS)  
The experts will present the participants with two picture of common pathology and ask the 
participants the following questions:   
- 
How would you interpret these ultrasound findings? (Item 5 in the OSAUS)  
- 
If you were to describe this examination in the medical record, what would you write? (Item 6 in the 
OSAUS) 
- 
What would you do if you found it? (Item 7 in the OSAUS) 
Immediately before each competence assessment by experts, participants will be asked to fill out 
a questionnaire where they declare whether or not they have POCUS scanning competence 
within this scanning modality to perform the scan un-supervised in general practice.  The expert 
assessor are blinded to this declaration.   
 
Participant commitment  
The educational intervention requires considerable commitments from the participants (Figure 
6). This will be outlined in both the course description, the introduction webinar and on the first 
teaching seminar. Participants will have to allocate three whole days for the teaching seminar 
and considerable time to practice scanning skills especially during the training phase (days 8-29).  
Furthermore, time will be allocated to perform assignments and follow the discussion on the 
online platform.  
To ensure this commitment, time will be spent on building group relations on the first teaching 
seminar. In addition, a teacher will be allocated each participant as a mentor during the learning 
process. The mentor will monitor individual progress in the online platform and correspond with 

General practitioners’ POCUS competence following structured training 
22 
the individual participant in the chat functions, provide feed-back on assignments and reach out 
to participants, who fail to be active on the online platform.  
 
 
Figure 6. Overview of participant activities in the educational intervention  
 
 
11b 
Criteria for discontinuing or modifying allocated interventions for a given trial 
participant  
The trial may be discontinued for a GP in case of withdrawal of an informed consent. Hence, 
data collection will stop for that person at the time of withdrawal of the informed consent. 
Otherwise, this is an intention-to-treat study hence participants will not be excluded because of 
low adherence to the educational elements. However, we will collect data of the degree of 
participation for each participant.  
 
11c 
Strategies to improve adherence to intervention protocols, and any procedures for 
monitoring adherence  
The teacher will act as mentors for the participants and monitor participants’ activity on the 
online platform. The teachers will monitor the activity of the participants, they are mentoring and 
reach out to participants, who fail be active on the online platform or complete assignments. 
Reminders are sent to the GPs during the six months to remind them to register all POCUS 
examinations performed during clinical work.  
 

General practitioners’ POCUS competence following structured training 
23 
11d 
Relevant concomitant care and interventions that are permitted or prohibited 
during the trial 
The GPs are asked to refrain from seeking other POCUS education or courses during the study 
(months 1- 6). Still, information seeking e.g. through internet sources or books are allowed 
throughout the study.  
 
12 
Outcome measures  
 
Primary outcomes:  
The primary outcome is the Objective Structured Assessment of Ultrasound Skills (OSAUS) 
score scored after three (P1) and six months (P2). 
 
The OSAUS assessment tool has been developed and validated as a generic tool for assessing 
scanning competence13. The OSAUS scale consists of seven items: ‘indication for the 
examination’, ‘applied knowledge of ultrasound equipment’, ‘image optimization’, ‘systematic 
examination’, ‘interpretation of images’, ‘documentation of the examination’ and ‘medical 
decision-making’ and each item is rated using a provided five-point Likert-scale with 
descriptions of performance ranging from very poor (score = 1) to excellent (score = 5). All items 
are weighted equally, as high inter-item correlation have been found previously14. Hence, for 
each scanning modality a total score from 7 to 35 points may be achieved.  
 
(P1): The summarized OSAUS score after the educational period (three months after baseline) 
for all ten modalities will be calculated as percentage of maximum score and presented as 
median, IQR, minimum and maximum score.  
 
(P2): The summarized OSAUS score after six months for all ten modalities will be calculated as 
percentage of maximum score and presented as median, IQR, minimum and maximum score.  
 
Secondary outcomes 
(S1). The total OSAUS score and the total items scores for each scanning modality included in 
the curriculum after the educational period (three months after baseline) will be calculated and 
presented as median, IQR, minimum and maximum score. 
 
(S2). We calculate the proportion of GPs, who achieve a minimum OSAUS score of three for all 
seven domains for each of the ten scanning modalities after the educational period (three months 
after baseline). As variation in scores can occur between the four expert assessors. We will 
normalize the scores by multiplying a given accessors score with (0.2 x sum of scores of all five 
accessors/the given accessors mean score) prior to calculating the proportion of successful GPs.  
 
(S3): We calculate the proportion of GPs, who achieve a minimum OSAUS score of three for all 
seven domains for each of the ten scanning modalities after six months.  
 
(S4): We calculate the proportion of GPs, who rate themselves as competent to perform POCUS 
un-supervised in general practice, after the educational period (three months after baseline), 
within each of the ten scanning modalities.  
 

General practitioners’ POCUS competence following structured training 
24 
(S5): We calculate the proportion of GPs, who rate themselves as competent to perform POCUS 
un-supervised in general practice, after six months, within each of the ten scanning modalities.  
 
Implementation process-related outcomes  
 
(PR1): The GPs keep a log book of all scans they perform. The number of scans of the 10 
modalities performed during months 1 to 3 and month 4 to 6 are summarized. Results are 
presented as the mean number of performed POCUS examinations by each GP during months 1 
to 3 and during months 4 to 6. 
 
(PR2): The number of adverse events and near-miss cases associated with the use of POCUS 
during months 1 to 6 will be summarized for each of the ten scanning modalities. Results will be 
presented as total numbers and frequencies.  
 
(PR3): We will graphically evaluate the mean OSAUS score (y-axis) at the end of the 
educational intervention (3 months after baseline) as a function of each of the following 
educational aspects (x-axis). 
a. 
course days 
b. webinars,  
c. 
pre-and post-self-quizzes   
d. assignments (upload and feed-back) 
e. 
scans performed during the educational intervention   
 
Background characteristics of participating GPs 
At baseline the following participant characteristics will be collected: Age (years), gender (M, F, 
other), year of graduation from medical school, experience as a GP working in general practice 
(years), previous experience with ultrasound use (yes/no), previous training in ultrasound use 
(yes/no), scanner type (low range, mid range, high end), type of employment (practice owner/ 
employed/other), type of practice (collaboration, partnership, solo), location of practice (urban, 
rural, mixed), distance to nearest radiology department (km), number of patients assigned to the 
practice, number of GPs working in the practice will be presented. 
 
13 
Time schedule  
 
Figure 7 Study timeline   
Week  
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
25 
26 
27 
28 
29 
30 
31 
32 
33 
34 
35 
webinar 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Teaching 
seminar  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Skills 
assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Educational 
period  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Transition 
period  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Teaching seminars: Marts 3rd and 30th and June 9th 2022 
Skills assessment: June 9th and September 1st 2022 
Data collection educational period (months 1-3): Marts 3rd – June 9th 2022 

General practitioners’ POCUS competence following structured training 
25 
Data collection after educational intervention (months 4-6): June 10th – September 1st 2022 
 
14 
Sample size  
 
Our potential study population is 20 GPs who have signed up to participate in an ultrasound 
course organized by PLO-e. We expect a participation rate of 80% corresponding to 16 GP. 
 
With 16 participants the total number of possible completed 7-item OSAUS questionnaires will 
be 16 for each modality and 160 for the combined estimate after 3 months and after 6 months. 
This is considered sufficient to estimate mean estimates and provide confidence intervals with 
acceptable spread.  
 
15 
Recruitment  
Generally, to successfully change health care professionals’ behaviours an intervention has to 
address motivation, capability, and opportunity32. From interviews with GPs not using POCUS 
(unpublished data) and a national survey20, we have identified the following specific barriers to 
implementation of POCUS in general practice: 
- 
cost of the ultrasound equipment  
- 
lack of remuneration for performing POCOS,  
- 
lack of education in the use of POCUS,  
- 
lack of guidelines,  
- 
high workload and time pressure in general practice.  
 
This intervention was designed to take these potential barriers into account. From cohort studies 
conducted in Danish general practice we know that the time consumption for performing 
POCUS is below 10 minutes for the majority of novice POCUS users8 and with a median of 5 
[IQR 3-8] minutes among experienced POCUS users10. However, we do not know if 
implementing POCUS in general practice overall increase or decrease work load. 
Assignment of interventions  
16a  
Allocation Sequence generation 
n/a 
16b 
Allocation concealment mechanism 
n/a 
16c 
Implementation 
n/a 
 
17 
Blinding  
Expert assessors performing the competence assessment (primary outcomes) have a medical 
background and are considered experts in the field. They will not be teaching participants in the 
training program. They will be blinded to the participants prior experience with POCUS, the 
number of performed POCUS examinations, and any other elements in the participants’ learning 
process. 
The researcher cleaning the data set and responsible for analyzing the primary outcome will have 
no knowledge of participants. He is a researcher with a physiotherapy background. 

General practitioners’ POCUS competence following structured training 
26 
Data collection, management, and analysis 
 
18a 
Data collection - Plans for assessment and collection of outcome, baseline, and other 
trial data 
The OSAUS ultrasound competence assessment tool have been developed as a genetic tool to 
assess ultrasound competence across medical specialities. The assessment tool was developed 
through a Delphi study13 and it has been used to assess clinicians’ ability to transfer learning 
from an ultrasonography course into diagnostic performance on patients11. Furthermore, the tool 
has been found valid and reliable to distinguish between novice POCUS users and experts34.    
 
The OSAUS assessment tool measures competency according to seven key domains: 1) 
Indication for the examination 2) Applied knowledge of ultrasound equipment 3) Image 
optimization 4) Systematic examination 5) Interpretation of images 6) Documentation of 
examination and 7) Medical decision making.  Each domain is rated using a five-point Likert 
scale with descriptions of performance ranging from very poor (score=1) to excellent (score=5).  
 
Figure 8. The OSAUS competence assessment tool 
 
 
From: Tolsgaard MG, Todsen T, Sorensen JL, Ringsted C, Lorentzen T, Ottesen B, et al. (2013) International Multispecialty Consensus on How 
to Evaluate Ultrasound Competence: A Delphi Consensus Survey. PLoS ONE 8(2): e57687. https://doi.org/10.1371/journal.pone.005768 
(reference 13) 

General practitioners’ POCUS competence following structured training 
27 
 
Education of POCUS expert assessors 
The POCUS expert assessors all have prior experience using the OSAUS score. Still, prior to the 
assessment of the participants’ performance in this study, the POCUS experts participate in a 90-
minutes online training session with the principal investigator (CAA). During this training 
session, the POCUS experts are presented to the OSAUS score and the procedure for assessing 
the participants in this study. The POCUS experts are instructed to rate according to the standard 
expected from a GP, who is capable of performing POCUS unsupervised in general practice. 
During the training session, the POCUS experts will rate five POCUS videos individually and 
afterwards compare and discuss the results until agreement is reached. A similar training of 
POCUS raters has been reported in previous studies14,34.   
 
Self-rated scanning competence  
Before the competence assessment by experts, the participants are asked to fill out a 
questionnaire, where they will declare whether or not they have the scanning competence to 
perform the given POCUS examination un-supervised in general practice.  
 
Registration of performed POCUS examinations  
The paper registration of clinical practice during patient consultations in general practice using 
APO registration sheets is a well-known and established method in Danish general practice35. 
A paper logbook for participants will be developed as registration sheets for the participating 
GPs registration of POCUS use during the educational intervention (months 1-3 after baseline) 
and in the months following the intervention (months 4-6 after baseline). The registration sheets 
will be adapted versions of the sheets used in a previous APO studies8 (figure 9). This 
registration sheet has been used in a pilot study of the educational intervention (unpublished 
material). 
 
Fig.9. Adapted version of a registration sheet used in a previous cohort study 
 
 

General practitioners’ POCUS competence following structured training 
28 
 
Adverse events and near-miss cases  
Adverse events (AE) and serious adverse events (SAE) related to or possibly related to the use of 
POCUS will be registered during all time after the training sessions. 
 
At the teaching sessions, participating GPs will be taught how to report AE and SAE related or 
possibly related to the use of POCUS as well as near-miss cases. These events will be reported to 
the study adverse event committee in an online questionnaire specifically designed for this 
purpose. The participants will have a link for an online questionnaire in SurveyXact (Rambøll, 
Aarhus Denmark) where they will register: (1) Type of POCUS, (2) indication for the 
examination, (3) description of the event, (4) participant’s reflections after the events and (5) 
questions for the adverse events committee.        
 
The reporting of AE/SAEs to the study adverse event committee does not substitute or have any 
influence on the GPs responsibility to report adverse events to the Danish authorities (UTH 
anmeldelse). 
 
Educational activities 
The participants’ participation and activity in the educational elements will be registered during 
the educational period (months 1-3) on the online platform and by the principal investigator 
using Excel.   
 
18b 
Data collection - Plans to promote participant retention and complete follow-up 
During the study, the principal investigator is available for consultation for the participating GPs 
in order to resolve any problems or obstacles. Monthly remainders will be sent to the 
participating GPs remaining them to include patients and contact the research team in case of 
problems.   
 
19 
Data management 
The OSAUS assessment will be filled out by the expert assessors in questionnaires using tablets. 
The expert assessors will access the SurveyXact app (Rambøll, Aarhus, Denmark) on the tablets 
using unique access links. The Raters will then insert the GP ID number and fill out the 
questionnaire. After filling out the questionnaire, the access will close. As internet access may be 
unstable at the training facilities, the questionnaire can be filled out on both offline and online 
tablets. If the tablet is online, the questionnaire is stored directly on SurveyXact’s server. If the 
tablet is offline, the questionnaire is stored safely in the app for direct upload when internet 
access is achieved. Questionnaires stored in the app cannot be accessed. The questionnaires 
stored on SurveyXact’s server can only be accessed by the research team. Backup copies from 
the SurveyXact server are weekly collected and stored at a secure server at Aalborg University 
during the data collection period.  
 
The participating GPs will be asked to bring paper versions of the registration sheets (Logbook) 
at the third training day and the final day of skills assessment, where the principal investigator 
will collect these and bring them to CAM AAU, where the questionnaires will be imputed into 
the database by a research assistant.        
 

General practitioners’ POCUS competence following structured training 
29 
All study data registered on the online platform will be transferred and imputed in an excel sheet 
at the end of the educational intervention. All digital study related data are stored on secure 
server on Aalborg University and handled according to the General Data Protection Regulation. 
 
20a 
Statistical methods for analysing primary and secondary outcomes.  
All statistical analyses will be performed using STATA version 17 (StataCorp, Texas, USA) and 
analyzed according to a predefined statistical analysis plan, which will be uploaded prior to the 
data collection for the primary outcome (three months after baseline).   
 
20b Methods for any additional analyses (e.g. subgroup and adjusted 
analyses). 
Sensitivity analyses will be performed without imputation of missing values by only including 
complete OSAUS scores.  
Sub-analyses will be performed to explore the importance of different educational elements in 
the intervention. These sub-analyses will be defined in the statistical analysis plan.   
 
20c 
Missing data  
A predictive mean matching (pmm) imputation method will be used to fill in missing values by 
the command “mi impute pmm” in Stata36, for all OSAUS scores after 3 and 6 months. 
Predictive mean matching (PMM) is a partially parametric method that matches the missing 
value to the observed value with the closest predicted mean37. 
Data monitoring 
 
21a 
Data monitoring committee (DMC). 
The principal investigator (CAA) will monitor the data collection and contact the project steering 
committee in case of problems related to data collection or the validity of the collected data. The 
principal investigator (CAA) will also contact the steering committee in care of participant drop-
out.    
 
21b 
Description of any interim analyses and stopping guidelines, including who will have 
access to these interim results and make the final decision to terminate the trial 
n/a 
 
22 
Harms  
 
The participating GPs will be obliged to report any Suspected Unexpected Serious Adverse 
Reactions (SUSARs), Serious Adverse Events (SAEs) and Adverse Events (AEs) related or 
possibly related to the use of POCUS to the adverse event committee.  
 
23 
Auditing 
n/a 

General practitioners’ POCUS competence following structured training 
30 
Ethics and dissemination 
24 
Research ethics approval 
The study will be performed in accordance with the Declaration of Helsinki. The project was 
notified to the regional ethical committee (Den Videnskabsetiske Komité for Region 
Nordjylland, reference number 2022-000764) who responded that according to Danish Law 
(komitélovens § 14, stk. 2), no ethical approval is needed for this project.  
The project has been registered and conducted according to the regulations of the Danish Data 
Protection Agency (registration number ID-242-2).  
 
25 
Protocol amendments 
 
Any modifications to the protocol that will impact the conduct of the study such as study 
objectives, study design, patient population, sample sizes, study procedures or significant 
administrative aspects will be communicated to the Ethics Committee of North Denmark Region 
for approval. The registration on clinicaltrials.gov will be updated if any of the above-mentioned 
modifications are made. 
 
26a 
Consent or assent 
 
Informed consent form the participating GPs will be collected by the principal investigator prior 
to the study.  
 
26b 
Additional consent provisions for collection and use of participant data and 
biological specimens in ancillary studies, if applicable 
n/a 
 
27 
Confidentiality 
 
Personal information about participants consenting to participate will be stored on a secure 
server at Aalborg University. All data will be kept for 10 years after completion of the study 
which in accordance with The European Code of Conduct for Research Integrity.  
 
28 
Declaration of interests 
The authors declare that they have no competing interests. 
 
29 
Access to data 
During the educational intervention the following authors will have access to data on the online 
platform (UM, TMJ, TL, NS, LD, BS, CAA). Participants will during the educational 
intervention have access to their own data shared on the online platform. The following authors 
will have access to collected data stored at the secure server at Aalborg University (AR, MBJ 
and CAA).  
 
30 
Ancillary and post-trial care 
 
Any participants who suffer harm from trial participation will be eligible to seek compensation 
by The Patient Compensation Association.  
 
31a 
Dissemination policy  
We aim to publish positive, negative or inconclusive results of the study in a peer-reviewed 
journal. The project group will also present results at conferences.  

General practitioners’ POCUS competence following structured training 
31 
 
31b 
Authorship eligibility guidelines  
We aim to follow the definition of authors defined on ICMJE´s four criteria1:  
 
• 
Substantial contributions to the conception or design of the work; or the acquisition, 
analysis, or interpretation of data for the work; AND 
• 
Drafting the work or revising it critically for important intellectual content; AND 
• 
Final approval of the version to be published; AND 
• 
Agreement to be accountable for all aspects of the work in ensuring that questions related 
to the accuracy or integrity of any part of the work are appropriately investigated and 
resolved. 
 
31c 
Plans for granting public access to the full protocol, participant-level dataset, and 
statistical code 
It is unsure if data can be anonymized sufficiently to be made publicly available. 
 
32 
Informed consent materials 
The Danish informed consent form will be attached as an appendix   
 
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